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Objectives <p>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.</p> Methods <p>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).</p> Results <p>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&#xa0;month, and 95.7% at 24&#xa0;months. Through 24&#xa0;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%).</p> Conclusion <p>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.</p>

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

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  • 发表日期：

    2025年2月1日

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  • Yoshimasa Seike,
  • Sophie B. Green,
  • Keita Mori,
  • Kimberly Reid,
  • Hitoshi Matsuda,
  • Naotaka Motoyoshi,
  • Masaki Hata,
  • Hiroyuki Kamiya,
  • Ichiro Ideta,
  • Joji Fukada,
  • Genta Chikazawa,
  • Hiroshi Ishitoya,
  • Takafumi Masai,
  • Tetsuo Sonomura,
  • Kenjiro Kaneko,
  • Yoshikatsu Saiki,
  • Hirokazu Minamimura,
  • Shoichi Takahashi,
  • Masanao Toma,
  • Masafumi Morita,
  • Yutaka Makino,
  • Kazuo Abe,
  • Shinichi Iwakoshi,
  • Toshihiro Funatsu,
  • Keiji Iwata,
  • Ryuta Kiuchi,
  • Kei Kazuno,
  • Yoshiharu Nishimura,
  • Masao Yoshitatsu,
  • Hisashi Satoh,
  • Shinichiro Shimura,
  • Tetsuya Horai

摘要

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.