Frozen Elephant Trunk With Terumo Hybrid Plexus Prosthesis: A French Postmarket Longitudinal Study With Midterm Results

<h2>Abstract</h2><h3>Background</h3> We report on midterm follow-up of the EPI-Flex postmarket study in France, assessing the safety of the Thoraflex on a nationwide scale. <h3>Methods</h3> A prospective, multicenter trial was conducted of all frozen elephant trunk procedures using Thoraflex in France between April 4, 2016, and April 3, 2019. Patients were divided into elective surgery (n = 214) and nonelective surgery (n = 137). We defined safety end points as age-adjusted 3-year survival including in-hospital mortality and a composite secondary end point including new stroke, spinal cord injury, acute kidney injury requiring dialysis, recurrent laryngeal nerve palsy, massive blood transfusion (>10 packs of red blood cells), and unexpected repeated thoracic endovascular aortic repair or aortic surgery within 30 days. <h3>Results</h3> We included 351 patients (73% male; median age, 61 years; interquartile range, 55-70 years). In-hospital mortality rate was 54 of 351 (15.4%) and did not differ between elective and nonelective cases (<i>P</i> = .1). Classification random forest analysis, trained for 16 preoperative and perioperative covariates with 500 trees, identified age, deep hypothermia, and each time of cardiopulmonary bypass, visceral ischemia, or myocardial ischemia as the most influential factors associated with in-hospital mortality. Including in-hospital mortality, 3-year age-adjusted survival rates for elective and nonelective patients were 76% ± 6% and 70% ± 8%, respectively (<i>P</i> = .23). The composite end point significantly affected in-hospital mortality (<i>P</i> = 10⁻⁵) and 3-year age-adjusted survival rates (<i>P</i> = 10⁻³). <h3>Conclusions</h3> Our results highlight that frozen elephant trunk with a Thoraflex remains a complex and evolving strategy for aortic arch diseases. Careful patient selection and optimized procedure engineering are essential to mitigate procedural risks.