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中华临床医师杂志(电子版) ›› 2025, Vol. 19 ›› Issue (04) : 277 -283. doi: 10.3877/cma.j.issn.1674-0785.2025.04.006

临床研究

CleanerTM旋转式血栓清除系统在下肢深静脉血栓中的临床应用
杨建平, 唐加热克, 管圣()   
  1. 830001 乌鲁木齐,新疆维吾尔自治区人民医院血管外科
  • 收稿日期:2025-04-05 出版日期:2025-04-15
  • 通信作者: 管圣
  • 基金资助:
    自治区自然科学基金项目(2024D01C93); 院内项目(20240201)

Clinical application of CleanerTM rotary thrombus removal system in lower extremity deep vein thrombosis

Jianping Yang, Tangjiareke, Sheng Guan()   

  1. Department of Vascular Surgery, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830001, China
  • Received:2025-04-05 Published:2025-04-15
  • Corresponding author: Sheng Guan
引用本文:

杨建平, 唐加热克, 管圣. CleanerTM旋转式血栓清除系统在下肢深静脉血栓中的临床应用[J/OL]. 中华临床医师杂志(电子版), 2025, 19(04): 277-283.

Jianping Yang, Tangjiareke, Sheng Guan. Clinical application of CleanerTM rotary thrombus removal system in lower extremity deep vein thrombosis[J/OL]. Chinese Journal of Clinicians(Electronic Edition), 2025, 19(04): 277-283.

目的

CleanerTM旋转式血栓清除系统是一种新型的血栓清除设备,本文探讨其在髂-股静脉血栓形成(I-FVT)的临床应用及安全性。

方法

本研究选取新疆维吾尔自治区人民医院2021年3月~ 2022年2月经下肢彩色多普勒超声确诊为I-FVT且使用CleanerTM旋转式血栓清除系统治疗的15例患者作为研究对象。收集的临床资料包括术前术后彩超、术中影像、双下肢(膝上、膝下15 cm处)周径、围手术期并发症,随访期血栓复发及血栓后综合征发生情况等。利用术中影像及下肢彩超评估静脉管腔通畅度,患肢与健肢周径差减少程度来评价疗效。

结果

15例I-FVT患者中13例仅行CleanerTM旋转式血栓清除治疗,2例术中辅助大口径导管抽吸击碎的残余血栓碎屑,造影显示Ⅲ级血栓清除13例(86.7%)、Ⅱ级2例(13.3%),平均失血量(28.0±15.2)ml,3例左侧髂静脉植入支架,无器械相关的不良事件,无大出血、有症状肺栓塞等并发症发生。术后48 h患肢与健肢膝上15 cm处肢体周径减少(5.07±2.18 vs 0.64±1.58)cm,膝下周径减少(3.02±1.30 vs 0.52±0.89)cm,差异均具有统计学意义(P<0.05)。24个月随访中无血栓复发、PTS发生,Villalta评分平均为(1.33±0.23)。

结论

经皮机械性CleanerTM旋转式血栓清除系统可适应不同直径的下肢静脉管腔、迅速清除血栓、减少血栓残余,避免导管溶栓相关的风险,是一种安全、有效的血栓清除方法。

Objective

To assess the clinical application and safety of the CleanerTM rotary thrombus removal system, a novel thrombus removal device, in iliac-femoral venous thrombosis (I-FVT).

Methods

In this study, 15 patients who were diagnosed with I-FVT by lower limb color Doppler ultrasonography and treated with the CleanerTM rotary thrombus removal system in the People's Hospital of Xinjiang Uygur Autonomous Region from March 2021 to February 2022 were included. The clinical data collected included preoperative and postoperative color ultrasound images, intraoperative images, circumference of both lower limbs (15 cm above and below the knee), perioperative complications, recurrence of thrombosis and post-thrombotic syndrome during follow-up, etc. Intraoperative imaging and lower limb color ultrasound were used to evaluate the patency of venous lumen and the reduction of the circumference difference between the affected and healthy limbs to evaluate the curative effect.

Results

Among the 15 patients with I-FVT, 13 only received CleanerTM rotary thrombolectomy, and 2 had residual thromboclastic debris crushed by assisted large-diameter catheter aspiration. Angiography showed that 13 cases (86.7%) of grade Ⅲ thromboli and 2 cases (13.3%) of grade II were cleared, with an average blood loss of (28.0±15.2) ml. In 3 patients with left iliac vein stent implantation, no device-related adverse events, major bleeding, symptomatic pulmonary embolism, or other complications occurred. Forty-eight hours after surgery, both the limb circumference at 15 cm above the knee (5.07±2.18 cm vs 0.64±1.58 cm) and that below the knee (3.02±1.30 cm vs 0.52±0.89 cm) decreased significantly (P<0.05). There was no recurrence of thrombosis or PTS during the 24-month follow-up, and the average Villalta score was (1.33±0.23).

Conclusion

The percutaneous mechanical CleanerTM rotary thrombus removal system is a safe and effective thrombus removal method, which can be adapted to different diameters of lower limb venous lumen, quickly remove thrombus, reduce residual thrombus, and avoid the risks associated with catheter thrombolysis.

表1 15例患者一般临床资料
图1 CleanerTM旋转式血栓清除及造影图像。图a为CleanerTM导管未工作状态;图b为CleanerTM导管工作状态;图c为血栓清除后造影
表2 15例患者血栓清除程度[例(%)]
表3 患肢与健肢周径差改变及血栓分布评分比较
表4 15例患者患肢肿胀改善程度[例(%)]
表5 24个月内随访情况
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