Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure
Jagmeet P Singh1, Christopher A Rinaldi2,3, Prashanthan Sanders4
1Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Insights
A novel leadless cardiac resynchronization therapy (CRT) system, the WiSE CRT, effectively reduced left ventricular end-systolic volume in heart failure patients. This innovative pacing method offers a promising alternative for those unresponsive to traditional CRT.
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.
Importance:
Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are untreatable due to anatomical constraints.
Objective:
To assess the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system for patients at high risk for a CRT upgrade or whose coronary sinus (CS) lead placement/pacing with a conventional CRT system failed.
Design, Setting, And Participants:
The SOLVE-CRT study was a prospective multicenter trial enrolling January 2018 through July 2022, with follow-up at 6 months. Data were analyzed from January 17, 2018, through February 15, 2023. The trial combined data from an initial randomized, double-blind study (n = 108) and a subsequent single-arm part (n = 75). It took place at 36 centers across Australia, Europe, and the US. Participants were nonresponders, previously untreatable (PU), or high-risk upgrades (HRU). All participants contributed to the safety analysis. The primary efficacy analysis (n = 100) included 75 PU-HRU patients from the single-arm part and 25 PU-HRU patients from the randomized treatment arm.
Interventions:
Patients were implanted with the WiSE CRT System (EBR Systems) consisting of a leadless LV endocardial pacing electrode stimulated with ultrasound energy delivered by a subcutaneously implanted transmitter and battery.
Main Outcomes And Measures:
The primary safety end point was freedom from type I complications. The primary efficacy end point was a reduction in mean LV end systolic volume (LVESV).
Results:
The study included 183 participants; mean age was 68.1 (SD, 10.3) years and 141 were male (77%). The trial was terminated at an interim analysis for meeting prespecified stopping criteria. In the safety population, patients were either New York Heart Association Class II (34.6%) or III (65.4%). The primary efficacy end point was met with a 16.4% (95% CI, -21.0% to -11.7%) reduction in mean LVESV (P = .003). The primary safety end point was met with an 80.9% rate of freedom from type I complications (P < .001), which included 12 study device system events (6.6%), 5 vascular events (2.7%), 3 strokes (1.6%), and 7 cardiac perforations which mostly occurred early in the study (3.8%).
Conclusions And Relevance:
The SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF. This novel system may represent an alternative to conventional CRT implants in some HF patient populations.
Trial Registration:
ClinicalTrials.gov Identifier: NCT0292203.
