The midterm results of thoracic endovascular aortic repair with a precurved fenestrated endograft in zone 0–1

Abstract

Abstract OBJECTIVES Thoracic endovascular aortic repair (TEVAR) for the treatment of aortic arch disease remains challenging due to certain anatomical and haemodynamic features. The purpose of this study was to evaluate the midterm results of TEVAR with a second-generation fenestrated endograft for aortic arch disease. METHODS This non-randomized, interventional study was part of a multicentre clinical trial conducted between 2010 and 2011 and was designed to assess the effectiveness of a second-generation precurved fenestrated endograft for aortic arch disease. Midterm data collected during the fifth postoperative year from 205 patients treated with this endograft with the proximal landing of zone 0 or 1 were assessed regarding survival, reoperation and complications. RESULTS The initial and technical success rates were 94% and 91%, respectively. Ninety-seven percent of patients were treated using zone 0. The rate of in-hospital deaths was 3%. Overall survival was 71% at 5 years; thoracic aorta-related death-free survival rates at 1 and 5 years after surgery were 99.5% and 97.8%, respectively. Aneurysm-related event-free survival rates at 1 and 5 years after surgery were 86.8% and 77.1%, respectively. Reoperation-free survival rates at 5 years were 86.6%. The most frequent reason for reoperation was type Ia endoleak (5%), followed by type II endoleak (2%). Incidences of cerebral infarction, device migration, spinal cord ischaemia and supra-aortic branch stenosis were 6%, 1%, 1% and 1%, respectively. CONCLUSIONS The precurved fenestrated endograft provided appropriate conformability to the aortic arch and made zone 0 landing possible with simplified, less-invasive manipulations. The midterm results of TEVAR with this endograft suggest this method is a valuable endovascular treatment option for aortic arch disease. Clinical trial registration number UMIN000007213.