Research Pgysician University of Nottingham, United States
Purpose: To evaluate the real-world efficacy and safety of the CLEANER Vac Thrombectomy System in the treatment of symptomatic venous thrombosis.
Materials and Methods: This retrospective, multicenter analysis included 110 adults (≥18 years) with acute or subacute symptomatic venous thrombosis confirmed by duplex US, CT venography, or conventional venography. Vascular access was obtained via femoral, popliteal, or jugular veins. The CLEANER Vac was advanced under fluoroscopic guidance and aspiration thrombectomy performed. Completion venography assessed clearance; adjunctive therapy (angioplasty, rotational maceration) was used at physician discretion. Data collected included demographics, clot burden pre- and post-procedure, clearance rates, number of device passes, adjunctive therapy use, estimated blood loss (EBL), and complications.
Results: Mean patient age was 66.8 years (range 28–88); 26.7% were female. An average of 2 venous segments were treated per patient. Mean pre-treatment clot burden of 85.7% was reduced to 16.5% post-procedure, yielding 85.0% average clearance; 83 patients (75.5%) achieved ≥90% clearance. Results compare favorably with published benchmarks (CLOUT: 88.9% patency, 99.4% single-session completion; PEERLESS: residual thrombus 16.2%, win ratio 5.01 favoring thrombectomy over CDT). Adjunctive therapy was used selectively, most often rotational maceration and balloon angioplasty. The mean number of passes was 2.8; mean EBL was 323 mL. No major device-related complications occurred. Minor access-site hematomas occurred in 2.4%. One death occurred secondary to stent-related rupture, adjudicated unrelated to the device. Active PE was present in 6.1%. Treated indications were primarily peripheral venous thrombosis of the extremities (70%).
Conclusion: The CLEANER Vac achieved high rates of clot clearance with manageable blood loss and a favorable safety profile, supporting its role as an effective thrombectomy option for venous thrombosis. Further prospective studies with larger cohorts and long-term follow-up are warranted to validate durability, refine patient selection, and optimize outcomes.
