Human trial using the novel bioprosthetic VenoValve in patients with chronic venous insufficiency

Abstract

BackgroundChronic venous insufficiency (CVI) is a disease characterized by failure of the venous valves that allow blood from the lower limbs to return to the heart. The more severe types of CVI (C4b-C6 disease) significantly influence patients' quality of life (QOL). The treatment options for CVI of the deep system are limited. The present study is the first-in-human study using a prosthetic venous valve, VenoValve, to initially evaluate patient outcomes. We evaluated the feasibility, initial safety, and performance outcomes of the VenoValve. MethodsTen patients with C5-C6 CVI of the deep venous system secondary to postthrombotic syndrome had had a VenoValve surgically implanted into the femoral vein in Bogota, Colombia, under approval of the local ethics committee and Colombian National Food and Drug Surveillance Institute, national health care regulatory body, or the Colombian National Food and Drug Surveillance Agency. Follow-up examinations were conducted postoperatively at 2 and 14 days and then every 30 days for 6 months. The results of the assessments for adverse events, reflux time, disease severity (venous clinical severity scores), pain scores (visual analog scale), and QOL (VEINES-QOL/Sym [venous insufficiency epidemiological and economic study–QOL/symptoms] questionnaire) were documented. ResultsTen patients underwent successful implantation of the VenoValve into the femoral vein as outpatients (100% technical success rate). Of the 10 patients, 9 had undergone VenoValve placement under regional anesthesia and 1 under local anesthesia. Six patients had required bovine patch angioplasty of the vein. Four adverse events occurred, including one case of hematoma at the incision site that was aspirated, 2 cases of superficial wound infection in C6 patients treated with antibiotics, and 1 case of a bleeding complication due to warfarin anticoagulation. One patient's VenoValve had thrombosed at 5 months due to nontherapeutic anticoagulation. Improvements in all 5 patients who had reached the 6-month follow-up mark with the VenoValve were demonstrated during the study period by decreases in the venous clinical severity scores (61% decrease from baseline), visual analog scale for pain scores (57% decrease), and reflux time (40% decrease) and a statistically significant improvement in the VEINES-QOL/Sym questionnaire. The patient with the occluded VenoValve had experienced improvements in all areas except for the reflux time. The latter patient had shown improvement because her ulcer had nearly healed before the occurrence of the thrombosis. ConclusionsThe early results of the first-in-human trial using the VenoValve appear promising, with improvements in clinical outcomes and QOL. The VenoValve is the first prosthetic valve that has shown success at 6 months of follow-up. These findings offer insight for creating better outcomes for these highly disabled patients.