Ussia Gian Paolo, Cammalleri Valeria, Mulè Massimiliano, Scarabelli Marilena, Barbanti Marco, Scardaci Francesco, Mangiafico Sarah, Immè Sebastiano, Capodanno Davide, Tamburino Corrado
Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy.
Catheter Cardiovasc Interv. 2009 Oct 1;74(4):607-14. doi: 10.1002/ccd.22033.
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).
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.
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.
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.
经皮闭合卵圆孔未闭（PFO）通常使用非生物装置进行，其特点是存在持续的轻度炎症反应。我们报告了使用生物可吸收装置BioSTAR（美国NMT公司）闭合PFO的经验。
2007年9月至2008年9月，14例偏头痛患者（8例有先兆）和脑磁共振显示无症状性缺血阳性的患者，以及9例既往有心血管意外（CVA）的患者接受了使用BioSTAR闭合PFO的治疗。1例患者为镰状细胞贫血杂合子。8例患者对镍过敏。在术后24小时、1个月和6个月进行超声心动图检查。在6个月和12个月时分别安排了对比经颅多普勒（c-TCD）和经食管超声心动图（TOE）检查。
BioSTAR成功植入22例患者（96%）。平均手术时间和平均透视时间分别为22±6分钟和4±2分钟。平均住院时间为3±0.5天。平均随访7.8±3.5个月后，发生了1例与双重抗血小板聚集相关的出血性卒中。未记录到其他CVA或过敏反应。有2例房性心律失常。15例患者在c-TCD检查时无残余分流，而4例患者观察到有少量微气泡通过。9例未使用对比剂的患者进行的TOE检查显示装置位置良好，外形低，无血栓形成。
根据我们的经验，使用BioSTAR闭合PFO在预防复发性CVA方面是安全有效的。对于镍过敏和血液系统疾病患者，使用该装置可能具有优势。该装置的潜在益处需要在更大规模的患者队列中进行更长时间的随访来证实。
