Advertisement

A randomized trial comparing axillary versus innominate artery cannulation for aortic arch surgery

Published:November 30, 2020DOI:https://doi.org/10.1016/j.jtcvs.2020.10.152

      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 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.

      Graphical abstract

      Key Words

      Abbreviations and Acronyms:

      ACE CardioLink-3 (Aortic Surgery Cerebral Protection Evaluation CardioLink-3), ACP (antegrade cerebral protection), CPB (cardiopulmonary bypass), DW-MRI (diffusion-weighted magnetic resonance imaging), HCA (hypothermic circulatory arrest), MRS (Modified Rankin Scale), NSE (neuron-specific enolase), RCTs (randomized controlled trials), S100β (S100 calcium-binding protein β), TIA (transient ischemic attack)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to The Journal of Thoracic and Cardiovascular Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Olsson C.
        • Thelin S.
        • Stahle E.
        • Ekbom A.
        • Granath F.
        Thoracic aortic aneurysm and dissection: increasing prevalence and improved outcomes reported in a nationwide population-based study of more than 14,000 cases from 1987 to 2002.
        Circulation. 2006; 114: 2611-2618
        • WISQARS (Web-based Injury Statistics Query and Reporting System)
        Leading causes of death reports, 1981-2016 2017.
        2018 (Available at:) (Accessed December 19, 2020)
        • Elefteriades J.A.
        • Sang A.
        • Kuzmik G.
        • Hornick M.
        Guilt by association: paradigm for detecting a silent killer (thoracic aortic aneurysm).
        Open Heart. 2015; 2: e000169
        • Elefteriades J.A.
        • Farkas E.A.
        Thoracic aortic aneurysm clinically pertinent controversies and uncertainties.
        J Am Coll Cardiol. 2010; 55: 841-857
        • Patel H.J.
        • Deeb G.M.
        Ascending and arch aorta: pathology, natural history, and treatment.
        Circulation. 2008; 118: 188-195
        • Algra S.O.
        • Jansen N.J.
        • van der Tweel I.
        • Schouten A.N.
        • Groenendaal F.
        • Toet M.
        • et al.
        Neurological injury after neonatal cardiac surgery: a randomized, controlled trial of 2 perfusion techniques.
        Circulation. 2014; 129: 224-233
        • Hagl C.
        • Ergin M.A.
        • Galla J.D.
        • Lansman S.L.
        • McCullough J.N.
        • Spielvogel D.
        • et al.
        Neurologic outcome after ascending aorta-aortic arch operations: effect of brain protection technique in high-risk patients.
        J Thorac Cardiovasc Surg. 2001; 121: 1107-1121
        • Wolman R.L.
        • Nussmeier N.A.
        • Aggarwal A.
        • Kanchuger M.S.
        • Roach G.W.
        • Newman M.F.
        • 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: 514-522
        • Sun X.
        • Lindsay J.
        • Monsein L.H.
        • Hill P.C.
        • Corso P.J.
        Silent brain injury after cardiac surgery: a review: cognitive dysfunction and magnetic resonance imaging diffusion-weighted imaging findings.
        J Am Coll Cardiol. 2012; 60: 791-797
        • Knipp S.C.
        • Matatko N.
        • Schlamann M.
        • Wilhelm H.
        • Thielmann M.
        • Forsting M.
        • et al.
        Small ischemic brain lesions after cardiac valve replacement detected by diffusion-weighted magnetic resonance imaging: relation to neurocognitive function.
        Eur J Cardiothorac Surg. 2005; 28: 88-96
        • Meller S.M.
        • Baumbach A.
        • Voros S.
        • Mullen M.
        • Lansky A.J.
        Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL cardiac device innovation summit.
        BMC Med. 2013; 11: 257
        • Goldstein L.J.
        • Davies R.R.
        • Rizzo J.A.
        • Davila J.J.
        • Cooperberg M.R.
        • Shaw R.K.
        • et al.
        Stroke in surgery of the thoracic aorta: incidence, impact, etiology, and prevention.
        J Thorac Cardiovasc Surg. 2001; 122: 935-945
        • Appoo J.J.
        • Bozinovski J.
        • Chu M.W.
        • El-Hamamsy I.
        • Forbes T.L.
        • Moon M.
        • et al.
        • Committee CCCTADG
        Canadian Cardiovascular Society/Canadian Society of Cardiac Surgeons/Canadian Society for Vascular Surgery joint position statement on open and endovascular surgery for thoracic aortic disease.
        Can J Cardiol. 2016; 32: 703-713
        • Di Bartolomeo R.
        • Pilato E.
        • Pacini D.
        • Savini C.
        • Di Eusanio M.
        Cerebral protection during surgery of the aortic arch.
        Multimed Man Cardiothorac Surg. 2011; 2011 (mmcts.2010.004457)
        • Svensson L.G.
        • Blackstone E.H.
        • Rajeswaran J.
        • Sabik III, J.F.
        • Lytle B.W.
        • Gonzalez-Stawinski G.
        • et al.
        Does the arterial cannulation site for circulatory arrest influence stroke risk?.
        Ann Thorac Surg. 2004; 78: 1274-1284
        • Centofanti P.
        • Barbero C.
        • D'Agata F.
        • Caglio M.M.
        • Caroppo P.
        • Cicerale A.
        • et al.
        Neurologic and cognitive outcomes after aortic arch operation with hypothermic circulatory arrest.
        Surgery. 2016; 160: 796-804
        • Gulbins H.
        • Pritisanac A.
        • Ennker J.
        Axillary versus femoral cannulation for aortic surgery: enough evidence for a general recommendation?.
        Ann Thorac Surg. 2007; 83: 1219-1224
        • Perreas K.
        • Samanidis G.
        • Thanopoulos A.
        • Georgiopoulos G.
        • Antoniou T.
        • Khoury M.
        • et al.
        Antegrade or retrograde cerebral perfusion in ascending aorta and hemiarch surgery? A propensity-matched analysis.
        Ann Thorac Surg. 2016; 101: 146-152
        • Reich D.L.
        • Uysal S.
        • Ergin M.A.
        • Griepp R.B.
        Retrograde cerebral perfusion as a method of neuroprotection during thoracic aortic surgery.
        Ann Thorac Surg. 2001; 72: 1774-1782
        • Strauch J.T.
        • Spielvogel D.
        • Lauten A.
        • Lansman S.L.
        • McMurtry K.
        • Bodian C.A.
        • et al.
        Axillary artery cannulation: routine use in ascending aorta and aortic arch replacement.
        Ann Thorac Surg. 2004; 78: 103-108
        • Chu M.W.
        • Losenno K.L.
        • Gelinas J.J.
        • Garg V.
        • Dickson J.
        • Harrington A.
        • et al.
        Innominate and axillary cannulation in aortic arch surgery provide similar neuroprotection.
        Can J Cardiol. 2016; 32: 117-123
        • Rescigno G.
        • Aratari C.
        • Matteucci M.L.
        Axillary artery cannulation pitfalls.
        J Thorac Cardiovasc Surg. 2009; 138 (author reply 251-2): 251
        • Schachner T.
        • Nagiller J.
        • Zimmer A.
        • Laufer G.
        • Bonatti J.
        Technical problems and complications of axillary artery cannulation.
        Eur J Cardiothorac Surg. 2005; 27: 634-637
        • Sabik J.F.
        • Lytle B.W.
        • McCarthy P.M.
        • Cosgrove D.M.
        Axillary artery: an alternative site of arterial cannulation for patients with extensive aortic and peripheral vascular disease.
        J Thorac Cardiovasc Surg. 1995; 109: 885-890
        • Sabik J.F.
        • Nemeh H.
        • Lytle B.W.
        • Blackstone E.H.
        • Gillinov A.M.
        • Rajeswaran J.
        • et al.
        Cannulation of the axillary artery with a side graft reduces morbidity.
        Ann Thorac Surg. 2004; 77: 1315-1320
        • Garg V.
        • Tsirigotis D.N.
        • Dickson J.
        • Dalamagas C.
        • Latter D.A.
        • Verma S.
        • et al.
        Direct innominate artery cannulation for selective antegrade cerebral perfusion during deep hypothermic circulatory arrest in aortic surgery.
        J Thorac Cardiovasc Surg. 2014; 148: 2920-2924
        • Apostolakis E.
        • Koletsis E.N.
        • Dedeilias P.
        • Kokotsakis J.N.
        • Sakellaropoulos G.
        • Psevdi A.
        • et al.
        Antegrade versus retrograde cerebral perfusion in relation to postoperative complications following aortic arch surgery for acute aortic dissection type A.
        J Card Surg. 2008; 23: 480-487
        • Okita Y.
        • Minatoya K.
        • Tagusari O.
        • Ando M.
        • Nagatsuka K.
        • Kitamura S.
        Prospective comparative study of brain protection in total aortic arch replacement: deep hypothermic circulatory arrest with retrograde cerebral perfusion or selective antegrade cerebral perfusion.
        Ann Thorac Surg. 2001; 72: 72-79
        • Bachet J.
        • Guilmet D.
        • Goudot B.
        • Dreyfus G.D.
        • Delentdecker P.
        • Brodaty D.
        • et al.
        Antegrade cerebral perfusion with cold blood: a 13-year experience.
        Ann Thorac Surg. 1999; 67: 1874-1878
        • Halkos M.E.
        • Kerendi F.
        • Myung R.
        • Kilgo P.
        • Puskas J.D.
        • Chen E.P.
        Selective antegrade cerebral perfusion via right axillary artery cannulation reduces morbidity and mortality after proximal aortic surgery.
        J Thorac Cardiovasc Surg. 2009; 138: 1081-1089
        • Banbury M.K.
        • Cosgrove III, D.M.
        Arterial cannulation of the innominate artery.
        Ann Thorac Surg. 2000; 69: 957
        • Harky A.
        • Grafton-Clarke C.
        • Hadlett M.
        • Shuttleworth E.
        In thoracic aortic surgery, is innominate artery cannulation a safe and effective alternative to axillary artery cannulation?.
        Interact Cardiovasc Thorac Surg. 2019; 29: 604-607
        • Garg V.
        • Peterson M.D.
        • Chu M.W.
        • Ouzounian M.
        • MacArthur R.G.
        • Bozinovski J.
        • et al.
        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.
        BMJ Open. 2017; 7: e014491
        • Tian D.H.
        • Wilson-Smith A.
        • Koo S.K.
        • Forrest P.
        • Kiat H.
        • Yan T.D.
        • et al.
        Unilateral versus bilateral antegrade cerebral perfusion: a meta-analysis of comparative studies.
        Heart Lung Circ. 2019; 28: 844-849
        • Lansky A.J.
        • Messe S.R.
        • Brickman A.M.
        • Dwyer M.
        • van der Worp H.B.
        • Lazar R.M.
        • et al.
        Proposed standardized neurological endpoints for cardiovascular clinical trials: an academic research consortium initiative.
        J Am Coll Cardiol. 2017; 69: 679-691
      1. ACR–ASNR–SPR practice parameter for the performance and interpretation of magnetic resonance imaging (MRI) of the brain.
        (Available at:)
        • Food and Drug Administration Center for Drug Evaluation and Research
        Clinical trial imaging endpoint process standards guidance for industry.
        (Available at:)
        • Foley L.S.
        • Yamanaka K.
        • Reece T.B.
        Arterial cannulation and cerebral perfusion strategies for aortic arch operations.
        Semin Cardiothorac Vasc Anesth. 2016; 20: 298-302
        • Jassar A.S.
        • Vallabhajosyula P.
        • Bavaria J.E.
        • Gutsche J.
        • Desai N.D.
        • Williams M.L.
        • et al.
        Direct innominate artery cannulation: an alternate technique for antegrade cerebral perfusion during aortic hemiarch reconstruction.
        J Thorac Cardiovasc Surg. 2016; 151: 1073-1078
        • Preventza O.
        • Garcia A.
        • Tuluca A.
        • Henry M.
        • Cooley D.A.
        • Simpson K.
        • et al.
        Innominate artery cannulation for proximal aortic surgery: outcomes and neurological events in 263 patients.
        Eur J Cardiothorac Surg. 2015; 48: 937-942
        • Preventza O.
        • Price M.D.
        • Spiliotopoulos K.
        • Amarasekara H.S.
        • Cornwell L.D.
        • Omer S.
        • et al.
        In elective arch surgery with circulatory arrest, does the arterial cannulation site really matter? A propensity score analysis of right axillary and innominate artery cannulation.
        J Thorac Cardiovasc Surg. 2018; 155: 1953-1960.e4
        • Uchino G.
        • Yunoki K.
        • Sakoda N.
        • Saiki M.
        • Hisamochi K.
        • Yoshida H.
        Innominate artery cannulation for arterial perfusion during aortic arch surgery.
        J Card Surg. 2017; 32: 110-113
        • Griepp R.B.
        • Di Luozzo G.
        Hypothermia for aortic surgery.
        J Thorac Cardiovasc Surg. 2013; 145: S56-S58
        • Yan T.D.
        • Bannon P.G.
        • Bavaria J.
        • Coselli J.S.
        • Elefteriades J.A.
        • Griepp R.B.
        • et al.
        Consensus on hypothermia in aortic arch surgery.
        Ann Cardiothorac Surg. 2013; 2: 163-168
        • Ziganshin B.A.
        • Rajbanshi B.G.
        • Tranquilli M.
        • Fang H.
        • Rizzo J.A.
        • Elefteriades J.A.
        Straight deep hypothermic circulatory arrest for cerebral protection during aortic arch surgery: safe and effective.
        J Thorac Cardiovasc Surg. 2014; 148: 888-898
        • Tian D.H.
        • Wan B.
        • Bannon P.G.
        • Misfeld M.
        • LeMaire S.A.
        • Kazui T.
        • et al.
        A meta-analysis of deep hypothermic circulatory arrest versus moderate hypothermic circulatory arrest with selective antegrade cerebral perfusion.
        Ann Cardiothorac Surg. 2013; 2: 148-158
        • Kruger T.
        • Weigang E.
        • Hoffmann I.
        • Blettner M.
        • Aebert H.
        • GERAADA Investigators
        Cerebral protection during surgery for acute aortic dissection type A: results of the German registry for acute aortic dissection type A (GERAADA).
        Circulation. 2011; 124: 434-443
        • Di Eusanio M.
        • Dimitri Petridis F.
        • Folesani G.
        • Berretta P.
        • Zardin D.
        • Di Bartolomeo R.
        Axillary and innominate artery cannulation during surgery of the thoracic aorta: a comparative study.
        J Cardiovasc Surg (Torino). 2014; 55: 841-847
        • Di Eusanio M.
        Innominate artery cannulation during surgery of the thoracic aorta is simple, safe and effective.
        Eur J Cardiothorac Surg. 2015; 48: 943-944
        • Di Eusanio M.
        • Ciano M.
        • Labriola G.
        • Lionetti G.
        • Di Eusanio G.
        Cannulation of the innominate artery during surgery of the thoracic aorta: our experience in 55 patients.
        Eur J Cardiothorac Surg. 2007; 32: 270-273
        • Kahlert P.
        • Knipp S.C.
        • Schlamann M.
        • Thielmann M.
        • Al-Rashid F.
        • Weber M.
        • et al.
        Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study.
        Circulation. 2010; 121: 870-878
        • Ghanem A.
        • Muller A.
        • Nahle C.P.
        • Kocurek J.
        • Werner N.
        • Hammerstingl C.
        • et al.
        Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging.
        J Am Coll Cardiol. 2010; 55: 1427-1432
        • Fairbairn T.A.
        • Mather A.N.
        • Bijsterveld P.
        • Worthy G.
        • Currie S.
        • Goddard A.J.
        • et al.
        Diffusion-weighted MRI determined cerebral embolic infarction following transcatheter aortic valve implantation: assessment of predictive risk factors and the relationship to subsequent health status.
        Heart. 2012; 98: 18-23
        • Barber P.A.
        • Hach S.
        • Tippett L.J.
        • Ross L.
        • Merry A.F.
        • Milsom P.
        Cerebral ischemic lesions on diffusion-weighted imaging are associated with neurocognitive decline after cardiac surgery.
        Stroke. 2008; 39: 1427-1433
        • Kahlert P.
        • Eggebrecht H.
        • Janosi R.A.
        • Hildebrandt H.A.
        • Plicht B.
        • Tsagakis K.
        • et al.
        Silent cerebral ischemia after thoracic endovascular aortic repair: a neuroimaging study.
        Ann Thorac Surg. 2014; 98: 53-58
        • Abdul-Jawad Altisent O.
        • Ferreira-Gonzalez I.
        • Marsal J.R.
        • Ribera A.
        • Auger C.
        • Ortega G.
        • et al.
        Neurological damage after transcatheter aortic valve implantation compared with surgical aortic valve replacement in intermediate risk patients.
        Clin Res Cardiol. 2016; 105: 508-517
        • Vermeer S.E.
        • Longstreth Jr., W.T.
        • Koudstaal P.J.
        Silent brain infarcts: a systematic review.
        Lancet Neurol. 2007; 6: 611-619
        • Thijs V.N.
        • Lansberg M.G.
        • Beaulieu C.
        • Marks M.P.
        • Moseley M.E.
        • Albers G.W.
        Is early ischemic lesion volume on diffusion-weighted imaging an independent predictor of stroke outcome? A multivariable analysis.
        Stroke. 2000; 31: 2597-2602
        • Lovblad K.O.
        • Baird A.E.
        • Schlaug G.
        • Benfield A.
        • Siewert B.
        • Voetsch B.
        • et al.
        Ischemic lesion volumes in acute stroke by diffusion-weighted magnetic resonance imaging correlate with clinical outcome.
        Ann Neurol. 1997; 42: 164-170
        • Leshnower B.G.
        • Rangaraju S.
        • Allen J.W.
        • Stringer A.Y.
        • Gleason T.G.
        • Chen E.P.
        Deep hypothermia with retrograde cerebral perfusion versus moderate hypothermia with antegrade cerebral perufsion for arch surgery.
        Ann Thorac Surg. 2019; 107: 1104-1110
        • Apostolakis E.E.
        • Baikoussis N.G.
        • Katsanos K.
        • Karanikolas M.
        Postoperative peri-axillary seroma following axillary artery cannulation for surgical treatment of acute type A aortic dissection.
        J Cardiothorac Surg. 2010; 5: 43

      Linked Article

      • Commentary: Axillary versus innominate artery cannulation for proximal aortic arch surgery
        The Journal of Thoracic and Cardiovascular SurgeryVol. 164Issue 5
        • Preview
          The efficacy of cerebral protection measures during operations on the aortic arch likely remains the most important determinant of favorable postoperative neurologic outcomes. Deep hypothermia with complete circulatory arrest was the gold standard for years, but surgeons were always concerned about the actual “safe” duration of cold ischemia on the brain, the deleterious systemic effects of profound hypothermia, and the untoward sequelae of the prolonged cardiopulmonary bypass (CPB) times required to cool and then rewarm.
        • Full-Text
        • PDF
      • Commentary: Innominate artery cannulation for antegrade cerebral perfusion: Keeping the light bulb lit
        The Journal of Thoracic and Cardiovascular SurgeryVol. 164Issue 5
        • Preview
          Peterson and colleagues1 report the results of a randomized trial comparing axillary versus innominate artery cannulation for antegrade cerebral perfusion (ACP) during hypothermic circulatory arrest (HCA) in 111 patients undergoing proximal aortic arch surgery. The primary safety outcome was the presence of new severe ischemic lesions on diffusion-weighted magnetic resonance imaging (DW-MRI) and was no different in patients cannulated via the axillary artery (38.8%) or innominate artery (34%). Secondary safety outcomes of stroke/transient ischemic attack were also similar between groups (7.1% axillary and 3.6% innominate; P = .43), as were neurocognitive assessments.
        • Full-Text
        • PDF
      • Commentary: Radiographic stroke: The silent killer?
        The Journal of Thoracic and Cardiovascular SurgeryVol. 164Issue 5
        • Preview
          Since Griepp and colleagues' initial report1 of arch replacement using deep hypothermic circulatory arrest, cerebral-protection strategies have rapidly evolved. In the last decade, there has been an increase in use of moderate hypothermic circulatory arrest (MHCA) with antegrade cerebral perfusion (ACP) via the right axillary (RA) or innominate artery (IA). Despite multiple retrospective reports on the safety of IA cannulation for ACP, the site of arterial cannulation for ACP has never been rigorously investigated.
        • Full-Text
        • PDF