Prospective LIFE Registry Studies the Endologix 14-F Ovation Prime EVAR Stent Graft

September 20, 2016—Zvonimir Krajcer, MD, presented the LIFE study during the second Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which is sponsored by VIVA Physicians, Inc. and held September 18–22, 2016 at the Wynn Las Vegas in Las Vegas, Nevada.

Using the fast­-track endovascular aneurysm repair (EVAR) protocol, the LIFE (Least-Invasive Fast­-Track EVAR) study is a prospective, nonrandomized, postmarket registry designed to demonstrate the clinical and cost benefits associated with the ultra-low­-profile (14-F) Ovation Prime abdominal stent graft platform (Endologix, Inc.) under the least-invasive conditions defined by the protocol.

As explained by Dr. Krajcer, the successful completion of the fast­-track EVAR protocol required bilateral percutaneous access, avoidance of general anesthesia and intensive care unit admission, and next­-day discharge. The study enrolled 250 eligible patients treated electively at up to 40 centers in the United States.

Dr. Krajcer reported at VIVA 16 that vascular access, stent graft delivery, and stent graft deployment were successful in the 250 patients. Bilateral percutaneous access was achieved in 97% of cases. The fast­-track EVAR protocol was successfully completed in 216 (87%) patients.

Comparing the fast-­track cohort (n = 216) to the non–fast­-track cohort (n = 34), procedure time was 84 versus 110 minutes, use of general anesthesia was 0% versus 18%, need for intensive care unit stay was 0% versus 32%, and hospital stay was 1.2 days versus 1.9 days.

Patients were followed through 1 month after treatment. No device­-related or procedure­-related major adverse events, abdominal aortic aneurysm (AAA) ruptures, surgical conversions, or AAA-­related secondary interventions were reported in the study. One (0.9%) patient in the fast­-track group died from acute respiratory failure. Freedom from type I/III endoleak was 99% and 100%, respectively.

A cost-­utility analysis compared fast­-track EVAR to an EVAR control group of 8,306 patients identified from a contemporary inpatient discharge database. Completion of the fast­-track protocol was associated with over $21,000 in perioperative cost savings relative to standard EVAR, largely driven by differences in hospital stay costs. Additionally, the 30­-day hospital readmission rate in the LIFE study was 1.6% compared to 8% reported for EVAR from the American College of Surgeons National Surgical Quality Improvement Program.

Fast­-track EVAR using the Ovation Prime stent graft is feasible, safe, and lowers perioperative costs, and the results warrant establishment of a fast­-track EVAR protocol in experienced EVAR centers, concluded Dr. Krajcer at VIVA 16.