ArticleCirculation. Cardiovascular quality and outcomes2024
Approval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure Story.
Article in Circulation. Cardiovascular quality and outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 15 citations in OpenAlex.
- Patent Foramen Ovale: Epidemiology, Risk Factors, Pathophysiology, Clinical Features, Diagnosis, and Management.MedComm · 2026Review
- Closing the Gap: Why Percutaneous Patent Foramen Ovale and All Atrial Septal Defect Closures Belong in the NCDR IMPACT Registry.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Article
- Migraine and patent foramen ovale: correlation, coexistence, dependence. A narrative review.Headache · 2026Review
- Transcatheter atrial septal defects and patent foramen ovale closure: Medicare utilization and reimbursements.World journal of methodology · 2025Article
- Diagnostic value of transesophageal echocardiography on morphology and function of left atrial appendage in patients with unclosed foramen ovale complicated with atrial fibrillation.BMC cardiovascular disorders · 2025Article
- National Trends, In-Hospital Mortality, and Outcomes of Atrial Septal Defect/Patent Foramen Ovale Closure Procedure: An Analysis From the National Inpatient Sample.Structural heart : the journal of the Heart Team · 2024Article
- Low Burden of Atrial Fibrillation After PFO Closure: Is There a Need to Worry?Journal of the Society for Cardiovascular Angiography & Interventions · 2024Article
- The Incidence of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure Detected by Implantable Loop Recorders.Journal of the Society for Cardiovascular Angiography & Interventions · 2024Article
- Atrial Fibrillation After Patent Foramen Ovale Closure: Incidence, Pathophysiology, and Management.Journal of the American Heart Association · 2024Review
- Cryptogenic Stroke and Migraine: Using Probabilistic Independence and Machine Learning to Uncover Latent Sources of Disease from the Electronic Health Record.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2024Article
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Authors and funding
10 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundFollowing 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.
methodsWe 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.
resultsWe 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.
conclusionsFrom 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.