Abstract
Post-market evaluation is important to ensure the ongoing safety and effectiveness of cardiovascular implantable electronic device (CIED) leads. The Twenty-First Century Cures Act and subsequent Food and Drug Administrative (FDA) Guidance provide an opportunity to leverage real-world data sources for this purpose. The past 4 years have seen the development of EP PASSION: a multi-stakeholder, collaborative effort between the FDA, CIED manufacturers, Heart Rhythm Society, and academics. Using real-world data, EP PASSION enables longitudinal evaluation of the long-term safety of CIED leads, addressing limitations of current approaches to generate evidence that informs regulatory, clinical, and manufacturer decision-making. This state of the art article describes the impetus for and launch of EP PASSION, the lessons learned, its current state, the current analytic approach, and the strengths and limitations of leveraging extant data sources for post-market lead evaluation. We also compare EP PASSION to traditional post-approval studies and describe possible future directions.
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SSD receives research funding from the Food and Drug Administration (FDA), the National Evaluation System for Health Technology Coordinating Center (NESTcc), the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) (K12HL138046), the National Institute for Healthcare Management, Arnold Ventures, and the Greenwall Foundation. YN is an employee and owns stock of Abbott. VS is an employee of Boston Scientific. SM is an employee of Biotronik. LZ was an employee of Medtronic. EPZ provides consulting services to Medtronic Inc and receives research funding from Boston Scientific and the National Cardiovascular Data Registry (NCDR).
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Dhruva, S.S., Zeitler, E.P., Caños, D. et al. Evaluation of cardiovascular implantable electronic device leads post implant: ElectroPhysiology Predictable And SuStainable Implementation Of National Registries (EP PASSION). J Interv Card Electrophysiol 66, 997–1004 (2023). https://doi.org/10.1007/s10840-022-01189-x
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DOI: https://doi.org/10.1007/s10840-022-01189-x