A Randomized Trial Comparing Axillary vs. Innominate Artery Cannulation for Aortic Arch Surgery

ABSTRACT Background Cerebral protection remains the cornerstone of successful aortic surgery however there is no consensus as to the optimal strategy. Objective To compare the safety and efficacy of innominate to axillary artery cannulation for delivering antegrade cerebral protection (ACP) during proximal aortic arch surgery. Methods This randomized controlled trial (ACE CardioLink-3, NCT02554032), conducted across 6 Canadian centers between January 2015 and June 2018, allocated 111 individuals to innominate or axillary artery cannulation. The primary safety outcome was neuroprotection per the appearance of new severe ischemic lesions on the postoperative diffusion-weighted (DW)-MRI. The primary efficacy outcome was the difference in total operative time. Secondary outcomes included 30-day all-cause mortality and post-operative stroke. Results 102 individuals (mean age 63±11 years) were in the primary safety per-protocol analysis. Baseline characteristics between the groups were similar. New severe ischemic lesions occurred in 19 participants (38.8%) in the axillary vs. 18 (34%) in the innominate group (P for non-inferiority = .0009). Total operative times were comparable - median 293 (IQR 222, 411) min for axillary vs. 298 (IQR 231, 368) min for innominate (P for superiority = .47). Stroke/transient ischemic attacks occurred in 4 (7.1%) participants in the axillary vs. 2 (3.6%) in the innominate group (P =.43). 30-day mortality, seizures, delirium, and duration of mechanical ventilation were similar in both groups. Conclusions DW-MRI assessments indicate that ACP with innominate cannulation is safe and affords similar neuroprotection to axillary cannulation during aortic surgery, though the burden of new neurological lesions is high in both groups.