Background. Boston Scientific INGEVITY+ pacing lead (Boston Scientific, Marlborough, MA, USA) has been upgraded to INGEVITY. The performance of the INGEVITY+ pacing lead has not yet been reported. This study aimed to evaluate the short- and long-term safety, effectiveness, and handling experience of INGEVITY+ leads. Methods. Consecutive patients were included from 9 institutions in Korea, where 400 leads (200 right ventricular active fixation leads and 200 right atrial active fixation leads) were implanted or attempted in 200 subjects. Results. During the implantation, only one patient required a lead change because of lead screw failure. The handling questionnaires of the lead received very positive feedback with 88% of operators agreeing that it is easy for leads to pass through small vessels or vessels with multiple leads. At the 3-month follow-up, 95.7% of RA leads and 99.5% of RV leads had pacing thresholds less than 1.5 V. A total of 92.4% of atrial leads had amplitudes greater than 1.5 mV, and 96.5% of ventricular leads had sensing amplitudes greater than 5 mV at 3 months. A total of 99.8% had impedances between 300 and 1,300 ohms. The lead-related complication-free rate for all leads during follow-up was 100%, and the overall rates of lead dislodgment, perforation, and pericardial effusion were all 0.0%. Conclusions. The INGEVITY+ pacing lead exhibited exceptional clinical performance, with a high complication-free rate throughout the 3-month follow-up period. In addition, the lead displayed excellent electrical characteristics, and the lead-handling experience was reported to be very good.

中文翻译：

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INGEVITY+ 主动固定导联的性能和医生经验：韩国前瞻性 INGEVITY+ 导联临床研究

背景。波士顿科学公司 INGEVITY+ 起搏导线（波士顿科学公司，美国马萨诸塞州马尔伯勒）已升级为 INGEVITY。INGEVITY+ 起搏导线的性能尚未有报道。本研究旨在评估 INGEVITY+ 导线的短期和长期安全性、有效性和操作体验。方法。连续纳入来自韩国 9 个机构的患者，其中 200 名受试者植入或尝试了 400 根导线（200 根右心室主动固定导线和 200 根右心房主动固定导线）。结果。在植入过程中，只有一名患者因导螺杆失效而需要更换导联。引线处理问卷得到了非常积极的反馈，88%的操作员同意引线很容易穿过小容器或多引线的容器。在 3 个月的随访中，95.7% 的 RA 导联和 99.5% 的 RV 导联的起搏阈值小于 1.5 V。总共 92.4% 的心房导联的振幅大于 1.5 mV，96.5% 的心室导联的起搏阈值小于 1.5 mV。 3 个月时感应幅度大于 5 mV。总共 99.8% 的阻抗在 300 至 1,300 欧姆之间。随访期间所有导联无导联相关并发症率为100%，导联脱出、穿孔、心包积液总体发生率均为0.0%。结论。INGEVITY+ 起搏导线表现出卓越的临床表现，在整个 3 个月的随访期内无并发症率很高。此外，铅还表现出优异的电气特性，据报道铅处理体验非常好。