Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data

• Published in: Pragmatic and observational research 2024, Vol.15, p.233-241
• Main Authors: Mullane, Steven, Hicks, Jacob B, Sharmin, Kazi, Harrell, Camden, Rock, Angie, Miller, Crystal
• Format: Article
• Language: English
• Subjects: cardiac lead; Original Research; pacemaker; real-world data; real-world evidence
• ISSN: 1179-7266; 1179-7266
• DOI: 10.2147/POR.S499248

As part of Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION), a multi-stakeholder collaboration between the US Food and Drug Administration (FDA), academic and society partners, and cardiovascular implantable electronic device manufacturers, a 5-year bradycardia lead study transitioned from a traditional post-approval study (PAS) to a real-world data (RWD) approach using a novel method to evaluate chronic cardiac lead complications. Lead complications were identified using a combination of diagnosis and procedure codes from 2013 to 2020 fee-for-service Medicare claims data along with BIOTRONIK device registration and Medical Device Reporting data from patients implanted between 2013 and 2015 with a Solia S lead. A proof-of-concept analysis was performed using McNemar's test to compare lead complications reported in the traditional PAS with lead complications identified in the RWD. Kaplan-Meier survival and incidence rates were evaluated to determine real-world long-term safety. The proof-of-concept analysis of 896 patients found in both traditional PAS and RWD sources demonstrated a 99.7% proportion of overall agreement in identifying lead complications (p = 0.0833). Following this validation, 1841 study leads from 1015 Medicare patients were analyzed. A total of 33 lead complications (attributable or possibly attributable to the study lead) were identified for a rate of 0.005 complications per lead-year. The complication-free rate at 5-years post-implant was 97.2% (95% CI: 96.07%, 98.06%). These results led to the first FDA approval for transition of a cardiac lead PAS to long-term safety reporting using RWD, paving the way for future real-world cardiac lead and device surveillance studies. NCT01791127.