background: The purpose of this study was to report an early experience with the use of the new CARDIA Ultrasept TM device for the percutaneous occlusion of patent foramen ovales. Methods: Patients of any age or weight with a patent foramen ovale and previous embolic events or migraines with poor clinical control were selected by transesophageal echocardiography. The efficacy criteria included a lack of residual shunt on the transesophageal echocardiogram with microbubble testing after six

more »

... s and no recurrence of neurologic events. No patients were excluded based on the morphological patent foramen ovale criteria. results: From April of 2011 to May of 2012, 22 patients (six males and 16 females) ranging in age from 16 to 68 years were submitted to the occlusion procedure. Only one patient had no history of stroke or transient ischaemic attack, instead having migraines with a poor clinical response. No patient had an atrial septal aneurysm. The device was implanted in all cases, for a total of 23 devices; the 25 mm device was most often used. Only one patient presented a residual shunt at the one-month follow-up echocardiogram and remains under observation. There have been no recurrences to date. There were two minor complications and no deaths. Conclusions: The CARDIA Ultrasept TM device is safe, effective and easy to use. It must be further evaluated in more complex cases, such as larger patent foramen ovales and in the presence of atrial septal aneurysms. DESCrIPTOrS: Foramen ovale, patent. Heart catheterisation. Prostheses and implants.