Consensus Statement: Minimal Criteria for Reporting the Systemic Inflammatory Response to Cardiopulmonary Bypass
AbstractThe lack of established cause and effect between putative mediators of inflammation and adverse clinical outcomes has been responsible for many failed anti-inflammatory interventions in cardiopulmonary bypass (CPB). Candidate interventions that impress in preclinical trials by suppressing a given inflammation marker might fail at the clinical trial stage because the marker of interest is not linked causally to an adverse outcome. Alternatively, there exist examples in which pharmaceutical agents or other interventions improve clinical outcomes but for which we are uncertain of any antiinflammatory mechanism. The Outcomes consensus panel made 3 recommendations in 2009 for the conduct of clinical trials focused on the systemic inflammatory response. This panel was tasked with updating, as well as simplifying, a previous consensus statement. The present recommendations for investigators are the following: (1) Measure at least 1 inflammation marker, defined in broad terms; (2) measure at least 1 clinical end point, drawn from a list of practical yet clinically meaningful end points suggested by the consensus panel; and (3) report a core set of CPB and perfusion criteria that may be linked to outcomes. Our collective belief is that adhering to these simple consensus recommendations will help define the influence of CPB practice on the systemic inflammatory response, advance our understanding of causal inflamatory mechanisms, and standardize the reporting of research findings in the peer-reviewed literature.
Aldea GS, Soltow LO, Chandler WL, et al. 2002. Limitation of thrombin generation, platelet activation, and inflammation by elimination of cardiotomy suction in patients undergoing coronary artery bypass grafting treated with heparin-bonded circuits. J Thorac Cardiovasc Surg 123:742-55.nAllen S, McBride WT, Young IS, et al. 2005. A clinical, renal and immunological assessment of surface modifying additive treated (SMART) cardiopulmonary bypass circuits. Perfusion 20:255-62.nAllen SJ, McBride WT, McMurray TJ, et al. 2007. Cell salvage alters the systemic inflammatory response after off-pump coronary artery bypass grafting surgery. Ann Thorac Surg 83:578-85.nBanbury MK, Brizzio ME, Rajeswaran J, Lytle BW, Blackstone EH. 2006. Transfusion increases the risk of postoperative infection after cardiovascular surgery. J Am Coll Surg 202:131-8.nBone RC, Balk RA, Cerra FB, et al. 1992. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest 101:1644-55.nBrown JR, Toler AW, Kramer RS, Landis RC. 2009. Anti-inflammatory effect of aprotinin: a meta-analysis. J Extra Corpor Technol 41:79-86.nBrown MC, Donnelly JE. 2000. Impact of closed versus open venous reservoirs on patient outcomes in isolated coronary artery bypass graft surgery. Perfusion 15:467-72.nBrown WR, Moody DM, Challa VR, Stump DA, Hammon JW. 2000. Longer duration of cardiopulmonary bypass is associated with greater numbers of cerebral microemboli. Stroke 31:707-13.nBurris NS, Brown EN, Grant M, et al. 2008. Optical coherence tomography imaging as a quality assurance tool for evaluating endoscopic harvest of the radial artery. Ann Thorac Surg 85:1271-7.nButler J, Rocker GM, Westaby S. 1993. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg 55:552-9.nChristen S, Finckh B, Lykkesfeldt J, et al. 2005. Oxidative stress precedes peak systemic inflammatory response in pediatric patients undergoing cardiopulmonary bypass operation. Free Radic Biol Med 38:1323-32.nCribbs SK, Martin GS, Rojas M. 2008. Monitoring of endothelial dysfunction in critically ill patients: the role of endothelial progenitor cells. Curr Opin Crit Care 14:354-60.nDavis CL, Kausz AT, Zager RA, Kharasch ED, Cochran RP. 1999. Acute renal failure after cardiopulmonary bypass is related to decreased serum ferritin levels. J Am Soc Nephrol 10:2396-402.nDe Hert SG, Turani F, Mathur S, Stowe DF. 2005. Cardioprotection with volatile anesthetics: mechanisms and clinical implications. Anesth Analg 100:1584-93.nDe Somer F. 2009. Optimal versus suboptimal perfusion during cardiopulmonary bypass and the inflammatory response. Semin Cardiothorac Vasc Anesth 13:113-7.nDe Somer F, Van BY, Caes F, et al. 2002. Phosphorylcholine coating offers natural platelet preservation during cardiopulmonary bypass. Perfusion 17:39-44.nDiego RP, Mihalakakos PJ, Hexum TD, Hill GE. 1997. Methylprednisolone and full-dose aprotinin reduce reperfusion injury after cardiopulmonary bypass. J Cardiothorac Vasc Anesth 11:29-31.nEdmunds LH Jr. 1993. Blood-surface interactions during cardiopulmonary bypass. J Card Surg 8:404-10.nEntman ML, Youker K, Shoji T, et al. 1992. Neutrophil induced oxidative injury of cardiac myocytes. A compartmented system requiring CD11b/CD18-ICAM-1 adherence. J Clin Invest 90:1335-45.nEvans BJ, Haskard DO, Finch JR, Hambleton IR, Landis RC, Taylor KM. 2008. The inflammatory effect of cardiopulmonary bypass on leukocyte extravasation in vivo. J Thorac Cardiovasc Surg 135:999-1006.nFalase BA, Bajaj BS, Wall TJ, Argano V, Youhana AY. 1999. Nicorandilinduced peripheral vasodilatation during cardiopulmonary bypass. Ann Thorac Surg 67:1158-9.nFerraris VA, Ferraris SP, Saha SP, et al. 2007. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg 83(suppl):S27-86.nFritz H, Wunderer G. 1983. Biochemistry and applications of aprotinin, the kallikrein inhibitor from bovine organs. Arzneimittelforschung 33:479-94.nFurnary AP, Wu Y, Hiratzka LF, Grunkemeier GL, Page US III. 2007. Aprotinin does not increase the risk of renal failure in cardiac surgery patients. Circulation 116(suppl):I127-33.nGiomarelli P, Scolletta S, Borrelli E, Biagioli B. 2003. Myocardial and lung injury after cardiopulmonary bypass: role of interleukin (IL)-10. Ann Thorac Surg 76:117-23.nGoudeau JJ, Clermont G, Guillery O, et al. 2007. In high-risk patients, combination of antiinflammatory procedures during cardiopulmonary bypass can reduce incidences of inflammation and oxidative stress. J Cardiovasc Pharmacol 49:39-45.nGunaydin S, Modine T, Sari T, Zorlutuna Y, Gourlay T. 2009. Clinical efficacy of two-phase leukocyte filtration in high-risk patients undergoing coronary revascularization with cardiopulmonary bypass. J Extra Corpor Technol 41:149-56.nHabib RH, Zacharias A, Schwann TA, et al. 2005. Role of hemodilutional anemia and transfusion during cardiopulmonary bypass in renal injury after coronary revascularization: implications on operative outcome. Crit Care Med 33:1749-56.nHammon JW, Stump DA, Butterworth JF, et al. 2006. Single crossclamp improves 6-month cognitive outcome in high-risk coronary bypass patients: the effect of reduced aortic manipulation. J Thorac Cardiovasc Surg 131:114-21.nHaugen O, Farstad M, Myklebust R, Kvalheim V, Hammersborg S, Husby P. 2007. Low perfusion pressure during CPB may induce cerebral metabolic and ultrastructural changes. Scand Cardiovasc J 41:331-8.nHill GE, Pohorecki R, Alonso A, Rennard SI, Robbins RA. 1996. Aprotinin reduces interleukin-8 production and lung neutrophil accumulation after cardiopulmonary bypass. Anesth Analg 83:696-700.nHsu LL, Champion HC, Campbell-Lee SA, et al. 2007. Hemolysis in sickle cell mice causes pulmonary hypertension due to global impairment in nitric oxide bioavailability. Blood 109:3088-98.nJones TJ, Deal DD, Vernon JC, Blackburn N, Stump DA. 2002. How effective are cardiopulmonary bypass circuits at removing gaseous microemboli? J Extra Corpor Technol 34:34-9.nJones TJ, Deal DD, Vernon JC, Blackburn N, Stump DA. 2002. Does vacuum-assisted venous drainage increase gaseous microemboli during cardiopulmonary bypass? Ann Thorac Surg 74:2132-7.nKamiya T, Katayama Y, Kashiwagi F, Terashi A. 1993. The role of bradykinin in mediating ischemic brain edema in rats. Stroke 24:571-5.nKaplanski G, Marin V, Fabrigoule M, et al. 1998. Thrombin-activated human endothelial cells support monocyte adhesion in vitro following expression of intercellular adhesion molecule-1 (ICAM-1; CD54) and vascular cell adhesion molecule-1 (VCAM-1; CD106). Blood 92:1259-67.nKato GJ, McGowan V, Machado RF, et al. 2006. Lactate dehydrogenase as a biomarker of hemolysis-associated nitric oxide resistance, priapism, leg ulceration, pulmonary hypertension, and death in patients with sickle cell disease. Blood 107:2279-85.nKincaid EH, Ashburn DA, Hoyle JR, Reichert MG, Hammon JW, Kon ND. 2005. Does the combination of aprotinin and angiotensinconverting enzyme inhibitor cause renal failure after cardiac surgery? Ann Thorac Surg 80:1388-93.nLandis RC, Arrowsmith JE, Baker RA, et al. 2008. Consensus statement: defining the minimal criteria for reporting the systemic inflammatory response to cardiopulmonary bypass. Heart Surg Forum 11:290-6.nLandis RC, Brown JR, Murkin JM, Likosky DS, Baker RA. 2008. An evidencebased review of pharmaceutical interventions to limit the systemic inflammatory response in coronary surgery [abstract]. Heart Surg Forum 11:E307.nLandis RC. 2009. Redefining the systemic inflammatory response. Semin Cardiothorac Vasc Anesth 13:87-94.nLevy JH. 2008. Pharmacologic methods to reduce perioperative bleeding. Transfusion 48(suppl):31S-8S.nLidington EA, Haskard DO, Mason JC. 2000. Induction of decayaccelerating factor by thrombin through a protease-activated receptor 1 and protein kinase C-dependent pathway protects vascular endothelial cells from complement-mediated injury. Blood 96:2784-92.nMaillet JM, Le BP, Cantoni M, et al. 2003. Frequency, risk factors, and outcome of hyperlactatemia after cardiac surgery. Chest 123:1361-6.nMalik I, Danesh J, Whincup P, et al. 2001. Soluble adhesion molecules and prediction of coronary heart disease: a prospective study and metaanalysis. Lancet 358:971-6.nMcBride WT, Armstrong MA, Crockard AD, McMurray TJ, Rea JM. 1995. Cytokine balance and immunosuppressive changes at cardiac surgery: contrasting response between patients and isolated CPB circuits. Br J Anaesth 75:724-33.nMinneci PC, Deans KJ, Zhi H, et al. 2005. Hemolysis-associated endothelial dysfunction mediated by accelerated NO inactivation by decompartmentalized oxyhemoglobin. J Clin Invest 115:3409-17.nMurkin JM, Adams SJ, Novick RJ, et al. 2007. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg 104:51-8.nNg CS, Wan S, Wan IY, et al. 2009. Ventilation during cardiopulmonary bypass: impact on neutrophil activation and pulmonary sequestration. J Invest Surg 22:333-9.nPerry TE, Muehlschlegel JD, Liu KY, et al. 2009. C-Reactive protein gene variants are associated with postoperative C-reactive protein levels after coronary artery bypass surgery. BMC Med Genet 10:38.nPoston RS, Gu J, Brown JM, et al. 2006. Endothelial injury and acquired aspirin resistance as promoters of regional thrombin formation and early vein graft failure after coronary artery bypass grafting. J Thorac Cardiovasc Surg 131:122-30.nRabelink TJ, de Boer HC, de Koning EJ, van Zonneveld AJ. 2004. Endothelial progenitor cells: more than an inflammatory response? Arterioscler Thromb Vasc Biol 24:834-8.nRadaelli A, Loardi C, Cazzaniga M, et al. 2007. inflammatory activation during coronary artery surgery and its dose-dependent modulation by statin/ACE-inhibitor combination. Arterioscler Thromb Vasc Biol 27:2750-5.nRanucci M, Balduini A, Ditta A, Boncilli A, Brozzi S. 2009. A systematic review of biocompatible cardiopulmonary bypass circuits and clinical outcome. Ann Thorac Surg 87:1311-9.nRanucci M, De TB, Isgro G, Romitti F, Conti D, Vicentini M. 2006. Hyperlactatemia during cardiopulmonary bypass: determinants and impact on postoperative outcome. Crit Care 10:R167.nRanucci M, Isgro G, Romitti F, Mele S, Biagioli B, Giomarelli P. 2006. Anaerobic metabolism during cardiopulmonary bypass: predictive value of carbon dioxide derived parameters. Ann Thorac Surg 81:2189-95.nRanucci M, Romitti F, Isgro G, et al. 2005. Oxygen delivery during cardiopulmonary bypass and acute renal failure after coronary operations. Ann Thorac Surg 80:2213-20.nRinder CS, Rinder HM, Johnson K, et al. 1999. Role of C3 cleavage in monocyte activation during extracorporeal circulation. Circulation 100:553-8.nRinder CS, Smith MJ, Rinder HM, et al. 2007. Leukocyte effects of C5a-receptor blockade during simulated extracorporeal circulation. Ann Thorac Surg 83:146-52.nRothlein R, Kishimoto TK, Mainolfi E. 1994. Cross-linking of ICAM-1 induces co-signaling of an oxidative burst from mononuclear leukocytes. J Immunol 152:2488-95.nRoyston D, Cardigan R, Gippner-Steppert C, Jochum M. 2001. Is perioperative plasma aprotinin concentration more predictable and constant after a weight-related dose regimen? Anesth Analg 92:830-6.nRubens FD, Nathan H, Labow R, et al. 2005. Effects of methylprednisolone and a biocompatible copolymer circuit on blood activation during cardiopulmonary bypass. Ann Thorac Surg 79:655-65.nScheubel RJ, Zorn H, Silber RE, et al. 2003. Age-dependent depression in circulating endothelial progenitor cells in patients undergoing coronary artery bypass grafting. J Am Coll Cardiol 42:2073-80.nSchwartz AE, Sandhu AA, Kaplon RJ, et al. 1995. Cerebral blood flow is determined by arterial pressure and not cardiopulmonary bypass flow rate. Ann Thorac Surg 60:165-9.nSeekamp A, Mulligan MS, Till GO, et al. 1993. Role of beta 2 integrins and ICAM-1 in lung injury following ischemia-reperfusion of rat hind limbs. Am J Pathol 143:464-72.nShann KG, Likosky DS, Murkin JM, et al. 2006. An evidence-based review of the practice of cardiopulmonary bypass in adults: a focus on neurologic injury, glycemic control, hemodilution, and the inflammatory response. J Thorac Cardiovasc Surg 132:283-90.nShappell SB, Toman C, Anderson DC, Taylor AA, Entman ML, Smith CW. 1990. Mac-1 (CD11b/CD18) mediates adherence-dependent hydrogen peroxide production by human and canine neutrophils. J Immunol 144:2702-11.nShaw DM, Sutherland AM, Russell JA, Lichtenstein SV, Walley KR. 2009. Novel polymorphism of interleukin-18 associated with greater inflammation after cardiac surgery. Crit Care 13:R9.nShigeta O, Kojima H, Jikuya T, et al. 1997. Aprotinin inhibits plasmininduced platelet activation during cardiopulmonary bypass. Circulation 96:569-74.nSpiess BD, Royston D, Levy JH, et al. 2004. Platelet transfusions during coronary artery bypass graft surgery are associated with serious adverse outcomes. Transfusion 44:1143-8.nStensrud PE, Nuttall GA, de Castro MA, et al. 1999. A prospective, randomized study of cardiopulmonary bypass temperature and blood transfusion. Ann Thorac Surg 67:711-5.nStump DA. 2007. Deformable emboli and inflammation: temporary or permanent damage? J Extra Corpor Technol 39:289-90.nSyrovets T, Tippler B, Rieks M, Simmet T. 1997. Plasmin is a potent and specific chemoattractant for human peripheral monocytes acting via a cyclic guanosine monophosphate-dependent pathway. Blood 89:4574-83.nTanaka K, Kanamori Y, Sato T, et al. 1991. Administration of haptoglobin during cardiopulmonary bypass surgery. ASAIO Trans 37:M482-3.nTaylor KM. 1998. Central nervous system effects of cardiopulmonary bypass. Ann Thorac Surg 66(suppl):S20-4.nTousoulis D, Andreou I, Antoniades C, Tentolouris C, Stefanadis C. 2008. Role of inflammation and oxidative stress in endothelial progenitor cell function and mobilization: therapeutic implications for cardiovascular diseases. Atherosclerosis 20:236-47.nVerrier ED, Shernan SK, Taylor KM, et al. 2004. Terminal complement blockade with pexelizumab during coronary artery bypass graft surgery requiring cardiopulmonary bypass: a randomized trial. JAMA 291:2319-27.nWachtfogel YT, Kucich U, Hack CE, et al. 1993. Aprotinin inhibits the contact, neutrophil, and platelet activation systems during simulated extracorporeal perfusion. J Thorac Cardiovasc Surg 106:1-9.nWeiss SJ. 1989. Tissue destruction by neutrophils. N Engl J Med 320:365-76.nWojciak-Stothard B, Potempa S, Eichholtz T, Ridley AJ. 2001. Rho and Rac but not Cdc42 regulate endothelial cell permeability. J Cell Sci 114(pt 7):1343-55.n
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