Opening book details…
Can I read Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story on EtoBox?
Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story by Andrew M. Goldsweig; Yihong Deng; Xiaoxi Yao; Nihar R. Desai; David J. Cohen; Herbert D. Aronow; Steven R. Messé; Joseph S. Ross; Alexandra J. Lansky; Samuel T. Savitz is a Medicine article available to read on EtoBox.
What is Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story about?
## 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 f
Who reads Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story?
It is typically read by researchers, students, and practitioners in Medicine.
- Author
- Andrew M. Goldsweig; Yihong Deng; Xiaoxi Yao; Nihar R. Desai; David J. Cohen; Herbert D. Aronow; Steven R. Messé; Joseph S. Ross; Alexandra J. Lansky; Samuel T. Savitz
- Publisher
- Ovid Technologies (Wolters Kluwer Health)
- Published
- 2024
- Language
- EN
- Field
- Medicine (Health Sciences)