Initial results with use of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) device (W.L. Gore & Associates) for minimally invasive thoracic endovascular aortic repair (TEVAR) of arch aneurysms have demonstrated promise, with good midterm patency and durability reported, as well as low rates of graft-associated complications. These findings were published in the European Journal of Vascular & Endovascular Surgery.
An open-label, multicenter, prospective, observational feasibility trial (ClinicalTrials.gov Identifier: NCT02777528) of the GORE TAG TBE device, a thoracic endovascular graft that incorporates a single retrograde branch for aortic arch vessel perfusion, for the treatment of aortic arch atherosclerotic aneurysms was conducted.
The investigators sought to report 3-year outcomes regarding the use of a single-branched thoracic endograft, following the prior publication of both perioperative and 1-year outcomes. This analysis examines the midterm follow-up.
The primary efficacy endpoint of the study was technical success, which was defined as successful access and deployment of the TBE and procedural side branch patency at the conclusion of the procedure. Secondary endpoints were 1-month side branch primary patency and 1-month device-related endoleaks. Midterm follow-up outcomes included side branch patency, endoleaks, reintervention, neurologic events, mortality, and aneurysm-associated mortality at 3 years. Data were obtained prospectively from each of the study sites with the use of standardized case report forms.
The first study arm enrolled individuals with an intact descending thoracic aortic aneurysm that extended to the distal arch with left subclavian artery incorporation (zone 2). The second study arm enrolled patients with arch aneurysms that required incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularization of the remaining arch vessels.
A total of 40 participants were enrolled in the study, which included 31 individuals who were treated in the zone 2 arm and 9 patients who were treated in the zone 0/1 arm. Overall, 52% of the participants were men. The mean follow-up was 1408±552 days in the zone 2 cohort and 1187±766 days in the zone 0/1 cohort. Technical success was declared to be 100% in both cohorts.
Results of the study showed that no device migration, fracture, or aortic rupture occurred in either arm during the 3-year follow-up. In the zone 2 group, freedom from reintervention was 97% at both 1 year and 3 years, but 2 side branch occlusions occurred. Additionally, 2 of the participants exhibited aneurysm enlargement of wider than 5 mm without any documented endoleak or reintervention.
Freedom from mortality was 90% and 84% at 1 year and 3 years, respectively. In the zone 0/1 cohort, no reinterventions, loss of branch patency, or aneurysm enlargement was reported at 3 years. During follow-up, cerebrovascular events occurred in 3 participants, 2 of which were unrelated to the device or the procedure and 1 was of an unknown relationship. Further, 2 patients in the zone 0/1 arm died during the follow-up period, with both of the deaths unrelated to the aneurysm or the procedure.
A key limitation of the trial is the small sample size, which is due to the feasibility nature of the study. Further, this trial is an Investigational Device Exemption study of a commercially manufactured device, with financial support from the company sponsor.
According to the investigators, “Continuing study of endovascular arch repair is necessary to confirm safety and efficacy of the device.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Liang NL, Dake MD, Fischbein MP, et al. Mid-term outcomes of endovascular repair of aortic arch aneurysms with the Gore Thoracic Branch Endoprosthesis. Eur J Vasc Endovasc Surg. Published online August 12, 2022. doi:10.1016/j.ejvs.2022.08.003