国产新型肺动脉血栓取出装置治疗急性肺动脉栓塞的有效性与安全性  

The efficacy and safety of a novel domestic pulmonary artery thromoectomy system in the treatment of acute pulmonary embolization

作　　者：张文广[1] 陈鹏飞[1] 张萌帆 刘红[2] 刘绍霞[2] 杨海波[3] 宋燕[4] 冯德广[5] 任建庄[1] 韩新巍[1] Zhang Wenguang;Chen Pengfei;Zhang Mengfan;Liu Hong;Liu Shaoxia;Yang Haibo;Song Yan;Feng Deguang;Ren Jianzhuang;Han Xinwei(Department of Interventional Radiology,Institute of Interventional Radiology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Department of Respiratory and Critical Care,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Department of Cardiology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Department of Vascular Surgery,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Department of Cardiac Surgery,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China)

机构地区：[1]郑州大学第一附属医院介入科、郑州大学介入治疗研究所,郑州450000 [2]郑州大学第一附属医院呼吸与危重症科,郑州450000 [3]郑州大学第一附属医院心血管内科,郑州450000 [4]郑州大学第一附属医院血管外科,郑州450000 [5]郑州大学第一附属医院心血管外科,郑州450000

出　　处：《中华放射学杂志》2023年第10期1100-1105,共6页Chinese Journal of Radiology

基　　金：河南省高校重点研发项目(23A320056);河南省创新型科技人才队伍建设工程专项基金(172101510002);河南省中青年卫生健康科技创新杰青人才项目(YXKC2023)。

摘　　要：目的探讨国产新型Tendvia^(TM)肺动脉血栓取出装置治疗急性肺动脉栓塞(APE)中高危患者的有效性和安全性。方法采用前瞻性、单臂、单中心临床试验,于2022年2月1日至10月31日在郑州大学第一附属医院纳入APE中高危患者24例,均使用Tendvia^(TM)肺动脉血栓取出系统接受经皮机械血栓清除术(PMT)治疗。疗效主要指标为基线至术后48 h右心室/左心室比值(RV/LV)的下降值,次要指标包括手术成功率、平均肺动脉压(mPAP)、动脉血氧分压(PaO_(2))及术后即刻的靶血管血栓清除率;安全性评价包括手术即刻、随访过程中PMT相关并发症及48 h内与器械相关主要不良事件发生率。采用配对样本t检验和Wilcoxon符号秩合检验比较APE患者PMT治疗前后的变化,评估Tendvia^(TM)肺动脉血栓取出系统的安全性和疗效。结果24例受试者采用Tendvia^(TM)装置行PMT的手术成功率为100%,手术前后RV/LV比值分别为1.19±0.25、0.82±0.16,术后48 h RV/LV较术前降低,差异具有统计学意义(t=7.03,P<0.001);手术前后mPAP分别为(31.09±6.09)、(25.91±4.36)mmHg,术后mPAP较术前下降,差异具有统计学意义(t=6.73,P<0.001);手术前后PaO_(2)分别为(74.66±11.28)、(88.01±10.57)mmHg,PaO_(2)较术前升高,差异有统计学意义(t=-4.08,P<0.001)。血栓清除率为68.17%±22.66%,其中血栓清除率Ⅱ级以上21例(87.5%)。1例患者术中出现咯血,保守治疗后咯血消失,48 h主要不良事件发生率为4.17%(1/24),无器械相关死亡,无全因死亡。结论国产Tendvia^(TM)肺动脉血栓取出系统治疗中高危APE患者安全有效,可以即刻清除肺动脉血栓,为APE患者提供一种新的治疗选择。Objective To evaluate the efficacy and safety of a novel domestic pulmonary thromoboectomy system Tendvia^(TM) in the treatment for high-risk patients complicated with acute pulmonary embolization(APE).Methods The study was designed as a prospective single-center clinical trial.Twenty-four high-risk patients with APE were recruited and underwent percutaneous mechanical thromoectomy(PMT)with the Tendvia^(TM) pulmonary thromoboectomy system.The primary efficacy endpoint was the reduction of RV/LV ratio at the post-operative 48 h.The secondary efficacy endpoints included technical success rate,mean pulmonary arterial pressure(mPAP),arterial PaO_(2) and the instant post-operative thrombus clearance rate.The evaluation of the safety included the intraoperative complications and related complications during the follow-up period associated with the PMT operation and the major adverse event(MAE)rate within the post-operative 48 h.The pre-and post-operative data were compared with paired sample t-test or Wilcoxon rank sum test to evaluate the efficacy and safety of Tendvia^(TM) pulmonary thromoboectomy system.Results The technical success rate of PMT with Tendvia^(TM) pulmonary thromoboectomy system was 100%(24/24).The 48 h pre-operative RV/LV ratio was 1.19±0.25 and the post-operative RV/LV ratio was 0.82±0.16.The mean RV/LV ratio of the patients was decreased by 0.37±0.25 at post-operative 48 h with significant statistical difference(t=7.03,P<0.001).The 48 h pre-operative mPAP was(31.09±6.09)mmHg and the post-operative mPAP was(25.91±4.36)mmHg.The mPAP of the patients was reduced by 5.18 mmHg at post-operative 48 h with significant statistical difference(t=6.73,P<0.001).The pre-operative PaO_(2) was(74.66±11.28)mmHg and the post-operative PaO_(2) was(88.01±10.57)mmHg.The pressure of oxygen in artery was increased by 13.36 mmHg.The differences were statistically significant(t=-4.08,P<0.001).The rate of thrombus removal was 68.17%±22.66%.87.5%(21 cases)of patients achieved a thrombus removal greater than gradeⅡ.

关 键 词：肺栓塞 经皮机械血栓清除术 右心室/左心室比值 

分 类 号：R563.5[医药卫生—呼吸系统]