Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
BACKGROUND
Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. The Edwards SAPIEN valve was approved for transcatheter aortic valve implantation transfemoral delivery in the European Union in November 2007 and for transapical delivery in January 2008.


RESULTS
The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results of the Edwards SAPIEN valve in consecutive patients in Europe after commercialization. Cohort 1 consists of 1038 patients enrolled at 32 centers. Patients who were treated with the transapical approach (n=575) suffered more comorbidities than the transfemoral patients (n=463), resulting in a significantly higher logistic EuroSCORE (29.1% versus 25.7%; P<0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was observed in 93.8%. The incidence of valve embolization was 0.3% (n=3), and coronary obstruction was reported for 0.6% (n=6 cases). Incidence of stroke was 2.5% and similar for both procedural approaches. Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients. The occurrence of vascular complications was not a predictor of <30-day mortality in the transfemoral population.


CONCLUSIONS
Technical proficiency can be learned and adapted readily as demonstrated by the short-term procedural success rate and low 30-day mortality rates reported in the SOURCE Registry. Specific complication management and refinement of patient selection are needed to further improve outcomes.
Thomas
Martyn
M
St Thomas' Hospital, London, UK. mttwins@aol.com
Schymik
Gerhard
G
Walther
Thomas
T
Himbert
Dominique
D
Lefèvre
Thierry
T
Treede
Hendrik
H
Eggebrecht
Holger
H
Rubino
Paolo
P
Michev
Iassen
I
Lange
Rüdiger
R
Anderson
William N
WN
Wendler
Olaf
O
D000704:Analysis of Variance; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000601:surgery; D005060:Europe; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000000981:diagnostic imaging / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006801:Humans; D007564:Japan; D015999:Multivariate Analysis; D009204:Myocardial Revascularization / Q000379:methods / Q000706:statistics & numerical data; D018579:Patient Selection; D011859:Radiography; D012008:Recurrence; D012042:Registries; D012086:Reoperation / Q000706:statistics & numerical data; D012307:Risk Factors; D013997:Time Factors