One-year outcomes of total arch replacement and frozen elephant trunk using the E-vita Open NEO

In this cohort study, we aimed to assess the 1-year clinical outcomes of using the E-vita Open NEO™ hybrid prosthesis for total arch replacement with frozen elephant trunk (FET) to repair extensive aortic pathologies.

We reviewed individuals who underwent thoracic aortic surgery between April 2021 and March 2023 from the Gangnam Severance Aortic Registry. Exclusion criteria included ascending aortic replacement, 1 or 2 partial arch replacement, descending aortic replacement and total arch replacement without an FET. Finally, all consecutive patients who underwent total arch replacement and FET with E-vita Open NEO for aortic arch pathologies between April 2021 and March 2023 were included in this cohort study. The patients were divided into 3 groups based on their pathology: acute aortic dissection, chronic aortic dissection and thoracic aortic aneurysm. The primary end point was in-hospital mortality. The secondary end points during the postoperative period comprised stroke, spinal cord injury and redo sternotomy for bleeding. Additionally, the secondary end points during the follow-up period included the 1-year survival rate, 1-year freedom from all aortic procedures and 1-year freedom from unplanned aortic interventions.

The study included 167 patients in total: 92 patients (55.1%) with acute aortic dissection, 20 patients (12.0%) with chronic aortic dissection and 55 patients (32.9%) with thoracic aortic aneurysm. The in-hospital mortality was 1.8% (n = 3). Strokes occurred in 1.8% (n = 3) of the patients, spinal cord injury in 1.8% (n = 3) and redo sternotomy for bleeding was performed in 3.0% (n = 5). There were no significant differences between the pathological groups. The median follow-up period (quartile 1-quartile 3) was 198 (37-373) days, with 1-year survival rates of 95.9%. At 1 year, the freedom from all aortic procedures and unplanned aortic interventions were 90.3% and 92.0%, respectively.

The 1-year clinical outcomes of total arch replacement with FET using the E-vita Open NEO were favourable. Long-term follow-up is required to evaluate the durability of the FET.