Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety
Autor: | Raj Makkar, Ashley M. Lowry, Oluseun Alli, E. Murat Tuzcu, Augusto D. Pichard, John Ehrlinger, Sa'ar Minha, Charanjit S. Rihal, Jeevanantham Rajeswaran, David R. Holmes, Kevin L. Greason, Eugene H. Blackstone, Rebecca Torguson, Lars G. Svensson, Martin B. Leon, Rakesh M. Suri, Michael J. Mack, Vinod H. Thourani, Ron Waksman, Lowell P. Satler |
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Rok vydání: | 2015 |
Předmět: |
Aortic valve
medicine.medical_specialty Transcatheter aortic business.industry medicine.medical_treatment Retrospective cohort study General Medicine 030204 cardiovascular system & hematology medicine.disease Surgery 03 medical and health sciences 0302 clinical medicine medicine.anatomical_structure Valve replacement Learning curve Aortic valve stenosis Severity of illness Emergency medicine medicine Radiology Nuclear Medicine and imaging 030212 general & internal medicine Cardiology and Cardiovascular Medicine Adverse effect business |
Zdroj: | Catheterization and Cardiovascular Interventions. 87:165-175 |
ISSN: | 1522-1946 |
DOI: | 10.1002/ccd.26121 |
Popis: | Objectives To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF-TAVR), and determine if adverse events were linked to the technical performance learning curve. Background TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes. Methods From 4/2007–2/2012, 1521 patients underwent TF-TAVR in the PARTNER-I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post-procedure length of stay. Institutional variation was accounted for by mixed-model non-linear techniques, which were also used to identify contribution of the procedure time learning curve to 30-day major adverse events and length of stay. Results Eighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30-day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30-day major adverse events and post-procedure length of stay was procedure time (P |
Databáze: | OpenAIRE |
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