Patent foramen ovale closure with the Intrasept occluder: Complete 6-56 months follow-up of 247 patients after presumed paradoxical embolism

Objective: We report our experience of transcatheter patent foramen ovale (PFO) closure with the new Intrasept occluder. Background: The Intrasept device is the fourth generation of the Cardia occluder family. Developed for transcatheter closure of PFO, the main difference between the Intrasept and prior generations of the Cardia occluder is its articulating center post. This modification allows better alignment of the umbrellas on both sides of the atrial septum. We report our experience with this new PFO occluder. Methods: From July 2002 until October 2006, PFO closure with the Intrasept occluder was attempted in 247 patients with presumed paradoxical embolism. Prior to PFO closure, a total of 269 cerebrovascular thromboembolic events (TEs) had occurred. Implantation of the device was guided by fluoroscopy and transesophageal echocardiography with conscious sedation. Results: Median age was 53 years (range, 21–77). One hundred twenty‐seven (51%) patients had an atrial septal aneurysm. The device was implanted successfully in all cases. Acute complications occurred in 4 (1.6%) patients (air embolism = 2, pericardial effusion = 1, supraventricular tachycardia = 1). Follow‐up information is available for all 247 (100%) patients. Median follow‐up time was 14 months (range 6–56). Residual shunt at 6 months follow‐up was 13%. After 1 year, the presence of residual shunt rate decreased to 10%. Following PFO closure, seven recurrent TEs (TIA = 4, CVA = 3) were observed in 6 patients. No wire fractures or device‐associated thrombi were seen. Conclusions: PFO closure with the Intrasept occluder is safe and efficient. Rates of residual shunt and recurrent TE compare favorably with other contemporary devices. © 2008 Wiley‐Liss, Inc.