Background: Spinal cord ischemia (SCI) is a dreaded complication of thoracic and complex endovascular aortic repair (TEVAR/cEVAR). Controversy exists surrounding cerebrospinal fluid drain (CSFD) use, especially preoperative prophylactic placement, owing to concerns regarding catheter-related complications. However, these risks are balanced by the widely accepted benefits of CSFDs during open repair to prevent and/or rescue patients with SCI. The importance of this issue is underscored by the paucity of data on CSFD practice patterns, limiting the development of practice guidelines. Therefore, the purpose of the present analysis was to evaluate the differences between patients who developed SCI despite preoperative CSFD placement and those treated with therapeutic postoperative CSFD placement.Methods: All elective TEVAR/cEVAR procedures for degenerative aneurysm pathology in the Society for Vascular Surgery Vascular Quality Initiative from 2014 to 2019 were analyzed. CSFD use over time, the factors associated with preoperative prophylactic vs postoperative therapeutic CSFD placement in patients with SCI (transient or permanent), and outcomes were evaluated. Survival differences were estimated using the Kaplan-Meier method.Results: A total of 3406 TEVAR/cEVAR procedures met the inclusion criteria, with an overall SCI rate of 2.3% (n ¼ 88). The SCI rate decreased from 4.55% in 2014 to 1.43% in 2018. Prophylactic preoperative CSFD use was similar over time (2014, 30%; vs 2018, 27%; P ¼ .8). After further exclusions to evaluate CSFD use in those who had developed SCI, 72 patients were available for analysis, 48 with SCI and prophylactic CSFD placement and 24 with SCI and therapeutic CSFD placement. Specific to SCI, the patient demographics and comorbidities were not significantly different between the prophylactic and therapeutic groups, with the exception of previous aortic surgery, which was more common in the prophylactic CSFD cohort (46% vs 23%; P < .001). The SCI outcome was significantly worse for the therapeutic group because 79% had documented permanent paraplegia at discharge compared with 54% of the prophylactic group (P ¼ .04). SCI patients receiving a postoperative therapeutic CSFD had had worse survival than those with a preoperative prophylactic CSFD (50% 6 10% vs 71% 6 9%; log-rank P ¼ .1; Wilcoxon P ¼ .05).Conclusions: Prophylactic CSFD use with TEVAR/cEVAR remained stable during the study period. Of the SCI patients, postoperative therapeutic CSFD placement was associated with worse sustained neurologic outcomes and overall survival compared with preoperative prophylactic CSFD placement. These findings highlight the need for a randomized clinical trial to examine prophylactic vs therapeutic CSFD placement in association with TEVAR/cEVAR.
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.
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