Initial Experience with the Terumo Aortic “Treo” Device For Fenestrated EVAR
Jake F Hemingway, Benjamin W Starnes, Brenda Allen-Kline, Niten Singh
University of Washington, Seattle, WA
BACKGROUND: The Terumo Aortic (TA) TREO Device is an endograft with unique features that lends itself to fenestrated EVAR (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 AAAs. METHODS: As part of an ongoing PS-IDE (#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 were compared to patients undergoing elective FEVAR with other commercially available devices. RESULTS: 155 patients were enrolled in the study, with 41 subjects undergoing elective FEVAR with the TA TREO device. Demographics are listed in Table 1 and procedural details are listed in Table 2. Mean aneurysm size was 65.8mm. Mean pre-op neck length was 5.6mm and mean final seal zone length was 46.0mm. Average hospital and ICU lengths of stay were 2.4 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 fifteen endoleaks detected on follow up (T1a = 0, T1b = 0, T2=13, T3=1), requiring one 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. 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=<0.0001 one-way ANOVA) compared to Zenith (54.9 minutes) and Medtronic (54.1 minutes). CONCLUSIONS: Our institution has exclusive world-wide 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.
| Demographics | N (percentage) |
| Mean Age (years) | 74.5 |
| Male | 30 (73) |
| BMI | 27.4 |
| Hypertension | 29 (71) |
| Coronary Artery Disease | 13 (32) |
| Hyperlipidemia | 35 (85) |
| Chronic Obstructive Pulmonary Disease | 13 (32) |
| Diabetes Mellitus | 6 (15) |
| Chronic Renal Insufficiency | 8 (20) |
| Procedural Detail | Value (SD) |
| Length of Procedure (min) | 143 (56.4) |
| Length of Anesthesia (min) | 188 (61.7) |
| Total Fluoroscopy Time (min) | 30.1 (14.7) |
| EBL (mL) | 77.4 (68.2) |
| Contrast Usage (mL) | 105 (27) |
| Anesthesia (General) | 98% |
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