新型全腔内经股动脉三分支覆膜支架系统治疗主动脉弓部病变的FIM研究
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中国人民解放军空军军医大学第一附属医院 心血管外科

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国家重点研发计划基金资助项目(2016YFC1301900,2016YFC1301901)。


FIM study of a new femoral endovascular access supra-arch branched stent graft for the treatment of aortic arch disease
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Department of Cardiovascular Surgery, the First Affiliated Hospital of Air Force Military Medical University, Xi''an 710032, China)

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    摘要:

    背景与目的:目前,主动脉弓部病变还是以常规全弓置换为主要治疗手段。常规全弓置换术需要在开胸及深低温体外循环状态下完成,手术时间可达10余小时,是名副其实的“血战、夜战、死战”手术。由于主动脉弓部特殊的解剖结构,使其长期被视为腔内治疗的“禁区”。虽然主动脉弓部腔内技术日新月异,但其瓶颈问题始终无法突破,目前仍很难在临床上广泛应用。本文报告笔者中心采用一款新型全腔内经股动脉三分支覆膜支架系统治疗主动脉弓部病变的first-in-man(FIM)研究结果,初步评价其应用效果与安全性。 方法:分析2023年10月—2023年12月空军军医大学第一附属医院采用新型全腔内经股动脉三分支覆膜支架系统为3例主动脉弓部存在病变的患者实施治疗的临床结果。采集患者基本信息及病变特点、术中相关指标、术后主动脉弓部修复及相关并发症情况。 结果:3例患者均为男性,年龄50~74岁。手术全部成功,无短期术后并发症及死亡。3例患者包括主动脉弓部夹层动脉瘤1例,主动脉弓部瘤伴溃疡2例;其中2例患者因胸痛就诊,1例为查体发现。3例患者均合并高血压,合并糖尿病1例。2例患者病变位于1~3区,累及左颈总动脉;1例患者病变位于0~3区,累及无名动脉和左颈总动脉。平均手术时间125 min。1例带管入重症监护室(ICU),其余2例均于手术室内拔管。术中无脑部缺血过程,未出现心脑血管并发症。术中支架均由股动脉入路导入,支架植入顺利,术中行数字减影血管造影提示支架位置、形态良好,血流通畅,病变区域完全隔绝,无内漏及分支动脉狭窄的不良事件出现。ICU平均停留时间31 h。术后复查主动脉血管成像显示主体及分支支架位置良好,瘤体隔绝良好,无内漏及分支血管狭窄闭塞等情况。术后无心脑血管并发症出现。 结论:应用新型全腔内经股动脉三分支覆膜支架系统治疗主动脉弓部病变,术中无脑缺血过程,输送系统均由股动脉入路,操作更加简便,创伤进一步减小。手术过程平顺,手术效果良好,术后短期疗效满意,具有较好的临床应用前景。

    Abstract:

    Background and Aims: Currently, conventional total arch replacement remains the main treatment for lesions involving the aortic arch. Conventional total arch replacement requires completion under the open chest and cardiopulmonary bypass, with a surgical duration of over 10 hours, earning it the title of a "bloody, night-long, life-or-death" surgery. Due to the unique anatomical structure of the aortic arch, it has long been considered a "forbidden zone" for endovascular treatment. Although intra-aortic techniques for the aortic arch are advancing rapidly, the bottleneck issue still needs to be solved, making it difficult to be widely applied in clinical practice. Here, the authors report the results of the first-in-man (FIM) study of a new femoral endovascular access supra-arch branched stent graft for treating aortic arch lesions to evaluate its application effectiveness and safety preliminarily. Methods: The clinical results of 3 patients with aortic arch lesions treated using the femoral endovascular access supra-arch branched stent graft at the First Affiliated Hospital of Air Force Medical University from October 2023 to December 2023 were analyzed. Patient baseline information, lesion characteristics, intraoperative parameters, postoperative aortic arch repair, and related complications were collected. Results: All three patients were male, aged between 50 and 74. All surgeries were successful without short-term postoperative complications or deaths. The three patients included one case of aortic arch coarctation aneurysm and two cases of aortic arch aneurysm with ulceration; two of them presented with chest pain, and one was incidentally found during physical examination. All three patients had concomitant hypertension, and one had diabetes. The lesions in two patients were located in zones 1-3, involving the left common carotid artery, and in one patient, the lesion was located in zones 0-3, involving the innominate artery and the left common carotid artery. The average operative time was 125 min. One patient was admitted to the intensive care unit (ICU) with catheter indwelling, while the remaining two had their catheters removed in the operating room. There was no cerebral ischemia process, and no cardiovascular or cerebrovascular complications occurred during the operation. The stents were all introduced via the femoral artery route, and the implantation was smooth. Intraoperative digital subtraction angiography showed excellent position and shape of the stent graft with good patency, complete isolation of the lesion area, and no adverse events such as endoleak or branch artery stenosis. The average length of ICU stay was 31 h. Postoperative reexamination of aortic vascular imaging showed good positions of the main and branch stents, good isolation of the lesions, and no endoleak or branch vessel stenosis or occlusion. There were no postoperative cardiovascular and cerebrovascular complications. Conclusion: Applying this new femoral endovascular access supra-arch branched stent graft to treat aortic arch lesions results in no cerebral ischemia during the operation. Moreover, the delivery system is accessed via the femoral artery route, making the procedure more straightforward and reducing trauma further. The surgery proceeds uneventfully, with good outcomes, and the short-term postoperative efficacy is satisfactory, indicating promising clinical application prospects.

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左健,刘金成,俞世强,易蔚,张静隆,陈佳,李超,孙子兰,李子林.新型全腔内经股动脉三分支覆膜支架系统治疗主动脉弓部病变的FIM研究[J].中国普通外科杂志,,().

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  • 收稿日期:2024-01-23
  • 最后修改日期:2024-01-23
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  • 在线发布日期: 2024-05-17