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

OBJECTIVES: The objective of this study was to enhance the efficiency of aortic arch replacement through the development of a novel frozen elephant trunk (FET) prosthesis with an endovascular side branch for left subclavian artery (LSA) connection. After successful pre-clinical testing, the feasibility and safety of implementing this innovative prosthesis in human subjects were investigated. METHODS: Between September 2020 and September 2021, 4 patients (mean age 67) 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 (SACP) and distal aortic perfusion. Anastomosis of the FET prosthesis with the aortic arch occurred in zone 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 LSA was required in all cases to prevent endoleak formation. One patient received a stent graft extension at the end of the operation, while 2 others underwent the procedure during their hospital stay. One patient was diagnosed with an 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 FET 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 sidearm.

Translumbar treatment of type II endoleaks after endovascular repair of abdominal aortic aneurysm.

The modality of treatment and the appropriate time point to treat type II endoleaks after endovascular repair of abdominal aortic aneurysms (EVAR) remain controversial issues. The purpose of the present study was to assess the efficacy of translumbar embolization of type II endoleaks after endovascular repair of aortic aneurysm repair. Eighty-four consecutive patients after EVAR were analyzed for the onset of type II endoleaks. Of these, five patients had experienced translumbar embolization after ineffective intraartrial approach to exclude the endoleak. A combination of several liquid embolic agents was used as sealant. Post-procedural contrast-enhanced ultrasound (CEUS) was used to document the outcome of the embolization. Translumbar embolization was successful in four patients. Complete sealing of the nidus was seen on CEUS 24 h after the procedure. In one patient with a duplication of the inferior vena cava, the procedure was aborted because an additional type Ib endoleak was found. The procedure was well tolerated by all patients. The translumbar approach to treat growing aneurysm sacs in patients with persistent type II endoleaks is safe and well tolerated. The immediate post-interventional outcome as documented on CEUS is promising. Long-term follow-ups are yet to be performed.