磁性导丝辅助腹主动脉瘤腔内修复术中通路建立的初步研究

Application of magnetic guidewire-assisted vascular access establishment in endovascular repair of abdominal aneurysm:preliminary results in experimental sheep

目的通过动物实验评价新型导丝在辅助腹主动脉瘤血管腔内修复术中通路建立过程中的操作性能和安全性。方法6只绵羊全身麻醉后,通过股动脉和肱动脉入路分别送入1根钕铁硼N50永磁体为磁头的磁性导丝,6 F Guiding协助导丝在腹主动脉末端或髂总动脉内对接,成功对接后将导丝拉出体外,建立导丝通路。观察导丝的可视性、可操作性及其与导管适配性。记录磁性导丝对接拉力、距离,分离拉力和操作时间等。实验后复查造影明确有无并发症,取材病理检查有无血管内膜损伤。结果在6 F Guiding导丝协助下,磁性导丝在5只羊腹主动脉中顺利对接,另1只羊主动脉迂曲经5次尝试后成功对接,建立了腔内修复通路。平均操作时间15 s,导丝平均对吻距离为0.64 cm,平均分离拉力为0.7 N。术后复查造影未发现血栓形成、夹层、动脉穿孔等并发症,组织病理学检查无动脉内膜损伤。结论磁性导丝具有良好的操作性和安全性,可快速建立腹主动脉瘤腔内修复术中导丝通路,有利于解决髂动脉分支置管中导丝选入支架短腿困难的问题。

Objective Through animal experiments to evaluate the efficacy and safety of a novel magnetic guidewire in assisting vascular access establishment for the performance of endovascular repair of abdominal aneurysm.Methods A total of 6 experimental sheep were used in this study.Under general anesthesia,two magnetic guidewires,which had a magnetic head made by neodymium iron boron(NdFeB)N50 permanent magnet,were separately inserted via the femoral artery and via the brachial artery,a 6-F guiding catheter was inserted to assist the two magnetic guidewires to be connected at the lower end of abdominal aorta or in the common iliac artery,the 6-F guiding catheter was pulled out when successful connection of the two magnetic guidewires was accomplished,in this way a guidewire pathway was established.The visibility and maneuverability of guidewire,and the adaptability of guidewire to catheter were evaluated.The kissing force,the kissing distance,the separation force of the magnetic guidewires were measured,and the time spent for manipulation was recorded.Postoperative reexamination of angiography was performed to identify complications,and pathological examination of tissue sample was conducted to identify vascular intima lesions.Results With the assistance of 6-F guiding catheter,successful connection of the two magnetic guidewires in abdominal aorta was accomplished in 5 sheep,in the remaining one sheep the connection of two magnetic guidewires was achieved until five attempts failed as the abdominal aorta was tortuous.A guidewire pathway used for endovascular repair procedure was thus established.The mean time spent for manipulation was 15 seconds,the average kissing distance of guidewires was 0.64 cm,and the mean separation force was 0.7N.Postoperative reexamination of angiography showed that no complications such as thrombosis,dissection,arterial perforation,etc.occurred.Pathological examination of tissue sample indicated that no vascular intima injury was observed.Conclusion The magnetic guidewire has excellent maneuverability and clinical safety,the use of it can help quickly establish the guidewire ring-pathway,and solve the clinical issue that the guidewire is difficult to enter stent short-leg when catheterization via iliac branch.