Fundacion Santa Fe de Bogota, 27991Universidad de Los Andes, Bogota, Colombia.
Hancock Jaffe Laboratories, Irvine, CA, USA.
Vasc Endovascular Surg. 2022 Apr;56(3):277-283. doi: 10.1177/15385744211073730. Epub 2022 Feb 7.
The clinical outcomes of this first-in-human (FIH) study provide safety and performance results 1 year after implantation of the VenoValve.
Chronic venous insufficiency (CVI) is most often caused by valve failure in the venous system, which circulates blood from the lower limbs back to the heart and lungs. Severe diseases significantly influence quality of life, and current treatment options are limited. This study provides 1-year patient outcomes from 11 patients implanted with the VenoValve for treatment of severe deep venous CVI in C5 and C6 patients. Earlier results from 6-month follow-ups were previously published.
This prospective FIH study assessed the safety and performance of the VenoValve surgically implanted in 11 patients with C5 and C6 disease. All patients were followed up for at least 1 year. Assessments for adverse events, reflux time, disease severity, pain scores, and quality of life were reported.
Implantation of VenoValve into the deep femoral vein was successful in all patients. Adverse events included 1 hematoma, 3 superficial wound infections, and 1 bleeding complication due to over-anticoagulation. One VenoValve became occluded due to patient non-compliance with anticoagulation medication. One-year clinical outcomes included significant decreases in mean reflux times (54%), and significant improvements in mean disease severity revised venous clinical severity score (56%), mean visual analog scale pain scores (76%), and Venous Insufficiency Epidemiologic and Economic Study QOL/sym scores.
The promising results from this FIH study demonstrate sustained safety and effectiveness of the VenoValve at 1 year post-implantation, and support further study for its use as a novel treatment for severe, deep venous CVI caused by valvular incompetence. A pivotal, prospective, non-blinded, single-arm, multi-center study in the United States with seventy-five (75) patients is in progress to assess the safety and effectiveness of VenoValve in these patients through 30 days and 6 months. The clinical trial is registered on ClinicalTrials.gov under identifier: NCT04943172 (https://clinicaltrials.gov/ct2/show/NCT04943172?term=hancock+jaffe&draw=2&rank=1).
这项首次人体（FIH）研究的临床结果提供了植入 VenoValve 一年后的安全性和性能结果。
慢性静脉功能不全（CVI）最常由静脉系统中的瓣膜失效引起，静脉系统将血液从下肢循环回心脏和肺部。严重疾病极大地影响生活质量，目前的治疗选择有限。这项研究提供了 11 名患者植入 VenoValve 治疗 C5 和 C6 患者严重深部静脉 CVI 的 1 年患者结果。之前发表了 6 个月随访的早期结果。
这项前瞻性 FIH 研究评估了 11 名 C5 和 C6 疾病患者手术植入的 VenoValve 的安全性和性能。所有患者均随访至少 1 年。报告了不良事件、反流时间、疾病严重程度、疼痛评分和生活质量评估。
所有患者均成功将 VenoValve 植入股深静脉。不良事件包括 1 例血肿、3 例浅表伤口感染和 1 例因过度抗凝导致的出血并发症。由于患者不遵守抗凝药物治疗，1 个 VenoValve 发生阻塞。1 年的临床结果包括平均反流时间显著减少（54%），平均疾病严重程度修订静脉临床严重程度评分（56%）、平均视觉模拟疼痛评分（76%）和静脉功能不全流行病学和经济研究 QOL/症状评分显著改善。
这项 FIH 研究的有前景结果表明，植入 VenoValve 1 年后持续安全有效，支持进一步研究将其作为瓣膜功能不全引起的严重深部静脉 CVI 的新型治疗方法。一项在美国进行的、有 75 名患者参与的、前瞻性的、非盲的、单臂、多中心研究正在进行中，通过 30 天和 6 个月评估 VenoValve 在这些患者中的安全性和有效性。临床试验在 ClinicalTrials.gov 上注册，标识符为：NCT04943172（https://clinicaltrials.gov/ct2/show/NCT04943172？term=hancock+jaffe&draw=2&rank=1）。
