Introduction Neurological injury remains the major cause of morbidity and mortality following open aortic arch repair. Systemic hypothermia along with antegrade cerebral perfusion (ACP) is the accepted cerebral protection approach, with axillary artery cannulation being the most common technique used to establish ACP. More recently, innominate artery cannulation has been shown to be a safe and efficacious method for establishing ACP. Inasmuch as there is a lack of high-quality data comparing axillary and innominate artery ACP, we have designed a randomised, multi-centre clinical trial to compare both cerebral perfusion strategies with regards to brain morphological injury using diffusion-weighted MRI (DW-MRI).
Methods and analysis 110 patients undergoing elective aortic surgery with repair of the proximal arch requiring an open distal anastamosis will be randomised to either the innominate artery or the axillary artery cannulation strategy for establishing unilateral ACP during systemic circulatory arrest with moderate levels of hypothermia. The primary safety endpoint of this trial is the proportion of patients with new radiologically significant ischaemic lesions found on postoperative DW-MRI compared with preoperative DW-MRI. The primary efficacy endpoint of this trial is the difference in total operative time between the innominate artery and the axillary artery cannulation group.
Ethics and dissemination The study protocol and consent forms have been approved by the participating local research ethics boards. Publication of the study results is anticipated in 2018 or 2019. If this study shows that the innominate artery cannulation technique is non-inferior to the axillary artery cannulation technique with regards to brain morphological injury, it will establish the innominate artery cannulation technique as a safe and potentially more efficient method of antegrade cerebral perfusion in aortic surgery.
Trial registration number NCT02554032.
- minate artery
- axillary artery
- antegrade cerebral perfusion
- randomised trial
- moderate hypothermia
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Contributors VG, MDP, CDM and SV conceived the study and designed the study protocol. VG, MDP, CDM and SV significantly contributed to the planning of analyses of the data. VG, MDP, AG, CDM and SV drafted the manuscript. VG, MDP, MWAC, MO, RGGM, JB, IH, FVC, AG, JH, KET, ND, HT, TRM, DAL, AQ, MM, PJ, CDM and SV critically revised the manuscript for important intellectual content, reviewed and approved the final manuscript and agree to be accountable for all aspects of the work.
Competing interests MDP has received research grant support and speaker/consulting honoraria from Edwards Lifesciences. MWAC has received speaker/consulting honoraria from Medtronic, Canada, Edwards Lifesciences, Livanova and Symetis. The other authors have no conflicts to declare.
Patient consent Not obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All collected data will be accounted for in the published study. No unpublished data will be made available to any parties.
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