Early Experience with the New CARDIA Ultrasept™ Device for Patent Foramen Ovale Occlusion: Still a Good Option

ABSTRACTBackgroundThe purpose of this study is to report the early experience with the use of the new CARDIA Ultrasept™ device for percutaneous occlusion of patent foramen ovale.MethodsPatients with patent foramen ovale with previous embolic events, of any age or weight, or migraine with poor clinical control, were selected by transesophageal echocardiography. Efficacy criteria included lack of residual shunt at the transesophageal echocardiogram with microbubble testing after 6 months and no recurrence of neurologic events. No patients were excluded based on morphological patent foramen ovale criteria.ResultsFrom April 2011 to May 2012, 22 patients (6 males and 16 females) with ages ranging from 16 to 68 years were submitted to the occlusion procedure. Only one patient had no history of stroke or transient ischemic attack, but migraine with poor clinical response. None of the patients had atrial septal aneurysms. The device was implanted in all cases, 23 devices were used and the 25mm device was used most often. Only one patient presented residual shunt at the 1-month follow-up echocardiogram and remains under observation. There have been no recurrences to date. There were two minor complications and no deathsConclusionsThe CARDIA Ultrasept™ device is safe, effective and easy to use. It must be further evaluated in more complex cases, such as larger patent foramen ovales and with atrial septal aneurysms