No Differences in Lead Failure in Most Common ICD Leads: NCDR Post-Market Surveillance Study
Among the four most common ICD leads, there are no clinically significant differences in high-energy lead failure, according to a study recently published in Circulation: Cardiovascular Quality and Outcomes.
In a post-market surveillance study, Frederic S. Resnic, MD, MSc, FACC, et al., used data from ACC's ICD Registry to assess the comparative long-term safety of the four most commonly used ICD leads. The study's primary safety outcome was survival without lead failure for any reason, based on ICD Registry records of a subsequent procedure to remove and/or replace the original lead. The secondary outcome was late lead survival, which included only patients who did not experience lead failure within the first 30 days following ICD implantation. For each of the four ICD leads, a propensity-matched control population consisting of patients treated with any of the other leads was identified to create device-specific comparisons.
According to the results, 374,132 patients received one of the four ICD leads of interest. Patients had a mean age of 65 years, 39% had diabetes and 29% were female. About 58% of patients had ischemic cardiomyopathy and 78% received the ICD for primary prevention of sudden death. Of identified lead failures, 44% occurred within 30 days of ICD implantation. After five years of surveillance, there were no safety alerts for lead failure for any of the four leads. In addition, after five years, freedom from lead replacement ranged from 97.7% to 98.9% for each of the four high-energy leads. There were no differences in freedom of lead replacement among different patient cohorts, including women, patients younger or older than 60 years, those who received the ICD for primary or secondary prevention, or patients with diabetes or end-stage renal disease. The study's findings "support the feasibility of prospective, active surveillance of a large, representative ICD Registry to monitor high-energy lead failure in near real time." The study showed "no clinically significant differences in high-energy lead failure among the four most commonly used ICD leads in contemporary practice," they conclude.
The study "is a great step towards repurposing clinical data for public health and safety," Emily P. Zeitler, MD, MHS, FACC, and Kimberly A. Selzman, MD, MPH, FACC, write in an accompanying editorial. The set of surveillance software tools developed for the analysis "serve as a path forward for repurposing existing data systems to serve the medical device ecosystem and public health at large," they conclude.
Keywords: Secondary Prevention, Public Health, Prospective Studies, Feasibility Studies, Registries, National Cardiovascular Data Registries, Primary Prevention, Kidney Failure, Chronic, Diabetes Mellitus, Death, Sudden, ICD Registry
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