AIMS: To compare in a observational study acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices.
METHODS AND RESULTS: Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure either with the Amplatzer (n=179) or the Figulla (n=227) device after a stroke or a transient ischemic attack ascribed to the PFO. A right-to- left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed-up with contrast transthoracic echocardiogram and clinically at 24-hour, six-month, and twelve-months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to- left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02).
CONCLUSIONS: According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the Amplatzer device.
- Journal Article