Mechanical Thrombectomy System for the Treatment of Intermediate-Risk Acute Pulmonary Embolism: The CLEAR Study

被引：0

作者：

Zhang, Wenguang ^{[1
]}

Hu, Tao ^{[2
]}

Ding, Song ^{[3
]}

Wang, Zhouming ^{[4
]}

Hu, Hongyao ^{[6
]}

Fang, Xin ^{[7
]}

Pang, Honggang ^{[8
]}

Guo, Mingjin ^{[9
]}

Yu, Bo ^{[10
]}

Zhuang, Hui ^{[11
]}

Zhang, Nuofu ^{[12
]}

Han, Baoshi ^{[13
]}

Wang, Qiguang ^{[14
]}

Cai, Mingzhi ^{[15
]}

Wang, Kuan ^{[16
]}

Guo, Pingfan ^{[17
]}

Xu, Bin

Fang, Peiliang

Tu, Shengxian

Jiang, Yi ^{[18
]}

Shi, Hongyu ^{[19
]}

Yang, Zhenwen

Zhang, Tao ^{[5
]}

Han, Xinwei ^{[1
]}

Tian, Hongyan ^{[8
]}

Pu, Jun ^{[3
]}

Zhang, Xiaoming ^{[5
]}

机构：

[1] Zhengzhou Univ, Affiliated Hosp 1, Dept Intervent Radiol, Zhengzhou, Henan, Peoples R China

[2] Xijing Hosp, Dept Cardiol, Xian, Peoples R China

[3] Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Dept Cardiol, Shanghai, Peoples R China

[4] Tianjin Med Univ, Gen Hosp, Dept Cardiol, Tianjin, Peoples R China

[5] Peking Univ Peoples Hosp, Dept Vasc Surg, Beijing, Peoples R China

[6] Wuhan Univ, Renmin Hosp, Dept Vasc & Intervent Radiol, Wuhan, Hubei, Peoples R China

[7] Affiliated Hangzhou First Peoples Hosp, Sch Med, Dept Vasc Surg, Hangzhou, Zhejiang, Peoples R China

[8] First Affiliated Hosp Xian Jiao Tong Univ, Dept Thorac Surg, Xian, Shaanxi, Peoples R China

[9] Qingdao Univ, Dept Vasc Surg, Affiliated Hosp, Qingdao, Shandong, Peoples R China

[10] Fudan Univ, Shanghai Pudong Hosp, Dept Vasc Surg, Pudong Med Ctr, Shanghai, Peoples R China

[11] Xiamen Univ, Xiamen Cardiovasc Hosp, Dept Vasc Surg, Xiamen, Fujian, Peoples R China

[12] First Affiliated Hosp Jinan Univ, Dept Pulm & Crit Care Med, Guangzhou, Guangdong, Peoples R China

[13] Peoples Liberat Army Gen Hosp, Med Ctr 6, Dept Cardiol, Beijing, Peoples R China

[14] Gen Hosp Northen Theater Command, Dept Cardiol, Shenyang, Liaoning, Peoples R China

[15] Zhangzhou Municipal Hosp Fujian Prov, Dept Vasc Surg, Zhangzhou, Fujian, Peoples R China

[16] Peking Univ, Binhai Hosp, Dept Cardiol, Tianjin, Peoples R China

[17] Fujian Med Univ, Affiliated Hosp 1, Dept Vasc Surg, Fuzhou, Fujian, Peoples R China

[18] Tongji Univ, Shanghai East Hosp, Sch Med, Dept Emergency Internal Med, Shanghai, Peoples R China

[19] Fudan Univ, Zhongshan Hosp, Wusong Branch, Wusong Branch, Shanghai, Peoples R China

来源：

CARDIOVASCULAR INNOVATIONS AND APPLICATIONS | 2025年 / 10卷

关键词：

prospective studies; pulmonary embolism; thrombectomy; thrombolytic therapy; hemorrhage; hospitali-; zation; CATHETER-DIRECTED THROMBOLYSIS; MULTICENTER TRIAL; SINGLE-ARM; FIBRINOLYSIS; MANAGEMENT;

D O I：

10.15212/CVIA.2024.0066

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: Mechanical thrombectomy is effective and safe for treating pulmonary embolism (PE). Although the Tendvia mechanical thrombectomy system has been validated in pigs, further evidence supporting its use in PE treatment is needed. Objectives: This study was aimed at evaluating the safety and efficacy of the Tendvia system for intermediate-risk acute PE. Methods: This prospective, single-arm, multicenter study included symptomatic patients with acute PE >= 18 years of age, with a right ventricular (RV)/left ventricular (LV) diameter ratio >= 0.9. The primary efficacy endpoint was the change in RV/LV diameter ratio from baseline to 48 hours postprocedure. The primary safety endpoint was the incidence of major adverse events (AEs), device-related death, 48-hour postprocedure major bleeding, pulmonary vascular injury, and cardiac injury. The secondary efficacy endpoint was the systolic pulmonary arterial pressure (PAP) change from pre- to postprocedure. Secondary safety endpoints included 48-hour postprocedure clinical deterioration, device- related AEs, and symptomatic PE recurrence within 30 days. Results: Of 127 patients at 15 centers with intermediate-risk acute PE who underwent mechanical thrombectomy with the Tendvia system (September 2021 to December 2022), 123 underwent analysis. The mean RV/LV diameter ratio decrease was 0.42 +/- 0.28; 95% CI: 0.37-0.47; P < 0.001. The bleeding risk was low, and the hospitalization duration was short. One patient experienced clinical deterioration within 48 hours, and none experienced major AEs, device- related pulmonary vascular injury, cardiac injury, or major bleeding within 48 hours. Seven patients had 11 serious AEs within 30 days. The mean systolic PAP decrease was 7.10 mmHg (P < 0.001). Conclusion: The Tendvia system for mechanical thrombectomy is safe and effective for intermediate-risk acute PE, in agreement with the safety profiles in other studies.

引用

页码：1 / 14

页数：14

共 27 条

[1] Freund Y, Cohen-Aubart F, Bloom B., Acute pulmonary embolism: a review, J Am Med Assoc, 328, 13, pp. 1336-1345, (2022)
[2] Gong JN, Yang YH., Current clinical management status of pulmonary embolism in China, Chin Med J (Engl), 130, 4, pp. 379-381, (2017)
[3] Law Y, Chan YC, Cheng SWK., Epidemiological updates of venous thromboembolism in a Chinese population, Asian J Surg, 41, 2, (2018)
[4] Konstantinidis SV, Meyer G, Becattini C, Bueno H, Geersing G-J, Harjola V-P, Et al., 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS): the Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC), Eur Respir J, 54, 4, pp. 543-603, (2020)
[5] Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Et al., A prospective, single-arm, multicenter trial of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute massive and submassive pulmonary embolism: the SEATTLE II study, JACC Cardiovasc Interv, 8, 10, pp. 1382-1392, (2015)
[6] Tu T, Toma C, Tapson VF, Adams C, Jaber WA, Silver M, Et al., A prospective, single-arm, multicenter trial of catheter-directed mechanical thrombectomy for intermediate-risk acute pulmonary embolism: the FLARE study, JACC Cardiovasc Interv, 12, 9, pp. 859-869, (2019)
[7] Toma C, Jaber WA, Weinberg MD, Bunte MC, Khandar S, Stegman B, Et al., Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism, EuroIntervention, 18, 14, pp. 1201-1212, (2023)
[8] Dobrev G, Petrov I, Stankov Z, Tasheva I, Polomski P., Interventional treatment of pulmonary embolism – where do we currently stand?, Bulgarian Cardiol, 28, 3, pp. 24-29, (2022)
[9] Park CY, Yoo SM, Rho JY, Ji YG, Lee HY., The ratio of descending aortic enhancement to main pulmonary artery enhancement measured on pulmonary CT angiography as a finding to predict poor outcome in patients with massive or submassive pulmonary embolism, Tuberc Respir Dis (Seoul), 72, 4, pp. 352-359, (2012)
[10] Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Et al., Indigo aspiration system for treatment of pulmonary embolism: results of the EXTRACT-PE trial, JACC Cardiovasc Interv, 14, 3, pp. 319-329, (2021)

← 1 2 3 →