ABSTRACT
OBJECTIVE: To assess the feasibility, safety, and clinical utility of a fast-track endovascular aneurysm repair (EVAR) protocol. BACKGROUND: Despite recent advances in EVAR technology and techniques, considerable opportunity exists to further improve EVAR efficiency and outcomes. METHODS: Eligible patients underwent elective EVAR with the Ovation Prime stent graft. Successful completion of the fast-track protocol required bilateral percutaneous access, avoidance of general anesthesia and intensive care unit admission, and next-day discharge. Patients were followed through 1-month post-treatment. RESULTS: Between October 2014 and September 2015, 129 patients were enrolled in the study. Vascular access, stent graft delivery, and stent graft deployment were successful in all patients. The fast-track EVAR protocol was successfully completed in 114 (88%) patients. Bilateral percutaneous access was achieved in 97% of cases. Comparing patients who completed fast-track requirements to those who failed at least one component, procedure time was 86 vs. 122 min, use of general anesthesia was 0% vs. 20%, need for intensive care unit stay was 0% vs. 13%, hospital stay was 1.1 vs. 2.1 days, and postoperative groin pain severity (0-10 scale) was 1.2 vs. 4.0. No type I or III endoleaks, serious device-related adverse events, AAA ruptures, surgical conversions, or AAA-related secondary procedures were reported. One (0.9%) patient in the fast-track group died from acute respiratory failure. CONCLUSIONS: Initial results from the LIFE study are encouraging and suggest that a fast-track protocol is feasible, safe, and may improve efficiency of healthcare resource allocation in select patients undergoing EVAR. © 2016 Wiley Periodicals, Inc.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/methods , Length of Stay , Patient Discharge , Aged , Aged, 80 and over , Anesthesia, General , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Delivery of Health Care/organization & administration , Efficiency, Organizational , Elective Surgical Procedures , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Feasibility Studies , Female , Humans , Male , Middle Aged , Operative Time , Pain, Postoperative/etiology , Program Evaluation , Prospective Studies , Prosthesis Design , Registries , Respiratory Insufficiency/etiology , Respiratory Insufficiency/mortality , Stents , Time Factors , Time Management , Treatment Outcome , United StatesABSTRACT
BACKGROUND: Considerable technological advancements have recently been made with endovascular stent grafts for the treatment of abdominal aortic aneurysm (AAA). However, there is opportunity to further improve the efficiency of endovascular aneurysm repair (EVAR), which may yield better patient outcomes and lower perioperative treatment costs. METHODS/DESIGN: The Least Invasive Fast-Track EVAR (LIFE) registry was developed to determine the clinical utility and cost effectiveness of the Ovation® Prime stent graft when used under least invasive conditions using a defined fast-track protocol. The LIFE study is a prospective multicenter post-market registry of the ultra-low profile (14F) 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. The primary endpoint of the study is the proportion of subjects that experience a major adverse event within 30 days of the initial procedure. Primary endpoint data will be compared to a target performance goal. 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02224794.
