One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study.

BACKGROUND: A stent with characteristics of a hybrid design may have advantages in improving the patency of symptomatic iliofemoral vein obstruction. This study assessed the safety and effectiveness of the V-Mixtent Venous Stent in treating symptomatic iliofemoral outflow obstruction. METHODS: Eligible patients had a Clinical-Etiologic-Anatomic-Physiologic (CEAP) C classification of ≥ 3 or a Venous Clinical Severity Score (VCSS) pain score of ≥ 2. The primary safety endpoint was the rate of major adverse events within 30 days. The primary effectiveness endpoint was the 12-month primary patency rate. Secondary endpoints included changes in VCSS from baseline to 6 and 12 months, alterations in CEAP C classification, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) scores at 12 months, and stent durability measures. RESULTS: Between December 2020 and November 2021, 171 patients were enrolled across 15 institutions. A total of 185 endovenous stents were placed, with 91.81% of subjects receiving one stent and 8.19% receiving 2 stents. Within 30 days, only two major adverse events occurred (1.17%; 95% confidence interval [CI], 0.14-4.16%), below the literature-defined performance goal of 11% (P < .001). The 12-month primary patency rate (91.36%; 95% CI, 85.93-95.19%; P < .001) exceeded the literature-defined performance goal. VCSS changes from baseline demonstrated clinical improvement at 6 months (- 4.30 ± 3.66) and 12 months (- 4.98 ± 3.67) (P < .001). Significant reduction in symptoms, as measured by CEAP C classification and CIVIQ-14, was observed from pre-procedure to 12 months (P < .001). CONCLUSIONS: The 12-month outcomes confirm the safety and effectiveness of the V-Mixtent Venous Stent in managing symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared to before treatment.

Efficacy of percutaneous mechanical thrombus removal in acute lower extremity deep venous thrombosis.

BACKGROUND: Acute lower extremity deep venous thrombosis (LEDVT) is a common vascular emergency with significant morbidity risks, including post-thrombotic syndrome (PTS) and pulmonary embolism. Traditional treatments like catheter-directed thrombolysis (CDT) often result in variable success rates and complications. AIM: To investigate the therapeutic efficacy of percutaneous mechanical thrombus removal in acute LEDVT. METHODS: A retrospective analysis was performed to examine 58 hospitalised patients with acute LEDVT between August 2019 and August 2022. The patients were categorised into the percutaneous mechanical thrombectomy (PMT) group (n = 24) and CDT group (n = 32). The follow-up, safety and treatment outcomes were compared between the two groups. The main observational indexes were venous patency score, thrombus removal effect, complications, hospitalisation duration and PTS. RESULTS: The venous patency score was 9.04 ± 1.40 in the PMT group and 8.81 ± 1.60 in the CDT group, and the thrombus clearance rate was 100% in both groups. The complication rate was 8.33% in the PMT group and 34.84% in the CDT group, and the difference was statistically significant (P < 0.05). The average hospitalisation duration was 6.54 ± 2.48 days in the PMT group and 8.14 ± 3.56 days in the CDT group. The incidence of PTS was lower in the PMT group than in the CDT group; however, the difference was not statistically significant (P < 0.05). CONCLUSION: Compared with CDT, treatment of LEDVT via PMT was associated with a better thrombus clearance rate, clinical therapeutic effect and PTS prevention function, but the difference was not statistically significant. Moreover, PMT was associated with a reduced urokinase dosage, shortened hospitalisation duration and reduced incidence of complications, such as infections and small haemorrhages. These results indicate that PMT has substantial beneficial effects in the treatment of LEDVT.