# Draadloos ultrasound-gebaseerd CRT-systeem bij hartfalen

*geplaatst 2024-10-01 · Hartfalen · JAMA cardiology · doi 10.1001/jamacardio.2024.2050 · https://hartvaat.nl/2024/10/01/draadloos-ultrasound-gebaseerd-crt-systeem-bij-hartfalen/*

Studie presenteerde een draadloos leadless ultrasound-gebaseerd CRT-systeem als alternatief voor conventionele CRT bij hartfalen. De technologie biedt een minder invasieve benadering voor cardiale resynchronisatie.

## English: Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure.

This study presented a wireless, leadless ultrasound-based cardiac resynchronization system as an alternative to conventional CRT, addressing the 40% of eligible heart failure patients who fail to respond to or cannot receive traditional CRT devices.

## Abstract (original, from the publication)

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.

Auteurs: Jagmeet P Singh, Christopher A Rinaldi, Prashanthan Sanders, Spencer H Kubo, Simon James, Imran K Niazi, Timothy Betts, Christian Butter, Toshimasa Okabe, Ryan Cunnane, Emad Aziz, Mauro Biffi, Amir Zaidi, Jeffrey Alison, Pascal Defaye, Angelo Aurrichio, Michael R Gold, JoAnn Lindenfeld, Tyson Rogers, Mary Norine Walsh

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Bron: JAMA cardiology, https://doi.org/10.1001/jamacardio.2024.2050. Bijgewerkt 2026-07-03T13:30:14Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.