Transcatheter Aortic Valve Implantation in Patients With Concomitant Mitral and Tricuspid Regurgitation

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Transcatheter Aortic Valve Implantation in Patients With Concomitant Mitral and Tricuspid Regurgitation Andrea Hutter, MD, Sabine Bleiziffer, MD, PhD, Valerie Richter, MS, Anke Opitz, MD, Ina Hettich, MD, Domenico Mazzitelli, MD, Hendrik Ruge, MD, and Ruediger Lange, MD, PhD Clinic for Cardiovascular Surgery, German Heart Center, Munich, Germany ADULT CARDIAC Background. The impact of atrioventricular valve regurgitation in patients who undergo transcatheter aortic valve implantation (TAVI) is not known. We examined the clinical outcome after TAVI in patients with moderate or more severe concomitant mitral or tricuspid regurgitation (TR). Methods. Two hundred sixty-eight consecutive patients who underwent TAVI at our institution since July 2007 were enrolled in this study. Patients had preoperative echocardiographic assessment of aortic stenosis and concomitant valve disease. At 6 months and 1 year, survival, New York Heart Association (NYHA) functional status, self-assessed state of health, and severity of mitral regurgitation (MR) and tricuspid regurgitation (TR) were assessed. Results. Preoperatively, 22.4% of patients (60/268) had moderate or more severe MR, 20.1% (54/268) had moderate or more severe TR, and 9.3% (25/268) had moderate or more severe MR and TR. With moderate or more severe TR, 1 year all-cause mortality was significantly higher compared with that of mild or less severe TR (33.9% and 20.9%, respectively; log rank p 0.028). With moderate or more severe MR, 1-year all-cause mortality was 30.2% compared with 21.2% in mild or less severe MR (log rank p 0.068). Neither moderate or more severe MR nor TR emerged as an independent risk factor. At 6 months, heart failure symptoms were significantly reduced regardless of the extent of atrioventricular valve regurgitation. Sixty-seven percent of patients with moderate or more severe MR and 50% of patients with moderate or more severe TR had an improvement of valve regurgitation. Conclusions. Atrioventricular valve regurgitation is present in a subgroup of patients undergoing TAVI whose survival is impaired. The majority of surviving patients exhibit the clinical benefits of TAVI with amelioration of heart failure symptoms and a decrease in severity of atrioventricular valve regurgitation. At present, moderate or more severe atrioventricular valve regurgitation cannot be considered a contraindication for TAVI. (Ann Thorac Surg 2013;95:77 84) 2013 by The Society of Thoracic Surgeons Transcatheter aortic valve implantation (TAVI) has emerged as a therapeutic option for high-risk patients with aortic stenosis. Among the comorbidities in these patients are concomitant moderate or severe mitral regurgitation (MR) and tricuspid regurgitation (TR) in approximately 20% of cases [1, 2]. The role of atrioventricular regurgitation has been questioned in patients receiving TAVI [3]. In studies to evaluate the clinical outcome of TAVI, severe MR is named as an exclusion criterion in patient stratification (1). In patients scheduled for surgical aortic valve replacement (SAVR), concomitant MR has been described as decreasing after SAVR, spontaneously in some cases [4]. Conversely, guidelines for the treatment of valvular heart disease suggest combined SAVR and mitral valve repair in patients with severe concomitant MR [5, 6]. Furthermore, impaired survival has been described in patients with Accepted for publication Aug 2, 2012. Address correspondence to Dr Hutter, Heart and Vascular Center am Diako, Froelichstr. 13, Augsburg, 86150, Germany; e-mail: andrea. hutter@gmx.de. moderate MR who undergo SAVR without mitral valve repair [7]. In patients undergoing cardiac operations for valve disease, concomitant moderate or more severe TR may also be considered for surgical annuloplasty [5].Inthe context of these conflicting suggestions, we report the outcomes after TAVI, comparing patients with mild or less severe atrioventricular valve regurgitation to patients with moderate or more severe preoperative regurgitation. Patients and Methods Study Design and Patient Population In a single-center observational study, we evaluated 268 consecutive patients with severe symptomatic aortic stenosis who underwent TAVI between June 2007 and Dr Bleiziffer discloses a financial relationship with Medtronic; and Dr Mazzitelli with Edwards Lifesciences and Medtronic. 2013 by The Society of Thoracic Surgeons 0003-4975/$36.00 Published by Elsevier Inc http://dx.doi.org/10.1016/j.athoracsur.2012.08.030

ADULT CARDIAC 78 HUTTER ET AL Ann Thorac Surg TAVI AND ATRIOVENTRICULAR VALVE REGURGITATION 2013;95:77 84 Abbreviations and Acronyms AF atrial fibrillation ANOVA analysis of variance AVA aortic valve area BNP brain-derived natriuretic peptide CI confidence interval COPD chronic obstructive pulmonary disease LVEF left ventricular ejection fraction MPG mean pressure gradient MR mitral regurgitation NYHA New York Heart Association PAP pulmonary artery pressure RV right ventricular SAVR surgical aortic valve replacement STS Society of Thoracic Surgeons TAVI transcatheter aortic valve implantation TR tricuspid regurgitation TTE Transthoracic echocardiography Prostheses and Procedures Commercially available prostheses the Medtronic CoreValve Revalving System (Medtronic, Minneapolis, MN) and the Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA) were implanted in this study. Choice of valve type (Medtronic CoreValve or Edwards Sapien) and size as well as implantation procedures have been described before [10, 11]. Every patient referred for TAVI had preoperative TTE at our institution using a Sonos 5500 ultrasonographic system with a 2.5 MHz transducer (Hewlett Packard, Andover, MA) or a Siemens Sequoia ultrasonographic system (Siemens AG, Erlangen, Germany). All preoperative TTE was performed by 3 experienced echocardiographers. Evaluation of left and right ventricular function, severity of aortic valve disease, and concomitant atrioventricular valve disease was performed according to the current guidelines [12, 13]. Mild to moderate or less severe MR or TR was classified as mild regurgitation and moderate or worse regurgitation was considered to be moderate or more severe regurgitation. August 2009 and who had at least a 12-month follow-up until August 2010. Five patients who underwent conversion to conventional aortic valve replacement, 2 patients who were lost to follow-up, and 6 patients with bad sonic conditions that made echocardiographic evaluation of both atrioventricular valves impossible were excluded. The study complied with the Declaration of Helsinki and was approved by the local ethics committee (2234/08). All patients signed an informed consent form. All-cause mortality was the primary endpoint using the endpoint definitions by the Valve Academic Research Consortium [8]. Improvement of heart failure symptoms and state of health measures were secondary endpoints. Causes of death were classified according to the guidelines for reporting mortality and morbidity after cardiac valve interventions [9]. Functional status was graded according to the New York Heart Association (NYHA) classification. Self-assessed state of health was obtained with the question: How is your general state of health on a scale of 0% to 100%? Preoperatively, the patients= severity of aortic valve stenosis, presence and severity of concomitant mitral valve and tricuspid valve disease, NYHA classification, and self-assessed overall state of health were evaluated. According to the extent of atrioventricular valve regurgitation, patients were divided into 4 groups: Group 0 had no or mild MR and TR, group 1 had moderate or more severe MR, group 2 had moderate or more severe TR, and group 3 had moderate or more severe MR and TR. Follow-up visits (including NYHA class, self-assessed state of health, adverse events and hospital admissions, and transthoracic echocardiography [TTE]) were performed at 6 and 12 months after the procedure and yearly thereafter. When patients could not come to the institution for follow-up-visits, telephone follow-up was performed and echocardiographic data as documented by the patient=s treating cardiologist were used. Data Collection and Statistical Analysis Patient demographics and preoperative and postoperative data were recorded prospectively in an institutional registry database for transcatheter aortic valve procedures. Descriptive data for continuous variables are presented as means standard deviation or as medians with ranges; comparisons were made with the use of the Student=s t test. Categorical variables are presented as relative frequencies and were compared with the use of the 2 test or Fisher=s exact test. For descriptive data, a global analysis of variance or 2 test was performed for all patients. In the case of significant differences between patients, post hoc analysis was applied with pairwise comparisons between all patient groups with the t test, 2 test or Fisher=s exact test with a Bonferroni correction. Survival curves were constructed on the basis of all available follow-up data with the use of Kaplan-Meier estimates and were compared with the use of the logrank test. Deaths from unknown causes were assumed to be deaths from cardiovascular causes. To identify risk factors for death, variables with complete data for all patients (with the exception of the variable TR, for which preoperative TR could not be reliably evaluated in 17 patients) were included in a logistic regression model. Results are presented as odds ratios with 95% confidence intervals (CIs). The variables were female sex, age, implanted valve type, logistic EuroSCORE and Society of Thoracic Surgeons (STS) score, moderate or more severe preoperative MR, moderate or more severe preoperative TR, previous cardiac operation, coronary artery disease or cerebral infarction, severely depressed left ventricular function defined as an ejection fraction less than or equal to 35%, atrial fibrillation, renal failure defined as a creatinine level greater than 1.5 mg/dl, restrictive or obstructive pulmonary disease, and an estimated systolic pulmonary artery pressure of greater than or equal to 60 mm Hg. Backward variable selection was applied. A p value of less than 0.05 was considered statistically signif-

Table 1. Patient Characteristics Variable All Patients Group 0: No/Mild MR and TR Group 1: Moderate or More Severe MR Group 2: Moderate or More Severe TR Group 3: Moderate or More Severe MR and TR Significance Comparison of all Patients Significance Pairwise Comparison of Groups 0 4 Female sex 167/268 (62.3%) 113/179 (63.1%) 22/35 (62.9%) 19/29 (65.5%) 13/25 (52%) 0.73 a... Mean age (y) (n 268) 80.9 6.5 80.8 6.4 83.0 5.6 80.5 7.4 79.3 7.5 0.15 b... Valve type 194/268 (72.4%) Core Valve, 74/268 (27.6%) Sapien 123/179 (68.7%) Core Valve, 56/179 (31.3%) Sapien 32/35 (91.4%) Core Valve, 3/35 (8.6%) Sapien 20/29 (69.0%) Core Valve, 9/29 (31.0%) Sapien 19/25 (76.0%) Core Valve, 6/25 (24.0%) Sapien 0.053 a 0.005 a (groups 0/1) Transapical access 74/268 (27.6%) 55/179 (30.7%) 4/35 (11.4%) 8/29 (27.6%) 7/25 (28.0%) 0.14 a... Preoperative AVA (cm 2 ) 0.64 0.18 0.66 0.18 0.56 0.12 0.60 0.19 0.64 0.19 0.015 b... (n 265) Preoperative MPG aortic 48.7 16.7 50.4 17.6 45.6 12.7 44.9 13.4 45.1 17.3 0.13 b... valve (mm Hg) (n 267) Coronary artery disease 142/268 (53.0%) 88/179 (49.2%) 21/35 (60.0%) 16/29 (55.2%) 17/25 (68.0%) 0.26 a... Cerebrovascular accident 36/268 (13.4%) 22/179 (12.3%) 5/35 (14.3%) 6/29 (20.7%) 3/25 (12.0%) 0.66 a... Previous cardiac 48/268 (17.9%) 26/179 (14.5%) 4/35 (11.4%) 10/29 (34.5%) 8/25 (32.0%) 0.011 a... operation COPD/restrictive lung 57/268 (21.3%) 40/179 (22.3%) 8/35 (22.8%) 7/29 (24.1%) 2/25 (8.0%) 0.40 a... disease Renal failure (Creatinine 51/268 (19.0%) 29/179 (16.2%) 11/35 (31.4%) 6/29 (20.7%) 5/25 (20.0%) 0.21 a... level 1.5 mg/dl) LVEF 35% 44/268 (16.4%) 23/179 (12.8%) 11/35 (31.4%) 3/29 (10.3%) 7/25 (28.0%) 0.014 a 0.008 a (groups 0/1) RV dysfunction 45/206 (17.3%) 16/135 (11.9%) 5/27 (18.5%) 13/26 (50.0%) 11/18 (61.1%) 0.001 a 0.001 a (groups 0/2 and 0/3) 0.01 a (groups 1/2 and 1/3) Preoperative AF 62/268 (23.1%) 26/179 (14.5%) 7/35 (20.0%) 20/29 (69.0%) 9/25 (36.0%) 0.001 a 0.001 a (groups 0/2 and 1/2) Preoperative systolic 62/268 (23.1%) 31/179 (17.3%) 9/35 (25.7%) 10/29 (34.5%) 12/25 (48.0%) 0.002 a 0.001 a (groups 0/3) PAP 60 mm Hg Logistic EuroSCORE 20.6 12.7% 19.4 12.4% 24.1% 12.6% 20.7% 12.1% 24.6% 15.0% 0.077 b... (n 268) STS score 6.3 4.2 5.7 3.4 8.3 6.4 7.1 4.3 7.1 4.2 0.002 b 0.003 c (groups 0/1) (n 267) Preoperative BNP (n 220) 6694 13,651 5,359 9,593 5,459 5,117 8,739 9,535 16,176 34,345 0.007 b 0.005 c (groups 0/3) a 2 test or Fisher=s exact test; b analysis of variance; c Student=s t test. Analysis of variance or 2 test was performed for all patients (significance with p 0.05). In the case of significant differences between all patients, post hoc analysis was applied with pairwise comparisons between all patient groups with the t test, 2 test, or Fisher=s exact test with Bonferroni correction (significance with p 0.0125). AF atrial fibrillation; AVA aortic valve area; BNP brain-derived natriuretic peptide; COPD chronic obstructive pulmonary disease; EuroSCORE European System for Cardiac Operative Risk Evaluation; LVEF left ventricular ejection fraction; MPG mean pressure gradient; MR mitral regurgitation; PAP pulmonary artery pressure; RV right ventricular; STS Society of Thoracic Surgeons; TR tricuspid regurgitation. Ann Thorac Surg HUTTER ET AL 2013;95:77 84 TAVI AND ATRIOVENTRICULAR VALVE REGURGITATION 79 ADULT CARDIAC

ADULT CARDIAC 80 HUTTER ET AL Ann Thorac Surg TAVI AND ATRIOVENTRICULAR VALVE REGURGITATION 2013;95:77 84 icant. Analyses were performed with SPSS, version 18.0 for Windows (SPSS Inc, Chicago, IL). Results Patient Characteristics Two hundred sixty-eight patients were included in this study. The median follow-up period was 406 days (minimum 0 days and maximum 1,155 days). Eighty-nine of 268 (33.2%) patients exhibited moderate or more severe valve regurgitation (Table 1). Sixty of 268 patients (22.4%) presented with moderate or more severe MR and 54/268 patients (20.1%) had moderate or more severe TR. Thirtyfour of 268 patients (12.7%) had mild mitral stenosis. The patient group with moderate or more severe MR had higher STS scores than did the patients with no or mild Fig 1. Kaplan-Meier analyses and log-rank test. (A) Survival in patients with no/mild, or moderate or more severe mitral regurgitation (MR). (B) Survival in patients with no/mild, or moderate or more severe tricuspid regurgitation (TR). In 17 patients, the tricuspid valve could not be evaluated with transthoracic echocardiography. (C) Survival in patients with no/mild, or moderate or more severe regurgitation of both atrioventricular valves. (TAVI transcatheter aortic valve implantation.)

Ann Thorac Surg HUTTER ET AL 2013;95:77 84 TAVI AND ATRIOVENTRICULAR VALVE REGURGITATION MR. The patient group with moderate or more severe TR or moderate or more severe regurgitation of both atrioventricular valves presented with a significantly higher percentage of preoperative atrial fibrillation, previous cardiac operations, evidence of right ventricular dysfunction, a higher proportion of patients with systolic pulmonary artery pressures greater than 60 mm Hg, and higher preoperative levels of brain-derived natriuretic peptide (Table 1). Concerning survival status, follow-up was 100% complete at 6 months and 1 year after the procedure. After 6 and 12 months, 142/197 (72.1%) and 105/160 (65.5%) surviving patients, respectively, underwent echocardiography. Mortality Thirty days after the index procedure, the rate of death from any cause was 9.6% in the patient group with mild or less severe MR and 13.3% in the patient group with moderate or more severe MR as calculated by Kaplan- Meier analysis. At 6 months, the rates of death were 20.8% and 26.7%, respectively. At 1 year, the rates of death were 21.2% and 30.2%, respectively (log rank p 0.068). In the patient group with mild or less severe TR versus moderate or more severe TR, the rates of death were 9.6% and 11.2% at 30 days, 19.8% and 32.0% at 6 months, and 20.9% and 33.9% at 1 year, respectively (log rank p 0.028). In the patient group with mild or less severe regurgitation versus moderate or more severe regurgitation of both atrioventricular valves, rates of death were 10.7% and 8.0% at 30 days, 21.1% and 32.0% at 6 months, and 21.9% and 36.0% at 1 year, respectively (log rank p 0.072) (Fig 1). Multivariate analysis identified preoperative atrial fibrillation and a higher STS score as independent risk factors for death of any cause at 1 year (odds ratio for atrial fibrillation, 2.65 [95% CI, 1.36 to 5.15] and odds ratio for higher STS score, 1.09 [95% CI, 1.01 to 1.18]) (Table 2). The presence of moderate or more severe MR or TR or regurgitation of both atrioventricular valves did not emerge as independent risks factor for all-cause mortality at 1 year after the index procedure. Preoperative Aortic Valve Area and Postoperative Effective Orifice Area The preoperative aortic valve area was 0.64 0.18 cm 2, with no statistically significant difference between the patient groups with or without moderate or more severe MR or TR, or both. The mean effective orifice area at the 6-month follow-up improved significantly (1.45 0.31 cm 2 ; p 0.001) and remained stable at 12 months (1.45 0.31 cm 2 and 1.45 0.32 cm 2, respectively). There was no significant difference in the effective orifice area between the groups with or without moderate or more severe MR or TR, or both. NYHA Classification and Overall Self-Assessed State of Health Preoperatively, all patients had moderate or severe symptoms of heart failure (NYHA functional class III or IV). At 6 months, symptoms of heart failure were significantly reduced in all patient groups and remained stable at 1 year, regardless of whether or not they had moderate or more severe atrioventricular valve disease (no significant difference for all comparisons; p 0.05). In all patients, overall self-assessed state of health on a scale of 0% to 100% improved significantly 6 months after TAVI, regardless of concomitant atrioventricular valve regurgitation (n 88; 51.6% 16.4% preoperatively and 62.0% 21.3% at 6 months; p 0.001). The improvement remained stable at the 12-month follow-up (n 47; 65.6% 19.9% at 6 months and 66.2% 15.8% at 12 months; p 0.87). Severity of Atrioventricular Valve Disease Thirty-one of 41 surviving patients (75.6%) with moderate or more severe MR preoperatively had an echocardiographic follow-up at 6 months; 21 of these patients (67.7%) showed a decrease of at least 1 grade in the severity of MR. Eight patients (25.8%) exhibited no change in the degree of MR. In 2 patients (6.5%), MR worsened by 1 grade. Twenty-two of 35 surviving patients (62.9%) with moderate or more severe preoperative TR had an echocardiographic evaluation of TR at 6 months. Eleven of these patients (50.0%) showed a decrease of at least 1 grade in the severity of TR; in 8 patients (36.4%) TR did not change and in 3 patients (13.6%) the degree of TR increased (Fig 2). Comment In this series of 268 patients undergoing TAVI, 33% exhibited moderate or more severe MR or TR before the procedure. Concerning the mitral valve, this is in accor- 81 ADULT CARDIAC Table 2. Results of the Logistic Regression Variable Univariate p Value Multivariate p Value Odds Ratio 95% CI Preoperative AF 0.005 0.004 2.65 1.36 5.15 STS score 0.02 0.026 1.09 1.01 1.18 Moderate or more severe TR 0.042......... Moderate or more severe MR 0.089......... Moderate or more severe MR and TR 0.061......... AF atrial fibrillation; CI confidence interval; MR mitral regurgitation; STS Society of Thoracic Surgeons; TR tricuspid regurgitation.

ADULT CARDIAC 82 HUTTER ET AL Ann Thorac Surg TAVI AND ATRIOVENTRICULAR VALVE REGURGITATION 2013;95:77 84 Fig 2. Severity of mitral regurgitation (MR) and tricuspid regurgitation (TR) preoperatively and at 6 months after transcatheter aortic valve implantation. (A) In the patient group with moderate or more severe MR preoperatively, grading of MR 6 months postoperatively showed a decrease of MR of at least 1 echocardiographic grade in 67.7% of patients. (B) In the patient group with moderate or more severe TR preoperatively, grading of TR 6 months postoperatively showed a decrease of TR of at least 1 echocardiographic grade in 50.0% of patients.

Ann Thorac Surg HUTTER ET AL 2013;95:77 84 TAVI AND ATRIOVENTRICULAR VALVE REGURGITATION dance with previous studies reporting moderate to severe MR in 18% to 48% of patients [14 17]. The presence and severity of TR in patients undergoing TAVI has, to the best of our knowledge, not been described before. Furthermore, patients with moderate or more severe TR had a higher incidence of atrial fibrillation, severely reduced right ventricular function, pulmonary artery hypertension, and a higher STS score. All-cause mortality after TAVI in this subgroup was significantly higher. However, this may not be attributable only to TR but to the whole complex of right-sided heart disease, with the combination of right ventricular dysfunction, atrial fibrillation, pulmonary hypertension, and TR. To date the presence of severe MR has been an exclusion criterion for randomized studies [1]. No explicit recommendations exist concerning whether patients with moderate or more severe regurgitation of the mitral or tricuspid valve should be excluded from receiving TAVI. In this series, moderate or more severe atrioventricular valve regurgitation indicated a subgroup of patients with an especially high-risk profile, but this could not be identified as an independent risk factor for allcause mortality. In contrast, in SAVR moderate MR has been described as an independent risk factor having an impact on long-term survival in elderly patients 70 years of age or older [7]. Until additional data from randomized studies provide more information, we conclude that the presence of moderate or more severe atrioventricular valve regurgitation should not lead to a general exclusion of these patients from receiving TAVI. The clinical outcome measures (NYHA functional class and self-assessed state of health) showed an improvement in both patient groups regardless of the presence or absence of moderate or more severe MR or TR. Concerning MR, this finding has been described for the TAVI population [17, 18]. Furthermore, 67% of the patients with moderate or more severe MR had an improvement in the severity of MR and 50% of the patients with moderate or more severe TR had an improvement of the severity of TR at 1 year after the TAVI procedure. This has been described before for MR [15 17, 19] but not for TR. This study had several limitations. During screening for TAVI, severe MR and TR led to the exclusion of some patients, which might have introduced a selection bias as an inherent limitation of an observational study. In an analysis of 381 patients referred to our institution for TAVI between June 2007 and August 2009, 141 patients did not undergo TAVI [20]. Thirteen of 141 patients (9.3%) were refused for TAVI because of severe MR or TR. A methodologic problem is the pooling of moderate and severe MR or TR into 1 group with moderate or more severe MR or TR. However, a further stratification of MR or TR would have made the patient groups too small for statistical analysis. The results of this study need to be interpreted in the context of the sample size, especially concerning the echocardiographic data. Although 72% of the surviving patients had an echocardiographic follow-up examination at 6 months after the procedure, MR and TR were evaluated in only 40% to 55% of them. Consequently, the regress or progress of atrioventricular valve regurgitation was described only in this subset of patients. This could represent a selection bias. If one assumes that the subset of patients without echocardiographic evaluation of MR and TR at 6 months did not have a regress of regurgitation, only 21/41 patients (51.2%) with moderate or more severe MR and only 11/35 patients (31.4%) with moderate or more severe TR would have had a regress of regurgitation of the respective atrioventricular valve. In conclusion, moderate or more severe TR is present in a subgroup of patients undergoing TAVI whose survival is significantly impaired. However, surviving patients of this subgroup exhibit amelioration of NYHA status and a decrease in the severity of atrioventricular valve regurgitation. At the moment, moderate or severe atrioventricular valve regurgitation cannot be considered an exclusion criterion for TAVI. The authors thank Petra Wolf from the Institute for Medical Statistics and Epidemiology, Technical University Munich for statistical support. References 1. Leon MB, Smith CR, Mack M, et al. Transcatheter aorticvalve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597 1607. 2. Bleiziffer S, Ruge H, Mazzitelli D, et al. Results of percutaneous and transapical transcatheter aortic valve implantation performed by a surgical team. Eur J Cardiothorac Surg 2009;35(4):615 621. 3. De Jaegere PP, Ruiz C, Bonhoeffer P, et al. Transcatheter aortic valve implantation. Where are we? EuroIntervention 2009;5(2):169 171. 4. Tunick PA, Gindea A, Kronzon I. Effect of aortic valve replacement for aortic stenosis on severity of mitral regurgitation. Am J Cardiol 1990;65(18):1219 1221. 5. Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease. Circulation 2006;114(5):e84 231. 6. Bonow RO, Carabello BA, Chatterjee K, et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease. Circulation 2008;118(15):e523 661. 7. Barreiro CJ, Patel ND, Fitton TP, et al. Aortic valve replacement and concomitant mitral valve regurgitation in the elderly: impact on survival and functional outcome. Circulation 2005;112:I443 I447. 8. Leon MB, Piazza N, Nikolsky E, et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. Eur Heart J;32(2):205 217. 9. Akins CW, Miller DC, Turina MI, et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions. Ann Thorac Surg 2008;85:1490 5. 10. Bleiziffer S, Ruge H, Mazzitelli D, et al. Survival after transapical and transfemoral aortic valve implantation: talking about two different patient populations. J Thorac Cardiovasc Surg 2009;138(5):1073 1080. 11. Hutter A, Opitz A, Bleiziffer S, et al. Aortic annulus evaluation in transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2010;76(7):1009 1019. 12. Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr 2003;16(7):777 802. 83 ADULT CARDIAC

ADULT CARDIAC 84 HUTTER ET AL Ann Thorac Surg TAVI AND ATRIOVENTRICULAR VALVE REGURGITATION 2013;95:77 84 13. 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 European Society of Cardiology. Eur Heart J 2007;28:230 68. 14. Tzikas A, Piazza N, van Dalen BM, et al. Changes in mitral regurgitation after transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2010; 75:43 9. 15. Cribier A, Eltchaninoff H, Tron C, et al. Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol 2006;47:1214 23. 16. Webb JG, Pasupati S, Humphries K, et al. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation 2007;116:755 63. 17. Toggweiler S, Boone RH, Rodes-Cabau J, et al. Transcatheter aortic valve replacement. Outcomes of patients with moderate or severe mitral regurgitation. J Am Coll Cardiol 2012; 59:2068 74. 18. Webb JG, Altwegg L, Boone R, et al. Transcatheter aortic valve implantation: impact on clinical and valve-related outcomes. Circulation 2009;119:3009 16. 19. Durst R, Avelar E, McCarty D, et al. Outcome and improvement predictors of mitral regurgitation after transcatheter aortic valve implantation. J Heart Valve Dis 2011;20:272 81. 20. Bleiziffer S, Socha J, Ruge H, et al. Abstract 19599: survival in high risk patients with severe aortic stenosis: intervention versus surgery versus medical therapy. Circulation 2010;122:A19599. ABTS Requirements for the 10-Year Milestone for Maintenance of Certification in 2013 Diplomates of the American Board of Thoracic Surgery (ABTS) who plan to participate in the 10-Year Milestone for the 2013 Maintenance of Certification (MOC) process as Certified-Active must hold an unrestricted medical license in the locale of their practice and privileges in a hospital accredited by the JCAHO (or other organization recognized by the ABTS). In addition, a valid ABTS certificate is an absolute requirement for entrance into the MOC process. If your certificate has expired, the only pathway for renewal of a certificate is to take and pass the Part I (written) and the Part II (oral) certifying examinations. The CME requirements are 150 Category I credits earned since January 1, 2009. At least half of these CME hours need to be in the broad area of thoracic surgery. Category II credits are not allowed. Interested individuals should refer to the Board s website (www.abts.org) for a complete description of acceptable CME credits. Diplomates will be required to take and pass a secured exam after their application has been approved. Taking SESATS in lieu of the secured exam is not an option. The secured exam will be given from September 9 to September 21, 2013, at Pearson Vue Testing Centers, which are located nationwide. Diplomates will have the opportunity to select the day and location of their exam. Diplomates who wish to maintain a Certified-Active status will be required to submit a summary of cases and will be required to participate in an outcomes database. For more details about this requirement, please visit the Board s website. Diplomates may apply for MOC in the year their certificate expires or, if they wish to do so, they may apply up to two years before it expires. However, the new certificate will be dated 10 years from the date of expiration of their original certificate or most recent MOC certificate. In other words, going through the MOC process early does not alter the 10-year validation. Diplomates certified prior to 1976 (the year that time-limited certificates were initiated) are also required to participate in MOC if they wish to maintain valid certificates. The deadline for submitting an application for MOC is March 1, 2013; however, the Board will accept late applications until April 15, 2013. A brochure outlining the rules and requirements for MOC in thoracic surgery is available on the Board s website. For additional information, please contact the American Board of Thoracic Surgery, 633 N St. Clair St, Ste 2320, Chicago, IL 60611; telephone (312) 202-5900; fax (312) 202-5960; e-mail: info@abts.org. 2013 by The Society of Thoracic Surgeons Ann Thorac Surg 2013;95:84 0003-4975/$36.00 Published by Elsevier Inc