TY - JOUR
T1 - A randomized trial comparing axillary versus innominate artery cannulation for aortic arch surgery
AU - ACE CardioLink-3 Trial Working Group
AU - Peterson, Mark D.
AU - Garg, Vinay
AU - Mazer, C. David
AU - Chu, Michael W.A.
AU - Bozinovski, John
AU - Dagenais, François
AU - MacArthur, Roderick G.G.
AU - Ouzounian, Maral
AU - Quan, Adrian
AU - Jüni, Peter
AU - Bhatt, Deepak L.
AU - Marotta, Thomas R.
AU - Dickson, Jeffrey
AU - Teoh, Hwee
AU - Zuo, Fei
AU - Smith, Eric E.
AU - Verma, Subodh
AU - Khan, M. Nazir
AU - Saad, Feryal
AU - Mamdani, Muhammad
AU - Latter, David A.
AU - Floyd, Thomas F.
AU - Fedak, Paul W.M.
AU - Bharatha, Aditya
AU - Hall, Judith
AU - Nadamalavan, Danusha
AU - Al-Omran, Mohammed
AU - El-Hamamsy, Ismail
AU - Thorpe, Kevin E.
N1 - Funding Information:
Supported in part through the CardioLink Trial Group at St Michael's Hospital, Toronto, Ontario, Canada, and the Walter And Maria Schroeder Foundation.Dr Mazer has received honoraria and/or research grants to the institution from Amgen and Boehringer Ingelheim. Dr Chu has received honoraria and/or research grants from Abbott Vascular, Boston Scientific, Cryolife, LivaNova, Medtronic, and Terumo Aortic. Dr Jüni has received research grants to the institution from AstraZeneca, Biosensors International, Biotronik, Eli Lilly, and The Medicines Company, and serves as an unpaid member of the steering group of trials funded by AstraZeneca, Biosensors International, Biotronik, St. Jude Medical, and The Medicines Company. Dr Bhaat is a member of the advisory board for Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; on the board of directors for Boston VA Research Institute, and Society of Cardiovascular Patient Care; chair of the American Heart Association Quality Oversight Committee; a member of the data monitoring committees of Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Population Health Research Institute; has received honoraria from American College of Cardiology, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications, Duke Clinical Research Institute (clinical trial steering committees), HMP Global, Journal of the American College of Cardiology, Population Health Research Institute (clinical trial steering committee), Slack Publications, Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Clinical Cardiology, NCDR-ACTION Registry Steering Committee, VA CART Research and Publications Committee; and received research funding from Abbott, Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, sanofi-aventis, Synaptic, and The Medicines Company; received royalties from Elsevier; is a site co-investigator for Biotronik, Boston Scientific, St Jude Medical (now Abbott), and Svelte; has served as a trustee for the American College of Cardiology; and conducted unfunded research for FlowCo, Merck, PLx Pharma, and Takeda. Dr Teoh reports receiving honorarium from Boehringer Ingelheim and writing fees for unrelated manuscripts from Merck Canada Inc and Servier. Mr Smith has received research service contracts from St Michael's Hospital (Toronto), McMaster University, and the Ottawa Heart Institute; consulting fees from Portola; and writing fees from Up-to-Date. Dr Verma reports receiving research grants and/or speaking honoraria from Amgen, AstraZeneca, Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck, Novartis, Novo Nordisk, and Sanofi and is president of the Canadian Medical and Surgical Knowledge Translation Research Group. All other authors reported no conflicts of interest.
Publisher Copyright:
© 2020 The American Association for Thoracic Surgery
PY - 2022/11
Y1 - 2022/11
N2 - 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 during proximal aortic arch surgery. Methods: This randomized controlled trial (The Aortic Surgery Cerebral Protection Evaluation CardioLink-3 Trial, ClinicalTrials.gov Identifier: 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-magnetic resonance imaging. The primary efficacy outcome was the difference in total operative time. Secondary outcomes included 30-day all-cause mortality and postoperative stroke. Results: One hundred two 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 versus 18 (34%) in the innominate group (P for noninferiority = .0009). Total operative times were comparable (median, 293 minutes; interquartile range, 222-411 minutes) for axillary versus (298 minutes; interquartile range, 231-368 minutes) for innominate (P for superiority = .47). Stroke/transient ischemic attack occurred in 4 (7.1%) participants in the axillary versus 2 (3.6%) in the innominate group (P = .43). Thirty-day mortality, seizures, delirium, and duration of mechanical ventilation were similar in both groups. Conclusions: diffusion-weighted magnetic resonance imaging assessments indicate that antegrade cerebral protection with innominate cannulation is safe and affords similar neuroprotection to axillary cannulation during aortic surgery, although the burden of new neurological lesions is high in both groups.
AB - 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 during proximal aortic arch surgery. Methods: This randomized controlled trial (The Aortic Surgery Cerebral Protection Evaluation CardioLink-3 Trial, ClinicalTrials.gov Identifier: 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-magnetic resonance imaging. The primary efficacy outcome was the difference in total operative time. Secondary outcomes included 30-day all-cause mortality and postoperative stroke. Results: One hundred two 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 versus 18 (34%) in the innominate group (P for noninferiority = .0009). Total operative times were comparable (median, 293 minutes; interquartile range, 222-411 minutes) for axillary versus (298 minutes; interquartile range, 231-368 minutes) for innominate (P for superiority = .47). Stroke/transient ischemic attack occurred in 4 (7.1%) participants in the axillary versus 2 (3.6%) in the innominate group (P = .43). Thirty-day mortality, seizures, delirium, and duration of mechanical ventilation were similar in both groups. Conclusions: diffusion-weighted magnetic resonance imaging assessments indicate that antegrade cerebral protection with innominate cannulation is safe and affords similar neuroprotection to axillary cannulation during aortic surgery, although the burden of new neurological lesions is high in both groups.
KW - antegrade cerebral protection
KW - axillary artery cannulation
KW - cardiopulmonary bypass
KW - deep hypothermic circulatory arrest
KW - diffusion-weighted magnetic resonance imaging
KW - innominate artery cannulation
KW - new ischemic brain lesions
KW - replacement of the ascending aorta
KW - transient ischemic attack
UR - http://www.scopus.com/inward/record.url?scp=85099153459&partnerID=8YFLogxK
U2 - 10.1016/j.jtcvs.2020.10.152
DO - 10.1016/j.jtcvs.2020.10.152
M3 - Article
AN - SCOPUS:85099153459
SN - 0022-5223
VL - 164
SP - 1426-1438.e2
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 5
ER -