Significant aortic neck dilation occurs after repair of juxtarenal aneurysms with fenestrated endovascular aneurysm repair.

OBJECTIVE: Aortic neck dilation is a reported mode of failure and can be associated with aneurysm sac expansion after standard endovascular abdominal aortic aneurysm repair (EVAR). Fenestrated EVAR (FEVAR) of the juxtarenal segment increases the seal zone length and is often used to treat this disease progression. However, the frequency and risk factors for neck dilation after FEVAR is unknown. METHODS: We evaluated 124 consecutive FEVARs performed under an investigational device exemption clinical trial for juxtarenal aneurysms (ClinicalTrials.gov identifier, NCT01538056). The aortic diameter at the level of the superior mesenteric artery (SMA; highest fenestration) and lowest renal artery (lowest fenestration) was assessed from computed tomography angiography preoperatively, at 30 days, and annually thereafter. A subgroup analysis was performed to assess aortic neck dilation by the graft type used, degree of oversizing, infrarenal neck length, effective seal zone length, and aortic diameter at the level of the lowest and highest fenestration. Multivariable analysis was then performed to evaluate for predictors of aortic neck dilation. RESULTS: Of the 124 patients, 56 had complete anatomic detail and follow-up data available for ≥3 years. Those without preoperative or follow-up data available were excluded. The aortic diameter had increased significantly by 3 years at the level of both the SMA (2.4 mm; P < .01) and the lowest renal artery (3.2 mm; P < .01). When those with and without aortic dilation (>3 mm) were compared, only oversizing differed at the level of the SMA (14% vs 19%; P < .01). At the level of the lowest renal artery, the graft diameter differed (30 mm vs 28 mm; P = .02). However, after adjusted analysis, these differences were not significant. Finally, a subgroup analysis was performed to evaluate aortic dilation over time stratified by anatomic factors and should that aortic dilation occurred across differing aneurysm diameters, percentage of oversizing, graft types, and seal zone lengths. CONCLUSIONS: Aortic neck dilation in the visceral segment can occur after endovascular repair of juxtarenal aneurysms using FEVAR. Further research is warranted to determine how these changes might affect the long-term outcomes.

Initial experience with the Terumo aortic Treo device for fenestrated endovascular aneurysm repair.

OBJECTIVE: The Terumo aortic (TA) Treo device (Terumo, Somerset, NJ) is an endograft with unique features that lends itself to fenestrated endovascular aneurysm repair (FEVAR), including a low device profile, a wide amplitude stent design, and an increased interstent distance. We have described our initial experience with the Treo device for FEVAR to treat short neck and juxtarenal abdominal aortic aneurysms. METHODS: As part of an ongoing physician-sponsored investigational device exemption clinical trial (ClinicalTrials.gov identifier, NCT01538056), subjects were prospectively enrolled and underwent elective FEVAR using a variety of devices. Demographic and procedural details were collected. The data from subjects treated specifically with the Treo device from November 3, 2016 to May 2, 2019 were collected and analyzed. RESULTS: Of a cohort of 161 patients who had undergone elective FEVAR, 46 had been treated with the TA Treo device. Most patients were men (70%), with a mean age of 75 years 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 preoperative infrarenal neck length was 5 mm, and the mean final seal zone length was 45 mm. The average hospital and intensive care unit lengths of stay were 2.4 and 1.5 days, respectively. A total of 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 of 46), with only one renal artery not successfully preserved. The mean follow-up period was 598 days. During the study period, 18 endoleaks were detected (17 type II and 1 type III), with one patient with a type III endoleak requiring reintervention. Three subjects had died within 30 days, one of intracranial hemorrhage, one of respiratory failure, and one of ischemic colitis. The graft modification times for the TA Treo were significantly shorter (43 minutes) than those for other commercially available devices (Cook Zenith, 55 minutes; Medtronic Endurant, 54 minutes; P < .0001). CONCLUSIONS: Our institution has reported exclusive worldwide experience using the TA Treo device for FEVAR. This device provides for a highly efficient and technically successful procedure for most patients. The procedural and fluoroscopy times were low even in the setting of high complexity. The technical success rates and simplification of the FEVAR procedure have made this approach a preferred technique for most patients at our institution.

Long-term durability of a physician-modified endovascular graft.

We present a unique assessment confirming the long-term durability of a physician-modified endograft deployed as part of an Investigational Device Exemption clinical trial (NCT# 01538056). After receiving an intact postmortem aorta 7 years after the index procedure, we performed microcomputed tomography, necropsy, and metallurgical analysis on the specimen. Microcomputed tomography showed a single strut fracture not noted during previous surveillance. Necropsy revealed no graft fabric compromise, and examination of all three visceral fenestrations showed excellent alignment with no evidence of degradation. Analysis of the strut fracture implicated an initially small, fatigue-induced crack that likely succumbed during postmortem handling.

Cigarette Management System: An operating procedures guide to obtaining and managing investigational tobacco products for regulatory science research.

Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes features of the CMS. The CMS and procedures described have been field tested for the past three years and have dispensed over 160,000 cigarette packs to participants. The CMS can accommodate a range of practical issues with real-world study implementation making it a robust application that is scalable to any study.