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.

Aalborg University Hospital Aalborg Denmark

CHU Grenoble Alpes Grenoble France

Division of Imaging Sciences and Biomedical Engineering King's College London United Kingdom; Cardiology Department Guys and St Thomas' NHS Foundation Trust London United Kingdom

Hopital La Timone Marseille France

Immanuel Klinikum Bernau Herzzentrum Brandenburg Bernau Germany

King's College London London United Kingdom

Na Homolce Hospital Prague Czech Republic

Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom

Policlinico S'Orsola Bologna Italy

San Raffaele Hospital Milan Italy

St Antonius Ziekenhuis Nieuwegein Utrecht Netherlands AUMC Amsterdam Netherlands

St Bartholomew's Hospital London United Kingdom

St Vincent's University Hospital Dublin Ireland

The James Cook Hospital South Tees Hospitals NHS Foundation Trust Middlesbrough United Kingdom

University Hospital Erlangen Department of Cardiology Erlangen Germany

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European experience with a first totally leadless cardiac resynchronization therapy pacemaker system

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ClinicalTrials.gov
NCT02610673