Clinical experience with the RELAY NBS PLUS stent-graft for aortic arch pathology.

ABSTRACT

PURPOSE: To assess the safety, efficacy and performance of the RELAY NBS PLUS stent-graft in patients with aortic arch pathology. METHODS: From July 2010 to December 2011, the RELAY NBS PLUS was used to treat 13 patients (eight males; mean age 59.8 years, range 29-78 years) suffering from aortic arch pathology. The distribution of the proximal landing zone was Zone 0 in one case, Zone 1 in three cases and Zone 2 in nine cases. Bypass of the cervical branches was performed in 11 patients. RESULTS: The surgery-related mortality within 30 days and postoperative morbidity were 0%. Postoperative computed tomography at discharge confirmed 100% clinical success without any endoleaks. The mean radius of the inner curve in the aortic arch was 16.2 mm (range 5.8-25.7 mm). We detected two bird-beak configurations with a severely angulated aortic arch with a radius of the inner curve <15 mm. At the mid-term follow-up (mean 22.1 months; range 13.8-28.2 months), all patients were alive without aorta- or device-related complications. CONCLUSIONS: RELAY NBS PLUS stent-grafts can be safely and effectively implanted with controlled deployment to satisfactorily repair aortic arch pathology, even in the cases considered to present with an unfavorable anatomy for the first generation commercially available stent-graft devices. These encouraging outcomes will need to be confirmed in a larger series with a longer follow-up.