TY - JOUR
T1 - Feasibility of leadless left ventricular septal pacing with the WiSE-CRT system to target the left bundle branch area
T2 - A porcine model and multicenter patient experience
AU - Elliott, Mark K.
AU - Vergara, Pasquale
AU - Wijesuriya, Nadeev
AU - Mehta, Vishal S.
AU - Bosco, Paolo
AU - Jacon, Peggy
AU - Lee, Michael
AU - Taloni, Silvia
AU - Niederer, Steven
AU - Alison, Jeffrey
AU - Piot, Olivier
AU - Roberts, Paul R.
AU - Paisey, John
AU - Defaye, Pascal
AU - Shute, Andrew
AU - Rinaldi, Christopher A.
N1 - 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
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Cardiac resynchronization therapy
KW - Conduction system pacing
KW - Endocardial left ventricular pacing
KW - Heart failure
KW - Leadless pacing
KW - Left bundle branch area pacing
UR - http://www.scopus.com/inward/record.url?scp=85136271710&partnerID=8YFLogxK
U2 - 10.1016/j.hrthm.2022.07.017
DO - 10.1016/j.hrthm.2022.07.017
M3 - Article
C2 - 35940464
AN - SCOPUS:85136271710
SN - 1547-5271
VL - 19
SP - 1974
EP - 1983
JO - Heart Rhythm
JF - Heart Rhythm
IS - 12
ER -