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Feasibility of leadless left ventricular septal pacing with the WiSE-CRT system to target the left bundle branch area: A porcine model and multicenter patient experience

Research output: Contribution to journalArticlepeer-review

Mark K. Elliott, Pasquale Vergara, Nadeev Wijesuriya, Vishal S. Mehta, Paolo Bosco, Peggy Jacon, Michael Lee, Silvia Taloni, Steven Niederer, Jeffrey Alison, Olivier Piot, Paul R. Roberts, John Paisey, Pascal Defaye, Andrew Shute, Christopher A. Rinaldi

Original languageEnglish
Pages (from-to)1974-1983
Number of pages10
JournalHeart Rhythm
Volume19
Issue number12
Early online date5 Aug 2022
DOIs
E-pub ahead of print5 Aug 2022
PublishedDec 2022

Bibliographical note

Funding Information: Funding Sources: The study was supported by the Wellcome EPSRC Centre for Medical Engineering (WT203148/Z/16/Z). The animal model study was funded by EBR Systems. The patients included in the human observational study were enrolled in trials funded by EBR Systems. Disclosures: Ms Taloni, Mr Lee, and Mr Shute are employees of EBR Systems. Outside the submitted work, Drs Elliott and Mehta have received fellowship funding from Abbott. Dr Vergara has received travel fees from EBR Systems. Dr Roberts has received consultancy payments from Medtronic and Boston Scientific and research funding from Boston Scientific. Dr Piot has received consultancy payment from Abbott, Boston Scientific, Medtronic, and MicroPort. Prof Rinaldi receives research funding and/or consultation fees from Abbott, Medtronic, Boston Scientific, MicroPort, and EBR Systems. The remaining authors have no competing interests. Funding Information: Funding Sources: The study was supported by the Wellcome EPSRC Centre for Medical Engineering (WT203148/Z/16/Z). The animal model study was funded by EBR Systems. The patients included in the human observational study were enrolled in trials funded by EBR Systems. Disclosures: Ms Taloni, Mr Lee, and Mr Shute are employees of EBR Systems. Outside the submitted work, Drs Elliott and Mehta have received fellowship funding from Abbott. Dr Vergara has received travel fees from EBR Systems. Dr Roberts has received consultancy payments from Medtronic and Boston Scientific and research funding from Boston Scientific. Dr Piot has received consultancy payment from Abbott, Boston Scientific, Medtronic, and MicroPort. Prof Rinaldi receives research funding and/or consultation fees from Abbott, Medtronic, Boston Scientific, MicroPort, and EBR Systems. The remaining authors have no competing interests. Publisher Copyright: © 2022 Heart Rhythm Society

King's Authors

Abstract

BACKGROUND: The WiSE-CRT system delivers leadless endocardial left ventricular (LV) pacing to achieve cardiac resynchronization therapy. The electrode is conventionally placed on the lateral wall, but implanting on the LV septum may have advantages, including capture of the left bundle branch, and improved battery longevity owing to reduced distance from the transmitter. OBJECTIVE: The purpose of this study was to assess the feasibility of leadless LV septal pacing via the WiSE-CRT system. METHODS: Two pigs underwent electrode implantation on the LV septum with subsequent anatomical and histological examination. Eight patients underwent implantation of the WiSE-CRT system with deployment of the electrode on the LV septum via an interatrial transseptal approach. RESULTS: Deployment of the electrode on the LV septum was successful in both animals. Histological examination demonstrated electrode tines in close proximity to Purkinje tissue. WiSE-CRT implantation with an LV septal electrode was successful in all patients. Biventricular capture was confirmed, with a significant reduction in QRS duration (187.1 ± 33.8 ms vs 149.5 ± 15.7 ms; P = .009). Temporary LV pacing achieved further QRS reduction (139.8 ± 12.4 ms), and in 4 patients the peak LV activation time in lead V5/V6 was <90 ms, suggesting left bundle branch capture. At early follow-up, the median LV pacing percentage was 98.5% and 5 patients (62.5%) improved symptomatically. The transmitter-to-electrode distance was lower than the distance to the lateral wall during acoustic window screening (8.8 ± 1.6 cm vs 11.9 ± 1.5 cm; P = .002). CONCLUSION: Leadless LV septal pacing with the WiSE-CRT system to target the left bundle branch appears feasible. Further study is required to assess the efficacy and safety of this technique.

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