New York-Presbyterian-Weill Cornell Medical Center, New York, New York.
North Mississippi Medical Center, Tupelo, Mississippi.
Heart Rhythm. 2024 Nov;21(11):2242-2249. doi: 10.1016/j.hrthm.2024.05.007. Epub 2024 May 19.
Left bundle branch area pacing (LBBAP) has swiftly emerged as a safe and effective alternative to right ventricular pacing. Limited data exist on the use of retractable-helix, stylet-driven leads for LBBAP.
The objective of this study was to prospectively evaluate the performance and safety of a stylet-driven pacing lead in a rigorously controlled multicenter trial to support US market application.
A multicenter, prospective, nonrandomized trial enrolled patients with standard pacing indications. Implant procedure and lead data, including threshold, sensing, impedance, and capture type, were collected through 3 months. Primary end points were freedom from LBBAP lead-related serious complications through 3 months and LBBAP implant success according to prespecified criteria. A blinded clinical events committee adjudicated all potential end point complications.
A total of 186 patients were included from 14 US sites. LBBAP implants were successful in 95.7% (178 of 186; 95% confidence interval 91.7%-98.1%; P < .0001 for comparison to the performance goal of 88%). Through the 3-month follow-up visit, 3 patients (1.7%) experienced a serious LBBAP complication (all lead dislodgments), resulting in a LBBAP lead-related complication-free rate of 98.3%. A total of 13 patients (7.8%) experienced any system- or procedure-related complication. The mean threshold was 0.89 V at 0.4 ms, the sensing value was 10.8 mV, and impedance was 608 Ω.
The short-term results from this prospective trial demonstrate both high implant success and freedom from LBBAP lead-related complications using this stylet-driven retractable helix lead. This trial supports the safety, use, and effectiveness of stylet-driven leads for performing contemporary physiologic pacing.
左束支区域起搏（LBBAP）已迅速成为一种安全有效的右心室起搏替代方法。关于可回收螺旋、导丝驱动导联用于 LBBAP 的使用数据有限。
本研究旨在前瞻性评估在严格控制的多中心试验中使用导丝驱动起搏导联的性能和安全性，以支持美国市场应用。
一项多中心、前瞻性、非随机试验纳入了具有标准起搏适应证的患者。通过 3 个月收集植入程序和导联数据，包括阈值、感知、阻抗和捕获类型。主要终点是通过 3 个月时无 LBBAP 导联相关严重并发症和根据预设标准的 LBBAP 植入成功。一个盲法临床事件委员会对所有潜在终点并发症进行裁决。
从 14 个美国站点共纳入 186 例患者。LBBAP 植入成功率为 95.7%（178/186；95%置信区间 91.7%-98.1%；与 88%的性能目标相比，P<0.0001）。通过 3 个月随访，有 3 例（1.7%）患者发生严重的 LBBAP 并发症（均为导联脱位），导致 LBBAP 导联相关无并发症率为 98.3%。共有 13 例（7.8%）患者发生任何系统或手术相关并发症。平均阈值为 0.89 V，脉宽为 0.4 ms，感知值为 10.8 mV，阻抗为 608 Ω。
这项前瞻性试验的短期结果表明，使用这种导丝驱动的可回收螺旋导联，植入成功率高，且 LBBAP 导联相关并发症低。该试验支持导丝驱动导联在进行现代生理起搏中的安全性、使用和有效性。
