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

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.