Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure

Area of Science:

• Cardiology
• Medical Devices
• Heart Failure Treatment

Background:

• Approximately 40% of heart failure (HF) patients eligible for cardiac resynchronization therapy (CRT) show no response or are untreatable due to anatomical issues.
• Conventional CRT systems may face challenges with lead placement in the coronary sinus (CS).

Purpose of the Study:

• To evaluate the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system.
• To assess this system in high-risk patients for CRT upgrade or those with failed conventional CRT lead placement.

Main Methods:

• The SOLVE-CRT study was a prospective, multicenter trial involving 183 patients (non-responders, previously untreatable, or high-risk upgrades).
• Patients received the WiSE CRT System, a leadless LV endocardial pacing electrode.
• Primary efficacy endpoint was reduction in LV end-systolic volume (LVESV); primary safety endpoint was freedom from type I complications.

Main Results:

• The study met its primary efficacy endpoint, demonstrating a 16.4% reduction in mean LVESV (P=.003).
• The primary safety endpoint was met with an 80.9% freedom from type I complications (P<.001).
• Complications included device system events, vascular events, strokes, and cardiac perforations.

Conclusions:

• Leadless LV endocardial pacing with the WiSE CRT system significantly reduces LVESV in heart failure patients.
• This novel system presents a potential alternative to conventional CRT in specific HF populations.