OBJECTIVE: The purpose of this study was to report the initial experience with the IntraseptTM device (CARDIA, Inc., Burnsville, MN, USA) for percutaneous PFO closure. METHODS: Patients with 1. previous cryptogenic thromboembolic event and/or 2. migraine with aura symptoms associated with 3. transesophageal echocardiographic (TEE) evidence of a PFO with right-to-left shunt were included. The device's efficacy was defined as the absence of rightto-left shunt assessed by TEE and/or transcranial Doppler (TCD) 6 months after the procedure and no evidence of recurrent thromboembolic events during follow-up. The device was considered safe in the absence of peri or post procedural major complications. Since March 2006 until June 2007, 15 patients underwent percutaneous PFO closure with the IntraseptTM device (8 female; age 19 to 64 years, median of 33). Association with an atrial septal aneurysm (ASA) and prominent Eustachian valve was seen in 3 (20%) and 2 (13%) patients, respectively. RESULTS: Implantation of the occluder was technically successful in all patients. No major complications occurred. Eleven patients (73%) were submitted to TEE and/or TCD during late follow-up and no residual shunt was observed. During a mean total follow-up period of 9.2 ± 5.8 months, no recurrent thromboembolic event occurred and 2 of the 3 patients with migraine had improvement in the frequency and severity of migraine symptoms. CONCLUSION: In this initial experience, percutaneous occlusion of oval patent foramen with the IntraseptTM device was technically simple, safe and effective, constituting a new alternative for the interventionist.
Heart septal defects, atrial; Heart catheterization; Prostheses and implants
