One year safety and effectiveness of the Alto Abdominal Stent Graft in the ELEVATE IDE Trial.

OBJECTIVE: This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the polymer based Endologix Alto Stent Graft System in treating abdominal aortic aneurysms (AAA), with sealing seven millimeters below the top of the fabric in aortic neck diameters from 16 to 30mm.

METHODS: Seventy-five patients were treated with Alto devices between March 2017 to February 2018 in sixteen centers in the United States for infrarenal abdominal aortic aneurysms (AAA) (max diameter ≥5.0 cm in diameter or size increase by 0.5cm in six months or diameter ≥ 1.5 times the adjacent normal aorta). Patients were followed for 30-days, 6 months, and 1-year by clinical evaluation and CT and abdominal x-ray imaging. Treatment success was defined as technical success and freedom from AAA enlargement, migration, type I or III endoleak, AAA rupture, or surgical conversion, stent graft stenosis, occlusion, kink, thromboembolic events, and stent fracture attributable to the device requiring secondary intervention through 12 months. Preoperative characteristics, perioperative variables, follow-up clinical evaluations and radiographic examination results through the first one year were analyzed.

RESULTS: The mean patient age was 73 years with 93% male. The 30-day major adverse event rate (MAE) rate was 5.3%. At one year, the primary endpoint was met with a treatment success rate of 96.7%. Through one-year post-treatment, all-cause mortality was 4.0%. No AAA-related mortality occurred. AAA enlargement was 1.6%, type I endoleak rate was 1.4%, with 100% freedom from type III endoleaks, device migration, device fracture, stent occlusion, or AAA rupture. The device-related secondary intervention rate was 2.7%.

CONCLUSIONS: This prospective study demonstrates the Endologix Alto is safe and effective in treating AAA with appropriate anatomy at one year. The safety endpoint is met by a 5.3% 30 day MAE rate, whereas the effectiveness endpoint is met by a treatment success rate of 96%.