新型卵圆孔未闭封堵器的研制及临床应用进展

Design and Clinical Practice of Novel Patent Foramen Ovale Occluders

卵圆孔是房间隔上一个先天性的薄弱区域,约75%的人群在婴幼儿期均会自行关闭,少数人成年后仍未能自行关闭称之为卵圆孔未闭(PFO)。近几年,经导管PFO封堵术在PFO相关卒中或偏头痛的循证证据逐年增加。目前美国食品和药物管理局批准应用于临床的PFO封堵器械有Amplatzer PFO封堵器和Gore Cardioform PFO封堵器,其他封堵器也在临床上广泛应用。但现有器械仍存在术后新发心房颤动、封堵器相关血栓、房间隔周围组织磨蚀等封堵器相关并发症,新型PFO封堵器械的研发一直是行业热点,现对这一领域的研究进展做一综述。

Foramen ovale is an embryonic defect in the interatrial septum.About 75% of the population will self close during infancy,and a few people may still fail to self close after adulthood,which is called patent foramen ovale(PFO).In recent years,the evidence-based data on transcatheter PFO occlusion for the treatment of PFO-related stroke or migraine is increasing year by year.Currently,the PFO occluder devices approved by the US Food and Drug Administration for clinical use include Amplatzer PFO occluder and Gore Cardioform PFO occluder.Other occluder devices are also widely used in clinical practice.However,the existing devices still have occluder-related complications such as new-onset atrial fibrillation after surgery,occluder-related thrombus,and tissue abrasion around the atrial septum.The research and development of novel PFO occluder devices has always been a hot spot in the industry.Now,this paper reviews the research progress in this field.