Safety and Efficacy of Pfo Closure Devices Implantation and Clinical Outcomes: A Single–center Long–term Review

Abstract Introduction Patent foramen ovale (PFO) is present in up to 25% of the general population, and it is a relevant cause of cryptogenic stroke. The current standard of care for selected patients with PFO and cryptogenic stroke is transcatheter closure, but the risk of post–closure–new–onset atrial fibrillation (AF) has been described. Published trials report a 3.6%–5.8% prevalence of recurrent ischemic stroke and 2%–6.6% incidence of postimplant AF, and some authors assume that to protect from one embolic stroke aetiology, there is the risk of creating another one. We aimed to investigate the efficacy and safety of device implantation in a single–center study, but as well as the long–term clinical outcomes up to over 16 years of follow–up. Methods This is a prospective, non–randomised study in Vicenza, from February 2007 to July 2021, enrolling 200 consecutive patients addressed to PFO closure, with implantation of various devices. A research was performed via telephone interviews and clinical follow–up reports on outcomes of percutaneous PFO closure. The main endpoint was recurrence of stroke/transient ischemic attack (TIA). Other outcomes included new–onset AF, major bleeding, serious adverse events, and device–related complications. All–cause mortality was examined too. Results Two–hundred patients were enrolled over 14 years; 106 (53%) were men. Mean age was 49±10 years, ROPE score was 5.9±1.5. All patients had a device implanted and technical success was 99.5% (number of devices per case 1.0±0.07). Post–procedural trivial residual shunt was observed in 2 patients. Procedural success, defined as no serious adverse device–related event or large shunt, was 198/200, resulting in 99% success rate. The incidence of recurrent stroke/TIA and AF was the same (2.5%), so the rate of both recurrences was 2.7 events per 1000 patient–years. Adverse events occurred in 8 patients: 1 access site hematoma, 1 supraventricular tachycardia, 4 deep vein thromboses and 2 pulmonary embolisms. Four patients died from malignancies, 1 from sudden death and 1 from stroke. Conclusions Our review represents one of the largest cohort of PFO patients treated with devices, and shows that their use is associated with high procedural success and low adverse events on a long–term follow–up (mean follow–up of 9.4 years). The efficacy and safety results are lower than those reported by randomized studies, probably due to good patient selection and effective cardio–neurological teamwork.