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

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, 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

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.

Keywords: Cardiac resynchronization therapy; Endocardial pacing; Heart failure; Leadless pacing; Nonresponder.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1
Figure 1
The WiSE-CRT pacing system.
Figure 2
Figure 2
A: The WiSE-CRT delivery catheter across the aortic valve, with the pacing electrode advanced to the tip of the catheter and about to be deployed in the myocardium. The battery and ultrasound (US) pulse generator also are visible. B: The WiSE-CRT electrode affixed to the myocardium after release. C: Posteroanterior view of the Micra transcatheter pacing system (TPS) (Medtronic Inc, Minneapolis, MN) and the WiSE-CRT US pulse generator and pacing electrode in situ.D: Right anterior oblique view of the Micra TPS and WiSE-CRT US pulse generator, battery, and pacing electrode. E: Posterior chest radiograph showing the WiSE-CRT system in situ in combination with the Micra TPS. F: Lateral chest radiograph showing the WiSE-CRT system in situ in combination with the Micra TPS.

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