Perioperative and midterm outcomes of thoracic endovascular aneurysm repair using commercially available fenestrated stent graft (Najuta endograft)

Abstract

multticenter post-market registry of the ultra-low profile (14 F) Ovation Prime stent graft when used in the treatment of patients with AAA 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. A total of 250 subjects will be enrolled at up to 40 sites in the United States. The first subject in this study was enrolled in October 2014 and enrollment is anticipated to continue through mid-2016. Results: The primary endpoint of the LIFE registry is the incidence of major adverse events (MAE) through 30 days' follow-up. All adverse events are adjudicated by a Clinical Events Committee. Secondary endpoints of the LIFE registry include operative details, technical success, procedure-and device-related complications, patient convalescence, and ability to successfully complete all components of the fast-track protocol. Patients will be followed in the LIFE registry for 30 days posttreatment. Conclusions: The recent development of ultra low-profile stent grafts enables EVAR using least invasive methods. A structured fast-track EVAR protocol may yield clinical and cost benefits versus standard EVAR.