Findings Published on Initial Use of Gore Septal Occluder for PFO Closure

September 19, 2012—Preliminary results from the initial use of the Gore septal occluder (Gore & Associates, Flagstaff, AZ) for patent foramen ovale (PFO) closure are available online ahead of print in Catheterization and Cardiovascular Interventions.

Simon T. MacDonald, BMBCH, DPhil, et al concluded that this initial experience suggests that the Gore septal occluder is a safe and effective device for PFO closure. They found that the device can be implanted under local anesthesia and intracardiac echocardiography (ICE) with low procedural and fluoroscopy times and a high procedural success rate as a day case.

According to the investigators, this study reports the first clinical implantation experience with the new Gore septal occluder, which is a nonself-centering device consisting of an expanded polytetrafluoroethylene tube supported by a frame of nitinol wire conforming into a double disk.

As detailed in Catheterization and Cardiovascular Interventions, the investigation was composed of 20 consecutive patients. 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 anesthesia and intracardiac ICE in addition to fluoroscopy. The investigators examined procedural data, as well as acute and early closure rates.

According to the investigators, 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 implantation and 100% (14/14) at 1 month. The average PFO balloon size was 8.0 ± 3.6 mm (range, 2.0–16.7), mean fluoroscopic implantation time was 3.0 ± 1.7 min (range, 0.7–6.3), radiation dose was 283 ± 340 μGym² (range, 6–1,431), and total procedural time was 34.8 ± 8.0 min (range, 22–53).

The investigators aimed to use device sizes of at least twice the balloon PFO size; they implanted five devices of 20 mm², seven of 25 mm², and eight of 30 mm². Cases included aneurysmal septums with up to 30-mm deviation and tunnels up to 12-mm length. 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/neurologic events were reported and no residual shunts were seen, stated the investigators in Catheterization and Cardiovascular Interventions.