Log in to MyACC
Case Volume vs. Outcomes With Balloon-Expandable TAVR Valves
Study Questions:
What is the volume–outcomes relationship (VOR) in balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) beyond the initial learning curve?
Methods:
The investigators analyzed data collected by the TVT registry for BE valve implants from November 2011 through January 2017 (n = 61,949). Primary outcomes included 30-day all-cause mortality, stroke, and major vascular complications. For each center, all implants were ordered chronologically according to case sequence number (CS#). To determine where the learning curve terminated, a grid search analysis was applied across a range of CS# from 10 to 300 by increments of 1. After learning curve terminated, the VOR was assessed by examining case volume/month by center. This analysis was performed separately for: 1) all BE valve types, 2) Sapien 3 (S3) only, and 3) S3 in BE valve naïve sites.
Results:
In experience with all commercially available BE valve types, there was an initial learning curve that terminates around case #201. After the initial learning curve, a VOR was no longer evident. In analysis limited to S3, there was no demonstrable learning curve or VOR. Likewise, there was no demonstrable learning curve or VOR with S3 for BE valve naïve sites.
Conclusions:
The authors concluded that after a case experience of 200 cases, the learning curve terminated and subsequent to initial learning, a VOR was no longer evident.
Perspective:
This study reports that there was an initial learning curve with TAVR, but after experience of approximately 200 cases, the learning curve ended. Also, no VOR was observed beyond the initial learning curve. Furthermore, there was no learning curve for the current generation of commercial BE valve, S3, with no VOR. It appears that with a multidisciplinary heart team approach, refinements of procedural techniques, dissemination of best practices, extensive knowledge sharing, rigorous proctoring, ongoing case support, and improvements in device technology, excellent outcomes with BE valves may be expected even early in a center’s experience, and are sustainable regardless of the center’s case volume. Additional studies are needed to assess how to accelerate dissemination of innovations and information that improve patient care and safety.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve, Heart Valve Diseases, Heart Valve Prosthesis, Learning Curve, Outcome Assessment, Health Care, Patient Care, Secondary Prevention, Stroke, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement, Vascular Diseases
< Back to Listings
