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December 1, 2020Journal of Innovations in Cardiac Rhythm Management4 citationsOpen Access

First Demonstration of Cardiac Resynchronization Therapy Defibrillator Service Life Exceeding Patient Survival in a Heart Failure with Reduced Ejection Fraction Cohort

JWJeffrey L. WilliamsBHBertha HardleyGWGabriella Williams

Key Result

In patients with heart failure with reduced ejection fraction, the use of a 2.1-Ah cardiac resynchronization therapy defibrillator resulted in patient death being a more frequent cause of device out of service (65.6%) than battery depletion (15%).

Study Design

Type

Cohort (n=418)

Multicenter

No

Structured PICO

Does the 2.1-Ah CRT-D system provide battery longevity exceeding patient survival in patients with HFrEF?

P
Population
418 patients with heart failure with reduced ejection fraction who received a 2.1-Ah cardiac resynchronization therapy defibrillator, followed for a mean of 4.7 years.
E
Exposure
2.1-Ah cardiac resynchronization therapy defibrillator (CRT-D) system
O
Outcome
Device out of service (OOS) due to the battery reaching an elective replacement indicator (ERI) point, patient death, infection/erosion, advisory/recall, heart transplant, or unspecifiedcomposite

In a contemporary HFrEF cohort, the use of a 2.1-Ah CRT-D battery resulted in device longevity exceeding patient survival, potentially reducing the need for and complications of generator replacements.

Limitations

  • Only examined outcomes of the 2.1-Ah CRT-D, as the larger 2.192-Ah battery device was not used at the facility during the study period
  • Retrospective single-center design
  • Did not examine hospitalization rates, which could affect survival estimates
  • The burden of arrhythmia, ventricular tachycardia/fibrillation therapies, and New York Heart Association classification were not examined
  • Single-center retrospective design
  • Only examined outcomes of the 2.1-Ah CRT-D
  • Did not examine hospitalization rates
  • Burden of arrhythmia, VT/VF therapies, and NYHA classification were not examined
  • Survival rate could be misleading due to censoring after initial device reached OOS

Abstract

The occurrence of patient longevity exceeding implantable cardioverter-defibrillator (ICD) service life has important implications for patient outcomes and the cost of care. Battery capacity as measured in ampere-hours (Ah) is a strong predictor of survival to an elective replacement indicator (ERI) point and 2.1 Ah is the largest-capacity ICD battery in use at our facility. This was a long-term study of ICDs out of service (OOS) in patients with heart failure with reduced ejection fraction who received a 2.1-Ah cardiac resynchronization therapy defibrillator (CRT-D). All 2.1-Ah CRT-D systems implanted (n = 418) from August 1, 2008 through August 31, 2016 were included in this retrospective chart review. The primary endpoint was device OOS due to the battery reaching an ERI point, patient death, infection/erosion, advisory/recall, heart transplant, or unspecified. The maximum follow-up period was 10.3 years, with a mean follow-up length of 4.7 years. The most common reason for device OOS was patient death (65.6%), with only 5.7% of devices reaching the ERI point during the study. There was a period of OOS acceleration driven numerically by patient death in the sixth to ninth years of follow-up. Male sex, ischemic cardiomyopathy, elevated creatinine level, advanced age, and reduced ejection fraction were associated with OOS (p < 0.05). To our knowledge, this is the first study to report ICD battery life exceeding patient survival in a chronic heart failure cohort. During an accelerated time of CRT-D OOS (when it is expected that ~98% of 1.0-Ah and 1.4-Ah CRT-D systems reach an ERI point), patient death resulted in substantially more device OOS than battery replacement and avoided costs of complications and generator changes. These results help to explain the elevated risks of CRT-D generator changes in shorter-longevity devices.

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Cite This Study

Williams et al. (2020) conducted a cohort in Heart failure with reduced ejection fraction (HFrEF) (n=418). 2.1-Ah cardiac resynchronization therapy defibrillator (CRT-D) was evaluated on Device out of service (OOS) due to the battery reaching an elective replacement indicator (ERI) point, patient death, infection/erosion, advisory/recall, heart transplant, or unspecified. In patients with heart failure with reduced ejection fraction, the use of a 2.1-Ah cardiac resynchronization therapy defibrillator resulted in patient death being a more frequent cause of device out of service (65.6%) than battery depletion (15%).

synapsesocial.com/papers/6a8578a4afd961f1253da7d0https://doi.org/10.19102/icrm.2020.111203
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