Heart and Vascular Center, St. Joseph Hospital, Orange, Calif.
Division of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, NC.
J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):192-200. doi: 10.1016/j.jvsv.2017.10.014. Epub 2017 Dec 28.
The objective of this study was to assess the safety and efficacy of a dedicated venous stent (the VICI VENOUS STENT; VENITI, Fremont, Calif) for treatment of symptomatic iliofemoral venous outflow obstruction.
Thirty patients (24 female; median age, 43 years) were enrolled in the feasibility phase of an international, multicenter investigational device exemption trial from June 2014 to February 2015. All patients exhibited unilateral venous disease with ≥50% stenosis in the iliofemoral veins. Patients within 3 months of acute deep venous thrombosis or with prior surgical or endovascular intervention of the target vessel were excluded. Lesions were primarily of post-thrombotic causes (63%), with a left limb-right limb ratio of 5:1. Nine patients (30%) had lesions extending beneath the inguinal ligament. Median baseline stenosis was 91%; 11 patients (37%) had occlusions.
Fifty-one stents were implanted successfully in 30 patients. Median residual stenosis was 0%, as estimated by venography and intravascular ultrasound. Median follow-up was 701 days. At 12 months, primary, assisted-primary, and secondary patency was 93%, 96%, and 100%, respectively. The stent occluded in two patients through the 12-month window (occurring at 19 and 385 days). Both occlusions occurred in patients presenting with post-thrombotic obstruction. No patients in this cohort exhibited stent fracture at 12 months. Symptomatic improvement of ≥2 points on the Venous Clinical Severity Score was observed in 23 patients (85%) at 12 months (median score improvement, 5 points). There was a median 12-month pain reduction of 20 mm on the visual analog scale score and 15-point improvement on the Chronic Venous Insufficiency Questionnaire score. Scores improved significantly on all three clinical and quality of life scales at 6 and 12 months.
The VICI VENOUS STENT is safe and feasible for treatment of symptomatic iliofemoral venous obstruction, with excellent 12-month patency rates and significant improvement seen in clinical symptoms and quality of life indices. The pivotal phase (170 patients, 22 centers) of this investigational device exemption trial is currently ongoing.
本研究旨在评估专用静脉支架（VICI 静脉支架；VENITI，加利福尼亚州弗里蒙特）治疗症状性髂股静脉流出道阻塞的安全性和疗效。
2014 年 6 月至 2015 年 2 月，30 例（24 例女性；中位年龄 43 岁）患者参加了这项国际多中心研究性器械豁免试验的可行性阶段。所有患者均表现为单侧静脉疾病，髂股静脉狭窄≥50%。3 个月内有急性深静脉血栓形成或目标血管有既往手术或血管内介入治疗的患者被排除在外。病变主要为血栓后原因（63%），左侧肢体与右侧肢体的比例为 5:1。9 例（30%）患者病变延伸至腹股沟韧带以下。中位基线狭窄率为 91%；11 例（37%）患者有闭塞。
30 例患者成功植入 51 枚支架。血管造影和血管内超声估计，中位残余狭窄率为 0%。中位随访时间为 701 天。12 个月时，初始通畅率、辅助初始通畅率和二级通畅率分别为 93%、96%和 100%。2 例患者在 12 个月的窗口期内发生支架闭塞（分别发生在 19 天和 385 天）。这两例闭塞均发生在血栓后阻塞的患者中。在这一组患者中，没有患者在 12 个月时出现支架断裂。12 个月时，23 例患者（85%）静脉临床严重程度评分至少改善 2 分（中位评分改善 5 分）。视觉模拟量表评分中位数疼痛减轻 20mm，慢性静脉功能不全问卷评分改善 15 分。6 个月和 12 个月时，所有三个临床和生活质量量表的评分均显著改善。
VICI 静脉支架治疗症状性髂股静脉阻塞是安全可行的，12 个月通畅率高，临床症状和生活质量指标显著改善。目前正在进行这项研究性器械豁免试验的关键阶段（170 例患者，22 个中心）。
