First in Human Evaluation of an Innovative Stent Graft for Endovascular Repair of Acute Ascending Aortic Syndromes.

Abstract

Endovascular repair of Stanford type A aortic dissection (TAAD) remains technically challenging because of the complex anatomy and dynamic biomechanics of the ascending aorta. This study aimed to evaluate the technical feasibility and safety of an innovative stent graft system in patients with acute ascending aortic syndromes. Ten patients were enrolled across three centres. Diagnoses comprised classic TAAD (n = 2), retrograde TAAD (n = 4), penetrating aortic ulcer (n = 1), and intramural haematoma (n = 3). All procedures were performed under general anaesthesia with percutaneous femoral access. One patient experienced fatal cardiac arrest during anaesthesia induction before device deployment and was excluded from analysis, as per protocol. The remaining nine patients underwent successful stent graft implantation. Primary outcomes included technical success and major adverse events at 1, 6, and 12 months. Among the nine patients, the stent graft system was successfully implanted intra-operatively in all cases. However, technical success at 30 days was achieved in eight patients, as one patient developed a type Ia endoleak on post-operative day seven. Two patients experienced new aortic dissections during follow up: one de novo and one stent graft induced new entry; only the latter underwent surgical intervention. At 12 months, no death, stroke, myocardial infarction, spinal cord injury, or stent graft migration was observed. The innovative stent graft system demonstrated technical feasibility and an acceptable short term safety profile for endovascular repair of acute ascending aortic syndromes. This anatomically responsive design may expand the therapeutic options for selected high risk patients. Larger, long term studies are needed to confirm these preliminary findings.