Naomichi Uchida1, Akira Katayama2, Shinichi Higashiue3, Motomi Shiono4, Mitsumasa Hata4, Kazutomo Minami5, Kazuo Yamanaka6, Shinji Miyamoto7, Yoshiki Sawa8, Toru Kuratani8, Masaaki Kato9. 1. Department of Cardiovascular Surgery, Akane-foundation, Tsuchiya General Hospital, Hiroshima, Japan uchidacvs@yahoo.co.jp. 2. Department of Cardiovascular Surgery, Hiroshima City Asa General Hospital, Hiroshima, Japan. 3. Division of Cardiovascular Surgery, Kishiwada Tokushukai Hospital, Kishiwada, Japan. 4. Department of Cardiovascular Surgery, Nihon University Itabashi Hospital, Tokyo, Japan. 5. Department of Cardiovascular Surgery, Kitakanto Junkanki Hospital, Gunma, Japan. 6. Department of Cardiovascular Surgery, Tenri Hospital, Tenri, Japan. 7. Department of Cardiovascular Surgery, Faculty of Medicine, Oita University, Oita, Japan. 8. Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. 9. Department of Cardiovascular Surgery, Morinomiya Hospital, Osaka, Japan.
Abstract
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.
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.