Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Performance

Background:

• Pacemakers significantly improve patient lives globally.
• Limited independent data exists on pacemaker device performance and longevity.

Purpose of the Study:

• To investigate reasons for pacemaker pulse generator and transvenous lead removal from service.
• To evaluate causes, adverse events, detection, and management of device end-of-service life behavior.

Main Methods:

• Prospective data collection via a web-based format for pulse generator and lead removals.
• Defined normal battery depletion by elective replacement indicator (>3 years post-implant).
• Characterized lead failure as pacing, sensing, fixation malfunction, high threshold, or abnormal impedance.

Main Results:

• 2,652 pulse generators and 615 leads removed from 1998-2006; average generator implant duration 7.3 years.
• 87% of generators replaced for normal battery depletion; 13% for other issues (depletion, advisories, defects).
• Lead failures (median 7.2 years) primarily due to insulation defects; 16% incidence of major adverse clinical events, avoided with early detection.

Conclusions:

• Overall pacemaker pulse generator performance is satisfactory, with variations in battery longevity among models.
• Elective replacement indicators sometimes preceded adverse events; pacemaker follow-up is crucial for detecting end-of-service life and impending lead failure.
• Long-term lead performance studies are needed for optimal clinical management strategies, including lead extraction recommendations.