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 (R) (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 (R). 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 (R) 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 micro-bubbles 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 (R) 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. (C) 2009 Wiley-Liss, Inc.

Ussia, G.p., Cammalleri, V., Mule, M., Scarabelli, M., Barbanti, M., Scardaci, F., et al. (2009). Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device: single-centre experience. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 74(4), 607-614 [10.1002/ccd.22033].

Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device: single-centre experience

Ussia G. P.;Cammalleri V.;
2009-01-01

Abstract

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 (R) (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 (R). 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 (R) 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 micro-bubbles 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 (R) 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. (C) 2009 Wiley-Liss, Inc.
2009
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE
English
patent foramen ovale (PFO); bioabsorbable device; stroke; Adult; Arrhythmias, Cardiac; Cardiac Catheterization; Echocardiography, Doppler, Color; Echocardiography, Transesophageal; Female; Foramen Ovale, Patent; Humans; Ischemic Attack, Transient; Length of Stay; Male; Middle Aged; Migraine Disorders; Prosthesis Design; Secondary Prevention; Stroke; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Transcranial; Absorbable Implants; Septal Occluder Device
Ussia, G.p., Cammalleri, V., Mule, M., Scarabelli, M., Barbanti, M., Scardaci, F., et al. (2009). Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device: single-centre experience. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 74(4), 607-614 [10.1002/ccd.22033].
Ussia, Gp; Cammalleri, V; Mule, M; Scarabelli, M; Barbanti, M; Scardaci, F; Mangiafico, S; Imme, S; Capodanno, D; Tamburino, C
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/228557
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