Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER‐I trial: Success and safety. Issue 1 (1st October 2015) - Minha, Sa'ar
Abstract : 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 < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve ( P = 0.6). Conclusions: By end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.