TY - JOUR
T1 - Case Volume and Outcomes After TAVR With Balloon-Expandable Prostheses
T2 - Insights From TVT Registry
AU - Russo, Mark J.
AU - McCabe, James M.
AU - Thourani, Vinod H.
AU - Guerrero, Mayra
AU - Genereux, Philippe
AU - Nguyen, Tom
AU - Hong, Kimberly N.
AU - Kodali, Susheel
AU - Leon, Martin B.
N1 - Funding Information:
The views or opinions presented in this manuscript do not represent those of the American College of Cardiology, the Society of Thoracic Surgeons, or the STS/ACC TVT Registry. The statistical analyses for this manuscript were performed by Edwards Lifesciences. Dr. Russo has served as a study investigator, a consultant, and a proctor for Edwards Lifesciences, Boston Scientific, and Abbott. Dr. McCabe has served as a consultant for Edwards Lifesciences. Dr. Guerrero has received research grant support from and served as a proctor for Edwards Lifesciences. Dr. Nguyen has served as a consultant for Edwards Lifesciences, Abbott, and LivaNova. Dr. Kodali has served on the advisory board of Abbott Vascular, Biotrace Medical, Dura Biotech, and Thubrikar Aortic Valve, Inc.; has served as a consultant for Merrill Lifesciences and Claret Medical; has received honoraria from Abbott Vascular, Claret Medical, and Merrill Lifesciences; and has equity in Dura Biotech, Thubrikar Aortic Valve, Inc., and Biotrace Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2019 The Authors
PY - 2019/2/5
Y1 - 2019/2/5
N2 - Background: Given conflicting findings of previous studies, much remains to be understood regarding a volume-outcomes relationship (VOR) in transcatheter aortic valve replacement (TAVR). Objectives: The purpose of this study was: 1) to determine if, after the initial learning curve (LC), a VOR for balloon-expandable (BE) TAVR persisted; and 2) to determine if LCs and VORs differed across different device generations. Methods: Data collected by the TVT registry for BE valve implants from November 2011 through January 2017 were included in this analysis (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 (LCT), a grid search analysis was applied across a range of CS# from 10 to 300 by increments of 1. After LCT, 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 LC that terminates around case #201. After the initial LC, a volume–outcomes relationship was no longer evident. In analysis limited to S3, there was no demonstrable LC or VOR. Likewise, there was no demonstrable LC or VOR with S3 for BE valve naïve sites. Conclusions: After a case experience of 200 cases, there was LCT; subsequent to initial learning, a VOR was no longer evident. In the S3-only analysis, there was no LC or no demonstrable VOR. With current-generation BE-TAVR, centers should expect to achieve consistently excellent outcomes even during early case experience.
AB - Background: Given conflicting findings of previous studies, much remains to be understood regarding a volume-outcomes relationship (VOR) in transcatheter aortic valve replacement (TAVR). Objectives: The purpose of this study was: 1) to determine if, after the initial learning curve (LC), a VOR for balloon-expandable (BE) TAVR persisted; and 2) to determine if LCs and VORs differed across different device generations. Methods: Data collected by the TVT registry for BE valve implants from November 2011 through January 2017 were included in this analysis (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 (LCT), a grid search analysis was applied across a range of CS# from 10 to 300 by increments of 1. After LCT, 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 LC that terminates around case #201. After the initial LC, a volume–outcomes relationship was no longer evident. In analysis limited to S3, there was no demonstrable LC or VOR. Likewise, there was no demonstrable LC or VOR with S3 for BE valve naïve sites. Conclusions: After a case experience of 200 cases, there was LCT; subsequent to initial learning, a VOR was no longer evident. In the S3-only analysis, there was no LC or no demonstrable VOR. With current-generation BE-TAVR, centers should expect to achieve consistently excellent outcomes even during early case experience.
KW - TAVR
KW - health outcomes
KW - learning curves
KW - volumes outcomes
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U2 - 10.1016/j.jacc.2018.11.031
DO - 10.1016/j.jacc.2018.11.031
M3 - Article
C2 - 30704575
AN - SCOPUS:85060293454
VL - 73
SP - 427
EP - 440
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 4
ER -