Background: The Premere™ PFO closure device has a special design for closure of patent foramen ovale (PFO) including a flexible distance and angulation between the right and left disc providing minimal septal distortion. The primary objective of the study was to determine the degree of risk for stroke or transient ischemic attack (TIA) in patients after Premere™ PFO closure device implantation.
Methods: In this multicenter, prospective observational registry, patients with a clinical indication for PFO closure were included. Patients had a history of stroke or TIA with right to left shunt. Follow-up visits were scheduled according to routine clinical practice.
Results: In 23 centers from 10 countries, 267 patients with successful device implantation were included. Assessment of right to left shunt after device implantation revealed no residual shunt in 71 %, small shunts in 16.8 %, and moderate or large residual shunts in 5.6 and 6.5 %. With common clinical practice, use of Coumadin or heparin decreased from 27 % pre- to 3 % post-implantation, while use of acetylsalicylic acid or thienopyridines increased from 64 to 95 % and 27 to 80 %, respectively; 18 % of patients were discharged with anti-platelet monotherapy. Mean follow-up was 11 ± 9 months (range 1-24 months). There was no stroke or TIA. During follow-up, there was one sudden death. Atrial fibrillation occurred in five (1.9 %) patients. One (0.4 %) patient with a thrombophilic diathesis developed a thrombus.
Conclusions: In this prospective, international, multicenter PRECISE registry, the use of the Premere™ PFO closure device for closure of PFO after stroke or TIA resulted in good clinical results with no recurrent event.