European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2025
Early and Midterm Results of a Novel Stented Graft for Patients with Stanford Type A Aortic Dissection.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Yang Jue, Hu Jia, Yan Yang, Cao Yong, Wu Jinlin, Luo Jianfang, Sun Tucheng, Yu Changjiang, Li Xin, Peng Yucheng, Liu Yuan, Fan Ruixin
Аннотация
OBJECTIVES: The objective of this study was to assess the feasibility and effectiveness of the novel stented graft in treating Stanford type A aortic dissection (TAAD).
METHODS: This research was a prospective, multicentre, single-arm study that enrolled patients with Stanford TAAD at high risk for open aortic repair. Primary end-points included aorta-related mortality or reintervention at 1 month. Secondary end-points comprised type Ia and III endoleak, major adverse cardiovascular and cerebrovascular events at 1 month, 6 months, and 12 months.
RESULTS: Fifty-three patients were enrolled with a mean age of 63.3 years (range 30-81), of whom 44 (83.0%) were male. Forty-six (86.8%) patients presented with retrograde Stanford TAAD, while the remainder had DeBakey type II aortic dissection. Forty-eight patients (90.6%) were in the acute phase. Carotid-to-subclavian artery bypass was performed in 17(32.1%) patients. The stented graft was successfully delivered via the femoral artery in all cases. Follow-up occurred at 1 month, 6 months, and 12 months. The median follow-up was 6 months (range 1-24). The all-cause mortality was 3.8% (2/53) and the aorta-related mortality was 1.9% (1/53). Six(11.3%) patients required open surgery due to left ventricular rupture (1 patient), retrograde progression of aortic dissection (3 patients), and severe type Ia endoleak (2 patients). Mild type Ia endoleak was observed in 1 patient and 1 patient suffered from cerebral infarction.
CONCLUSIONS: The early and midterm results of the first-in-man evaluation of the new stented graft for Stanford TAAD were satisfactory, achieving 100% technical success and 1.9% aorta-related mortality.
CLINICAL TRIAL REGISTRATION NUMBER: This clinical trial was registered in the Chinese Clinical Trial Registry under the identifier ChiCTR2200057706 (Chinese Clinical Trial Register (ChiCTR)-The world health organization international clinical trials registered organization registered platform).
METHODS: This research was a prospective, multicentre, single-arm study that enrolled patients with Stanford TAAD at high risk for open aortic repair. Primary end-points included aorta-related mortality or reintervention at 1 month. Secondary end-points comprised type Ia and III endoleak, major adverse cardiovascular and cerebrovascular events at 1 month, 6 months, and 12 months.
RESULTS: Fifty-three patients were enrolled with a mean age of 63.3 years (range 30-81), of whom 44 (83.0%) were male. Forty-six (86.8%) patients presented with retrograde Stanford TAAD, while the remainder had DeBakey type II aortic dissection. Forty-eight patients (90.6%) were in the acute phase. Carotid-to-subclavian artery bypass was performed in 17(32.1%) patients. The stented graft was successfully delivered via the femoral artery in all cases. Follow-up occurred at 1 month, 6 months, and 12 months. The median follow-up was 6 months (range 1-24). The all-cause mortality was 3.8% (2/53) and the aorta-related mortality was 1.9% (1/53). Six(11.3%) patients required open surgery due to left ventricular rupture (1 patient), retrograde progression of aortic dissection (3 patients), and severe type Ia endoleak (2 patients). Mild type Ia endoleak was observed in 1 patient and 1 patient suffered from cerebral infarction.
CONCLUSIONS: The early and midterm results of the first-in-man evaluation of the new stented graft for Stanford TAAD were satisfactory, achieving 100% technical success and 1.9% aorta-related mortality.
CLINICAL TRIAL REGISTRATION NUMBER: This clinical trial was registered in the Chinese Clinical Trial Registry under the identifier ChiCTR2200057706 (Chinese Clinical Trial Register (ChiCTR)-The world health organization international clinical trials registered organization registered platform).