Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers

Area of Science:

• Cardiology
• Medical Devices
• Interventional Cardiology

Background:

• The increasing adoption of leadless pacemaker (LP) technology necessitates reliable long-term device retrieval solutions.
• Ensuring patient safety and device efficacy are paramount with the growing use of LPs.

Purpose of the Study:

• To evaluate the safety and effectiveness of retrieving an active helix-fixation leadless pacemaker (LP).
• This assessment was conducted within the context of global regulatory clinical trials.

Main Methods:

• Analysis of data from subjects undergoing LP retrieval at least 6 weeks post-implantation across multiple clinical trials.
• Evaluation of retrieval success rates and quantification of site-reported complications.
• Adjudication of complication severity and relationship by an independent clinical events committee.

Main Results:

• A total of 234 chronic LP retrieval attempts were made in 233 subjects, with an overall success rate of 87.6%.
• The primary reason for retrieval failure was inaccessible LP docking buttons (86.2% of failures).
• Retrieval-related complications occurred in 3.9% of subjects, with no significant impact of implantation duration on success.

Conclusions:

• Chronic retrieval of active helix-fixation leadless pacemakers is safe and effective.
• The study supports the long-term viability of LP retrieval in an international clinical setting, with data extending up to 9 years.