Background: Several progressively refined percutaneous devices for patent foramen ovale (PFO) closure have been recently developed. We describe our single-center experience with the new Gore septal occluder (GSO).
Methods: Between January 2012 and May 2013, all consecutive patients with a PFO and previous cerebral thromboembolic events underwent percutaneous closure with the GSO system. Device implantation was performed under local anesthesia with combined fluoroscopic and intracardiac echographic monitoring. Follow-up schedule was: transthoracic echo at day 1 and day 30, as well as transcranial Doppler at 6 months and 12 months, all with clinical concomitant evaluation.
Results: Twenty-two patients (11 males and 11 females) with a mean age of 51.2 ± 13.9 years (range, 40-74 years) had PFO closure. At baseline, 4 and 18 subjects had medium-grade and large-grade right to left permanent shunt, respectively; isolated PFO was present in 13 patients and PFO with atrial septal aneurysm was present in 9 patients. Device placement was successful in all patients. Median procedural and fluoroscopic times were 40.5 minutes (range, 22-92 minutes) and 6.5 minutes (range, 3-16 minutes), respectively. Clinical and instrumental follow-up data were obtained at 12 months in 22 patients (100%). A low-grade (<5 microbubbles) permanent residual shunt was registered in 5 patients at 6 months and in 2 patients (during Valsalva only) at 12-month follow-up. Functional PFO occlusion was thus obtained in all patients.
Conclusion: This single-center initial experience suggests that the GSO is a safe and effective closure device, straightforward to implant with quick deployment and minimal imaging, and suitable for a range of atrial septal anatomies. Incidence and entity of residual shunts at follow-up were consistent with functional PFO occlusion in all patients.