Early Feasibility of Endovascular Repair of Distal Aortic Arch Aneurysms Using Patient-Specific Single Retrograde Left Subclavian Artery Branch Stent Graft

OBJECTIVE: To describe the feasibility and outcomes of endovascular repair of distal aortic arch aneurysms using a patient-specific stent graft with a pre-loaded single retrograde left subclavian artery (LSA) branch stent graft. METHODS: We reviewed the clinical data and outcomes of consecutive patients enrolled in an ongoing prospective, non-randomized physician-sponsored investigational device exemption study to evaluate the outcomes of endovascular aortic arch repair using patient-specific arch branch stent grafts (William Cook Europe, Bjaeverskov, Denmark) between 2019 and 2022. All patients received a design with triple-wide scallop and a single retrograde LSA branch with a pre-loaded catheter. RESULTS: There were five male patients with median age of 77 years old (72–80) treated using the single LSA branch stent graft. Technical success was achieved in all patients. Median operating time, fluoroscopy time, and total radiation dose area product were 103 (78–134) minutes, 26 (19–39) minutes, and 123 (71–270) mGy.cm(2), respectively. There were no 30-day or in-hospital mortality, neurological or other major adverse events (MAEs). During median follow-up of 21 (20–27) months, all patients were alive with patent LSA branches, except for one who died of COVID-19 complications. There was no branch instability or secondary interventions. CONCLUSION: This early feasibility study demonstrates successful endovascular repair of distal aortic arch aneurysms using a patient-specific stent graft with single retrograde LSA branch without technical failures, mortality or neurological events. Larger clinical experience and longer follow-up are needed to determined effectiveness of this approach in patients who need endovascular repair with proximal extension into Zone 2.