Thirty-Day Results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry

Ovid Technologies (Wolters Kluwer Health) - Tập 122 Số 1 - Trang 62-69 - 2010
Martyn Thomas1, Gerhard Schymik1, Thomas Walther1, Dominique Himbert1, Thierry Lefèvre1, Hendrik Treede1, Holger Eggebrecht1, Paolo Rubino1, Iassen Michev1, Rüdiger Lange1, William N. Anderson1, Olaf Wendler1
1From St Thomas’ Hospital, London, UK (M.T.); Städisches Klinikum und Herzklinik, Karlsruhe, Germany (G.S.); Herzzentrum, Leipzig, Germany (T.W.); Hôpital Bichat, Paris, France (D.H.); Jacques Cartier, Massy, France (T.L.); University Heart Center, Hamburg, Germany (H.T.); Uniklinik, Essen, Germany (H.E.); Clinica Montevergine, Mercogliano, Italy (P.R.); Hospital San Raffaele, Milan, Italy (I.M.); Deutsches Herzzentrum, Munich, Germany; Lake Forest, Calif (W.N.A.); and King’s College Hospital,...

Tóm tắt

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. Methods and 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. Conclusion— 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.

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Ovid Technologies (Wolters Kluwer Health)

Tập 122 Số 1

62-69

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