Ten-year performance of an optim-insulated defibrillation lead using large real-world data
H Haqqani, R D Schaller, A Jan, W Li, Y Nabutovsky, M Desmond, R Shaw, K Lee, C LeclercqAbstract
Background
The Optim-insulated defibrillation lead incorporates design enhancements intended to improve long-term durability and reduce complications. Despite its widespread use, clinical evidence on its long-term performance remains limited. Real-world data offers the advantage of scalable, longitudinal patient follow-up, providing a robust resource for evaluating device performance over extended periods.
Purpose
To assess the long-term performance of the Optim-insulated defibrillation lead using linked real-world datasets.
Methods
This analysis employed the same methodology as previously published by Braghieri, Heart Rhythm, 2025.[1] Abbott device registration database was linked with Medicare Fee-For-Service (FFS) claims to identify patients implanted with a cardioverter defibrillator and an Optisure defibrillation lead February 2014-December 2024. Lead complications were defined as claims containing both a diagnosis code for mechanical lead malfunction and a procedure code for a lead-related surgical intervention occurring >30 days post-implant. A multi-step algorithm incorporating claims, internal Abbott complaints, and out-of-service dates was used to determine whether complications were related to the defibrillation lead. The best-case scenario included only confirmed defibrillation lead-related complications, while the worst-case scenario also included complications with undetermined relation. Kaplan-Meier survival analysis was performed to estimate the lead complication-free survival rates over a 10-year follow-up period, with censoring at death, lead removal, switch to Medicare Advantage, or end of claims availability.
Results
A total of 26,830 patients (mean age 73.8 ± 8.6 years, 71.6% male, 17.4% single-chamber ICD, 32.8% Dual-chamber ICD, 49.8% CRT-D) with 27,033 Optisure leads were successfully linked to Medicare FFS data. At 10 years, the lead complication-free survival rate was 97.2% (95% CI: 96.7%–97.7%) in the best-case scenario, and 95.4% (95% CI: 94.7%–96.1%) in the worst-case scenario.
Conclusion
In this large real-world cohort with up to 10 years of follow-up, the Optisure defibrillation lead demonstrated high long-term durability and a low rate of mechanical complications. These findings provide important evidence supporting the safety profile of the Optim-insulated defibrillation lead over extended use, reinforcing its role in long-term defibrillation therapy.