Department of Congenital Heart Disease - Pediatric Cardiology, Deutsches Herzzentrum der Charité, Berlin, Germany.
Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Catheter Cardiovasc Interv. 2023 Aug;102(2):359-363. doi: 10.1002/ccd.30747. Epub 2023 Jun 14.
Device thromboses after patent foramen ovale (PFO) and atrial septal defect (ASD) closure are rare but serious complications. They have been reported in different devices of virtually all manufacturers. Here, we report three cases of left atrial device thrombosis after atrial defect closure with the Gore® Cardioform septal occluder (GSO) in our recent institutional experience. All patients were symptomatic with new-onset neurological impairments and evidence of cerebral thromboembolism. Device thromboses have occurred despite antiplatelet therapy in two patients and moreover were observed late, at approximately 2 years after implantation, in two patients. One device was surgically explanted while in two cases, thrombi completely resolved with initiated anticoagulation. All patients had a favorable neurological recovery. Our observations suggest that regular follow-up echocardiography beyond 6 months after device implantation might be advisable in patients with GSO devices to rule out late device thromboses. More long-term follow-up data considering safety and late complications of contemporary PFO and ASD devices is required to establish confident evidence-based recommendations on long-term follow-up management and antithrombotic therapy regimen after PFO and ASD closure.
卵圆孔未闭（PFO）和房间隔缺损（ASD）封堵术后器械血栓形成较为罕见，但较为严重。几乎所有制造商的不同器械都有过相关报道。在此，我们报告了在最近的机构经验中，使用戈尔®Cardioform 房间隔封堵器（GSO）治疗房间隔缺损后出现左心房器械血栓形成的 3 例病例。所有患者均出现新的神经系统损伤症状和脑血栓栓塞的证据。尽管两名患者进行了抗血小板治疗，但仍发生了器械血栓形成，且在两名患者中，该血栓形成发生较晚，约在植入后 2 年。一个器械被手术取出，而在另外两例中，启动抗凝治疗后血栓完全溶解。所有患者的神经功能恢复良好。我们的观察结果表明，对于植入 GSO 器械的患者，在器械植入后 6 个月以上，可能需要定期进行超声心动图随访，以排除晚期器械血栓形成。需要更多的长期随访数据来考虑当代 PFO 和 ASD 器械的安全性和晚期并发症，以便为 PFO 和 ASD 封堵术后的长期随访管理和抗血栓治疗方案提供基于证据的明确建议。
