Short- and mid-term safety and effectiveness of transcatheter aortic valve implantation in a failing surgical aortic bioprosthesis.

The feasibility of transcatheter aortic valve implantation (TAVI) in patients with a failing surgical aortic bioprosthesis has been reported from single centres. We present results from a multi-centre feasibility study in such patients followed for 1 year after TAVI. This study evaluated 18 patients undergoing implantation with the 18-Fr CoreValve TAVI prosthesis in a failing surgical aortic bioprosthesis at three centres in Germany. Subject inclusion requirements included >= 75 years old and either surgical risk with logistic European System for Cardiac Operative Risk Evaluation >= 15% or >= 1 high-risk co-morbidity. Implanted subjects were 79 +/- 4 years old, 67% males, 78% NYHA Class III/IV, with logistic EuroSCORE 34 +/- 14, and had failed surgical bioprostheses from six manufacturers. The procedure was considered technically successful in 94% (17/18) of cases. One subject was converted to surgery during the procedure. Mortality at 30 days and 1 year was 11% (2/18) and 28% (5/18), respectively. Two cardiac deaths occurred, including 1 within 30 days. Two subjects had strokes, both within 30 days. After 30 days and 1 year, respectively, 86 and 73% of subjects improved at least 1 NYHA class and the remainder had no change. No aortic regurgitation was reported beyond mild (Grade 1) at 6- and 12-month follow-up. Most patients with a failing aortic surgical bioprosthesis were successfully implanted with a TAVI prosthesis in this multi-centre feasibility study. Outcomes at 30 days were within expectations for this very high-risk subgroup and improvements were sustained through 12 months.