Centro Cardiologico "Monzino", IRCCS, Department of Cardiovascular Sciences, University of Milan, Italy.
Centro Cardiologico "Monzino", IRCCS, Department of Cardiovascular Sciences, University of Milan, Italy.
Int J Cardiol. 2023 Sep 15;387:131116. doi: 10.1016/j.ijcard.2023.06.007. Epub 2023 Jun 8.
Percutaneous closure represents the first line of treatment in patients with cryptogenic stroke and documented patent foramen ovale (PFO). Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech, Germany).
Consecutive patients undergoing PFO closure with a Figulla Flex II device at a single, high-volume Institution were included. Baseline clinical and procedural features were collected and patients were followed up for up to 10 years. The device's long-term safety was assessed, as well as mortality, recurrent cerebrovascular events, new-onset atrial fibrillation (AF) and residual shunt.
Overall, 442 patients were included. The main indication for PFO closure was cryptogenic stroke/transitory ischemic attack (65.5%), followed by migraine (21.7%), silent lesions at MRI (10.8%), and decompression disease (2.0%). Atrial septal aneurysm was present in 20.8% of cases, Eustachian valve in 9.0%, Chiari network in 19.9%. The most frequently implanted device was the 23/25 mm (49.5% of cases). One procedural failure due to device embolization; in-hospital complications occurred in 15 cases (3.4%; 4 minor access site complications, 11 transient supraventricular tachycardias (SVT)/AF). After a follow-up of 9.2 years, 2 patients suffered recurrent TIA (with no residual R-L shunt detected). A moderate or severe residual shunt was observed in 3 patients after discharge.
Figulla Flex II devices for PFO closure are associated with high procedural success and low incidence of adverse events even at long-term follow-up.
经皮封堵术是隐源性卒中且有明确卵圆孔未闭（PFO）患者的一线治疗方法。应用 Figulla Flex II 封堵器治疗 PFO 的患者长期预后的数据较少。
连续纳入在一家高容量单中心接受 Figulla Flex II 封堵器治疗的 PFO 患者。收集基线临床和程序特征，并对患者进行长达 10 年的随访。评估该装置的长期安全性，以及死亡率、复发性脑血管事件、新发心房颤动（AF）和残余分流。
共纳入 442 例患者。PFO 封堵的主要适应证为隐源性卒中和短暂性脑缺血发作（65.5%），其次为偏头痛（21.7%）、MRI 上无症状性病变（10.8%）和减压病（2.0%）。20.8%的患者存在房间隔瘤，9.0%的患者存在欧氏瓣，19.9%的患者存在 Chiari 网。最常植入的装置是 23/25mm（49.5%的病例）。1 例因器械栓塞导致手术失败；住院期间发生并发症 15 例（3.4%；4 例轻微的入路部位并发症，11 例短暂性室上性心动过速/AF）。随访 9.2 年后，2 例患者发生复发性 TIA（未检测到残余右向左分流）。3 例患者出院后发现中度或重度残余分流。
Figulla Flex II 封堵器治疗 PFO 的成功率高，不良事件发生率低，即使在长期随访中也是如此。
