Outcomes of a Novel Single Branched Aortic Stent Graft for Treatment of Type B Aortic Dissection.

Background: Intervention on Type B dissection frequently requires landing the proximal edge of the stent graft between the left common carotid artery and left subclavian artery (LSA). The Gore® TAG® Thoracic Branch Endoprosthesis (TBE) is a technology which allows LSA preservation with a single internal branch.

Methods: This study was a prospective non-randomized single-arm clinical trial of patients with type B aortic dissection that were treated with the single branched device. Patients with operative indications for acute, chronic or residual Type B dissections that originated distal to the origin of a left subclavian artery suitable for branch graft placement were eligible for the study. Native aortic and surgical graft proximal landing zones were eligible.

Results: Among the 132 patients, there were 25 (18.9%) acute type B dissections, 79 (59.8%) of chronic type B dissections and 28 (21.1%) of residual dissections after previous open Type A repair. Percutaneous access was used in 105 (79.5%) patients. Overall, 30-day mortality occurred in 6 patients (4.5%). The overall 30 day stroke rate was 2/132(1.5%) and the one-year freedom from stroke was 96.8%. Device Technical Success and Procedural Success was achieved in 129/132(97.7%) and 110/132(83.3%) of subjects, respectively and there was one instance of loss of side branch patency. There was no persistent antegrade false lumen flow observed.

Conclusions: In this study of a novel branched endograft device to preserve the LSA in patients with type B dissection undergoing TEVAR, we demonstrate acceptable safety and efficacy outcomes at one year.