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The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry.The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions.Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%).The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Background— Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear. Methods and Results— TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1–Q3=178–490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P =0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery ( P =0.04), larger aortic annulus ( P =0.0004), and smaller prosthesis diameter ( P =0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery( P =0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P =0.0001) and SE-TAVR (hazard ratio=2.11; P =0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR Conclusions— Postprocedural AR≥grade 2 was observed in 15.8% of successful TAVR and was the strongest independent predictor of 1-year mortality. The use of the SE device was a powerful independent predictor of postprocedural AR≥grade 2.

We thank Drs Iqbal and Serruys for their interesting comments on our study.1 Transcatheter aortic valve replacement is a very good alternative to conventional surgical replacement in patients with aortic stenosis at increased risk for surgery.2,3 As efficient as it is, transcatheter aortic valve replacement has important limitations, including postprocedural aortic regurgitation (AR). Our study was designed to (1) describe the rate of postprocedural AR evaluated at discharge in a large series of consecutive patients treated with balloon-expandable (BE) and self-expandable devices, (2) analyze the predictors of postprocedural ARs in the overall population for each device, and (3) analyze the impact of postprocedural ARs on clinical outcome. The results of our study1 and others2 demonstrate clearly that postprocedural AR≥moderate as evaluated by echocardiography at discharge is frequent (15%) and is an independent predictor of long-term mortality. Our study demonstrates also that the clinical significance of a postprocedural AR≥moderate is …

Introduction: Atrial fibrillation (AF) is well-known to be associated with mortality and morbidity after conventional cardiac surgery. In the present sub-analysis of the FRANCE 2 registry, we investigated the impact of AF on VARC-defined outcomes in patients with severe aortic stenosis undergoing transcatether aortic valve implantation (TAVI). Methods: The FRANCE 2 registry included all TAVI performed in France between January 2010 and December 2011. Analyses were performed at 2 different time points: (1) AF vs no AF, before valve implantation, and (2) AF vs no AF, after the procedure, among the survivors at day 2. Comparisons of clinical outcomes at 30 days and 1 year, between patients with and without AF, were adjusted for baseline (all analysis) and procedural (analysis 2) characteristics by multivariate analysis. Results: In total, 3875 patients whose pre-TAVI ECG was reported were included (25.8% with AF) (study population for analysis 1). Procedural success was 94% in the non-AF group and 94.5% in the AF group. Three hundred thirteen patients (8.1%) died during the first 24 hours (non-AF: 7.8%, AF: 9.2%; P=0.13); 3377 were alive at day 2 with an ECG (study population for analysis 2); 827 (24.5%) were in AF, including 164 patients with new onset AF (4.8%). The main findings concerning the clinical outcomes of the study populations are displayed in the table. The higher rate of VARC-defined combined efficacy endpoint observed in patients with AF vs those without, in both analysis, is driven by cardiovascular deaths, worsening congestive heart failure and NYHA functional status class III or IV. Conclusion: AF, before and after TAVI, is associated with a higher rate of one-year mortality and morbidity.

A 39-year-old man presented with atypical angina and hemoptysis. This soldier traveled regularly to the Middle-East and Africa. Initial clinical examination was within normal limits, as were also the ECG, biochemistry, and hematologic blood samples. Transthoracic echocardiography showed an intracardiac multilobe cyst fixed to the anterior papillary muscle and on the anterior mitral leaflet (A2) (online-only Data Supplement Movie I). Doppler mode revealed associated trivial mitral regurgitation (online-only Data Supplement Movie II). Magnetic resonance imaging showed an enhancing cystic lesion fixed on the anterior papillary muscle (Figure 1): low signal intensity noted on T1-weighted images and higher signal intensity …

BACKGROUND Aortic stenosis is the most common valvular lesion occurring among elderly patients and has become extremely frequent because of changing demographics in industrialized countries. Surgical risk after the age of 70 has increased. The increasing older age of patients having surgery justifies an analysis of mortality predictive factors. METHODS AND RESULTS Between 1976 and February 1993, we performed 2871 operations for aortic stenosis. This study concerns 675 patients (278 men and 397 women) who were > or = 75 years old. Mean age was 78.5 +/- 3 years. Associated lesions were found in 226 patients. A bioprosthesis was implanted in 632 patients (93.6%). Concomitant surgical procedures were performed in 133 patients. Surgical mortality was 12.4% (84 deaths). A longitudinal analysis has been carried out over four successive time periods to evaluate population evolution during these 17 years. Statistical analysis was performed on 46 variables. Multivariate analysis found age (P < .0001), left ventricular failure (P < .0001), lack of sinus rhythm (P < .01), and emergency status (P < .02) to be presurgical independent predictive factors of mortality. CONCLUSIONS Risk-reducing strategy should both favor relatively early surgery to avoid cardiac failure and emergency situations and pay careful attention to the use of myocardial protection and cardiopulmonary bypass. Indications for surgery should remain broad since analysis failed to determine specific high-risk groups to be eliminated, and surgery remains the only treatment for aortic stenosis.