New York Langone Health, New York, NY.
Sentara Vascular Specialists, Norfolk, VA.
J Vasc Surg Venous Lymphat Disord. 2022 Nov;10(6):1251-1259. doi: 10.1016/j.jvsv.2022.04.015. Epub 2022 Jun 14.
The all-comer ClotTriever Outcomes registry assessed indicators of thrombus chronicity in patients with acute, subacute, and chronic lower extremity deep vein thrombosis (DVT). The effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) by chronicity subgroup was also assessed and reported here in this subanalysis.
All-comer patients with lower extremity DVT were enrolled, with no limitation based on the patients' symptom duration. Chronicity was assessed three times and compared: before the procedure based on symptom duration, during the procedure based on available pre-thrombectomy imaging, and visual inspection of the extracted thrombus morphology after thrombectomy. Patients were grouped into acute, subacute, and chronic subgroups according to their post-thrombectomy thrombus chronicity based on thrombus morphology. Analyses on baseline and procedural characteristics along with thrombus removal were performed across subgroups. The effectiveness of thrombus removal was determined by Marder scores adjudicated by an independent core laboratory, with a prespecified primary effectiveness end point of complete or near-complete (≥75%) thrombus removal.
Of the 260 treated limbs from 250 patients, using symptom duration alone, 70.7% were considered acute, 20.9% subacute, and 8.4% chronic. Upon visual inspection, the extracted thrombus chronicity was approximately one-third in each subgroup: 32.7% had acute thrombus, 35.4% subacute thrombus, and 31.9% chronic thrombus. Chronicity assessed using symptom duration alone mismatched the post-thrombectomy chronicity in 55.1% of limbs (P < .0001) with 49.0% being more chronic than suggested by the patients' duration of symptoms. Chronicity assessed using pre-thrombectomy imaging mismatched the post-thrombectomy chronicity in 17.5% of limbs (P < .0001). No patients received thrombolytics and 99.6% were treated in a single session. Complete or near-complete thrombus removal was achieved in a high percentage of limbs regardless of thrombus chronicity: 90.8%, 81.9%, and 83.8% in limbs with acute, subacute, and chronic thrombus, respectively.
This subanalysis from the all-comer ClotTriever Outcomes registry demonstrates that extracted thrombus in DVT may be more chronic than suggested by the patients' duration of symptoms. The addition of imaging is helpful to determine the ability of thrombus to respond to therapy. Irrespective of thrombus chronicity, the ClotTriever system can be effective at removing acute, subacute, and chronic thrombus in a single-session procedure without the need for thrombolytics.
所有患者入组的血栓切除术结果登记处评估了急性、亚急性和慢性下肢深静脉血栓形成（DVT）患者血栓形成慢性的指标。本亚分析还评估并报告了血栓切除术系统（Inari Medical，加利福尼亚州欧文）按慢性亚组的有效性。
所有入组的下肢 DVT 患者均无限制地根据患者的症状持续时间进行治疗。通过三次评估慢性程度并进行比较：手术前根据症状持续时间，手术过程中根据可用的术前血栓切除术影像学检查，以及血栓切除术提取血栓后进行的形态学检查。根据术后血栓慢性程度将患者分为急性、亚急性和慢性亚组，具体分类基于血栓形态。对亚组内的基线和手术特征以及血栓清除进行了分析。通过独立核心实验室裁决的 Marder 评分确定血栓清除的有效性，预设的主要有效性终点为完全或接近完全（≥75%）的血栓清除。
在 250 名患者的 260 条治疗肢体中，仅根据症状持续时间，70.7%被认为是急性，20.9%为亚急性，8.4%为慢性。通过肉眼观察，每个亚组的提取血栓慢性程度约为三分之一：32.7%为急性血栓，35.4%为亚急性血栓，31.9%为慢性血栓。仅根据症状持续时间评估的慢性程度与术后慢性程度不符，55.1%的肢体存在这种情况（P<0.0001），其中 49.0%的肢体比患者的症状持续时间所提示的更慢性。术前影像学评估的慢性程度与术后慢性程度不符，占 17.5%的肢体（P<0.0001）。没有患者接受溶栓治疗，99.6%的患者接受了单次治疗。无论血栓慢性程度如何，都能实现高比例的肢体完全或接近完全的血栓清除：急性、亚急性和慢性血栓的肢体分别为 90.8%、81.9%和 83.8%。
来自所有患者入组的血栓切除术结果登记处的本亚分析表明，DVT 中提取的血栓可能比患者的症状持续时间所提示的更慢性。添加影像学检查有助于确定血栓对治疗的反应能力。无论血栓慢性程度如何，血栓切除术系统都可以在单次治疗过程中有效地清除急性、亚急性和慢性血栓，而无需溶栓治疗。
