Cost-effectiveness of a prosthetic venous valve versus compression therapies and wound care for treatment of infra-inguinal deep vein reflux.

backgroundPatients with chronic venous insufficiency secondary to infra-inguinal deep vein reflux have few treatment options available to them, given the focus-to-date has been directed toward obstruction rather than reflux. The SAVVE trial was a prospective, non-blinded, single arm, multicenter study designed to assess the safety and efficacy of VenoValve, a bioprosthetic replacement venous valve that is surgically implanted into the deep venous system for treatment of patients with severe infra-inguinal deep venous reflux (Clinical, Etiological, Anatomical, and Pathophysiological classification C4b-C6). This study was designed to estimate the cost-effectiveness of VenoValve compared to the current standard of care for patients with severe infra-inguinal deep vein reflux.

methodsA semi-Markov cohort model was developed to simulate clinical and economic outcomes among patients with deep venous chronic venous insufficiency through health states defined by revised Venous Clinical Severity Score. Patients could experience deep vein thrombosis, pulmonary embolism, ulcer healing, and ulcer recurrence. Key input values were sourced from the SAVVE trial and publicly available sources. Outcomes were compared over 5 years.

resultsTreatment with VenoValve resulted in an average of 2.2 ulcers avoided per-patient over 5 years. These clinical benefits translated into savings of $32,153 per patient, $14,779 per ulcer avoided, and a cost per revised Venous Clinical Severity Score point change of $4065; VenoValve was dominant relative to standard of care (ie, lower costs, higher quality-adjusted life years). Results were robust in one-way sensitivity analyses.

conclusionsIn our model, VenoValve yields substantial economic benefits and improved health outcomes for patients suffering from severe infra-inguinal chronic venous insufficiency.