Neuzil Petr, Exner Derek V, Knops Reinoud E, Cantillon Daniel J, Defaye Pascal, Banker Rajesh, Friedman Paul, Hubbard Chris, Delgado Stephanie M, Bulusu Anuradha, Reddy Vivek Y
Na Homolce Hospital, Prague, Czech Republic.
University of Calgary, Calgary, Alberta, Canada.
J Am Coll Cardiol. 2025 Mar 25;85(11):1111-1120. doi: 10.1016/j.jacc.2024.10.094. Epub 2025 Jan 8.
The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term.
This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials.
Subjects enrolled in the LEADLESS II phase 1 investigational device exemption, LEADLESS Observational, or LEADLESS Japan trials with an attempted LP retrieval at least 6 weeks postimplantation were included. The retrieval success rate was evaluated for all attempted retrievals. Site-reported complications associated with LP retrievals were quantified, with the severity and relationship adjudicated by an independent clinical events committee.
There were 1,423 successful LP implants and 234 chronic LP retrieval attempts in 233 subjects. The overall retrieval success rate was 87.6% (205 of 234 attempts). The most common reason for failed retrieval (86.2%, 25 of 29 attempts) was inability to access the LP docking button. The mean time from implantation to attempted retrieval was 3.2 years (range 0.2-9.0 years) and did not significantly influence the retrieval success (P = 0.71). The clinical events committee adjudicated 11 complications in 9 subjects as being retrieval related (3.9%, 9 of 233 subjects).
The safety and efficacy of chronic LP retrieval of an active helix-fixation device was demonstrated in an international clinical trial setting, with implant durations up to 9 years.
无导线起搏器（LP）技术的使用日益增加，这就需要长期安全有效的解决方案来取出和移除这些设备。
本研究旨在评估在全球监管临床试验中研究的有源螺旋固定LP的取出情况。
纳入参加无导线II期1类研究性器械豁免试验、无导线观察性试验或无导线日本试验且在植入后至少6周尝试取出LP的受试者。评估所有尝试取出的成功率。对与LP取出相关的现场报告并发症进行量化，由独立的临床事件委员会判定其严重程度和相关性。
233名受试者中有1423次成功植入LP，234次慢性LP取出尝试。总体取出成功率为87.6%（234次尝试中的205次）。取出失败的最常见原因（86.2%，29次尝试中的25次）是无法触及LP对接按钮。从植入到尝试取出的平均时间为3.2年（范围0.2 - 9.0年），且对取出成功率无显著影响（P = 0.71）。临床事件委员会判定9名受试者中的11例并发症与取出有关（233名受试者中的9例，占3.9%）。
在国际临床试验环境中，有源螺旋固定设备慢性LP取出的安全性和有效性得到了证实，植入时间长达9年。
