The Terumo Aortic (TA) Treo Device is an endograft with unique features that lends itself to fenestrated endovascular aneurysm repair (FEVAR), including low device profile, wide amplitude stent design, and increased inter-stent distance. We sought to describe our initial experience with this device for FEVAR to treat short neck and juxtarenal abdominal aortic aneurysms (JAAA).
As part of an ongoing physician sponsored investigational device exemption clinical trial (#NCT01538056), subjects were prospectively enrolled and underwent elective FEVAR using a variety of devices. Demographic and procedural details were collected. Data from subjects treated specifically with the Treo device between 11/3/16 and 5/2/19 were collected and analyzed.
46 subjects out of a cohort of 161 elective FEVAR were treated with the TA Treo device. The majority of patients were male (70%), with a mean age of 75 and high rates of hypertension (74%), hyperlipidemia (83%), coronary artery disease (33%), and chronic obstructive pulmonary disease (33%). The mean aneurysm size was 66 mm, the mean pre-operative infrarenal neck length was 5 mm, and the mean final seal zone length was 45 mm. Average hospital and ICU lengths of stay were 2.4 and 1.5 days, respectively. 129 fenestrations were created for 44 superior mesenteric and 85 renal arteries (2.8 fenestrations per patient). Technical success, defined as successful implantation of the device with all target vessels preserved, was 98% (45/46), with only one renal artery not successfully preserved. Mean follow up was 598 days. During this time, 18 endoleaks were detected (17 type II, 1 type III), with one patient with a type III endoleak requiring a re-intervention. Three subjects died within 30 days, one due to an intracranial hemorrhage, one due to respiratory failure, and one due to ischemic colitis. Graft modification times of the TA Treo were significantly shorter (43 minutes) versus other commercially available devices (Cook Zenith 55 minutes, and Medtronic Endurant 54 minutes, P<.0001).
Our institution has exclusive world-wide experience using the TA 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 at our institution.