Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2020 Aug;17(8):1291-1297.
doi: 10.1016/j.hrthm.2020.03.002. Epub 2020 Mar 9.

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

Benjamin J Sieniewicz  1 , Timothy R Betts  2 , Simon James  3 , Andrew Turley  3 , Christian Butter  4 , Martin Seifert  4 , Lucas V A Boersma  5 , Sam Riahi  6 , Petr Neuzil  7 , Mauro Biffi  8 , Igor Diemberger  8 , Pasquale Vergara  9 , Martin Arnold  10 , David T Keane  11 , Pascal Defaye  12 , Jean-Claude Deharo  13 , Anthony Chow  14 , Richard Schilling  14 , Jonathan Behar  15 , Christopher A Rinaldi  16
Affiliations
Multicenter Study

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

Benjamin J Sieniewicz et al. Heart Rhythm. 2020 Aug.

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.

PubMed Disclaimer

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.
See this image and copyright information in PMC

References

    1. Petersen S., Rayner M., Wolstenholme J. British Heart Foundation; London: 2002. Coronary Heart Disease Statistics: Heart Failure Supplement.
    1. Neeland I.J., Kontos M.C., de Lemos J.A. Evolving considerations in the management of patients with left bundle branch block and suspected myocardial infarction. J Am Coll Cardiol. 2012;60:96–105. - PMC - PubMed
    1. Nelson G.S., Berger R.D., Fetics B.J. Left ventricular or biventricular pacing improves cardiac function at diminished energy cost in patients with dilated cardiomyopathy and left bundle-branch block. Circulation. 2000;102:3053–3059. - PubMed
    1. Cleland J.G.F., Daubert J.C., Erdmann E. Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005;352:1539–1549. - PubMed
    1. European Society of Cardiology (ESC) European Heart Rhythm Association (EHRA), Brignole M, et al. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association. Europace. 2013;15:1070–1118. - PubMed

Publication types

Associated data