Transcatheter aortic valve implantation: efficacy, safety and mortality at 30-­days to 1- year from a nationwide eight year registry

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016.Background: Transcatheter aortic valve implantation (TAVI) is currently an established therapy in patients with symptomatic severe aortic stenosis who are deemed inoperable or of very high surgical risk. Large population registries provide invaluable real world data. Purpose: To analyse the 30 days to 1­year results of all TAVI procedures performed throughout 8 years in an entire country. Methods: Nationwide TAVI registry from 2007 to 2015. Endpoints were defined according to the Valve Academic Research Consortium­2. Long­term composite endpoints were clinical efficacy (after 30 days) and time­related valve safety. Other non­composite enpoints, namely cardiovascular mortality and all­cause mortality were concomitantly assessed. For statistical analysis we used the univariate and multivariate Cox regression and Kaplan­Meier Survival. Results: 819 patients underwent TAVI (mean age 80±8 years, 47% male). The most common diagnosis was aortic stenosis (94,7%), followed by bioprosthesis dysfunction (3,4%) and aortic disease (1,8%). Mean valve area was 0,65±0,18 cm2 . The mean Euroscore II was 5,8±4,4 and the mean STS score was 6,6±5,8. 61% of patients were considered high­risk and the remainder inoperable. The implanted prosthesis was a Medtronic CoreValve® in 467 (57%) patients, an Edwards Sapien® model in 319 (39%) patients or another type in the remainder. The transfemoral route was used in 83% of cases, a transapical approach in 11,8% a transaortic route in 1,7% and a subclavian approach in 3,2%. Device success was achieved in 88,4% of patients. Mean follow­up was 585±611 days. After implantation, 92% of patients were in NYHA functional class I or II. Clinical efficacy (after 30 days) was 75%. Between 30 days and 1 year, all­cause mortality was 11,8% (cardiovascular mortality was 6,3%) and prosthesis dysfunction was 14,4%. The variables associated with 30­days to 1­year mortality were age (p=0,042) STS mortality score (p=0.034), non­transfemoral route (p=0.006), indication for TAVI other than aortic stenosis (p=0,015), chronic pulmonary disease (p=0,036), chronic renal disease (p=0,043), acute kidney injury (p II after TAVI (p<0,001), stroke after TAVI (p=0,031), and hospital readmission (p<0,001). Independent predictors of 30­days to 1­year mortality by multivariate Cox regression were hospital readmission (HR 4,73; 95% CI 2,52–8,89; p<0,001) and indication for TAVI other than aortic stenosis (HR 2,64; 95% CI 1,03–6,78; p=0,043). By Kaplan­Meier analysis survival was significantly lower in both groups (Log Rank 32,48 p