Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081 Ulm, Germany.
Clin Res Cardiol. 2012 Oct;101(10):787-93. doi: 10.1007/s00392-012-0458-9. Epub 2012 Apr 10.
The Premere™ PFO closure device has a special design for closure of patent foramen ovale (PFO) including a flexible distance and angulation between the right and left disc providing minimal septal distortion. The primary objective of the study was to determine the degree of risk for stroke or transient ischemic attack (TIA) in patients after Premere™ PFO closure device implantation.
In this multicenter, prospective observational registry, patients with a clinical indication for PFO closure were included. Patients had a history of stroke or TIA with right to left shunt. Follow-up visits were scheduled according to routine clinical practice.
In 23 centers from 10 countries, 267 patients with successful device implantation were included. Assessment of right to left shunt after device implantation revealed no residual shunt in 71 %, small shunts in 16.8 %, and moderate or large residual shunts in 5.6 and 6.5 %. With common clinical practice, use of Coumadin or heparin decreased from 27 % pre- to 3 % post-implantation, while use of acetylsalicylic acid or thienopyridines increased from 64 to 95 % and 27 to 80 %, respectively; 18 % of patients were discharged with anti-platelet monotherapy. Mean follow-up was 11 ± 9 months (range 1-24 months). There was no stroke or TIA. During follow-up, there was one sudden death. Atrial fibrillation occurred in five (1.9 %) patients. One (0.4 %) patient with a thrombophilic diathesis developed a thrombus.
In this prospective, international, multicenter PRECISE registry, the use of the Premere™ PFO closure device for closure of PFO after stroke or TIA resulted in good clinical results with no recurrent event.
Premere™ PFO 封堵器具有特殊设计，可用于封堵卵圆孔未闭（PFO），其左右盘之间具有灵活的距离和角度，可将对隔瓣的最小扭曲。该研究的主要目的是确定 Premere™ PFO 封堵器植入后患者发生中风或短暂性脑缺血发作（TIA）的风险程度。
在这项多中心、前瞻性观察性注册研究中，纳入了有 PFO 封堵适应证的患者。这些患者具有中风或 TIA 病史，且存在右向左分流。根据常规临床实践安排随访。
在来自 10 个国家的 23 个中心，纳入了 267 例成功植入封堵器的患者。封堵器植入后评估右向左分流显示，无残余分流者占 71%，小分流者占 16.8%，中度或大量残余分流者分别占 5.6%和 6.5%。采用普通临床实践，华法林或肝素的使用率从植入前的 27%降至植入后的 3%，而阿司匹林或噻吩吡啶类药物的使用率则分别从 64%增至 95%和从 27%增至 80%；18%的患者出院时接受抗血小板单药治疗。平均随访时间为 11±9 个月（1~24 个月）。无中风或 TIA 再发。随访期间发生 1 例猝死。5 例（1.9%）患者发生心房颤动。1 例（0.4%）存在血栓形成倾向的患者发生血栓形成。
在这项前瞻性、国际性、多中心 PRECISE 注册研究中，Premere™ PFO 封堵器用于封堵中风或 TIA 后 PFO，结果临床效果良好，无再发事件。
