Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry.

Background: Permanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry.
Methods: Patients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure.
Results: From July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus.
Conclusion: From 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed.
Competing Interests: Declaration of competing interest Dr. Harvey is a proctor and serves on the speakers' bureau and advisory board for Medtronic and Boston Scientific, is a proctor and serves on the speakers' bureau for Abiomed, and serves on the advisory board for Avail and Opsens; Dr. Puri is a consultant, speaker and proctor for Medtronic, consults for Centerline Biomedical, Boston Scientific, Abbott, Philips, Products & Features, Shockwave Medical, VDyne, VahatiCor, Advanced Nanotherapies, NuevoSono, TherOx, GE Healthcare, BioVentrix, Protembis, and has equity interest in Centerline Biomedical, VahatiCor and NuevoSono. Dr. Grubb has served as a consultant, speaker, proctor and advisory board member for Boston Scientific and Medtronic, as a member of the advisory board for Abbott, and as a principal investigator for Medtronic and a speaker for Edwards Lifesciences; Dr. Yakubov has received institutional research grants from Boston Scientific and Medtronic; Dr. Mahoney is a consultant and proctor for Medtronic, Abbott, and Edwards; Dr. Gada is a consultant to Abbott, Bard, Edwards LifeSciences and Medtronic; Dr. Coylewright has received research grants from Edwards Lifesciences and Boston Scientific; and has served on consulting/advisory boards for Medtronic, and Occlutech; Dr. Poulin has nothing to disclose; Dr. Chetcuti serves as a consultant for Boston Scientific and consultant and proctor for Medtronic; Dr. Sorajja reports grants and personal fees from Medtronic, grants and personal fees from Edwards Lifesciences, grants and personal fees from Abbott Vascular, personal fees from Anteris, personal fees from WL Gore, grants and personal fees from Boston Scientific, outside the submitted work; Dr. Rovin serves as a consultant, proctor and speaker for Abbott and Medtronic; Ms. Eisenberg is a shareholder and employee of Medtronic plc; Dr. Reardon has received fees to his institution from Medtronic for consulting and providing educational services.
(Copyright © 2024. Published by Elsevier Inc.)