Approval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure Story
Author Department
Cardiology; Medicine
Document Type
Article, Peer-reviewed
Publication Date
1-2024
Abstract
Background: Following regulatory approval, medical devices may be used "off-label." Patent foramen ovale (PFO) closure is indicated to reduce recurrent stroke but has been proposed for other indications, including migraine, transient ischemic attack, and diving decompression illness. We sought to evaluate PFO closure rates and indications relative to the timing of regulatory approval and publication of key randomized trials.
Methods: We performed a retrospective cohort study using the OptumLabs Data Warehouse of US commercial insurance enrollees from 2006 to 2019. We quantified PFO closure among individuals with ≥2 years of preprocedure coverage to establish indications, classified hierarchically as stroke/systemic embolism, migraine, transient ischemia attack, or other.
Results: We identified 5315 patients undergoing PFO closure (51.8% female, 29.2%≥60 years old), which increased from 4.75 per 100 000 person-years in 2006 to 6.60 per 100 000 person-years in 2019. Patients aged ≥60 years accounted for 29.2% of closures. Procedure volumes corresponded weakly with supportive clinical publications and device approval. Among patients with PFO closure, 58.6% underwent closure for stroke/systemic embolism, 10.2% for transient ischemia attack, 8.8% for migraine, and 22.4% for other indications; 17.6% of patients had atrial fibrillation at baseline; and 11.9% developed atrial fibrillation postprocedure. Those aged ≥60 years and male were less likely to undergo closure for migraine than stroke/systemic embolism.
Conclusions: From 2006 to 2019, PFO closure use was consistently low and corresponded weakly with clinical trial publications and regulatory status. Nearly half of patients underwent PFO closure for indications unapproved by the Food and Drug Administration. Regulators and payers should coordinate mechanisms to promote utilization for approved indications to ensure patient safety and should facilitate clinical trials for other possible indications.
Keywords: adult; cardiology; device approval; health services; patent foramen ovale.
Recommended Citation
Goldsweig AM, Deng Y, Yao X, Desai NR, Cohen DJ, Aronow HD, Messé SR, Ross JS, Lansky AJ, Savitz ST. Approval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure Story. Circ Cardiovasc Qual Outcomes. 2024 Jan 8:e010200. doi: 10.1161/CIRCOUTCOMES.123.010200. Epub ahead of print.
PMID
38189127