Transcatheter patent foramen ovale closure using the premere PFO occlusion system.

OBJECTIVES: To evaluate the safety and efficacy profile of the new Premere patent foramen ovale (PFO) occlusion system. BACKGROUND: Several different devices have been used so far for transcatheter PFO closure but no data has been published so far on the efficacy and safety of the Premere PFO occlusion system. METHODS: Since September 2005, 15 patients (seven males, eight females; mean age 51.2 +/- 10.8 years) at our institution underwent transcatheter PFO closure because of cryptogenic stroke, using the Premere PFO occlusion system. The procedure was performed under fluoroscopic and transesophageal echocardiographic (TEE) guidance in all patients. Seven patients (47%) had an associated atrial septal aneurysm and two patients had had >1 stroke. Five patients (33%) had an associated thrombophilia, whereas three patients (20%) had a diagnosis of migraine headache with aura, by the referring neurologist. Residual shunt was assessed immediately after and 1 month (only in 11 patients) after the procedure by both transcranial Doppler and TEE. RESULTS: Premere PFO devices could be implanted in all patients (20 mm size in seven patients, 25 mm size in eight). Fluoroscopy time was 7.3 +/- 1.9 and procedural time was 11 +/- 3 min (range 7-17 min), reflecting our initial learning curve with this device. No complication occurred during the procedure or at follow-up. A residual shunt was noted immediately after the procedure in eight patients (53%) and at 1 month in 4/11 patients (36%). Residual shunt was mild in all patients. After a median follow-up of 4.2 months (0.2-5.8 months), no patient had a recurrent stroke. All patients with migraine headache with aura had resolution of symptoms. CONCLUSIONS: Our preliminary experience with the Premere PFO occlusion system shows that this device is safe and effective.