Shaikh Abdullah, Marino Angelo G, Siah Michael, Choi Min H, Abramowitz Steven D
Department of Radiology, Allegheny Health Network Research Institute, Pittsburgh, Pennsylvania.
Department of Radiology & Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.
J Soc Cardiovasc Angiogr Interv. 2025 Mar 20;4(4):102571. doi: 10.1016/j.jscai.2025.102571. eCollection 2025 Apr.
After venous stent placement, patients may develop in-stent thrombosis (IST). The RevCore thrombectomy catheter (Inari Medical) is a novel device specifically designed to treat venous IST. Herein, the safety and feasibility of this device are evaluated.
Patients were retrospectively included if they were ≥18 years old, had lower extremity venous IST, and were treated using the study device. The primary end point is technical success, defined as an average postprocedural effective diameter ≥50% and calculated using stent diameter and flow channel diameter on intravascular ultrasound. The safety end points are 30-day device-related serious adverse events, namely mortality, readmission, clinically significant pulmonary embolism, and vessel perforation.
Data from 44 patients (48 treated limbs, 6 treated stent types) from 4 centers were analyzed. Mean age was 54.8 ± 17.1 years, and 23 (52.3%) patients were female. Median IST symptom duration was 8.0 (IQR, 2.0-104.0) weeks. The primary end point was achieved in all 48 limbs. Comparing baseline with postprocedural measurements, effective stent diameter increased from 21.1% ± 26.5% to 89.6% ± 10.1%. No patient met a safety end point. On the first follow-up at 40.0 (29.0-62.5) days, primary patency was demonstrated in 32 (94.1%) of the 34 treated limbs with available data. Six (85.7%) limbs with Clinical-Etiology-Anatomy-Pathophysiology scores of C at baseline had longer-term data available (3.1 ± 0.7 months), and all limbs demonstrated improvement of C disease, with 3 (50.0%) improving to class C.
A thrombectomy procedure for deep-vein IST reestablished patency in all cases and across multiple stent types. Patency was sustained through the first follow-up in 94% of limbs.
静脉支架置入术后，患者可能发生支架内血栓形成（IST）。RevCore血栓切除术导管（Inari Medical公司）是一种专门设计用于治疗静脉IST的新型装置。在此，对该装置的安全性和可行性进行评估。
回顾性纳入年龄≥18岁、患有下肢静脉IST且使用研究装置进行治疗的患者。主要终点为技术成功，定义为术后平均有效直径≥50%，并根据血管内超声检查的支架直径和血流通道直径计算得出。安全终点为30天内与装置相关的严重不良事件，即死亡率、再入院率、具有临床意义的肺栓塞和血管穿孔。
分析了来自4个中心的44例患者（48条治疗肢体，6种治疗支架类型）的数据。平均年龄为54.8±17.1岁，23例（52.3%）患者为女性。IST症状持续时间的中位数为8.0（四分位间距，2.0 - 104.0）周。所有48条肢体均达到主要终点。将基线测量值与术后测量值进行比较，有效支架直径从21.1%±26.5%增加至89.6%±10.1%。没有患者达到安全终点。在40.0（29.0 - 62.5）天的首次随访中，34条有可用数据的治疗肢体中有32条（94.1%）显示出原发性通畅。6条基线时临床病因解剖病理生理学（Clinical-Etiology-Anatomy-Pathophysiology，CEAP）评分C级的肢体（85.7%）有长期数据（3.1±0.7个月），所有肢体的C级疾病均有改善，其中3条（50.0%）改善为C级。
针对深静脉IST的血栓切除术在所有病例和多种支架类型中均重建了通畅。94%的肢体在首次随访时保持了通畅。
