Department of Surgery at Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, Bethesda, Maryland.
The Johns Hopkins Hospital, School of Medicine, Baltimore, Maryland.
J Surg Res. 2023 Nov;291:116-123. doi: 10.1016/j.jss.2023.04.012. Epub 2023 Jun 23.
Vascular reconstruction requires technical expertise and is often time consuming. As a novel alternative to traditional hand-sewn vascular anastomoses, the VasoLock (VL), is a nonabsorbable, sutureless anastomosis device with traction anchors designed to hold free artery ends together. These anchors do not penetrate the vessel wall but adhere by leveraging the elasticity of the vessels to fasten blood vessels together. This pilot study assesses the performance and patency of this novel device in a porcine model of femoral artery injury.
Female swine (n = 7) underwent femoral artery exposure for a total of 10 VL implanted. Study animals underwent hemodilution to a target hematocrit of 15% and ROTEM was used to assess coagulopathy, followed by an arterial injury via transection. The VL was inserted without any sutures. Flow-probe monitors were positioned proximal and distal to the device and flow rates were measured continuously for a total of 90 min. Flow was analyzed and presented as a ratio of distal to proximal flow with the slope of this ratio across time subsequently determined. Angiographic assessment was completed to evaluate for patency and technical complications after 90 min of implant.
The average animal weight was 44.1 ± 3.2 kg. The average mean arterial pressure at the time of implant was 51.2 ± 7.8 mmHg, median heart rate was 77.4 (IQR = 77.25-157.4) beats per minute, and average temperature was 36.1 ± 1.5°C. The baseline hematocrit was 13.5 ± 3.0%, average pH was 7.20 ± 0.1, average clotting time was 154.1 ± 58.7 s and average clot formation time was 103.4 ± 10.9 s all demonstrating the acidotic, hypothermic, and coagulopathic state of the swine at the time of insertion. During the 90-min observation period, the average flow gradient identified across the VL was 0.99 ± 0.24, indicating no significant change in flow across the VL. The average slope of the gradients was 0.0005 (P = 0.22), suggesting the ratio of proximal and distal flow did not change over the 90 min. Following 90 min of dwell time, all VL were patent without technical complication. Angiographic assessment at 90 min demonstrated no evidence of dissection, device migration, arterial extravasation, or thromboembolism with any of the 10 devices.
This pilot study demonstrated technical feasibility of the novel VL device over a 90-min observation period. All VL were patent and no negative events or complications were identified. This technology demonstrated significant promise in a coagulopathic state: additional investigation, involving long-term survival, is warranted for further validation.
血管重建需要专业技术，并且通常耗时较长。作为传统手工血管吻合术的一种新替代方法，VasoLock（VL）是一种不可吸收的无缝线吻合装置，带有牵引锚，旨在将游离动脉端固定在一起。这些锚钉不会穿透血管壁，而是通过利用血管的弹性来附着，从而将血管固定在一起。这项初步研究评估了这种新型装置在猪股动脉损伤模型中的性能和通畅性。
雌性猪（n=7）接受股动脉暴露，共植入 10 个 VL。研究动物接受目标血细胞比容为 15%的血液稀释，使用 ROTEM 评估凝血功能障碍，然后通过横断造成动脉损伤。VL 无需任何缝线即可插入。在装置的近端和远端放置流量探头，并连续测量 90 分钟的流量。分析流量并以装置远端与近端的流量比表示，并随后确定该比值随时间的斜率。在植入 90 分钟后，通过血管造影评估通畅性和技术并发症。
平均动物体重为 44.1±3.2kg。植入时平均平均动脉压为 51.2±7.8mmHg，中位数心率为 77.4（IQR=77.25-157.4）次/分钟，平均体温为 36.1±1.5°C。基础血细胞比容为 13.5±3.0%，平均 pH 值为 7.20±0.1，平均凝血时间为 154.1±58.7 秒，平均凝血形成时间为 103.4±10.9 秒，所有这些都表明了猪在插入时的酸中毒、低体温和凝血功能障碍状态。在 90 分钟的观察期间，VL 上确定的平均流量梯度为 0.99±0.24，表明 VL 上的流量没有明显变化。梯度的平均斜率为 0.0005（P=0.22），表明近端和远端流量的比值在 90 分钟内没有变化。经过 90 分钟的驻留时间，所有 VL 均保持通畅，无技术并发症。90 分钟时的血管造影评估显示，10 个装置均无夹层、装置迁移、动脉外渗或血栓栓塞等不良事件。
这项初步研究表明，新型 VL 装置在 90 分钟的观察期内具有技术可行性。所有 VL 均保持通畅，未发现任何负面事件或并发症。该技术在凝血功能障碍状态下显示出显著的应用前景，需要进一步的长期生存研究来进一步验证。
