Comparing complication rates between Abbott Tendril 2088 and competitive manufacturer leads: Novel real-world data approach

• Published in: Journal of cardiovascular electrophysiology
• Main Authors: Ahmed, Aamir, Wilkoff, Bruce L, Kim, Jeeyun A, Nabutovsky, Yelena, Kim, Grant, Desmond, Matthew, Ganz, Leonard, Curtis, Anne B
• Format: Journal Article
• Language: English
• Published: United States 29.09.2024
• Subjects: Tendril STS 2088TC; lead safety; real‐world evidence; pacing; lead complications
• ISSN: 1045-3873; 1540-8167; 1540-8167
• DOI: 10.1111/jce.16437

While several studies have reported on the reliability of cardiac pacing leads, there are limited comparative data on lead performance. We compared long-term performance of Abbott Tendril™ STS 2088TC (Tendril 2088) leads with competitive manufacturer (CM) pacing leads using novel real-world data analytic methods. Medicare fee-for-service (FFS) claims and Abbott device registration databases were linked to identify patients implanted with single-chamber or dual-chamber pacemakers with the Abbott Tendril 2088 lead from January 1, 2014 to December 31, 2019 and were followed through December 31, 2021. Medicare pacemaker patients who did not link to Abbott devices were assumed to have CM leads. Patients in both groups had to be enrolled in Medicare FFS at least 1 year before implant date and have an initial pacemaker and associated lead(s) implanted on the same date. Lead complications were identified based on a diagnosis code for a mechanical lead complication and a procedure code for a lead-related surgery on the same claim. Kaplan-Meier curves for lead intervention-free survival rates for up to 7 years of follow-up were compared between groups at the device level using a log-rank test. The study cohort had 89 629 Tendril 2088 and 433 481 CM lead patients. Groups were comparable in age (79.7 ± 8.6 years), sex (52.2% male), race/ethnicity, and baseline comorbidities. At 7 years, there was no significant difference in intervention-free survival rates between groups (97.48% Tendril 2088 vs. 97.52% CM, p = .3435). In this large Medicare population, there was no significant difference in lead complication rates between Tendril 2088 and CM pacing leads over 7 years of follow-up.