Randomized Controlled Trial

. 2017 Jun 10;7(6):e014491.

doi: 10.1136/bmjopen-2016-014491.

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 Garg¹, Mark D Peterson^{2

3}, Michael Wa Chu⁴, Maral Ouzounian^{3

5}, Roderick Gg MacArthur⁶, John Bozinovski⁷, Ismail El-Hamamsy⁸, F Victor Chu⁹, Ankit Garg¹, Judith Hall¹⁰, Kevin E Thorpe^{10

11}, Natasha Dhingra², Hwee Teoh^{12

13}, Thomas R Marotta^{14

15}, David A Latter^{2

3}, Adrian Quan¹², Muhammad Mamdani^{15

16

17

18

19}, Peter Juni^{10

16}, C David Mazer^{20

21}, Subodh Verma^{3

12

22}

Affiliations

¹ Department of Internal Medicine, University of Toronto, Toronto, Ontario, Canada.
² Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
³ Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
⁴ Division of Cardiac Surgery, London Health Sciences Center, University of Western Ontario, London, Ontario, Canada.
⁵ Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
⁶ Division of Cardiac Surgery, University of Alberta Hospital, University of Alberta, Edmonton, Alberta, Canada.
⁷ Division of Cardiac Surgery, Royal Jubilee Hospital, University of British Columbia, Victoria, British Columbia, Canada.
⁸ Division of Cardiac Surgery, Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.
⁹ Division of Cardiac Surgery, Department of Surgery, Hamilton General Hospital, McMaster University, Hamilton, Ontario, Canada.
¹⁰ Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
¹¹ Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
¹² Division of Cardiac Surgery, Keenan Research Centre for Biomedical Science and Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
¹³ Division of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
¹⁴ Department of Diagnostic and Therapeutic Neuroradiology, Keenan Research Centre for Biomedical Science of St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
¹⁵ Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁶ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹⁷ Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
¹⁸ Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada.
¹⁹ Li Ka Shing Centre for Healthcare Analytics Research and Training (LKS-CHART), St. Michael's Hospital, Toronto, Ontario, Canada.
²⁰ Department of Anesthesia, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
²¹ Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.
²² Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.

PMID: 28601820
PMCID: PMC5623414
DOI: 10.1136/bmjopen-2016-014491

Randomized Controlled Trial

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 et al. BMJ Open. 2017.

. 2017 Jun 10;7(6):e014491.

doi: 10.1136/bmjopen-2016-014491.

Authors

Affiliations

¹ Department of Internal Medicine, University of Toronto, Toronto, Ontario, Canada.
² Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
³ Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
⁴ Division of Cardiac Surgery, London Health Sciences Center, University of Western Ontario, London, Ontario, Canada.
⁵ Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
⁶ Division of Cardiac Surgery, University of Alberta Hospital, University of Alberta, Edmonton, Alberta, Canada.
⁷ Division of Cardiac Surgery, Royal Jubilee Hospital, University of British Columbia, Victoria, British Columbia, Canada.
⁸ Division of Cardiac Surgery, Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.
⁹ Division of Cardiac Surgery, Department of Surgery, Hamilton General Hospital, McMaster University, Hamilton, Ontario, Canada.
¹⁰ Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
¹¹ Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
¹² Division of Cardiac Surgery, Keenan Research Centre for Biomedical Science and Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
¹³ Division of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
¹⁴ Department of Diagnostic and Therapeutic Neuroradiology, Keenan Research Centre for Biomedical Science of St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
¹⁵ Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁶ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹⁷ Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
¹⁸ Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Ontario, Canada.
¹⁹ Li Ka Shing Centre for Healthcare Analytics Research and Training (LKS-CHART), St. Michael's Hospital, Toronto, Ontario, Canada.
²⁰ Department of Anesthesia, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
²¹ Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.
²² Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.

PMID: 28601820
PMCID: PMC5623414
DOI: 10.1136/bmjopen-2016-014491

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.

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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.

Figures

**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**
Study schematic of the ACE CardioLink-3 randomised trial.

See this image and copyright information in PMC

References

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1. Wolman RL, Nussmeier NA, Aggarwal A, et al. . Cerebral injury after cardiac surgery: identification of a group at extraordinary risk. Multicenter Study of Perioperative Ischemia Research Group (McSPI) and the Ischemia Research Education Foundation (IREF) Investigators. Stroke 1999;30:514–22. - PubMed
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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

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Medical

Miscellaneous