Early and 3-Year Outcomes of Frozen Elephant Trunk Procedure with Evolving E-vita Hybrid Grafts: A Retrospective Single-Centre Cohort Study over 11 Years.

Abstract

Background/objectives: The frozen elephant trunk (FET) technique is a cornerstone procedure for complex thoracic aortic pathologies. This single-center retrospective study evaluates early and midterm outcomes of total arch replacement (TAR) using three generations of the E-vita Open hybrid prosthesis over 11 years.

Methods: From January 2013 to June 2024, 51 patients underwent TAR with the FET technique using the E-vita Open prostheses. Exclusion criteria were isolated ascending or descending aortic replacement, partial arch replacement, TAR without FET, and use of other stent grafts. We analyzed outcomes including in-hospital mortality, survival, stroke, spinal cord injury, and renal complications across three prosthesis generations.

Results: The cohort included 52.9% males, with a mean age of 61.5 ± 10.51 years. FET as reoperation was performed in 52.9% patients. In-hospital mortality was 7.8% and, unexpectedly, only occurred with the newest E-vita Open Neo (23.5%), despite this being the latest generation. Overall survival was 72.5% at one year, 60.8% at two years, and 54.9% at three years. Stroke occurred in 17.6% with marked variation by pathology: 0% in dissection, 31.6% in aneurysm, and 13.6% in combined disease. Spinal cord injury occurred in 7.8%. Re-operation was a significant risk factor for complications and was strongly associated with renal complications (85.7% of dialysis patients) but not mortality. Secondary endovascular procedures were required in 49% of patients.

Conclusions: The FET technique with E-vita Open prostheses demonstrates acceptable outcomes in high-risk patients with complex aortic pathologies. While perioperative morbidity is significant, particularly in reoperative cases, it varies significantly by underlying pathology and prosthesis generation, with unexpected trends suggesting that technological advancement does not automatically translate into improved outcomes. Despite this, the procedure enables comprehensive management of extensive aortic disease through a staged approach.