Long-term safety and efficacy outcomes of the Acellular Tissue Engineered Vessel (ATEV) in extremity arterial trauma repair.

BACKGROUND

In cases of arterial injury, use of autologous vein for arterial repair is sometimes not feasible. We previously reported the short-term (ie, 30-day) outcomes of the Acellular Tissue Engineered Vessel (Symvess) in treating extremity vascular injuries. This study evaluates the long-term safety, efficacy, and mechanical durability of Symvess in patients with arterial trauma.

METHODS

This prospective analysis focused on patients from the CLN-PRO-V005 clinical study who sustained noniatrogenic vascular injuries to the extremities, and for whom saphenous vein was not feasible for use. Patients received Symvess and were followed for up to 36 months. Primary outcomes include graft patency, limb salvage, adverse events, and mechanical durability, as assessed through clinical evaluation, imaging, and independent adjudication. Long-term patency, limb salvage, patient survival and infection rates were analyzed by the Kaplan-Meier method.

RESULTS

This study evaluated 54 patients who underwent extremity vascular repair with Symvess and were followed for up to 36 months. Mechanisms of injury were primarily penetrating (57%) or blast-related. Follow-up ranged from 1 day to 42 months (median, 10.7 months), totaling 59.5 patient-years. Primary patency was 58.3%, and secondary patency was 65.7% at month 12; limb salvage at month 12 was 87.3%. Infection-free rates remained at 92.9% from months 3 through 36, with no infections after day 37. All deaths (n = 6; 11.1%) occurred within the first 6 months. No deaths or amputations were attributed to the Symvess conduit. Adverse events and serious adverse events declined over time, and no cases of immune-mediated rejection were observed. There were no cases of unprovoked, spontaneous Symvess rupture or mechanical failure.

CONCLUSIONS

Symvess use for arterial reconstruction in setting of limb threatening arterial injury is associated with low infection rates, and acceptable limb salvage outcomes over 36 months in a high-risk trauma population when use of saphenous vein was not feasible. These results suggest Symvess represents a new alternative when autologous vein is not feasible for arterial reconstruction in extremity trauma.