Kolb Christof, Zima Endre, Arnold Martin, Fedorco Marián, Bonnemeier Hendrik, Deneke Thomas, Schumacher Burghard, Nordbeck Peter, Steinwender Clemens, Storz Theresa, Merkely Béla, Anneken Lars, Felk Angelika, Lennerz Carsten
Department of Cardiology, German Heart Centre, TUM University Hospital, Technical University of Munich, 80636 Munich, Germany.
Department of Cardiology, Rhythmology, Angiology and Intensive Care Medicine, Heart Centre Osnabrück, Hospital Osnabrück, Westphalian Wilhelms University of Münster, 49076 Osnabrück, Germany.
J Clin Med. 2025 Jul 15;14(14):5009. doi: 10.3390/jcm14145009.
Patients with normal sinus rhythms undergoing cardiac resynchronization therapy defibrillator (CRT-D) implantation may benefit from a novel two-lead CRT-D system (CRT-DX), which features an atrial sensing dipole integrated into the right ventricular lead. This single-arm, international, non-controlled investigation focused on the safety and clinical efficacy of CRT-DX devices in CRT-D candidates who do not require atrial pacing. Patients indicated for CRT-D implantation (resting heart rates > 40 bpm and ≥100 bpm during exercise, no second or higher-degree AV block, and no history of persistent or permanent atrial fibrillation) were enrolled across 21 sites in four European countries. The primary endpoint was the need for an additional RA lead implantation within 12 months. Secondary endpoints comprised any invasive re-intervention to the CRT-DX system or infection. Among the 110 patients (mean age 62 years, 70% male), 60% had an underlying non-ischemic cardiac disease. During 12 months of follow-up, RA lead implantation was required in two patients for atrial undersensing or chronotropic incompetence (RA lead implantation-free rate: 98.2% (95% CI: 92.7-99.5%)). Atrial sensing amplitudes were stable (mean: 4.7 ± 1.7 mV), AV-synchrony was maintained at >99%, and the median percentage of biventricular pacing exceeded 98%. The left ventricular ejection fraction improved by an absolute 14.7%. Using simple, clinically applicable inclusion criteria, the two-lead CRT-DX system demonstrated a low rate of subsequent RA lead implantations (1.8%) and maintained adequate RA sensing amplitudes throughout the observation period. The two-lead CRT-DX concept appears to be a feasible alternative for patients with preserved chronotropic competence.
接受心脏再同步治疗除颤器（CRT-D）植入的窦性心律正常患者，可能会从一种新型双腔CRT-D系统（CRT-DX）中获益，该系统的特点是将心房感知偶极集成到右心室导线中。这项单臂、国际性、非对照研究聚焦于CRT-DX设备在不需要心房起搏的CRT-D候选患者中的安全性和临床疗效。入选CRT-D植入（静息心率>40次/分且运动时≥100次/分，无二度或更高程度房室传导阻滞，且无持续性或永久性房颤病史）的患者来自四个欧洲国家的21个地点。主要终点是12个月内是否需要额外植入右心房导线。次要终点包括对CRT-DX系统的任何侵入性再次干预或感染。在110例患者（平均年龄62岁，70%为男性）中，60%患有潜在的非缺血性心脏病。在12个月的随访期间，两名患者因心房感知不足或变时性功能不全需要植入右心房导线（无右心房导线植入率：98.2%（95%CI：92.7-99.5%））。心房感知幅度稳定（平均：4.7±1.7mV），房室同步维持在>99%，双心室起搏的中位数百分比超过98%。左心室射血分数绝对提高了14.7%。使用简单、临床适用的纳入标准，双腔CRT-DX系统显示后续右心房导线植入率较低（1.8%），并在整个观察期内维持了足够的右心房感知幅度。对于变时性功能正常的患者，双腔CRT-DX概念似乎是一种可行的替代方案。
