Leadless left ventricular stimulation with WiSE-CRT System – Initial experience and results from phase I of SOLVE-CRT Study (nonrandomized, roll-in phase)

Background: Left ventricular (LV) endocardial pacing is a promising method to deliver cardiac resynchronization therapy (CRT). WiSE-CRT is a wireless LV endocardial pacing system, and delivers ultrasonic energy to an LV electrode. Objective: The purpose of this study was to present short-term outcom...

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Main Authors: Bank, A.J (Author), Hummel, J.D (Author), Kindsvater, S. (Author), McGrew, F.A (Author), Niazi, I.K (Author), Okabe, T. (Author), Oza, S.R (Author), Scherschel, J.A (Author), Singh, J.P (Author), Walsh, M.N (Author)
Format: Article
Language:English
Published: Elsevier B.V. 2022
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Summary:Background: Left ventricular (LV) endocardial pacing is a promising method to deliver cardiac resynchronization therapy (CRT). WiSE-CRT is a wireless LV endocardial pacing system, and delivers ultrasonic energy to an LV electrode. Objective: The purpose of this study was to present short-term outcomes with the WiSE-CRT system in centers with no prior implanting experience. Methods: Data were prospectively collected from 19 centers where WiSE-CRT systems were implanted during the roll-in phase of the SOLVE-CRT trial. Patients were followed at 1, 3, and 6 months, including transthoracic echo (TTE) at 6 months. Results: The WiSE-CRT was successfully implanted in all 31 attempted cases, and 30 patients completed the 6-month follow-up. One patient underwent heart transplantation 1 month after implantation, and was excluded. Fourteen (46.7%) patients demonstrated ≥1 NYHA class improvement. TTE data were available in 29 patients. LV ejection fraction, LV end-systolic volume, and LV end-diastolic volume improved from 28.3% ± 6.7% to 33.5% ± 6.9% (P <.001), 134.9 ± 51.3 mL to 111.1 ± 40.3 mL (P =.0004), and 185.4 ± 58.8 mL to 164.9 ± 50.6 mL (P =.0017), respectively. There were 3 (9.7%) device-related type 1 complications: 1 insufficient LV pacing, 1 embolization of an unanchored LV electrode, and 1 skin infection. Conclusions: We demonstrated a high success rate of LV endocardial electrode placement in centers with no prior implanting experience. Favorable clinical responses in heart failure symptoms and significant LV reverse remodeling were noted. © 2021 Heart Rhythm Society
Physical Description:8
ISBN:15475271 (ISSN)
DOI:10.1016/j.hrthm.2021.06.1195