Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device: single-centre experience.
BACKGROUND
Percutaneous closure of patent foramen ovale (PFO) is routinely performed with nonbiological devices, characterized by a persistent low-grade inflammatory response. We report our experience about PFO closure with a bioabsorbable device, BioSTAR (NMT Inc, USA).


METHODS
From September 2007 to September 2008, 14 patients with migraine (eight with aura) and cerebral magnetic resonance positive for silent ischemia and nine patients with prior cardiovascular accident (CVA) underwent closure of PFO using BioSTAR. One patient had heterozygosis for sickle-cell-anaemia. Nickel allergy was present in eight patients. Echocardiogram was performed at 24 hr, one and 6 months. At 6 and 12 months a contrast-transcranial-doppler (c-TCD) and a trans-oesophageal echocardiogram (TOE) were scheduled, respectively.


RESULTS
BioSTAR was successfully implanted in 22 patients (96%). The mean procedural time and the mean fluoroscopy time were 22 +/- 6 and 4 +/- 2 minutes, respectively. The mean in-hospital stay was 3 +/- 0.5 days. After a mean follow-up of 7.8 +/- 3.5 months there was an hemorrhagic stroke related to double antiaggregation. No other CVA or allergic reactions were registered. There were two cases of atrial arrhythmia. Fifteen patients had not residual shunts at c-TCD, while in four patients we observed a trivial microbubbles passage. The TOE, achieved in nine patients without contrast, showed the device well positioned, with a low profile and without thrombus.


CONCLUSIONS
In our experience PFO closure with BioSTAR is safe and efficacious in preventing recurrent CVA. Its use could be advantageous in patients with nickel allergy and haematological disorders. The potential benefits of this device need to be certified in a larger cohort of patients with a longer follow-up.
Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy. gpussia@hotmail.com
Gian Paolo
GP
Ussia
Valeria
V
Cammalleri
Massimiliano
M
Mulè
Marilena
M
Scarabelli
Marco
M
Barbanti
Francesco
F
Scardaci
Sarah
S
Mangiafico
Sebastiano
S
Immè
Davide
D
Capodanno
Corrado
C
Tamburino
D020341:Absorbable Implants; D000328:Adult; D001145:Arrhythmias, Cardiac / Q000209:etiology; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D011474:Prosthesis Design; D055502:Secondary Prevention; D055989:Septal Occluder Device; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D017585:Ultrasonography, Doppler, Transcranial