PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE WITH A BIOABSORBABLE OCCLUDER DEVICE: SINGLE CENTRE EXPERIENCE

Background: Percutaneous closure of patent foramen ovale (PFO) is routinely per- formed with nonbiological devices, characterized by a persistent low-grade inflamma- tory response. We report our experience about PFO closure with a bioabsorbable de- vice, BioSTARVR (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 BioSTARVR . 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: Bio- STARVR was successfully implanted in 22 patients (96%). The mean procedural time and the mean fluoroscopy time were 22 6 6 and 4 6 2 minutes, respectively. The mean in- hospital stay was 3 6 0.5 days. After a mean follow-up of 7.8 6 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 micro- bubbles passage. The TOE, achieved in nine patients without contrast, showed the de- vice well positioned, with a low profile and without thrombus. Conclusions: In our ex- perience PFO closure with BioSTARVR 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