Management of High-Risk Patients With Aortic Stenosis and Coronary Artery Disease

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1 Management of High-Risk Patients With Aortic Stenosis and Coronary Artery Disease Daniel Wendt, MD, Philipp Kahlert, MD, Tim Lenze, Markus Neuhäuser, MD, Vivien Price, Thomas Konorza, MD, Raimund Erbel, MD, Heinz Jakob, MD, and Matthias Thielmann, MD Departments of Thoracic and Cardiovascular Surgery and Cardiology, West-German Heart Center Essen, University Hospital Essen, Essen, Germany; and Department of Mathematics and Technology, Koblenz University of Applied Science, Remagen, Germany Background. Aortic valve replacement with coronary artery bypass graft surgery is currently the standard therapy for patients with aortic stenosis and concomitant coronary artery disease. We sought to determine whether transcatheter aortic valve implantation combined with percutaneous coronary intervention might be an equivalent strategy. Methods. A total of 243 high-risk patients (Society of Thoracic Surgeons [STS] score >10% and/or European System for Cardiac Operative Risk Evaluation [EuroSCORE] >15%) presenting with aortic stenosis with concomitant coronary artery disease were studied. Patients were treated either by surgical aortic valve replacement combined with coronary artery bypass graft (group 1, n 184) or by percutaneous coronary intervention within 12 months before transapical or transfemoral transcatheter aortic valve implantation (group 2, n 59). A propensity score adjusted regression analysis was used to compare 30-day mortality as the primary study endpoint between the groups. Results. Group 1 mean age (75 6 years), EuroSCORE (18.1% 13.8%), and STS score (13.1% 8.7%) were significantly different from group 2 (mean age 80 6 years, Euro- SCORE 27.5% 16.3%, and STS score 16.7% 10.5%; p < 0.001). Thirty-day mortality was 12.5% in group 1 compared with 11.9% in group 2 (odds ratio 0.94, 95% confidence interval: 0.38 to 2.32, p 0.89). Univariate analysis revealed left ventricular ejection fraction, pulmonary hypertension, renal insufficiency, STS score, EuroSCORE, and previous cardiac surgery as predictors for 30-day mortality (p < 0.05). Risk-adjusted multivariate regression analysis showed only left ventricular ejection fraction to be strongly associated with 30-day mortality and confirmed no significant difference between the groups (p 0.44). To further control for study bias, a 10-layer propensity score model based on the univariate analysis again indicated equivalence regarding the primary endpoint (p 0.33). Conclusions. The present study demonstrates that transcatheter aortic valve implantation in combination with prior percutaneous coronary intervention within 12 months produces similar results in a propensity score matched high-risk patient population. (Ann Thorac Surg 2013;95: ) 2013 by The Society of Thoracic Surgeons Accepted for publication July 26, Address correspondence to Dr Wendt, Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Hospital Essen, Hufelandstrasse 55, Essen 45122, Germany; daniel.wendt@uk-essen.de. Surgical aortic valve replacement (AVR) and coronary artery bypass grafting (CABG) is currently the proven standard therapy for patients with aortic stenosis and concomitant coronary artery disease [1, 2]. It is anticipated that coronary artery disease preexists in approximately 25% of patients presenting with aortic valve stenosis and may increase as much as 50% in the prevalence of typical angina [3]. However, coexisting coronary artery disease clearly increases operative morbidity and mortality in such concomitant operations [4]. Transcatheter aortic valve implantation (TAVI), as an alternative to conventional aortic valve replacement, has currently changed the paradigms in the treatment of aortic valve stenosis (5). This technique has been initially considered as a stand-alone procedure only targeting patients presenting with isolated aortic valve stenosis deemed at highest operative risk for conventional surgery [6, 7]. A recently published randomized controlled trial suggested TAVI to be as good as surgery [8]. However, in daily practice, more and more patients are presenting with coronary artery disease, which is often treated in the forefront or even during transcatheter aortic valve implantation. This group of patients should, therefore, be compared with patients who undergo concomitant aortic valve replacement with CABG surgery rather than with patients who have isolated aortic valve replacement. The aim of the present study was to compare the outcome of patients treated completely percutaneously (TAVI plus percutaneous coronary intervention [PCI]) with the outcome of patients who underwent a complete surgical concomitant operation (AVR plus CABG). Material and Methods The present study was a nonrandomized, single-center study including 243 consecutive patients who underwent either surgical aortic valve replacement combined with CABG (group 1) or PCI followed by transcatheter aortic valve implantation within 12 months (group 2) at the West-German Heart Center Essen. The present study 2013 by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc

2 600 WENDT ET AL Ann Thorac Surg HIGH-RISK PATIENTS WITH AS AND CAD 2013;95: obtained Institutional Review Board approval according to the Declaration of Helsinki. Only patients with a logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) greater than 15% or The Society of Thoracic Surgeons (STS) score greater than 10% were enrolled in the present study. All remaining patients did not fulfill the inclusion criteria because of a calculated risk score lower than the cutoff points of the present study. Patients were selected for the hybrid approach if they were deemed to be at excessive risk because of comorbidities and other risk factors not being captured by scoring systems (eg, porcelain aorta, frailty, or prior chest radiation). The indication for the percutaneous approach in the individual patient was discussed for each patient in a consensus conference ( heart team ) of cardiologists and cardiac surgeons (D.W., P.K., T.K., and M.T.), and the patient s or physician s preference alone was not considered adequate for decision making. Transcatheter aortic valve implantation was performed by means of either transfemoral access or transapical access, as previously described [9 12]. The Sapien and Sapien XT (Edwards Lifesciences, Irvine, CA) balloon-expandable valves were used both for transapical and transfemoral access, and the self-expandable CoreValve (Medtronic, Minneapolis, MN) prosthesis was used only for the transfemoral approach. Conventional aortic valve replacement combined with CABG was performed by sternotomy according to our institute s standard techniques, as described by our group previously [13]. The Medtronic Mosaic Ultra (Minneapolis, MN), and both the Edwards Magna and Magna Ease (Edwards Lifesciences) aortic valve bioprostheses were used for surgical valve replacement. The primary study endpoint was in-hospital mortality, defined as all causes of death within 30 days, including all enrolled patients. A follow-up was also performed. Patient and operative demographics were recorded in a prospective institutional database and retrospectively extracted and evaluated. Peripheral vessel disease and chronic obstructive pulmonary disease were defined as per the Euro- SCORE definition. Perioperative deaths (30-day mortality) were tracked from the institutional database or by active follow-up. Survival was obtained by active follow-up. Calculation of completeness of follow-up was 100%. Moreover, the rate of cardiac reintervention (valve or vascular reintervention) for both groups was evaluated. Statistics Descriptive statistics are summarized for categorical variables as frequencies (%). Continuous variables were reported as mean SD. Categorical variables are presented as median and range. Groups were compared using Student s t test, Pearson s 2, or Fisher s exact tests as appropriate. Univariate and multivariable logistic regression analyses were performed to identify preoperative independent risk factors for inhospital mortality. The following preoperative variables were used for the regression analysis: sex, age, number of diseased and grafted vessels, New York Heart Association functional class, left ventricular function, chronic obstructive pulmonary disease, peripheral vessel disease, pulmonary hypertension, renal insufficiency, STS score, EuroSCORE, and reoperation. Those variables indentified by the univariate analysis with a p value less than 0.1 were added to the multivariable model, in addition to group membership. To further control for selection bias, the propensity score was computed based on the patients major risk factors. A conditional logistic regression analysis was applied, and patients were matched into 10 strata according to the propensity score [14]. The following factors were used for the propensity score calculation: left ventricular ejection fraction, pulmonary hypertension, renal insufficiency, STS score, EuroSCORE, and reoperation. These are the variables indentified by the univariate analysis with a p value less than 0.1, as noted above. In general, a p value less than 0.05 was considered to indicate statistical significance. Survival curves were generated with the Kaplan-Meier method and compared by log rank (Mantel- Cox) analysis. All statistical analyses were performed using SAS, version 9.2 (SAS Institute, Cary, NC). Results A total of 243 consecutive patients who underwent either surgical aortic valve replacement combined with CABG or percutaneous coronary intervention followed by transcatheter aortic valve implantation within 12 months were identified. Of these, 184 patients were treated by a surgical approach (AVR CABG), whereas 59 patients received PCI followed by transcatheter aortic valve implantation. The mean time interval of PCI before TAVI was days (range, 3 to 340). All patients within group 1 received a conventional biological aortic valve substitute (Medtronic Mosaic Ultra, n 51; Edwards Perimount Magna, n 72; or Edwards Perimount Magna Ease, n 61). Patients of group 2 were treated by either a transapical approach (n 21) or a transfemoral approach (n 38). Patients treated by the retrograde transfemoral approach received either a Sapien, Sapien XT (n 21), or CoreValve prosthesis (n 17). Preoperative characteristics of both groups are summarized in Table 1. The two groups were similar for all listed characteristics, except age, peripheral vascular disease, left ventricular function, and both calculated risk scores (logistic Euro- SCORE and STS score). Patients in the TAVI PCI group were significantly older (75 6 years versus 80 6 years, p 0.001), showed a higher percentage of peripheral vascular disease (27.1% versus 42.4%, p 0.001), and more limited left ventricular function (53.4% versus 49.4%, p 0.03). Furthermore, preoperative risk assessment showed higher estimated risk scores for the TAVI PCI group (logistic EuroSCORE 18.1% 13.8% versus 27.5% 16.3%, p 0.001; and STS score 13.1% 8.7% versus , p 0.001). Moreover, both groups were similar (p 0.75) in regard to preoperative renal disease (serum creatinine cutoff-level 200 mol/l). An exact breakdown of the diseased coronary vessels is shown in Table 1. With respect to the diseased coronary vessels, in group 2, single-vessel disease was predominant at 55.9%, which was significantly higher than in group 1, in which significantly more patients had triple-vessel disease (31.0% versus 5.1%, p 0.001). Comparing both groups, there was no difference with regard to in-hospital mortality (30-day mortality). Within the

3 Ann Thorac Surg WENDT ET AL 2013;95: HIGH-RISK PATIENTS WITH AS AND CAD 601 Table 1. Baseline Patient Characteristics Variable Group 1 (AVR CABG) (n 184) Group 2 (TAVI PCI) (n 59) p Value a Demographics Age, years Female 100 (54.3) 33 (55.9) 0.88 Risk factors and comorbidities NYHA class (range) 3 (2 4) 3 (2 4)... Peripheral vascular disease 50 (27.1) 25 (42.4) COPD 56 (30.4) 24 (40.1) 0.15 Renal disease (serum Cr 200 mol/l) 60 (32.6) 21 (35.6) 0.75 Diabetes mellitus 36 (19.6) 19 (32.2) 0.05 Previous stroke 27 (14.7) 2 (3.4) 0.02 Cardiac history LVEF,% Pulmonary hypertension 48 (26.1) 20 (33.9) 0.25 Previous cardiac surgery 14 (7.6) 6 (10.2) 0.58 Coronary artery disease One-vessel disease 64 (34.8) 33 (55.9) Two-vessel disease 63 (34.2) 23 (39.0) 0.53 Three-vessel disease 57 (31.0) 3 (5.1) Risk scores STS score, % Logistic EuroSCORE, % Data are presented as mean SD or number (%); New York Heart Association (NYHA) class presented as median. a Group 1 versus group 2. AVR aortic valve replacement; CABG coronary artery bypass grafting; COPD chronic obstructive pulmonary disease; Cr creatinine; EuroSCORE European System for Cardiac Operative Risk Evaluation; LVEF left ventricular ejection fraction; PCI percutaneous coronary intervention; STS The Society of Thoracic Surgeons; TAVI transcatheter aortic valve implantation. AVR CABG group, there was 30-day mortality of 12.5% (n 23), compared with 11.9% (n 7) in the TAVI PCI group (odds ratio 0.94, 95% confidence interval: 0.38 to 2.32, p 0.89). In group 1, freedom from all-cause death was 74.5% at 2 years, 68.1% at 4 years and 60.7% at 6 years. In group 2, survival was 71.2% at 2 years, 53.0% at 4 years, and 45.4% at 6 years. There was no statistical significant difference between survival of both groups (p 0.191). Kaplan-Meier survival curves are given in Figure 1. Comparing both groups in regard to cardiac reintervention, there was no statistical significance (p 0.178), although no patient in the percutaneously treated group underwent cardiac reintervention. Freedom from cardiac reintervention is illustrated in Figure 2. The mean number of distal anastomoses within the surgical AVR CABG group was (range, 1 to 6). All patients within the TAVI PCI group presented with single-, two-, or three-vessel coronary artery disease. The mean implanted stent number within the percutaneously treated group was (range, 1 to 6 stents); and PCI was directed to the right coronary artery in 31 cases, to the left anterior coronary artery in 33 cases, and to the circumflex artery in 30 cases, resulting in a mean number target vessels treated. The mean number of distal CABG anastomoses was significantly higher compared with the mean number of vessels treated by PCI (p 0.001). The PCI was performed using either bare metal stents, in 41 cases (69.5%), or drug-eluting stents, in 18 cases (30.5%), and was successful in all patients. A detailed summary of intraprocedural and postprocedural data is presented in Table 2. Interestingly, maximum postprocedural cardiac troponin-i levels were significantly lower in group 2 (p 0.001). Regression Analysis To evaluate independent predictors for in-hospital mortality, a logistic regression analysis was constructed. Several univariate indicators (left ventricular ejection fraction, pulmonary hypertension, renal insufficiency, STS score, EuroSCORE, and previous cardiac surgery) were found to predict for in-hospital mortality as shown in Table 3. Enrollment in neither group 1 nor in group 2 could be identified as an independent risk factor for in-hospital mortality within the multivariate regression model (p 0.44). Finally, to further control for study bias, a propensity score was developed based on the six major risk factors as revealed by the multivariate analysis. Both groups were adjusted according to the calculated propensity score, and this also confirmed no statistical significant difference between group 1 and group 2 with regard to in-hospital mortality (odds ratio 0.62, 95% confidence interval: 0.25 to 1.60; p 0.33). Comment The present study demonstrates that transcatheter aortic valve implantation combined with PCI produces similar results for in-hospital mortality in high-risk patients presenting with

4 602 WENDT ET AL Ann Thorac Surg HIGH-RISK PATIENTS WITH AS AND CAD 2013;95: Fig 1. Kaplan-Meier survival curves for patients treated either by surgical aortic valve replacement combined with coronary artery bypass grafting (black line) or by percutaneous coronary intervention within 12 months before transapical or transfemoral transcatheter aortic valve implantation (gray line). aortic valve stenosis and concomitant coronary artery disease compared with high-risk patients undergoing surgical aortic valve replacement with CABG surgery. At present, combined surgical aortic valve replacement with coronary artery bypass grafting represents the standard treatment of patients with aortic valve stenosis and concomitant coronary artery disease [1, 2]. However, coexisting coronary artery disease has been clearly demonstrated to increase operative morbidity and mortality in such concomitant conventional operations [4]. To date, transcatheter aortic valve implantation has been suggested as an alternative treatment option to conventional AVR in selected patients and has become a more widely available and accepted therapeutic option [15, 16]. Moreover, because this subgroup of elderly high-risk patients with aortic valve stenosis presents more often with concomitant coronary artery disease, the concept of combining percutaneous coronary intervention with transcatheter aortic valve implantation has been proposed recently [17, 18]. This current trend is amplified by emerging PCI procedures as the main treatment option for coronary artery disease, and therefore, the number and frequency of PCI procedures is rapidly increasing worldwide. Owing to increasing numbers of percutaneous combination therapies such as TAVI and PCI being performed, the initial target group for transcatheter aortic valve implantation has expanded. It, therefore, stands to reason that patients undergoing TAVI PCI should be compared with patients undergoing concomitant aortic valve replacement with CABG surgery. Transcatheter aortic valve implantation was primarily developed for patients presenting with isolated aortic valve stenosis; however, it is obvious that an equally large number of patients are presenting with symptomatic aortic valve stenosis and concomitant coronary artery disease [6, 7, 18]. The overall mortality of isolated aortic valve replacement ranges between 2% and 4%, rising in high-risk patients to approximately 8% [19]. Mortality further increases disproportionally to as high as 10% to 15% in elderly or high-risk patients undergoing combination surgery for aortic valve replacement and coronary artery bypass grafting [20]. Hence, a less invasive or even total percutaneous treatment or a staged percutaneous treatment might be beneficial for such patients. Whether a simultaneous percutaneous treatment with TAVI and PCI within the same procedure or a staged approach with PCI before or after TAVI is superior currently can not be answered [17]. Recently, the first single-center experiences and case reports of simultaneous approaches have been published; however, the ideal time point for intervention is as yet uncertain [17]. Because of a theoretical risk of periprocedural myocardial ischemia caused by coronary stenosis, our institutional policy from the beginning was to treat every significant coronary stenosis before TAVI. We, therefore, sought to evaluate the outcomes of patients who have received a staged percutaneous treatment with PCI within 1 year before TAVI compared with a patient group who underwent the standard simultaneous surgical approach with conventional aortic valve replacement and CABG surgery. In the present report, combined procedures either by a complete surgical or by a complete but staged percutaneous approach Fig 2. Freedom of cardiac reintervention for patients treated either by surgical aortic valve replacement combined with coronary artery bypass grafting (black line) or by percutaneous coronary intervention within 12 months before transapical or transfemoral transcatheter aortic valve implantation (gray line).

5 Ann Thorac Surg WENDT ET AL 2013;95: HIGH-RISK PATIENTS WITH AS AND CAD 603 Table 2. Intraprocedural and Postprocedural Data Variable Group 1 (AVR CABG) (n 184) Group 2 (TAVI PCI) (n 59) p Value a Intraprocedural data Distal anastomoses Proximal anastomoses Total arterial grafting 34 (18.5) LIMA use 130 (70.7) Implanted stents One stent (35.6)... Two stents (37.3)... Three stents (18.6)... Four stents... 5 (8.5)... Postprocedural data Maximum ctni, ng/ml Reexploration for bleeding 4 (2.2) 0 (0) 0.57 Packed RBC transfusion Stroke, 30 days 6 (3.2) 1 (1.7) 1.00 Pacemaker implantation 8 (4.4) 4 (6.8) 0.49 Data are presented as mean SD or number (%). a Group 1 versus group 2. AVR aortic valve replacement; CABG coronary artery bypass graft surgery; ctni cardiac troponin I; LIMA left internal mammary artery; PCI percutaneous coronary intervention; RBC red blood cells; TAVI transcatheter aortic valve implantation. were compared in 184 versus 59 high-risk patients and controlled by risk adjustment and propensity score matching. As a result, the observed in-hospital mortality was increased, as expected, with 12.5% in the AVR CABG group compared with isolated aortic valve replacement. In the TAVI PCI group, the observed inhospital mortality was comparable with 11.9%, despite the preoperatively calculated predicted mortality being significantly higher as compared with the AVR CABG group. Furthermore, none of the patients died within the time interval between the initial PCI and the final TAVI procedure. Observed mortality rates of the present study correlate with the current literature on combined surgical aortic valve replacement with concomitant coronary bypass grafting in high-risk patients [13]. Therefore, the elevated risk scores and the high percentage of comorbidities of both patients groups have to be considered. It should be emphasized that despite nearly equal 30-day mortality rates between the two groups in the present study, patients in group 2 (TAVI PCI) showed a significantly higher risk profile (as predicted, for example, by the STS score and EuroSCORE) and in addition were older as compared with group 1. After precise risk adjustment and further m:n propensity score analysis, the mortality remained equal between the two groups, favoring the staged percutaneous approach. Survival within the current report is similar between both groups. It should be emphasized however, as already mentioned, that the total percutaneous group was older and showed significant higher preoperative risk scores compared Table 3. Univariate and Multivariate Logistic Regression Analysis of Variables Associated With In-Hospital Mortality Univariate Analysis Multivariate Analysis Variable Odds Ratio (95% CI) p Value Odds Ratio (95% CI) p Value Age 1.05 ( ) Sex 0.91 ( ) LVEF 0.95 ( ) ( ) 0.01 COPD 1.90 ( ) Peripheral vessel disease 1.86 ( ) Pulmonary hypertension 3.02 ( ) ( ) 0.08 Renal insufficiency 3.11 ( ) ( ) 0.26 STS score 1.05 ( ) ( ) 0.49 EuroSCORE 1.03 ( ) ( ) 0.91 Previous cardiac surgery 3.55 ( ) ( ) 0.06 Group 1/group ( ) ( ) 0.44 CI confidence interval; COPD chronic obstructive pulmonary disease; EuroSCORE European System for Cardiac Operative Risk Evaluation; LVEF left ventricular ejection fraction; STS The Society of Thoracic Surgeons.

6 604 WENDT ET AL Ann Thorac Surg HIGH-RISK PATIENTS WITH AS AND CAD 2013;95: with the conventionally treated group. Moreover, with regard to the results of the present study, it should be considered that the present analysis included several transcatheter approaches (transfemoral/transapical) and different devices (including first-generation devices) and also partially reflects some early experience of operators. Conversely, the conventionally treated group who underwent surgical AVR and CABG surgery indeed reflects a surgical high-risk group with a STS score of 13.1% 8.7% and a mean age of 75 years. Therefore, although there was no significant difference in survival, this finding should be handled with caution and warrants future discussion as real long-term data (decades) evaluating TAVI results are as yet unavailable. In our percutaneous cohort, 69.5% of the patients received a bare metal stent implantation and 30.5% received a drug-eluting stent, without any difference in mortality between treatments (p 0.66). Whether bare metal stents or drug-eluting stents should be used before the TAVI procedure has to evaluated in the future. The present study, furthermore, aimed to identify independent risk factors predicting in-hospital mortality. Our data confirm that only left ventricular ejection fraction was related to mortality for both groups. Both risk scoring algorithms (EuroSCORE and STS score) however, were not predictive for mortality within the multivariate analysis. Whether there is an advantage of one approach over the other remains to be elucidated. Within the present study, only patients showing highest risk for surgery or percutaneous treatment were included. At the present time, a move toward percutaneous treatment for all patients with aortic valve stenosis and coronary artery disease is not advisable, and we strongly believe that, particularly in young patients, the treatment should not deviate from the current gold standard therapy of surgical AVR combined with CABG. Although others have shown excellent results in the use of TAVI (8), real long-term results are missing, and currently only elderly and high-risk patients should be considered for TAVI. Study Limitations The present study was performed at a single tertiary care medical center with a relatively small sample size, was retrospective, and was not randomized. The interval of PCI before final TAVI represents a major limitation. Therefore, we could not evaluate a staged versus simultaneous approach for PCI and TAVI. Although both groups fulfilled the inclusion criteria (STS score 10% or EuroSCORE 15%), a fairly higher number of patients within the TAVI PCI group showed higher risk scores and comorbidities. Therefore, the surgical control group naturally differs from the TAVI PCI group because TAVI patients are currently elderly patients who are deemed at highest risk for conventional surgery. Furthermore, continued long-term follow-up including markers of health outcome will determine if one or both concepts translate into increased life expectancy or better quality of life. Finally, the cost effectiveness of TAVI PCI compared with surgical AVR CABG has to be questioned. Therefore, before advocating a definitive benefit of one treatment strategy (AVR CABG or TAVI PCI), a longer follow-up and higher patient numbers must be evaluated. In conclusion, the present descriptive study is the first to demonstrate that TAVI combined with PCI produces at least equivalent results for in-hospital mortality in high-risk patients presenting with aortic valve stenosis and concomitant coronary artery disease compared with high-risk patients undergoing surgical AVR with CABG surgery. Finally, even though patients in the TAVI PCI group had a higher risk profile and more comorbidities, the results showed the total percutaneous approach as an equivalent and acceptable alternative treatment option compared with surgery. It should be emphasized, however, that to date, surgical AVR with combined CABG represents the standard therapy. A multidisciplinary heart team approach is recommended for decision making in these patients. To what extent the increasing number of PCIs combined with TAVI will have an influence on decision making between the two treatment options has to be investigated in the near future. Further work needs to be done to determine the clinical significance of these findings with a larger patient population in randomized studies. We want to thank Mr Wolfgang Ristau, Mr Markus Schumann, and Mrs Eva Gottstein for their continuous data and clinical site monitoring. References 1. He GW, Grunkemeier GL, Starr A. Aortic valve replacement in elderly patients: influence of concomitant coronary grafting on late survival. Ann Thorac Surg 1996;61: Jamieson WRE, Munro AI, Burr LH, Germann E, Miyagishima RT, Ling H. Influence of coronary artery bypass and age on clinical performance after aortic and mitral valve replacement with biological and mechanical prostheses. Circulation 1995;92: Bonow RO, Carabello BA, Chatterjee K, et al Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease. Circulation 2008;118:e Edwards FH, Peterson ED, Coombs LP, et al. Prediction of operative mortality after valve replacement surgery. J Am Coll Cardiol 2001;37: Tuzcu EM, Kapadia SR, Svensson LG. SOURCE of enthusiasm for transcatheter aortic valve implantation. Circulation 2010;122: Walther T, Simon P, Dewey T, et al. Transapical minimally invasive aortic valve implantation: multicenter experience. Circulation 2007;116(Suppl):I Webb JG, Pasupati S, Humphries K, et al. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation 2007;116: Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364: Kahlert P, Al-Rashid F, Weber M, et al. Vascular access site complications after percutaneous transfemoral aortic valve implantation. Herz 2009;34: Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation 2010;121:870 8.

7 Ann Thorac Surg WENDT ET AL 2013;95: HIGH-RISK PATIENTS WITH AS AND CAD Thielmann M, Wendt D, Kahlert P, et al. Transcatheter off-pump aortic valve implantation in patients with very high risk for conventional aortic valve replacement. Ann Thoracic Surg 2009;88: Thielmann M, Eggebrecht H, Wendt D, et al. New techniques for the treatment of valvular aortic stenosis transcatheter aortic valve implantation with the SAPIEN heart valve. Min Invasive Ther Allied Technol 2009;18: Wendt D, Buck T, Janosi RA, et al. Results of a propensity score-matched comparison of the Perimount Magna and Mosaic Ultra aortic valve prostheses. J Heart Valve Dis 2009;18: D Agostino RB. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 1998;17: Walther T, Kempfert J. Transcatheter aortic valve implantation: the right procedure for the right patient by the right team. Eur J Cardiothorac Surg 2011;39: Lefèvre T, Kappetein AP, Wolner E, et al. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J 2011;32: Conradi L, Seiffert M, Franzen O, et al. First experience with transcatheter aortic valve implantation and concomitant percutaneous coronary intervention. Clin Res Cardiol 2011; 100: Dewey TM, Brown DL, Herbert MA, et al. Effect of concomitant coronary artery disease on procedural and late outcomes of transcatheter aortic valve implantation. Ann Thorac Surg 2010;89: Grossi EA, Schwartz CF, Yu PJ, et al. High-risk aortic valve replacement: are the outcomes as bad as predicted? Ann Thorac Surg 2008;85: Kobayashi KJ, Williams JA, Nwakanma L, Gott VL, Baumgartner WA, Conte JV. Aortic valve replacement and concomitant coronary artery bypass: assessing the impact of multiple grafts. Ann Thorac Surg 2007;83: INVITED COMMENTARY Wendt and associates [1] retrospectively examine the outcomes of percutaneous intervention (PCI)-first staged hybrid treatment of concomitant aortic stenosis and coronary artery disease (CAD) with transcatheter aortic valve replacement (TAVR) in a high-surgical-risk population using a propensity score analysis. Surprisingly, the 30-day mortality was not superior for the catheter-based treatment group compared with the surgical group (11.9% vs 12.5%). The lack of a difference may be related to the inclusion of learning curve TAVR cases, different risk profiles between the two intervention groups not included in the propensity analysis, or the timing of procedures in the staged hybrid arm, or it may suggest that very-high-risk populations carry a high procedural risk regardless of the intervention performed. Nevertheless, their 30-day mortality is in line with prior studies of high-surgical-risk patients with CAD undergoing TAVR (13.3%) [2] and of high-risk aortic stenosis patients undergoing PCI alone (15.4%) [3]. There are differences in baseline patient characteristics that could adversely affect the outcomes in the catheter group, including increased risk of mortality, based on the Society of Thoracic Surgeons (STS) and the European System for Cardiac Operative Risk Evaluation (EuroSCORE) predictive risk models, more patients with peripheral arterial disease and diabetes, and a lower mean left ventricular ejection fraction. Patients with diabetes and low ejection fraction are historically among those who benefit most from surgical revascularization. However, patients in the surgical group had more extensive CAD, which was also reflected by a greater number of vessels revascularized surgically. Unfortunately, left internal mammary artery use in the surgical group was only 70.7%. The concept of what constitutes significant CAD is trivialized in this study, and was not included in the propensity analysis, yet may be one of the most important details driving the success of the procedure in question. The degree to which CAD results in myocardial ischemia and lesion complexity affects which patients require concomitant coronary intervention, dictates technical difficulty for both PCI and surgical procedures, and affects short-term and long-term outcomes. Leacche and colleagues [4] recently demonstrated that the complexity of angiographic coronary lesions in addition to surgical risk dramatically affects the short-term outcome of hybrid coronary revascularization. Among the important findings of this study is that the authors begin to tease out which patients benefit most from this novel treatment strategy, specifically the impact of left ventricular ejection fraction. As the use of TAVR continues to expand and includes patients with CAD, which patient groups benefit from variations of this procedure needs to be elucidated. The current study demonstrates that a catheter-based hybrid approach to concomitant aortic stenosis and CAD in high-risk patients can be carried out with similar mortality as that of a traditional surgical approach. Eric J. Lehr, MD, PhD Division of Cardiac Surgery Swedish Heart and Vascular Institute 1600 E Jefferson St, Ste #110 Seattle, WA ericjlehr@gmail.com References 1. Wendt D, Kahlert P, Lenze T, et al. Management of high-risk patients with aortic stenosis and coronary artery disease. Ann Thorac Surg 2013;95: Dewey TM, Brown DL, Herbert MA, et al. Effect of concomitant coronary artery disease on procedural and late outcomes of transcatheter aortic valve implantation. Ann Thorac Surg 2010;89:758 67; discussion Goel SS, Agarwal S, Tuzcu EM, et al. Percutaneous coronary intervention in patients with severe aortic stenosis: implications for transcatheter aortic valve replacement. Circulation 2012;125: Leacche M, Byrne JG, Solenkova NS, et al. Comparison of 30-day outcomes of coronary artery bypass grafting surgery versus hybrid coronary revascularization stratified by SYNTAX and euroscore. J Thorac Cardiovasc Surg 2012; Apr 25 [E-pub ahead of print] by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc