Rate and predictors of electrical failure in non-recalled defibrillator leads.

BACKGROUND: Implantable cardioverter defibrillator (ICD) leads are considered as the 'weakest link' in defibrillator systems due to FDA recalls and advisories involving popular lead models from major manufacturers. The rate of electrical failure of ICD leads not implicated in a recall is however not well determined.

METHODS: Medical records of patients implanted with ICDs at hospitals of the University of Pittsburgh Medical Center between 2002 and 2014 were analyzed. Leads were classified as having electrically failed if removed or replaced for reasons other than infection or heart transplantation. Patients were followed to endpoint of death or electrical lead failure.

RESULTS: 2410 consecutive ICD recipients (mean age 66 ± 13 years, women 22%, single/dual/biventricular-ICD 20%/44%/36%) were included. During a mean follow-up of 3.9 ± 3.3 years, 1272 patients (53%) died, 55 patients (2.3%) had ICD lead electrical failure, and 1052 (44%) patients were alive with functional leads at the time of last follow-up. Patients with failed leads had higher BMI (p = 0.07), better functional status (p = 0.04), higher serum creatinine (p = 0.004), wider QRS complex (p = 0.01), higher number of implanted leads (p = 0.06) and were more likely to have ischemic cardiomyopathy (p = 0.03). After adjusting for these variables in a binary logistic regression model, only a lower BMI, presence of non-ischemic cardiomyopathy, and a better functional status remained independently predictive of electrical failure.

CONCLUSIONS: Only 2.3% of non-recalled ICD leads experience electrical failure (annual failure rate of 0.6%). A higher patient functional status, lower BMI, and non-ischemic etiology of cardiomyopathy are independently associated with higher rates of ICD lead failure.