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

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Acute aortic dissection; Chronic aortic dissection; Frozen elephant trunk; Thoracic aortic aneurysm; Thoracic endovascular aortic repair; Total arch replacement.