Reliability and longevity of implantable defibrillators.

Area of Science:

• Cardiovascular Medicine
• Biomedical Engineering
• Medical Device Technology

Background:

• Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization defibrillator-cardiac resynchronization therapy defibrillators (CRT-Ds) are crucial for managing heart rhythm disorders.
• Assessing the long-term reliability and longevity of these devices is essential for patient safety and effective therapy.

Purpose of the Study:

• To evaluate the clinical value of manufacturers' product performance reports (PPRs) for assessing ICD and CRT-D reliability and longevity.
• To identify differences in device performance and battery longevity across various manufacturers.

Main Methods:

• Analysis of 2019 PPRs for implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization defibrillator-cardiac resynchronization therapy defibrillators (CRT-Ds) marketed in the USA (2010-2019).
• Kaplan-Meier (K-M) analysis calculated probabilities of freedom from malfunction (MAL) and normal battery depletion (NBD).
• Comparison of device performance using log-rank tests across manufacturers and device types.

Main Results:

• Over 1.1 million ICD and CRT-D pulse generators were analyzed, with significant reliability differences (p < 0.001) observed between manufacturers.
• Abbott (ABT) devices showed the highest number of malfunctions (59.4%), with battery failure being the most common cause impacting therapy.
• Boston Scientific (BSC) demonstrated superior CRT-D performance, while Medtronic (MDT) and Biotronik (BIO) favored ICDs; BSC's subcutaneous ICD reliability was lower than its transvenous counterpart.

Conclusions:

• Product performance reports (PPRs) offer valuable aggregated data for physicians to inform clinical decisions regarding device selection.
• Significant variations in product reliability and battery longevity exist among ICD and CRT-D manufacturers.
• While battery longevity has improved, malfunctions continue to impact device performance, underscoring the utility of PPR data for assessing product issues and new technologies.