Contemporary Perioperative Results of Isolated Aortic Valve Replacement for Aortic Stenosis

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1 Contemorary Perioerative Results of Isolated Aortic Valve Relacement for Aortic Stenosis S. Chris Malaisrie, MD, Patrick M. McCarthy, MD, Edwin C. McGee, MD, Richard Lee, MD, Vera H. Rigolin, MD, Charles J. Davidson, MD, Nirat Beohar, MD, Brittany Lain, MPH, Haris Subačius, MA, and Robert O. Bonow, MD Divisions of Cardiothoracic Surgery and Cardiology, Northwestern University, Feinberg School of Medicine, Bluhm Cardiovascular Institute at Northwestern Memorial Hosital, Chicago, Illinois ADULT CARDIAC Background. Transcatheter aortic valve imlantation may become a otential treatment for high-risk atients with aortic stenosis (AS). We analyzed our contemorary series of isolated aortic valve relacement (AVR) for AS to determine imlications for atients referred for AVR. Methods. From Aril 2004 through December 2008, 190 atients (mean age, 68 years; 68% men) underwent isolated AVR for AS. Mean ejection fraction was Sixty-one ercent underwent minimally invasive AVR and 18% were reoerations. Twenty-one ercent were aged 80 years or older, and 34% were in New York Heart Association functional class III-IV. Estimated oerative mortality was 3.6%. Results. Thirty-day mortality was 0%. One in-hosital death (0.5%) occurred from comlications of an esohageal erforation. Reoeration for bleeding occurred in 4.7%. Acute renal failure develoed in 2.1%. Actuarial survival was 97% at 1 year and 94% at 3 years. Hosital length of stay was 7.0 days for atients aged 80 and older vs 5.0 days ( < 0.001), and they were less likely to be discharged to home (50% vs 83%, < 0.001). Conclusions. Contemorary results show that AVR for AS can be erformed with low oerative mortality and morbidity, although atients aged 80 years and older are at increased risk of rolonged recovery. Transcatheter aortic valve imlantation may be an alternative for highrisk atients, but AVR is still aroriate for low-risk atients. The low risk of AVR suorts the argument that asymtomatic atients who have a high likelihood of rogression of AS may be considered for earlier surgical referral. (Ann Thorac Surg 2010;89:751 7) 2010 by The Society of Thoracic Surgeons The natural history of severe, symtomatic aortic stenosis is dismal [1]. The onset of dysnea, angina, or syncoe marks a turning oint in the course of the disease, with an average life exectancy of less than 2 years [2]. Patients aged older 80 years have an even worse rognosis, with average life exectancy of about 1 year [3]. Although recent trials have examined the otential role of liid-lowering theray in delaying the rogression of aortic stenosis [4, 5], no theray exists that can reverse its course. Catheter-based interventional aroaches, such as the aortic balloon valvotomy, can temorarily imrove symtoms but do not affect the long-term of survival of these atients [6]. Oen heart oerations with aortic valve relacement (AVR) remain the standard treatment for atients with severe, symtomatic aortic stenosis [7] The oerative risk of AVR has imroved dramatically since the firstgeneration ball-in-valve design in the 1960s [8]. The national Medicare database showed an oerative mortality of 8.8% for AVR with or without coronary artery byass grafting in 1994 to 1999 [9]. More recent data from the Society of Thoracic Surgeons (STS) database Acceted for ublication Nov 9, Address corresondence to Dr Malaisrie, 201 E Huron St, Galter Pavilion , Chicago, IL 60614; cmalaisr@nmh.org. showed an in-hosital mortality of 2.6% for isolated AVR in 2006 [10]. Transcatheter aortic valve imlantation (TAVI) has the otential of becoming a revolutionary treatment otion for atients with aortic stenosis. Risk assessment in atients with aortic stenosis will be aramount in deciding which theraeutic intervention to ursue. The oerative risk of oen AVR continues to imrove, and the benchmark for contemorary results of isolated AVR in major centers should be established to judge the aroriate use of TAVI. In addition, the likelihood is very high in atients with severe calcific aortic stenosis, such as those with a eak velocity across the aortic valve of more than 4 m/s by Doler echocardiograhy, that symtoms will develo during the course of the next 5 years [11 13], warranting a class IIb indication for intervention in the current guidelines of the American College of Cardiology (ACC) and the American Heart Association (AHA) [7]. If surgical results in selected centers can redictably offer a Dr McGee discloses a financial relationshi with CardiacAssist, Inc and Thoratec Cororation; Dr Lee with Medtronic and Edwards Lifesciences; Drs Malaisrie, McCarthy, Davidson, and Bonow with Edwards Lifesciences by The Society of Thoracic Surgeons /10/$36.00 Published by Elsevier Inc doi: /j.athoracsur

2 ADULT CARDIAC 752 MALAISRIE ET AL Ann Thorac Surg CONTEMPORARY RESULTS OF AVR FOR AS 2010;89:751 7 Abbreviations and Acronyms ACC American College of Cardiology AHA American Heart Association AVA aortic valve area AVR aortic valve relacement AS aortic stenosis CAD coronary artery disease CI confidence interval COPD chronic obstructive ulmonary disease CPB cardioulmonary byass CVA cerebrovascular accident CVD cerebrovascular disease EF ejection fraction IRB Institution Review Board LOS length of stay MI myocardial infarction NYHA New York Heart Association OR odds ratio PVD eriheral vascular disease RC regression coefficient SD standard deviation SE standard error STS Society of Thoracic Surgeons TAVI transcatheter aortic valve imlantation low risk of erioerative morbidity and mortality, earlier referral of such atients might be considered. Material and Methods This study was aroved by the Institutional Review Board (IRB) at Northwestern University (IRB roject No ). The IRB waived the requirement of individual atient consent because the analysis was retrosective in nature. We queried the Bluhm Cardiovascular Institute Clinical Trials Units N-CORE Database at Northwestern Memorial Hosital for all atients who underwent AVR since the incetion of the database, Aril 2004 through December Data were collected from the database and the medical record. Table 2. Symtoms of Patients With Aortic Stenosis Undergoing Aortic Valve Relacement Chest ain, No. 27 (18.0) 6 (14.6) 33 (17.4) Syncoe, 11 (7.4) 5 (12.2) 16 (8.4) NYHA class, No I 19 (12.7) 3 (7.3) 22 (11.6) II 84 (56.4) 20 (48.8) 104 (54.7) III 41 (27.5) 16 (39.0) 57 (30.0) IV 5 (3.4) 2 (4.9) 7 (3.7) NYHA New York Heart Association. Patients We identified 918 atients who underwent an aortic valve rocedure during the study eriod. Excluded were 680 with concomitant rocedures or aortic valve reairs or resections, leaving 238 atients undergoing isolated AVR. From this grou, 190 were identified who underwent isolated AVR for aortic stenosis. Of note, 2 atients were enrolled in a United States multicenter randomized trial studying the use of transcatheter heart valves for the treatment of atients with severe, symtomatic aortic stenosis at high risk for standard AVR that was sonsored by Edwards Lifesciences (Irvine, CA). These 2 atients were randomized to surgical reair, which was erformed at our institution and therefore included in this analysis. Data collection from the database and medical records included atient demograhics, comorbidities, and oerative characteristics. The rimary end oint was oerative mortality classified by age grou (octogenarian and nonoctogenarian). Secondary end oints were short-term morbidities (within 30 days of the oeration) and overall survival. Comorbidities were defined and classified according to the Society of Thoracic Surgery (STS) National Database ( and included New York Heart Association (NYHA) functional class, ejection fraction, eriheral Table 1. Demograhics of Patients With Aortic Stenosis Undergoing Isolated Aortic Valve Relacement Patients, No. 149 (79) 41 (21) 190 (100) Age, y Mean SD Median 65 (25 79) 82 (80 92) 69 (25 92) (range) Male, 84 (56) 20 (49) 104 (55) BSA, mean SD m BSA body surface area; SD standard deviation. Fig 1. Age distribution is shown of atients with aortic stenosis undergoing isolated aortic valve relacement.

3 Ann Thorac Surg MALAISRIE ET AL 2010;89:751 7 CONTEMPORARY RESULTS OF AVR FOR AS Table 3. Comorbidities and Predicted Oerative Mortality Table 4. Oerative Characteristics 753 ADULT CARDIAC CAD, 16 (10.7) 14 (34.2) 30 (15.8) Hyertension, 82 (55.0) 31 (75.6) 113 (59.5) CVA, 5 (3.4) 4 (9.8) 9 (4.7) CVD, 17 (11.4) 8 (19.5) 25 (13.2) PVD, 10 (6.7) 5 (12.2) 15 (7.9) Smoking history, 48 (32.0) 9 (22.0) 57 (30.0) Renal dialysis, 5 (3.4) 0 5 (2.6) EF, mean SD Hyerliidemia, 91 (61.1) 26 (63.4) 117 (61.6) COPD, 26 (17.4) 8 (19.5) 34 (17.9) STS score, mean SD a a Predicted mortality. CAD coronary artery disease; COPD chronic obstructive ulmonary disease; CVA cerebrovascular accident (stroke); CVD cerebrovascular disease; EF, ejection fraction; PVD eriheral vascular disease; SD standard deviation; STS Society of Thoracic Surgeons. vascular disease, cerebrovascular disease, coronary artery disease (CAD), hyertension, renal failure, smoking history, chronic obstructive ulmonary disease, and reoerative status. The reoerative mean ressure gradient in 47 atients (25%) was less than 40 mm Hg. These comorbidities, along with reoerative characteristics of age, height, and weight, were entered into the STS risk calculator to generate an estimated oerative mortality for each atient [14]. Oerative mortality was defined as death within 30 days of the oeration (30-day mortality) or death before discharge from the hosital (in-hosital mortality). The indication for oeration was severe aortic stenosis. AVR was erformed using cardioulmonary byass (CPB) with cardiolegic arrest. Aroach was by a standard full median sternotomy or was minimally invasive Mini-AVR, No. 88 (59.1) 27 (65.9) 115 (60.5) Reeat sternotomy, 24 (16.1) 11 (26.8) 35 (18.4) st reoeration 21 (14.1) 10 (24.4) 31 (16.3) 2nd reoeration 2 (1.3) 1 (2.4) 3 (1.6) 3rd reoeration 1 (0.7) 0 (0.0) 1 (0.5) CPB time, 74.0 (22.0) 77.0 (22.0) 74.0 (22.0) median (IQR) min Cross-clam 61.0 (20.0) 61.0 (14.0) 61.0 (19.0) time, median (IQR) min Tissue valve, No. 147 (98.7) 41 (100) 188 (98.9) 1 AVR aortic valve relacement; IQR interquartile range. CPB cardioulmonary byass; through a small skin incision and artial uer hemisternotomy. For minimally invasive cases, cannulation for CPB, aortic cross claming, and administration of cardiolegia were erformed through the sternotomy, without the need for eriheral access. All atients were offered a artial sternotomy unless they had heart failure, were obese, or required a comlex reoeration. Statistical Analysis Demograhic variables, symtoms, comorbidities, oerative mortality, oerative characteristics, and morbidity Table 5. Morbidity and Mortality 30-day mortality, In-hosital 0 1 (2.4) 1 (0.5) mortality, No. Infection, Dee sternal Seticemia Re-o for 7 (4.7) 2 (4.9) 9 (4.7) 0.99 bleeding, No. Peri-o MI, No Permanent CVA, Atrial fibrillation, 31 (20.8) 13 (31.7) 44 (23.2) Renal failure, No. 1 (0.7) 3 (7.3) 4 (2.1) Dialysis required 0 (0.0) 1 (2.4) 1 (0.5) Prolonged ventilation, 5 (3.4) 5 (12.2) 10 (5.3) Fig 2. Distribution of rosthetic valve sizes is shown. CVA cerebrovascular accident (stroke); MI myocardial infarction.

4 ADULT CARDIAC 754 MALAISRIE ET AL Ann Thorac Surg CONTEMPORARY RESULTS OF AVR FOR AS 2010;89:751 7 Table 6. Recovery After Aortic Valve Relacement Post-o LOS, median (IQR) d Discharge to home, IQR interquartile range; P 5.0 (3.0) 7.0 (2.0) 5.0 (3.0) (83.2) 20 (50.0) 144 (75.8) LOS length of stay. Table 8. Multivariable Risk Factors for Discharge to Home After Aortic Valve Relacement OR 95% CI Age 2 / NYHA class NYHA New York Heart Association; OR odds ratio; CI confidence interval and mortality in atients with aortic stenosis undergoing isolated AVR were comared between atients who were 80 years old and older vs atients younger than 80 years. The 2 test and Fisher s exact test were used for categorical variables, and the t test was used for continuous variables. s with distributions that deviated from normality were transformed using natural logarithm or square of the raw data. Median and interquartile range rather than conventional mean standard deviation (SD) statistics are reorted for such variables. Multivariable analysis using multile regression was erformed to identify risk factors for rolonged recovery (length of stay) after isolated AVR for aortic stenosis using. Discharge to home vs other locations was similarly modeled using multile logistic regression. Patient long-term survival was assessed using the Kalan-Meier survival curve method. Results From Aril 2004 through December 2008, 190 atients with aortic stenosis underwent isolated AVR, of which 41 (21.5%) were aged 80 years or older (Table 1). The age distribution of atients is shown in Figure 1. Dysnea was the most frequent symtom on resentation (Table 2), with 33.7% of atients resenting with NYHA functional class III or IV symtoms. Comorbidities were similar between the two grous excet for lower body surface area and a higher incidence of hyertension and CAD in the octogenarians (Table 3). Ten atients had an estimated oerative mortality by STS risk calculator greater than 10%. The estimated oerative mortality was higher in octogenarians comared with younger atients ( 0.001). Minimally invasive AVR was erformed in 115 atients (61%) with both rimary sternotomy and reeat sternotomy (Table 4). Aortic cross-clam and CPB times were not statistically different between the two age grous. A stented biorosthetic valve was used in 99% of atients vs a mechanical valve. The distribution of valve sizes is shown in Figure 2, with 23 mm being the most common valve size. Mean gradients across the aortic valve decreased from mm Hg reoeratively to mm Hg ostoeratively. The 30-day mortality was zero for the entire grou, but 1 atient died in-hosital of comlications secondary to an esohageal erforation resumably caused by the intraoerative transesohageal echocardiograhy robe. The oerative mortality for atients aged 80 years and older was 2.4%. The incidence of rolonged ventilation and ostoerative renal failure was greater in octogenarians, but the incidence of renal failure requiring dialysis was not significantly different between the two grous (Table 5). Postoerative bleeding was 4.7% but did not result in any lasting morbidity. Recovery, as quantified by length of stay and discharge to home vs a nonhome destination such as an inatient rehabilitation facility or skilled nursing facility, was significantly different between the two grous (Table 6). Multivariable analysis revealed that age 80 years and older, male gender, ejection fraction, chronic obstructive Table 7. Multivariable Risk Factors for Length of Stay After Aortic Valve Relacement a RC 95% CI SE Age 2 / to Male gender to EF 3 /10, to COPD to CVD to a Only the redictors with 0.05 are included in this table. Outcomes were ln(ln[los]). CI confidence interval; COPD mild, moderate, or severe chronic obstructive ulmonary disease; CVD cerebrovascular disease; EF ejection fraction; LOS length of stay; RC regression coefficient; SE standard error. Fig 3. Overall survival is shown of atients with aortic stenosis undergoing isolated aortic valve relacement. The to curve corresonds to atients younger than 80 years and the bottom curve to atients aged 80 years or older. The number above each year indicates the number of atients at risk.

5 Ann Thorac Surg MALAISRIE ET AL 2010;89:751 7 CONTEMPORARY RESULTS OF AVR FOR AS lung disease, and cerebrovascular disease were associated with length of stay (Table 7). Multivariable analysis revealed that age and reoerative NYHA classification were associated with discharge to a nonhome destination (Table 8). Overall survival for the entire grou was 97% at 1 year and 94% at 3 years. Figure 3 shows the overall survival by age grou. Comment These contemorary results of isolated AVR demonstrate the imroved safety of oen heart oerations in exerienced centers for atients with aortic stenosis. The ercetion of oor outcomes after isolated AVR has generated interest in alternative treatment strategies, including aortic balloon valvotomy, aortic valve byass using aicoaortic conduits, and most recently, TAVI. Nevertheless, near-zero oerative mortality adds to increasing weight of evidence that isolated AVR should continue to be the gold standard theray for most atients. Certain atients have been identified as having increased oerative risk, in articular, the elderly atient. Although an oerative mortality as high as 14% has been reorted for octogenarians [15], more recent data suggest that oerative mortality for this age grou can be as low as 5%, comarable with our result of 2.4% [16, 17]. The favorable results of this study also reflect careful atient selection before surgical referral. However, many similar atients in the general oulation are not offered surgical correction due to age alone. This study suggests that such atients may benefit from surgical correction with an accetable surgical risk. The AHA/ACC guidelines have, therefore, clearly stated that age should not be a contraindication for surgical intervention in atients with severe symtomatic aortic stenosis [7]. Desite accetable oerative risk in the octogenarian, rolonged recovery with return to normal lifestyle is, nevertheless, an imortant concern for these atients. A study of the New York State Deartment of Health s Cardiac Reorting System showed that only 52% of octogenarians were discharged to home after coronary artery byass grafting [18]. We similarly assessed shortterm recovery using the variables of length of stay and discharge disosition in this current study and found that the length of stay was increased by 2 days and that 50% of octogenarians were discharged to a nonhome destination after isolated AVR. Because many risk factors are not adequately reflected in reoerative risk assessments, age itself may be a roxy for factors such as frailty and hence the ability to recover. Current trials involving TAVI are enrolling atients otherwise considered high risk for surgical AVR. Preliminary data on atients referred for TAVI indicate a comlex and heterogeneous grou [19]. In contrast, most surgeons in contemorary ractices are not referred many atients for AVR due to advanced age and comorbid conditions [20]. Similarly in our tertiary care center, high-risk atients, as defined by an STS score greater than 10, account for the minority of the series. A limitation of this study, therefore, is that these results may not 755 aly to the high-risk atients currently being enrolled in the ongoing ivotal trials. However, the urose of this study was not to examine the role of AVR in high-risk atients, but rather to set a contemorary benchmark for AVR outcomes in low- and medium-risk atients. A concern for emerging technologies designed for the treatment of high-risk atients with aortic stenosis is the future inaroriate off-label use in low-risk atients. Off-label use already comrises most cases in atients with stent imlants. A Food and Drug Administration anel concluded in 2006 that off-label use comrises aroximately 60% of drug-eluting stent imlants, and that off-label use was associated with worse outcomes comared with on-label use [21]. In Euroe, where the TAVI technology has been commercially aroved, we are already hearing anecdotal stories of TAVI use in low-risk atients [22]. Even in the octogenarians and atients with other risk factors, AVR can be erformed safely today. Only long-term follow-u and new randomized trials will determine if the emerging TAVI technology can match those results in a healthier atient oulation. On the other end of the sectrum, the management of low-risk atients with severe aortic stenosis but without symtoms remains controversial [7, 23]. Only with low oerative risk can a recommendation be made for an early oeration in these atients. Conditions in which early intervention may be warranted in the absence of symtoms include extremely severe aortic stenosis (aortic valve area [AVA] 0.6 cm 2, eak jet velocity 5.0 m/s, or mean gradient 60 mm Hg) [7], deressed left ventricular function (ejection fraction 0.50), abnormal exercise test result, markedly calcified aortic valve, raid rogression of aortic stenosis (increase in eak jet velocity 0.3 m/s er year, or decrease in AVA 0.1 cm 2 er year), or exected delays in the diagnosis or treatment of disease rogression [15]. It is also aarent that atients with severe aortic stenosis (defined as eak jet velocity 4 m/s) have a high likelihood of acquiring AVR during the next 5 years because of onset of symtoms [11 13]. These results, therefore, suort the argument for intervening in severe aortic stenosis even before the onset of symtoms in selected atients in centers achieving very low rates of oerative mortality and morbidity. The alternative of watchful waiting for atients who are asymtomatic has otential risks. Careful clinical follow-u and echocardiograhic surveillance every 6 to 12 months is recommended but may nevertheless fail to uncover symtoms in a timely fashion. Patients who are educated to self-reort the onset of new symtoms often reduce their daily activities to adat their rogressive heart failure. The raid rogression of heart failure with undiagnosed symtomatic aortic stenosis may therefore significantly worsen oerative risk when atients are finally referred for surgical intervention. In conclusion, oen AVR should remain the standard treatment for severe, symtomatic aortic stenosis. The contemorary results from a single, tertiary care center show a near-zero oerative mortality. A few atients who undergo isolated AVR are considered high-risk as de- ADULT CARDIAC

6 ADULT CARDIAC 756 MALAISRIE ET AL Ann Thorac Surg CONTEMPORARY RESULTS OF AVR FOR AS 2010;89:751 7 fined by an estimated oerative mortality greater than 10%, and therefore, these results may not be comarable in current trials with high-risk atients undergoing TAVI. Nevertheless, elderly atients are at risk for increased rolonged recovery and discharge to a nonhome destination. These end oints may be of additional imortance if mortality is equal in ongoing TAVI trials. On the other hand, the alication of TAVI to low-risk atients is inaroriate, and early surgical intervention for atients with asymtomatic, severe aortic stenosis should be considered. References 1. Ross J Jr, Braunwald E. Aortic stenosis. Circulation 1968;38(1 sul): Horstkotte D, Loogen F. The natural history of aortic valve stenosis. Eur Heart J 1988;9(sul E): Varadarajan P, Kaoor N, Bansal RC, Pai RG. Survival in elderly atients with severe aortic stenosis is dramatically imroved by aortic valve relacement: results from a cohort of 277 atients aged or 80 years. Eur J Cardiothorac Surg 2006;30: Cowell SJ, Newby DE, Prescott RJ, et al. A randomized trial of intensive liid-lowering theray in calcific aortic stenosis. N Engl J Med 2005;352: Rossebo AB, Pedersen TR, Boman K, et al. Intensive liid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med 2008;359: Safian RD, Berman AD, Diver DJ, et al. Balloon aortic valvulolasty in 170 consecutive atients. N Engl J Med 1988;319: Bonow RO, Carabello BA, Kanu C, et al. ACC/AHA 2006 guidelines for the management of atients with valvular heart disease: a reort of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease). Circulation 2006;114:e Gott VL, Alejo DE, Cameron DE. Mechanical heart valves: 50 years of evolution. Ann Thorac Surg 2003;76:S Goodney PP, O Connor GT, Wennberg DE, Birkmeyer JD. Do hositals with low mortality rates in coronary artery byass also erform well in valve relacement? Ann Thorac Surg 2003;76:1131 6; discussion Brown JM, O Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve relacement in North America comrising 108,687 atients in 10 years: changes in risks, valve tyes, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg 2009; 137: Otto CM, Burwash IG, Legget ME, et al. Prosective study of asymtomatic valvular aortic stenosis. Clinical, echocardiograhic, and exercise redictors of outcome. Circulation 1997;95: Pellikka PA, Sarano ME, Nishimura RA, et al. Outcome of 622 adults with asymtomatic, hemodynamically significant aortic stenosis during rolonged follow-u. Circulation 2005; 111: Rosenhek R, Binder T, Porenta G, et al. Predictors of outcome in severe, asymtomatic aortic stenosis. N Engl J Med 2000;343: Edwards FH, Grover FL, Shroyer AL, Schwartz M, Bero J. The Society of Thoracic Surgeons National Cardiac Surgery Database: current risk assessment. Ann Thorac Surg 1997;63: Olsson M, Granstrom L, Lindblom D, Rosenqvist M, Ryden L. Aortic valve relacement in octogenarians with aortic stenosis: a case-control study. J Am Coll Cardiol 1992;20: Filsoufi F, Rahmanian PB, Castillo JG, Chikwe J, Silvay G, Adams DH. Excellent early and late outcomes of aortic valve relacement in eole aged 80 and older. J Am Geriatr Soc 2008;56: Thourani VH, Myung R, Kilgo P, et al. Long-term outcomes after isolated aortic valve relacement in octogenarians: a modern ersective. Ann Thorac Surg 2008;86: ; discussion Bardakci H, Cheema FH, Tokara VK, et al. Discharge to home rates are significantly lower for octogenarians undergoing coronary artery byass graft surgery. Ann Thorac Surg 2007;83: Dewey TM, Brown DL, Das TS, et al. High-risk atients referred for transcatheter aortic valve imlantation: management and outcomes. Ann Thorac Surg 2008;86:1450 6; discussion Bach DS, Cimino N, Deeb GM. Unoerated atients with severe aortic stenosis. J Am Coll Cardiol 2007;50: Pinto Slottow TL, Waksman R. Overview of the 2006 Food and Drug Administration Circulatory System Devices Panel meeting on drug-eluting stent thrombosis. Catheter Cardiovasc Interv 2007;69: Piazza N, Otten A, Schultz C, et al. Adherence to atient selection criteria in atients undergoing transcatheter aortic valve imlantation with the 18F CoreValve ReValvingTM System Results from a single-center study. Heart 2009 [in-ress; doi: hrt v1]. 23. Vahanian A, Baumgartner H, Bax J, et al. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the Euroean Society of Cardiology. Eur Heart J 2007;28: INVITED COMMENTARY Historically, oerative mortality has been the measuring stick by which varying techniques, rocedures, or theraies are comared. Death has the benefit of being a well-defined end oint with generally little ambiguity. But as we attemt to reconcile novel theraies, such as transcatheter aortic valve imlantation to more conventional aroaches, different metrics of success in addition to death will likely need to be considered. Survival both immediate and long-term is an imortant measure of success, articularly between matched oulations. But other erformance measures, such as duration of hositalization, time to return to work or normal activity, discharge to a nonhome environment, and resource utilization, can be increasingly imortant indicators of theraeutic success when evaluating outcomes among diverse oulations. It is intuitive that different oulations might have diverse treatment and outcome exectations, all of which need to be accounted for when matching rocedure to atient. Thus, the 60- year-old atient has different longevity and functionality requirements after aortic valve relacement than does the 85-year-old atient, whose rimary concern is quality of remaining life rather than quantity. Going forward, the weight given to these different variables may significantly affect the tye of oerative aroach offered to atients by The Society of Thoracic Surgeons /10/$36.00 Published by Elsevier Inc doi: /j.athoracsur

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