Hou Shiqiang, Wang Peng, Long Yuliang, Li Mingfei, Zhang Yuan, Zhang Lei, Zhang Xiaochun, Zhou Daxin, Pan Wenzhi, Ge Junbo
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
JACC Basic Transl Sci. 2025 Apr;10(4):422-433. doi: 10.1016/j.jacbts.2024.11.012. Epub 2025 Feb 5.
Traditional occluders for the closure of patent foramen ovale (PFO) may be associated with some potential risks, including device-related thrombus, induction of arrhythmias, residual shunt, and difficulty in puncturing atrial septum. The TriFlower device is a novel transcatheter PFO occluder that features a clamp arm design. The device success rate was 100% (n = 18) in the animal experiment. Endothelialization of the left clamp arms was completed at an early stage (30 days after implantation). The acute procedure success rate in 17 patients was 100%. At 6-month follow-up, the primary efficacy endpoint, an effective PFO closure defined as residual shunt grade 1 or lower, was met in 16 (94.1%) patients and 14 (82.4%) patients had a complete closure. There were no device-related complications. These findings indicate that the TriFlower device is feasible, safe, and effective for transcatheter PFO closure. Its potential advantages include rapid endothelialization and low left atrial interference.
用于闭合卵圆孔未闭（PFO）的传统封堵器可能存在一些潜在风险，包括与器械相关的血栓形成、诱发心律失常、残余分流以及穿刺房间隔困难。TriFlower装置是一种新型经导管PFO封堵器，其特点是采用夹臂设计。在动物实验中，该装置成功率为100%（n = 18）。左夹臂的内皮化在早期（植入后30天）完成。17例患者的急性手术成功率为100%。在6个月的随访中，主要疗效终点，即定义为残余分流1级或更低的有效PFO闭合，在16例（94.1%）患者中实现，14例（82.4%）患者实现完全闭合。没有与器械相关的并发症。这些发现表明，TriFlower装置用于经导管PFO闭合是可行、安全且有效的。其潜在优势包括快速内皮化和对左心房干扰小。
Zotero 插件
