A multicenter clinical trial of safety and effectiveness of Octoparms® vena cava filter in preventing pulmonary embolism
Author:
Affiliation:

1.Department of Vascular Surgery, Beijing Jishuitan Hospital, Beijing 100035, China;2.Department of Interventional Radiology, Nanjing Hospital (Nanjing First Hospital), Nanjing Medical University, Nanjing 210006, China;3.Department of Interventional Radiology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221000, China;4.Department of Interventional Radiology, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, China;5.Department of Endovascular Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;6.Department of Intervention, Union Hospital, Fujian Medical University, Fuzhou 350001,China;7.Department of Interventional Vascular Surgery, Hunan Provincial People's Hospital, Changsha 410008, China;8.Department of Interventional Radiology and Vascular Surgery, Affiliated Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210000, China;9.Department of Vascular Surgery, Henan Provincial People's Hospital, Zhengzhou 450003, China;10.Department of Vascular Surgery, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, China

Clc Number:

R654.3

Fund Project:

  • Article
  • |
  • Figures
  • |
  • Metrics
  • |
  • Reference
  • |
  • Related
  • |
  • Cited by
  • |
  • Materials
  • |
  • Comments
    Abstract:

    Background and Aims Octoparms? is the first retrievable conical inferior vena cava filter (VCF) made in China. To investigate the safety and effectiveness of this VCF in prevention of pulmonary embolism (PE), this study was conducted for a non-inferiority comparison between this VCF and foreign imported VCF.Methods Using a randomized multicenter, positive parallel controlled design, the eligible patients with acute deep venous thrombosis (DVT) of lower extremities from 10 centers from September 2017 to March 2019 in China were enrolled and designated to study group and control group at a 1∶1 ratio. The variables concerning safety and effectiveness were compared between Octoparms? filter and USA Celect filter.Results A total of 188 patients were enrolled with 94 cases in each study group and control group. The baseline data of the two groups of patients were balanced, and all filters were successfully implanted. Filter was successfully retrieved in 87 cases (92.6%) in study group a the median retention time of 11 (7-31) d, and 26 cases (27.6%) thrombus interception. Filter was successfully retrieved in 91 cases (96.8%) in control group a the median retention time of 12 (7-21) d and 35 cases (37.2%) had thrombus interception. During the filter implantation and removal, no symptoms of PE occurred in both groups, and no severe filter shift or rupture was observed. The self-centering effect of filter in study group was better than that in control group (P<0.05). In the 104 cases (55.3%) undergoing thrombolytic therapy, the filter was not removed in 2 cases (1.9%) and the hemorrhage event occurred in 17 cases (16.3%); in the 84 cases (44.7%) who did not receive thrombolytic therapy, the filter was not removed in 8 cases (9.5%) and the hemorrhage event occurred 5 cases (5.9%). There were statistical differences in filter retrieval rate and incidence of hemorrhage event between patients with and without thrombolytic therapy (χ2=3.928, P=0.048; χ2=4.858, P=0.028).Conclusion Using Octoparms? conical VCF for prevention of PE is safe and effective, and the overall efficacy is similar with that of foreign imported VCF. In addition, thrombolytic therapy can effectively reduce the load of DVT and increase the filter removal rate, but it will increase the risk of hemorrhage in patients.

    Reference
    Related
    Cited by
Get Citation

TIAN Xuan, LIU Jianlong, GU Jianping, XU Hao, NI Caifang, LI Zhen, YANG Weizhu, XIANG Hua, TENG Gaojun, ZAI Shuiting, ZHANG Yanrong, LI Jinyong. A multicenter clinical trial of safety and effectiveness of Octoparms® vena cava filter in preventing pulmonary embolism[J]. Chin J Gen Surg,2021,30(12):1395-1402.
DOI:10.7659/j. issn.1005-6947.2021.12.002

Copy
Share
Article Metrics
  • Abstract:
  • PDF:
  • HTML:
  • Cited by:
History
  • Received:September 18,2021
  • Revised:December 14,2021
  • Adopted:
  • Online: January 07,2022
  • Published: