Outcomes after Transcatheter Aortic Valve Implantation: a Single Center Registry of 350 Consecutive Cases

Introduction: The Valve Academic Research Consortium (VARC) consensus document on outcome reporting in transcatheter valves has recently been revised. We used these VARC-2 standardised endpoint definitions to report transcatheter aortic valve implantation (TAVI) outcome at our institution. Methods: The study included 350 consecutive patients undergoing TAVI at the University Hospital Zurich between May 2008 and November 2012. The Edwards SAPIEN (n = 158; 45%), the Medtronic CoreValve (n = 189, 54%), and the Medtronic Engager (n = 3, 1%) prostheses were implanted via either the transfemoral (83%) or the transapical (17%) access. Mean follow-up was 389 405 days. Results: Device success within 72 hours was achieved in 88% of patients without significant differences between access sites (p = 0.89) and prosthesis types (p = 0.24). Device failure was due to procedural mortality in 12 (3.4%) patients. In survivors, implantation of more than one prosthesis or malpositioning of the prosthesis was observed in six (1.7%) patients, an increased transvalvular pressure gradient >20 mm Hg in four (1.1%) patients, and moderate aortic regurgitation in 19 (5.4%) patients, respectively. Severe aortic regurgitation was observed in one (0.3%) patient. A ll-cause mortality was 9.1% at 30 days (12.0% in the first half of the patients vs 6.3% in the second half; p = 0.07), and 21.2% at 1 year. The composite endpoint "early safety" was met in 67 (19.1%) patients at 30 days (23% in the first half of the patients vs 15% in the second half; p = 0.04). Stroke was o bserved in 2.9%, life-threatening bleeding in 4.6%, vascular complications in 7.4% and acute renal failure in 5.7% of patients. Coro-nary obstruction was rarely observed (0.9%). Valve-related dysfunction requiring repeat procedure occurred in two (0.6%) patients. With multivariate regression analysis, major and life-threatening bleeding within 30 days (hazard ratio [HR] 4.74, 95% confidence interval [CI] 2.03-11.07, p <0.001), chronic obstructive pulmonary disease (HR 3.41, 95% CI 1.71-6.81, p = 0.001), and baseline New York Heart Association (NYHA) functional class III or IV (HR 3.08, 95% CI 1.18-8.5, p = 0.02) were found to be the strongest independent predictors of all-cause mortality at total follow-up. Conclusion: According to the newly revised VARC-2 standardised endpoint definitions, device success was met in 88% of patients, and the composite endpoint "early safety" was reached in 19% of patients. These results compare very favourably with the international experience using this novel technique. Thus, in selected patients with severe aortic stenosis TAVI is a valid therapeutic option.