Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system.

Abstract

BACKGROUND:

Biventricular endocardial pacing (BiV ENDO) is a therapy for heart failure patients who cannot receive transvenous epicardial cardiac resynchronization therapy (CRT) or have not responded adequately to CRT. BiV ENDO CRT can be delivered by a new wireless LV ENDO pacing system (WiSE-CRT system; EBR Systems, Sunnyvale, CA), without the requirement for lifelong anticoagulation.

OBJECTIVE:

The purpose of this study was to assess the safety and efficacy of the WiSE-CRT system during real-world clinical use in an international registry.

METHODS:

Data were prospectively collected from 14 centers implanting the WiSE-CRT system as part of the WiCS-LV Post Market Surveillance Registry. (ClinicalTrials.gov Identifier: NCT02610673).

RESULTS:

Ninety patients from 14 European centers underwent implantation with the WiSE-CRT system. Patients were predominantly male, age 68.2 ± 10.5 years, left ventricular ejection fraction 30.6% ± 8.9%, mean QRS duration 180.7 ± 27.0 ms, and 40% with ischemic etiology. Successful implantation and delivery of BiV ENDO pacing was achieved in 94.4% of patients. Acute (<24 hours), 1- to 30-day, and 1- to 6-month complications rates were 4.4%, 18.8%, and 6.7%, respectively. Five deaths (5.6%) occurred within 6 months (3 procedure related). Seventy percent of patients had improvement in heart failure symptoms.

CONCLUSION:

BiV ENDO pacing with the WiSE-CRT system seems to be technically feasible, with a high success rate. Three procedural deaths occurred during the study. Procedural complications mandate adequate operator training and implantation at centers with immediately available cardiothoracic and vascular surgical support.

• Authors: Benjamin J Sieniewicz, Timothy R Betts, Simon James, Andrew Turley, Christian Butter, Martin Seifert, Lucas V A Boersma, Sam Riahi, Petr Neuzil, Mauro Biffi, Igor Diemberger, Pasquale Vergara, Martin Arnold, David T Keane, Pascal Defaye, Jean-Claude Deharo, Anthony Chow, Richard Schilling, Jonathan Behar, Christopher A Rinaldi
• Journal: Heart rhythm (Heart Rhythm) Vol. 17 Issue 8 Pg. 1291-1297 (08 2020) ISSN: 1556-3871 [Electronic] United States
• PMID: 32165181 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Topics

• Aged
• Cardiac Resynchronization Therapy (methods)
• Cardiac Resynchronization Therapy Devices
• Endocardium
• Equipment Design
• Female
• Heart Failure (physiopathology, therapy)
• Heart Ventricles (physiopathology)
• Humans
• Male
• Prospective Studies
• Registries
• Stroke Volume (physiology)
• Treatment Outcome
• Ventricular Function, Left (physiology)