Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.
Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.
Heart Rhythm. 2017 Dec;14(12):1801-1806. doi: 10.1016/j.hrthm.2017.07.015. Epub 2017 Jul 14.
Early experience with leadless pacemakers has shown a low rate of complications. However, little is known about system revision in patients with these devices.
The purpose of this study was to describe the system revision experience with the Micra Transcatheter Pacing System (TPS).
Patients with implants from the Pre-market Micra Transcatheter Pacing Study and the Micra Transcatheter Pacing System Continued Access Study (N = 989) were analyzed and compared with 2667 patients with transvenous pacemakers (TVPs). Revisions included TPS retrieval/explant, repositioning, replacement, or electrical deactivation (with or without prior attempt at retrieval, generally followed by TVP implant) for any reason. Kaplan-Meier revision rates were calculated to account for varying follow-up duration and were compared using a Fine-Gray competing risk model.
The actuarial rate for revision at 24 months postimplant was 1.4% for the TPS group (11 revisions in 10 patients), 75% (95% confidence interval 53%-87%; P < .001) lower than the 5.3% for the TVP group (123 revisions in 117 patients). TPS revisions occurred 5-430 days postimplant for elevated pacing thresholds, need for alternate therapy, pacemaker syndrome, and prosthetic valve endocarditis; none were due to device dislodgment or device-related infection. TPS was disabled and left in situ in 7 cases, 3 were retrieved percutaneously (range 9-406 days postimplant), and 1 was surgically removed during aortic valve surgery.
The overall system revision rate for patients with TPS at 24 months was 1.4%, 75% lower than that for patients with TVPs. TPS was disabled and left in situ in 64% of revisions, and percutaneous retrieval was successful as late as 14 months postimplant.
无导线起搏器的早期经验显示其并发症发生率较低。然而，对于这些设备的患者，系统修订知之甚少。
本研究旨在描述 Micra 经导管起搏系统（TPS）的系统修订经验。
分析了来自上市前 Micra 经导管起搏研究和 Micra 经导管起搏系统持续准入研究的植入患者（N=989），并与 2667 例经静脉起搏器（TVP）患者进行了比较。修订包括 TPS 取出/取出、重新定位、更换或电停用（无论是否先尝试取出，通常随后植入 TVP），原因不限。使用 Fine-Gray 竞争风险模型对 Kaplan-Meier 修订率进行计算，并进行比较。
植入后 24 个月时，TPS 组的修正率为 1.4%（10 例患者中有 11 例修正），比 TVP 组的 5.3%（117 例患者中有 123 例修正）低 75%（95%置信区间为 53%-87%；P<.001）。TPS 修订发生在植入后 5-430 天，原因是起搏阈值升高、需要替代治疗、起搏器综合征和人工瓣膜心内膜炎；均不是由于器械移位或器械相关感染引起的。7 例 TPS 被禁用并留在原位，3 例经皮取出（植入后 9-406 天），1 例在主动脉瓣手术中被手术取出。
植入 TPS 的患者在 24 个月时的总体系统修订率为 1.4%，比 TVP 患者低 75%。64%的修订是将 TPS 禁用并留在原位，植入后 14 个月经皮取出是成功的。
