Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure.

IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
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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引用次数: 0

Abstract

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.

治疗心力衰竭的无导线超声心脏再同步系统
重要性:在符合心脏再同步化疗法(CRT)条件的心力衰竭(HF)患者中,约有 40% 的患者因解剖学限制而无法接受治疗或治疗无效:目的:评估新型无导联左心室(LV)心内膜起搏系统的安全性和有效性,该系统适用于CRT升级的高风险患者或冠状窦(CS)导联置入/传统CRT系统起搏失败的患者:SOLVE-CRT研究是一项前瞻性多中心试验,于2018年1月至2022年9月入组,2023年3月进行随访。数据分析时间为年月日至年月日。该试验结合了最初的随机双盲研究(n = 108)和随后的单臂部分(n = 75)的数据。试验在澳大利亚、欧洲和美国的 36 个中心进行。参与者包括无应答者、既往无法治疗者(PU)或高风险升级者(HRU)。所有参与者都参与了安全性分析。主要疗效分析(n = 100)包括单臂部分的 75 名 PU-HRU 患者和随机治疗臂的 25 名 PU-HRU 患者:患者植入 WiSE CRT 系统(EBR Systems),该系统由一个无导联左心室心内膜起搏电极组成,通过皮下植入的发射器和电池提供超声能量刺激:主要安全性终点是无 I 型并发症。主要疗效终点是左心室收缩末期平均容积(LVESV)的降低:该研究包括 183 名参与者;平均年龄为 68.1 岁(标准差,10.3 岁),141 名男性(77%)。试验在中期分析时因达到预设的终止标准而终止。在安全人群中,患者为纽约心脏病协会 II 级(34.6%)或 III 级(65.4%)。主要疗效终点为平均 LVESV 降低 16.4%(95% CI,-21.0% 至 -11.7%)(P = .003)。主要安全性终点达到了 80.9% 的 I 型并发症发生率(P 结论和意义):SOLVE-CRT 研究表明,使用 WiSE CRT 系统进行无导联左心室心内膜起搏可降低心房颤动患者的左心室舒张功能。在某些高频患者群体中,这种新型系统可能是传统 CRT 植入的替代方案:试验注册:ClinicalTrials.gov Identifier:NCT0292203.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
JAMA cardiology
JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍: JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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