Two-Year Results of a First-In-Human Study in Patients Surgically Implanted With a Bioprosthetic Venous Valve, the VenoValve in Patients With Severe Chronic Venous Insufficiency.

OBJECTIVE: Two-year follow-up results from a first-in-human study of patients implanted with the VenoValve are evaluated for supporting the long-term clinical safety and performance of the device. BACKGROUND: Chronic Venous Insufficiency (CVI) involves improper functioning of lower limb vein valves and inability of these valves to move blood back towards the heart. CVI symptoms include swelling, varicose veins, pain, and leg ulcers. Currently, there is no cure for this condition and treatment options are limited. This study provides 2-year outcomes for 8 patients who were implanted with the bioprosthetic VenoValve for treating severe CVI with deep venous reflux measured at the mid-popliteal vein. The 6-month and 1-year results were previously published. METHODS: Eleven patients with C5 & C6 CVI were implanted with VenoValve into the midthigh femoral vein and followed for 2 years. Assessed clinical outcomes include device-related adverse events, reflux time, disease severity, and pain scores. RESULTS: All 11 implant procedures were successful. Two-year follow-up data was obtained for 8 subjects: 1 patient died of non-device related causes, 1 was lost to follow-up, and 1 refused to follow-up due to the COVID-19 pandemic. No device-related adverse events occurred between the first and second years of follow-up. Reported 2-year clinical performance outcomes included significant decreases in mean reflux times of the mid-popliteal vein (61%), and significant improvements in mean scores for disease severity rVCSS (56%) and VAS pain (87%). CONCLUSIONS: Results from this study support long-term safety and effectiveness of the VenoValve for improving CVI severity by reducing reflux and thereby venous pressures in the lower extremities. With limited treatments for valvular incompetence involved in severe, deep venous CVI, the device may be considered as a novel therapy. A pivotal trial in the United States is currently being conducted to assess the device in a larger number of patients.

Clinical outcomes of radiofrequency ablation for patients with varicose veins of the lower extremities combined with grade II iliac vein compression.

BACKGROUND: Iliac vein compression (IVC) is a common condition in patients with varicose veins (VVs) of the legs. IVC has been classified into three grades in previous studies. Grade II IVC is defined by >50% stenosis without the development of collateral circulation. The purpose of the present study was to investigate the outcomes of radiofrequency ablation (RFA) for patients with VVs combined with grade II IVC. METHODS: A retrospective analysis was conducted of 339 patients who had undergone RFA for VVs of the left leg from March 2017 to January 2019. Duplex ultrasonography, computed tomography venography, and venography were performed to evaluate for grade II IVC. All the patients were divided into two groups. Group 1 included patients with VVs only, and group 2, patients with VVs combined with grade II IVC. Propensity score matching was used to ensure an even distribution of confounding factors between groups. The venous clinical severity score (VCSS) and chronic venous insufficiency questionnaire (CIVIQ) score were recorded during the 12-month follow-up. Occlusion of the truncal veins was evaluated using duplex ultrasound scans. RESULTS: Using 1:1 propensity score matching, 50 pairs of patients were enrolled in the present analysis. The average age of groups 1 and 2 was 58.7 ± 13.1 and 60.1 ± 7.1 years, respectively. The VCSS had decreased significantly from baseline to 12 months postoperatively (group 1, from 5 to 1; group 2, from 4 to 1; P < .01). A significant increase in the CIVIQ score was found between the baseline and 12-month evaluations for both groups (group 1, from 62.5 to 69; group 2, from 63 to 70; P < .01). The truncal occlusion rate was 98% in both groups at 12 months. No significant differences were found between the two groups in the VCSS, CIVIQ score, procedure complications, or occlusion rate during the 12-month follow-up. CONCLUSIONS: RFA is effective for patients with VVs combined with grade II IVC.