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目的在大动物中观察新型无膜双腰封堵器应用的安全性及有效性。方法选取健康实验犬12只,应用新型无膜双腰封堵器进行单侧肾动脉封堵,封堵后即刻行肾动脉造影评估封堵效果,并于术后1、3及6个月复查肾动脉造影。复查造影结束后处死实验犬,观察肾脏大体标本并行肾脏病理检查,并观察封堵器表面内皮化情况。结果 12只实验犬均成功实施单侧肾动脉封堵,其中1只因麻醉药物过量死亡,其余11只存活良好。6只实验犬在植入封堵器后即刻完全封堵,全部实验犬均在植入封堵器后12min内完全封堵肾动脉血流。封堵器释放后,封堵器位置均固定良好,未见明显封堵器移位。所有实验犬复查肾动脉造影均显示封堵器位置固定良好,无残余分流。大体观察发现封堵侧肾脏较对侧肾脏明显缩小,肾脏表面凹凸不平,质略硬。内皮细胞在术后1个月即开始覆盖封堵器表面,3个月时内皮细胞完全覆盖。结论新型无膜双腰封堵器具有良好的安全性、组织相容性及有效性,由于其优异的通过性,在小外径鞘管内即可完成封堵器输送。
Objective To observe the safety and effectiveness of a novel non-membrane double-waist occluder in large animals. Methods Twelve healthy dogs were selected and unilateral non-membrane occluder was used to seal the unilateral renal artery. Immediately after sealing, renal artery angiography was used to evaluate the occlusion effect, and the results were checked at 1, 3 and 6 months after operation Renal artery angiography. The dogs were sacrificed at the end of the contrast examination, and the kidney specimens were examined for renal pathology, and the endothelialization of the occluder surface was observed. Results All 12 experimental dogs were successfully unilateral renal artery occlusion, of which 1 died of overdose of anesthetic drugs and the remaining 11 survived well. Six experimental dogs were completely blocked immediately after implanted occluder, and all experimental dogs completely blocked renal artery blood flow within 12 minutes after implanted occluder. After the occluder was released, the position of the occluder was well fixed, and no obvious occluder displacement was observed. All experimental dogs were reviewed renal artery angiography showed a good occlusion device position, no residual shunt. In general, it was found that the kidneys on the occluded side were significantly smaller than the contralateral kidneys, and the surfaces of the kidneys were rough and slightly stiff. Endothelial cells began to cover the surface of the occluder 1 month after surgery and completely covered by endothelial cells at 3 months. Conclusions The new membraneless double lumbar occlusion device has good safety, histocompatibility and effectiveness. Because of its excellent permeability, the occluder delivery can be completed in a small external diameter sheath.