Objective: The objective of this study was to evaluate the safety, efficacy, and outcomes of the conformable thoracic endograft (Conformable TAG Thoracic Endoprosthesis [CTAG]; W. L. Gore & Associates, Flagstaff, Ariz) for acute complicated and uncomplicated type B aortic dissection (TBAD).
Methods: Between February and October 2016, 52 consecutive patients with acute complicated or uncomplicated TBAD were treated with a CTAG device. We assessed safety, complications, and device conformability using intraoperative angiography and computed tomography angiography. The mean follow-up period was 8.2 ± 3.5 months (range, 4-12 months).
Results: All patients survived through the follow-up period. No endoleaks, retrograde aortic dissection, distal new entry tear, stroke, or paraplegia was observed postoperatively. Two patients (3.8%) experienced minor wound hematomas without further treatment. Eleven patients (21.2%) underwent a chimney technique to rebuild supra-arch vessels. A bird-beak configuration was observed in seven (13.5%) patients, five of whom underwent a chimney technique. Analysis of aortic remodeling showed that the minimal true lumen area significantly increased in both complicated and uncomplicated acute TBAD (P < .001 and P = .047, respectively). Likewise, the maximal false lumen area significantly decreased in uncomplicated dissection (P = .006), but no change in maximal false lumen area was detected in complicated dissection (P = .32).
Conclusions: Early outcomes indicate that the CTAG device provides reliable clinical effectiveness and excellent conformability in treating acute complicated and uncomplicated TBAD without risk of major complications. Studies with larger sample sizes and longer follow-up periods are required to evaluate longer term outcomes.
Copyright © 2017. Published by Elsevier Inc.