A new device as an open stent graft for extended aortic repair: a multicentre early experience in Japan

• Published in: European journal of cardio-thoracic surgery 2016-04, Vol.49 (4), p.1270-1278
• Main Authors: Uchida, Naomichi, Katayama, Akira, Higashiue, Shinichi, Shiono, Motomi, Hata, Mitsumasa, Minami, Kazutomo, Yamanaka, Kazuo, Miyamoto, Shinji, Sawa, Yoshiki, Kuratani, Toru, Kato, Masaaki
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aneurysm, Dissecting - diagnostic imaging; Aneurysm, Dissecting - surgery; Aorta - diagnostic imaging; Aorta - surgery; Aortic Aneurysm - diagnostic imaging; Aortic Aneurysm - surgery; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - instrumentation; Blood Vessel Prosthesis Implantation - methods; Blood Vessel Prosthesis Implantation - statistics & numerical data; Female; Humans; Japan; Male; Middle Aged; Postoperative Complications; Prosthesis Design; Stents
• ISSN: 1010-7940; 1873-734X
• DOI: 10.1093/ejcts/ezv310

OBJECTIVES Open stent grafting for extended aortic repair has been widely carried out around their world. We reported the effectiveness of a new device as an open stent graft for extended aortic repair. METHODS A new device was used as an open stent graft in this study. The graft part of the device has a woven structure made of Nitinol wire, a superelastic/shape-memory alloy. The subjects of this study were patients aged 20–84 with aneurysms (n = 38) or aortic dissection (n = 22) in the thoracic aorta, including the distal aortic arch and the proximal descending aorta. This study was a multicentre, non-blinded study. The follow-up period was 36 months. RESULTS Three subjects (5.0%) died during hospitalization due to multiorgan failure. Spinal cord injury (SCI) was observed in 4 subjects (6.7%): paraplegia in 1 and paraparesis in 3 subjects. The 3-year survival rate was 76.7% overall: 68.4% for the subjects diagnosed as having aortic aneurysms (the aortic aneurysm group) and 90.9% for those having aortic dissection (the aortic dissection group). For the aortic aneurysm group, thrombus formation in the aortic aneurysm was observed in 97% of the patients 6 months after operation, and in 100% 12 months after operation. Meanwhile, for the aortic dissection group, with regard to the false lumen of aortic dissection, thrombus formation was observed in 94% of the patients 6 months after operation, in 94% 12 months after operation and in 100% 24 months after operation. Expansion of the aortic aneurysm sac was observed in 2 subjects (6.1%). Among these 2 subjects, endoleak was observed in 1 subject, which was improved by additional thoracic endovascular aortic repair. CONCLUSIONS The safety and effectiveness of this investigational device was verified over a period up to 36 months after operation. A long-term follow-up would be necessary to further verify the effectiveness of the device in the future.