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Aortic Valve and Ascending Aorta Guidelines for - …

SPECIAL REPORT Aortic Valve and Ascending Aorta Guidelines for Management and Quality Measures Writing Committee Members: Lars G. Svensson, MD, PhD (Chair),

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DOI: 2013;95:1-66 Ann Thorac SurgVinod H. Thourani, E. Murat Tuzcu, John Webb and Mathew R. Williams Michael Reardon, T. Brett Reece, G. Russell Reiss, Eric E. Roselli, Craig R. Smith, Kodali, Samir Kapadia, Martin B. Leon, Brian Lima, Bruce W. Lytle, Michael J. Mack,Dewey, Richard S. D'Agostino, Thomas G. Gleason, Katherine B. Harrington, Susheel Joseph E. Bavaria, Eugene H. Blackstone, Tirone E. David, Nimesh D. Desai, Todd Miller, Patrick T. O'Gara, David M. Shahian, Hartzell V. Schaff, Cary W. Akins, Lars G. Svensson, David H. Adams, Robert O. Bonow, Nicholas T. Kouchoukos, D. MeasuresAortic Valve and Ascending Aorta Guidelines for Management and Quality on the World Wide Web at: The online version of this article, along with updated information and services, isPrint ISSN: 0003-4975; eISSN: 1552-6259. Southern Thoracic Surgical Association. Copyright 2013 by The Society of Thoracic Surgeons. is the official journal of The Society of Thoracic Surgeons and theThe Annals of Thoracic Surgery by on May 28, 2013 from SPECIAL REPORTAortic Valve and Ascending Aorta Guidelinesfor Management and Quality MeasuresWriting Committee Members: Lars G. Svensson, MD, PhD (Chair),David H. Adams, MD (Vice-Chair), Robert O. Bonow, MD (Vice-Chair),Nicholas T. Kouchoukos, MD (Vice-Chair), D. Craig Miller, MD (Vice-Chair),Patrick T. O Gara, MD (Vice-Chair), David M. Shahian, MD (Vice-Chair),Hartzell V. Schaff, MD (Vice-Chair), Cary W. Akins, MD, Joseph E. Bavaria, MD,Eugene H. Blackstone, MD, Tirone E. David, MD, Nimesh D. Desai, MD, PhD,Todd M. Dewey, MD, Richard S. D Agostino, MD, Thomas G. Gleason, MD,Katherine B. Harrington, MD, Susheel Kodali, MD, Samir Kapadia, MD,Martin B. Leon, MD, Brian Lima, MD, Bruce W. Lytle, MD, Michael J. Mack, MD,Michael Reardon, MD, T. Brett Reece, MD, G. Russell Reiss, MD, Eric E. Roselli, MD,Craig R. Smith, MD, Vinod H. Thourani, MD, E. Murat Tuzcu, MD, John Webb, MD,and Mathew R. Williams, MDCleveland Clinic, Cleveland, Ohio; Mount Sinai Medical Center, New York, New York; Northwestern University Medical School,Chicago, Illinois; Cardiac, Thoracic and Vascular Surgery, Inc, St. Louis, Missouri; Falk Cardiovascular Research Center, Palo Alto,California; Brigham and Women s Hospital, Boston, Massachusetts; Massachusetts General Hospital, Boston, Massachusetts; MayoClinic, Rochester, Minnesota; Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; Toronto General Hospital,Toronto, Ontario; Technology Institute, Dallas, Texas; Lahey Clinic Medical Center, Burlington, Massachusetts; University of PittsburghSchool of Medicine, Pittsburgh, Pennsylvania; Stanford University Medical Center, Stanford, California; New York PresbyterianHospital/Columbia University Medical Center, New York, New York; Columbia University Medical Center, New York, New York;Baylor Health Care System, Dallas, Texas; Methodist Hospital, Houston, Texas; University of Colorado, Boulder, Colorado; Dean HealthSystem, Madison, Wisconsin; Emory University School of Medicine, Atlanta, Georgia; and St. Paul s Hospital, Vancouver, BritishColumbia1. Introduction and MethodologyThe question may be asked why another Guidelinemanuscript is needed. The reasons arefivefold: (1) tooutline pros and cons of treatment options; (2) to outlineareas where further research is needed, potentially fromupdated Society of Thoracic Surgeons (STS) data collec-tion variables as there are few randomized trials that givemore absolute answers to questions; (3) to provide tech-nical guidelines for aortic valve and aortic surgery; (4) toprovide background for recommended quality measuresand suggest quality measures; and (5) to present the newSTS valve data collection variables that address issuesrelated to the preoperative testing and technical aspectsof aortic valve surgery (Appendix 1).The evaluation of aortic valve procedures suffers froma dearth of prospective randomized trials that haveshown definitive superiority of one procedure overothers, although this has been attempted (eg, mechanicalversus biological valves, and homografts versus Rossprocedure, etc)[2 18]. Indeed, when valve devices arecompared for survival (homograft, biological valves,mechanical valves or Ross procedure) and the onlyadjustment made is for age, there is no difference at all inlate survival and thus the debate revolves more aroundvalve durability and anticoagulation[14] (Figs 1 to 3).Hence, the guidelines rely primarily on nonrandomizedtrials, observational studies, registries, propensity anal-yses, and consensus statements of experts. Clearly, thesemay require revision over time, particularly related to thenew transcatheter aortic valve replacement (TAVR)procedures. The application of class of recommendationand level of evidence characterization is according to thoserecommended by ACCF/AHA (Table 1).The guidelines address only the adult population andnot the pediatric population. When needed, the guide-lines draw heavily from the previously published 2010The Society of Thoracic Surgeons Clinical Practice Guidelines are inten-ded to assist physicians and other health care providers in clinical decisionmaking by describing a range of generally acceptable approaches for thediagnosis, management, or prevention of specific diseases or guidelines should not be considered inclusive of all proper methodsof care or exclusive of other methods of care reasonably directed atobtaining the same results. Moreover, these guidelines are subject tochange over time, without notice. The ultimate judgment regarding thecare of a particular patient must be made by the physician in light of theindividual circumstances presented by the the full text of this and other STS Practice Guidelines, the official STS Web site ( ).Address correspondence to Dr Svensson, The Cleveland Clinic, 9500Euclid Ave, Desk F-25 CT Surgery, Cleveland, OH authors disclosure of industry relationships, seeAppendix 2. 2013 by The Society of Thoracic SurgeonsAnn Thorac Surg 2013;95:S1 S66 0003-4975/$ by Elsevier by on May 28, 2013 from ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/S VMguideline for the diagnosis and management of patientswith thoracic aortic disease. Hence, indications forsurgery are not covered in detail, except where newevidence suggests an update is needed. The previousguidelines for severity of disease and the managementof outcomes for patients with asymptomatic disease aresummarized and covered in detail in the 2010 docu-ment[1, 19, 20]. For cardiologists and cardiac surgeons,there have been few options and no guidelines on howto manage the high risk, previously inoperable,patients. The TAVR technology and particularly thepivotal Placement of Aortic Transcatheter (PARTNER)trials and the ongoing CoreValve trial have furtherfocused efforts on managing this population. Previousstudies have suggested that between 38% of patients(Europe) and two thirds of patients (southern Cal-ifornia) with severe aortic valve stenosis go untreated[21, 22]. With the advent of TAVR both the traditionallyopen aortic valve replacement (AVR) procedures andballoon aortic valvuloplasty (BAV) have also pari passuevolved. Hence, these aspects are discussed. Thefield israpidly developing, and undoubtedly later guidelineswill need to update recommendations based on searches were conducted using standard-ized MeSH terms from the National Library of MedicinePUBMED database list of search terms. Section authorsthen drafted their recommendations, using prior pub-lished guidelines as a reference when available, andcirculated to the entire writing committee as were made until consensus was reached onclass, level of evidence, references, and , the full document was submitted for approvalby the STS Workforce on Evidence Based Surgerybefore publication. The guidelines were posted on theSTS website for an open comment period. The guide-lines then were also submitted to the STS Council onQuality, Research, and Patient Safety Operating Boardand the STS Executive Committee before submission Evaluation of a Valve ProcedureParamount to evaluating a valve procedure is (1) easeof procedure; (2) safety; (3) efficacy (hemodynamicperformance, effective orifice area, and energy loss); (4)durability, measured as freedom from structural valvedeterioration; and (5) event-free aortic valves this would entail (1) ease of prostheticaortic valve insertion or valve repair; (2) safety of theFig 1. Options for minimally invasive J and AcronymsABP = antegrade brain perfusionACE = angiotensin-converting enzymeAR= aortic regurgitationAS= aortic stenosisAVA = aortic valve areaAVR = aortic valve replacementBAV = balloon aortic valvuloplastyBSA = body surface areaCABG = coronary artery bypass graftCAD = coronary artery diseaseCT= computed tomographyDLCO = diffusing capacity of lung for carbonmonoxideECG = electrocardiogramEF= ejection fractionEOA = effective orifice areaFDA = Food and Drug AdministrationHCA = hypothermic circulatory arrestIMH = intramural hematomaINR = international normalized ratioIVUS = intravascular ultrasoundLV= left ventricularMRI = magnetic resonance imagingPFT = pulmonary function testPPM = patient-prosthetic mismatchPROM = preoperative risk of mortalityRBP = retrograde brain perfusionRVOT = right ventricular outflow tractSVD = structural valve deteriorationTAVR = transcatheter aortic valve replacementTEE = transesophageal echocardiogramTTE = transthoracic echocardiogramS2SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from operation; (3) effective orifice area (EOA) includinggradients and energy loss; and (4) long-term durability,with no difference in survival compared with otherdevices, but better than the untreated , there are few, if any medical procedures that areas effective in relieving symptoms, improving quality of life,and also increasing long-term survival as much as AVR foraortic stenosis (AS) or aortic regurgitation (AR), but forperhaps the exception of heart transplantation, but the latteradds the problem of managing new medications andincreased monitoring. Recent data from 3,600 Medicarepatients show that there is a reduced hospital readmissionrate and increased survival among high-risk Medicarepatients (aged 65 years) treated with AVR for severe AS,despite the extra cost. Of note, open AVR does not reducethe cost when compared with medical management despitethe multiple readmissions for heart failure in the potential population needing AVR for severe AS isestimated at 350,000 and increasing. The exact number ofaortic valve procedures, including repairs and replace-ments, is unknown. A number of 48,000 has been reported[23]; however, a number of 95,000 Medicare patients wasreported in a recent publication[24](Tables 2and3).Table 2shows the number of valves sold to hospitals forone year (92,514). The STS Adult Cardiac SurgeryDatabase (ACSD) does not capture the number as onlypatients who undergo single valve or valve plus coronarybypass are tracked. Double valve, AVR plus aorta, and soforth, are not tracked. Nevertheless, the STS data showAVR is increasing, probably because of the agingpopulation and increasing awareness of good results, andthe option of TAVR. Despite this, on average an STS sitedoes 23 isolated aortic valves and on average a cardiacsurgeon only does 8 AVR per annum (Fig 4). Figures 5through 18show some important new STS valve data module adds various vari-ables that members of the writing committee and the STSWorkforce on National Databases considered would beimportant information for future studies, and that wouldallow for further research to improve both the process of anaortic valve insertion as well as the procedure quality ofcare. Clearly this will raise new questions that will result inthe evolution and iteration of newer guidelines based onFig 2. (A) Relationship of late survival to years after aortic valveinsertion in 13,258 patients, divided by aortic valve prosthesis.(B) Survival by 3. Survival by age groups: (A) younger patients; (B) middle-agedpatients; (C) elderly patients. Note that differences Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from the data collected by the STS database. Online inAppendix 1are the newfields specific to valve the comments relevant to specificfields referenced. Inthis document we have avoided reference to companynames and models as there are 368 models of biologicalvalves alone that are available for Summary and Update of ACCF/AHA Guidelinesfor Indications and Timing of SurgeryMajor advances in the evaluation and management ofpatients with valvular heart disease during the pastseveral decades have resulted in substantial improve-ment in the outcomes of patients in terms of survival andquality of life. These advances include the developmentof imaging modalities (most notably cardiac ultrasonog-raphy) that have yielded essential data on natural historyand the predictors of outcome after operative interven-tion. At that same time, the steady and significantadvances in cardiac surgery have expanded operativewindows to include surgery on both older patients withsevere comorbidities and younger patients earlier in thenatural history of the disease, even those who 1. ACCF/AHA Classification of Recommendations and Level of Evidence*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history ofprior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that therecommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomizedtrials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful or comparative effec-tiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve directcomparisons of the treatments or strategies being evaluated. Reprinted with permission from [Jacobs AK, et 2013;127:268 310. 2013 American Heart Association, Inc.]S4SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from These advances, coupled with the growing prevalenceof diseases of heart valves in an aging population andthe impact on quality of life, health care resources andneed for quality improvement, stimulated the ACCF/AHA Task Force on Practice Guidelines to establisha writing committee to formulate guidelines for themanagement of patients with valvular heart disease. TheACCF/AHA guidelines for the management of patientswith valvular heart disease werefirst published in1998[25], extensively revised in 2006[20], and updatedin 2008[19]. The knowledge base summarized inthe guidelines is channeled into a large number ofspecific recommendations supported by the literatureto assist clinicians in their care of patients across thewide spectrum of valvular heart disease, includingdiagnosis, medical management and indications forsurgical intervention. Comparable guidelines from theEuropean Society of Cardiology have been publishedin 2007[26].Although the ACCF/AHA guideline recommendationsrepresent a major step forward in improving and stan-dardizing quality of care, there are fundamental weak-nesses in the underpinnings of these guidelines. Unlikemany other areas of cardiovascular disease, such assecondary prevention, acute coronary syndromes andheart failure, there is a major scarcity of large-scalemulticenter trials addressing the diagnosis and treat-ment of patients with valvular disease from which toderive the definitive evidence base required forfirmrecommendations. The available data in the literaturerepresent primarily the experiences reported by singleinstitutions in relatively small numbers of patients. In theabsence of an authoritative database, management issuesin many situations remain controversial or , virtually all of the recommendations in theACCF/AHA document are based on expert consensus(level of evidence C) rather than on prospective multi-center randomized trials (level of evidence A). In fact, inthe 2006 document, only 1 of 320 recommendations ( )was based on level of evidence A data[27]. In this context,it is noteworthy that the consensus-driven recommen-dations in the ACCF/AHA document are remarkablysimilar to those in the European Society of Cardiologyguidelines on the management of valvular heart disease[26]. This underscores the collective experience that hasaccumulated over the past several decades on bothsides of the Atlantic. Nonetheless, implementation ofprospective randomized trials is necessary to move thefield of RecommendationsThe ACCF/AHA guidelines for the management ofpatients with valvular heart disease recommendationsfollow the standard format established for other ACCF/AHA recommendations (Table 1): Class I: conditions for which there is evidence forand/or general agreement that the procedure ortreatment is beneficial, useful, and effective Class II: conditions for which there is conflictingevidence and/or a divergence of opinion about theusefulness/efficacy of a procedure or treatment Class IIa: weight of evidence/opinion is in favor ofusefulness/efficacy Class IIb: usefulness/efficacy is less well establishedby evidence/opinion Class III: conditions for which there is evidence and/or general agreement that the procedure/treatmentis not useful/effective and in some cases may beharmfulTable 2. Valves Sold in the United States for the Year EndingJune 2011ValveNumberMechanicalAll (conduits 11%)16,780TissueAll75,734ATS216Carbomedi cs5,290Edwards39,367Medtronic18,688St. Jude11,666Total92,514Tissue valve costs:All, $435,716, 3. Trends in Hospital Volumes of Medicare Patients and the Proportion of Medicare Patients Who Underwent Aortic ValveReplacement Operations in High-Volume Hospitals From 1999 through 2008. Note this is for two-year dataVariable Period1999 20002001 20022003 20042005 20062007 2008AVRNo. of hospitals1,0131,0641,1051,1391,161No. of patients74,54180,22385,55687,42195,033Ho spital volumeMedian5354575360Interquartile range28 9929 10530 10429 10231 108Patient number is for 2-year periods. Hospital volume is per aortic valve Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from Indications for Aortic Valve AORTIC STENOSIS RECOMMENDATIONSClass I1. AVR is recommended in patients with severe AS atthe onset of symptoms of dyspnea, angina, or light-headedness or syncope (Fig 1) [28 36] . (Level ofevidence B)2. AVR is recommended, regardless of symptoms, withthe identification of left ventricular (LV) systolicdysfunction (ejection fraction [EF]<50%). (Level ofevidence C)3. AVR is recommended in patients with severe AS whoare scheduled to undergo coronary artery bypass graftsurgery (CABG), surgery on other cardiac valves, orsurgery on the aortic root or ascending aorta. (Level ofevidence C)Class IIa1. AVR is reasonable in patients with moderate ASundergoing CABG or surgery on the aorta or otherheart valves[37 40] . (Level of evidence B)Class IIb1. Exercise testing in asymptomatic patients with AS todetermine the need for AVR may be considered to elicitexercise-induced symptoms and abnormal bloodpressure responses[41 43] . (Level of evidence B)2. AVR may be considered for asymptomatic patientswith severe AS and abnormal response to exercise(eg, asymptomatic hypotension). (Level of evidence C)3. AVR may be considered for adults with severeasymptomatic AS if there is a high likelihood of rapidprogression (age, calcification, and CAD) or if surgerymight be delayed at the time of symptom onset. (Levelof evidence C)Table 4. Valve Academic Research Consortium Criteria for Successful Valve Insertion and Composite EndpointsDevice success1. Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system2. Correct position of the device in the proper anatomical location3. Intended performance of the prosthetic heart valve (aortic valve area cm2and mean aortic valve gradient 20 mm Hg or peak velocity 3 m/s, without moderate or severe prosthetic valve aortic regurgitation)4. Only one valve implanted in the proper anatomical locationCombined safety endpoint (at 30 days)1. All-cause mortality2. Major stroke3. Life-threatening (or disabling) bleeding4. Acute kidney injury stage 3 (including renal replacement therapy)5. Periprocedural myocardial infarction6. Major vascular complication7. Repeat procedure for valve-related dysfunction (surgical or interventional therapy)Combined efficacy endpoint, at 1 year or longer1. All-cause mortality (after 30 days)2. Failure of current therapy for aortic stenosis, requiring hospitalization for symptoms of valve-related or cardiacdecompensation3. Prosthetic heart valve dysfunction (aortic valve area cm2and mean aortic valve gradient 20 mm Hg or peakvelocity 3 m/s, or moderate or severe prosthetic valve aortic regurgitation)Fig 4. Average annual valve procedures for STS sites (left axis)and busy practice (right axis) over time. (AVR aortic valvereplacement; CAB coronary artery bypass; CCF ClevelandClinic Foundation; MV mitral valve repair.)Fig 5. Coronary artery bypass and percutaneous coronaryintervention volume REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from 4. AVR may be considered in patients undergoingCABG who have mild AS when there is evidence,such as moderate to severe valve calcification, thatprogression may be rapid. (Level of evidence C)5. AVR may be considered for asymptomatic patientswith extremely severe AS (aortic valve area [AVA]< cm2, mean gradient>60 mm Hg, and jet velocity> m/s) when the patient s expected operativemortality is less than 1%. (Level of evidence C)Class III1. AVR is not useful for the prevention of sudden deathin asymptomatic patients with AS who have normalLV systolic function[44]. (Level of evidence B)The guideline recommendations for AVR in patientswith AS pertain only to those with severe AS (Fig 19). Nointervention is recommended in patients with mild ormoderate AS unless there are indications for otherforms of cardiac surgery. However, it is understood thatestablishing the diagnosis of severe AS is not alwaysstraightforward. For purposes of the guidelinesrecommendations, severe AS in patients with normalLV systolic function is defined as (1) a peak aortic jetvelocity by Doppler echocardiography more than 4 m/s;(2) a mean aortic valve gradient more than 40 mm Hg;and (3) a calculated AVA less than cm2or valve areaindex less than cm2/m2[20]. Critical aortic valvestenosis has been defined as less than class IIb indications in the ACCF/AHAguidelines that may be used to consider AVR includeasymptomatic patients with severe AS in whom there isa high likelihood of rapid progression (such as severevalvular calcification), in whom surgery might be delayedat the time of symptom onset, or in whom the AS isextremely severe (AVA< cm2, mean gradient>60 mmHg, and jet velocity> m/s). However, surgery isconsidered reasonable in an asymptomatic patient only ina center in which the anticipated operative mortality or less[19]. AORTIC REGURGITATION RECOMMENDATIONSClass I1. AVR or repair is indicated for symptomatic patientswith severe AR irrespective of LV systolic function(Fig 2)[45 51] . (Level of evidence B)2. AVR or repair is recommended for asymptomaticpatients with chronic severe AR and LV systolicdysfunction (EF 50%) at rest[45 61] . (Level ofevidence B)3. AVR or repair is recommended in patients withchronic severe AR who are undergoing CABG orsurgery on the aorta or other heart valves. (Level ofevidence C)Fig 6. Trends in volume for STS sites and a large center withincreasing valve and thoracic aorta numbers. (AVR aortic valvereplacement; CAB coronary artery bypass; CAD coronary arterydisease; CCF Cleveland Clinic Foundation; MV mitral valve;O/E observed to expected mortality ratio at CCF.)Fig 7. Predicted global trends for transcatheter aortic valve replace-ment (TAVR).Fig 8. Predicted trends for transcatheter aortic valve replacement(TAVR) in the United 9. Targeted market and likely population of transcatheter aorticvalve replacement (TAVR).S7Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from Class IIa1. AVR or repair is reasonable for asymptomatic patientswith severe AR with normal LV systolic function(EF>50%) but with severe LV dilation (end-diastolicdimension>75 mm or end-systolic dimension>55 mm)[46, 47, 51 55, 57 60, 62]. (Level of evidence B)Class IIb1. AVR or repair may be considered in patients withmoderate AR who are undergoing CABG or surgeryon the aorta or other heart valves. (Level of evidence C)2. AVR or repair may be considered for asymptomaticpatients with severe AR and normal LV systolicfunction at rest (EF>50%) when the degree of LVdilation exceeds an end-diastolic dimension of 70 mmor end-systolic dimension of 50 mm, when there isevidence of progressive LV dilation, declining exer-cise tolerance, or abnormal hemodynamic responsesto exercise. (Level of evidence C)Class III1. AVR is not indicated for asymptomatic patients withmild, moderate, or severe AR and normal LV systolicfunction at rest (EF>50%) when the degree of LVdilation is not moderate or severe (Fig 20)[63 67] .(Level of evidence B)As with AS, surgical intervention in patients with AR isrecommended only for those with severe AR, and there areno recommendations for surgery in those with mild ormoderate AR unless patients are undergoing other forms ofcardiac surgery. Determining severity of AR, however, isinherently less precise than assessing AS severity. TheACCF/AHA guidelines adopted the definitions of severityof AR promulgated by the American Society of Echocardi-ography[68] in an attempt to emphasize the need to usequantitative rather than simply qualitative, visualassessments. Severe AR, using Doppler echocardiographymethods, is defined as a vena contracta width more cm, a regurgitant volume greater than 60 mL per beat,a regurgitant fraction more than 60%, and an effectiveregurgitant orifice area more than cm2[20, 68]. SevereAR should also be accompanied by evidence of a volumeload on the left ventricle, with an elevated LV end-diastolicvolume or increased LV end-diastolic diameter. Themanagement strategies are summarized inFigures 5through AORTIC ROOT DISEASEDilation of the ascending aortaand/or aortic root is among the most common causes ofisolated AR and in some patients, the severity of aorticFig 10. Trends for in-hospital mortality for coronary artery bypassgraft surgery (CABG) in Pennsylvania. Note the decline. Source:Cardiac Surgery in Pennsylvania 2008 2009. Used with permissionof PA Health Care Cost Containment 11. Trends for in-hospital mortality for valve procedures inPennsylvania. Note the decline. Source: Cardiac Surgery inPennsylvania 2008 2009. Used with permission of PA Health CareCost Containment 12. (A) Seven-day readmission after valve surgery (noteincreasing trend) for Pennsylvania. (B) Thirty-day readmission aftervalve surgery. Source: Cardiac Surgery in Pennsylvania 2008 with permission of PA Health Care Cost Containment REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from enlargement becomes the principal indication forsurgery. This is particularly the case in patients withbicuspid aortic valves. The ACCF/AHA guidelines onvalvular heart disease discuss aortic root disease only inthe context of bicuspid aortic valves[20], with emphasison obtaining measurements by computed tomography(CT) or magnetic resonance imaging (MRI) in additionto echocardiography. The guidelines also emphasizethat a number of factors must be considered regardingsurgical indications, including the patient s age, therelative size of the aorta and aortic root, the structureand function of the aortic valve, and the experience ofthe surgical guidelines recommend that patients with bicuspidvalves undergo elective repair of the aortic root orreplacement of the ascending aorta if the diameter ofthese structures exceeds cm (Class I, level of evidenceC) and should be performed by a surgical team withestablished expertise in these procedures[69, 70]. Othershave recommended a value of more than cm/m2orgreater as the indication for surgery[71]or a cross-sectional area to height ratio of more than 10[1, 14].Surgery is also recommended if the rate of increase inaortic dilation is cm per year or more (Class I, levelof evidence C). If patients with bicuspid valves andassociated aortic root enlargement have indications forAVR because of severe AS or AR, it is recommendedthat repair of the aortic root or replacement of theascending aorta be performed if the diameter of thesestructures is more than cm (Class I, level of evidenceC) [72]. Similar indications for aortic surgery in patientswith bicuspid aortic valves were recommended in the2010 ACCF/AHA guidelines for the diagnosis andmanagement of patients with thoracic aortic disease[1].The thoracic aortic disease guidelines also providerecommendations for surgery in other conditions associ-ated with aortic root disease[1]. Surgery is indicated atlower size thresholds in patients with certain geneticsyndromes (Class IIa, level of evidence C). Examplesinclude a threshold of cm to cm for Marfansyndrome and cm for Loeys-Dietz syndrome ora confirmed TGFBR1 or TGFBR2 mutation. Specific ClassIIa (level of evidence C) recommendations are also madefor women with Marfan syndrome contemplating preg-nancy, in whom one might consider elective aortic surgerywhen the diameter exceeds cm, and in patientswith Marfan syndrome in whom the ratio of the maximalFig 13. Readmission costs and Medicarepayments for Pennsylvania. (CABG coronary artery bypass graft surgery.) Source:Cardiac Surgery in Pennsylvania 2008 with permission of PA Health Care CostContainment 14. Average number of heart procedures performed by Pennsyl-vania hospitals (solid line) and surgeons (stippled line). Source:Cardiac Surgery in Pennsylvania 2008 2009. Used with permissionof PA Health Care Cost Containment 15. Hospital infections after cardiac surgery in the 37% at surgical site. Source: Cardiac Surgery in Pennsyl-vania 2008 2009. Used with permission of PA Health Care CostContainment Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from cross-sectional area in square centimeters of the ascendingaorta or root to the patient s height in meters exceeds 10[1].In the absence of a bicuspid valve or genetic/familial causeof aortic enlargement, the threshold recommended forelective surgery is an aortic diameter of cmfor patients with degenerative thoracic aneurysms,chronic aortic dissections, intramural hematomas (IMH),penetrating atherosclerotic ulcers, mycotic aneurysms, orpseudoaneurysms (Class I, level of evidence C)[1]. AORTIC VALVE ENDOCARDITIS RECOMMENDATIONSClass I1. AVR is recommended in patients with aortic valveinfective endocarditis and severe heart failure orcardiogenic shock due to aortic valve dysfunctionwhen there is a reasonable likelihood of recovery withsatisfactory quality of life after surgery[20, 73 76].(Level of evidence B)2. Surgery is recommended in patients with annular oraortic abscesses, heart block, infections resistant toantibiotic therapy, and fungal endocarditis[73 77] .(Level of evidence B)Class IIa1. Surgery is reasonable in patients with infectiveendocarditis who present with recurrent emboli andpersistent vegetations despite appropriate antibiotictherapy. (Level of evidence C)Class IIb1. Surgery to prevent embolization might be consideredfor patients with large vegetation size (> cm),Fig 16. Outcomes after hospital infections,increase in cost, and estimated Medicarereimbursement. (CABG coronary arterybypass graft surgery; HAI hospital acquiredinfection.) Source: Cardiac Surgery in Penn-sylvania 2008 2009. Used with permission ofPA Health Care Cost Containment 17. Material decline in coronary artery bypass surgery (CAB) bySTS sites from an average of approximately 400 cases per 18. (A) Survival for 3,624 Medicare patients treated in 2003 forisolated aortic valve stenosis. The 5% random sample showed 31%were treated medically, 651 were categorized as high-risk medicallytreated. The associated variables in the 651 medically treated high-risk patients were central nervous system or psychiatric disease 53%,unstable angina 43%, prior surgery 40%, peripheral vascular disease28%, chronic pulmonary disease 22%, pulmonary hypertension 20%,and cancer 18%. These variable likely influenced the decision not tooperate. The curves show the 5-years survivals. (HR high risk;MM medically managed; NHR not high risk; ST surgicaltreatment.) (B) Cost of care over 5 years for those operated on ortreated in 2003. Costs are Medicare payments for Parts A, B, andschedule beneficiary cost REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from especially if other relative indications for surgery arepresent (eg, severe AR) and the surgical risk is low[78, 79]. (Level of evidence C)Surgery should not be delayed in the setting of activeinfective endocarditis when heart failure , surgery is not indicated if complications (severeembolic brain damage) or comorbid conditions make theprospect of recovery remote. The indications for surgeryfor infective endocarditis in patients with stable hemo-dynamics are less Preoperative Testing and Assessment ofComorbid Disease and FrailtyAs a disease, the natural history of unoperated on AS haslargely remained unchanged for half a century. The meansurvival of patients with symptomatic severe AS has beenreported to be 23 5 months, with 1-year and 5-yearprobability of survival 50% and 18%, respectively. Inlight of the poor prognostic fate of patients symptomaticfrom severe AS, the majority of clinicians believe that therisk-benefit analysis of surgical AVR should always err onthe side of surgery. This has led to many innovations insurgical technique to the point where AVR can often beperformed minimally invasively with outstanding results,even in higher risk cohorts. In-hospital mortality for high-risk AVR remains between 3% and 10% using standardcardiac surgery methods, although there is evidence thata minimally invasive J incision may benefit some high-risk patients, particularly with severe chronic pulmo-nary disease[14, 80]. Indeed, less than 1% mortality hasbeen reported for minimally invasive J incisionoperations[14]. However, some patients remain poorsurgical candidates under any circumstance and haveheretofore been left with no option other than medicaltherapy alone. As recently highlighted from the resultsof the PARTNER trial, cohort B, medical therapy alonefor this too high risk population carries a 50%mortality at 12 months; a higher risk than mostadvanced cases[81]. With the introduction of TAVR,more emphasis on a quantitative assessment ofcomorbidity of the patient with severe AS is , many high-risk AS patients are notconsidered for surgery at many institutions[21, 22]. Freedand associates[21] found that in a large academic medicalcenter only 31% of patients with severe AS were referredfor AVR including almost half the patients who hadalready manifested symptoms. Much of this lack ofsurgical referral was attributable to physicians notrecognizing symptoms and overestimating operative lack of referral is an important issue that must berevisited[21] . In the age of TAVR the decision regardingwhich patients should forego aortic valve surgerysecondary to prohibitively high risk should no longer bemade in a surgical vacuum. In particular, the riskassessment of the aged and frail subpopulation shouldinvolve a multidisciplinary consultation with cardiologists,surgeons, imaging specialists, and , an interested and qualified heart team shoulddiscuss each case individually. Although each patientmust undergo comprehensive objective testing andevaluation regardless of intervention, it is imperative tokeep in mind that due to lack of convincing randomizeddata at this time, the key element in the preoperativeassessment of the patient with aortic valve disease isFig 19. Management strategy for severe aorticstenosis. Preoperative coronary angiographyshould be performed routinely as determinedby age, symptoms, and coronary risk catheterization and angiography mayalso be helpful when there is discordancebetween clinicalfindings and echocardiog-raphy. (AVA aortic valve area; BP bloodpressure; CABG coronary artery bypassgraft; LV left ventricular; Vmax maximalvelocity across aortic valve by Doppler echo-cardiography.) Reprinted with permissionfrom [Bonow RO, et ;118:e523 e661. 2008 American HeartAssociation, Inc.]S11Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from whether he or she is too high risk for intervention, eitherAVR or TAVR. This assessment is still highly dependenton clinical judgment, and should be used in associationwith quantitative evaluation[82] .The preoperative assessment of patients with aortic valvedisease should include verification of disease severity,evaluation of LV function, detection and characterization ofcoronary artery disease (CAD) in at-risk persons, anddelineation of major comorbidities, including functionalstatus and frailty. In addition to a focused history andphysical examination, minimal routine testing comprises anelectrocardiogram (ECG), transthoracic echocardiogram(TTE), chest radiograph, complete blood count, compre-hensive metabolic panel, and coagulation function. Coro-nary angiography is performed in patients with known orsuspected CAD and/or multiple atherosclerotic risk of the extent of ascending aortic calcification,when indicated, can be obtained with noncontrast chest surgical risk score (eg, STS-Preoperative Risk of Mortality[PROM] or the European System for Cardiac Operative RiskEvaluation[EuroSCORE])andfrailtyinde xshouldcompletethe assessment and help guide counseling. The latter mayrequire carefully supervised exercise testing (ie, 6-minute or5-meter walk test).With regard to functional capacity and constitutionalmake-up, establishing an accurate measure of anindividual patient s resilience defined roughly as onesability to withstand a surgical procedure or interventionand return to a reasonable quality of life after hospitaldischarge is paramount. Resilience includes the ability tocope with stress of surgery and regain health by learningand adaptation, a well-known capacity of the humanmind[83]. With the increasingly frail population of olderadults, the line between tolerating a procedure withsuccessful return to activities of daily living or death hasnever beenfiner. Thus, a measurement of frailty alongwith selective use of objective functional testing such asdobutamine stress and exercise testing is required inevery high-risk patient s workup before aortic have been made at risk modeling thataccount for preoperative patient factors that may impactoutcomes. The STS uses such risk models to create risk-adjusted performance reports for participants in the STSACSD. Although risk models were initially developed forCABG surgery, similar models have now been developedfor use with heart valve surgery, particularly as theproportion of such procedures has increased[84]. The lastpublished STS model for isolated valve surgery wasbased on data from 2002 to 2006 models and includesseveral nonfatal complications in addition to this time, TAVR has not yet been incorporated intoFig 20. Management strategy with chronicsevere aortic regurgitation. Preoperativecoronary angiography should be performedroutinely as determined by age, symptoms,and coronary risk factors. Cardiac catheteri-zation and angiography may also be helpfulwhen there is discordance between clinicalfindings and echocardiography. Stable refers to stable echocardiographic measure-ments. In some centers, serial follow-up maybe performed with radionuclide ventriculog-raphy (RVG) or magnetic resonance imaging(MRI) rather than echocardiography to assessleft ventricular (LV) volume and systolicfunction. (AVR aortic valve replacement;DD end-diastolic dimension; Echo echocardiography; EF ejection fraction;SD end-systolic dimension. Reprinted withpermission from [Bonow RO, et 2008;118:e523 e661. 2008American Heart Association, Inc.]S12SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from the risk scoring process leaving individual centers toextrapolate calculated PROM based on parameters anddata for surgical AVR, but the new STS data collectionmodule will include more information that willmake the latter one assesses patients for aortic valve intervention,either surgical AVR or TAVR, it is important to keep inmind that there is a new and yet to be fully definedpopulation of aortic valve patients who are too high riskfor AVR, but are suitable for TAVR. An elderly patientwith a hostile mediastinum from prior surgery or thepresence of a porcelain aorta would be examples of thispopulation. In addition, there is also an ultra-high riskGroup C population that is not suitable for eitherintervention. This latter population is analogous toterminal cancer patients both in quality of life and prog-nosis. The goal of the preoperative assessment shouldthen be to sort out which patients can be treated withintervention, surgical AVR versus TAVR and which arebest left to medical therapy and palliation, possibly withthe judicious use of confirming the diagnosis, an extensive review ofsystems and comorbidities should be undertaken withparticular attention to those preexisting conditions thathave been shown to negatively affect outcome in thesurgical patient. These conditions include but are notlimited to CAD, heart failure, peripheral arterial andcerebral vascular disease, diabetes mellitus, renal insuf-ficiency, chronic pulmonary disease, immunocompro-mised states, radiation heart disease, liver or other organdysfunction[80, 84, 85]. After performing initial functionalstudies, the preoperative testing and assessment becomesmore straightforward and involves objective testingmainly related to anatomical considerations. The caveathere is that once a patient is directed to a particularintervention, surgical AVR versus TAVR, the neededobjective prospective data can differ slightly for eachgroup. For example, in surgical AVR an evaluation of theaortoiliac system is generally unwarranted, yet the entirefeasibility of TAVR options depends upon its extensivecharacterization by multislice CT scan of the chest,abdomen, pelvis, and intravascular ultrasound (IVUS)and/or aortoiliac Surgical Risk Scores RecommendationsCLASS IIA1. Performing risk score analysis is reasonable to eval-uate patients undergoing surgical AVR or TAVR toquantitate PROM[81, 84, 86]. (Level of evidence B)CLASS IIB1. Performing risk score analysis may be reasonable toaid in determining which patients should undergoAVR, TAVR or medical therapy alone in high-riskpatients. (Level of evidence C)Surgical risk scores such as the logistic EuroSCORE andthe STS-PROM are commonly used to identify high-risksurgical or inoperable patients for TAVR (Fig 21) [87].Using STS data from 2002 to 2006, isolated valve surgeryrisk models were developed for operative mortality,permanent stroke, renal failure, prolonged ventilation(more than 24 hours), deep sternal wound infection,reoperation for any reason, a major morbidity ormortality composite endpoint, prolonged postoperativelength of stay, and short postoperative length of STS study population consisted of adult patientswho underwent one of three types of valve surgery: iso-lated AVR (n 67,292), isolated mitral valve replacement(n 21,229), or isolated mitral valve repair (n 21,238).The population was divided into a 60% developmentsample and a 40% validation sample. After an initialempirical investigation, the three surgery groups werecombined into a single logistic regression model withnumerous interactions to allow the covariate effects todiffer across these groups. Variables were selected basedon a combination of automated stepwise selection andexpert panel review. Unadjusted operative mortality (in-hospital regardless of timing, and 30-day regardless ofvenue) for all isolated valve procedures was , andunadjusted in-hospital morbidity rates ranged from deep sternal wound infection to for prolongedventilation. The number of predictors in each modelranged from 10 covariates in the sternal infection modelFig 21. Surgical evaluation of patients for aortic valve replacement(AVR) or transcatheter aortic valve replacement (TAVR). (AS aorticstenosis; AVI aortic valve implantation; BAV balloon aorticvalvuloplasty; Cath catheterization; LA left atrium; LVEF leftventricular ejection fraction; LV left ventricle; PET positronemission tomography; PFTs pulmonary function tests; TA transapical; TAVI transcatheter aortic valve implantation; TF transfemoral; Vel velocity.)S13Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from to 24 covariates in the composite mortality plus morbiditymodel. Discrimination as measured by the c-indexranged from for reoperation to for patients in the validation sample were groupedinto 10 categories based on deciles of predicted risk, theaverage absolute difference between observed versuspredicted events within these groups ranged from deep sternal wound infection to for prolongedpostoperative stay[84].The EuroSCORE was also developed with similar goalin mind to stratify risk of cardiac surgery; however,several studies have shown that the STS score, althoughmore reliable in predicting outcomes still often over-estimates mortality, but not as much as the EuroSCORE,which may overestimate by up to three times as much[88, 89]. The STS score appears to be a powerful tool forpredicting long-term outcome and for selecting patientswho may benefit from early surgery. Hence, risk-scoringusing the STS score should be routinely performed inhigh-risk patients with AS to support the clinicaldecision-making process[90]. Frailty AssessmentThe assessment of frailty has become increasingly usefulas a tool for predicting how an individual patient willrespond or tolerate surgical intervention. Several groupshave begun to systematically quantify frailty as a predic-tive measure of risk in the preoperative assessment[91-94]. Fried and colleagues[95]initially provideda potential standardized definition for frailty incommunity-dwelling older adults and offered concur-rent and predictive validity for the definition. This studyinvolving 5,317 men and women aged more than 65 yearsfound that there is an intermediate stage identifying thoseat high risk of frailty and provided evidence that frailty isnot synonymous with either comorbidity or disability, butcomorbidity is an etiologic risk factor for, and disability isan outcome of, frailty. Frailty was defined as a clinicalsyndrome in which three or more of the following criteriawere present: unintentional weight loss (10 lbs in the pastyear), self-reported exhaustion, weakness (grip strength),slow walking speed, and low physical activity[95].To date, frailty as a specific measure associated witha patient s ability to undergo surgical AVR or TAVR hasnot been studied in a randomized fashion. ColumbiaUniversity has developed the Columbia Frailty Index,which may become as a useful quantitative measure forfrailty to be used in preoperative , many centers are adopting at minimum the6-minute walk test, as required by the Food and DrugAdministration (FDA) TAVR studies, or a gait speeddetermination in the assessment of frailty. In a studywhen rate of death, myocardial infarction, or stroke byEuroSCORE risk was stratified by 6-minute walkingdistance, the 6-minute walk test added prognostic infor-mation[93]. In a Cox regression analysis, 6-minute walktest distance was the only variable retained as an inde-pendent predictor of the composite outcome of death,myocardial infarction or stroke at 12 months (hazard , 95% confidence interval: to ,p ). Theinvestigators concluded that the 6-minute walk test is safeand feasible to carry out in patients with severe AS beforeAVR, and provides potentially important functional andprognostic additional information to clinical assessmentand the risk score[93].Alfilalo and colleagues[91]studied a multicenterprospective cohort of elderly patients undergoing cardiacsurgery at four tertiary care hospitals between 2008 and2009. Patients were eligible if they were aged 70 years ormore and were scheduled for CABG or valve replacementor repair, or both. The primary predictor was slow gaitspeed, defined as the time taken to walk 5 meters in morethan 6 seconds. The primary endpoint was a composite ofin-hospital postoperative mortality or major cohort consisted of 131 patients with a mean age years; 34% were female. Sixty patients (46%)were classified as slow walkers before cardiac walkers were more likely to be female (43% versus25%,p ) and diabetic (50% versus 28%,p ).Thirtypatients (23%) experienced the primary composite endpointof mortality or major morbidity after cardiac surgery. Slowgait speed was an independent predictor of the compositeendpoint after adjusting for the STS risk score (odds , 95% confidence interval: to )[91] .Usinga comprehensive assessment of frailty test, Sundermanand colleagues[94] studied 400 patients aged 74 years ormore who were admitted to a single center betweenSeptember 2008 and January 2010[94] . For comparison,the STS score and the EuroSCORE were calculated. Theprimary endpoint was the correlation of frailty score to30-day mortality. The study involved 206 female and 194male patients. There were low-to-moderate albeit signifi-cantcorrelations of frailty score with STS score andEuroSCORE (p< ). There was also a significant corre-lation between frailty score and observed 30-day mortality(p< )[94] .Considerationshouldalsobegiventoa mini-mental evaluation of borderline elderly Physical ExaminationAortic stenosis typically isfirst suspected on the basis of thefinding of a systolic ejection murmur on cardiac ausculta-tion; however, physical examinationfindings are specificbutnot sensitive for the diagnosis of AS severity[96] . The classicfindings of a loud (grade 3 to 4/6), basal, mid-to-late peakingsystolic murmur that radiates to the carotids, a single orparadoxically split second heart sound, and delayed anddiminished carotid upstroke confirm the presence of severeAS. However, in the elderly, the carotid upstroke may benormal because of the effects of aging on the vasculature. Inother settings, the murmur may be soft (especially if LVsystolic function is impaired) or may radiate to the apex(Galavardin effect). The only physical examinationfindingthat is reliable in excluding the possibility of severe AS isa normally split second heart sound[96] . Echocardiographyis indicated when there is a systolic murmur that is grade 3/6or greater, a single S2, or symptoms that might be due to AR is associated with a decrescendo diastolicmurmur along the left or right sternal border, a wide pulsepressure, and bounding pulses. The normal differencebetween systolic leg and arm pressures is REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from Transthoracic echocardiography is indicated for evaluationof any diastolic Chest RadiographyPosteroanterior and lateral chest roentgenograms oftenyield qualitative information on cardiac chamber size,pulmonary bloodflow, pulmonary and systemic venouspressure, chronic pulmonary disease, and aortic calcifi-cations. Although cardiac size is often normal in patientswith AS, occasionally rounding of the LV border andapex due to the LV hypertrophy is apparent. Car-diomegaly is a late feature in patients with AS andwarrants careful echocardiographic analysis. In cases ofadvanced heart failure, the right atrium and rightventricle may also be enlarged. The lungfields shouldalso be checked for tumors, emphysema, interstitialdisease, andfluid collections[97]. With right-side heartfailure, the lungs become unusually radiolucent becauseof decreased pulmonary bloodflow. Conversely, signifi-cant failure on the left side of the heart is characterizedby the presence of pulmonary edema or a cephalic blood-flow pattern. Aortic valve and aortic root calcificationare best appreciated in the lateral projections or Pulmonary Function TestingThe variables that are conventionally measured to assesslung function before heart surgery include forced expiratoryvolume in 1 second, forced vital capacity, forced expiratoryflow between 25% and 75%, diffusing capacity of lung forcarbon monoxide (DLCO), and arterial blood gases. The STShas defined mild, moderate, and severe chronic obstructivepulmonary disease. Although few papers exist specificallyregarding preoperative pulmonary function tests (PFTs) inpredicting outcomes after AVR, it has been well defined thatsevere airway obstruction carries significant surgical risk,leading to an increased expectation of difficult weaning fromthe ventilator and the possibility of tracheostomy[98].Generally, preoperative hypercarbia (pCO2>50 mm Hg),forced expiratory volume in 1 second less than 30%predicted, forced expiratoryflow between 25% and 75%less than 25%, or DLCO less than 50% carries risk forpostoperative complications and prolonged intensive careunit stay. Data from Adabag and associates[98] show thata DLCO less than 50% of predicted on preoperativepulmonary function testing is an independent risk factorincreasing the risk of mortality more than threefold afteradjusting for a validated mortality risk , the risk conferred by reduced DLCO wasadditive to that brought by airway obstruction, increasingmortality risk by 10 times among patients with bothairway obstruction and reduced DLCO[98] .Nevertheless, it remains critically important to ascer-tain the reasons for poor PFT such that every attempt atdetermining the etiology of dyspnea before interventionshould be made. Pleural effusions should be drainedbefore performance of PFTs. Similarly, bronchitis orpneumonia should be treated before pulmonary is an important factor to consider even in theabsence of restrictive or obstructive spirometry values,because the sternotomy may compromise cough and theability to clear secretions. It is plausible that replacementof the aortic valve in some patients with dyspnea largelyattributable to pulmonary disease may prolong life, butnot necessarily improve quality of life. In this scenario,BAV can be performed as an initial procedure to eval-uate the improvement of the dyspnea. Improvementin shortness of breath and repeat PFTs may indicatea more robust and predictable success of AVR. Whenthe contribution of chronic pulmonary disease to theoverall pattern of heart failure, particularly dyspnea,is uncertain, BAV maybe a physiologic test that bet-ter determines the pulmonary contribution. A markedimprovement would suggest that AS is a majorcontributing terms of TAVR with the transfemoral approach, thestrict adherence to the traditional guidelines can berelaxed somewhat with many centers proficient in TAVRallowing patients to qualify for treatment with PFTs in anapproximately 25% predicted lower range. This againdepends on analysis of each individual case and origin ofsymptoms. It also should be noted that as the newgeneration devices become available more centers willpush to perform TAVR in the nonintubated patient withworse PFTs. As for transapical TAVR, this still requiresmandatory intubation and a minithoracotomy. Directaortic approaches also require intubation and mini-thoracotomy or J mini sternotomy approaches. At thistime, it is best to remain rigid in the requirement to meetthe standard PFT guidelines for patients undergoingthoracotomy or sternotomy for transapical or direct aorticapproaches. Regardless of the approach, surgical AVR orTAVR should be considered in patients with severechronic pulmonary disease if life expectancy of more than1 year is anticipated; otherwise BAV may be a morereasonable palliative approaches and incisions have been used fordoing procedures on the aortic valve. A median sternotomyis the traditional approach however minimal invasiveapproaches such as a paramedian incision, hemi-sternotomy J incision and right mini thoracotomy havebeen used with varying success. However, the J incisionappears to have a benefit in patients with chronic pulmo-nary disease[1, 99 106]. The newer approach of TAVR willbe reviewed ElectrocardiographyThe typicalfinding on ECG in patients with severe AS isLV hypertrophy, often with secondary repolarizationabnormalities. Left atrial enlargement, as indicated bya P-wave abnormality (P s), or LV hypertrophy, orconduction delay is present in more than 80% of severeAS patients. Conduction abnormalities may include leftor right bundle branch block with left or right axisdeviation, or occasionally, isolated right bundle branchblock. That may be due to extension of the calcificationinto the surrounding conduction system. Atrialfibrilla-tion can also develop, particularly in older patients andthose with hypertension[97].S15Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from Echocardiography RecommendationsCLASS I[107]1. TTE is recommended for the diagnosis and assess-ment of AS or AR severity. (Level of evidence B)2. Echocardiography is recommended in patients withAS or AR for the assessment of LV wall thickness,size, and function. (Level of evidence B)3. TTE is recommended for reevaluation of patients withknown AS or AR and changing symptoms or signs.(Level of evidence B)4. TTE is recommended for the assessment of changes inhemodynamic severity and LV function in patientswith known AS or AR during pregnancy. (Level ofevidence B)5. TTE is recommended for reevaluation of asymptom-atic patients: every 6 months for severe AS or AR,every 1 to 2 years for moderate AS or AR, and every 3to 5 years for mild AS or AR. (Level of evidence B)6. Intraoperative TEE is recommended to check repairsor replacements. (Level of evidence B)Transthoracic echocardiography is the imagingmodality of choice for diagnosis and assessment of AS orAR. Moreover, TTE is valuable for determining the LVresponse to pressure overload, detecting other associatedvalve lesions, and in estimating pulmonary artery pres-sures. In nearly all patients, the severity of the stenoticlesion can be defined with Doppler measurements ofmaximum jet velocity, mean transvalvular pressuregradient, and continuity equation valve area, as discussedin the 2003 ACC/AHA/ASE guidelines for the clinicalapplication of echocardiography[108].Transthoracic echocardiography demonstrates themorphology of the aortic valve and can often delineate ifit is trileaflet or bicuspid. The spectrum of calcific aorticvalve disease ranges from aortic sclerosis withoutobstruction to severe AS. Aortic sclerosis is common andis often seen in people aged more than 65 years. On TTE,it is characterized by focal areas of valve thickening,typically located in the leaflet center with commissuralsparing and normal leaflet mobility. Diffuse leafletthickening is not characteristic of aortic sclerosis; instead,it suggests normal aging changes, a different valvularpathology, or an imaging artifact. With aortic sclerosis,valvular hemodynamics are within normal limits, with anaortic valve velocity of less than m/s and a aortic valveopening of cm to cm[109]. In patients with severeAS and normal LV systolic function, TTE parametersinclude a jet velocity more than m/s, mean aorticvalve gradient more than 40 mm Hg, AVA less than , or a valve area index less than cm2/m2[19].In patients with AS, the aortic valve leaflets are usuallythickened and calcified, with limited excursion anda reduced AVA. Doming of the aortic leaflets due toasymmetry and restriction is often seen in young patientswith bicuspid aortic valves. The ascending aorta shouldalso be evaluated and measured to detect associatedaortic aneurysms, which are particularly common inpatients with bicuspid valves. In the absence of heartfailure, the LV cavity is usually of normal size or ventricular hypertrophy is often present, as is leftatrial enlargement; LV systolic function is usually heart failure has developed, the left ventricle may beenlarged and systolic function depressed[97].As the AVA decreases with time, the velocity of forwardflow across the valve increases. Assessing the severity ofAS using Doppler criteria is dependent not only on theseverity of AS, but also on the aorticflow. In patients withlow cardiac output, such as patients with LV dysfunction,the calculated gradients and AVA may not be represen-tative of the true severity of stenosis. In such cases of lowoutput, low gradient AS, the administration of low-dosedobutamine may be needed to truly assess the severity ofAS and to differentiate patients with anatomically severeAS from those with pseudo AS [97, 110, 111].Severe AR is defined as a vena contracta width morethan cm, regurgitation volume more than 60 mL perbeat, regurgitation fraction more than 60%, and effectiveregurgitation orifice more than cm2[20, 68]. Exercise Testing RecommendationsCLASS IIB1. Exercise testing in asymptomatic patients with AS orAR may be considered to elicit exercise-inducedsymptoms and abnormal blood pressure responses.(Level of evidence B)CLASS III1. Exercise testing should not be performed in symp-tomatic patients with AS or AR. (Level of evidence B)Exercise testing can provide valuable information inpatients with valvular heart disease, either AS or AR,especially in those whose symptoms are difficult toassess. It can be combined with echocardiography,radionuclide angiography, and cardiac catheterization. Ithas a proven track record of safety, even among asymp-tomatic patients with severe AS or AR. Exercise testinghas generally been underutilized in this patient pop-ulation and should constitute an important component ofthe evaluation patients with AS or AR do not recognize symp-toms that may develop gradually and cannot differentiatefatigue and dyspnea from aging and physical decondi-tioning. Other patients modify their lifestyle to preventsymptoms from occurring. In apparently asymptomaticpatients with severe AS or AR, exercise testing may havea role in eliciting symptoms or an abnormal blood pres-sure response to exercise. Such testing should be per-formed with close physician supervision and should notbe performed on patients with symptoms[19, 111].Exercise testing in adults with AS has poor diagnosticaccuracy for evaluation of concurrent CAD. Presumably,this is due to the presence of an abnormal baseline ECG,LV hypertrophy, and limited coronaryflow ST-segment depression duringexercise occurs in 80% of adults with asymptomatic ASand has no known prognostic REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from Exercise testing should not be performed in symp-tomatic patients owing to a high risk of , in asymptomatic patients, exercise testing isrelatively safe and may provide information that is notuncovered during the initial clinical evaluation[41 43, 96,112, 113]. When the medical history is unclear, exercisetesting can identify a limited exercise capacity, abnormalblood pressure responses, or even exercise-inducedsymptoms[41 43] . In one series, patients manifestingsymptoms, abnormal blood pressure (<20 mm Hgincrease), or ST-segment abnormalities with exercise hada symptom-free survival at 2 years of only 19% comparedwith 85% symptom-free survival for patients who hadnone of thesefindings with exercise[42]. Four patientsdied during the course of this study ( annualmortality rate); all had an AVA less than cm2and anabnormal exercise test. In another series, exercisetesting brought out symptoms in 29% of patients whowere considered asymptomatic before testing; in thesepatients, spontaneous symptoms developed in 51% overthe next year compared with only 11% of patients whohad no symptoms on exercise testing[43]. An abnormalhemodynamic response (eg, hypotension or failure toincrease blood pressure with exercise) in a patient withsevere AS is considered a poor prognosticfinding[42, 114]. Finally, in selected patients, the observationsmade during exercise may provide a basis for adviceabout physical activity. Exercise testing in asymptomaticpatients should be performed only under the supervisionof an experienced physician with close monitoring ofblood pressure and the Dobutamine Stress Echocardiography and CardiacCatheterization for Low-Flow/Low-Gradient AorticStenosis RecommendationsCLASS IIA1. Dobutamine stress echocardiography is reasonable toevaluate patients with low-flow/low gradient AS andLV dysfunction for possible AVR or TAVR[81, 113,115 122]. (Level of evidence B)2. Cardiac catheterization for hemodynamic measure-ments with infusion of dobutamine can be useful forevaluation of patients with low-flow/low-gradient ASand LV dysfunction. (Level of evidence C)Patients with severe AS and low cardiac output oftenpresent with a relatively low transvalvular pressuregradient (ie, mean gradient<30 mm Hg). Such patients canbe difficult to distinguish from those with low cardiacoutput and only mild to moderate AS. In the former (trueanatomically severe AS), the stenotic lesion contributes toan elevated afterload, decreased EF, and low strokevolume. In the latter, primary contractile dysfunction isresponsible for the decreased EF and low stroke volume;the problem is further complicated by reduced valveopening forces that contribute to limited valve mobility andapparent stenosis. In both situations, the low-flow state andlow-pressure gradient contribute to a calculated effectivevalve area that can meet criteria for severe measures of AS severity have been proposedas being lessflow dependent than gradients or valve include valve resistance and stroke work , all of these measures areflow dependent, havenot been shown to predict clinical outcome, and have notgained widespread clinical use[123]. In selected patientswith low-flow/low-gradient AS and LV dysfunction, itmay be useful to determine the transvalvular pressuregradient and to calculate valve area during a baseline stateand again during exercise or low-dose pharmacologic(ie, dobutamine infusion) stress, with the goal of deter-mining whether stenosis is severe or only moderate inseverity[113, 115 119, 121, 122]. Such studies can be per-formed in the echocardiography laboratory or in thecardiac catheterization laboratory. This approach is basedon the notion that patients who do not have true anatom-ically severe stenosis will exhibit an increase in the valvearea and little change in gradient during an increase instroke volume[115, 117]. Thus, if a dobutamine infusionproduces an increment in stroke volume and an increase invalve area more than cm2and little change in gradient, itis likely that baseline evaluation overestimated the severityof stenosis. In contrast, patients with severe AS will haveafixed valve area with an increase in stroke volume and anincrease in gradient. These patients are likely to respondfavorably to surgery. Patients who fail to show an increasein stroke volume with dobutamine (<20%), referred to as lack of contractile reserve, appear to have a very poorprognosis with either medical or surgical therapy[108, 120]. Dobutamine stress testing in patients with ASshould be performed only in centers with experience inpharmacologic stress testing and with a cardiologist clinical approach to the patient with low-output ASrelies on integration of numerous sources of data. Inaddition to measurement of Doppler velocity, gradient,and valve area, the extent of valve calcification should beassessed. Severe calcification and minimal leaflet move-ment suggests that AVR may be beneficial. When trans-thoracic images are suboptimal, transesophageal imagingorfluoroscopy may be used to assess the degree of valvecalcification and orifice area. The risks of surgery andpatient comorbidities also are taken into patients with low-output severe AS have a poorprognosis, in those with contractile reserve, outcome isstill better with AVR than with medical therapy[120].Some patients without contractile reserve may alsobenefit from AVR, but decisions in these high-riskpatients must be individualized because there are fewdata indicating who will have a better outcome Computed TomographyTraditional use of a CT scan in the assessment of thepatient with aortic valve disease has been reserved asa secondary testing modality to further elucidate unusualanatomy, quantitate the calcium burden, and assess risksof reoperation. Both electron beam and multislice cardiacCT can provide quantitative assessment of valveS17Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from calcification and have been shown to correlate with echo-cardiographic assessment and clinical outcome[124]. Therole of CT in clinical management of AS is not yet welldefined, but CT has an established role in evaluating thepresence and severity of aortic root and ascending aorticdilation in patients with associated aortic aneurysms[97].In TAVR, however, accurate preoperative assessment ofpotential leaflet calcium obstructing the coronary ostiaand the aortic annulus diameter is critical for correctvalve sizing to minimize the potential for paravalvularAR or device migration. However, a gold standard hasnot yet been established[125]. Compared withfluoroscopy and standard echocardiography, limited bytheir two-dimensionality, multislice CT can providethree-dimensional data sets with a high spatial resolution[126]. The utility and cost effectiveness of TTE, TEE, and CTscan has not fully been evaluated for TAVR, and there aresome data suggesting that TEE may be all that is needed forpreoperative assessment. One study involving 187 patientsreferred for TAVR dual-source CT and TTE could notdefinitely predict TEE measurements. The TEE measure-ments showed good intraobserver and interobservervariability, which is more satisfactory than that for dual-source CT measurements[127]. The researchersconcluded that taking TEE annulus measurements asdecisive parameter for the implantation is safe with a lowrate of complications such as necessity of valve-in-valveimplantation, severe paravalvular leak, or valve important component in the assessment forTAVR entails evaluation of the aortoiliac system[128].Thatcan be done by way of at least three different imagingmodalities: angiogram, IVUS, or CT scan[129, 130].Theaortoiliac angiogram is usually performed at the comple-tion of the cardiac catheterization and adds little tono morbidity to the procedure in the patient withnormal renal function[131]. In patients with concomitantrenal disease where dye load is of concern, IVUS is anexcellent option for analyzing calcium and plaqueburden, and vessel size. IVUS does not, however, impartcritical information related to tortuosity. Multislice CTscan with contrast is being used alone or in combinationwith the other modalities in most ongoing TAVR clinicaltrials including with a catheter leaflet in the distal aortaat the time of catheterization[81] . Again, in patientswith renal issues, contrast can be forgone but deliverssuboptimal imaging, and these patients are probablybettered served by having a minimal contrast aortoiliacangiogram with complimentary Cardiac Catheterization RecommendationsCLASS I1. Coronary angiography is recommended before AVRin patients with AS or AR at risk for CAD. (Level ofevidence B)2. Patients aged more than 45 years undergoing a valveprocedure should undergo coronary imaging. (Levelof evidence C)3. Cardiac catheterization for hemodynamic measure-ments is recommended for assessment of severity ofAS or AR in symptomatic patients when noninvasivetests are inconclusive or when there is a discrepancybetween noninvasive tests and clinicalfindings.(Level of evidence C)4. Coronary imaging is recommended before AVR inpatients with AS or AR for whom a pulmonaryautograft (Ross procedure) or root procedure iscontemplated and if the origin of the coronary arterieswere not identified by noninvasive technique. (Levelof evidence C)CLASS IIB1. For patients aged less than 45 years, CT coronaryangiography may be considered. (Level of evidence C)CLASS III1. Cardiac catheterization for hemodynamic measure-ments is not recommended for the assessment ofseverity of AS before AVR when noninvasive tests areadequate and concordant with clinicalfindings. (Levelof evidence C)2. Cardiac catheterization for hemodynamic measure-ments is not recommended for the assessment of LVfunction and severity of AS or AR in asymptomaticpatients. (Level of evidence C)Because of the accuracy of echocardiographic assess-ment of the severity of AS or AR, cardiac catheterizationis currently used most often to identify the presence ofassociated CAD rather than to define hemodynamicabnormalities. However, invasive hemodynamicmeasurements are helpful in patients in whom thenoninvasive tests are inconclusive or provide discrepantresults regarding the severity of AS or AR. This is per-formed by measuring simultaneous LV and ascendingaortic pressures and measuring cardiac output by eitherthe Fick principle or the indicator-dilution technique. TheAVA can be calculated and considered severe when thevalve area is cm2or less, or the AVA index is less. Coronary arteriography is recommendedbefore AVR for all patients aged 35 years or more and forpatients aged less than 35 years if they have LV systolicdysfunction, possible symptoms or signs suggestingCAD, or two or more risk factors for premature CAD[97].For patients with AS or AR, the indications for cardiaccatheterization and angiography are essentially the sameas for other conditions, namely, to assess the coronarycirculation and confirm or clarify the clinical diagnosis. Inpreparation for AVR, coronary angiography is indicatedfor patients suspected of having CAD. If the clinical andechocardiographic data are typical of severe isolated ASor AR, coronary angiography may be all that is neededbefore AVR. A complete left-side and right-side heartcatheterization may be necessary to assess the hemody-namic severity of the AS if there is a discrepancy betweenclinical and echocardiographic data or a patient hasa history of radiation heart disease. The pressure gradientacross a stenotic valve is related to the valve orifice areaand the transvalvularflow [132]. Thus, in the presence ofdepressed cardiac output, relatively low pressureS18SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from gradients may be obtained in patients with severe , during exercise or other high-flow states,significant pressure gradients can be measured in mini-mally stenotic valves. For these reasons, completeassessment of AS requires the following: measurement oftransvalvularflow; determination of the mean trans-valvular pressure gradient; and calculation of the effectivevalve to detail with accurate measurements ofpressure andflow is important, especially in patients withlow cardiac output or a low transvalvular pressuregradient[19].In patients with associated extensive CAD and poor LVfunction, the contribution of the individual componentsof valve disease or CAD to poor function can be difficultto assess. In this scenario, the use of either PET scanningor cardiac MRI may help in differentiating the etiologyand as to whether a patient may potentially improve withAVR or STS data collection form, version , can befound online (Web address provided inAppendix 1).Perusal of it will show that members of the writingcommittee, and other contributors, added newfieldsthat particularly gather data on sicker patients,especially for TAVR. The newfields gather informationrelated to patient frailty including nutritional andfunctional reserve. Clearly, as more patients undergoTAVR, the number of patients with frailty and limitedreserve or very high risk that undergo conventionalsurgery will decline. Thus, some of thefields may notbe part of global predictive models, such as radiationheart disease or cirrhosis, but for subgroup analysis,these data would be useful. Thefields also incorporatedata that is relevant to Cannulation Options for Aortic Valve and RootSurgery RecommendationsClass I1. For most patients requiring a simple aortic valveprocedure without ascending aortic disease, the distalascending aorta is recommended as the site for can-nulation[14]. (Level of evidence B)2. For complex repairs involving the arch or a calcifiedaorta or porcelain aorta, use of the axillary artery witha side graft is recommended[14]. (Level of evidence B)The site of cannulation for aortic valve procedures, withor without ancillary procedures, has been found toinfluence stroke and survival. Arterial cannulation forprocedures involving the aortic valve through theascending aorta can be tailored for each patient s specificpathology. These guidelines address the most commonlyutilized, but not all, of these options for cannulation withregard to valve and proximal aortic abnormalities. Thesites of cannulation discussed here will include theascending aorta, the aortic arch, the LV apex, the leftaxillary or subclavian artery, and the femoral options will be discussed in relation to simple AVR, the porcelain aorta, redo sternotomies, andprocedures involving the aortic arch. The advantages anddisadvantages of each site are discussed relative to thespecific related to the cannulation site, approaches tobrain protection will not be discussed in detail in thissection. For further information on brain protection,reference should be made of the recently completedguidelines on thoracic aortic disease[1]. Principles ofbrain protection will be referred to, but not discusseddirectly outside of the cannulation options. Theadvantages, disadvantages and some of the data foreach approach will be Ascending AortaThe ascending aorta remains the most commonly utilizedsite of arterial cannulation for cardiac surgery, includingaortic valve surgery. The main advantage of theascending aorta is proximity as it is exposed duringexposure of the heart in creating the pericardial well. Incases limited to the aortic valve or root, there is sufficientdistance to isolate the proximal ascending aorta witha cross clamp and distal perfusion. Further, the cannu-lation is probably the most straightforward, with directcannulation within one or two pursestrings. For isolatedaortic valve and root procedures without a calcified aorta,few would argue that this is not the optimal site , the drawbacks mainly deal with theabnormal ascending aorta, whether it is thin, aneurysmalor dissected. Although some surgeons do cannulateaneurysms or dissections directly, many others preferalternate sites to avoid complications of the cannulationincluding dissection, rupture, and the need to cannulateagain after resection of the ascending aorta. Thesecomplications can occur to any access site, but in this casethe dissection would require ascending aortic replace-ment[133 135]. Another aortic abnormality that maypreclude ascending aortic replacement is the presence ofintraluminal abnormalities that can embolize. Atheromaor atherosclerotic disease of the aorta can embolizeanywhere in the arterial tree resulting in stroke, bowelinfarct, or other end organ Cleveland Clinic and Baylor both published largestudies demonstrating the safety of ascending aorticcannulation for cardiopulmonary bypass[136, 137]. Thecomplication rates were minimal including rates of strokeand dissection. Cannulation of the ascending aorta hasbeen described in even Type A dissection repair inselected patients with good results in small single centercohorts[138, 139]. Epiaortic echocardiographic scanningmay aid in decision Aortic ArchCannulation of the arch has the advantage of being distalto ascending aortic pathologies. The cross-clamp can beplaced up to the base of the innominate artery. The extralength can be particular helpful in not only ascendingaortic pathology, but also in circumstances where aorticdomain can be compromised because of vein graft prox-imal anastomosis and even because of outflow grafts forS19Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from ventricular assist devices. In many patients, the archtissue may be more robust than the ascending disadvantages of arch cannulation can be the depthand angulation of the arch. Moreover, cannulationcomplications of this site can be difficult to repair whencomplications do occur. It provides no benefit for archoperations except for speed of cannulation as the site willbe resected, and it provides no access for selective ante-grade perfusion during the open ,butBorgerand associates[140]demonstrated fewer embolic eventsduring CABG by transcranial Doppler. They foundno clinical correlates of stroke or neuropsychologicalimpairment to these emboli, but the study was small[141].Importantly, these studies demonstrated no right sidedmalperfusion with this technique demonstrating it can besafe for cases with loss of ascending aortic domain fromprevious operations or a fragile ascending aorta. Earlystudies have shown adequate perfusion to the brain witharch cannulation confirmed by electroencephalogram andfewer strokes compared with peripheral cannulation[142].No study directly compares ascending to arch cannulation,but few data exist suggesting that arch cannulation is Right Axillary or Subclavian ArteryThe right axillary or subclavian artery started beingutilized because of the anatomy of the innominate cannulating the right axillary, the right side of thebrain can be perfused by occlusion of the this site, the transition from full body perfusion toselective antegrade brain perfusion (ABP) is easy. Further,it may facilitate the de-airing of the arch once the openportion is complete by allowing pressurization of thebrachiocephalic vessels before reapplication of the cross-clamp and returning to full body reperfusion. Addition-ally, this site is an excellent choice for the difficult redosternotomy. If the heart or great vessels are attached tothe posterior sternum and potential injury during entry islikely, axillary artery cannulation can be a safe approachto secure arterial access before sternal disadvantage to axillary cannulation is that it takestime to sew on a graft. While some centers will directlycannulate the artery, overwhelmingly an 8-mm Dacrongraft is sewn on for access since this is associated with lessstrokes and brachial plexus nerve injury. This facilitatesclosure later and allows continued right arm proximity of the brachial plexus and the axillary veincan put these structures at risk for injury and can causechronic pain in some patients. While the peripheralpositioning of this site may be its most significantadvantage, it can also be a drawback. For instance, theneedle holes from this graft can bleed throughout theheparinization which tends to drain away from the peri-cardial well. If the area is not draped properly to catchthis bleeding or a pump suction basket placed in the well,a significant amount of blood can be lost during longbypass data regarding this site are limited to single insti-tutional studies, but most suggests a stroke benefit withuse of axillary perfusion including when using selectiveABP. The Cleveland Clinic demonstrated that directcannulation may have more complications than sewingon a side arm, and that this approach may limit the strokeincidence in arch and circulatory arrest cases[143, 144].More retrospective evidence has arisen from Halkos andcolleagues that axillary cannulation during proximalaortic procedures can reduce resource utilization throughreduced pulmonary and renal complications[145]. Thedata regarding the optimal cannulation for archoperations are mainly retrospective and singleinstitution, but the majority of arch surgeons utilize thiscannulation site for selective antegrade brain protectionduring the open arch. Of note, Merkkola and colleagues[146, 147]suggested that selective ABP through the axil-lary alone would not fully perfuse the left hemisphere ofthe brain which is why some advocate multiple sites ofantegrade perfusion during hypothermic circulatoryarrest (HCA). The clinical significance of this is still notknown although in approximately 14% of patients thecircle of Willis is not complete, endangering Femoral ArteryFemoral artery cannulation may be the easiest and fastestsite of cannulation in emergency. Both open and percu-taneous exposures are relatively uncomplicated in mostpatients. The access can be further facilitated by accessingthe artery with a wire or arterial line, especially in caseswhere hasty arterial access may be anticipated. Before thepopularization of axillary artery cannulation, the femoralapproach was very commonly utilized in aortic dissec-tions with success. In almost all cases, one femoral arteryor the other is spared from the dissection and mostly theright is spared 80% of the time. Additionally, the femoralarteries are commonly utilized for minimally invasivesurgery. The arterial cannulation is completely separatefrom the operativefield and therefore out of the drawbacks of the femoral artery are essentiallyrelated to size and to atherosclerotic disease. The femoralartery of some patients may be too small to achieve anappropriate cardiac index on bypass. Atheroscleroticdisease can complicate both cannulation and cannulationcomplications may arise, such as retrograde brain embo-lization. Distal limb perfusion may also be compromisedand hence some surgeons advocate a second smaller distalcannula or use of a side graft. Clearly for transfemoralTAVR, distal limb ischemia may be a problem for longprocedures. Preoperative CT scanning or TEE screeningfor atherosclerotic disease may reduce the risk of stroke,particularly for minimally invasive procedures, includingrobotic procedures. Diminished femoral pulses can makeidentification and wiring of the vessel more difficult,particularly in obese patients or for reoperation[148].Further, opening diseased vessels can lead to furtherstenosis of the artery at the cannulation site with repair aswell as lead to potential retrograde embolization with theinitiation of bypass[149, 150]. For aortic dissections,retrogradeflow on bypass can even extend the dissectionproximally or distally. Despite these potential drawbacks,S20SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from femoral cannulation with retrograde corporal perfusionremains widely used with a reasonable safety profile [151]. Left Ventricular ApexCannulationoftheapexoftheheartremainsanoptionwhenother possibilities are exhausted. The cannula can be placedthrough an apical purse string with passage of the cannulaout through the aortic valve. This can be particularly valu-able in cases where the aorta cannot be safely manipulatedsuch as dissection or porcelain aorta[152, 153].Although this can be a valuable bailout, other strategiesare preferred because this site requires manipulation ofthe apex of the heart which is not well tolerated in mostpatients. Further, the outflow of the cannula must bedistal to the aortic valve to avoid ventricular can also be caused by aortic insufficiency fromthe cannula crossing the valve. A LV vent is suggested forboth potential removal of air and prevention of ventric-ular distension. While in theory the apical cannulationcould affect the ventricular function, this small change inshape with closure of this access site does not appear tocause any clinically evident decrease in , the scar created by this repair could potentiallylead to aberrant ventricular electrical conduction, clotformation, or an apical have shown the feasibility of transapical can-nulation during dissection. Recently Sosnowski andcoworkers[154]reported their preferred technique ofcannulation for aortic dissection requiring TEE guidanceto insure appropriate true lumen perfusion. Thisapproach has been utilized for various types ofprocedures for cardiopulmonary bypass, but may bemore of a bailout than a preferred approach for arterialcannulation with the majority of publications referringto aortic dissection repair[153, 155]. Further ResearchThe optimal approach to cannulation of straightforwardcases is probably the ascending aorta. However, theoptimal approach to cannulation for cases involving theascending aorta and arch will be dependent on the optimalapproach to brain protection during the open arch research would require a multicenter comparison ofneurocognitive outcomes using selective antegradeperfusion with perfusion of the right carotid, both carotids,or all three brachiocephalic vessels compared with retro-grade brain perfusion (RBP) and HCA. To complicate theevaluation, patient factors such as atherosclerotic burdenand distribution can play a significant role in this decisionand evaluation. Only then can the optimal cannulation sitefor these cases be narrowed Quality MeasuresThe Achilles heel to cannulation continues to be embo-lization. Quality measures need to be focused on the mostcrippling of embolization: cerebrovascular delirium can also be a significant measureto follow as small emboli or air embolization may causesignificant perioperative confusion. At this time, conse-quences of high-intensity transcranial Doppler signalsor MRI-related defects are poorly understood in theabsence of frank stroke. Other considerations would beiatrogenic dissection or rupture secondary to , the interdependence of cannulation with thetype of brain protection may not muddy the picturesufficiently that cannulation strategy alone becomesa covariable. Thus, we do not believe a specific cannula-tion site is an absolute ConclusionsThe optimal site for cannulation remains a surgeon pref-erence. No perfect site exists and probably needs to betailored to the specific patient anatomy, the perfusionrequirements of the procedure, and the surgeon s prefer-ence for potential brain protection. For the overwhelmingmajority of cases the cannulation of the ascending aorta ispreferred, but the choice of arterial cannulation site can betailored with thoughtful consideration of both the patient sanatomy and the procedure being Mechanical Aortic Valves RecommendationsClass I1. Before mechanical AVR, all patients who have knownCAD, have had a prior myocardial infarction, haveangina pectoris as a symptom, or are greater than age45, should have preoperative screening of theircoronary arteries, either by direct coronary angiog-raphy. (Level of evidence C)2. All patients undergoing mechanical AVR shouldreceive perioperative prophylactic antibiotics to coverboth gram positive and negative organisms. (Level ofevidence C)3. All patients receiving a mechanical aortic valveshould receive postoperative anticoagulation, begin-ning after valve implantation. (Level of evidence C)4. All patients with mechanical aortic valve prosthesesshould receive prophylactic antibiotics for all dentalor surgical procedures to prevent prosthetic endo-carditis. (Level of evidence C)Class IIa1. Nasal mupirocin is probably indicated for methicillinresistant organism or routinely before and afteroperations. (Level of evidence C)2. Preoperative chlorhexidine showers and mouthwashes should be considered. (Level of evidence C)Quality Measures1. All patients receiving a mechanical aortic valveshould receive indefinite postoperative anti-coagulation therapy. Controversy exists over the exacttarget international normalized ratio (INR) levels formechanical aortic valve prostheses. Appropriatelevels of therapeutic INR vary according to concomi-tant patient risk factors[156]. The safety of lowerlevels of anticoagulation is improved with patient-controlled anticoagulation[157].S21Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from 2. All patients with mechanical aortic valve prosthesesshould receive prophylactic antibiotics for all dental orsurgical procedures to prevent prosthetic Angiotensin-converting enzyme (ACE) inhibitortherapy should be considered in patients with low available mechanical aortic valve prostheseshave several advantages, including ease of insertion,safety, durability, excellent hemodynamics and long-termtrack record of performance. Mechanical aortic valves areall relatively easy for cardiac surgeons to implant. Thereare often different types of cloth sewing rings availableto adjust for annular differences. In addition, all currentmechanical valves have a low profile, making implanta-tion much easier. The potential for obstruction of thecoronary ostia during implantation is minimal. Care mustbe taken, however, to insure that the tails left onimplanting sutures cannot impinge between the disc andvalve housing during valve dysfunction of currently approved mechan-ical heart valves is extremely rare but not zero. Becausemost mechanical prosthetic occluders are constructed ofsome form of pyrolytic carbon, they are susceptible tosome degree to chipping or fracture that can be inducedby trauma at the time of insertion, such as metal-inducedscratches, or cavitation erosion. For all intents andpurposes, however, current mechanical aortic prostheseshave endured accelerated bench testing withoutdestruction for the equivalent of several patient younger patients who want to minimize the risk ofreoperation, mechanical aortic valves are the best mechanical aortic valves currently available in theUnited States are of some type of bileaflet design, sinceMedtronic, Inc, withdrew its single tilting disc prosthesisfrom the market in late 2009. Generally speaking, thehemodynamic performance of bileaflet aortic prosthesesis excellent with efficacious orifice-to-annulus ratios andthus EOAs. Whereas all mechanical valves have someintentionally designed regurgitation, this is rarely ofclinical models of currently available mechanical aorticvalves have been in clinical use for more than 30 , excellent long-term data on large numbers ofpatients with mechanical aortic valves are available toprove their low incidence of structural dysfunction,nonstructural dysfunction, and prosthetic endocarditis,and also to define anticoagulation strategies that minimizethromboembolic events while limiting anticoagulant-related bleeding valve prostheses have their disadvantages, some ofwhich are common to all prostheses and some of which arespecific to different types or designs. As with all prostheses,mechanical aortic valves have a thromboembolic potential,risk of prosthetic endocarditis, tissue ingrowth, and risk fornonstructural dysfunction, including paravalvular leakand hemolysis[158]. The thromboembolic potential ofmechanical aortic prostheses is substantially greater thanthat of bioprosthesis, and all mechanical valves requiresome type of anticoagulation. The gold standard foranticoagulation of mechanical valves has been suggested target levels of therapeutic INR formechanical valves vary more according to associatedpatient risk factors than to the individual commercialmodels. Higher target levels of INR are associated withsignificantly increased risk of anticoagulant-relatedbleeding. Lower risks of thromboembolism andanticoagulant-related bleeding have been achieved withpatient-monitored anticoagulation. As with all anti-coagulation strategies, the risks of thromboembolism andanticoagulant-related bleeding are essentially two sides ofthe same coin. One can often lower the risk of one but onlyby increasing the risk of the other. Thus, the compositethromboembolism and bleeding index is the most accurateassessment of the combined risk[159]. The ongoing andcumulative risks of thromboembolism and bleeding haveled most patients in recent years to opt for bioprosthesis,accepting the probable need for controversy exists concerning the efficacyof adding antiplatelet agents, usually aspirin, to warfarinfor anticoagulation of mechanical aortic valves. Severalstudies have suggested lower rates of thromboembolism,particularly in patients with concomitant CAD, while moststudies have shown a significantly increased incidence ofgastrointestinal bleeding with the combined , in patients who, for example developamaurosis fugax, particularly with composite mechanicalvalves, the addition of aspirin may alleviate the trials of using only antiplatelet therapy formechanical heart valves are in process with no clear proofof the safety of that strategy. One future hope for anti-coagulation therapy lies with direct thrombin inhibitors,which might obviate many of the complications associ-ated with risk of prosthetic endocarditis accrues to all pros-thetic heart valve designs. Although the risk is quite lowand probably unrelated to differences in commercialdesigns, the potential mandates antibiotic coverage of allpatients with mechanical aortic valves during operativeand dental dysfunction of mechanical aortic valvesusually presents in one of two ways, predominantlyparavalvular leak or less frequently hemolysis. The inci-dence of paravalvular leak relates more to patient factorssuch as heavily calcified aortic annulus or technicalfactors at the time of insertion than it does to differencesin commercial designs. There are various types of clothsewing rings available for some mechanical aortic valvesthat may contribute to lowering the risk of due to mechanical aortic valves is probablypresent at a low, but clinically insignificant, level in allpatients. Occasionally individual mechanical valves canbe associated with clinically significant hemolysis, rarelynecessitating valve replacement. Hemolysis in a patientwith a mechanical aortic prosthesis may not be due to theS22SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from valve itself, as there are obviously other medical causes are some hemodynamic issues with aorticbileaflet designs that are of some hypothetic, if not clin-ical, concern. There is no orientation of a bileaflet pros-thesis in the aortic annulus that is not associated with atleast some turbulence during systolicflow. The orienta-tion that places the axis of the two leaflets in the middle ofthe noncoronary cusp yields the least mechanical valves also have some intentional,built-in regurgitation during diastole, meant to washaway microthrombi. Different commercial models ofbileaflet mechanical aortic valves all have different hingedesigns, some of which theoretically wash better duringdiastole. In large prostheses this regurgitant fraction isnot insignificant. Theoretically the combination ofturbulence during systole and regurgitation during dias-tole contributes to energy loss for the left are some disadvantageous features of mechanicalvalves that are unique to their design, as compared withbioprosthesis. When forced into a tight-fitting annulus, theleaflets may not function normally. Another is patient-sensed noise. In occasional patients mechanical pros-theses are associated with audible or sensed soundsduring virtually every heart beat. Some patientsfind thisunnerving and completely unacceptable, whereas otherpatients have found it to be , isolated AVR should be able to be performedwith certainly less than 5% mortality; in purely electivesituations, this should be 1% or literature review[158]suggests that thelinearized rates of valve-related complications formechanical aortic valve prostheses should be in thefollowing ranges: Structural deterioration, 0% to per patient-year Nonstructural dysfunction, to per patient-year Thromboembolism, to per patient-year Anticoagulant-related bleeding, to perpatient-year Composite thromboembolism and bleeding, per patient-year Prosthetic endocarditis, to per patient-year6. Biological Valves RecommendationsClass I1. A bioprosthesis is recommended for AVR inpatients of any age who will not take anti-coagulation, either warfarin or the direct factor Xaor thrombin inhibitors or who have major medicalcontraindications to anticoagulation[20]. (Level ofevidence C)2. A bioprosthesis is recommended for AVR in patientsaged 65 years or more without risk factors forthromboembolism[20]. (Level of evidence C)Class IIa1. Patient preference is a reasonable consideration in theselection of aortic valve prosthesis if appropriatesurgical counseling is carried IIb1. A bioprosthesis may be considered for AVR ina woman of childbearing age who desires to havechildren[20]. (Level of evidence C)2. A bioprosthesis may be reasonable for AVR inpatients aged less than 65 years who elect to receivethis valve for lifestyle considerations after detaileddiscussions of the risks of anticoagulation versus thelikelihood that AVR may be necessary in the future[20]. (Level of evidence C)Quality Measures1. All patients should receive both gram-positive andgram-negative prophylactic antibiotics before AVRand broad-spectrum antibiotic strict prophylaxisbefore any surgical, endoscopic, dental, or otherprocedure associated with the chance of All centers performing AVR should report theirresults to a national database such as the STS To evaluate meaningfully the choice of appropriateprosthesis it is imperative to have standardizedguidelines for reporting mortality and morbidityafter valve interventions[159]. Much of the confusionand conflicting evidence comparing different valvetypes derives from the heterogeneity of the patientsamples studied and the different definitions usedin reporting complications and structural valvedeterioration (SVD) rates. Freedom from reoperationfor SVD underestimates the true incidence ofSVD. Structural valve deterioration should representdysfunction determined by reoperation, autopsy,or clinical investigation, including periodicechocardiograms. It is also important to distinguishbetween patient outcome versus valve outcome tocounsel individual patients on valve of the prosthesis (valve-related events),when looking at nonfatal complications, is usuallyreported using the Kaplan-Meier actuarial methodwith the number at risk at each interval indicated. TheKaplan-Meier method, however, is designed forpopulation studies and overestimates the actual eventprobability for an individual patient; therefore topredict valve outcome for an individual patient, thecumulative incidence (or observed cumulativefrequency) actual statistical method should be actual (cumulative incidence) estimates arebest suited for individual patient counseling andpatient management decisions[160].4. ACE inhibitor therapy should be considered inpatients with low EF are several options for patients who chosea biologic or tissue valve: Stented xenograft bioprosthesis,S23Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from stentless bioprosthesis, homografts (or allografts), andautografts (ie, the Ross procedure). The followingdiscussion is devoted to stented tissue bioprosthesis, asthe other biological options are covered elsewhere. Therewas initial hope that stentless bioprosthesis would moreclosely mimic the native aortic root, provide betterhemodynamics, favor more LV hypertrophy regression,and be associated with longer valve durability, but thishas not yet translated into improved clinical outcomes[161]. Unless independent aortic pathology or concern forsevere patient-prosthetic mismatch (PPM) necessitatesxenograft or homograft aortic root replacement, a stentedbioprosthesis should be the biologic valve of choice forroutine AVR in the elderly patients who cannot be safelyanticoagulated, and patients who select a biological valvefor lifestyle stented bioprosthetic valves are available onthe market today for AVR and can be divided into porcinevalves, which consist of porcine aortic valve leafletsmounted on stents (some of which are compositeconstruction eliminating the right coronary cusp with itsmuscular shelf), and pericardial valves (mostly bovine,although an equine pericardial valve is now available),which are fabricated from sheets of pericardium mountedeither inside or outside the supporting stent frame. A newcategory of sutureless and rapidly implantable bio-prosthesis now have European CE marks and areundergoing clinical are several differences between tissue valvetypes which are purported to confer advantages over theircounterparts. These can be divided broadly into stentdesign and leafletfixation technique. Stents are made ofstainless steel, steel alloy, cobalt chromium alloys, tita-nium alloys, or plastic polymers. More recent designshave modified the material andflexibility of the annularsewing ring and commissural stent posts, as well asshortening the height of the posts for ease of implant. Allbiologic valves leaflets undergo collagen cross-linkingwith glutaraldehyde to block immune response andincrease tissue stabilization; however, this creates calciuminflux as well as exposes residual phospholipids withinthe cell membrane, which then serve as calcium bindingsites. To mitigate valve calcification most companies havedeveloped proprietary tissue treatments aimed atremoving residual glutaraldehyde or phospholipidmoieties to reduce calcium binding and hopefullyenhance durability. Among these are treatment withalcohol and various antisurfactants but none has provedsuperior to standard porcine and pericardial stented bio-prosthetic valves, the internal diameter by intraoperativesizing is equal to the selected labeled size of the valveminus 4 mm to 6 mm after insertion; however, compar-ison data for ex-vivo sizes are typically larger. Hence,a 21-mm labeled bioprosthetic valve may have an internalsize of 15 mm to 17 mm. For supraannular valves, theinternal size is 2 mm to 4 mm smaller. Hence, fora labeled 21-mm valve the internal diameter may beapproximately 17 mm to 19 mm. Although aortic valvesizers reflect the true external diameter of thebioprosthetic ring and struts with some variation inshape, supraannular valves will oftenfit when an intra-annular would notfit; however, care needs to be takenthat the coronary ostia do not become obstructed as thesupraannular sewing skirt can encroach upon low-lyingostia. When sizing an annulus for a valve, surgeonsshould initially use a sizer that looselyfits until theybecome comfortable with the limits of being able tofita tight-fitting available stented bioprosthesis have severaladvantages, but the main one is the hope to avoid theneed for long-term anticoagulation therapy. The throm-botic potential of biologic valves is much lower than theirmechanical counterparts. Because the risk of thrombo-embolic events is higher early postoperatively, currentACCF/AHA guidelines recommend (as IIa) warfarintherapy during thefirst 3 months after bioprosthetic AVRuntil the sewing ring is endothelialized, although manymajor centers just rely on aspirin only[20]. This need forwarfarin has been called into question by many majorinstitutions. Currently, more than 30% of centers useonly 81 mg aspirin indefinitely for patients in sinusrhythm after bioprosthetic AVR. There are severalpatient populations in which avoidance of long-termanticoagulation is desirable, including women of child-bearing age who wish to start a family and those whoselifestyle or lack of reliable access to health care does notallow frequent anticoagulation monitoring necessary forsafe indefinite general, rates of thromboembolic complications( to per year) are similar for carefully anti-coagulated patients with mechanical valves and thosewith bioprosthetic valves not on warfarin. The incidenceof high-intensity transient signals from the middle cere-bral artery detected by transcranial Doppler is lower withbiological valves when compared with mechanical valves,although the clinical importance of this is main advantage is avoidance of long-term anti-coagulation therapy, which should translate to a lowerrisk of bleeding complications. The risk of major bleedingwith long-term anticoagulation is approximately 1% peryear; however, this significantly increases with increasingage. The CHADS2score is a composite score reflectingbleeding risk in which one point is assigned for conges-tive heath failure, hypertension, age 75 years, or dia-betes mellitus, and two points for prior stroke or transientischemic attack. Individuals with a CHADS2score of 3 orgreater have significantly higher bleeding rates and maynot safely tolerate anticoagulation therapy. As a result,some argue that for elderly patients or those patients athigh risk for bleeding who are already receiving warfarinfor another reason (eg, atrialfibrillation), a biologic valvestill may be the most appropriate choice. Choice ofa mechanical valve in these patients exposes them to therisk of anticoagulant-related bleeding as well as the riskof thromboembolism and mechanical valve thrombosisshould anticoagulation therapy need to be stoppedduring a major bleeding REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from The rates of hemolysis, considered nonstructural valvedeterioration, especially clinically significant hemolysis,are lower with biologic than mechanical the late postoperative rates of SVD are higherwith biologic valves compared with mechanical pros-theses, the deterioration usually is gradually progressivestenosis for pericardial valves, but occasionally leafletstears at the commissures may cause acute AR for porcinebioprosthetic valves, allowing detection and monitoringwith regular routine echocardiographic follow-up. Echo-cardiographic evaluation of biologic valves should beperformed at discharge, atfirst follow-up, and then at 3years in the absence of clinical indication, or wheneverthere is clinical suspicion of valve dysfunction. Structuralvalve deterioration of modern mechanical valves is rare ifanticoagulation control is good; an exception is late pan-nus valves do not have any of the audiblemetallic clicks that are associated with mechanical , one advantage of a stented bioprosthesis in theaortic position is ease of potential reoperation; it is lesscomplicated to do a redo AVR for SVD of a stented tissuevalve than is the case for a stentless tissue valve orxenograft aortic root replacement or for the potential for transcatheter valve-in-valveprocedures should favor the more frequent use of bio-logical valves, particularly in younger patients, isunknown but main disadvantage of biologic valves compared withmechanical valves is their limited durability, which ismost common in younger patients. This exposes thepatient to the hemodynamic insult of progressive AS orAR, or both, and eventual need for reoperation. All bio-logic valves eventually sustain SVD over time at somenonlinear rate. Observational studies show that the SVDrate for current porcine and bovine pericardial bio-prosthesis used in the aortic position begins to accelerateafter approximately 10 years and continues to increasethereafter in patients aged more than 65 years; theshoulder on the freedom-from-SVD curve occurs muchearlier in younger patients, which limits the usefulness oftissue valves in these patients. Other patient-related andvalve-related factors also increase the rate of bio-prosthetic deterioration[4], for example, female sex,larger valve size, and mitral age of the patient at the time of implantation is thestrongest predictor of accelerated SVD. Younger patientshave significantly higher SVD rates. Fifteen years post-operatively, roughly 9% of patients aged more than 65years of age, 26% of patients aged less than 65 years[7],and nearly 40% of patients aged less than 40 years willhave sustained SVD. Certain other medical problemssuch as end-stage renal disease, hyperparathyroidism,and hypertension can also hasten the development ofSVD. In certain patient cohorts such as those on dialysis,life expectancy is so bleak that concern about acceleratedSVD is moot and should not prevent them from receivinga biologic valve. It is important not just to take intoaccount the absolute age of the patient, but also theirexpected biological life expectancy based on the severityof cardiac dysfunction, other cardiac problems, medicalcomorbidities, and their family history of longevity. Thereis also no good evidence that statins or antiinflammatorydrugs can mitigate this pathogenesis of SVD in biologic valves is largelythought to be a degenerative process caused by calciuminflux. Most companies have developed various proprietarytissue treatments aimed at reducing calcium binding,although some contemporary valves do not offer anyspecificanticalcification treatment. In general, newergeneration tissue valves purport to have lower SVD ratesthan do older bioprosthesis, but there have been nocontrolled studies showing a difference in SVD ratesbetween different types of porcine valves. Several reportshave claimed lower valve deterioration rates in patientswho received bovine pericardial valves, but the definitionused in all of these studies is freedom from reoperation forSVD, which underestimates the true SVD there have been many retrospective studiesattempting to compare SVD rates among different types ofstented bioprosthesis, as of now there are too many con-founding variables to make any conclusive statements aboutrelative durability between the porcine aortic and bovinepericardial tissue valves used today in the aortic should be noted, however, that the mechanisms ofdeterioration differ between porcine and pericardialtissue valves. Porcine xenograft bioprosthesis tend todevelop dysplastic calcification in the leaflets near thecommissures (high-stress regions) which leads to leaflettears and sometimes sudden valvular regurgitation; thiscan be detected clinically by a new murmur andconfirmed by echocardiography. Pericardial xenograftbioprosthesis also calcify, but typically in a diffusemetaplastic manner across the leaflets that can lead tooccult severe AS without being detected by a newmurmur. The leaflets of both types of bioprosthesis mayalso develop commissural calcified have hypothesized that immunologic, arterio-sclerotic, and inflammatory processes are also involved inSVD. There was a burst of initial enthusiasm for statintherapy in the hope that their pleiotropic effects wouldretard SVD, but this has not been proved to stented bioprosthesis used for AVR haveinferior hemodynamic performance compared withmechanical valves has been debated. This has led toconcern about PPM, especially as biologic valves aremore commonly implanted in the elderly with calcified,smaller annuli. Clinical interest in PPM is based on thereports of increased short- and long-term mortality ratesas well as less symptomatic improvement if an importantdegree of PPM exists ( or cm2/m2) [162]. The EOAindex, which is obtained by dividing the valve EOA by thepatient s body surface area (BSA), should be used foridentifying PPM. Many valve companies provide EOAcharts plotting valve size against BSA, which can beused as a rough guide for choice of valve size and valvetype but should not supersede the clinical judgment ofthe surgeon and taking into account the severity of theS25Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from AS preoperatively and how physically active the patient islikely to be postoperatively. Patient age, sex, LV functionand size, and hypertrophy must be considered inchoosing an appropriate bioprosthesis should be implanted in thesupraannular position to maximize the size of tissue valvethat can be implanted. Additionally, two new types ofpericardial xenograft valves have the bovine pericardialcusps mounted outside the stent frame for the samereason. Every effort should be made to avoid severe PPM(EOA index< cm2/m2), including selecting a type ofbioprosthesis with superior hemodynamic characteristicsor resorting to annular enlargement or even completexenograft or homograft root replacement if necessary inhighly selected patients. Moderate PPM ( or cm2/m2), however, is generally well tolerated. The patient sactivity level, age, sex, ventricular hypertrophy (LV mass),ventricular function, BSA, and severity of AS all should betaken into account. The risk-to-benefit ratio of an annularenlargement procedure to avoid moderate PPM isacceptable in younger patients who can be expected toengage in vigorous physical activities, whereas it wouldnot be prudent in an elderly patient who is presence of the stents in bioprosthetic tissue valvemounting frame leads to a higher profile substitute valve,more so for porcine tissue valves than pericardial valves,particularly at the nadir of the frame. This hypotheticallyincreases the risk of coronary ostial obstruction. Sometissue valve designs have minimized this with lowerprofile struts to facilitate implantation. Orienting thestruts with the native commissures will generally avoidostial obstruction in native tricuspid aortic valves. Theaortic annulus in patients with bicuspid aortic valves whotend to be younger can be markedly ellipsoidal in with a bicuspid aortic valve frequently also havethe left main coronary ostium located more rightward(straight posteriorly) such that the coronaries arise about180 degrees apart, which must be considered whenpositioning the struts of the valve endocarditis is a risk for patients withany type of artificial heart valve, and there is no docu-mented difference in this risk between mechanical andtissue valves over the long term. Although the incidenceof prosthetic valve endocarditis is low, after the initial 90-day high-hazard phase, aggressive antibiotic prophylaxisfor all patients after prosthetic or bioprosthetic AVR ismandatory. Prosthetic valve endocarditis, especially earlyactive prosthetic valve endocarditis, can prove to bea devastating and often fatal harvested from the STS ACSD from 2002 to 2006show the operative mortality risk in the United States forisolated AVR is [84]. In patients undergoingconcomitant AVR and CABG, the STS operativemortality risk for the same time period was almostdouble ( )[163]. Operative risk increases slightlywith patient age in the contemporary era, butconsiderably so if associated comorbidities are to the online STS-PROM risk calculator, thepredicted operative mortality risk for a 70 year oldwithout any comorbidities is for a male and fora female; for an 80-year-old without any comorbidities, itis for a male and for a female[164].Nonstructural valve dysfunction, which includes anyabnormality not intrinsic to the valve, includes hemolysis(incidence closeto0),significantparavalvularleak (1%to 2%ofpatients at1-year follow-up)[165],andPPM(riskofseverePPM 2% to 10% of all patients)[162]. Thromboembolic rateswith biologic valves in the aortic position are to per patient-year. Prosthetic valve endocarditisrates are per patient-year[166].Future of Biological ValvesWith the advent of TAVR in very high risk or inoperablepatients with AS, there has been much talk aboutpotential valve-in-valve implantation as a minimallyinvasive solution for redo AVR operations when SVD ofa bioprosthesis occurs. There have been successfultransapical valve-in-valve TAVR cases reported fora failing aortic tissue valve (both stented and stentless)[167, 168], although there is concern for the potential ofPPM. Measured postimplantation gradients across thetranscatheter heart valve appear to be high after TAVR insurgically implanted valves smaller than 23-mm externaldiameter. Depending on the specific type of bioprosthesisused initially, valve-in-valve TAVR may not be successfulunless the original surgical bioprosthesis was 23 mm orlarger given the limited sizes of commercially availabletranscatheter percutaneous valves available today. Thesmaller transcatheter heart valve prosthesis being devel-oped will address the size problem but not the PPMproblem as internal space is quite limited inside stentedbioprosthesis. It remains unknown how many patientswill be eligible for this potential treatment of SVD in thefuture, but valve-in-valve TAVR in the context of a failingAVR bioprosthesis has been shown to be Enlargement of the AorticAnnulus RecommendationsClass I1. Patch enlargement of the aortic annulus should beconsidered when the aortic annulus does not allowimplantation of a heart valve with EOA index morethan cm2/m2[169 171]. (Level of evidence B)Class IIb1. Patch enlargement of the aortic annulus may beconsidered when the aortic annulus does not allowimplantation of the heart valve with EOA index of (Level of evidence C)The development of operative techniques to enlargethe aortic annulus and LV outflow tract preceded theknowledge of PPM introduced by Rahimtoola in 1978[12].Enlargement of the aortic annulus is performed to allowimplantation of larger prosthetic valves to optimize theS26SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from effective aortic valve orifice. Surgeons who enlarge theaortic annulus to implant larger prosthetic valves musthave a sound knowledge of the anatomy of the aorticroot and its relationship with surrounding Konno procedure, or aortoventriculoplasty, involvesincising the aortic root through the right aortic sinusand into the muscular interventricular septum[172].This incision creates a muscular ventricular septaldefect and by closing the defect with a patch, the aorticannulus is enlarged proportionally to depth of theseptal incision and width of the patch. A second patchis needed to close the right ventricular outflow tract(RVOT).Alternative methods to enlarge the aortic annulusinvolve incisions in thefibrous portion of the LV outflowtract. In the Manouguian procedure, an incision is madethrough the commissure of the left and noncoronarycusps and extended into the subcommissural triangle andanterior leaflet of the mitral valve[173]. The dome of theleft atrium has to be opened when this incision isextended in to the mitral valve. A patch is used to closethe incision and increase the diameter of the aorticannulus. A separate patch may be needed to close thedome of the left atrium. The Nicks procedure forenlargement of the aortic root involves an aortotomy inthe middle of the noncoronary aortic sinus, through theaortic annulus and into the intervalvularfibrous body,and may be extended into the anterior leaflet of themitral valve[174]. Annular enlargement is made witha patch as described above. Another method to implanta prosthetic valve one size larger than the size of theannulus is to suture it in a supraannular position[175].Most currently used bioprosthetic aortic valves aredesigned to be secured in the supra-annular , the midsection of the annulus in each sinuscan be excised to gain one size larger Konno procedure is far more effective in enlargingthe diameter of the LV outflow tract and aortic annulusthan the other procedures but it is also more is frequently used in children and teenagers withcongenitally small roots but less so in adults except forreoperations in young patients with PPM. The procedurecan be done with either a homograft or mechanicalvalves. The Manouguian and the Nicks techniques ofpatch enlargement of the aortic annulus allow to upsizethe prosthetic heart valve by one or two sizes. Attempts tofurther increase the diameter of the aortic annulus bysuturing wider patches deforms the LV outflow tract andcauses so much disturbance offlow that may not improvethe hemodynamic of the prosthetic option that optimizes EOA in patients withsmall aortic annulus is replacement of the aortic root witha bioprosthetic stentless valve or a homograft. However,such procedures must balance the potential benefitofimplanting a larger valve against the possible increase inoperative morbidity and has been shown that the diameter of the aorticannulus is closely related to the patient s BSA[176]. Thus,for a man with BSA of m2to m2the mean aorticannulus diameter is mm, and for a BSA of m2the annulus is mm based onrelaxed aortic root size in cadavers. Women haveslightly smaller aortic annulus than men. Patients whoneed AVR may have an aortic annulus of normal orabnormal diameter depending on the valve pathology,for example the diameter may vary markedly in patientswith bicuspid mismatch has been defined basedon the EOA index of the prosthetic valve[169, 170].Ithas been determined that the ideal EOA index shouldbe more than cm2/m2. Moderate PPM is definedas EOA index of more than cm2/m2to cm2/m2or less, and severe PPM as EOA index of cm2/m2or less. To prevent PPM, it is important to matchthe size of the prosthetic aortic valve EOA to thepatient s BSA. The patient s BMI is also an clinical relevance of PPM has been debated in theliterature, with some studies unable to demonstratea relationship between valve size and outcome[177 179]and others suggesting that PPM increases early and latemortality, decreased exercise tolerance, and decreased LVmass regression[169, 171, 179 182]. Patient-prosthesismismatch may be particularly important in patientswith impaired LV function[169]. Surgeons must thereforebe familiar with the EOAs of various mechanical andbioprosthetic valves that they use and at the time ofAVR, and an attempt should be made to avoid who routinely used patch enlargement of theaortic annulus during AVR believe this procedure can beadded with minimal increase operative mortality andmorbidity[183, 184].8. Homograft (Allograft) Replacement of the AorticValve RecommendationsClass I1. Homograft replacement of the aortic root should beconsidered for patients with extensive active endo-carditic destruction of the aortic annulus[185 189].(Level of evidence B)2. For patients undergoing homograft replacement ofthe aortic valve, a total root replacement technique isrecommended[190, 191]. (Level of evidence B)Class IIa1. Homograft replacement of the aortic valve can beconsidered for patients with endocarditis withoutannular destruction, especially when the potential forreinfectioniselevated[14, 192, 193].(LevelofevidenceB)2. Homograft replacement of the aortic valve can beconsidered for patients undergoing reoperative aorticroot surgery in whom anatomic or physiologicconstraints mitigate against more conventionalcomposite graft replacement or for whom lifeS27Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from expectancy is less than the projected durability of thehomograft[194 196]. (Level of evidence B)Class III1. Homografts are not recommended for routine available xenografts have excellent hemo-dynamics, durability comparable to homografts andare simpler to replace[197 199]. (Level of evidence B)Quality Measures1. All patients undergoing homograft implantationshould receive perioperative prophylactic antibioticswith broad spectrum All patients with a potential for CAD or coronaryanomalies should undergo preoperative evaluation oftheir coronary anatomy by coronary Annual transthoracic echocardiogram to evaluate forAS and Antibiotic prophylaxis against endocarditis for pros-thetic ACE inhibitor therapy should be considered forpatients with low EF successful homograft (allograft) replacementof the aortic valve was reported by Ross in 1962. At thattime, the allograft held the promise of being the idealaortic valve substitute. The ensuing 5 decades of experi-ence with this prosthesis has demonstrated key strengthsand weaknesses and has helped to define its current rolein the surgical management of aortic valve disease. In theUnited States over the past 20 years, homografts havebeen used in less than 3% of AVRs annually. Thatfigurehas decreased in recent experience, and the homograft iscurrently used in approximately of AVRs, mostly forendocarditis[200].ProsThe aortic homograft is human tissue with humananatomy. It has a central orifice with virtually normalhemodynamics and is associated with low transvalvulargradients both at rest and at exercise. This characteristic isof value when treating patients who wish to maintaina physically active lifestyle or younger patients with smallaortic roots where the potential for PPM is greater. Thepotential for thromboembolic problems is negligible andthey do not require anticoagulation therapy. Because ofits natural pliability, when used as a root replacement, itcan conform more readily to deformities and asymme-tries present in the recipient root. The homograft s mostcompelling advantage is that it is devoid of any prostheticmaterial, which confers an apparent resistance to infec-tion. Additionally, the attached anterior mitral leaflet andmuscular cuff can be used to correct defects caused byadvanced endocarditis as characterized by extensiveannular abscess,fistulas, and annular disruption. It is inthe management of advanced native and prosthetic valveendocarditis that the homograft has demonstrated itsgreatest utility[185 189].ConsHomograft implantation is technically more demandingthan mechanical or bioprosthetic stented AVR. Threetechniques have been employed over time: subcoronaryor freehand implant, root inclusion cylinder, and totalroot replacement with coronary ostial in select hands the subcoronary technique hasproduced excellent results[201, 202]and also has beenshown to simplify the inevitable reoperation, most expe-rience with this technique has been less favorable owingto the development of AR[191, 203]. This is related to thejudgment required to replicate proper commissuralspacing and alignment and also related to changes in thegeometry of the retained native aortic root. The rootinclusion cylinder maintains aortic valve geometry butoccupies greater space within the native aortic root, but isuseful when large abscesses are present in conjunctionwith reoperations. Valve sizing is important and there isthe potential for hematoma formation between the nativeaortic wall and the homograft cylinder. Today, total rootreplacement with coronary ostial mobilization is mostcommonly employed because it has demonstrated morereproducible results over a spectrum of pathology, bearssimilarity with the technique for composite valve grafts,does not require precise valve sizing, and can accom-modate native annular deformities[190]. Hemostasis canbe more challenging than with the other two techniques,especially in the setting of extensive endocarditic that worldwide homograft experience isadversely skewed by a greater representation of endo-carditis cases, it is clear that even in experienced centersearly morbidity and mortality are greater than for AVRwith conventional prostheses[14, 192, 193, 201]. Further-more, the homograft root tends to calcify extensively overtime[204], and reoperations are technically challengingand associated with greater perioperative are not immunologically privileged andresidual cells and native proteins elicit a low-gradeimmunologic and inflammatory response that contrib-utes to structural degeneration over time[205]. Indeed,the greatest disappointment with the homograftexperience relates to the issue of SVD. Initially hopedfor extended durability has not been realized and iscomparable to that of pericardial valves (Fig 22).The two most commonly employed methods of pres-ervation are, one, cryopreservation in a solution of anti-biotics and dimethyl sulfoxide and, two, fresh homografts(stored at 4 C in a solution of antibiotics) that areimplanted within weeks of harvest. Cryopreserved valvesare more readily available and most commonly fresh storage results initially in more viablecells and potentially a greater immune response, itappears that there is no significant difference in durabilitybetween these two methods of preservation. As withxenografts, patient age at implantation is the singlegreatest predictor of SVD. Importantly, when adjusted forage at implantation, the durability of homografts closelyparallels that of second and third generation xenograftsS28SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from [14, 193, 198, 199]. In a recently reported and rarerandomized study comparing homografts to the stentlessxenograft, homografts showed greater rates of SVD andneed for reoperation at mid-term follow-up[197].Finally, although the utility of the homograft in treatingcases of advanced endocarditis is well established, severalcenters have reported excellent short and long-termfreedom from recurrent infection with the simplermethod of mechanical or bioprosthetic valve replacementand annular repair with bovine pericardial patch in theabsence of abscesses or extensive tissue destruction orcomposite graft root replacement[194 196].ResultsPrecise comparison and analysis of results isconfounded by (1) the variability in methods of homo-graft preservation and implantation used by and amongreporting centers over time; (2) varying prevalence ofendocarditis in patient cohorts; (3) study time framesoften spanning decades; and (4) the lack of randomizedtrials. Operative mortality for isolated homograft rootreplacement is higher even in experienced centers, andranges from 2% to 8%[14, 191 193, 198, 199, 201, 202].Overall survival after operation ranges from 50% to 81%and from 35% to 58% at 10 and 20 years, respectively[14,191 193, 198, 201, 202]. Valve thrombosis is virtuallynonexistent and thromboembolic events average patient-year. Ten-year and 20-year freedom fromthromboembolism is approximately 93% and 88%,respectively. Homograft durability is primarily depen-dent on age at implantation, and median time to reop-eration for SVD approximates 12, 14, and 16 years fora 30-, 45-, and 60-year-old patient, respectively. In thelargest single reported series to date[198], freedom fromreoperation at 20 years was 47% for patients aged lessthan 21 years, 85% for those between 21 and 40 years,81% for those aged 41 to 60 years, and 94% forpatients aged more than 60 years. However, meta-analysis and microsimulation using more contempora-neous data suggest that freedom from reoperation forSVD at 10 years after operation approximates 74%, 82%,88%, and 92% for ages 35, 45, 55, and 65 years, respec-tively. At 15 years after operation approximately 35%,51%, 63%, and 74% of patients aged 35, 45, 55, and 65years are still free from explant[14, 193, 206].Freedomfrom recurrent endocarditis in several larger series ofpatients undergoing replacement for endocarditis isexcellent and ranges from 82% to 92% at 10 yearspostoperatively[185, 186, 188, 189].9. Stentless Aortic ValvesStentless heterograft valves were developed to takeadvantage of the physiologic nature of homograft valveswith a more standardized method of implantation. Theyare constructed from porcine roots with minimal clothexternally for accepting sutures and tissue are no rigid components or true sewing stentless valves were used in the subcoronarycoronary position for AVR. However, a full root imple-mentation was developed to allow for full root implan-tation and also mitigate early subcoronary valve failuresdue to native aortic root dilation. They can be implantedas subcoronary implants, full root replacements, oruncommonly, inclusion subcoronary placement of this valve is designed toenable conformation to the patient s own aortic root,reproducing a normal valve/root complex. Clinicalstudies have shown residual transvalvular gradientssimilar to native valves and superior to stented valves atearly to midterm follow-up[207]. Exercise gradients werealso superior with the stentless valves at midterm follow-up indicating the valve may perform better under phys-iological stresses than stented valves[208]. That mayeliminate the theoretical risk of PPM in larger patientswith small stented bioprosthesis that have hightransprosthetic gradients[209]. Additionally, morephysiologic laminarflow patterns the sinuses ofValsalva have been observed in stentless valves and arepostulated to decrease the opening and closing stresseson the valve leaflets [210]. Among patients requiring fullroot replacement, porcine bio roots have excellenthemodynamics and do not require life-long anti-coagulation major concerns regarding stentless prosthesesrelate to risk related to increased technical complexity ofimplant, particularly versus simple AVR, issues regardinglong-term durability, and concern for the safety of valve-in-valve Subcoronary Stentless Valve Implantation for AorticValve Replacement RecommendationsCLASS I1. Before subcoronary stentless AVR, all patients whohave known CAD, have had a prior myocardialinfarction, have angina pectoris as a symptom, or aremore than 45 years of age, should have preoperativescreening of their coronary arteries, by direct coro-nary angiography. (Level of evidence C)Fig 22. Relationship between age of patient for pericardial orhomograft valve and the risk of reoperation within 12 years ofsurgery. (SVD structural valve deterioration). This graph is usefulfor discussing with patients the risk of reoperation for biologicalaortic valve Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from 2. Intraoperative TEE is recommended to check thevalve function. (Level of evidence C)3. Prophylactic antibiotics for any invasive procedure,including dentistry, are recommended. (Level ofevidence C)CLASS IIB4. Stentless valves may be a reasonable prosthesis choicein patients aged more than 70 years with non-regurgitant, trileaflet AS who desire a tissue prosthesisand are at risk for PPM. (Level of evidence C)QUALITY MEASURES1. Prophylactic gram-positive and gram-negativecoverage should be used at the time of Intraoperative echocardiography should Postoperative aspirin or clopidogrel should Patients should be discharged on ACE inhibitor therapy should be considered inpatients with low EF valves in the subcoronary position provideexcellent hemodynamics with gradients unmatched bytraditional stented prostheses and have no requirementfor long-term anticoagulation therapy. These excellenthemodynamics are particularly important in small aorticroot where a stented prosthesis may have a high residualgradient. They are more readily available than homo-grafts. They do not require obligatory stentless valve implantation issubstantially more technically demanding and requiressignificantly longer cardiac ischemic times than tradi-tional stented AVR. Long-term durability of these valvesremains unknown and there are concerns of early struc-tural and nonstructural deterioration. Stentless valveshave been shown to have higher failure rates due to rootdilation splaying out the commissures and causinginsufficiency in patients with preoperative AR or bicuspidpathology, although this may be mitigated with preser-vation of the porcine noncoronary sinus tofixate two ofthe commissures. There are theoretical concerns thatstentless valves may be more prone to coronary coverageduring TAVR for prosthetic failure due to their leafletheight and lack of sinuses or a stent. Stentless valvereoperations are reported to have higher mortality thanother aortic valve reoperations and frequently requirecomplex root replacement. Nevertheless, the calcificationis less than that of a a well-designed randomized trial of 99 patientscomparing subcoronary stentless valve implantation toa traditional pericardial prosthesis, despite slightlyimproved gradients in the stentless group, there was nodemonstrated benefit in LV mass regression or physicalactivity status between groups[211]. Recent 10-yearfollow-up of these patients confirmed better hemody-namics in the stentless group but no difference in LVremodeling or physical activity[161]. Thesefindings havebeen confirmed in multiple small trials[212, 213]. Dura-bility of stentless valves in the subcoronary position hasbeen reported to be lower than 80% at 8 to 10 years,implying poorer durability than traditional stented pros-theses[214]. Freedom from thromboembolism andendocarditis are typically greater than 90% at 7 to 10years[214]. Full Aortic Root Replacement With a StentlessProsthesis RecommendationsCLASS I1. Before aortic root replacement, all patients who haveknown CAD, have had a prior myocardial infarction,have angina pectoris as a symptom, or are aged morethan 45 years, should have preoperative screening oftheir coronary arteries by direct coronary angiog-raphy. (Level of evidence C)2. Intraoperative TEE is required to check the valvefunction. (Level of evidence C)3. Prophylactic antibiotics for any invasive procedureincluding dentistry are recommended. (Level ofevidence C)CLASS IIA1. Stentless aortic valve full root replacement may beconsidered in patients aged more than 70 years withaortic root dilation. (Level of evidence C)CLASS IIB1. Stentless aortic valve full root replacement may beconsidered in patients aged more than 70 years athigh risk for PPM who desire a tissue prosthesis.(Level of evidence B)QUALITY MEASURES1. Prophylactic gram-positive and gram-negativecoverage should be used at the time of Intraoperative echocardiography should Postoperative aspirin or clopidogrel should Patients should be discharged on ACE inhibitor therapy should be considered inpatients with low EF of a stentless root prosthesis isusually performed as a traditional root implant withinterrupted pledgeted sutures and coronary buttonreimplantation that is intuitive to perform for mostcardiac surgeons. A running suture technique may alsobe used although this is a more technically demandingprocedure. Stentless roots provide excellent hemody-namics. In cases of extremely small roots in largerpatients, full root implantation may be used for thepurposes of aortic root replacement to implant a largerprosthesis size despite lack of intrinsic aneurysmal rootpathology. Similarly, a stentless prosthesis may be usedin the setting of aortic valve endocarditis with peri-annular REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from CONSStentless aortic roots are technically more difficultto implant than a stented composite root and lack a robustsewing ring to provide a blood-tight seal in diseased orinfected annular tissue. Indeed, the cloth sewing ring maymake them more prone to recurrent infection thanhomografts. They also have a greater potential fordistortion as they lack a rigid stent. The long-term dura-bility of stentless valves remains unknown and reopera-tions are complex. There are theoretical concerns thatstentless valves may be more prone to coronary coverageduring TAVR for prosthetic failure owing to their leafletheight and lack of (30-day) mortality in experiencedcenters is typically between 2% and 4% for elective oper-ations although in early series it exceeded 10%[215].Inarandomized study of 166 patients, within 8 years ofimplant, homografts showed significantly poorer freedomfrom structural failure than the stentless prosthesisfor full root replacement[197]. This and several otherstudies have shown more than 95% freedom fromreoperation and more than 85% freedom fromechocardiographic valve dysfunction at 7 to 10 years offollow-up with preserved low gradients[197, 216].Freedom from thromboembolic events and prostheticendocarditis are generally greater than 90% over the 7 to 10years[197]. Although reoperation is rare over the mediumterm, longer term outcomes are still for failed bio roots are purported to havehigh operative mortality[217].10. Pulmonary Autograft (Ross Procedure) RecommendationsClass I1. The Ross procedure is recommended in infants andsmall children for whom no satisfactory alternativevalve substitute exists. (Level of evidence C)Class IIb1. The Ross procedure may be considered in olderchildren and young adults because of low operativerisk, but patients and their families must be informedof the possible need for reoperation which increasesover time. (Level of evidence C)Class III1. The Ross procedure is not recommended formiddle-aged or older adults when suitable alterna-tives to autograft replacement of the aortic valve areavailable with comparable results and without theneed for replacement of the RVOT, as the latteradds the additional risk of pulmonary valvedysfunction and subsequent replacement. (Level ofevidence C)2. The Ross procedure is not recommended forpatients with bicuspid valves and AR or aorticdilation if other alternatives are available. (Level ofevidence C)Quality Measures1. Patients aged 45 years or more or patients who areyounger with risk factors for CAD undergoing theRoss procedure should have preoperative coronaryartery Patients undergoing the Ross procedure should becounseled about the risk for reoperation on both thepulmonary autograft and the pulmonary Annual TTE should be performed to monitor the sizeof the aortic root and ascending aorta and the functionof the autograft and homograft Appropriate prophylaxis against endocarditis shouldbe performed for invasive ACE inhibitor drug therapy should be considered inpatients with low EF pulmonary autograft (Ross procedure) forreplacement of the aortic valve was introduced by DrDonald Ross in l967. It involves replacement of the aorticvalve or aortic root with the pulmonary valve, which isexcised en bloc from the RVOT. A pulmonary homograftis most commonly used to replace the RVOT. Substantialexperience with the procedure has been accumulatedover the past 25 experienced centers, the procedure can be accom-plished with extremely low mortality in selected youngadults and children[15, 218 226]. Ten-year survival isexcellent, more than 90%, and approaches that for age-and sex-matched populations. Hemodynamic perfor-mance is excellent, anticoagulation is not required,thromboembolic events are rare, and infection infre-quent. It is an important therapeutic option for infantsand children where alternative substitutes performpoorly[225, 226].ConsLong-term follow-up has demonstrated progressivedilation of the autograft when used as a root replacement,neoaortic valve regurgitation, and need for reoperationon the autograft as well as on the allograft in the RVOT[15, 218 224, 226]. Use of the root inclusion rather than theroot replacement technique (the most widely utilized) toprevent autograft dilation has not reduced the rate ofreoperation[222, 224]. The risk of dilation appears to beincreased in patients with bicuspid valves, particularly ifassociated with AR or aortic dilation[224].ResultsOperative mortality in the largest reported series has rangedbetween and [15, 218 224, 226]. Major post-operative complications were infrequent. Minimal gradientshave been observed across the autografts and these remainstable. Mild to moderate gradients exist across the valvesubstitutes in the RVOT, and some become sufficientlysevere to require percutaneous or open surgical proceduresfor correction[15, 218 224, 226]. Ten-year survival hasranged between 92% and 98% and is remarkably consistentamong centers[218 224]. Survival approaches that forS31Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from age-and sex-matched populations[219, 220, 224].Amongchildren requiring AVR, use of the Ross procedure confersa survival advantage over mechanical valves in youngerchildren but not in young adults[225, 226].The principal limitations of the procedure areprogressive dilation of the autograft at the sinus andcommissural levels with the root replacement technique,neoaortic valve regurgitation with both the root replace-ment and inclusion techniques, and the need for reop-eration on the autograft and the homograft in the percentage of patients free from reoperation on theautograft at 10 years varies from 75% to 94% among thelarge reported series[218 222, 224]. Longer follow-upfrom the largest reported series of patients (n 487) re-ported by Elkins and colleagues[221]indicatesa continued decline in the number of patients free ofreoperation or valve-related death (86% at 10 years and74% at 16 years). Freedom from reoperation on thepulmonary allograft in the RVOT is better and moreconsistent, ranging from 90% to 97% at 10 years[218 224].Freedom from any reoperation is reported lessfrequently, and varies from 73% to 90% in four series at 10years[218, 219, 223, 224].Endocarditis occurs infrequently (25 of 1,660 patients[ ]) with data suitable for analysis in the large series[218 224]. Major thromboembolic episodes (principallystroke) occurred in 11 of the 1,160 patients ( ), and inseveral instances were associated with the developmentof availability of bioprosthetic aortic valve substitutesthat have acceptable hemodynamic characteristics, do notrequire anticoagulant therapy, and have comparable laterates of reoperation on the aortic valve or root, calls intoquestion the role of the Ross procedure for all but infantsand small children for whom no suitable alternative valvesubstitute is Balloon AorticValvuloplasty RecommendationsClass IIa1. BAV can be useful as bridge to AVR in hemody-namically unstable adult patients with severe ASwhere immediate AVR is not feasible. (Level ofevidence C)2. BAV should be considered for patients with contraindications to AVR who can potentially be bridged toAVR or TAVR in future. (Level of evidence C)3. BAV should be considered in severely symptomaticpatients with multiple comorbidities where contri-bution of AS to symptomatology such as chronicpulmonary disease or poor LV function, remainsunclear. (Level of evidence C)Class IIb1. BAV may be reasonable in severely symptomaticpatients where AVR is not an option for symptomrelief. (Level of evidence C)2. BAV may be considered in patients with symptomaticsevere AS who require urgent major noncardiacsurgery. (Level of evidence C)3. BAV may be considered as a palliative measurein individual cases when surgery is contraindi-cated because of severe comorbidities. (Level ofevidence C)4. Hemodynamic assessment including cardiac output,aortic, LV and pulmonary pressures may be consid-ered before, during and after the procedure. (Level ofevidence C)5. Rapid ventricular pacing may be performed to stabi-lize balloon during inflation unless self seatingdumbbell shaped or other specifically designedballoons are available that do not require pacing.(Level of evidence C)Quality Measures1. Candidacy for AVR should be thoroughly assessed incollaboration with cardiac Assessment of annular diameter and preproceduralAR should be carefully made with Vascular access should be carefully evaluated withangiography before insertion of the closure deviceand a large Stepwise dilation of the aortic valve can be used toachieve desired hemodynamic Hemodynamic monitoring during BAV shouldinclude aortic diastolic pressure, LVfilling pressuresand cardiac Procedural outcomes with special attention to groincomplications, AR, and procedural mortality shouldbe Patients should be monitored for the rate at which thepatients are bridged to surgical AVR or aortic valvuloplasty is performed mainly tobridge high-risk patients to surgical AVR or for bridging include temporary contraindicationsto valve replacement (sepsis, severe debilitation, acuteneurological event, coagulopathy, congestive heartfailure, ventilator dependence etc.), significant othercardiac lesions (coronary, mitral valve, tricuspid valve,myocardial disease) where relative contribution of AS toheart failure remains questionable, or in patients withsevere noncardiac comorbidities where role of AS inpresenting symptoms is difficult to determinate (eg,severe lung disease, cirrhosis, severe debilitation, etc)[227]. Infrequently, BAV can be used for patients withsymptomatic severe AS who require urgent majornoncardiac surgery. Rarely, it can be helpful forpalliation in adult patients with AS in whom AVRcannot be performed because of serious comorbidconditions, although short-lived improvement makessuch an effort a temporary success. Sometimes BAV ishelpful to assess the contribution of AS to respiratoryfailure when combined with severe chronic obstructivepulmonary disease. A marked improvement suggests thatS32SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from AS is a major contributor although lack of improvement isnot very specific for pulmonary aortic valvuloplasty can be performed eitherwith retrograde or antegrade approach[228, 229]. Theretrograde approach entails femoral arterial access. In theantegrade approach from the femoral vein, a transseptalpuncture is performed and the aortic valve is approachedthrough the mitral valve going antegrade through the aortic valvuloplasty provides the only treatmentoption for hemodynamically unstable patients who arenot candidates for surgical or transcatheter AVR. Hemo-dynamic improvement is rapid which provides anopportunity to manage comorbidities while more defini-tive valve replacement is BAV is technically easier but requiresreasonable groin access. Antegrade BAV can be performedin patients with poor arterial access but can be more chal-lenging especially in patients with small left ventricles,severe mitral regurgitation or hemodynamic efficacy is only moderate with a typical AVAof less than cm2. Procedural risk is also not trivial anddepending on the patient population there can be as highas 10% 30-day mortality with the procedure. Further, theprocedural benefits are short lived with most patientsrestenosing in 6 are several improvements to the procedure thatmay help with each of the above issues. With rapidpacing of the ventricle and use of larger balloons, an AVAof more than cm2is feasible in increasingly largernumber of patients although conclusive data are can be reduced by better management of thevascular access site. Restenosis risk is still a problembut since the most common indication of this procedureis a bridge to more definitive therapy, it may not bea fundamental limitation. Conversely, use of BAV asa stand-alone procedure has limited value unlesscombined with bridging to surgical AVR or aortic valvuloplasty combined with radiation hasnot received much success is classically defined as more than25% increase in AVA or more than 50% reduction inmean aortic gradient. Procedural mortality (1% to 5%) isprimarily from AR, and 30-day mortality (6% to 10%)results from persistent heart failure along with othercomorbidities[227, 230 236]. One-year mortality inpatients not bridged to AVR is 40% to 60%, very similarto the estimated mortality of symptomatic AS patientstreated with medical management alone. Seriousvascular complications rates were reported to be morethan 20% in the past, but with recent improvements inclosure devices and availability of smaller profileballoons, these rates are in 1% to 2% range[237 239].Repeat valvuloplasties for recurrent symptoms ininoperable patients have been successfully accom-plished with very similar risks and outcomes as thefirstBAV, but subsequent BAV procedures have less recently reported PARTNER B trial suggestedsurvival to 2 years was improved in medically treatedpatients who also underwent BAV for AV, although themerits of advocating BAV in patients not eligible forTAVR is debatable[81] .12. Transcatheter Aortic Valve ReplacementTranscatheter aortic valve replacement has been usedworldwide in more than 40,000 cases to date at the time ofwriting, using balloon expandable and self-expandingvalves. This extensive experience suggests similarprocedural success. Introduction into the United States isrelatively recent with the completion of the PARTNERtrial using a balloon expandable valve and the FDAapproval for nonoperative patients. The US Pivotal trialfor a self-expanding valve is under way and was expectedto complete enrollment in 2012. Guidelines can only beconstructed for approved devices, thus limiting thecommittee despite extensive data from abroad. Theguidelines for TAVR are thus constructed with this inmind and reflect what is currently allowed in the UnitedStates and may be incomplete outside this country. Withthe completion of current and future trials and potentialFDA approvals, the committee may issue an addendumto these guidelines as TAVR With the Balloon-ExpandableValve Recommendations1CLASS I1. Evaluation for TAVR should be performed bya multidisciplinary team and panel[81, 240]. (Level ofevidence A)2. TAVR should be performed by a multidisciplinarycardiovascular and cardiac surgery team[81, 240].(Level of evidence A)3. If available as part of a research protocol or after FDAapproval, transfemoral AVR is recommended ininoperable patients provided they have an expectedsurvival of greater than 1 year[81]. (Level of evidenceA)4. If available as part of a research protocol or after FDAapproval, transfemoral, transaortic, transaxillary, ortransapical AVR with the balloon expandable valvecan be considered in patients who are operativecandidates and have a predicted surgical mortalitygreater than 15% and an STS score greater than 10%by two independent surgical assessments[240]. (Levelof evidence A)5. TAVR should be performed in a hybrid operating orcatheterization room dedicated to the procedure andnot with mobile c-arms[81, 240]. (Level of evidence B)1The self-expanding nitinol bioprosthesis is currently available inEurope and is under investigation in the US Pivotal trials, butUS recommendations are not Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from CLASS III1. Transfemoral aortic valve implantation witha balloon-expandable valve should not be performedin patients who are not at high risk for conventionalsurgery. (Level of evidence C)2. Transfemoral aortic valve implantation witha balloon-expandable valve should not be performedin patients who have other comorbidities that limit1-year survival or whose extreme frailty limits thelikelihood of functional recovery after TAVR. (Level ofevidence C)QUALITY MEASURES1. Patients being considered for TAVR should havesurgical assessment by a multidisciplinary teamincluding two independent surgeons to determineoperative risk. Objective measures of risk such as theEuroSCORE and STS risk score should be used todocument risk but should not be used independentof a surgical Patients being considered for TAVR will needa thorough preoperative assessment including TTE,diagnostic catheterization, PFTs, and CT Asymptomatic mild or moderate CAD does not needto be treated before TAVR. Clinically significantCAD that would impact the safety of TAVR proce-dure should be revascularized before Vascular access should be assessed by iliac andfemoral angiography as well as CT angiography. Inpatients with renal insufficiency, vessel anatomy canbe assessed by IVUS and noncontrast CT. All studiesshould be reviewed by the physicians responsible forpotential vascular Intraprocedural TEE should be employed to assistwith, TAVR planning, valve positioning, and valveassessment after TAVR procedures should be performed by a cardio-vascular medicine and cardiac surgery multidisci-plinary team with extensive experience with high-riskvalve surgery and percutaneous coronary interven-tions and balloon Patients should be followed with annual TTE toassess valve function and monitor paravalvular Patients should continue on a regimen of clopidogrelfor 3 to 6 months and aspirin indefinitely after patients with atrialfibrillation, aspirin andwarfarin should be continued indefinitely if All centers performing TAVR should report theirresults to a national Procedure time,fluoroscopy time, transfusionrequirements, use of cardiopulmonary bypass,number of valves placed, need for sternotomy orconversion to conventional surgery, vascularcomplications, and amount of contrast used shouldbe measured for all Patients should be given routine antibiotic prophy-laxis for all invasive procedures and routine notion of TAVR started gaining momentum in theearly 1990s when Andersen and associates[241]demonstrated that a tissue valve mounted within a stentcould be delivered into the aorta in a closed-chest animalmodel. Thefirst successful human case of TAVR in a patientwith AS was performed in 2002 by Cribier and colleagues[242]. This initial case was performed with thefirst versionof a balloon expandable transcatheter equine pericardialvalve through the antegrade transfemoral vein approachin a patient who was refused for operation. Thisapproach, which required a transseptal catheterization,was technically challenging and associated with frequentcomplications[243]. Eventually the transseptal antegradeapproach was abandoned in favor of the currentlyaccepted retrograde transfemoral arterial major TAVR valves are in clinical trials in theUnited States, and these have been widely implantedoutside the US. Two available versions of the balloon-expandable transcatheter valve are under version initially studied in pivotal clinical trials in theUnited States consists of a trileaflet bovine pericardialvalve that is hand sutured into a stainless steel, tubular,slotted, balloon expandable stent. There are 23-mm and26-mm diameter valve sizes that can accommodate aorticannulus sizes between 18 mm and 25 mm, with a 29-mmvalve available in some countries. At the time of theprocedure, the sterile stent valve is crimped onto a stan-dard balloon catheter. The device is advanced retrogradethrough a common femoral artery access site througheither a 22F or 24F sheath depending on the valve sizeselected. Underfluoroscopic guidance, the valve isadvanced, positioned, and deployed with balloon infla-tion within the diseased native aortic valve. Brief rapidright ventricular pacing is utilized during deployment toprovide mechanical asystole, which minimizes valvemotion and migration. This procedure is usually doneunder general anesthesia with the assistance of trans-esophageal newest version of the balloon-expandable trans-catheter valve has a lower profile delivery system (18Fand 19F) that allows the entire system to be used insmaller iliofemoral self-expanding nitinol valve has porcine pericar-dial is alsodeliveredretrograde in the femoralartery with an 18F introduction system. Experience is alsogrowing with delivering this valve in both a subclavian ortransaortic approach. Two sizes are available in theUnited States for the pivotal trials, namely, a 26-mmlabeled valve for annular sizes 20 mm to 23 mm anda 29-mm valve for annular sizes 24 mm to 27 mm. The UStrial has an extreme risk arm for severe, symptomatic ASwith a predicted risk of death or irreversible morbidity at30 days exceeding 50%. The primary endpoint is all-causedeath or stroke at 1 year. The high-risk arm is enrollingpatients with a predicted risk of death of at least 15% witha primary endpoint of death at 1 year. Trial enrollmentwas expected to be completed in 2012. The version of theself-expanding stent being studied in the US Pivotal trialis a nitinol frame with a trileaflet porcine pericardialvalve. This valve comes in sizes of 23 mm, 26 mm, 29 mm,S34SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from and 31 mm covering annular sizes from 18 mm to 29 the time of the procedure, the valve is crimped on theprovided sterile delivery system and delivered retrogradeby either the femoral, transaxillary, or direct aortic routesfor the trial. A BAV is generally done under rapidventricular pacing. The valve is then positioned underfluoroscopic and echocardiographic control and isdeployed in a controlled fashion without the necessity ofrapid ventricular pacing. The extreme risk arm of this USpivotal trial has beenfilled and the high-risk arm wasexpected tofill during the implanting centers for the randomized trail,transfemoral AVR was performed with acceptable 30-dayand midterm mortality in appropriately selected high riskor extreme surgical risk patients[81, 240, 244 247]. Recentstudies have shown that more than 30% of patients withsymptomatic AS do not undergo surgical AVR[248].Many of these patients would now be candidates forTAVR. Hemodynamic results after TAVR have beenexcellent with valve areas comparable to those ofsurgically implanted aortic valves[81, 240, 246, 247].Todate, there has been no evidence of prosthetic valverestenosis in midterm follow-up. There is no need forlong-term anticoagulation therapy with this valve, andvalve-related thromboembolic events have been observedrarely. The procedure can often be performed percuta-neously, including arterial access and closure. Self-expanding valves are also easy to insert and also havea lower profile and can be used in patients with moresevere AR. At this time the balloon implantable valveshave not been studied in patients with severe procedure remains challenging and should belimited to experienced operators owing to the frequentoccurrence of periprocedural complications[81, 240, 246,247]. The current generation devices require largesheaths, 22F and 24F for the balloon expandable valve and18F for the self-expanding valve. That limits the ability toperform transfemoral aortic valve implantation inpatients with peripheral vascular disease. It also results invascular complications that are often problematic andmay result in increased mortality. In addition, there isa risk of embolic events, especially cerebrovascular,related to traversing the aorta and aortic valve with thedelivery catheter. Another concern with TAVR is para-valvular AR, which is generally mild, but in a smallpercentage of patients (7% to 10%) moderate or severeparavalvular AR has been reported. Other complicationssuch as annular rupture and coronary occlusion or heartblock are rare but unpredictable. If complications dooccur or the currently available valve is malpositioned,the device is not retrievable or repositionable. The nitinolself-expanding valve has been associated with a higherincidence of heart block and the need for pacemakers inapproximately 20% of patients[249].To establish a universal standard for evaluating TAVRoutcomes, the Valve Academic Research Consortiumdefinitions were established (Table 4) to track the last several years, there have beennumerous trials published evaluating transfemoral AVRwith both valve types. These studies have all beenobservational registries in high surgical risk patientsdeemed either inoperable or operable high-risk candi-dates for conventional AVR. Operative and 30-daymortality in these series ranged from to 12%.Valve function was excellent in all cases, with minimalgradients across the valve and valve areas greater than [81, 240, 246 248, 250, 251].Recent studies have reported improved proceduraloutcomes after TAVR. The European SAPIEN AorticBioprosthesis European Outcome (SOURCE) registry wasinitiated to collect outcomes after TAVR after commercialapproval in Europe[252]. Procedural success in this serieswas reported at with a 30-day mortality of procedural complications were similar to earlierseries with strokes and major vascularcomplications. One-year survival after transfemoral AVRin this study was [253]. Of the 32 centers in thisstudy, 23 (72%) had never done a transfemoral valveimplantation before the study. These data suggest thatthe device improvements as well as improved patientselection and procedural techniques will continue toresult in improved acute results. Similar results havebeen repeated for the nitinol self-expanding results are limited in these early mortality has been remarkably consistentbetween the different studies, varying between and26%[246, 247, 251, 253]. The majority of deaths werenonvalve related. In a series published by Webb andcoworkers[247], the 1-year valve-related mortality wasless than 5% and the all-cause mortality was 26%. Therehave been no reports of SVD in these studies at 1 year,and valve areas have remained more than cm2. Initialparavalvular AR has not changed significantly during1-year follow-up. There have been no reported cases ofvalve migration or strut fractures of the support that paraaortic valve regurgitation may result inincreased hemolysis or endocarditis has not been seen;however, continued heart failure related to regurgitationrequires further PARTNER B trial showed that TAVR reducesmortality in patients with AS who cannot have surgicalAVR[81]. At 26 centers, 699 patients who had severe ASwho were at high risk for operation were randomlyassigned to either AVR or TAVR (transfemoral ortransapical approach) using a balloon expandablebovine pericardial valve. The primary endpoint wasdeath from any cause at 1 year and the primaryhypothesis was that TAVR is noninferior to PARTNER trials are the only published random-ized trial evaluating transcatheter AVR. Entry criteriaincluded severe AS defined as less than cm2area andmean valve gradient 40 mm Hg or more or peak velocity m/s or greater. High-risk patients were required tohave an STS score of 10% or higher and a surgeonassessment of the predicted 30-day mortality of 15% orgreater. Inoperable patients had to have a combinedrisk of death or irreversible risk of serious morbiditymore than 50%. Patients were assessed bya multidisciplinary team and panel, and the TAVRS35Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from procedure was performed by a multidisciplinary cardiacsurgery and cardiovascular team. The primary endpointwas all-cause mortality at 1 year (noninferiority designin the high-risk surgical arm and superiority design in theinoperable study).In the nonoperative arm of the trial, 30-day mortalityafter TAVR was versus in the medically treatedpatients (p )[81]. Procedural complications weresimilar to earlier trials with a major stroke, vascular complication, and major bleedingevent rates. Valve hemodynamics were excellent, witha mean valve area of cm2. Paravalvular leakremained a problem with 13% of patients having morethan 2 regurgitation after the procedure. One-yearsurvival was dramatically improved with a 20% reduc-tion in absolute mortality in patients treated with TAVRversus medical therapy, versus (p< ).There were also significant improvements in New YorkHeart Association (NYHA) functional class and 6-minutewalk distances. There was a separate quality of life sub-study that revealed dramatic improvements after TAVRcompared with medical therapy that were sustained outto 1 year. The results from the nonoperative arm of thePARTNER trial demonstrated that TAVR is the standardof care for inoperable patients and should be offered toappropriate candidates[254].In the high-risk operative arm of the PARTNER trial,492 patients were randomized between transfemoralTAVR and surgery[240]. Thirty-day and 1-year mortalitywere not significantly different between transfemoralTAVR and surgery, versus at 30 days (p )and versus at 1 year (p ). That met theprespecified criteria for noninferiority (difference ,95% upper confidence limit , predefine margin ;p for noninferiority). There was no significantdifference in rates of major strokes after transfemoralTAVR compared with surgical AVR at 30 days ( ,p ) or 1 year ( versus ,p ). Including all strokes and transient ischemic attacks,events were more frequent after transfemoral TAVR thanafter AVR at 30 days ( versus ,p ) and at 1year ( or ). Major vascular complicationswere more frequent after TAVR ( versus ,p< ), whereas major bleeding ( versus ,p< ) and new-onset atrialfibrillation ( versus ,p< ) were more frequent after AVR. Symptomimprovement favored TAVR at 30 days but was similarafter 1 year. Paravalvular regurgitation was morefrequent after TAVR than AVR (p< ). The trialconcluded that for patients with severe AS who are athigh risk for surgery, TAVR and AVR was associatedsimilar survival after 1 year, although there were impor-tant differences in periprocedural hazards[240].In addition to the above studies for native AS, there hasbeen limited experience with TAVR for failed aortic andmitral bioprosthesis. The largest series includes 24patients, of whom 10 underwent TAVR for a failed aorticbioprosthesis[168]. There were no deaths at 30 daysamong these patients. In the future, these proceduresmay be performed through the transfemoral approachwith improvements in the device and proceduraltechnique. However, candidates will be limited by thetype and size of aortic bioprosthesis initially implanted,and patients with small surgical valves will not becandidates with the current generation Transarterial Aortic Valves: New Developmentsin Percutaneous Aortic New Valves and Delivery SystemsCurrently available valves appear to offer the potential forrelatively durable clinical benefit [247, 255]. Nevertheless,current valves have limitations, particularly in terms ofdeliverability, deployment, and annular sealing[256, 257].Valves and valve delivery systems function synergisti-cally, and changes in one component necessitate changesin the the greatest urgency is to reduce the risk ofarterial injury through the development of lower profiledelivery systems[256 259]. Approaches to further mini-aturization include use of reengineered lower profiledelivery catheters, more compressible frame designsconstructed of newer alloys, thinner and morecompressible leaflet materials, thinner walled sheaths orexpandable sheath systems, and systems that remove theneed to introduce an expanding balloon inside anexpandable frame (self-expanding, non balloon expand-able, or sequential balloon introduction systems).Newer systems will likely incorporate features tofacilitate positioning (recapture, reposition, and rede-ploy), sealing[260 262], coronary access[263 266]and, ifthese are not optimal, retrieval. A number of valves areundergoing early clinical evaluation and many more arein development[267 270]. In seeking lower profiles,retrievability, and other enhancements it will be impor-tant not to sacrifice ease of insertion, frame strength,hemodynamic function, or durability[271], the latter ofwhich will become increasingly important as theprocedure is more widely applied and in youngerpatients[272, 273]. Stroke PreventionThe reported incidence of clinically diagnosed stroke incurrent high-risk registries ranges from 2% to [246,247] . The majority of strokes are likely embolic and aredue to mobilization of atheromatous and calcificembolifrom the ascending aorta and native valve. Manipulationwithin the native valves appears to be an important MRI and transcranial Doppler suggest that subclin-ical brain embolization occurs in the majority of patients,raising concerns about neurocognitive decline[274, 275].Whether preprocedural echocardiographic or CTscreening for arch atheroma is of value is delivery systems are likely to be lower profile andless traumatic. Whether there is a difference in risk ofstroke according to valve type or access approached isunknown[252, 276]. A number of embolic control devicesare under investigation such as deflection andfilteringdevices. Whether this will translate into clinical benefitisalso REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from Procedural ImagingHigh-qualityfluoroscopic imaging is a prerequisite forTAVR. Portablefluoroscopic imaging systems are rarelyadequate owing to the limitations of these systems interms of image quality and review as well asflexibility andcamera positioning. Prompt access to transthoracic andtransesophageal echocardiographic imaging when neededto assess valve positioning and function, ventricular func-tion andfilling, and pericardial effusions is a necessity[277 280]. Three-dimensional TEE guidance during valveimplantation maybe of value, but the necessity of this iscontroversial for some devices[279, 281, 282].A number of advanced imaging systems are underdevelopment that utilize computerized real-timefluoro-scopic guidance[278], in-laboratory three-dimensionalangiographic reconstruction, CT coregistration[283], real-time magnetic resonance[284], or other modalities. Suchsystems are intended to assist in the evaluation of theaortic valvular complex and accurate positioning of theprosthesis. While promising, the role of these systemsremains to be Hybrid SuitesTypically, TAVR is performed in either a hybrid cardiaccatheterization laboratory or hybrid operating roomsetting. The requirement for high-qualityfluoroscopicimaging and ready access to rarely used catheterizationequipment may not be achieved in a standard operatingroom environment. Conversely, a standard cardiaccatheterization laboratory may not offer optimal sterilityor options for anesthetic or surgical support. Thepossibility of unexpected hemodynamic instability inpatients with AS argues for ready access to temporarycardiopulmonary support. Consequently, the concept ofa hybrid suite optimized for both endovascular andopen surgical procedures is recommended. It seemslikely that optimal outcomes will be achieved in thisoptimal Endovascular AccessTransvenous access to the aortic valve was problematicand has been abandoned in favor of transarterial accessfrom the femoral artery. Early systems required surgicalcutdown and open repair of the femoral artery. Withincreasing experience and a progressive reduction incatheter size, percutaneous closure is becoming increas-ingly reliable and will likely be routine[285].The major limitation of arterial access remains the risk ofvascular injury[271, 286]. Transapical access avoids therisk of arterial injury and provides ready access to theaortic valve[287]. It has been suggested the risk of aorticatheroembolism may be lower than retrogradeapproaches, although evidence for this is lacking. Limi-tations include the risk of apical injury, mitral injury, andthoracotomy. Percutaneous apical closure devices areunder investigation but as yet access alternatives have included retroperitonealaccess to the iliac artery and direct access to the aorta. Theminimal invasive upper sternal J incision[102]and smallright anterior thoracotomy with access to the ascendingaorta has become popular in many centers[288 290].Recently open transaxillary or subclavian arteries accesshas found greater favor[291 294]. Disadvantages includethe need for a cutdown, risk to mammary arterial grafts,compression of the delivery catheter, and surgical repairshould injury Valve-in-ValveImplantation of transcatheter valves within dysfunctionalor malpositioned transcatheter valves has been demon-strated to be feasible and potentially effective[261, 262,271, 295, 296]. Similarly experience with transcatheter valve-in-valve implantation has been favorable inpatients with failed surgical bioprostheses[168, 178, 262,288, 296 301]. Although experience has been favorable itmay be difficult if not impossible to evaluate all of thepossible combinations of types and sizes of prostheticvalves. The implications for valvular function and dura-bility are TAVR in Lower Risk PatientsThe FDA has made it clear that to use TAVR in lower riskpatients, randomized trials are required. Two trials areplanned and have obtained FDA approval to two trials, PARTNER II A and SURTAVI have similarenrollment criteria, including STS score 4 or higher. ThePARTNER trial will enroll 2,000 patients and SURTAVI,1,860 Transapical Aortic Valve RecommendationsClass I1. Transapical insertion of a balloon expandable aorticvalve is recommended in patients with symptomaticsevere AS who are considered to be at excessive riskfor conventional AVR and are not candidates fora transfemoral approach due to preexisting peripheralvasculature disease, and who have an expectedsurvival of at least 1 year[240]. (Level of evidence B)2. Evaluation for TAVR should be performed bya multidisciplinary team and panel[81, 240]. (Level ofevidence A)3. TAVR should be performed by a multidisciplinarycardiovascular and cardiac surgery team with exten-sive experience with high-risk valve surgery andpercutaneous coronary interventions and balloonvalvuloplasty[81, 240]. (Level of evidence A)4. If available as part of a research protocol or after FDAapproval, transfemoral, transaortic, transaxillary, ortransapical AVR with the balloon expandable valvecan be considered in patients who are operativecandidates and have a predicted surgical mortalitygreater than 15% and an STS score greater than 10%by two independent surgical assessments[240]. (Levelof evidence A)5. TAVR should be performed in a hybrid operating orcatheterization room dedicated to the procedure andnot with mobile c-arms[81, 240]. (Level of evidence B)S37Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from Class IIa1. Transapical insertion of a balloon expandable aorticvalve may be a reasonable alternative in patients withcritical AS who have an estimated mortality of at least15% as independently judged by two cardiothoracicsurgeons, or who have a predicted risk of mortalityusing the STS-PROM algorithm of 10% or greater,and do not have access for the transfemoral PARTNER A trial was not powered to accessnoninferiority. (Level of evidence C)Class III1. Transapical insertion of a balloon expandable aorticvalve is not recommended for low-risk patients withcritical AS who are considered good candidates forconventional valve replacement. (Level of evidence C)Quality Measures1. All patients referred for transapical TAVR, should beevaluated by multidisciplinary team and two cardio-thoracic surgeons to determine suitability forconventional valve All patients being considered for transapical TAVRshould have a preoperative left heart catheterization,TTE, PFTs, and a CT scan of the chest, abdomen, andpelvis through the femoral Intraoperative TEE should be used in addition tofluoroscopy to adequately position the valve Procedure time,fluoroscopy time, transfusionrequirements, use of cardiopulmonary bypass,number of valves placed, need for sternotomy orconversion to conventional surgery, vascular compli-cations, and amount of contrast used should bemeasured for all Patients should be placed on double antiplateletagents for at least 3 to 6 months unless contra-indicated, and aspirin indefinitely after the All patients should have a yearly TTE and Patients should be given routine antibiotic prophy-laxis for all invasive procedures and routine Patients should be enrolled in a national investigation into using the LV apex as an accesssite for catheter based implantation of a balloonexpandable aortic valve was initially performed asa collaborative effort between both surgeons and cardi-ologists[86, 302]. Building upon this preliminaryresearch, thefirst successful transapical implantation wasperformed at St Paul s Hospital in Vancouver, BritishColumbia, Canada, in 2005[303].Transapical valve implantation is performed through ananterior thoracotomy, usually entering thefifth or sixthintercostal space or resecting a short piece of rib to reachthe LV apex. The optimal insertion site for the deliverysheath is in the muscular portion of the apex, which isslightly cephalad and lateral to the true apex of the the apex of the left ventricle while watching theTEE helps confirm the correct entry site. Hemostaticcontrol of the insertion site is obtained using either pur-sestring or opposing U-type sutures, with as many as threesutures. The valve comes in two sizes, 23 mm and 26 mm,both of which are delivered through a 26F sheath. Aballoon valvuloplasty is performed to create space forblood toflow around the prosthesis as it is positioned inthe annulus. Optimal positioning is achieved usingfluo-roscopy and TEE such that native annulus hinge pointsbisect the midposition of the prosthesis. Rapid ventricularpacing is performed to reduce cardiac output during valvedeployment to reduce the risk of prosthesis recently, many centers deploy the valve slowly sothatfine adjustments can be performed during deploy-ment for optimal positioning. Sheath removal and closureof the LV apex is performed on a depressurized heart inmany centers by rapidly pacing the heart ventricle toreduce the patient s systolic blood with the transfemoral approach, for mostcenters the transapical technique is generally faster, usesless contrast, and requires shorterfluoroscopy , control of valve placement is enhanced withthe transapical approach owing to the stiffness of thedelivery catheter and the short working distance betweenthe apical insertion site and the aortic annulus. ThePARTNER trial results containing the outcomes of a high-risk group of patients having transapical aortic valveimplantation are published[240].ProsTransapical valve implantation can be performed closedchest, beating heart, and without the use of cardiopulmo-nary bypass, even in nonoperable or prohibitive-riskpatients. This approach is particularly efficacious forpatients who have had previous bypass grafting or cardiacsurgery as it obviates the risk of cardiac or inadvertentgraft injury due to repeat sternotomy. Compared withtransfemoral TAVR, sheath size for valve delivery is nota limiting factor in patient selection for the transapicalapproach. Thisflexibility in sheath size also enablesmodifications to be made to the structure of the valve toreduce the propensity for paravalvular leak, additions thatwould be challenging with peripherally implanted devicesdue to an emphasis on profile size. Some data suggest therisk of stroke is lower with the transapical valve implantation can be successfullyperformed in patients with occlusive peripheral vasculardisease and in patients with diminutive or tortuousperipheral vessels. Additionally, anatomic factors such astrue porcelain aorta, which would be a contraindication toconventional AVR, are amenable to a transapicalapproach. The hemodynamic performance of the valveshas been excellent, with low gradients and impressiveorifice areas, even in patients with small aortic annuli[304, 305].As with the transfemoral approach, the transapicalapproach has also been utilized as the access site ofS38SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from choice for the implantation of a transcatheter valve intoa degenerated bioprosthetic valve[306]. The ability toavoid a redo valve replacement with its attendantmorbidity and mortality is a significant benefitoftranscatheter technology. Although feasible througha transfemoral approach, the LV apex is a good accesssite for catheter based mitral valve replacement as itprecludes the need for a transseptal approach, thussimplifying the procedure. Current research is focusedon developing technology to enable a port accesstransapical procedure to be remains a significant learning curve to achievemastery of the transapical procedure. Procedural steps tobe mastered include exposure and control of the LV apex,valve positioning and deployment, and control of thechoreography of the procedure. Significant complica-tions, including catastrophic LV apical bleeding, werenoted in several early reports. Other complications notedwith the transapical procedure as with the transfemoralapproach include embolization of the valve, either distallyinto the aorta or proximally into the left ventricle, coro-nary obstruction, and aortic root rupture. Appropriatepatient selection is critical to ensuring optimal outcomeswith the transapical procedure, particularly in regard tothe recognition of unfavorable procedural leak remains a consistentfinding in themajority of patients undergoing both transapical andtransfemoral aortic valve implantation. Although hemo-lysis and endocarditis have not been significantly associ-ated with thisfinding, the long-term implications for theenergy loss associated with paravalvular leak are unknown[307]. Valve durability also remains unknown, particularlyin regard to the effect that crimping of the valve onto thedelivery balloon has on leaflet structure and longevity. Todate, the failure mode of the valve also remains unknownalthough root thrombus restricting leaflet motion hasbeen for the transapical procedure includecalcification of the pericardium or LV apex, patch repair ofthe apex secondary to an aneurysmectomy, LV apexthrombus, or severe respiratory insufficiency that would beexacerbated by a thoracotomy. Additionally, certainanatomic abnormalities that preclude accessing the LVapex, such as extreme rotation of the heart or previouspneumonectomy resulting in dislocation of the heart intoeither the right or left chest, rule out a transapical majority of the early results reported on the transapicalprocedure were observational in nature, describing eitherfeasibility outcomes or early multiple-center and colleagues[302]reporting thefirst 40transapical aortic valve implantations performed in theUnited States in an extremely high risk population withpatients having an STS-PROM score more than 15% orinoperability described a procedural success rate of a 30-day survival of The European multiple-center feasibility study, the TRAVERCE ((Trans-ApicalSurgical Delivery of the Cribier-Edwards Aortic Bio-prothesis Clinical Feasibility) trial, reported a larger cohortof 168 patients, showing a procedural success rate of 30-day survival of 85%[308]. These studies wereperformed early in the investigators TAVR experienceusingfirst-generation technology that included a 33Fdelivery sheath in many survival was demonstrated as center experi-ence increased. Rodes-Cabau and colleagues[246]reportedthe results of the Canadian Multicenter experience lookingat outcomes in 168 transfemoral patients and 177transapical patients. Overall procedural success was ,with a 30-day mortality of for the transfemoralpatients compared with for the transapical were no differences between the transapical transapical outcomes have also been comparedwith a propensity-matched cohort of patients havingconventional AVR surgery. Walther and associates[309]demonstrated 30-day, 6-month, and 1-year survival of90%, 75%, and 74%, respectively, for the transapical groupcompared with 85%, 70%, and 69%, respectively (p ),in the conventional surgery patients. Valve function wasexcellent in the transapical group with low mean gradientsand velocities across the prostheses over largest study reporting outcomes with transapicalvalve implantation is the European SOURCE registry,a 32-center registry designed to collect data during thefirst year of commercial activity after approval in Europe[252]; 575 transapical aortic valve implantations wereincluded in the registry. Procedural success in thetransapical group was , with a 30-day mortality Other procedural complications such as strokeand vascular access complications were low at respectively. Of note, the majority of the centershad no transcatheter experience before beginning transapical technique has also been used toperform valve-in-valve implantations for failed bio-prosthetic valves. These valves have been transapicallyinserted into degenerated bioprosthetic valves in theaortic, tricuspid, pulmonary, and mitral position. A recentlarge series of 24 patients reported by Webb and associ-ates[168]demonstrated a 30-day mortality of and nomore than mild regurgitation after PARTNER trial data reported transapical outcomesin a high-risk cohort of patients compared with conven-tional surgery. The data showed the transapical arm ofthe PARTNER A patients had more cerebrovasculardisease, had more CABG or PCI, more peripheralvascular disease, atrialfibrillation, more severe AS (asrisk factor for stroke), more liver disease, and porcelainaorta. In comparing the as-treated data, the transapicalTAVR mortality was and AVR (p ) andstroke/transient ischemic attack for transapical and AVR (p ). Of note, as-treated stroke/transient ischemic attack in the transfemoral TAVR versus for AVR (p ). The trial was notpowered sufficiently to determine if the transapicalapproach data were noninferior to open AVR[240].S39Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from Many centers are using transaortic, transsubclavian, orother alternative approaches for TAVR. These have notbeen studied in prospective studies but case series Transaortic ValveReplacement RecommendationsClass I1. Evaluation for TAVR should be performed bya multidisciplinary team and panel[81, 240]. (Level ofevidence A)2. TAVR should be performed by a multidisciplinarycardiovascular and cardiac surgery team[81, 240].(Level of evidence A)3. If available as part of a research protocol or after FDAapproval, transfemoral, transaortic, transaxillary, ortransapical AVR with the balloon expandable valvecan be considered in patients who are operativecandidates and have a predicted surgical mortalitygreater than 15% and an STS score greater than 10%by two independent surgical assessments[240]. (Levelof evidence A)4. TAVR should be performed in a hybrid operating orcatheterization room dedicated to the procedure andnot with mobile c-arms[81, 240]. (Level of evidence B)Class IIa1. Direct aortic insertion of a self-expanding or balloonexpandable aortic valve may be a reasonable alter-native in patients with critical aortic stenosis whoare contraindicated for conventional aortic valvereplacement and are not candidates for a transfemoralapproach due to preexisting peripheral vasculaturedisease, and who have an expected survival of at least1 year. (Level of evidence B)2. Direct aortic insertion of a self-expanding or balloonexpandable aortic valve may be a reasonable alterna-tive in patients with critical aortic stenosis who have anestimated mortality of at least 15% as independentlyjudged by two cardiothoracic surgeons or who havea predicted risk of mortality using the STS-PROMalgorithm of 10% or greater and do not have accessfor the transfemoral approach. (Level of evidence C)Class III1. Direct aortic insertion of a self-expanding or balloonexpandable aortic valve is not recommended in low-risk patients with critical aortic stenosis who areconsidered good candidates for conventional valvereplacement. (Level of evidence C)Quality Measures1. All patients referred for direct aortic TAVR, should beevaluated by multidisciplinary team and two cardio-thoracic surgeons to determine suitability forconventional valve All patients being considered for direct aortic TAVRshould have a preoperative left-side heart catheteri-zation, transthoracic echocardiogram, PFTs, and a CTscan of the chest, abdomen, and pelvis through thefemoral Intraoperative TEE should be used in addition tofluoroscopy to adequately position the valve Procedure time,fluoroscopy time, transfusionrequirements, use of cardiopulmonary bypass,number of valves placed, need for sternotomy orconversion to conventional surgery, vascular compli-cations, and amount of contrast used should bemeasured for all Patients should be placed on a regimen of doubleantiplatelet agents for at least 6 months unless con-traindicated and aspirin indefinitely after All patients should have a yearly transthoracic echo-cardiogram and physical Patients should be given routine antibiotic prophy-laxis for all invasive procedures and routine investigation into using the ascending thoracicaorta as an access site for catheter-based implantation ofa balloon expandable aortic valve was initially performedas a collaborative effort between both surgeons aortic valve implantation is performed througha small right anterior thoracotomy or an upper right J hemisternotomy through the second or third interspace[102]. Both provide good access to the ascending aortafor sheath insertion and allow ascending aorticcannulation in a fashion familiar to all cardiacsurgeons. Both self-expanding and balloon expandablevalves may be placed using this approach. Carefulplanning is important in choosing a direct aorticapproach. If a line is drawn on the chest CT from thesternum to the spine and the ascending aorta is to theleft of this line, a right thoracotomy approach may bedifficult and better exposure obtained through minis-ternotomy. If there is a patent LIMA graft, a rightthoracotomy generally allows aortic access away fromthe position of the LIMA. Hemostatic control of theinsertion site is obtained using two concentric pledgetedpursestrings. This approach is amenable to both thecurrently widely used valves and allows access to allsheath sizes required. A balloon valvuloplasty is per-formed to create space for blood toflow around theprosthesis as it is positioned in the annulus. Optimalpositioning is achieved usingfluoroscopy and TEE sothat native annulus hinge points bisect the midpositionof the prosthesis. Valve deployment is done in thestandard fashion according to the valve type removal and closure of the ascending aorta isfamiliar to cardiac surgeons and done in a with the transfemoral approach, manycentersfind the direct aortic access technique is oftenS40SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from faster, uses less contrast, and requires shorterfluoroscopytimes. Additionally, control of valve placement isenhanced with the direct aortic approach owing to theshort working distance between the aortic insertion siteand the aortic annulus allowing more precise control andless stored energy in the delivery system. Direct aorticaccess is part of the CoreValve US Pivotal trial, which wasexpected to reach completion in aortic valve implantation can be performed closedchest, beating heart, and without the use of cardiopul-monary bypass, even in nonoperable or prohibitive-riskpatients. This approach is particularly efficacious usingthe right thoracotomy approach for patients who havehad previous bypass grafting or cardiac surgery as itobviates the risk of cardiac or inadvertent graft injury dueto repeat sternotomy. Compared with transfemoral aorticvalve implantation, sheath size for valve delivery is nota limiting factor in patient selection for the directapproach. Thisflexibility in sheath size also enablesmodifications to be to future valves and may allow portaccess with the thoracotomy approach in the transapical, both the current balloon expandableand self-expanding valves can be deployed using thisaccess. Unlike transapical, all cardiac surgeons haveextensive experience placing large bore cannulae into theascending aorta. Valve positioning and deployment havebeen found, as is the case with transapical also, to besimpler and more precise owing to the closeness to thedeployment site and lack of stored energy of the directroute to the aortic valve. Additionally, in the event ofa catastrophic local insertion site complication, graftreplacement of the ascending aorta in an appropriatepatient is a familiar procedure to cardiac umbrella can be inserted at the time of theprocedure. The approach can also be used to quicklyconvert patients to full cardiopulmonary bypass can occur including rare catastrophicascending aortic bleeding, which mimics the potentialseen in any aortic cannulation for standard CPB. Appro-priate patient selection is critical to ensuring optimaloutcomes with the direct aortic procedure, particularly inregard to the recognition of unfavorable proceduralanatomy for reoperations and calcified for the direct aortic procedureinclude atheroma or calcification of the ascending aortathat the surgeon believes precludes placement and safeclosure of the aorta. Additionally, certain factors maypreclude a direct aortic approach such as anatomicdisplacement of the aorta (pneumonectomy).ResultsThe direct aortic approach to TAVR was not included inthe PARTNER trial but there is a growing Transaxillary or Subclavian ValveApproach RecommendationsClass I1. Evaluation for TAVR should be performed bya multidisciplinary team and panel[81, 240]. (Level ofevidence A)2. TAVR should be performed by a multidisciplinarycardiovascular and cardiac surgery team[81, 240].(Level of evidence A)3. If available as part of a research protocol or after FDAapproval, transfemoral, transaortic, transaxillary, ortransapical AVR with the balloon expandable valvecan be considered for patients who are operativecandidates and have a predicted surgical mortalitygreater than 15% and an STS score greater than 10%by two independent surgical assessments[240]. (Levelof evidence A)4. TAVR should be performed in a hybrid operating orcatheterization room dedicated to the procedure andnot with mobile c-arms[81, 240]. (Level of evidence B)Class IIa1. Transaxillary or subclavian insertion of a self-expanding or balloon expandable aortic valve maybe a reasonable alternative in patients with criticalaortic stenosis who are contraindicated for conven-tional aortic valve replacement and are not candidatesfor a transfemoral approach because of preexistingperipheral vasculature disease, and who have an ex-pected survival of at least 1 year. (Level of evidence B)2. Transaxillary or subclavian insertion of a self-expanding or balloon expandable aortic valve maybe a reasonable alternative in patients with criticalaortic stenosis who have an estimated mortality of atleast 15% as independently judged by two cardio-thoracic surgeons, or who have a predicted risk ofmortality using the STS-PROM algorithm of 10% orgreater and do not have access for the transfemoralapproach. (Level of evidence C)Class III1. Transaxillary or subclavian insertion of a self-expanding or balloon expandable aortic valve is notrecommended for low-risk patients with critical aorticstenosis who are considered good candidates forconventional valve replacement. (Level of evidence C)Quality Measures1. All patients referred for transaxillary or subclavianTAVR should be evaluated by multidisciplinary teamand two cardiothoracic surgeons to determine suit-ability for conventional valve All patients being considered for transaxillary orsubclavian TAVR should have a preoperative left-sideheart catheterization, transthoracic echocardiogram,S41Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from PFTs, and a CT scan of the chest, abdomen, and pelvisthrough the femoral Intraoperative transesophageal echocardiographyshould be used in addition tofluoroscopy toadequately position the valve for Procedure time,fluoroscopy time, transfusionrequirements, use of cardiopulmonary bypass,number of valves placed, need for sternotomy orconversion to conventional surgery, vascular compli-cations, and amount of contrast used should bemeasured for all Patients should be placed on a regimen of doubleantiplatelet agents for at least 6 months unless con-traindicated and aspirin indefinitely after All patients should have a yearly TTE and Patients should be given routine antibiotic prophylaxisfor all invasive procedures and routine dental axillary artery is exposed in the deltopectoralgroove. Many cardiac surgeons are familiar with thisapproach for axillary cannulation. The sheath may beinserted through a graft sutured to the artery or directlyinserted by the Seldinger technique. The subclavianartery can be used in the supraclavicular approach butthis is less common. The carotid arteries or innominateartery have also been used for or subclavian TAVR access, like trans-femoral, does not require the opening of a major bodycavity and can be done under local anesthesia as neces-sary. The catheter insertion site is closer to the deploy-ment site than transfemoral, generally leading to easierand more accurate of transaxillary or subclavian access on the right siderequires an annular angle from horizontal of 30 degreesor less, and the left is similar to transfemoral, requiring anangle from horizontal of 70 degrees or less. Use on the leftcan be complicated by dependency on a patent leftinternal thoracic artery Aortic Valve Leaflet Remodeling,Reimplantation, and RepairThe reason for trying to preserve the aortic valve orrepair regurgitant valves in patients with root dilation orbicuspid valves is because these are usually youngpatients, and mechanical valve insertion means a life-time of anticoagulation therapy and no possibility ofimplantation of a percutaneous valve at a later stage. Theother alternative of a biological valve is associated withreduced durability at a younger age. The root- andvalve-preserving alternatives are remodeling, reim-plantation, bicuspid valve repair, or sinotubular junctiontailoring[1, 14, 20, 69, 72, 99, 310 335] . More recent datashow that late survival and risk of reoperation is lowerfor both bicuspid and tricuspid valve repairs whencompared with biological AVR in younger patents[336](Figs 23 to 27). Survival is equivalent to age- andgender-matched Remodeling RecommendationsCLASS I1. Aortic valve repairs should be checked by intra-operative TEE after the repairs is completed. (Level ofevidence C)2. Patients should be followed postoperatively by yearlyechocardiograms after aortic valve repair. (Level ofevidence C)CLASS IIA1. Root remodeling may be considered for patients withsignificantly dilated roots and bicuspid valves orpatients with acute aortic dissection, including exci-sion of the non coronary sinus as a remodelingprocedure, also known as the Wolfe procedure. (Levelof evidence C)CLASS III1. Root remodeling should be avoided in patients withconnective tissue disorders. (Level of evidence C)QUALITY MEASURES1. Perioperative gram-positive and gram-negative anti-biotic coverage should be Intraoperative transesophageal echocardiographyshould be Postoperative beta-blockers should be valve repair is a relatively straightforwardprocedure when performed by expert aortic valvesurgeons with good initial results and a not-excessivecross-clamp time. Most surgeons are comfortable doingcoronary artery reattachments, using either free buttons orthe inclusion technique. The aortic annulus and commis-sures are less likely to be distorted. Remodeling works wellfor patients who have bicuspid valves and root repair of the valve, particularly with leafletprolapse, is less predictable. Leakage due to a dilatedannulus requires an outside banding or subannularFig 23. Survival for aortic valve repair, matched age and sex US lifepopulation, and matched biological aortic valve replacement (AVR).S42SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from encircling suture that pleats the annulus down toa normal size. Long-term results show a higher risk ofreoperation and valve replacement than the reimplanta-tion operation, particularly for patients with connectivetissue disorders such as Marfan less than 1% 30-day mortality rate for electiverepairs is to be expected, particularly for prophylacticoperations[323, 324, 327]. Long-term durability andfreedom from reoperation has varied at 10 years[1, 72,310, 312 316, 318, 320, 323, 324, 327, 337]. Reimplantation RecommendationsCLASS I1. Root size, particularly at the sinuses of Valsalvashould be measured by CT or MRI using the externaldiameter at its greatest extent. Conventionally TEE isused to measure the internal diameter at its greatestextent, usually from sinus to sinus[1]. (Level ofevidence B)2. Intraoperative TEE is recommended to check therepair. (Level of evidence C)3. Reimplantation is recommended for young patients,when feasible, who have aortic root dilation, with orwithout regurgitation, and a tricuspid aortic valve.(Level of evidence C)4. An aortic root greater than cm is recommended asa threshold for prophylactic repair for most patients,including patients with Marfan syndrome. (Level ofevidence C)5. In patient with a family history of aortic dissectionand Marfan syndrome, surgery is recommended ata size of cm in cross-sectional diameter. (Level ofevidence C)6. Gram-positive and gram-negative prophylactic anti-biotics should be administered at the time of surgery.(Level of evidence C)7. The patient should have yearly echocardiograms.(Level of evidence C)8. Prophylactic antibiotics for any invasive procedureincluding dentistry are recommended. (Level ofevidence C)CLASS IIA1. For patients with Loeys-Dietz syndrome, a thresholdof cm maybe considered for surgery. (Level ofevidence C)2. The cross-sectional area of the root in square centi-meters divided by the patient s height in meters andexceeding 10 may be considered an indication forsurgery. (Level of evidence C)Fig 24. Survival by bicuspid valve or Marfan syndrome aortic valverepair, US matched patients, degenerative root aneurysm/valverepairs of the aorta by tailoring, biological aortic valve replacement(AVR), and aortic dissection with valve 25. Survival by remodeling, reimplantation, US life, biologicaortic valve replacement (AVR), and 26. Hazard curves showing increasing risk of biological aorticvalve replacement (AVR) failure after approximately 7 years butdeclining risk with 27. Risk of reoperation by biological aortic valve replacement(AVR), tricuspid valve repair, mostly by modified David reimplan-tation, and for bicuspid Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from 3. In female patients with a connective tissue disorderwho are considering pregnancy, a prophylactic repairmay be considered when the aortic root exceeds (Level of evidence C)4. An antiplatelet agent should be considered post-operatively. (Level of evidence C)NATIONAL QUALITY FORUM MEASURES1. Prophylactic gram-positive and gram-negativecoverage should be used at the time of Intraoperative Postoperative aspirin or clopidogrel should Discharge should be on ACE inhibitor therapy should be considered inpatients with low EF operation is proven to have good to excellentmidterm durability. The late risk of stroke or thrombo-embolism appears to be low. Correction of AR, eitherbecause of malposition of the leaflets or because of annulardilation because of leaflet prolapse, can be correctedwithout affecting durability. Results have been excellentfor tri-leaflet valves, including patients with connectivetissue disorders such as Marfan syndrome, Loeys-Dietzsyndrome, and Ehlers-Danlos syndrome but less so forpatients with bicuspid aortic valves[313, 316, 320, 323, 336].CONSThe operation is technically more demanding andrequires judgment based on experience and regularlydoing the procedure. The procedure is also associatedwith the risk of producingfistulas, including perforationof the base of the anterior leaflet of the mitral valve, theright ventricular outflow tract, or ventricular septaldefects. Recovery from an intraoperative failure or latefailure usually requires an extensive operation and likelyinsertion of a homograft. Early transient ischemic attacksor amaurosis fugax, probably related to the extensive rawsurface area, is a possibility but with the use of clopi-dogrel this appears to be reduced. Endocarditis can stilloccur on late follow-up after reimplantation. Severaltechniques and modifications have been described andwhich is the ideal one is somewhat than a 1% mortality rate for elective reim-plantation is required to justify the operation asa prophylactic operation. Midterm results better than 95%freedom from reoperation at 10 years have been reported[1, 14, 310, 313, 315-317, 321, 324, 325, 327, 328, 330]. Bicuspid Valve Repair With or Without AorticTube Graft Replacement RecommendationsCLASS I1. All patients undergoing bicuspid repair shouldundergo intraoperative TEE. (Level of evidence C)2. Prophylactic antibiotics including both gram-positiveand gram-negative coverage should be used forpatients undergoing bicuspid valve repair. (Level ofevidence C)3. Postoperative beta-blockers should be consideredafter bicuspid valve repairs. (Level of evidence C)4. ACE inhibitor therapy should be considered in patientswith low EF postoperatively. (Level of evidence C)5. Patients should be given prophylactic antibiotics atany time that an invasive procedure is done,including dental procedures, after a bicuspid valverepair. (Level of evidence C)QUALITY MEASURES1. Prophylactic antibiotics for both gram-negative andgram-positive coverage for the operative Intraoperative Postoperative beta-blockers and Patients should be given prophylactic antibiotics anytime an invasive procedure is done, including of a bicuspid valve in young patients mayresult in good long-term results if in thefirst 1 or 2 yearsfailure does not occur. The incidences of bleeding, stroke,thromboembolic events, and infection are probably lowerthan with mechanical valve replacements[312, 336].Pa-tients do not need to be on warfarin therapy after most patients several steps may be required tosuccessfully repair the leaflets, including Cabrol suturesat the commissures, leaflet plication with a Trussler stitch,andfigure-of-eight commissure apical sutures. Thatrequires experience and judgment to result in a success-ful elective surgical mortality rate with or withoutreplacement of the ascending aorta should be less than1% mortality. Long-term durability is better than 80% outto 10 years, with most failures occurring thefirst 2 yearsafter repair[1, 14, 69, 72, 310, 312, 315 318, 320, 321,323 325, 327, 338]. Tailoring of Sinotubular JunctionIn older or high-risk patients with mild to moderateAR due to dilation of the of the sinotubular junction,tailoring down the sinotubular junction to a normal size,approximately 22 mm to 24 mm, depending on thepatient s size, may result in good long-term durability[1, 14, 314, 327, 334].18. Management of Acute Aortic Root andAscending Aortic Dissection RecommendationsClass I1. Timely diagnosis is recommended utilizing cross-sectional imaging techniques or TEE. The latter canbe performed in the operating room before sternot-omy if needed to confirm the diagnosis[1]. (Level ofevidence B)2. Ascending aortic replacement (including resection ofprimary aortic tear) should be performed for patientswith acute type A aortic dissection[1]. (Level ofevidence B)3. An open distal anastomotic, hemiarch or total archreplacement technique is effective for the distalS44SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from reconstruction of an acute type A dissection[1]. (Levelof evidence B)4. Ascending aortic and aortic arch replacement isindicated for patients with acute type A aorticdissection and a primary or secondary tear within thearch that involves or extends beyond the left commoncarotid arterial ostium with marked dilation of theaortic arch (>50 mm). (Level of evidence C)5. Aortic root replacement is indicated for patients withacute type A aortic dissection and a primary tear thatextends or originates in the left or right coronarysinuses or marked dilation (>45 mm) of the aortic rootbelow the sinotubular junction. (Level of evidence C)6. Arterial inflow cannulation for cardiopulmonarybypass during type A dissection repair should perfusethe true lumen directly. (Level of evidence C)7. Long-term radiologic surveillance after aortic dissec-tion with or without surgical reconstruction should beperformed at regular intervals of at least every 6months for thefirst year and then annually. (Level ofevidence C)8. Long-term annual echocardiographic surveillance isrecommended for patients in whom an aortic valve-preserving reconstruction or bioprosthetic valvereplacement was performed. (Level of evidence C)Class IIa1. It is reasonable to use ABP or RBP with HCA tocomplete aortic arch reconstructions to reduceneurologic complications[1]. (Level of evidence B)2. It is reasonable to utilize either an aortic valve-sparingor valve-replacement strategy when managing acutetype A dissection if an acceptably low mortality ratecan be achieved[1]. (Level of evidence B)3. It is reasonable to treat acute type A IMH with urgentsurgical intervention[1]. (Level of evidence B)4. Use of intraoperative TEE is encouraged[1]. (Level ofevidence B)5. Postoperative, lifelong cross-sectional radiologicsurveillance is reasonable in patients with residualaortic dissecting beyond the replaced aortic segment.(Level of evidence C)Class IIb1. Medical management and longitudinal surveillancemay be considered to treat high-risk patients withasymptomatic, radiologically stable type A IMH.(Level of evidence C)2. Medical management and longitudinal surveillancemay be considered in patients with type B dissectionsinvolving the aortic arch. (Level of evidence C)3. Annual echocardiography may be considered in typeA aortic dissection patients in whom the aortic valvewas resuspended, preserved or replaced with a bio-prosthesis. (Level of evidence C)Quality Measures1. Prophylactic perioperative antibiotics should be givenfor 24 to 48 hours at the surgeons Patients should be discharged on Patients with concomitant CAD should be dischargedon oral antiplatelet Patients with concomitant CAD should be dischargedon drug therapy for lowering low-density ACE inhibitor therapy should be considered inpatients with low EF diagnosis and initial management of aorticdissection patients was extensively reviewed in the 2010guideline for the management of patients with thoracicaortic disease produced by ACCF/AHA, AATS, and STS[1]. The surgical treatment and guidelines from thatdocument are referred to in this dismal prognosis (60% 1-year mortality) of medi-cally managed acute type A aortic dissection wasdemonstrated in 1991[339]. Even before that time it wasapparent that acute surgical intervention throughreplacement of the ascending aorta dramaticallyreduced the acute mortality of type A dissection so thatcenters of excellence now have hospital and 1-yearmortality rates of 5% to 26% (Table 5)[340 351]. Conse-quently, patients who present with acute type A aorticdissection should undergo immediate ascending aorticreplacement except perhaps in cases of markedlyadvanced age or comorbid status or those presenting withdevastating neurologic injury or bowel gangrene[352].With respect to age, it is clear that outcomes areconsiderably worse in the elderly; nevertheless,appropriately selected patients, even into their ninthdecade, can have a reasonable survival with surgery[353 357]. Equally, the presentation of acute devastatingstroke was in years past a recognized marker of very pooroutcome[349, 358]. However, in recent years evidencehas been accumulating that suggests that some patientswho present with significant stroke, even coma andacute type A aortic dissection, can have a reasonablechance of survival with acute surgical intervention[345,352, 359 361].Acute type A IMH, a variant of aortic dissection, cangive rise to the same devastating complications as thosearising from acute type A aortic dissection[331]. Datafrom the International Registry of Acute AorticDissection database and others demonstrate that IMH,while appearing to carry a better general prognosis thanovert dissection, still carries a significantly better chanceof long-term survival with ascending aortic replacementcompared with medical management[362-368]. However,given the more indolent course of many type A IMHpatients, delayed surgical intervention in high-riskpatients, and in selected cases medical management,may be reasonable for clinically and radiologically stablepatients[362, 369].The diagnosis of acute type A aortic dissection or IMHis best achieved by CT angiography, magnetic reso-nance angiography, or TEE. Magnetic resonance angi-ography may be less practical in the setting of an acutechest or back pain syndrome and should not delayS45Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from timely surgical intervention. Consequently, it is appro-priate to utilize CT angiography for diagnosis ofdissection given its speed, accuracy, and the diagnosis is suspected or presumed based onother objective data not intended to identify dissection(such as TTE or chest radiography), it is reasonable toforego additional imaging and perform definitive TEEintraoperatively before opening the patient D-dimer level is a remarkably sensitive but notspecific biomarker for acute aortic dissection[370].Oncethe diagnosis is made, most centers usually do notperform preoperative coronary angiography asa routine because it may delay operative intervention[371 373]. If, however, coronary angiography can beperformed while the operating room is being prepared,this is reasonable. For patients with a high risk for CAD,coronary angiography may be a good option for hemo-dynamically stable patients[1] .The primary goals of type A aortic dissection repairshould be to remove the primary tear site, to restoreaortic valvular competency, and to reconstitute truelumenflow while obliterating false lumen bloodflow inhopes of collectively preventing rupture, myocardialinfarction, stroke, malperfusion, and death. Establish-ment of adequate arterial pressure monitoring frommultiple sites to ensure uniform perfusion throughoutthe body during and after the reconstruction is impor-tant. The route of access to deliver arterial inflow foracute aortic dissection continues to be debated withoutresolution of superiority of technique (ie, axillary,subclavian, femoral, or central aortic)[139, 341, 349,374 381]. Regardless of access approach, it is impera-tive that true lumen cannulation is established andmaintained because false lumen cannulation andperfusion can significantly impair the adequacy ofregional tissue bed perfusion and increase the risk ofaortic disruption or stroke. Myocardial protection isconventional, as with open heart surgery. Directed brainmonitoring and protection strategies are advocated bysome during aortic dissection repair to reduce the inci-dence of perioperative stroke[1] .The aortic root should be assessed to establish (1) thecandidacy for aortic valve preservation; (2) patency andintegrity of the coronary ostia; and (3) the need for aorticroot replacement. The same factors that impact aorticvalve management in the setting of isolated AS or AR arerelevant at the time of aortic dissection repair with theadditional factor that patient longevity is significantlyimpacted by the dissection process itself particularly inpatients with residual arch and descending thoracic archdissection and a patent false lumen[346, 382 384].With10-year survival ranging from 40% to 80% amongsurgically treated patients with type A dissection, bio-prosthetic AVR may often be appropriate[351, 369,385 388].The distal extent of aortic replacement should bedependent on the presence and extent of an aortic tear(not extent of dissection) in the aortic arch, aortic archdiameter, and the ability to perform a durable distalanastomosis that will adequately restore distal true lumenTable 5. Results of Aortic Dissection VSRRAVR Supracor MortalitySun et al, 20092003 07 107100%100% et al, 2009 1979 03 19513%84%3%46%12%29%60%24%5%13%Fattouch et al, 2009 1992 06 18983%17%31%33%36% et al, 2008 2000 06 12090%10%100%30%20%39%11%5%Knipp et al, 20071995 03 3,013NANANANANANANANANANA26%Zierer et al, 20071984 05 17517%83%39%32%NANANANA18%IRAD, 20061996 03 27315% , 20051996 01 526NANA12%NANANANA32%NANA25%Kallenbach, et al,20041990 03 25781%19%100% , et al, 2004 1976 01 , et al, 2002 1992 02 16395%5%0%100%0%83%17% antegrade cerebral perfusion;AVR aortic valve replacement;HCA hypothermic circulatory arrest;NA not applicable;Pts. patients;RCP retrograde cerebralperfusion;Replace. replacement;Resusp. resuspension;VSRR valve separate root REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from flow and exclude false lumenflow. In the majority ofcases, with the possible exception of DeBakey type IIdissections, the distal reconstruction requires a period ofcirculatory arrest to allow for open interrogation andreconstruction of the aortic arch. Successful circulatoryarrest outcomes are realized with the use of deep HCAand, more recently, with moderate hypothermia used inconjunction with unilateral or bilateral ABP. The additionof either ABP or RBP may allow for safer, longer circu-latory arrest periods with lower brain comparisons of circulatory arrest andbrain perfusion strategies have been inconclusive indemonstrating superiority of HCA with ABP or HCA withRBP compared with HCA alone[337, 389-394]. Reliablecomparisons of HCA with ABP to HCA with RBP arescant largely because of institutional biases directing onestrategy over the other. There has been a trend worldwidetoward evolving from a strategy of deep HCA (14 Cto18 C) HCA with ABP or RBP to moderate HCA (25 Cto30 C) with ABP with the enthusiasm based on apparentlyequivalent results with the benefit of shorter cardiopul-monary bypass time[374, 380, 395]. However, reportedseries to date have included predominantly elective aorticarch surgeries, not aortic dissection repairs, which mayrequire longer circulatory arrest periods for complexrepairs. Furthermore, the incidence of multiple organfailure, because of poor visceral protection, may is a divergence of expert opinion on the safety ofapplying a total arch replacement strategy to the majorityof acute type A dissections (based largely on the Japaneseexperience) as opposed to the more limited open distal orhemiarch replacement strategy that is generally favoredworldwide. This discrepancy persists because ofcontinued concerns that broadly applied total archreplacement for type A aortic dissection invokes a higherrisk of morbidity and mortality. The addition of endo-vascular stents at the time of the repair is still aortic wall repair strategies at either theproximal or distal extent of ascending aortic replacementcontinue to evolve; these have included neomedialreconstruction, intimal and adventitial reinforcementwith felt, and biologic glues[349, 396, 397]. Early enthu-siasm for the use of biologic glues has waned morerecently because of reports of tissue necrosis, anastomoticbreakdown, pseudoaneurysm formation, and emboliza-tion[398 402].Longitudinal radiologic surveillance (through CTangiography or magnetic resonance angiography)after the diagnosis or repair of aortic dissectionshould be routinely performed. When renal insufficiencyis present, consideration should be given to altera surveillance strategy to eliminate the incidence ofcontrast-induced nephropathy by using unenhancedimaging techniques that still offer the minimum ofquantifying diameter and aneurysmal growth. Surveil-lance over the course of thefirst year after aorticdissection should be every 6 months to allow identifi-cation of patients with rapidly expanding aneurysmaldissections who are at greatest risk for a second aorticcatastrophe, and thereafter mortality after type A aortic dissection repair inthe current era ranges between 5% and 26% (Table 1)[341 343, 345 351]. This fairly broad range of reportedhospital mortality reflects data accumulated over manyyears when treatment protocols were evolving and insti-tutional infrastructures, experience, and treatment biaseswere changing. Neurologic complication rates are evenmore difficult to compare among the treatment strategiesbecause neurologic outcome reporting has been widelyvariable. Neurologic complication rates range from 30% depending on the inclusion of permanent stroke,paraplegia, and temporary neurologic dysfunction[337,341 343, 345 351, 354, 361, 389, 391 393].19. Ascending Aorta and AorticArch RecommendationsClass I1. All patients with suspected thoracic aortic disease onthe basis of family history, symptoms, or physicalexamination should have the entire thoracic aortaimaged. (Level of evidence C)2. All patients with a bicuspid aortic valve shouldundergo imaging of the thoracic aorta[1]. (Level ofevidence B)3. All patients with Marfan syndrome or Loeys-Dietzsyndrome or mutations associated with aorticdisease or dissection should have the entire aortaimaged and appropriate blood testing performed forgenetic mutations[1]. (Level of evidence B)4. First-degree relatives of young patients witha bicuspid aortic valve or genetic mutation associatedaortic disease of the thoracic aortic disease should beadvised to be further investigated. (Level of evidenceC)5. All patients for whom planned elective valvularsurgery is planned and who have associated thoracicaortic disease should undergo preoperative cardiaccatheterization[1]. (Level of evidence B)6. Additional testing to quantitate a patient s comorbidstatus and develop a risk profile is tests may include for particularly high-riskpatients CT of the chest if not already done, PFTs,24-hour Holter monitoring, noninvasive carotidscreening, brain imaging, echocardiography, neuro-cognitive testing, and assessment of degree of frailty.(Level of evidence C)7. Intraoperative TEE is recommended for all patientsundergoing surgery for thoracic aortic disease. (Levelof evidence C)8. Surgical repair is recommended when the ascendingaorta or aortic root exceeds cm if the patient hasno genetically based aortic disease and is otherwisea suitable candidate for surgery[1]. (Level ofevidence B)S47Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from 9. Patients with genetically associated aortic diseases,including those with a bicuspid aortic valve, shouldundergo surgery at diameters exceeding cmunless a family history of aortic dissection is present,then it is acceptable to lower the threshold to , patients with a maximal ascendingaortic area (Pr2,cm2) to height in meters ratioexceeding 10 should be considered for surgery[1].(Level of evidence B)10. Patients with a growth rate exceeding cm per yearshould be recommended to undergo surgery if noother limitations apply[1]. (Level of evidence B)11. For patients with Loeys-Dietz syndrome orconfirmed TGFBR1 or TGFBR2 mutation should beevaluated for repair of the aorta when the diameterexceeds cm. (Level of evidence C)12. For patients undergoing cardiac surgery other than foraortic indications, aortic repair is recommended whendiameter exceeds cm[1] . (Level of evidence B)13. Aortic diameters should be measured at right anglesto the axis offlow, which requires the use of three-dimensional reconstructive software. The maximaldiameters at each segment of the aorta should bereported. Echocardiography measures internaldiameters while CT and MRI measures externaldiameters, and thus some allowance should be madefor echocardiographic measurements being smaller.(Level of evidence C)14. Separate valve and ascending aortic replacement arerecommended for patients without significant aorticroot dilation, for elderly patients, and for youngpatients with minimal dilation in whom a biologicalvalve is being inserted or a bicuspid valve is beingrepaired[1]. (Level of evidence B)15. Patients with Marfan, Loeys-Dietz, and Ehlers-Danlos syndromes and root dilation shouldundergo excision of the sinuses in combination witha modified David valve reimplantation procedure iftechnically feasible or insertion of a valve graftconduit[1]. (Level of evidence B)16. For more complicated arch reconstructions requiringextended periods of circulatory arrest, use ofadjunctive brain perfusion techniques is recom-mended[1]. (Level of evidence B)Class IIa1. Regular echocardiography and MRI or CT evaluationafter repair of thoracic aortic disease is reasonable.(Level of evidence C)Quality Measures1. Prophylactic antibiotics for both gram-negative andgram-positive coverage should be administered forthe operative Intraoperative TEE is recommended in all All patients with a bicuspid aortic valve, Marfan,Loeys-Dietz, and Ehlers-Danlos syndromes, anda history consistent with familial thoracic aorticdisease thefirst-degree relatives should undergoimaging of the thoracic MRI or CT evaluation should be considered aftersurgical ACE inhibitor therapy should be considered inpatients with low EF of the ascending aorta and/or the arch entailsresection of the diseased aortic segment and replacementwith an interposition conduit. Currently, the procedure isperformed with cardiopulmonary bypass and cardiacarrest with or without HCA. Patients with ascendinganeurysms often have concomitant aortic valve or rootpathology, which may be addressed with arch disease often have multisegmentinvolvement, and so arch repair is usually combined withascending repair to address proximal pathology and theelephant trunk procedure is used to prepare for latertreatment of distal aortic and arch aortic aneurysms predictably lead todissection, rupture, and death depending on size,morphology, and etiology of the disease[328, 403, 404].Occasionally a very large aneurysm or those associatedwith anomalous vasculature can cause focal compressivesymptoms. Otherwise, most aneurysms are found inci-dentally or by screening those known to be at elevatedrisk for aneurysm formation such as those with Marfansyndrome, Loeys-Dietz syndrome, familial thoracic aorticdisease, a bicuspid aortic valve, or other mutations asso-ciated with aortic disease[405 407]. Indications foroperative repair of the proximal aorta in asymptomaticpatients are based on the predictability of death fromaortic complications. Surgery is indicated when the risk ofaortic complications outweighs the risk of repair. Electiveprophylactic repair can be performed safely and durablywith experience and proper patient selection for all vari-ations of proximal aortic repair, even the most extensivedisease[338, 408 419]. Timely repair of aortic aneurysmsprolongs survival and approaches that of age-matchedcontrols in select populations[72, 407, 413](Figs 24 27).Clearly, the institutional outcomes and experience mustbe taken into account when recommending prophylacticsurgery since the operative death risk must be lower thanthat of the risk of dissection or repair of dissection or rupture can be life-saving, but these patients are clearly at higher operativerisk than patients undergoing elective prophylactic repair[411, 412, 415]. The challenge is to balance the risks ofaortic complications against the risk of aortic acute complications of proximal aortic repairinclude death, stroke, and respiratory failure[338, 411,415, 419]. Elderly patients and patients with emergencyindications may be at higher risk for perioperativebleeding. Patients with atherosclerotic and atheromatousdisease involving the arch are at increased risk of embolicstroke[338, 411, 414, 415]. Although the use of circulatoryS48SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from arrest theoretically reduces the risk of embolization byminimizing the need for aortic manipulation, longerperiods of circulatory arrest and cardiopulmonary bypassare associated with neurologic deficit [338]. It is importantto note that patients successfully operated on for aorticdissection have a markedly reduced late survival associated with ascending or arch aortic repairranges from less than 1% to 15% depending on theurgency, operative center, and indications[338, 408 419].Emergency indications, older age, and more extensiverepair in the arch requiring longer pump times arepredictive of worse outcome. At experienced centers,mortality for primary elective repair of the ascendingaorta is consistently less than 5% and is reported by somecenters to be 1%. Rates of perioperative stroke range from0% to 7% depending on the atheroma burden in the aorticarch, cardiopulmonary bypass time, and the duration ofcirculatory arrest[338, 411, 414, 419]. The risk of strokeincreases significantly during circulatory arrest lastingmore than 40 minutes[338]. Reoperation for bleedingoccurs in less than 5%[413]but may be as high as 17%of patients with the most extensive disease. Long-termsurvival ranges from 50% to 93% at 10 years[410 413].Further Research NeededEndovascular therapies have quickly made a major impactin the treatment of disease involving the descending reports describe the use of this technology in theascending aorta and aortic arch either as purely endovas-cular repair or as a hybrid approach in combination withopen surgery[420]. Feasibility has been documented withthese approaches but further device development andunderstanding of the disease processes is is a need for additional studies focused onoutcomes for various subsets of proximal aortic repairbased on morphology and etiology. There is a need forimproved genetic and biologic understanding of themechanisms of aneurysm formation and directedmedical prophylaxis to slow the process[421].20. Statistical Analysis of Procedure Success, Safety,and Long-Term EffectivenessOver the last 5 decades, a number of events and longi-tudinal processes have been observed and documentedafter aortic valve and ascending aorta repair andreplacement that relate to procedure success (whether theintended procedure was accomplished as intended [easeof insertion]), safety (whether the device inserted, therepair, or the procedure to accomplish these has causedpatient morbidity directly or indirectly), and effectiveness(whether the device or repair accomplished its intendedpurpose of providing clinical benefit versus noninter-vention). Typical examples of procedure success includesecurefixation and deployment of a prosthetic heartvalve, secure replacement of the ascending aorta, andrepair of a purely regurgitant aortic valve without intro-ducing stenosis or leaving residual regurgitation. Typicalexamples of safety include the risk of systemic embolinecessitating anticoagulation of a thrombogenic heartvalve replacement device with its attendant risks ofhemorrhage, catastrophic prosthesis failure, prostheticvalve endocarditis, hemolysis from periprosthetic regur-gitation, stroke, paraplegia, and death early aftera procedure. Typical examples of effectiveness are elim-ination or substantial reduction of gradient across the LVoutflow tract by valve replacement (giving rise to terms ofreduced benefit such as PPM[12]), durability of repair,decreased hospitalizations for valve-related heartfailure, andfinally long-term patient number of quantitative and qualitative measuresfor success, safety, and effectiveness and their defini-tions have served the surgical community for decades,are well understood by readers of the surgical literature,and are embodied in regulations such as those of theFDA. With advent of percutaneous and endovasculartechniques to address these heretofore surgical diseases,a new group of interventionalists coming from differentbackgrounds, training, and experience is just nowbecoming familiar with these measures. This is resultingin refinement of definitions and development ofjoint documents by surgeons and interventional cardi-ologists (Table 4) [422].In addition, because of 50 years of experience, stan-dards have been set for many long-term safety anddurability measures in terms of objective performancecriteria with which new heart valve prostheses mustcomply[423, 424]. These standards of comparison are notwell suited to new types of devices applied to patientpopulations not formerly considered for open 2008 the AATS, the STS, and the European Asso-ciation for Cardio-Thoracic Surgery revised guidelines,first issued in 1988, for reporting mortality andmorbidity after heart valve interventions[159, 425, 426].These guidelines do not clearly differentiate proceduresuccess, safety, and effectiveness measures. Rather, theyestablish definitions of morbidity that are applicable toat least AVR, including TAVR, although not explicitlyaddressing those specific to either TAVR or ascendingaorta the preceding text, a number of measures, includingobservations, complications and morbidity, time-relatedevents, and longitudinal data have been described. Inmany trials, including those with FDA encouragement,composite endpoints have been used to measure devicesuccess. The challenge of composite endpoints, however,is that they combine different types of data, for example,death (binary data), stroke (time-dependent event), andNYHA functional class or aortic valve regurgitation(longitudinal time-dependent data).In the following text, some of these will be categorizedinto measures of procedure success, safety, and effec-tiveness, with remarks about some that contain elementsarguably related to two or all categories. In afinal sectionwe will highlight appropriate data analysis methods thatamplify those of Section5 of the 2008 valve reportingguidelines[159].S49Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from Procedure SuccessAlthough procedural success whether the intendedprocedure was accomplished as intended has beenimplicit in surgical thinking from the beginning of heartvalve replacement and treatment of the diseasedascending aorta, the advent of TAVR has made itimportant to be explicit. Questions today such as whetheror not the valve was deployed, has been deployed to itsintended location, been expanded properly or hasrequired open AVR or transcatheter valve-in-valve, andpatients left with minimal periprosthetic leakage mirrorquestions in previous decades, such as whether the minorand major orifices of a mechanical prosthesis have beenproperly directed, whether there is periprostheticleakage, or whether both leaflets of a bileaflet prostheticvalve are opening and general, definitions of procedural success aredependent on the particular procedure performed. ForTAVR, Valve Academic Research Consortium (VARC)participants have proposed a technical compositeendpoint that includes successful vascular access,delivery and deployment of the device, and successfulretrieval of the delivery system; correct positioning of thedevice; achieving intended performance of the prosthesis;and only thefirst valve deployed implanted in theintended location[422].Some aspects of procedure success become measuresof safety when success has not been achieved. A pros-thesis may be properly seated but obstruct a coronaryartery orifice; an ascending aortic posterior suture linemay leak and require reoperation to stop bleeding andprevent pseudoaneurysm formation; a percutaneousvalve may migrate; simple AVR in an elderly woman witha thick septum may lead to LV cavity obliteration andoutflow gradient[427]. SafetyTraditionally, safety whether the procedure has causedpatient morbidity directly or indirectly has beenassessed in terms of events that occur either in-hospital,within 30 days of the procedure, or a composite ofhospital death and deaths within 30 days for patientsdischarged alive before 30 days[422, 423]. However, foraortic valve repair and replacement, and surgery on theascending aorta, it has long been recognized that thereare also long-term safety measures that must be evalu-ated[159, 177]. SHORT-TERM SAFETY MEASURESNearly all the morbid-ities identified in surgical society guidelines, by the FDA,and by watchdog groups have now also been included inthe VARC definitions[159, 422, 425, 426]. The choice of in-hospital or 30 days is arbitrary, and scientifically shouldinclude the entire early hazard phase, which may beconsiderably prolonged beyond 30 days. In the UnitedStates, a period of 90 days is considered the extent ofrecovery from major procedures such as valve replace-ment or ascending aorta surgery. This period was adop-ted by the surgical community in their guidelines but notby the VARC[159, 422]. From a practical perspective,ascertaining 30- or 90-day morbidity events requiresactive follow-up of all patients, and that may not beeconomically LONG-TERM SAFETY MEASURESLong-term safetymeasures include nonstructural dysfunction of manytypes, ranging from periprosthetic leakage to hemolysisto panus ingrowth, valve thrombosis, stroke fromthromboembolism, anticoagulant-related bleeding, pros-thetic valve endocarditis, higher risk of stroke, andcomplications of reintervention. Long-term safetymeasures also include catastrophic structural prosthesisfailure, such as outlet strut fracture and occluder escapeobserved with the Bjork-Shiley mechanical valve[159,428, 429]. For surgical AVR, the FDA has focused ondeveloping objective performance criteria for safetyevents and determining the necessary amount of long-term active follow-up (length and number of patients)to adequately assess risks with meaningfully narrowconfidence are patient-related risk factors associated withsome of these safety endpoints. For example, a personexperiencing a preimplant stroke is at increased risk of apostimplant stroke. Similarly, once a person has had athromboembolism, he or she is at increased risk ofanother event[430]. Thus, we consider the interaction ofpatients with thrombogenicity of their implantedprosthesis to constitute a potential danger of thesedevices, and therefore that is a safety Long-Term EffectivenessEffectiveness whether the device or repair is accom-plishing its intended purpose of providing clinical bene-fit of AVR can be assessed by (1) prosthetic valveperformance, (2) patient longevity, and (3) patient PROSTHETIC VALVE PERFORMANCEThe intended purposeof AVR or repair is to produce a competent valve withminimal stenosis or valvular leakage, including peri-valvular. All prosthetic devices incur transprosthesisenergy loss, usually estimated as a pressure gradient thatincreases in vivo with exercise[431 433]. In somepatients, stenosis produced by the prosthesis is of suffi-cient severity to cause symptoms, called PPM[12]. Thereis currently considerable controversy as to how seriousa problem this is. Surprisingly, echocardiographiclongitudinal valve gradient data (often expressed asEOA) by prosthesis type, model, and size (in itselfa controversial issue) are addition to effectiveness of valve replacement onrelieving native AS or AR, performance of prostheticheart valves includes intrinsic properties, such as staticand dynamic in vitro performance. In vivo indirect esti-mates of performance include reversal of heart chamberand myocardial remodeling. A prosthetic valve shouldreverse morphologic and functional changes broughtabout by aortic valve disease to the extent that permanentdamage remits. These, too, are longitudinal , changes occur most rapidly in thefirst fewmonths after valve replacement, then plateau. As noted,S50SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from some remodeling cannot be reversed, such as myocardialfibrosis in AS leading to long-standing diastolicdysfunction or the continuing inflammatory processes ofrheumatic heart in particular exhibit longitudinal reduc-tion in performance from intrinsic prosthesis deteriora-tion, or SVD. Over time, this may lead to regurgitation orstenosis that may eventuate in device replacement. Therate of deterioration accelerates across time, well char-acterized by a Weibull function[434]. A universally foundrisk factor for accelerating this rate is younger age atimplant[14]. Periodic, routine echocardiographicsurveillance is required to detect SVD and to determinetiming of valve deterioration of certain bioprosthesis isa slow process occurring over 10 to 20 years. This slowprocess is characterized as intrinsic durability. Otherbioprosthesis may exhibit more rapid, but usually notcatastrophic, failure that requires reoperation. For prac-tical reasons, SVD classically has been assessed as time toreoperation to replace the prosthesis rather than as thelongitudinal process it is. Reoperation for SVD has theadvantage of being a hard endpoint that can be portrayedactuarially, but the disadvantage is inherent bias (gener-ally underestimation) introduced by variation in indica-tion and timing of reintervention by primary physicians,cardiologists, surgeons, and patients of aortic valve repair is generally assessed byechocardiographic estimates of developing stenosis orregurgitation. These are longitudinal data representing snapshots intime ofthestateofthe repair andnottime-to-event data. Accuracy of evaluating durability of valve repairdepends on intensity of echocardiographic LONGEVITYA primary clinical benefit of aortic valverepair or replacement and of repair of the ascending aortaversus nonintervention (medical) therapy is prolonginglife. This endpoint can be estimated by assessing time-related, long-term all-cause mortality and comparing itwith natural history without intervention (or to non-interventional therapy)[435]. It may be argued that thishard endpoint is diluted by non valve-related causes ofdeath and by deaths associated with valve-relatedmorbidity (safety). Attempts to define valve-related orcardiac-related death as a more specific endpoint arethwarted by subjectivity, poor family reporting, everdiminishing autopsy investigation, inaccurate mode ofdeath reported on death certificates, and increasing useof national death registries that poorly differentiate modeof death, if at estimation of effectiveness of preventingpremature death is the lack of contemporary data onnatural history of aortic valve and ascending aortadisease. Even the report of PARTNER data involvesa highly select group of natural history patients[81,240]. Thus, inferences about clinical benefit rely on datafrom an era of not only no valve replacement, but also lesssophisticated medical therapy[435].A controversial way that mortality after valve replace-ment has been assessed has been to informally compare itwith that of an age-race-sex matched reference pop-ulation. Use of such a reference standard began in thefieldof oncology when it was suggested that cure in a pop-ulation sense was when survival of the treated populationwas commensurate with that of the matched populationlife table[436]. It is argued on the one hand that the noise of nonrelated causes of death is reflected in thisgeneral population reference; it has been argued on theother hand that such a reference assumes incorrectlythat patients undergoing heart valve procedures arerepresentative of the general population. Indeed, forelderly patients, a subset is selected that is likely to havegood long-term survival and indeed after AVR, patientsafter the age of 80 years have better survival than thegeneral population. Nevertheless, the generalfinding thatthe younger the patient at AVR, the worse is his or hersurvival with respect to the general population is valuableinformation for stimulating research directed towardincreasing the benefits of valve replacement[435]. PATIENT WELL-BEINGPatient well-being classically hasbeen assessed by the nonamended original definition ofthe NYHA functional classes. This graded variable(statistically known as an ordinal variable) is subjective,but can be made less so by assessing the individual dataelements stipulated for each classification and derivingNYHA class algorithmically. Going a step further, the 6-minute walk test or 5-meter walk test in trial patientsmake more objective those less specific data elementsrelated to ability to walk certain distances; the 5-meterwalk test is easier to administer[93, 437].Two important analytic issues arise with self-reportedwell-being assessment instruments: (1) interruption ofthe longitudinal sequence of assessments by death, and(2) recognition that these instruments capture a snapshotin time and require a longitudinal sequence of reassess-ments to identify a pattern of change in a particularpatient set[438]. Some have addressed death by coding itas NYHA class V; others have imputed the lowest scoreson quality-of-life instruments. An assumption is thatthere is steady deterioration of well-being to death fromvalve-related disease, but that does not account for otherunrelated and competing modes of many years of AVR experience, there isa paucity of reports on longitudinal well-being assess-ment by instruments other than NYHA functional common error in reports that have been published hasbeen the assumption that assessment results are events(eg, status at last follow-up) rather than as a sequence ofsnapshots in time, for which longitudinal data analysismethods must be applied. There are also limited data onfunctional health status assessed objectively, such as byserial formal exercise Statistical AnalysisThe measurements, events, and longitudinal data describedfor procedure success, short- and long-term safety, andeffectiveness can be grouped into three general types ofanalysis: analysis of static (non time-related) data, analysisof time-to-event data, and analysis of longitudinal Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from ANALYSIS OF STATIC MEASUREMENTSObservation ofprocedure success and short-term morbidity can beexpressed in a non time-related fashion by descriptivesummary statistics. These include means and standarddeviations for continuous variables unless the distribu-tion of values is skewed, in which case typicallynonparametric median and percentiles are are summarized by simple proportions accompa-nied by confidence limits (intervals). These may becompared with external standards such as risk-adjustedestimates of observed versus predicted proportionsbased on the STS ACSD[84].Analysis of these data to generate risk-adjustedassessment has generally used parametric models suchas linear regression for continuous variables and logisticregression for binary variables. Limitations of thisapproach include the additive assumption of thesemodels (each factor considered is weighted by a coeffi-cient that accounts for all other variables in the modelsand these weighted factors are added together). Anotherassumption is that the scale of measurement for contin-uous variables is linear with respect to model assump-tions, which may not be true. These limitations can becircumvented by considering multiplicative factors andby transformation of measurement scale, , machine-learning non model-basedequivalents of linear and logistic regression may be used;this includes random forest methodology[439, 440]thatautomatically accounts for complex interactions amongvariables and nonlinearities with respect to the ANALYSIS OF TIME-RELATED EVENTSFor so-called termi-nating events (death, removal of a prosthesis, and otherone-time events), the most common non model-basedestimator is the Kaplan-Meier product-limit actuarialmethod. This method is defined in the probabilitydomain. An alternative is the Nelson estimator, which isdefined in the cumulative hazard domain[441]. Bothyield comparable results. The advantage of the Nelsonmethod is that it can also accommodate repeating(nonterminating) events, such as thromboembolism andbleeding episodes. A new Kaplan-Meier or Nelson esti-mate is made at the time of occurrence of each , these estimates are portrayed graphicallyacross time. These estimates should be accompanied atleast periodically by confidence limits and a depiction ofnumber of patients traced beyond a given set of points temporal pattern of risk of time-related events isexpressed by the hazard function (instantaneous risk ofan event). Nonparametric estimates of the hazard func-tion are usually noisy, so parametric methods may beused to estimate the temporal pattern of risk[442].Aflawin statistical analysis of some long-term safety events isthat it has often been assumed that risk remains the sameacross time (constant hazard at a so-called linearized rate)[443]. This assumption makes computations of hazardrates simple, namely, the number of events observeddivided by the patient-years of follow-up. However, theassumption may not be true. For example, prostheticvalve endocarditis generally has an early peaking hazardphase followed by a lower constant hazard phase; thatmeans that in short follow-up the linearized rate will behigh, and in longer-term follow-up lower. Structuralvalve deterioration has an accelerated late hazard; thelinearized rate is small for short follow-up and large forlonger follow-up. Characterizing the actual hazard func-tion is not difficult and is recommended; a constanthazard may be confirmed[444].If a device is itself being characterized, it can be arguedthat patient death is merely a censoring mechanism, justlike end of follow-up or removal of the device, and thatKaplan-Meier or Nelson estimates are appropriate[445].The estimates accurately assess the probability or risk ofevents related to an aortic valve prosthesis. Whenestimating the probability of an individual patientexperiencing a valve-related event, the patient is theunit of interest, and other competing risks such as deathmust be considered. These estimates will be highlypatient-specific, because there are many patient factorsthat relate to long-term mortality. A limitation ofcompeting risk estimates is that it is assumed that thevalve events and the patient s demise are unrelated(noninformative censoring). That may not be true, andmethods to estimate the magnitude of informativecensoring are an active topic of statistical research[446].Not addressed by surgical or VARC guidelines is anestimate of the adverse effect of safety events onlongevity. One way to assess the effect is to estimatesurvival after occurrence of the safety event. In a pop-ulation, these events should result in an acute decrease insurvival. A second way is to analyze safety events as time-varying covariables in one of two ways: as abrupt changesin level of the hazard function (the most commonapproach) or as a modulation of hazard (modulatedrenewal analysis, commonly performed in industrialsettings)[447]. Time-varying covariable analysis has twoadvantages. First, it permits one to assess quantitativelythe effect of the events. Second, it permits calculation ofpotential survival were these events not to have factors may be associated with shorter time toevents. The two most common approaches for identifyingrisk factors have been (1) semiparametric Cox propor-tional hazard regression[448]and (2) parametricmultiphase hazard function regression[442]. For someevents, particularly mortality, the proportionalityassumption of Cox regression is not reasonable;generally, factors related to early mortality have to dowith the status of the patient at operation, whereasfactors related to late mortality have more to do withchronic comorbidities (including age). Multiphasehazard regression accounts for nonproportional hazardsand permits identification of variables that relate todifferent temporal phases of risk. An alternative to bothofthese methods ismachinelearning nonparametricmethods such as the random forest survival method[440]. ANALYSIS OF LONGITUDINAL DATALongitudinal data maybe continuous (transprosthesis gradient), ordinal (NYHAfunctional class), or binary (episodes of atrialfibrillation).S52SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from Values for these outcomes are generally assessed atinfrequent intervals that vary from patient to patient. Asfor competing risks, any series of measurements is trun-cated by demise of the patient. A universal characteristicof longitudinal repeated measures data is that variabilitywithin the sequence of measurements for a given patientis less than variability among different patients. Thusstatistical analysis must take into account these twosources of variability[449, 450].Unfortunately, current standard statistical packagestend not to have procedures that modelfirst the under-lying ensemble average temporal pattern and thenidentify factors associated with modulation of that longi-tudinal pattern. However, progress is being made indeveloping such are important limitations in analysis of longitu-dinal data. Patients experiencing symptoms or suspectedof having developing problems may be assessed moreoften than those not having these. The result is an esti-mated ensemble average weighted (biased) second limitation is wide variation in assessmentfrequency. A third limitation is that device removal anddeath compete with continued longitudinal assessment. Itis assumed that these events are unrelated to longitudinalevolution of data. This is certainly not true, for example,of SVD. Methods to assess the effect of evolving longi-tudinal status data on events such as death are an activearea of statistical Future NeedsOver the last 5 decades, terminology for describing, andmethods for assessing, success, safety, and long-termeffectiveness of aortic valve and thoracic aorta replace-ment developed within the framework of single disci-plines. With advent of percutaneous and endovasculartechniques, more attention must be focused on accurateand harmonized definitions, cross-disciplinary data,robust long-term surveillance, and more meaningfulanalysis using new analytic DEFINITIONSDefinitions of postprocedural events thatevolved within single disciplines now require sharedunderstanding of their meaning and standardized defi-nitions. Cardiologists may not understand the term structural valve deterioration even after reading itssurgical definition; surgeons may not understand cardi-ologists focus on major adverse cardiac events, whichgrew out of reporting adverse events related to ischemicheart disease interventions; cardiovascular surgeons maynot know the definitions of types I to V endovascular leaknor appreciate their importance; none of the disciplinesmay understand current nomenclature and diagnosticcriteria for strokes that continue to evolve in , there is increasing need for, and value in, a sharednomenclature with clear definitions harmonized DATAWith procedures for the same diagnosisincreasingly carried out in different departments by physi-cians with differing background and training, and withdiffering local, regional, national, and internationalreporting mechanisms, it has become increasingly difficultto monitor comprehensively the success, safety, and effec-tiveness of treating aortic valve and thoracic aorta surgeons report to the STS ACSD and interven-tional cardiologists to the ACC national cardiovascular dataregistry. Vascular surgeons performing endovascularprocedures have limited national reporting. Yet all thesedatabases, assembled along traditional discipline lines forassessing and improving quality, need to be consolidatedacross these lines and barriers. The efforts of both STS andACC to address these issues, particularly for TAVR, area step forward. In the USA, for CMS payment, reporting tothe ACC/STS TVT registry is required and further studieson outcomes and appropriateness use are RANDOMIZED TRIALSObjective performance criteriahave been the mainstay of past assessment of new cardiacvalves[424]. Increasingly, randomized trials will berequired until new objective performance criteria can beestablished. Likely, randomized trials will compareexisting devices and procedures against new ormodified devices and not new devices against untreatednatural history or medical therapy SURVEILLANCELong-term surveillance for safety andeffectiveness is resource intensive and may not beeconomically sustainable. Increasingly active patientfollow-up is being hampered by confidentiality andprivacy regulations and idiosyncratic interpretation ofthese by local institutional review boards. Three alterna-tives to traditional follow-up are emerging. Thefirst isreliance on national registries for vital status[451, 452].These registries do not, however, help in detecting adversenonfatal events. The second is linkage of data to eitherprivate or national insurers and payors to assemblea longitudinal patient record that may document thesemorbid events. The third is perhaps the most interesting:social networks. Already, patients can report side effects ofneurologic drugs on Web sites such the data are not risk adjusted, nor do they trackindividual patients longitudinally, nor is it known howrepresentative the participants may be, as a generalsurveillance method for adverse events, these networksmay be the most cost-effective follow-up ANALYTIC METHODSBoth new and seldom-usedanalytic methods are worth exploring in the years ago, Wayne Nelson of General Electricaugmented time-to-event methods with cost of eachevent: the cumulative cost function[441]. The cost can bemonetary; it can also be a scale of morbidity[442].Earlier, machine learning methods were encompass a growing set of procedures that maysupplant parametric logistic regression and survivalmodels. They have superior predictive power comparedwith traditional statistical models[453].Longitudinal data analysis is still in its , the pervasiveness of those kind of data arestimulating statistical development of thefield, althoughtranslation into useful software is lagging. Just as machinelearning techniques have developed robust survivalanalysis methods, no doubt robust machine-learningS53Ann Thorac SurgSPECIAL REPORTSVENSSON ET AL2013;95:S1 S66AORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES by on May 28, 2013 from techniques for longitudinal data analysis will , a particularly daunting statistical challenge isassessing the interplay among evolving outcomes. Whatis the influence of evolving bioprosthesis deterioration ondeath or quality of life? What is the influence of residualmyocardial diastolic dysfunction on survival? How do riskfactors simultaneously influence the degree of couplingbetween or among outcomes? Important questions suchas these are hard to answer at the present time, butstatistical scientists are developing theory and methods toaddress and other new methods may atfirst appear asdaunting to those caring for patients as were logisticregression, actuarial analysis, and competing risksanalysis over the last 5 decades. To the extent, however,that they help us generate important new knowledgeto better perform the right procedure for the right patientat the right time, we should welcome them and tryto understand their place in the armamentarium ofmethods to assess procedure success, safety, and long-term effectiveness of aortic valve and thoracic Proposed National Quality Forum-BasedQuality Measures1. Patients with valvular heart disease are evaluated bymultidisciplinary specialists including a cardiologistand cardiac Preoperative Preoperative CT for reoperation and Aortic stenosis indication less than cm2or , plus gradient more than 40 mm Hg mean or64 mm Hg peak (>4 m/s) for isolated stenotic Cardiac catheterization for patients aged more than45 Pulmonary function Prophylactic antibiotics with both gram-positive andgram-negative Antibiotics given within 30 minutes of Intraoperative transesophageal Multidisciplinary evaluation and insertion team forpercutaneous Warfarin therapy for mechanical Aspirin or warfarin for biological ACE inhibitor therapy should be considered inpatients with low EF Postoperative echocardiogram less than 30 days SummaryThese guidelines have summarized the current knowl-edge in the treatment of aortic valve and aortic there are many questions and these can onlypartially be answered from incomplete data , newer iterations will update these guide-lines. The choice of the best procedure or valve forpatients is dependent on many factors as discussed aboveand no procedure or device is ideal. Ultimately it is up tothe patient, the cardiologist, and surgeon to reach a deci-sion on appropriate 6summarizes thebenefits of current devices relative to other options forthe relative target are grateful to Jesse Welsh, Rhonda Sweeney, and Tess Parryfor editorial Hiratzka LF, Bakris GL, Beckman JA, et al. 2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/S VM guide-lines for the diagnosis and management of patients withthoracic aortic disease. 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Kouchoukos NoD. Craig MillerYesMedtronic, St. JudeMedical, EdwardsLifesciencesPatrick T. O GaraNoDavid M. ShahianNoHartzell V. SchaffNoCary W. AkinsNoJoseph E. BavariaYesEdwards Lifesciences,St. Jude MedicalEugene H. BlackstoneNoTirone E. DavidNoNimesh D. DesaiNoTodd M. DeweyNoRichard S. D AgostinoNoThomas G. GleasonNoKatherine B. Harrington NoSusheel KodaliYesEdwards Lifesciences,St. Jude Medical,Thubrikar AorticValve, IncSamir KapadiaNoMartin B. LeonNoBrian LimaNoBruce W. LytleNoMichael J. MackNoMichael ReardonYesMedtronicT. Brett ReeceNoG. Russell ReissNoEric E. RoselliNoCraig R. SmithNoVinod H. ThouraniYesSt. Jude Medical,Edwards Lifesciences,SorinE. Murat TuzcuNoJohn WebbYesEdwards LifesciencesMathew R. WilliamsYesEdwards Lifesciences,MedtronicS66SPECIAL REPORTSVENSSON ET ALAnn Thorac SurgAORTIC VALVE/ASCENDING AORTA MANAGEMENT & QUALITY MEASURES2013;95:S1 S66 by on May 28, 2013 from DOI: 2013;95:1-66 Ann Thorac SurgVinod H. Thourani, E. Murat Tuzcu, John Webb and Mathew R. Williams Michael Reardon, T. Brett Reece, G. Russell Reiss, Eric E. Roselli, Craig R. Smith, Kodali, Samir Kapadia, Martin B. Leon, Brian Lima, Bruce W. Lytle, Michael J. Mack,Dewey, Richard S. D'Agostino, Thomas G. Gleason, Katherine B. Harrington, Susheel Joseph E. Bavaria, Eugene H. Blackstone, Tirone E. David, Nimesh D. Desai, Todd Miller, Patrick T. O'Gara, David M. Shahian, Hartzell V. Schaff, Cary W. Akins, Lars G. Svensson, David H. Adams, Robert O. Bonow, Nicholas T. Kouchoukos, D. MeasuresAortic Valve and Ascending Aorta Guidelines for Management and Quality & ServicesUpdated Information high-resolution figures, can be found at: References #at: This article cites 448 articles, 255 of which you can access for free Permissions & Licensing its entirety should be submitted to: Requests about reproducing this article in parts (figures, tables) or Reprints information about ordering reprints, please email: by on May 28, 2013 from

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