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

Martyn Thomas, Gerhard Schymik, Thomas Walther, Dominique Himbert, Thierry Lefèvre, Hendrik Treede, Holger Eggebrecht, Paolo Rubino, Antonio Colombo, Rüdiger Lange, Rebecca R. Schwarz, Olaf Wendler

Research output: Contribution to journalArticle

428 Citations (Scopus)

Abstract

Bacground-: 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 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. 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.

Original languageEnglish
Pages (from-to)425-433
Number of pages9
JournalCirculation
Volume124
Issue number4
DOIs
Publication statusPublished - Jul 26 2011

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Bioprosthesis
Registries
Mortality
Cause of Death
Benchmarking
Survival
Transcatheter Aortic Valve Replacement
Carotid Stenosis
Hyperlipidemias
Aortic Valve
Surgical Instruments
Renal Insufficiency
Comorbidity
Liver Diseases
Smoking
Stroke
Hypertension
Morbidity
Kidney
Equipment and Supplies

Keywords

  • aortic valve stenosis
  • heart valve prosthesis implantation
  • registries

ASJC Scopus subject areas

  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Cite this

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. / Thomas, Martyn; Schymik, Gerhard; Walther, Thomas; Himbert, Dominique; Lefèvre, Thierry; Treede, Hendrik; Eggebrecht, Holger; Rubino, Paolo; Colombo, Antonio; Lange, Rüdiger; Schwarz, Rebecca R.; Wendler, Olaf.

In: Circulation, Vol. 124, No. 4, 26.07.2011, p. 425-433.

Research output: Contribution to journalArticle

Thomas, M, Schymik, G, Walther, T, Himbert, D, Lefèvre, T, Treede, H, Eggebrecht, H, Rubino, P, Colombo, A, Lange, R, Schwarz, RR & Wendler, O 2011, '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', Circulation, vol. 124, no. 4, pp. 425-433. https://doi.org/10.1161/CIRCULATIONAHA.110.001545
Thomas, Martyn ; Schymik, Gerhard ; Walther, Thomas ; Himbert, Dominique ; Lefèvre, Thierry ; Treede, Hendrik ; Eggebrecht, Holger ; Rubino, Paolo ; Colombo, Antonio ; Lange, Rüdiger ; Schwarz, Rebecca R. ; Wendler, Olaf. / 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. In: Circulation. 2011 ; Vol. 124, No. 4. pp. 425-433.
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abstract = "Bacground-: 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 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. 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.",
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