Vascular Surgery Department, Fundacion Santa Fe de Bogota, Bogota, Colombia.
Faculty of Medicine, Universidad de Los Andes, Bogota, Colombia.
Vasc Endovascular Surg. 2023 Aug;57(6):547-554. doi: 10.1177/15385744231155327. Epub 2023 Feb 6.
Two-year follow-up results from a first-in-human study of patients implanted with the VenoValve are evaluated for supporting the long-term clinical safety and performance of the device.
Chronic Venous Insufficiency (CVI) involves improper functioning of lower limb vein valves and inability of these valves to move blood back towards the heart. CVI symptoms include swelling, varicose veins, pain, and leg ulcers. Currently, there is no cure for this condition and treatment options are limited. This study provides 2-year outcomes for 8 patients who were implanted with the bioprosthetic VenoValve for treating severe CVI with deep venous reflux measured at the mid-popliteal vein. The 6-month and 1-year results were previously published.
Eleven patients with C5 & C6 CVI were implanted with VenoValve into the midthigh femoral vein and followed for 2 years. Assessed clinical outcomes include device-related adverse events, reflux time, disease severity, and pain scores.
All 11 implant procedures were successful. Two-year follow-up data was obtained for 8 subjects: 1 patient died of non-device related causes, 1 was lost to follow-up, and 1 refused to follow-up due to the COVID-19 pandemic. No device-related adverse events occurred between the first and second years of follow-up. Reported 2-year clinical performance outcomes included significant decreases in mean reflux times of the mid-popliteal vein (61%), and significant improvements in mean scores for disease severity rVCSS (56%) and VAS pain (87%).
Results from this study support long-term safety and effectiveness of the VenoValve for improving CVI severity by reducing reflux and thereby venous pressures in the lower extremities. With limited treatments for valvular incompetence involved in severe, deep venous CVI, the device may be considered as a novel therapy. A pivotal trial in the United States is currently being conducted to assess the device in a larger number of patients.
评估首例接受 VenoValve 植入患者的两年随访结果，以支持该设备的长期临床安全性和性能。
慢性静脉功能不全（CVI）涉及下肢静脉瓣膜功能障碍以及这些瓣膜无法将血液回流至心脏。CVI 症状包括肿胀、静脉曲张、疼痛和腿部溃疡。目前，这种疾病尚无治愈方法，治疗选择有限。本研究提供了 8 名患者的两年随访结果，这些患者因严重 CVI 而接受了生物假体 VenoValve 植入治疗，深静脉反流在腘静脉中段测量。6 个月和 1 年的结果先前已发表。
11 名 C5 和 C6 CVI 患者在股静脉中植入 VenoValve，并随访 2 年。评估的临床结果包括与器械相关的不良事件、反流时间、疾病严重程度和疼痛评分。
所有 11 例植入手术均成功。8 名受试者获得了两年的随访数据：1 名患者因非器械相关原因死亡，1 名患者失访，1 名患者因 COVID-19 大流行拒绝随访。在随访的第一至第二年之间未发生与器械相关的不良事件。报告的两年临床性能结果包括腘静脉中段平均反流时间显著减少（61%），疾病严重程度 rVCSS 评分（56%）和 VAS 疼痛评分（87%）显著改善。
本研究结果支持 VenoValve 的长期安全性和有效性，通过降低反流和降低下肢静脉压力来改善 CVI 严重程度。对于严重、深静脉 CVI 中涉及的瓣膜功能不全，该设备可能被视为一种新的治疗方法。目前正在美国进行一项关键性试验，以评估该设备在更多患者中的效果。
