评价血管内冲击波碎石术在小型猪冠状动脉中应用的安全性

Safety of intravascular lithotripsy in normal porcine coronary arteries

目的评价血管内冲击波碎石术对比雅培非顺应性球囊在正常小型实验猪冠状动脉中应用的安全性。方法将12头正常巴马小型猪的36支冠状动脉随机平均分为两组,放弃直径小于2.5 mm的血管,最后入选实验组和对照组的冠状动脉分别为15支和11支。实验组使用冲击波冠状动脉球囊进行扩张,对照组使用雅培非顺应性球囊进行扩张。使用血管内超声(IVUS)评估扩张前后冠状动脉管腔内面积变化以及扩张后血管损伤情况。实验动物按1∶1∶1分为三组,分别于术后0 d、7 d和28 d复查冠状动脉造影并处死,处死后取球囊作用部位血管进行病理形态学检查和扫描电子显微镜检查。结果两组靶血管术中冠状动脉造影及IVUS检查均未见冠状动脉夹层、穿孔、血肿及血栓形成。球囊扩张前后,IVUS在两组靶血管分别测得内弹力膜面积、外弹力膜面积、内弹力膜面积/外弹力膜面积,差异均无统计学意义(均P<0.05)。病理学结果示:术后7 d,实验组内膜面积较对照组大[(0.07±0.06)mm~2比(0.05±0.02)mm~2,P=0.019];而术后28 d,实验组管腔面积较对照组小[(0.28±0.15)mm~2比(0.31±0.04)mm~2,P=0.032];两组病理学结果可见内膜脱落、内弹力膜和部分中膜肌纤维断裂、黏液聚集和胶原纤维增生;但未见炎症细胞浸润、血栓形成、壁间血肿和外弹力膜断裂。此外,实验组标本内膜增生、黏液聚集和胶原纤维增生较对照组明显。结论血管内冲击波碎石术在正常小型实验猪冠状动脉中应用具有良好的安全性。

Objective To evaluate safety of intravascular lithotripsy (IVL) compared with Abbott non-compliant balloon in normal porcine coronary arteries.Methods A total of 36 coronary arteries of 12normal experimental Bama mini-pigs were randomly divided into 2 groups.Arteries with diameter less than2.5 mm were excluded.A total of 15 coronary arteries were divided into the experimental group and 11 in the control group.IVL was implemented in the experimental group.Abbott non-compliant balloon was used in the control group.Intravascular ultrasound (IVUS) was used to evaluate the injury of target vessels before and after balloon dilation.The animals of the two groups were divided into three groups equally in which coronary angiography was performed 0 day,7 days and 28 days after operation.After that these pigs were executed and the target segments of arteries were pathomorphologically evaluated and observed by scanning electron microscope.Results Dissection,perforation,hematoma and thrombosis were not found in intraoperative coronary under angiography and IVUS.Before and after balloon dilatation,there was no signifi cant diff erences in the internal elastic membrane area(IELA),external elastic membrane area(EELA)and the ratio of IELA/EELA measured by IVUS between the two groups.The pathological results showed that 7 days after operation,the IELA in the experimental group increased compared with the control group[(0.07±0.06)mm~2vs.(0.05±0.02)mm~2,P=0.019].On the 28th day after operation,the lumen area of the experimental group was lower than that of the control group[(0.28±0.15) mm~2vs.(0.31±0.04)mm~2,P=0.032].The pathological results of both groups showed intimal abscission,rupture of internal elastic membrane and media smooth muscle,accumulation of mucus and proliferation of collagen.However,there was no infl ammation,thrombosis,hematoma,and rupture of the external elastic membrane.In addition,intimal hyperplasia,mucus aggregation and collagen fiber hyperplasia in the experimental group were significantly greater than those in the control group.Conclusions Intravascular lithotripsy is safe in normal experimental Bama minipig coronary arteries.