Abstract
Background: Venous thromboembolism (VTE), encompassing deep vein thrombosis (DVT) and pulmonary embolism (PE), remains a significant clinical challenge with substantial morbidity and mortality. Traditional therapeutic approaches, including anticoagulation and systemic thrombolysis, often provide suboptimal outcomes in cases of large-volume thrombus burden, chronic thrombosis, or high-risk patients. Mechanical thrombectomy has emerged as an alternative, offering rapid thrombus removal while reducing the risk of major bleeding complications associated with systemic thrombolysis. The CLEANER Vac™ Thrombectomy System, developed by Argon Medical Devices, represents a novel advancement in percutaneous mechanical thrombectomy, designed to facilitate controlled, large-bore aspiration of venous thrombus in the peripheral venous system.
Objective: This study provides a real-world, multicenter evaluation of 110 patients treated with the CLEANER Vac system across multiple institutions. The primary objective was to assess the procedural efficacy of the device in thrombus clearance, while secondary objectives included evaluating patient demographics (where available), procedural variables, success rates, adjunctive therapy use, estimated blood loss (EBL), and safety outcomes.
Methods: A retrospective, multicenter analysis was conducted across multiple institutions, evaluating patients with acute or subacute symptomatic venous thrombosis who underwent treatment with the CLEANER Vac thrombectomy device. Inclusion criteria included adults aged 18 years or older presenting with venous thrombus confirmed via duplex ultrasonography, CT venography, or conventional venography. Patients were treated using a standardized protocol, with vascular access achieved via femoral, popliteal, or jugular veins depending on thrombus location. The CLEANER Vac device was advanced to the thrombus site under fluoroscopic guidance, and aspiration thrombectomy was performed. Completion venography was utilized to assess clot clearance, and adjunctive therapies such as angioplasty or catheter-directed thrombus morcellation was performed at physician discretion when residual thrombus remained. Data collection included demographic details, pre- and post-procedure clot burden, thrombus clearance rates, adjunctive therapy use, EBL from aspiration, and procedural complications. Data aggregation focused on available metrics, with weighted averages where applicable. Clot burden and clearance were calculated per vessel and averaged per patient, then across cohorts.
Results: The aggregated cohort comprised 110 patients with a mean age of approximately 66.8 years (range: 28–88 years). The gender distribution in the 110 cases was 26.7% female and 73.3% male. On average, 2.0 venous segments were treated per patient across all 110 cases. The mean pre-treatment clot burden was 85.7%, which was reduced to an average post-treatment clot burden of 16.5%, resulting in an average clot clearance rate of 85.0%. A total of 83 patients (75.5%) achieved ≥90% clot clearance, demonstrating a high procedural success rate. These outcomes align with or exceed average success metrics from clinical studies on mechanical thrombectomy for DVT/PE, where procedural success rates typically range from 90-99% and ≥75-90% clot clearance is achieved in 81-100% of cases across registries like CLOUT (88.9% patency at 6 months, 99.4% single-session completion) and the PEERLESS trial (16.2% residual thrombus, win ratio 5.01 favoring large-bore mechanical thrombectomy over CDT), as well as meta-analyses showing
comparable 100% clearance rates to CDT with lower complications (8.33% vs. 34.84%). In the subset of patients requiring adjunctive therapy, rotational maceration was the most commonly used adjunct to aspiration thrombectomy in the initial cohort, with balloon angioplasty frequently utilized to optimize venous patency post-thrombectomy. Number of device passes were an average of 2.8 total passes per procedure. Mean EBL from aspiration, calculated from the numeric procedure data averaged 323 mL. Procedural safety was favorable overall, with no major complications (e.g., symptomatic pulmonary embolism, vessel perforation, or severe bleeding requiring transfusion). Potential access site complications occurred in 2.4% of patients representing minor hematoma not affiliated with the device itself. There was one case of patient death due to post-procedure stent-related extravasation/rupture, adjudicated to be unrelated to the device. Active PE was present in 6.1% of the cases prior to intervention. Procedure types across 110 cases were predominantly peripheral venous thrombosis in upper and lower extremities (70% overall), and other (e.g., ISR, TIPS) in 30% of patients.
Conclusions: This real-world, multicenter retrospective study highlights the efficacy and safety of the 18 French Thrombectomy System in the treatment of symptomatic venous thrombosis across 110 patients. The system demonstrated substantial clot burden reduction (average 85.0% clearance) with high success rates (75.5% achieving ≥90% clearance) comparable to established benchmarks in mechanical thrombectomy literature (e.g., 88.9% patency in CLOUT and superior outcomes in PEERLESS vs. CDT), minimal procedural complications, and manageable EBL (average of 323 mL). These findings support its role as an effective mechanical thrombectomy option for peripheral venous thrombosis management, with advantages in controlled aspiration minimizing blood loss and vessel trauma. The combined results affirm the device's performance. Further prospective and retrospective studies with larger cohorts, complete data capture, and long-term follow-up are warranted to validate sustained efficacy, durability of outcomes, and optimization for patient selection.