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Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Background— We assessed trends in the performance of transcatheter aortic valve implantation in the United Kingdom from the first case in 2007 to the end of 2012. We analyzed changes in case mix, complications, outcomes to 6 years, and predictors of mortality. Methods and Results— Annual cohorts were examined. Mortality outcomes were analyzed in the 92% of patients from England and Wales for whom independent mortality tracking was available. A total of 3980 transcatheter aortic valve implantation procedures were performed. In successive years, there was an increase in frequency of impaired left ventricular function, but there was no change in Logistic EuroSCORE. Overall 30-day mortality was 6.3%; it was highest in the first cohort (2007–2008), after which there were no further significant changes. One-year survival was 81.7%, falling to 37.3% at 6 years. Discharge by day 5 rose from 16.7% in 2007 and 2008 to 28% in 2012. The only multivariate preprocedural predictor of 30-day mortality was Logistic EuroSCORE ≥40. During long-term follow-up, multivariate predictors of mortality were preprocedural atrial fibrillation, chronic obstructive pulmonary disease, creatinine >200 μmol/L, diabetes mellitus, and coronary artery disease. The strongest independent procedural predictor of long-term mortality was periprocedural stroke (hazard ratio=3.00; P Conclusions— We analyzed transcatheter aortic valve implantation in an entire country, with follow-up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer-term outcomes improved, and patients were discharged earlier. Periprocedural stroke, nonfemoral access, and postprocedural aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors.

This study sought to assess the proportion of patients anatomically suitable for transcatheter aortic valve implantation by multiple access approaches.The devices currently in mainstream use for transcatheter treatment of severe aortic stenosis are those of Edwards (Edwards Lifesciences, Nyon, Switzerland) and Medtronic CoreValve (M-C) (Luxembourg City, Luxembourg). The range of patients that these can presently treat requires elucidation to guide the necessary evolution of these technologies and increase their scope of therapy.A consecutive series of patients were assessed with transthoracic or transesophageal echocardiography and invasive angiography to assess anatomical suitability by different approaches. The transfemoral access requirements for Edwards and M-C (Edwards currently 22- and 24-F, soon to be 18- and 19-F; M-C 18-F) as well as the aortic valve annular criteria (18 to 25 mm and 20 to 27 mm, respectively) were incorporated in this assessment. Patients unsuitable for the transfemoral approach were considered for Edwards transapical and M-C transaxillary and direct ascending aortic access. Patients suitable for these devices and access approaches were identified.Data were analyzed for 100 consecutive patients. Edwards suitability was 28% for Edwards-Sapien transfemoral, 78% for Edwards Novaflex transfemoral, and 88% for Edwards-Sapien transapical. Medtronic CoreValve suitability was 84% for transfemoral and 89% using additional transaxillary and direct aortic approaches. Of the 12 patients unsuitable for Edwards-based procedures, 8 were suitable for M-C. Of the 11 patients unsuitable for M-C-based techniques, 8 were suitable for Edwards. Only 3% were anatomically unsuitable for all approaches.In this series, 97% of patients were anatomically suitable for a complementary approach to treatment.

Severe aortic stenosis (AS) is associated with hypertrophy of the left ventricle (LVH), which is linked to adverse clinical outcomes. To date, the effects of the novel technology of percutaneous aortic valve replacement (PAVR) on LVH in severe AS have not been described. We sought to test the hypothesis that PAVR would result in regression of LVH associated with severe AS.Patients were recruited as part of a single-arm, prospective, safety, feasibility and clinical outcome study of the third-generation CoreValve percutaneous aortic bioprosthesis. To assess hypertrophy at baseline and at 1 month, the parasternal long-axis view in end-diastole was used to assess interventricular septal dimension and left ventricular posterior wall dimension.15 patients were studied. There were significant periprocedural reductions in peak (76.6 +/- 28.1 mmHg to 16.3 +/- 7.5 mmHg; p0.001) and mean (45.3 +/- 18.4 mmHg to 8.2 +/- 3.7 mmHg; p = 0.001) transvalvular gradients and increases in calculated aortic valve areas (0.73 +/- 0.19 cm2 to 1.5 +/- 0.3 cm2). Septal wall thickness regressed by 13% from 1.54 +/- 0.30 cm at baseline to 1.35 +/- 0.27 cm at 1 month (for difference; p = 0.002).We demonstrate an early regression of septal hypertrophy after PAVR for severe AS which is comparable to that seen at 1 year after conventional surgical aortic valve replacement.