Anatomic Eligibility for Commercial Branched Endograft Repair of Thoracoabdominal Aortic Aneurysms

Abstract

Background: First-generation "off-the-shelf" branched endovascular stent grafts are in development for treatment of thoracoabdominal aortic aneurysms (TAAAs). Prior studies have assessed eligibility rates among highly selected cohorts of patients referred for endovascular treatment, and the broader applicability of these devices to all patients with TAAA is unknown. The aims of this study were to assess the overall suitability of the 3 commercial 4-branched devices with or without adjunct procedure(s) in an unselected cohort of patients with TAAA and to identify areas for improvement in the next generation of devices.

Methods: A retrospective review of three-dimensional centerline reconstructions of contrast-enhanced computed tomography (CT) imaging was performed in consecutive patients with TAAA seen between 2013 and 2017. All patients with contrast-enhanced CT imaging were included, regardless of prior evaluation for suitability for endovascular repair. Eligibility for a device was assessed based on instructions for use (IFU) from the device manufacturer along with prespecified anatomic criteria. Adjunct procedures were defined as carotid-subclavian revascularization, target vessel endovascular intervention, and iliac conduit/revascularization.

Results: Of 165 patients with TAAA, 122 had CT scans adequate for study inclusion. Eighteen patients (14.8%) were eligible for at least 1 device by IFU, and 41 (33.6%) could have been made eligible for at least 1 device by an adjunct procedure. Sixty-three (51.6%) were not eligible for any device within IFU even with adjunct procedures, including 31 of 32 patients with TAAA due to dissection. The most common reasons for ineligibility were perivisceral flow channel diameter <20 mm (n = 43) and an inadequate proximal seal zone (n = 29). Women were significantly less likely to be eligible for an off-the-shelf device (P = 0.03) and were more likely to require an iliac procedure to become eligible (P = 0.006). Almost none of the patients with dissection could receive a device even if adjunct procedures were used.

Conclusions: Over half of patients with TAAA could not be made eligible for an off-the-shelf device based on manufacturers' criteria, even with adjunct procedures. Women and patients with TAAA due to dissection had higher rates of ineligibility. These data demonstrate that custom fenestrated devices and low-profile devices are needed to expand eligibility for endovascular repair of TAAA.