Research Fellow Mayo Clinic Rochester, Minnesota, United States
Objective: According to the Medicare database, 2.4 million people are affected with chronic venous insufficiency in the United States, with nearly one million treated for venous ulcerations per year. There are few options for patients that develop post-thrombotic syndrome with deep venous reflux. The mainstay of treatment is a non-surgical approach with compression, elevation, and wound care. VenoValve® has reached the clinical trial stage with excellent one-year and 24-month results in first-in-human trial (FIH) studies, being the only prosthetic valve with evidence of sustained efficacy, safety, and patency. We present our 36 months of follow-up, the first of its kind for a prosthetic device surgically placed in the femoral vein.
Methods: A novel venous bioprosthetic valve, VenoValve®, has been developed to be surgically implanted into the femoral vein in patients with C5-C6 disease. This device combines a 10 mm stainless-steel frame and a porcine aortic monocusp leaflet, producing unidirectional blood flow. After rigorous preclinical and animal testing established durability and minimization of risk, a first-in-human trial was conducted with promising results in terms of clinical improvement, reflux times, and quality of life. This is the first and longest report of a prosthetic device in the deep venous system in humans.
Results: 11 patients with C5-C6 disease underwent implant of the device into the femoral vein in the First-in-Man study in Bogota, Colombia. Originally, surgeries were performed in an ambulatory surgery center. 36-month results are reported with 8 patients, demonstrating a return to normal reflux time in 8 patients, with a 56 % improvement in reflux time over pre-operative levels. Significant improvements in VCSS scores, VAS scores, and VEINES QoL scores were also noted. No recurrent ulcers were seen in the C6 or C5 patients. The 36-month results include an unprecedented patency rate of 100% (8/8 patients), a fact that distinguishes VenoValve® from its predecessors. All patients were maintained on long-term anticoagulation. The operative technique was also perfected during this study.
Conclusions: The three years results of a First-in-Man study using a venous bioprosthetic valve appear promising with improving clinical outcomes, quality of life, and a marked reduction in pain. The device remained patent at 36 months in 8 patients, free of life-threatening adverse events. Due to the complexity and variable severity of the post-thrombotic syndrome, VenoValve® does appear to offer these patients long-term stability and improvement in their disease. We have developed a promising alternative for a group of complex and functionally impaired patients. A larger clinical/pivotal trial is ongoing in the U.S, with initial results to be reported soon.