Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis.

Background: Data on valve reintervention after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are limited.
Objectives: The authors compared the 5-year incidence of valve reintervention after self-expanding CoreValve/Evolut TAVR vs SAVR.
Methods: Pooled data from CoreValve and Evolut R/PRO (Medtronic) randomized trials and single-arm studies encompassed 5,925 TAVR (4,478 CoreValve and 1,447 Evolut R/PRO) and 1,832 SAVR patients. Reinterventions were categorized by indication, timing, and treatment. The cumulative incidence of reintervention was compared between TAVR vs SAVR, Evolut vs CoreValve, and Evolut vs SAVR.
Results: There were 99 reinterventions (80 TAVR and 19 SAVR). The cumulative incidence of reintervention through 5 years was higher with TAVR vs SAVR (2.2% vs 1.5%; P = 0.017), with differences observed early (≤1 year; adjusted subdistribution HR: 3.50; 95% CI: 1.53-8.02) but not from >1 to 5 years (adjusted subdistribution HR: 1.05; 95% CI: 0.48-2.28). The most common reason for reintervention was paravalvular regurgitation after TAVR and endocarditis after SAVR. Evolut had a significantly lower incidence of reintervention than CoreValve (0.9% vs 1.6%; P = 0.006) at 5 years with differences observed early (adjusted subdistribution HR: 0.30; 95% CI: 0.12-0.73) but not from >1 to 5 years (adjusted subdistribution HR: 0.61; 95% CI: 0.21-1.74). The 5-year incidence of reintervention was similar for Evolut vs SAVR (0.9% vs 1.5%; P = 0.41).
Conclusions: A low incidence of reintervention was observed for CoreValve/Evolut R/PRO and SAVR through 5 years. Reintervention occurred most often at ≤1 year for TAVR and >1 year for SAVR. Most early reinterventions were with the first-generation CoreValve and managed percutaneously. Reinterventions were more common following CoreValve TAVR compared with Evolut TAVR or SAVR.
Competing Interests: Funding Support and Author Disclosures This work was supported by Medtronic. Dr Grubb is a proctor, principal investigator, and serves on the Advisory Board for Medtronic; and serves on the Advisory Board or is a consultant for Ancora Heart, Boston Scientific, Abbott, 4C Medical, Edwards Lifesciences, and OpSens. Dr O’Hair has received personal consulting fees from Edwards Lifesciences and Medtronic; and serves as a proctor for Medtronic. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Mahoney has received proctor and consultant fees from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Van Mieghem has received research grants from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi-Sankyo, and AstraZeneca; and has received advisory and consultancy fees from JenaValve, Anteris, Abbott Vascular, Boston Scientific, Medtronic, Amgen, Siemens, Pie Medical, Teleflex, Daiichi-Sankyo, and AstraZeneca. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech. Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; and has served as an Advisory Board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and does not receive personal fees from any medical device or pharmaceutical company. Dr Yakubov has received grants and personal fees from Medtronic and Boston Scientific. Dr Williams has served as a consultant to Medtronic; and has received research funding from Edwards Lifesciences and Medtronic. Dr Chetcuti has received grants from Edwards Lifesciences, WL Gore Medical, Medtronic, and Boston Scientific; and has received personal fees from Medtronic, Boston Scientific, and Jena. Dr Deeb serves on an Advisory Board for Medtronic; has received institutional grant support from Boston Scientific, Edwards Lifesciences, and Medtronic; and has received fees as a proctor for the Medtronic-sponsored SMART Trial. Dr Kleiman has received research grants from Medtronic, Abbott, Edwards Lifesciences, and Boston Scientific. Dr Althouse is a full-time employee and shareholder for Medtronic. Dr Reardon has received research grants from Abbott, Boston Scientific, WL Gore Medical, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)