Early and midterm results of a novel stented graft for patients with Stanford type A aortic dissection

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. METHODS This research was a prospective, multicentre, single-arm study that enrolled patients with Stanford type A aortic dissectionat high risk for open aortic repair. Primary end-points included aorta-related mortality or reintervention at one month. Secondary end-points comprised type Ia and III endoleak, major adverse cardiovascular and cerebrovascular events at one 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 type A aortic dissection, 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 one month, six months, and twelve 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 (one patient), retrograde progression of aortic dissection (3 patients) and severe type Ia endoleak (2 patients). Mild type Ia endoleak was observed in one patient and one patient suffered from cerebral infarction. CONCLUSIONS The early and midterm results of the first-in-man evaluation of the new stented graft for Stanford type A aortic dissection were satisfactory, achieving 100% technical success and 1.9% aorta-related mortality.