用于经导管卵圆孔未闭封堵且保留房间隔穿刺区域的双侧不对称单铆钉封堵器装置的实验研究
Experimental study of the bilateral asymmetric single-rivet occluder device for transcatheter patent foramen ovale closure with reserved interatrial septal puncture area.
作者信息
Wei Yiting, Su Yanlin, Cao Suyan, He Ziqian, Wang Renrong, Qin Xian, Feng Yuanxi, Yang Chengjian, Jiang Haibin
机构信息
Department of Cardiology, Wuxi No.2 People's Hospital (Jiangnan University Medical Center), Wuxi, Jiangsu, China.
出版信息
Front Cardiovasc Med. 2024 Jan 5;10:1301412. doi: 10.3389/fcvm.2023.1301412. eCollection 2023.
PURPOSE
To evaluate a noval bilateral asymmetric single-rivet occluder with reserved interatrial septal puncture area for treating patent foramen ovale (PFO).
MATERIALS AND METHODS
The study established a pig model of patent foramen ovale (PFO) by puncturing the oval fossa and then performing high-pressure balloon dilation. A specially designed bilateral asymmetric occluder for the reserved interatrial septal puncture area was then. used to close the PFO through catheter-based intervention. The pigs were kept for 3 months before undergoing a second catheter-based intervention, involving interatrial septal puncture using a newly developed occluder in the reserved interatrial septal puncture area. During 6 months, the experimental pigs underwent assessment using digital subtraction angiography (DSA), echocardiography, and histological evaluation.
RESULTS
A patent foramen ovale (PFO) model was successfully established in 6 pigs using the puncture atrial septum high-pressure balloon dilation method. The diameter of the unclosed PFO was measured (3.56 ± 0.25 mm). Using the newly developed occluder device, all 6 pigs with unclosed PFO underwent successful catheter-based closure surgeries, with intraoperative and postoperative transesophageal echocardiography showing excellent device positioning and complete closure without residual shunting. After 3 months of implantation, the catheter-based interatrial septal puncture was performed through the reserved interatrial septal puncture area, and all procedures were successful. Immediately following euthanasia, a histological examination revealed intact and undamaged occluder devices with visible puncture holes in the reserved interatrial septal puncture area. No fracture of the nitinol wire was observed, and the surface of the occluder device showed coverage of endothelial and connective tissues. Utilizing a bilateral asymmetric single-rivet occluder device implanted through the reserved interatrial septal puncture area has proven effective in closing PFO. After implantation, the occluder device allows subsequent interatrial septal puncture procedures through the reserved area.
CONCLUSION
The novel occluder device demonstrated excellent closure performance, biocompatibility, and puncturability in the experiment. This indicates the feasibility of conducting further catheter-based interventions on the interatrial septum.
目的
评估一种具有保留房间隔穿刺区域的新型双侧不对称单铆封堵器治疗卵圆孔未闭（PFO）的效果。
材料与方法
本研究通过穿刺卵圆窝然后进行高压球囊扩张建立猪卵圆孔未闭（PFO）模型。然后使用一种专门设计的用于保留房间隔穿刺区域的双侧不对称封堵器，通过导管介入来闭合PFO。在进行第二次基于导管的介入（在保留的房间隔穿刺区域使用新开发的封堵器进行房间隔穿刺）前，将猪饲养3个月。在6个月期间，对实验猪进行数字减影血管造影（DSA）、超声心动图和组织学评估。
结果
采用穿刺房间隔高压球囊扩张法在6只猪中成功建立了卵圆孔未闭（PFO）模型。测量未闭合的PFO直径（3.56±0.25 mm）。使用新开发的封堵器装置，所有6只未闭合PFO的猪均成功进行了基于导管的闭合手术，术中及术后经食管超声心动图显示封堵器定位良好且完全闭合，无残余分流。植入3个月后，通过保留的房间隔穿刺区域进行基于导管的房间隔穿刺，所有操作均成功。安乐死后立即进行组织学检查，结果显示封堵器装置完整无损，在保留的房间隔穿刺区域可见穿刺孔。未观察到镍钛诺丝断裂，封堵器装置表面可见内皮和结缔组织覆盖。利用通过保留的房间隔穿刺区域植入的双侧不对称单铆封堵器装置已证明可有效闭合PFO。植入后，封堵器装置允许通过保留区域进行后续的房间隔穿刺操作。
结论
新型封堵器装置在实验中表现出优异的闭合性能、生物相容性和可穿刺性。这表明对房间隔进行进一步基于导管的介入治疗具有可行性。
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