Ten-year Performance of the Multi-Layer Insulated Defibrillation Lead in the Medicare Population.

BACKGROUND

Long-term surveillance of implantable cardioverter-defibrillator (ICD) leads is essential because clinically important mechanical failures may emerge years after implantation.

OBJECTIVE

To evaluate 10-year mechanical complication-free survival of the Optisure ICD lead (Abbott, Sylmar, CA) in a large real-world Medicare population.

METHODS

Manufacturer device-tracking records were linked to Medicare Fee-for-Service claims and device complaint data using the EP PASSION framework. Patients receiving an Optisure lead from February 2014 through December 2024 were included. Mechanical lead-related complications were defined by claims containing both a diagnosis of mechanical lead malfunction and a lead-related surgical intervention more than 30 days after implantation. Kaplan-Meier survival was estimated under a best-case scenario including confirmed Optisure-related events and a worst-case scenario also including potentially related events.

RESULTS

The cohort included 26,830 patients with 27,033 Optisure leads. Mean age was 73.8 ± 8.6 years, 28.4% were women, and 49.8% had cardiac resynchronization therapy ICDs. Overall, 379 complications were classified as confirmed lead-related and 606 as confirmed or potentially lead-related. At 10 years, complication-free lead survival was 97.2% (95% confidence interval [CI], 96.7%-97.7%) in the best-case scenario and 95.6% (95% CI, 94.9%-96.2%) in the worst-case scenario. Survival did not differ significantly by age, lead length, coil configuration, or device type.

CONCLUSION

The Optisure ICD lead demonstrated favorable mechanical performance through 10 years in routine clinical practice. These findings support both the long-term durability of Optisure and the use of integrated real-world data for post-market device surveillance.