Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Performance

Background:

• Implantable cardioverter-defibrillators (ICDs) are increasingly used, yet data on their performance and longevity, especially with advanced pacing, is limited.
• Understanding factors affecting ICD reliability is crucial for patient safety and device management.

Purpose of the Study:

• To evaluate the performance and failure modes of contemporary ICD pulse generators.
• To assess the impact of advanced pacing features on ICD reliability and replacement rates.

Main Methods:

• Prospective data collection from nine centers on ICD failures and recalls from 1998 to 2005.
• Defined ICD failure as removal from service and recalled ICDs as those replaced due to manufacturer advisories.
• Compared implant times and failure reasons between devices with and without advanced pacing functions.

Main Results:

• 1,220 ICDs failed and 135 were recalled; average implant times were 4.4 years (failed) and 1.7 years (recalled).
• ICDs with rate responsive or cardiac resynchronization therapy pacing (CRT-D) had significantly shorter implant times (P <.001).
• Advanced pacing ICDs showed earlier battery depletion (P <.001), higher electronic/housing failure rates (9% vs 5%), and recall rates (25% vs 1%).

Conclusions:

• Contemporary ICD performance is negatively impacted by premature battery depletion, electronic failures, and manufacturer recalls.
• Advanced pacing features are associated with reduced ICD longevity and increased failure rates.
• Further research is required to accurately estimate ICD longevity and the incidence of unexpected failures.