Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry.

BACKGROUND

Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs).

OBJECTIVES

The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures.

METHODS

Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs.

RESULTS

A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups).

CONCLUSIONS

In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Dr. Alperi was supported by a grant from the Fundación Alfonso Martin Escudero (Madrid, Spain). Dr. Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions, and has received institutional research grants from Edwards Lifesciences and Medtronic. Dr. Montorfano is a proctor for Edwards Lifesciences, Abbott, and Boston Scientific. Dr. Adam has received personal fees from Edwards Lifesciences and Boston Scientific; and has received grants and personal fees from Medtronic during the conduct of the study. Dr. Noble has received institutional research grants from Abbott Vascular, Edwards Lifesciences, and Medtronic; and is a proctor for Medtronic. Dr. Erlebach has received fees from Medtronic. Dr. Kempfert has received fees from Medtronic, Edwards Lifesciences, and Abbott. Dr. Pilgrim has received institutional research grants from Biotronik, Boston Scientific, and Edwards Lifesciences; has received speaker fees from Biotronik and Boston Scientific; has received consultancy fees from HighLife SAS (CEC); and has performed proctoring for Medtronic and Boston Scientific. Dr. Kim has received personal fees from, performed proctoring for, and has served on advisory boards for Abbott Vascular, Boston Scientific, Edwards Lifesciences, Meril, Medtronic, and Shockwave Med. Dr. Hildick-Smith has served as a proctor and advisor for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr. Dvir has provided consulting for Edwards Lifesciences, Medtronic, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.