Trends in Use of Cerebrospinal Fluid Drains and Outcomes Related to Spinal Cord Ischemia in the Vascular Quality Initiative

Abstract

neck and juxtarenal abdominal aortic aneurysms. Methods: As part of an ongoing physician-sponsored investigational device exemption trial (NCT01538056), participants were prospectively enrolled and underwent elective FEVAR with a variety of devices. Demographic and procedural details were collected. Data from patients treated specifically with the TREO device were compared with those of patients undergoing elective FEVAR with other commercially available devices. Results: There were 155 patients enrolled in the study, with 41 patients undergoing elective FEVAR with the Terumo Aortic TREO device. Demographics are listed in Table I, and procedural details are listed in Table II. Mean aneurysm size was 65.8 mm. Mean preoperative neck length was 5.6 mm, and mean final seal zone length was 46.0 mm. Average hospital and intensive care unit lengths of stay were 2.4 days and 1.4 days, respectively. There were 103 fenestrations created for 39 superior mesenteric and 64 renal arteries (2.5 fenestrations per patient). Treatment success, defined as successful implantation of the device with all target vessels preserved, was 97.6% (40/41), with only one renal artery not successfully preserved. Mean follow-up was 421 days (1.2 years). There were 15 endoleaks detected on follow-up (type IA, 0; type IB, 0; type II, 14; type III, 1), requiring one reintervention. Three patients died within 30 days, one of an intracranial hemorrhage, one of respiratory failure, and one of ischemic colitis. Compared with other commercially available devices, the TREO device performed favorably in terms of treatment success and had significantly shorter graft modification times (42.1 minutes; P < .0001, one-way analysis of variance) compared with Zenith (54.9 minutes; Cook Medical, Bloomington, Ind) and Medtronic (54.1 minutes; Medtronic, Santa Rosa, Calif). Conclusions: Our institution has exclusive worldwide experience using the Terumo Aortic TREO device for FEVAR. This device provides for a highly efficient and technically successful procedure in the majority of patients. Procedural and fluoroscopy times are low even in the setting of high complexity. Technical success rates and simplification of the FEVAR procedure make this approach a preferred technique for a majority of patients.