2024
Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story
Goldsweig A, Deng Y, Yao X, Desai N, Cohen D, Aronow H, Messé S, Ross J, Lansky A, Savitz S. Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story. Circulation Cardiovascular Quality And Outcomes 2024, 17: e010200. PMID: 38189127, PMCID: PMC10844981, DOI: 10.1161/circoutcomes.123.010200.Peer-Reviewed Original ResearchStroke/systemic embolismTransient ischemia attackPFO closureSystemic embolismIschemia attackRetrospective cohort studyTransient ischemic attackHalf of patientsOptumLabs Data WarehouseCommercial insurance enrolleesRegulatory approvalClinical trial publicationsIschemic attackRecurrent strokeCohort studyPatent foramenUnderwent closureAtrial fibrillationClinical trialsInsurance enrolleesDecompression illnessTrial publicationsOff labelPatientsProcedure volume
2013
Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis
Wolfrum M, Froehlich GM, Knapp G, Casaubon LK, DiNicolantonio JJ, Lansky AJ, Meier P. Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis. Heart 2013, 100: 389. PMID: 23793373, DOI: 10.1136/heartjnl-2013-304394.Peer-Reviewed Original ResearchConceptsBest medical therapyPatent foramen ovalPercutaneous PFO closurePFO closureCryptogenic strokePercutaneous closureMedical therapyAtrial fibrillationRelative riskSystematic reviewNew-onset atrial fibrillationOnset atrial fibrillationPooled relative riskRisk of bleedingPatent foramen ovaleMain end pointSignificant risk reductionRandom-effects modelStroke preventionMultivariate adjustmentSecondary preventionForamen ovaleClosure groupClinical trialsSignificant treatment effect