国产新型覆膜支架系统治疗腹主动脉瘤早期临床结果的多中心分析  

Endovascular abdominal aortic aneurysm repair with a new stent graft:early results from a multicenter study

作　　者：张宏鹏[1] 章希炜[2] 戴向晨[3] 田民 杨斌[5] 王志维[6] 舒小军[7] 陈俞宏[8] 姜剑军[9] 黄建华[10] 舒畅[11] 覃晓[12] 陆信武[13] 张鸿坤[14] 毕伟[15] 刘勇 陈兵[17] 胡志鹏[18] 左健 郭平凡[20] 罗军[21] 童新元[22] 郭伟[1] Zhang Hongpeng;Zhang Xiwei;Dai Xiangchen;Tian Min;Yang Bin;Wang Zhiwei;Shu Xiaojun;Chen Yuhong;Jiang Jianjun;Huang Jianhua;Shu Chang;Qin Xiao;Lu Xinwu;Zhang Hongkun;Bi Wei;Liu Yong;Chen Bing;Hu Zhipeng;Zuo Jian;Guo Pingfan;Luo Jun;Tong Xinyuan;Guo Wei(Department of Vascular Surgery,the First Medical Center,People′s Liberation Army General Hospital,Beijing 100853,China;Department of Vascular Surgery,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China;Department of Vascular Surgery,Tianjin Medical University General Hospital,Tianjin 300052,China;Second Department of General Surgery,Yanan Hospital,Kunming 650051,China;Department of Vascular Surgery,the First Affiliated Hospital of Kunming Medical University,Kunming 650031,China;Department of Cardiovascular Surgery,People′s Hospital of Wuhan University,Wuhan 430065,China;Department of Vascular Surgery,the First Hospital of Lanzhou University,Lanzhou 730099,China;Department of Cardiac and Vascular Surgery,Liuzhou People′s Hospital,Liuzhou 545026,China;Department of Vascular Surgery,Qilu Hospital of Shandong University,Jinan 250011,China;Department of Vascular Surgery,Xiangya Hospital,Central South University,Changsha 410028,China;Department of Vascular Surgery,Xiangya Second Hospital,Central South University,Changsha 410011,China;Department of Vascular Surgery,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;Department of Vascular Surgery,Ninth People′s Hospital Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China;Department of Vascular Surgery,the First Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310003,China;Department of Vascular Surgery,the Second Hospital of Hebei Medical University,Shijiazhuang 050004,China;Department of Vascular Surgery,the Affiliated Hospital of Southwest Medical University,Luzhou 646099,China;Department of Vascular Surgery,the Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310009,China;Department of

机构地区：[1]解放军总医院第一医学中心血管外科,北京100853 [2]南京医科大学第一附属医院血管外科,南京210029 [3]天津医科大学总医院血管外科,天津300052 [4]昆明市延安医院普外二科,昆明650051 [5]昆明医科大学第一附属医院血管外科,昆明650031 [6]武汉大学人民医院心血管外科,武汉430065 [7]兰州大学第一医院血管外科,兰州730099 [8]柳州市人民医院心脏血管外科,柳州545026 [9]山东大学齐鲁医院血管外科,济南250011 [10]中南大学湘雅医院血管外科,长沙410028 [11]中南大学湘雅二医院血管外科,长沙410011 [12]广西医科大学第一附属医院血管外科,南宁530021 [13]上海交通大学医学院附属第九人民医院血管外科,上海200011 [14]浙江大学医学院附属第一医院血管外科,杭州310003 [15]河北医科大学第二医院血管外科,石家庄050004 [16]西南医科大学附属医院血管外科,泸州646099 [17]浙江大学医学院附属第二医院血管外科,杭州310009 [18]宁夏医科大学总医院血管外科,银川750003 [19]空军军医大学西京医院心血管外科,西安710032 [20]福建医科大学附属第一医院血管外科,福州350004 [21]新疆医科大学第一附属医院血管甲状腺外科,乌鲁木齐830011 [22]解放军总医院医学统计教研室,北京100853

出　　处：《中华外科杂志》2022年第12期1049-1056,共8页Chinese Journal of Surgery

摘　　要：目的探讨使用国产新型覆膜支架系统腔内修复腹主动脉瘤的安全性和有效性。方法本研究为前瞻性、多中心、单组目标值法临床研究。纳入2018年9月至2019年9月中国21家中心收治的接受植入国产新型腹主动脉覆膜支架治疗的腹主动脉瘤患者的资料,分析患者出院前,术后30、180及360 d的治疗结果。主要安全性终点指标为术后30 d的主要不良事件(MAE)发生率,主要有效性终点指标为术后360 d腹主动脉瘤治疗成功率。次要安全性终点指标为围手术期入路并发症和急性下肢缺血发生率,术后180、360 d全因病死率,腹主动脉瘤相关病死率及严重不良事件(SAE)发生率。次要有效性终点指标为术后180、360 dⅠ型或Ⅲ型内漏发生率,支架移位发生率、中转开腹手术或二次介入干预发生率。结果研究共纳入156例患者,男性137例,女性19例,年龄(68.9±6.9)岁(范围:48.2~84.6岁)。动脉瘤最大直径为(50.8±11.2)mm(范围:25.0~85.0 mm),近端锚定区直径为(21.2±2.5)mm(范围:17.0~29.5 mm),锚定区长度为(31.4±13.0)mm(范围:11.0~75.0 mm)。术后30 d的MAE发生率为1.3%(2/156),均为死亡病例;术后360 d腹主动脉瘤治疗成功率为88.5%(138/156)。围手术期未发生支架输送相关并发症及急性下肢缺血;术后180 d全因病死率为2.0%(3/154),360 d为2.6%(4/153),无腹主动脉瘤相关死亡病例。术后180 d SAE发生率为23.0%(35/152),360 d为30.5%(46/151),未发生器械相关SAE。术后180 d的Ⅰ型或Ⅲ型内漏发生率为3.4%(5/147),360 d为3.5%(5/144)。结论本研究中验证的国产新型覆膜支架系统操作简便,早期安全性和有效性结果符合预期。Objective To examine the safety and effectiveness of a new stent graft system for endovascular repair of abdominal aortic aneurysm(AAA).Methods This is a prospective,multi-center,single-arm clinical trial.The patients with AAA treated with a new stent graft system were enrolled at 21 centers from September 2018 to September 2019 in China.Follow-up was performed before discharge,and at 30,180,360 days after operation,respectively.The primary safety endpoint was the incidence of major adverse events(MAE)within 30 days.The primary efficacy endpoint was the success rate of AAA treatment at 360 days.Secondary safety endpoints were the incidence of perioperative access complications and acute lower limb ischemia,all-cause mortality,AAA related mortality and incidence of serious adverse events(SAE)at 180 and 360 days.Secondary efficacy endpoints were the incidence of typeⅠorⅢendoleak,stent displacement,and conversion to open surgery or re-intervention at 180 and 360 days.Results One hundred and fifty-six patients were enrolled,including 137 males and 19 females.The age was(68.9±6.9)years(range:48.2 to 84.6 years).Maximum aneurysm diameter was(50.8±11.2)mm(range:25.0 to 85.0 mm),diameter of proximal landing zone was(21.2±2.5)mm(range:17.0 to 29.5 mm),and length of proximal landing zone was(31.4±13.0)mm(range:11.0 to 75.0 mm).The incidence of MAE was 1.3%(2/156)at 30 days,both were all-cause death cases.The success rate of AAA treatment was 88.5%(138/156)at 360 days.No perioperative access complication and acute lower limb ischemia occurred.All-cause mortality was 2.0%(3/154)at 180 days and 2.6%(4/153)at 360 days,and there was no AAA related death.The incidence of SAE was 23.0%(35/152)at 180 days and 30.5%(46/151)at 360 days,and no device-related SAE occurred.The incidence of typeⅠorⅢendoleak was 3.4%(5/147)at 180 days and 3.5%(5/144)at 360 days.Conclusion The new stent graft system is easy to operate,and early-term safety and effectiveness results are expected.

关 键 词：主动脉瘤 腹 支架 腔内修复术 髂动脉瘤 

分 类 号：R654.4[医药卫生—外科学]