Application of a temporary vascular shunt device with puncture-type balloon fixation in a porcine model of hind limb vascular recanalization

This study aimed to evaluate the efficacy of a novel temporary vascular shunt device utilizing puncture balloon fixation. A total of 13 healthy experimental Bama pigs were final enrolled and allocated to three groups (Group A, n = 5; Group B, n = 5; Group C, n = 3). Group A were treated with the novel n-TVS, Group B were treated with a commercially available TVS, and Group C underwent ligation without any diversion measures. The recanalization time of lower limb blood vessels was observed in all three groups. Following recanalization, at 0, 2, and 5 h, the levels of serum CK-MB, lactate, potassium, and other injury and inflammatory markers were measured across the three groups. The n-TVS effectively restored blood flow in severed arteries and securely fixed the catheter sheath under 6 atm pressure. Compared with c-TVS, n-TVS was associated with a significantly shorter time to achieve distal vascular reperfusion (65.0 ± 10.4 s vs. 125 ± 10.8 s, p < 0.05). It effectively restores distal limb blood flow and achieves injury control and minimized minimize blood loss. No adverse events, such as thrombosis or device detachment, were observed with its use. No adverse events, such as thrombosis, occurred in either model group. Moreover, n-TVS achieved comparable results to those of c-TVS in a significantly shorter period of time. In this porcine model, the n-TVS device achieved rapid short-term vascular recanalization.