RESUMO
OBJECTIVE: The clinical outcomes of this first-in-human (FIH) study provide safety and performance results 1 year after implantation of the VenoValve. BACKGROUND: Chronic venous insufficiency (CVI) is most often caused by valve failure in the venous system, which circulates blood from the lower limbs back to the heart and lungs. Severe diseases significantly influence quality of life, and current treatment options are limited. This study provides 1-year patient outcomes from 11 patients implanted with the VenoValve for treatment of severe deep venous CVI in C5 and C6 patients. Earlier results from 6-month follow-ups were previously published. METHODS: This prospective FIH study assessed the safety and performance of the VenoValve surgically implanted in 11 patients with C5 and C6 disease. All patients were followed up for at least 1 year. Assessments for adverse events, reflux time, disease severity, pain scores, and quality of life were reported. RESULTS: Implantation of VenoValve into the deep femoral vein was successful in all patients. Adverse events included 1 hematoma, 3 superficial wound infections, and 1 bleeding complication due to over-anticoagulation. One VenoValve became occluded due to patient non-compliance with anticoagulation medication. One-year clinical outcomes included significant decreases in mean reflux times (54%), and significant improvements in mean disease severity revised venous clinical severity score (56%), mean visual analog scale pain scores (76%), and Venous Insufficiency Epidemiologic and Economic Study QOL/sym scores. CONCLUSIONS: The promising results from this FIH study demonstrate sustained safety and effectiveness of the VenoValve at 1 year post-implantation, and support further study for its use as a novel treatment for severe, deep venous CVI caused by valvular incompetence. A pivotal, prospective, non-blinded, single-arm, multi-center study in the United States with seventy-five (75) patients is in progress to assess the safety and effectiveness of VenoValve in these patients through 30 days and 6 months. The clinical trial is registered on ClinicalTrials.gov under identifier: NCT04943172 (https://clinicaltrials.gov/ct2/show/NCT04943172?term=hancock+jaffe&draw=2&rank=1).