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

Abstract

Objectives: We tested the feasibility of percutaneous patent foramen ovale (PFO) closure utilizing the Amplatzer multifenestrated Cribriform atrial septal occluder device.

Background: This device recently became available and may offer unique advantages for closure of PFO.

Methods: 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.

Results: 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.

Conclusions: This initial experience suggests a number of favorable characteristics of the Amplatzer Cribriform device for PFO closure.