Axillary versus innominate artery cannulation for antegrade cerebral perfusion in aortic surgery: design of the Aortic Surgery Cerebral Protection Evaluation (ACE) CardioLink-3 randomised trial

Vinay Garg, Mark D Peterson, Michael Wa Chu, Maral Ouzounian, Roderick Gg MacArthur, John Bozinovski, Ismail El-Hamamsy, F Victor Chu, Ankit Garg, Judith Hall, Kevin E Thorpe, Natasha Dhingra, Hwee Teoh, Thomas R Marotta, David A Latter, Adrian Quan, Muhammad Mamdani, Peter Juni, C David Mazer, Subodh Verma, Vinay Garg, Mark D Peterson, Michael Wa Chu, Maral Ouzounian, Roderick Gg MacArthur, John Bozinovski, Ismail El-Hamamsy, F Victor Chu, Ankit Garg, Judith Hall, Kevin E Thorpe, Natasha Dhingra, Hwee Teoh, Thomas R Marotta, David A Latter, Adrian Quan, Muhammad Mamdani, Peter Juni, C David Mazer, Subodh Verma

Abstract

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.

Keywords: antegrade cerebral perfusion; axillary artery; minate artery; moderate hypothermia; randomised trial.

Conflict of interest statement

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.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Surgical technique used in innominate artery cannulation (with permission from Garg et al). (A) The innominate vein is isolated, retracted and the base of the innominate artery mobilised. Two purse string sutures are placed on the anterior wall of the proximal innominate artery before dilators and the cannula are inserted over a guide wire. (B) Antegrade cerebral protection is initiated by clamping the base of the innominate artery and connecting the afferent limb of the cardiopulmonary bypass circuit to the 14 or 16 Fr cannula. (C) After the distal anastamosis is completed, antegrade cerebral protection is discontinued, and the aortic line is connected to the 8 mm side limb. The graft is clamped distally and full cardiopulmonary bypass is resumed. Proximal reconstruction is performed.
Figure 2
Figure 2
Study schematic of the ACE CardioLink-3 randomised trial.

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