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

Martyn Thomas; Gerhard Schymik; Thomas Walther; Dominique Himbert; Thierry Lefèvre; Hendrik Treede; Holger Eggebrecht; Paolo Rubino; Iassen Michev; Rüdiger Lange; William N Anderson; Olaf Wendler

doi:10.1161/CIRCULATIONAHA.109.907402

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

Standard

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. / Thomas, Martyn; Schymik, Gerhard; Walther, Thomas; Himbert, Dominique; Lefèvre, Thierry; Treede, Hendrik; Eggebrecht, Holger; Rubino, Paolo; Michev, Iassen; Lange, Rüdiger; Anderson, William N; Wendler, Olaf.

in: CIRCULATION, Jahrgang 122, Nr. 1, 06.07.2010, S. 62-69.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Thomas, M, Schymik, G, Walther, T, Himbert, D, Lefèvre, T, Treede, H, Eggebrecht, H, Rubino, P, Michev, I, Lange, R, Anderson, WN & Wendler, O 2010, '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', CIRCULATION, Jg. 122, Nr. 1, S. 62-69. https://doi.org/10.1161/CIRCULATIONAHA.109.907402

APA

Thomas, M., Schymik, G., Walther, T., Himbert, D., Lefèvre, T., Treede, H., Eggebrecht, H., Rubino, P., Michev, I., Lange, R., Anderson, W. N., & Wendler, O. (2010). 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. CIRCULATION, 122(1), 62-69. https://doi.org/10.1161/CIRCULATIONAHA.109.907402

Vancouver

Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H et al. 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. CIRCULATION. 2010 Jul 6;122(1):62-69. https://doi.org/10.1161/CIRCULATIONAHA.109.907402

Bibtex

@article{dcfcd2e429774640b0c4745663ac3b90,

title = "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",

abstract = "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.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.",

keywords = "Analysis of Variance, Aortic Valve/diagnostic imaging, Coronary Restenosis/epidemiology, Europe, Follow-Up Studies, Heart Valve Diseases/diagnostic imaging, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation/adverse effects, Humans, Japan, Multivariate Analysis, Myocardial Revascularization/methods, Patient Selection, Radiography, Recurrence, Registries, Reoperation/statistics & numerical data, Risk Factors, Time Factors",

author = "Martyn Thomas and Gerhard Schymik and Thomas Walther and Dominique Himbert and Thierry Lef{\`e}vre and Hendrik Treede and Holger Eggebrecht and Paolo Rubino and Iassen Michev and R{\"u}diger Lange and Anderson, {William N} and Olaf Wendler",

year = "2010",

month = jul,

day = "6",

doi = "10.1161/CIRCULATIONAHA.109.907402",

language = "English",

volume = "122",

pages = "62--69",

journal = "CIRCULATION",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins",

number = "1",

}

RIS

TY - JOUR

T1 - 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

AU - Thomas, Martyn

AU - Schymik, Gerhard

AU - Walther, Thomas

AU - Himbert, Dominique

AU - Lefèvre, Thierry

AU - Treede, Hendrik

AU - Eggebrecht, Holger

AU - Rubino, Paolo

AU - Michev, Iassen

AU - Lange, Rüdiger

AU - Anderson, William N

AU - Wendler, Olaf

PY - 2010/7/6

Y1 - 2010/7/6

N2 - 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.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.

AB - 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.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.

KW - Analysis of Variance

KW - Aortic Valve/diagnostic imaging

KW - Coronary Restenosis/epidemiology

KW - Europe

KW - Follow-Up Studies

KW - Heart Valve Diseases/diagnostic imaging

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Humans

KW - Japan

KW - Multivariate Analysis

KW - Myocardial Revascularization/methods

KW - Patient Selection

KW - Radiography

KW - Recurrence

KW - Registries

KW - Reoperation/statistics & numerical data

KW - Risk Factors

KW - Time Factors

U2 - 10.1161/CIRCULATIONAHA.109.907402

DO - 10.1161/CIRCULATIONAHA.109.907402

M3 - SCORING: Journal article

C2 - 20566953

VL - 122

SP - 62

EP - 69

JO - CIRCULATION

JF - CIRCULATION

SN - 0009-7322

IS - 1

ER -