Multicenter global early feasibility study to evaluate total endovascular arch repair using three-vessel inner branch stent-grafts for aneurysms and dissections

PURPOSE: To evaluate the outcomes of total endovascular aortic arch repair using three-vessel inner branch stent-grafts for aneurysms and chronic dissections.

METHODS: We reviewed the clinical data and outcomes of consecutive patients treated by total endovascular aortic arch repair at eight academic centers using three-vessel inner branch stent-grafts (William Cook Europe, Bjaeverskov, Denmark) between 2016 to 2019. All patients received three vessel designs with two antegrade and one retrograde inner branch, which was used to incorporate the innominate (IA), left common carotid (LCCA) and left subclavian arteries (LSA). The antegrade inner branches were accessed via carotid or upper extremity access. A preloaded catheter was used for access to the retrograde LSA branch via trans-femoral approach. End-points were technical success, mortality, major adverse events (MAEs), any stroke (minor or major) or transient ischemia attack (TIA), secondary interventions, target vessel patency, target vessel instability, aneurysm-related mortality and patient survival.

RESULTS: There were 39 patients (31 male patients [79%], mean age 70±7) treated for 14 (36%) degenerative and 25 (64%) chronic post-dissection arch aneurysms. Clinical characteristics included American Society of Anesthesiologist (ASA) classification > 3 in 28 patients (95%) and prior median sternotomy for ascending aortic repair in 28 patients (72%). Technical success rate was 100%. There were two in-hospital or 30-day deaths (5%) and two strokes (one minor). Combined mortality/any stroke rate was 8% (n=3). MAEs occurred in 10 patients (26%), including respiratory failure in four patients (10%) and estimated blood loss >1L, myocardial infarction and acute kidney injury in two patients each (5%). Median follow up was 3.2 months (IQR, 1 to 14). Twelve patients (31%) required secondary interventions to treat vascular access complications in five patients, endoleak in six patients (three type II, one type IC, one type IA/IB, one type IIIA) and target vessel stenosis in one patient. At 1-year, primary and secondary patency rates and freedom from target vessel instability were 95%±5%, 100% and 91%±5%. Freedom from aortic-related mortality and patient survival were 94%±4% and 90%±6%, respectively.

CONCLUSION: This multicenter global experience demonstrates the technical feasibility and safety of total endovascular aortic arch repair for aneurysms and chronic dissections using three-vessel inner branch stent-grafts. Mortality and stroke rates compare favorably to open surgical repair in a higher risk group of patients. Rate of secondary interventions was high (31%), emphasizing need for larger experience and longer follow-up.