三维打印技术与传统测量方式指导下开窗/分支支架主动脉腔内修复术的多中心疗效对比分析  

Analysis of the effectiveness of three-dimensional (3D) printing technology and traditional measurement-guided fenestrated/branched endovascular aortic repair: a multicenter comparative study

作　　者：潘朝晖 付东生 韩月雪 段剑锋 孙莉莉 李文东 郭世奎[2] 陈志丹[3] 刘仁贵 华正东[5] 黄景勇[6] 于浩 苏奕明 李晓强 刘昭[1] Pan Zhaohui;Fu Dongsheng;Han Yuexue;Duan Jianfeng;Sun Lili;Li Wendong;Guo Shikui;Chen Zhidan;Liu Rengui;Hua Zhengdong;Huang Jingyong;Yu Hao;Su Yiming;Li Xiaoqiang;Liu Zhao(Department of Vascular Surgery,The Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China;Department of Vascular Surgery,The First People's Hospital of Yunnan Province,Kunming 650032,China;Department of Vascular Surgery,Xiangyang Central Hospital,Xiangyang 441021,China;Department of Vascular Surgery,The First Affiliated Hospital of Dali University,Dali 671013,China;Department of Cardiac Surgery,Wuhan Asia Heart Hospital,Wuhan 430022,China;Department of Vascular Surgery,The First Affiliated Hospital of Wenzhou Medical University,Wenzhou 325015,China;Department of Cardiovascular,General Hospital of Southern Theatre Command,Guangzhou 637399,China;Department of Vascular Surgery,Liuzhou Worker's Hospital,Liuzhou 545005,China)

机构地区：[1]南京大学医学院附属鼓楼医院血管外科,南京210008 [2]云南省第一人民医院血管外科,昆明650032 [3]襄阳市中心医院血管外科,襄阳441021 [4]大理大学第一附属医院血管外科,大理671000 [5]武汉亚洲心脏病医院心脏中心,武汉430022 [6]温州医科大学附属第一医院血管外科,温州325000 [7]南部战区总医院心血管外科,广州510010 [8]柳州市工人医院血管外科,柳州545005

出　　处：《中华血管外科杂志》2024年第5期319-327,共9页Chinese Journal of Vascular Surgery

基　　金：国家自然科学基金(82370520);江苏省卓博计划(2022ZB689);南京大学医学院附属鼓楼医院临床专项项目(2023-LCYJ-PY-23);南京大学医学院附属鼓楼医院国家自然科学基金青年培育项目(2022-JCYJ-QP-61);江苏省“双创博士”项目(JSSCBS20221864)。

摘　　要：目的比较三维(3D)打印技术引导下的开窗/分支支架主动脉腔内修复术(F/B EVAR)与传统测量方式指导下的F/B EVAR的疗效。方法本研究为回顾性队列研究。收集2018年1月至2023年12月全国64家医院接受医师自制支架F/B EVAR治疗胸腹主动脉疾病的患者临床资料,内脏分支定位方式分别采用传统测量方法和3D打印技术指导。通过比较手术时长、手术成功率、死亡率、重大不良事件发生率及分支重建成功率等方面分析两种术式的疗效差异。结果共纳入405例患者,其中男性325例,女性80例,年龄(60.3±12.8)岁。259例接受3D打印指导下的F/B EVAR(3D组),146例通过传统方法行F/B EVAR(传统组)。相较于传统组,3D组患者的腔内手术时长更短[116.3(89.8,146.5)min比106.0(82.0,132.5)min,Z=-2.095,P=0.036],术中分支重建失败率更低(8.9%比3.5%,χ^(2)=5.358,P=0.021),差异均有统计学意义;但两组术后30 d死亡率差异无统计学意义(3.4%比2.3%,χ^(2)=0.434,P=0.535)。3D组与传统组的中位随访时间分别为25(13,30)个月和27(14,32)个月。相较于传统组,3D组分支动脉闭塞发生率(7.5%比3.1%,χ^(2)=4.127,P=0.042)、内漏发生率(13.0%比6.2%,χ^(2)=5.527,P=0.019)及再干预率(14.4%比7.7%,χ^(2)=4.554,P=0.032)更低,差异均有统计学意义;但两组随访中的全因死亡率差异无统计学意义(2.1%比1.5%,χ^(2)=0.143,P=0.706)。结论3D打印技术引导下的F/B EVAR相较于传统的F/B EVAR,腔内手术时间更短,分支闭塞发生率、内漏发生率及再干预率更低,是一种可靠的主动脉病变全腔内治疗方法。Objective:To investigate whether three-dimensional(3D)printing measurements offer superior guidance in fenestrated/branched endovascular aortic repair(F/B EVAR)compared to traditional measurements in terms of their therapeutic effectiveness.Methods:This was a retrospective cohort study.Clinical data of 405 cases from 64 hospitals in China undergoing F/B EVAR(with physician-modified stent-grafts)for treating thoracic and abdominal aortic diseases from January 2018 to December 2023 were enrolled in the study.Among the cases,the localization of visceral branches in the surgery was guided either by traditional measurements or 3D-printing models.To compare and analyze the differences in the effectiveness of the two methods,collected data included surgical duration,surgical success rate,death rate,incidence of major adverse events,and success rate of branch reconstruction.Results:Among the 405 cases,325 were males and 80 were females,aged(60.3±12.8)years.259 patients underwent 3D-printing-guided F/B EVAR(3D group)and 146 underwent F/B EVAR through traditional methods(traditional group).Compared with the traditional group,the 3D group had a shorter surgery duration[116.3(89.8,146.5)mins vs 106.0(82.0,132.5)mins,Z=-2.095,P=0.036]and a lower failure rate of intraoperative branch reconstruction(8.9%vs 3.5%,χ^(2)=5.358,P=0.021),with statistically significant differences respectively.No statistically significant differences occurred in the 30-day postoperative death rate between the two groups(3.4%vs 2.3%,χ^(2)=0.434,P=0.535).The median follow-up time for the 3D group and the traditional group was 25(13,30)months and 27(14,32)months respectively.Compared with the traditional group,the 3D group had lower rates of branch occlusion(7.5%vs 3.1%,χ^(2)=4.127,P=0.042),endoleak(13.0%vs 6.2%,χ^(2)=5.527,P=0.019),and reintervention(14.4%vs 7.7%,χ^(2)=4.554,P=0.032),both with statistically significant differences.No statistically significant differences occurred in all-cause mortality between the two groups(2.1%vs 1.5%,χ^(2)=0.1

关 键 词：三维打印 开窗/分支支架主动脉腔内修复术 主动脉疾病 多中心 

分 类 号：R65[医药卫生—外科学]