Percutaneous transcatheter closure of patent foramen ovale with the Amplatzer Cribriform septal occluder

Abstract

We tested the feasibility of percutaneous patent foramen ovale (PFO) closure utilizing the Amplatzer multifenestrated Cribriform atrial septal occluder device. This device recently became available and may offer unique advantages for closure of PFO. Nineteen consecutive patients who underwent closure of PFO with the Cribriform device for a variety of indications under intracardiac echocardiographic and fluoroscopic guidance were studied. The degree of shunting was quantified pre- and postprocedure by echocardiography using both Doppler and agitated saline administration. The results with this device were compared to the prior 19 patients who underwent closure with a CardioSeal device. The mean age of patients was 52 years and 47% were female. Indications for closure were paradoxical embolism in 17 patients, and hypoxemia due to right to left shunt in 2 patients. The postprocedure bubble contrast study showed a marked improvement in right to left shunting with 13 patients (68%) demonstrating no shunt flow, 4 (21%) having trace shunting, and 2 (11%) mild shunting. There were no device-related complications. The mean procedure time was 28 +/- 10 min. In comparison to the CardioSeal device, a trend was apparent in terms of a greater percentage of patients with immediate closure with the Cribriform device, although a similar percentage of defect closure was seen at 6 months with both devices. Procedure time was shorter with the Cribriform device, related in part to the reduced need for balloon sizing. This initial experience suggests a number of favorable characteristics of the Amplatzer Cribriform device for PFO closure.