title: Implantable devices for the closure of patent foramen ovale in adults: an Italian rapid health technology assessment.
abstract: Percutaneous closure of patent foramen ovale (PFO) is offered to patients suffering from cryptogenic stroke, transient ischemic attack or persistent migraine. Several PFO closure devices are CE marked but none have yet been approved by the FDA. On the Italian market 11 different PFO closure devices are available and more than 2500 PFO procedures were reported in 2012. We report findings of a systematic review and meta-analysis of studies in which patients with PFO and transient ischemic attacks, cryptogenic stroke or persistent migraine who underwent PFO closure were compared to patients treated by usual care. We included five controlled clinical trials and one randomized controlled trial. Included studies had poor methodological quality and heterogeneity. In the included randomized controlled trial, 4.7% of procedure-related serious adverse events were observed. Large multicenter, sufficiently powered, and properly randomized trials need to be conducted in Europe with particular attention to patient selection.
authors: Agenas, Agenzia nazionale per i servizi sanitari regionali, Sez. ISS - Innovazione, Sperimentazione e Sviluppo, via Puglie, 23 - 00187 Rome, Italy.
authors: Antonio
authors: A
authors: Migliore
authors: Tom
authors: T
authors: Jefferson
authors: Marina
authors: M
authors: Cerbo
authors: Iosief
authors: I
authors: Abraha
authors: Alessandro
authors: A
authors: Montedori
mesh_terms: D000328:Adult; D020811:Biomedical Technology; D002986:Clinical Trials as Topic; D054092:Foramen Ovale, Patent / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000453:epidemiology; D019736:Prostheses and Implants; D020521:Stroke / Q000453:epidemiology / Q000401:mortality / Q000628:therapy; D013673:Technology Assessment, Biomedical