Outcomes of thoracic endovascular aortic repair for complicated type B acute aortic dissection from a multicenter Japanese post-market surveillance study.

Objective: A primary goal of thoracic endovascular aortic repair (TEVAR) for type B acute aortic dissection (BAAD) is exclusion of the primary entry tear with a suitable stent graft (SG) to reestablish true lumen flow and promote aortic remodeling. This study aimed to determine the safety and efficacy of a conformable thoracic SG in a Japanese population with complicated BAAD.

Methods: Between 2016 and 2017, 43 patients with complicated BAAD were enrolled in this prospective, nonrandomized, multicenter post-market surveillance study at 27 sites in Japan. All patients underwent TEVAR using the Gore TAG Conformable Thoracic Endoprosthesis (CTAG) (W.L. Gore and Associates, Flagstaff, AZ).

Results: The most common TEVAR indication for complicated BAAD was malperfusion (41.9%; 24 out of 43) and aortic rupture was observed in 32.5% of patients (14 out of 43). All SG implants were successfully completed and there was no patient with surgical conversion. Thirty-day mortality was 7.0% (3 out of 43) and one patient (2.3%) experienced spinal cord ischemia during hospitalization. Entry tear exclusion was achieved in 91.3% of patients at 1 month, and 95.7% at 24 months. Through 24 months after TEVAR, no retrograde type A aortic dissection was observed and distal stent graft induced new entry was observed in two patients (4.7%).

Conclusions: TEVAR utilizing the CTAG device for complicated BAAD in Japan demonstrated a low incidence of perioperative mortality and complications. Complications directly attributed to the SG including RTAD and dSINE were uncommon and the midterm outcomes were deemed satisfactory.