Clinical Performance of the New Gore Septal Occluder in Patent Foramen Ovale Closure: A Single-Center Experience.
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.


CONCLUSIONS
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.
1SC Cardiologia, AO Ospedale Treviglio, Treviglio (BG), Italy. Via Sismondi 48 20133 Milano, Italy. psganzerla@alice.it.
Paolo
P
Sganzerla
Mauro
M
Rondi
Andrea
A
Pavone
Eleonora
E
Aiolfi
Adele
A
Facchinetti
Alfonso
A
Funaro
Paola
P
Negrini
D000328:Adult; D000368:Aged; D054087:Atrial Septum / Q000000981:diagnostic imaging / Q000601:surgery; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D015150:Echocardiography, Doppler / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery; D006801:Humans; D020766:Intracranial Embolism / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D007558:Italy; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011474:Prosthesis Design; D055989:Septal Occluder Device; D063189:Symptom Assessment / Q000379:methods; D016896:Treatment Outcome