Weill Cornell Medicine/ New York Presbyterian Hospital, New York, NY (J.E.I.).
Huntington Memorial Hospital, Pasadena, CA (M.R.).
Circulation. 2024 Aug 6;150(6):439-450. doi: 10.1161/CIRCULATIONAHA.124.069006. Epub 2024 Jul 8.
A dual-chamber leadless pacemaker system has been designed for atrioventricular synchronous pacing using wireless, beat-to-beat, implant-to-implant (i2i) communication between distinct atrial and ventricular leadless pacemakers. The atrioventricular synchrony achieved across various ambulatory scenarios has yet to be systematically evaluated.
A prospective, single-arm, unblinded, multicenter, international clinical trial of the leadless pacemaker system was conducted in patients with a conventional dual-chamber pacing indication enrolled from February 2022 to March 2023. Leadless pacemaker systems were implanted, and 12-lead Holter electrocardiographic recordings were collected 3 months after implantation over various postures/activities: sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walk, and fast walk. An independent Holter core laboratory performed a manual adjudication of the percent of atrioventricular synchronous beats using the standard 300-millisecond PR interval limit. Atrium-to-ventricle and ventricle-to-atrium i2i communication success rates were also assessed. Post hoc summary statistics describing the relationships between atrioventricular synchrony and i2i success, posture/activity, implantation indication, atrioventricular event, and heart rate were calculated.
In the evaluable population (n=384 of 464 enrolled [83%]; 61% male; age, 70 years; weight, 82 kg; 60% ejection fraction; 95% of beats evaluable), the mean atrioventricular synchrony of 98% of beats observed across all postures using the standard 300-millisecond limit was greater than both atrial-to-ventricular i2i (94%) and ventricular-to-atrial i2i (94%; <0.001), exceeding both i2i values in 95% of patients. Atrioventricular synchrony was achieved in >95% of evaluable beats across all postures/activities, implantation indications, atrioventricular paced/sensed event combinations, and heart rate ranges (including >100 bpm).
This dual-chamber leadless pacemaker system demonstrated atrioventricular synchrony in 98% of evaluable beats at 3 months after implantation. Atrioventricular synchrony was maintained across postures/activities and remained robust for heart rates >100 bpm.
一种双腔无导线起搏器系统已被设计用于通过无线、逐搏、植入式对植入式(i2i)通信在不同的心房和心室无导线起搏器之间实现房室同步起搏。在各种活动场景下实现的房室同步性尚未得到系统评估。
一项前瞻性、单臂、非盲、多中心、国际临床试验对 2022 年 2 月至 2023 年 3 月期间因常规双腔起搏适应证而入选的患者使用无导线起搏器系统进行，在植入后 3 个月内收集 12 导联动态心电图记录，包括各种体位/活动：坐、仰卧、左侧卧位、右侧卧位、站立、正常行走和快速行走。一个独立的动态心电图核心实验室使用标准的 300 毫秒 PR 间期限制进行手动裁决，以评估房室同步搏动的百分比。还评估了心房到心室和心室到心房 i2i 通信成功率。事后总结描述了房室同步性与 i2i 成功、体位/活动、植入适应证、房室事件和心率之间关系的统计数据。
在可评估人群中（n=464 名入组患者中的 384 名[83%]；61%为男性；年龄 70 岁；体重 82kg；射血分数 60%；95%的搏动可评估），在所有体位下使用标准 300 毫秒限制观察到的平均房室同步率为 98%，高于心房到心室 i2i（94%）和心室到心房 i2i（94%；<0.001），在 95%的患者中超过了这两个 i2i 值。在所有体位/活动、植入适应证、房室起搏/感知事件组合和心率范围内（包括>100 次/分），在>95%的可评估搏动中实现了房室同步。
该双腔无导线起搏器系统在植入后 3 个月时在 98%的可评估搏动中实现了房室同步。在各种体位/活动中保持了房室同步，对于>100 次/分的心率仍然稳健。
