Araszkiewicz Aleksander, Sławek Sylwia, Trojnarska Olga, Lesiak Maciej, Grygier Marek
Department of Cardiology, Poznan University of Medical Sciences, Poland.
Catheter Cardiovasc Interv. 2018 Jul;92(1):159-164. doi: 10.1002/ccd.27386. Epub 2017 Oct 25.
Patent foramen ovale (PFO) was found to be associated with the increased risk of recurrent strokes or transient ischemic attacks (TIA) and there is a need of secondary prevention. Numerous devices have been developed and used for treatment.
The aim of the study was to evaluate the safety and effectiveness of a new PFO occluder Nit-Occlud PFO Occlusion Device (PFM medical, Germany).
Between January 2012 and August 2016, 151 patients (mean age 41 ± 11 years) who had suffered from a cryptogenic thromboembolic event underwent transcatheter PFO closure with the PFM Nit-Occlud PFO device. The procedure was successful in 150 patients (99.3%). Mean clinical follow-up time was 24.4 ± 16.1 months. Echocardiographic follow-up was done at 6 weeks and 6 months post intervention by transesophageal contrast echocardiography in 90 (60%) of patients. Clinical end-point was death, non-fatal stroke, or TIA.
No major periprocedural or in-hospital complications occurred. Stroke or TIA reoccurred generally in 5 (3.3%) patients (2 strokes and 3 TIA's). In one patient (0.7%) device, thrombosis was observed. Closure was sufficient with only minimal right-to-left residual shunt in seventeen cases of 90 examined patients (19%) after 6 weeks and in one patient (1.1%) 6 months post implantation.
The Nit-Occlud PFO device and its delivery system are safe and provides sufficient closure of PFO in patients who suffered from cryptogenic stroke, TIA or paradoxical peripheral embolism. It is associated with high procedural success and favorable rates of complete closure.
发现卵圆孔未闭（PFO）与复发性中风或短暂性脑缺血发作（TIA）风险增加相关，需要进行二级预防。已经研发并使用了多种装置用于治疗。
本研究旨在评估一种新型PFO封堵器Nit-Occlud PFO封堵装置（德国PFM医疗公司）的安全性和有效性。
2012年1月至2016年8月期间，151例（平均年龄41±11岁）发生隐源性血栓栓塞事件的患者接受了使用PFM Nit-Occlud PFO装置的经导管PFO封堵术。150例患者（99.3%）手术成功。平均临床随访时间为24.4±16.1个月。90例（60%）患者在干预后6周和6个月通过经食管对比超声心动图进行了超声心动图随访。临床终点为死亡、非致命性中风或TIA。
围手术期或住院期间未发生重大并发症。5例（3.3%）患者（2例中风和3例TIA）再次发生中风或TIA。1例患者（0.7%）观察到装置血栓形成。90例接受检查的患者中，17例（19%）在6周后仅有极小的右向左残余分流，1例患者（1.1%）在植入后6个月封堵充分。
Nit-Occlud PFO装置及其输送系统是安全的，可为发生隐源性中风、TIA或矛盾性外周栓塞的患者提供充分的PFO封堵。它具有较高的手术成功率和完全封堵的良好比率。
