Initial use of the new GORE(®) septal occluder in patent foramen ovale closure: implantation and preliminary results.

BACKGROUND: A number of devices are available for percutaneous closure of a clinically significant patent foramen ovale (PFO). The new GORE(®) septal occluder (GSO) is a nonself-centering device consisting of an expanded polytetrafluoroethylene tube supported by a frame of nitinol wire conforming into a double disk. This study reports the first clinical GSO implantation experience. METHODS: GSO implantation in 20 consecutive patients is reported. Inclusion criteria were all patients referred with a significant PFO implicated in paradoxical embolism or transient right to left shunting causing desaturation. Procedures were performed under local anaesthesia and intracardiac echocardiography (ICE) in addition to fluoroscopy. Procedural data, acute and early closure rates were examined. RESULTS: All patients underwent successful day-case device implantation. Eleven patients had previous stroke, five had transient ischemic attacks, two had a history suspicious of PFO-related desaturation, and two had a history suspicious of PFO-related peripheral thromboembolism. Acute closure rates on IVC injection bubble testing were 100% at implant and 100% (14/14) at 1 month. Average PFO balloon size was 8.0 ± 3.6(range 2.0-16.7) mm, mean fluoroscopic implantation time 3.0 ± 1.7(range 0.7-6.3) min, radiation dose 283 ± 340 (range 6-1,431) µGym(2), and total procedural time 34.8 ± 8.0 (range 22-53) min. 5 × 20 mm(2), 7 × 25 m(2), 8 × 30 mm(2) GSO devices were implanted, aiming for device size at least twice balloon PFO size. Cases included aneurysmal septums with up to 30 mm deviation and tunnels up to 12 mm long. Removal and repositioning of two devices was performed on two occasions after uncertainty about device locking. At 1 month follow-up, two patients had brief self-terminating episodes of suspected atrial fibrillation, all had normal resting ECGs. No thromboembolic/neurological events were reported. CONCLUSIONS: The GSO can be implanted under local anaesthesia and ICE with low procedural and fluoroscopy times with high procedural success as a day case. No residual shunts were seen. This initial experience suggests that it is a safe and effective device for PFO closure.