One-Year Outcomes of Cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry: The European Registry of Transcatheter Aortic Valve Implantation Using the Edwards SAPIEN Valve

M. Thomas, G. Schymik, T. Walther, D. Himbert, T. Lefevre, H. Treede, H. Eggebrecht, P. Rubino, A. Colombo, R. Lange, R. R. Schwarz;, O. Wendler
2011 Circulation  
Background-Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement. Methods and Results-The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in
more » ... urope. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (nϭ575) suffered more comorbidities than transfemoral patients (nϭ463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; Pϭ0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality. Conclusion-The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured. (Circulation. 2011;124:425-433.) Key Words: aortic valve stenosis Ⅲ heart valve prosthesis implantation Ⅲ registries Methods Since May 2009, further data collection has occurred, which allows us to present 100% of the procedural data, 99.9% of the 30-day data, and 98% of the 1-year outcomes. This is higher than the previously published report where 98% of 30-day outcomes were reported, Continuing medical education (CME) credit is available for this article. Go to to take the quiz.
doi:10.1161/circulationaha.110.001545 pmid:21747054 fatcat:gl6sygrjnnewnavndidq4nyssa