Abstract 2909: Prophylactic Extraction versus Continued Surveillance for the Fidelis Lead: A Decision Analysis
Background: For the over quarter of a million patients with Fidelis leads worldwide, and their physicians, the optimal approach to balance the long-term risk of a Fidelis lead failure, and the short-term risk of a “prophylactic” extraction of a currently functioning lead, is unknown. We examined the potential survival benefit of prophylactic removal of a Fidelis lead versus continued surveillance.
Methods: We used a Monte Carlo simulation model (10,000 runs) informed by literature-based meta-analysis estimates of lead extraction mortality (base-case 0.3%), Fidelis lead failure rate (1.8%/year), risk of a potentially fatal ventricular arrhythmia (VA) (4.2%/year), and sensitivity of the currently recommended algorithm to screen for a Fidelis lead failure (76%). Base-case demographics were based on the most recent national ICD registry report. We assumed that 10% of Fidelis lead failures are in the high-voltage coil which would fail to deliver a shock in the event of a potentially fatal VA and result in death.
Results: Compared with continued surveillance, prophylactic removal of a Fidelis lead in a cohort of ICD patients (mean age 68) increased survival by 5 days (95% CI −11 to +51), yielding a higher life-expectancy (LE) in 49% of the simulations, with a >1 month gain in LE in 6.7% of the simulations. An estimated 208 (95% CI, 60 –5887) prophylactic explants would be required to prevent one death from a Fidelis lead failure. With a continued surveillance strategy, the lifetime risk of requiring lead removal was 15% (95% CI 5.1–26%), and the lifetime risk of dying from a Fidelis lead high-voltage failure was 0.5% (95% CI 0.02–1.7%). A prophylactic removal strategy improved survival by at least one month when operative mortality from a lead explant was <0.2%, lead failure rate was >2.3% per year, rate of a potentially fatal VA was >5.4% per year, or patient age was <64 years.
Conclusion: On average, prophylactic removal and continued surveillance of a Fidelis lead have nearly equivalent effects on survival. The optimal strategy may depend on patient characteristics (age, comorbidity, risk for VA, their risk attitudes and preferences), lead factors (failure rate) and operator experience (extraction mortality risk).