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

OBJECTIVES

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%).

CONCLUSION

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.