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
Rok vydání: 2015
Předmět:
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