Abstract 16606: The Impact of Learning Curve on Success and Adverse Events After Transcatheter Aortic Valve Replacement: A PARTNER Substudy
Introduction: Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic stenosis in specific patient subsets. Procedural success and adverse events are dependent upon multiple factors, including the learning curve. The exact number of cases needed to establish optimal safe and successful outcomes is unknown. This study aims to identify the number of cases needed for completing a safe and successful TAVR.
Methods: From April 2007 to January 2012, a total of 2,621 patients underwent TAVR with an Edwards SAPIEN valve via transfemoral (TF; n=1,521) or transapical (TA; n=1,100) access in the PARTNER trial. Patient and procedural data were collected prospectively. Procedural success and adverse events at 30 days were identified using VARC-2 definitions. Full parametric modelling was used to plot outcomes for each parameter according to the site-specific patient sequence number. A comparison between TA and TF access was further performed.
Results: Successful device deployment was immediately high and sustained for TA-TAVR. Success rates for TF-TAVR started lower, improved, and plateaued at approximately 50 cases per site. (Fig 1a). TA was associated with a lower incidence of composite adverse events compared to TF. A sharp initial decrease in the rate of adverse events for both procedures occurred during the first 40 cases. (Fig 1b). Although hospital length of stay decreased gradually in both TA and TF patients, TA access was associated with a longer hospital stay (9.7±6.8 vs. 6.2±5.2 days; p <0.001).
Conclusion: TAVR success rates reach a constant plateau after about 50 cases and adverse event rates decrease significantly over a similar number of cases. Further, TA-TAVR was associated with rapid achievement of high success rates and a lower incidence of adverse events compared to TF-TAVR. We conclude that the learning curve needed for achieving satisfactory success rates and stable adverse event rates is approximately 40-50 cases per site.
- © 2013 by American Heart Association, Inc.