Results of First in Man implantation of a Prosthetic Venous Valve
marc H Glickman, Jorge H Ulloa
Universidad de los Andes, Bogota, Colombia
INTRODUCTION: 2.4 million people are affected with CVI (Chronic Venous Insufficiency) in the United States. Nearly one million people a year are treated for venous stasis ulcers determined by the Medicare data base. There are few options for those patients who develop post thrombotic disease secondary to deep venous reflux. These options include compression, elevation and wound care
METHODS: A new venous prosthetic valve, the VenoValve®, has been developed to be surgically implanted into the deep venous system, the femoral vein, of patients with C5-C6 disease. This device is a combination of a Stainless-steel frame and porcine aortic monocusp leaflet. 15 patients in Bogota, Colombia have undergone implant of this device into the femoral vein in a First in Man study in patients with C5- C6 disease. All surgeries were performed in an ambulatory surgery center.
RESULTS: Results of 9-month follow up demonstrates: a dramatic decrease in reflux time in 5 out of 6 patients, whom have reached the 9 months follow up period; 68% improvement in reflux time as compared to pre-operative values. Significant improvement in VCSS scores, VAS scores and VEINES QoL scores were also noted. Remaining patients with a mean follow up of 6 months, continue to demonstrate similar improvements. All patients were maintained on long term anticoagulation. Two patients who had venous stasis ulcers for over 2.5 years demonstrated near healing within 90 days of implants. Surgical implant technique has also been perfected during the course this study.
CONCLUSIONS: Results of a First in Man study, using a venous prosthetic valve, appear promising with improvement in clinical outcomes as well as quality of life evaluation and marked reduction in pain in these complex and difficult to treat patient population.
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