Bioengineered human blood vessels to treat hospital-acquired vascular complications

Background: Complications of vascular surgery and vascular procedures, including iatrogenic injuries, planned oncological tumor resections, and steal syndrome after arteriovenous access placement, are increasingly common in modern medical care. Harvesting of autologous vein to address these consequences and complications produces injury to the patient, and suitable vein may not be accessible in the urgent/emergent setting. Methods: The objective is to evaluate the performance of the acellular tissue engineered vessel (ATEV) in the repair of sequelae and complications of vascular procedures. CLN-PRO-V005 (clinicaltrials.gov NCT03005418; “V005”) is a multicenter, single-arm clinical trial at 19 level I trauma centers in the United States and Israel, that evaluated the safety and efficacy of the ATEV in the repair of arterial injuries. Twelve patients analyzed for this report sustained hospital-acquired iatrogenic injury, or incurred sequelae or complications of vascular surgical procedures, and had no autologous vein for repair. Results from these 12 patients have not been previously reported. Patients received the ATEV, which is a bioengineered vascular conduit grown from human vascular cells. Key outcome measures were patency, limb salvage, conduit infection, and patient survival, at day 30 and at completion of follow-up. Patients were followed for 36 months, or until withdrawal, death. or formal data closure. Results: The 12 patients in the V005 study with hospital-acquired iatrogenic injuries or consequences of vascular procedures were 50% male, 58% Caucasian, and aged 57.0 ± 16.9 years. Of all cases, 67% occurred in the lower extremities. The mean length of ATEV implanted was 12.1 ± 9.8 cm. The average follow-up was 23.3 ± 15.9 months. At day 30, all 10 evaluable patients had documented patency; 1 patient withdrew consent at day 2 with a patent conduit, and 1 patient died on day 12 with a patent conduit. At the conclusion of follow-up or at data cutoff, death, or withdrawal, 11 of 12 total patients retained patency, of whom 7 had primary patency, 3 had primary-assisted patency, 1 had secondary patency, and 1 patient underwent explantation of the ATEV. There were no losses of the treated limbs. There were no confirmed infections of the ATEV conduit reported for any patient. Four of the 12 patients died during follow-up, with no deaths related to ATEV. Conclusions: ATEV can provide limb salvage and durable patency in patients experiencing iatrogenic injury or complications and sequelae of planned vascular procedures.