title: 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.
abstract: 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.
  
  
  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 Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). 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.
  
  
  CONCLUSIONS
  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.
authors: Director of Cardiovascular Services, Cardiology Department, St. Thomas' Hospital, Westminster Bridge Rd., London, UK. mttwins@aol.com
authors: Martyn
authors: M
authors: Thomas
authors: Gerhard
authors: G
authors: Schymik
authors: Thomas
authors: T
authors: Walther
authors: Dominique
authors: D
authors: Himbert
authors: Thierry
authors: T
authors: Lefèvre
authors: Hendrik
authors: H
authors: Treede
authors: Holger
authors: H
authors: Eggebrecht
authors: Paolo
authors: P
authors: Rubino
authors: Antonio
authors: A
authors: Colombo
authors: Rüdiger
authors: R
authors: Lange
authors: Rebecca R
authors: RR
authors: Schwarz
authors: Olaf
authors: O
authors: Wendler
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality* / Q000601:surgery*; D006328:Cardiac Catheterization; D016893:Carotid Stenosis / Q000401:mortality; D002423:Cause of Death; D015331:Cohort Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality*; D006801:Humans; D006949:Hyperlipidemias / Q000401:mortality; D006973:Hypertension / Q000401:mortality; D007674:Kidney Diseases / Q000401:mortality; D008107:Liver Diseases / Q000401:mortality; D008297:Male; D011183:Postoperative Complications / Q000401:mortality; D012042:Registries; D012907:Smoking / Q000401:mortality; D016896:Treatment Outcome