Schneider Peter A, Krievins Dainis K, Halena Grzegorz, Schmidt Andrej, Lyden Sean, Lee Victoria, Hu Minyi, Adelman Mark
Division of Vascular and Endovascular Surgery, University of California, San Francisco, Calif.
Division of Vascular Surgery, Department of Surgery, P. Stradins Clinical University Hospital, Riga, Latvia.
J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1266-1272.e3. doi: 10.1016/j.jvsv.2020.12.080. Epub 2021 Jan 8.
The DETOUR 1 study was performed to assess the safety of the femoral vein as a "pass through" conduit for covered stent placement during fully percutaneous femoropopliteal bypass, also known as the DETOUR procedure.
At eight participating centers in this prospective, single-arm, international trial, 78 patients (82 femoropopliteal lesions) were enrolled. All patients had patent femoral veins measuring ≥10 mm in diameter at baseline. The DETOUR procedure involved delivery of a series of TORUS stent grafts, deployed from contralateral common femoral artery access, to the ipsilateral proximal superficial femoral artery, with entry into the femoral vein and re-entry into the arterial vasculature at the above-the-knee popliteal artery. The TORUS stent grafts are deployed in an overlapping configuration as an arterial-arterial conduit. Due to this novel transvenous approach, we assessed specific considerations related to the venous system to analyze the risk of risk of venous thromboembolic complications. Symptomatic deep vein thrombosis, nonocclusive material associated with the graft such as benign endovenous graft-associated material, pulmonary embolism, Venous Clinical Severity Score (VCSS) and Villalta scores, and luminal occupancy by the stent graft were assessed as the ratio of cross-sectional areas of the stent graft to the native vein at baseline and 1 year after the procedure.
A duplicate femoral vein was present in 20.7% of cases. The majority of patients (86.8%) had a femoral vein luminal area preservation of ≥55%. Thirty-two patients experienced an increase in the vein diameter over time after the procedure, but this pattern of venous remodeling was not uniform. The patients who had a compensatory increase in the vein diameter had a smaller average baseline vein diameter compared with the patients who did not have a compensatory increase in vein diameter (P = .0414). Only two patients (2.4%) developed ipsilateral symptomatic deep vein thrombosis) through 1 year of follow-up. There were no pulmonary embolism in any patient in the series. The overall VCSS and Villata scores did not change during follow-up. Mean VCSS and Villata were 0.8 ± 1.4 and 0.5 ± 1.1 at 1 year, compared with 0.6 ± 1.0 and 0.4 ± 0.9 at baseline, respectively.
As a percutaneous alternative to open surgical bypass for complex femoropopliteal peripheral arterial disease, the transvenous bypass has a low rate of deep venous thrombotic and obstructive complications. Cross-sectional vein area is preserved, and in some patients, the compensatory vein diameter increases with time, supporting the feasibility and safety of using the lower extremity deep venous system as a pass-through conduit for the DETOUR percutaneous femoropopliteal bypass.
NCT02471638.
进行DETOUR 1研究以评估在完全经皮股腘动脉搭桥术（即DETOUR手术）中，股静脉作为覆膜支架置入的“贯通”管道的安全性。
在这项前瞻性、单臂、国际试验的8个参与中心，纳入了78例患者（82个股腘病变）。所有患者在基线时股静脉直径≥10 mm且通畅。DETOUR手术包括从对侧股总动脉入路输送一系列TORUS支架移植物，将其部署到同侧股浅动脉近端，进入股静脉并在膝上腘动脉处重新进入动脉血管系统。TORUS支架移植物以重叠配置作为动脉-动脉管道进行部署。由于这种新颖的经静脉方法，我们评估了与静脉系统相关的特定因素，以分析静脉血栓栓塞并发症的风险。评估有症状的深静脉血栓形成、与移植物相关的非闭塞性物质（如良性静脉内移植物相关物质）、肺栓塞、静脉临床严重程度评分（VCSS）和维拉塔评分，以及支架移植物的管腔占有率，以基线时和术后1年支架移植物与天然静脉的横截面积之比来表示。
20.7%的病例存在双股静脉。大多数患者（86.8%）股静脉管腔面积保留率≥55%。32例患者术后随时间推移静脉直径增加，但这种静脉重塑模式并不一致。与静脉直径没有代偿性增加的患者相比，静脉直径有代偿性增加的患者平均基线静脉直径较小（P = 0.0414）。通过1年的随访，只有2例患者（2.4%）发生同侧有症状的深静脉血栓形成。该系列中任何患者均未发生肺栓塞。随访期间总体VCSS和维拉塔评分未发生变化。1年时平均VCSS和维拉塔评分分别为0.8±1.4和0.5±1.1，而基线时分别为0.6±1.0和0.4±0.9。
作为复杂股腘外周动脉疾病开放手术搭桥的经皮替代方法，经静脉搭桥术深静脉血栓形成和阻塞性并发症发生率较低。静脉横截面积得以保留，并且在一些患者中，代偿性静脉直径随时间增加，这支持了将下肢深静脉系统用作DETOUR经皮股腘动脉搭桥术的贯通管道的可行性和安全性。
NCT-02471638。
Zotero 插件