Department of Cardiology, Guangdong General Hospital and Guangdong Cardiovascular Institute, Guangzhou, China.
Cerebrovasc Dis. 2011;32(1):51-6. doi: 10.1159/000326078. Epub 2011 May 11.
To evaluate the feasibility, safety and efficacy of the Spider™ patent foramen ovale (PFO) occluder for the treatment of PFOs in an animal model.
The foramen ovale was punctured to establish an animal model of a PFO. Under fluoroscopic guidance, the PFO was occluded with the Spider PFO occluder. The piglets were electively sacrificed at months 1, 2, 3, 6 and 12 after occlusion for macroscopic and microscopic examination.
PFOs were successfully created and occluded percutaneously in 20 piglets. All piglets recovered from the procedure in good condition and completed follow-up. Macroscopic examination of all hearts showed complete closure of the PFO. The position of each device was correct. All devices were completely covered and embedded in pale and smooth tissue. There was no evidence of interference with adjacent structures of the heart or valves. The occluder was partially covered by endocardium after 1 month, almost completely covered by fresh endocardium after 3 months, and embedded within thick fibrous tissues and fresh vessels after 6 months. The tissue covering both occluder discs demonstrated some infiltration of inflammatory cells, including patches of lymphocyte aggregation. This inflammatory cell reaction diminished with increasing distance from the device. Furthermore, the number of inflammatory cells decreased gradually during follow-up and eventually, at 6-month follow-up, the inflammatory response was no longer visible. The 12-month histological findings did not differ from the 6-month findings.
Transcatheter closure of PFO with the Spider PFO occluder is effective and safe in an animal model. These results support further investigation of this device in animals and, if the results are confirmed, in human clinical trials.
评估 Spider™ 卵圆孔未闭（PFO）封堵器治疗动物模型中 PFO 的可行性、安全性和有效性。
经卵圆孔穿刺建立 PFO 动物模型。在透视引导下，应用 Spider PFO 封堵器封堵 PFO。在封堵后 1、2、3、6 和 12 个月，选择性处死小猪，进行大体和显微镜检查。
在 20 只小猪中成功经皮穿刺建立并封堵 PFO。所有小猪均在手术中恢复良好，并完成了随访。所有心脏的大体检查均显示 PFO 完全闭合。每个装置的位置均正确。所有装置均完全被覆盖并嵌入苍白光滑的组织中。没有证据表明对心脏或瓣膜的邻近结构有干扰。封堵器在 1 个月后部分被心内膜覆盖，在 3 个月后几乎完全被新鲜心内膜覆盖，在 6 个月后嵌入厚纤维组织和新鲜血管中。覆盖两个封堵盘的组织有一些炎症细胞浸润，包括淋巴细胞聚集的斑块。这种炎症细胞反应随着与装置的距离增加而减少。此外，随着随访时间的延长，炎症细胞的数量逐渐减少，最终在 6 个月随访时，炎症反应不再可见。12 个月的组织学发现与 6 个月时无差异。
在动物模型中，经导管封堵 PFO 应用 Spider PFO 封堵器是有效且安全的。这些结果支持在动物中进一步研究该装置，如果结果得到证实，也支持在人体临床试验中研究该装置。
