Hailong Zou, You Zhao, Zhongjie Ji, Bo Chen, Tianhua Zhang
The Zhongtian SWAM system achieved comparable thrombus clearance to the AngioJet system with significantly shorter procedural time, reduced thrombolytic drug use, lower PE incidence, and markedly attenuated hemolysis. These findings support the SWAM system as a safe and effective alternative for percutaneous mechanical thrombectomy in acute lower extremity DVT.
BACKGROUND: Acute lower extremity deep vein thrombosis (DVT) poses a significant clinical burden due to its association with post-thrombotic syndrome (PTS) and pulmonary embolism (PE). While the AngioJet rheolytic thrombectomy system has established clinical utility, device-related hemolysis and embolic complications remain concerns. The Zhongtian SWAM (Synchronized Wave Aspiration and Maceration) system represents an innovative mechanical thrombectomy technology designed to minimize these adverse effects.
OBJECTIVE: To compare the clinical efficacy and safety profile of the Zhongtian SWAM mechanical thrombectomy system versus the AngioJet rheolytic thrombectomy system in patients with acute lower extremity DVT in a prospective, randomized trial.
METHODS: Between January 2022 and December 2024, 290 patients with acute lower extremity DVT (symptom duration ≤14 days) were randomized 1:1 to the SWAM group (n = 145) or the AngioJet group (n = 145). The primary endpoint was thrombus clearance grade (I-III) assessed by completion venography. Secondary endpoints included procedural time, urokinase dose, symptomatic PE incidence, hemolytic indices (plasma-free hemoglobin [PfHgb]), and 6-month primary patency.
RESULTS: Grade III thrombus clearance was achieved in 78.6% of SWAM patients versus 72.4% of AngioJet patients (P = 0.221). Procedural time was significantly shorter in the SWAM group (42.3 ± 12.7 vs. 58.6 ± 15.4 min; P < 0.001). Urokinase consumption was markedly reduced in the SWAM group (150,000 ± 50,000 vs. 350,000 ± 100,000 IU; P < 0.001). Symptomatic PE occurred in 1.4% versus 5.5% of patients (P = 0.048). Post-procedural PfHgb levels were substantially lower in the SWAM group (112.4 ± 45.3 vs. 438.7 ± 168.5 mg/dL; P < 0.001). Six-month primary patency was 91.0% versus 86.2% (P = 0.152).
CONCLUSIONS: The Zhongtian SWAM system achieved comparable thrombus clearance to the AngioJet system with significantly shorter procedural time, reduced thrombolytic drug use, lower PE incidence, and markedly attenuated hemolysis. These findings support the SWAM system as a safe and effective alternative for percutaneous mechanical thrombectomy in acute lower extremity DVT.