Abstract
SUMMARY Initial Experience with the CardiaIntrasept TM Device for PercutaneousOcclusion of Oval Patent Foramen Objective: The purpose of this study was to report theinitial experience with the Intrasept TM device (CARDIA,Inc., Burnsville, MN, USA) for percutaneous PFO closure. Methods: Patients with 1. previous cryptogenic thrombo-embolic event and/or 2. migraine with aura symptomsassociated 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 right-to-left shunt assessed by TEE and/or transcranial Doppler(TCD) 6 months after the procedure and no evidence ofrecurrent thromboembolic events during follow-up. Thedevice was considered safe in the absence of peri or postprocedural major complications. Since March 2006 untilJune 2007, 15 patients underwent percutaneous PFO closurewith the Intrasept TM 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.
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