Preliminary Economic Data from LIFE Registry Support Fast-Track EVAR Approach With TriVascular's 14-F Ovation Stent Graft

November 3, 2015—At VIVA 15, the 13th annual Vascular InterVentional Advances meeting, Zvonimir Krajcer, MD, concluded that preliminary results of the LIFE study are encouraging and demonstrate improved patient outcomes and compelling economic data when utilizing the ultra–low-profile 14-F Ovation abdominal stent graft platform (TriVascular, Inc.) with a fast-track endovascular aneurysm repair (EVAR) protocol.

The data were revealed during the second of two Late-Breaking Trials sessions at the meeting, which is sponsored by VIVA Physicians, Inc., and is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

As summarized by VIVA, the LIFE—Least Invasive Fast-Track EVAR—registry was developed to determine the clinical utility and cost effectiveness of the 14-F Ovation platform when used under least-invasive conditions. The prospective multicenter registry is evaluating the treatment of patients with abdominal aortic aneurysm using a fast-track protocol consisting of appropriate patient selection, bilateral percutaneous access, avoidance of general anesthesia and intensive care unit admission, and next-day discharge.

In the registry, patients are enrolled and treated with EVAR if the investigator determines that the patient can meet the fast-track protocol based on medical history and aortoiliac anatomy. After enrollment, patients remain in the study regardless of whether all components of the fast-track program are completed. Patient outcomes are recorded through hospital discharge and at the 30-day follow-up visit. A total of 250 patients will be enrolled at up to 40 sites in the United States.

The primary endpoint of the study is the proportion of patients that experience a major adverse event within 30 days of the initial procedure. No events have been adjudicated to be a major adverse event and there have not been any device-related serious or nonserious adverse events reported to date. Secondary endpoints include treatment success, vascular access complications, technical success, freedom from rupture, conversion, type I and III endoleaks and migration, hospital stay, quality of life, groin pain, etc., reported Dr. Krajcer at VIVA.