First-in-men experience with a novel frozen elephant trunk prosthesis featuring an endovascular side branch for left subclavian artery connection

Abstract

OBJECTIVES The objective of this study was to enhance the efficiency of aortic arch replacement through the development of a novel frozen elephant trunk prosthesis with an endovascular side branch for left subclavian artery (LSA) connection. After successful preclinical testing, the feasibility and safety of implementing this innovative prosthesis in human subjects were investigated. Patients and Methods Between September 2020 and September 2021, four patients (mean age 67a) with conditions such as penetrating ulcer, non A-non B aortic dissection, and chronic arch aneurysm underwent surgery utilizing the customized device. Surgeries were performed under high moderate hypothermia (27 °C), employing bilateral selective antegrade cerebral perfusion (ASCP) and distal aortic perfusion. Anastomosis of the frozen elephant trunk prosthesis with the aortic arch occurred in zones 1, followed by separate reimplantation of the left common carotid artery and the brachiocephalic artery. RESULTS All patients were discharged in good clinical condition. The mean aortic cross-clamp, antegrade selective cerebral perfusion, and distal aortic perfusion times were 111, 71, and 31 min, respectively. Endovascular extension of the side branch for the left subclavian artery was required in all cases to prevent endoleak formation. One patient received a stent graft extension at the end of the operation, while two others underwent the procedure during their hospital stay. One patient was diagnosed with endoleak at the first follow-up after 3 months, and endoleak sealing was achieved via the brachial artery with an extension stent graft. CONCLUSIONS Preliminary clinical outcomes suggest that the newly designed frozen elephant trunk prosthesis shows promise in simplifying total arch replacement. These initial findings provide a foundation for planned clinical studies to further assess the effectiveness of this modified surgical hybrid graft, with particular attention to the length and diameter of the LSA side arm.