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Reliability and longevity of implantable defibrillators.

Robert G Hauser1,2, Susan A Casey3, Christopher B Gitter3

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PubMed
Summary

Product performance reports reveal significant differences in implantable cardioverter-defibrillator (ICD) and cardiac resynchronization defibrillator (CRT-D) reliability and battery longevity among manufacturers. Malfunctions and battery failures impact device performance, highlighting the need for careful product assessment.

Keywords:
BatteryCardiac resynchronizationImplantable defibrillatorLongevityMalfunctionReliability

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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.