Allied Professionals (Non-physician submissions only) -> Clinical Research D-PO01-NC - Non-CME Poster Session (ID 14) Poster

D-PO01-NC-05 - Transition Of Post-approval Study Reporting For The Siello S Pacing Lead To Real-world Data Methodology (ID 1479)

  T.K. Collins: Salary from Employment (Commercial Interest) - Biotronik.


Background: Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION), a collaboration of industry, academia, Heart Rhythm Society, American College of Cardiology, and the Food and Drug Administration (FDA), aims to develop a sustainable mechanism to collect real-world performance data across the Total Product Life Cycle of cardiac pacing and defibrillation leads. As part of EP PASSION, BIOTRONIK and successfully transitioned the Post-Approval Study (PAS) for the Siello and Solia S pacing lead (referred to as Siello) from a traditional design based on long-term clinical follow-up to a new approach utilizing extant real-world data sources.
Objective: Demonstrate real world data methodology to evaluate the long-term safety of a pacing lead can successfully generate real-world evidence to fulfill condition of approval reporting to FDA.
Methods: To identify Siello lead complications, patients implanted with a Siello lead during a two year period were identified in BIOTRONIK’s device tracking database and linked via direct identifiers with Medicare data through 2018. Complications ≤ 30 days post-implant were excluded. Kaplan-Meier (KM) survival and incidence rates were estimated.
Results: Data for 1,344 patients implanted with 2,458 Siello leads (1,130 right atrial (RA), 1,322 right ventricular (RV), and 6 with unknown implant location) was analyzed. Cumulative follow-up time was 8228.5 years. Thirty-six Siello lead complications attributable to the Siello lead were identified in 36 out of 2,458 leads (0.004 complications per system year). The KM survival estimate for freedom from complications at 1,559 days is 98.28% (SE 0.45%; 95% CI: 97.39%, 99.18%). Of the 36 complications, 14 were associated with the RA implant location and 18 were attributed to the RV implant location for incidence rates of 0.004 complications per system year in both locations. The remaining four complications could not be attributed definitively to a specific location.
Conclusion: These data represent the first report on the long-term safety of the Siello pacing lead using real world data sources and demonstrate the successful transition of a traditionally designed pacing lead PAS to an approach generating real-world evidence.