Retrieval of chronically implanted active helix-fixation leadless pacemakers was successful in 87.6% of attempts with a 3.9% complication rate, demonstrating safe retrievability up to 9 years post-implantation.
Observational (n=233)
Yes
Does catheter-based retrieval of chronically implanted active helix-fixation leadless pacemakers achieve high success rates with low complications in patients requiring device removal?
Catheter-based retrieval of chronically implanted active helix-fixation leadless pacemakers is highly successful (87.6%) and safe (3.9% major complication rate) even up to 9 years post-implantation.
BACKGROUND The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term. OBJECTIVES This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials. METHODS 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. RESULTS 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). CONCLUSIONS 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.
“This article summarizes the worldwide experience retrieving chronically implanted active helix-fixation leadless ventricular pacemakers (the Aveir/Abbott platform) across regulatory clinical trials. The authors assess real-world feasibility, procedural techniques, success rates, and complications of retrieval after long dwell times, demonstrating that devices can be removed safely and effectively even years after implant—up to about 9 years in follow-up. Overall, chronic retrieval success remained high with a low rate of serious adverse events, supporting helix-fixation leadless systems as a manageable long-term pacing strategy when replacement or removal is needed.”
Neužil et al. (Wed,) conducted a observational in Chronically implanted leadless pacemaker requiring retrieval (n=233). Leadless pacemaker retrieval was evaluated on Retrieval success rate. Retrieval of chronically implanted active helix-fixation leadless pacemakers was successful in 87.6% of attempts with a 3.9% complication rate, demonstrating safe retrievability up to 9 years post-implantation.
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