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双腔 ICD 用于左束支区域起搏:通过左束(交叉左)先导研究进行心脏再同步和心律失常感知。

Dual-chamber ICD for left bundle branch area pacing: the cardiac resynchronization and arrhythmia sensing via the left bundle (cross-left) pilot study.

机构信息

Service de Cardiologie, Centre Hospitalier Universitaire Trousseau Et Faculté de Médecine, Université de Tours, EA7505, Tours, France.

出版信息

J Interv Card Electrophysiol. 2023 Jun;66(4):905-912. doi: 10.1007/s10840-022-01342-6. Epub 2022 Aug 16.

DOI:10.1007/s10840-022-01342-6
PMID:35970951
Abstract

BACKGROUND

Left bundle branch area pacing (LBBAP) has emerged as a promising technique to deliver cardiac resynchronization therapy (CRT). However, safety and efficacy of ventricular arrhythmia sensing via the left bundle in implantable cardioverter-defibrillator (ICD) recipients remain unclear. We sought to evaluate the feasibility of a single LBBAP lead connected to a dual-chamber ICD in patients indicated with a CRT-D implantation.

METHODS

The CROSS-LEFT pilot study prospectively included 10 consecutive patients with a reduced ejection fraction and a complete left bundle branch block, indicated with a prophylactic CRT-D. A DF-1 lead was implanted at the right ventricular (RV) apex, and an LBBAP lead through the interventricular septum. Ventricular fibrillation was induced at implantation in both conventional (RV) and left bundle branch area sensing configurations. The latter was the final sensing configuration, and patients were implanted with a dual-chamber DF-1 ICD connected to the atrial lead (RA port), the LBBAP lead (RV IS-1 port), and the defibrillation lead (RV DF-1 port), the IS-1 pin being capped. Atrioventricular delay was optimized to ensure fusion between LBBAP and native conduction from the right bundle. Patients were followed during 6 months.

RESULTS

No difference between both configurations was observed regarding R-wave sensing in sinus rhythm (p = 0.22), ventricular fibrillation median interval detection (p = 1.00), or total induced episode duration (p = 0.78). LBBAP resulted in a significant reduction of median QRS width from 164 to 126 ms (p = 0.002). Median ventricular sensing significantly improved from 9.7 at implantation to 18.8 mV at 6 months (p = 0.01). Median LVEF also significantly improved from 29 to 44% at 6 months (p = 0.002).

CONCLUSION

Ventricular arrhythmia sensing and defibrillation can be performed via a single LBBAP lead connected to a dual-chamber ICD, and is associated with significant electromechanical reverse remodeling.

CLINICAL TRIAL REGISTRATION NUMBER

NCT05102227 In patients presenting with left bundle branch block and left ventricular systolic dysfunction, a left bundle branch area pacing lead connected to a DF-1 dual-chamber implantable cardioverter-defibrillator provides safe ventricular arrhythmia sensing and efficient electro-mechanical resynchronization.

摘要

背景

左束支区域起搏(LBBAP)已成为提供心脏再同步治疗(CRT)的有前途的技术。然而,在植入式心脏复律除颤器(ICD)受者中,通过左束支进行室性心律失常感测的安全性和有效性仍不清楚。我们旨在评估在具有 CRT-D 植入指征的患者中,将单个 LBBAP 导联连接至双腔 ICD 的可行性。

方法

前瞻性纳入 10 例射血分数降低和完全性左束支传导阻滞的连续患者,指征为预防性 CRT-D。DF-1 导联植入右心室(RV)心尖,LBBAP 导联穿过室间隔。在植入时,在传统(RV)和左束支区域感测配置中均诱发心室颤动。后者是最终的感测配置,患者植入带有双腔 DF-1 ICD 的心房导联(RA 端口)、LBBAP 导联(RV IS-1 端口)和除颤导联(RV DF-1 端口),IS-1 销钉被覆盖。优化房室延迟以确保 LBBAP 与来自右束的固有传导之间的融合。在 6 个月的时间内对患者进行随访。

结果

两种配置在窦性心律时 R 波感测(p=0.22)、心室颤动中位间隔检测(p=1.00)或总诱发发作持续时间(p=0.78)方面无差异。LBBAP 可使中位 QRS 宽度从 164 毫秒降至 126 毫秒(p=0.002)。中位心室感测从植入时的 9.7 mV 显著改善至 6 个月时的 18.8 mV(p=0.01)。中位左心室射血分数(LVEF)也从 6 个月时的 29%显著改善至 44%(p=0.002)。

结论

通过连接至双腔 ICD 的单个 LBBAP 导联可进行室性心律失常感测和除颤,并且与显著的机电逆重构相关。

临床试验注册号

NCT05102227 在具有左束支传导阻滞和左心室收缩功能障碍的患者中,连接至 DF-1 双腔植入式心脏复律除颤器的左束支区域起搏导联可提供安全的室性心律失常感测和有效的机电同步化。

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