Vasudevan Thodur, Robinson David A, Hill Andrew A, Ouriel Kenneth, Holden Andrew, Gagnon Joel, Machan Lindsay, Nammuni Isuru, Thomas Shannon D, Varcoe Ramon L
Department of Vascular Surgery, The Alfred, Melbourne, Australia.
Department of Vascular Surgery, Royal Prince Alfred Hospital, Sydney, Australia.
J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1200-1208. doi: 10.1016/j.jvsv.2020.12.073. Epub 2021 Jan 19.
Definitive treatment techniques for symptomatic deep venous reflux have been relegated to complex and invasive open surgery which is rarely performed today. The BlueLeaf System provides an endovenous method for the formation of deep venous valves without an implant, avoiding the complications associated with permanent foreign materials. The system has the adaptability to form valves within the femoral and popliteal veins at multiple levels in a single procedure. The aim was to determine the midterm safety and efficacy of this novel device in an early feasibility study.
Feasibility of endovenous deep venous valve formation was assessed in patients with chronic venous insufficiency (Clinical, Etiologic, Anatomic, Pathophysiologic [CEAP] 4-6). Follow-up was completed through 1 year, assessing vein patency and reflux time (RT) with duplex ultrasound examination. Venous clinical improvement was evaluated using the revised Venous Clinical Severity Scale.
Of the 14 patients, 13 (93%) had successful formation of at least one monocuspid valve, with a mean number of 1.4 valves (range, 0-3 valves) per patient. There were no device-related serious adverse events during the index procedure. There were no deep venous thromboses reported at any time point, including 10 patients through the 1-year follow-up. In patients with at least one valve formed, site reported duplex ultrasound examination measured the average RT in the popliteal vein below valve formations, was 3.0 ± 1.0 seconds at baseline, 3.9 ± 3.1 seconds at 30 days, and 3.6 ± 2.1 seconds at 360 days. The revised Venous Clinical Severity Scale improved in all 13 successfully treated patients, decreasing from 15.0 ± 6.0 at baseline to 11.6 ± 5.5 at 30 days, 10.7 ± 5.3 at 210 days, and 9.4 ± 5.0 at 360 days (P = .0002; baseline to 360 days). Among the five patients with an ulcer who reached the 360-day follow-up visit, all (100%) healed at least one ulcer. Two patients (40%) healed all ulcers and three patients (60%) had a decrease in ulcers number but remained at C6 at 360 days. The five patients with a total of nine active ulcers at baseline had four active ulcers at 360 days.
The BlueLeaf System holds promise as a minimally invasive means to safely form fully autogenous deep venous valves. Reconstructed deep veins remained patent, without deep venous thrombosis and symptomatic improvement was consistently observed; however, a decrease in the RT was not. Incremental device design improvements have been undertaken to improve valve function. The results of these iterations await further clinical evaluation.
有症状的深静脉反流的确定性治疗技术已被归为复杂且侵入性的开放手术，如今这种手术很少进行。BlueLeaf系统提供了一种无需植入物即可形成深静脉瓣膜的腔内方法，避免了与永久性异物相关的并发症。该系统具有在一次手术中在多个层面的股静脉和腘静脉内形成瓣膜的适应性。本早期可行性研究的目的是确定这种新型装置的中期安全性和有效性。
对慢性静脉功能不全（临床、病因、解剖、病理生理[CEAP] 4 - 6级）患者评估腔内深静脉瓣膜形成的可行性。通过1年完成随访，用双功超声检查评估静脉通畅情况和反流时间（RT）。使用修订的静脉临床严重程度量表评估静脉临床改善情况。
14例患者中，13例（93%）成功形成至少一个单尖瓣，每位患者平均形成1.4个瓣膜（范围为0 - 3个瓣膜）。在索引手术期间没有与装置相关的严重不良事件。在任何时间点均未报告深静脉血栓形成，包括10例患者的1年随访。在至少形成一个瓣膜的患者中，现场报告的双功超声检查测量瓣膜形成下方腘静脉的平均RT，基线时为3.0±1.0秒，30天时为3.9±3.1秒，360天时为3.6±2.1秒。13例成功治疗的患者的修订静脉临床严重程度量表均有改善，从基线时的15.0±6.0降至30天时的11.6±5.5、210天时的10.7±5.3和360天时的9.4±5.0（P = .0002；基线至360天）。在达到360天随访的5例溃疡患者中，所有患者（100%）至少愈合一个溃疡。2例患者（40%）愈合了所有溃疡，3例患者（60%）溃疡数量减少，但在360天时仍为C6级。基线时共有9个活动性溃疡的5例患者在360天时还有4个活动性溃疡。
BlueLeaf系统有望成为安全形成完全自体深静脉瓣膜的微创手段。重建后的深静脉保持通畅，无深静脉血栓形成，且持续观察到症状改善；然而，反流时间并未缩短。已对装置设计进行了渐进式改进以改善瓣膜功能。这些迭代的结果有待进一步临床评估。
