PFO closure with the Premere PFO closure device: Acute results and follow-up of 263 patients

Aims: The aim was to assess the safety and efficacy of percutaneous patent foramen ovale (PFO) closure with the Premere (St. Jude Medical, Inc., St. Paul, MN, USA) device. Methods and results: This is a prospective clinical and echocardiographic follow-up of 264 patients who underwent transcatheter PFO closure with planned implantation of the Premere device. Implantation was successful in 263 patients (99.6%). Complete closure demonstrated echocardiographically occurred in 92.7%. The 30-day adverse event rate was 5.4% (atrial fibrillation in six, pericardial effusion in three, acute coronary syndrome in two, pseudoaneurysm/fistula formation at the access site in two patients and device dislocation in one patient). At a mean follow-up of 19.3 months (±14.2 months) stroke or transient ischaemic attack (TIA) occurred in nine (3.5%) and thrombus formation on the left atrial anchor in one (0.4%) patient. Conclusions: These data demonstrate that PFO closure with the Premere closure device is safe and effective. Complication rates and efficacy are similar to previously studied devices.