Braun Martin U, Fassbender Dieter, Schoen Steffen P, Haass Markus, Schraeder Rainer, Scholtz Werner, Strasser Ruth H
Department of Cardiology, University of Dresden, Dresden, Germany.
J Am Coll Cardiol. 2002 Jun 19;39(12):2019-25. doi: 10.1016/s0735-1097(02)01904-6.
The present study was conducted to determine the safety of the transcatheter closure of a patent foramen ovale (PFO) in patients with cryptogenic cerebral ischemia and the midterm follow-up of recurrent thromboembolic events after interventional PFO closure.
Current therapeutic options for stroke prevention in patients with PFO and a history of thromboembolic events include chronic antithrombotics and more invasive treatments such as surgical closure or minor invasive transcatheter permanent closure of the PFO. Promising preliminary and pilot data with the Amplatzer Septal Occluder or the PFO-Star Occluder have been reported. Systematic and long-term data are still missing.
A total of 276 consecutive patients with a PFO and a history of at least one thromboembolic event were recruited in four medical centers and underwent percutaneous PFO closure with the PFO-Star device. Follow-up data were analyzed over an average of 15.1 months, equivalent to 345 patient-years.
The implantation was successful in all 276 patients. Peri-interventional reversible complications included transient ST-segment elevations (1.8%) and transient ischemic attack (TIA) (0.8%). Two devices have been removed surgically. During follow-up the annual recurrence rate of thromboembolic events was 1.7% for TIA, 0% for stroke and 0% for peripheral emboli.
Interventional PFO closure with the PFO-Star device appears to be a reliable and promising technique resulting in a low recurrence rate of thromboembolic events, especially stroke in patients with a history of cryptogenic ischemia presumably due to paradoxical embolization. To our knowledge, this is the largest coherent and prospective study for interventional PFO closure.
本研究旨在确定卵圆孔未闭（PFO）封堵术治疗不明原因脑缺血患者的安全性，以及介入性PFO封堵术后复发性血栓栓塞事件的中期随访情况。
对于有PFO且有血栓栓塞事件病史的患者，目前预防中风的治疗选择包括长期抗血栓治疗以及更具侵入性的治疗，如手术封堵或微创经导管永久性封堵PFO。已有关于Amplatzer房间隔封堵器或PFO-Star封堵器的有前景的初步和试验性数据报道。但系统的长期数据仍然缺乏。
四个医疗中心共招募了276例连续的有PFO且至少有一次血栓栓塞事件病史的患者，使用PFO-Star装置进行经皮PFO封堵。平均随访15.1个月，相当于345患者年，并对随访数据进行分析。
所有276例患者植入均成功。围手术期可逆性并发症包括短暂性ST段抬高（1.8%）和短暂性脑缺血发作（TIA）（0.8%）。有两个装置已通过手术取出。随访期间，TIA的血栓栓塞事件年复发率为1.7%，中风为0%，外周栓塞为0%。
使用PFO-Star装置进行介入性PFO封堵似乎是一种可靠且有前景的技术，可使血栓栓塞事件，尤其是不明原因缺血病史患者因反常栓塞导致的中风复发率较低。据我们所知，这是关于介入性PFO封堵的最大规模的连贯前瞻性研究。
