Arrhythmias & electrophysiology
Ten-year Performance of the Multi-Layer Insulated Defibrillation Lead in the Medicare Population
Authors' 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.
Study context
- Population
- Medicare patients receiving an Optisure implantable cardioverter-defibrillator (ICD) lead from February 2014 through December 2024patients with 27,033 Optisure leads
- Participants
- 26,830 patients
- Outcome
- Mechanical lead-related complications
Methodological detailsreal-world, EP PASSION framework, manufacturer device-tracking records linked to Medicare Fee-for-Service claims and device complaint data
- Real-world
- EP PASSION framework
- Manufacturer device-tracking records linked to Medicare Fee-for-Service claims and device complaint data
Main finding
As reported in the abstract
Confirmed lead-related complications
379
Confirmed or potentially lead-related complications
606
Further findings
Complication-free lead survival · 10 years
- Best-case scenario
- 97.2% (95% CI, 96.7%-97.7%)
- Worst-case scenario
- 95.6% (95% CI, 94.9%-96.2%)
- Kaplan-Meier
Complication-free lead survival by age, lead length, coil configuration, or device type
- Survival did not differ significantly by age, lead length, coil configuration, or device type
Baseline characteristics
- Mean age
- 73.8 ± 8.6 years
- Women
- 28.4%
- Cardiac resynchronization therapy ICDs
- 49.8%
Original publication
Ten-year Performance of the Multi-Layer Insulated Defibrillation Lead in the Medicare Population. Heart Rhythm. Published 22 October 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →