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Long-Term Risk of Device-Related Complications After ICD
Study Questions:
What is the long-term risk for implantable cardioverter-defibrillator (ICD)-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications?
Methods:
This was an analysis of the National Cardiovascular Data Registry (NCDR) ICD registry linked with Medicare fee-for-service claims data.
Results:
There were 114,484 patients aged 65 years or older (mean age, 74.8 years; 72.4% male) receiving an ICD for the first time. During a median follow-up of 2.7 years, 40,072 patients died, representing 12.6 deaths per 100 patient-years of follow-up. When the risk for death was accounted for, there were 6.1 ICD-related complications per 100 patient-years that required reoperation or hospitalization and 3.9 reoperations per 100 patient-years for reasons other than complications. Younger age at implantation (65-69 vs. >85 years), receipt of a cardiac resynchronization therapy with a defibrillator (CRT-D) device versus a single-chamber device, female sex, and black race were associated with the greatest increased risks for ICD-related complications.
Conclusions:
Patients have a high rate of device-related complications and reoperation for other causes after ICD implantation. Risks of ICD implantation and strategies to reduce them should be actively considered before implantation.
Perspective:
The vast majority of patients with ICDs do not receive shocks, but many are exposed to device-related harms. The current study suggests that the long-term complications, hospitalizations (inpatient admissions, emergency department visits, and observation stays), and reoperations for noncomplications are higher than previously reported. Still, some complications were not captured in the NCDR ICD registry, such as inappropriate shocks that did not lead to hospitalization. Inappropriate shocks, we know, are associated with an increased risk of death. Many complications may be preventable. Of note, the authors included elective generator replacements for low battery, whether premature or not, because ‘reoperation is a substantial event from the patient’s perspective.’
Keywords: Arrhythmias, Cardiac, Cardiac Resynchronization Therapy, Defibrillators, Implantable, Emergency Service, Hospital, Geriatrics, Heart Failure, ICD Registry, National Cardiovascular Data Registries, Fee-for-Service Plans, Medicare, Secondary Prevention, Reoperation, Risk
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