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CONSENSUS STATEMENT Drug, Devices, Technologies, and Techniques for Blood Management in Minimally Invasive and Conventional Cardiothoracic Surgery A Consensus Statement From the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) 2011 Alan H. Menkis, MD,* Janet Martin, PharmD, MSc (HTA),Þ Davy C.H. Cheng, MD,Þ David C. Fitzgerald, CCP,þ John J. Freedman, MD,§ Changqing Gao, MD, Andreas Koster, MD, PhD,¶ G. Scott Mackenzie, MD,# Gavin J. Murphy, MD,** Bruce Spiess, MD,ÞÞ and Niv Ad, MDþþ Methods: The consensus panel short-listed the potential topics for Objective: The objectives of this consensus conference were to eval- review from a comprehensive list of potential drugs, devices, tech- uate the evidence for the efficacy and safety of perioperative drugs, nologies, and techniques. The process of short-listing was based on technologies, and techniques in reducing allogeneic blood transfusion the need to prioritize and focus on the areas of highest importance for adults undergoing cardiac surgery and to develop evidence-based to surgeons, anesthesiologists, perfusionists, hematologists, and al- recommendations for comprehensive perioperative blood manage- lied health care involved in the management of patients who un- ment in cardiac surgery, with emphasis on minimally invasive cardiac dergo cardiac surgery whether through the conventional or minimally invasive approach. MEDLINE, Cochrane Library, and Embase data-bases were searched from their date of inception to May 2011, andsupplemental hand searches were also performed. Detailed method- Accepted for publication August 29, 2012.
ology and search strategies are outlined in each of the subsequently From the *WRHA Cardiac Sciences Program, Department of Surgery, University published systematic reviews. In general, all relevant synonyms for of Manitoba, Winnipeg, MB Canada; †Evidence-Based Perioperative drugs (antifibrinolytic, aprotinin, ?-aminocaproic acid, tranexamic acid Clinical Outcomes Research (EPiCOR), Department of Anesthesia and [TA], desmopressin, anticoagulants, heparin, antiplatelets, anti-Xa Perioperative Medicine, Western University, London, ON Canada; ‡Inova agents, adenosine diphosphate inhibitors, acetylsalicylic acid [ASA], Heart and Vascular Institute, Falls Church, VA USA; §Division of He-matology, Department of Medicine, St. Michael Hospital, Toronto, ON factor VIIa [FVIIa]), technologies (cell salvage, miniaturized car- Canada; Department of Cardiovascular Surgery, Minimally Invasive and diopulmonary bypass (CPB) circuits, biocompatible circuits, ultra- Robotic Cardiac Surgery Center, PLA General Hospital, Beijing, China; filtration), and techniques (transfusion thresholds, minimally invasive ¶Heart and Diabetes Center NRW, Bad Oeynhausen, Germany, Ruhr- cardiac or aortic surgery) were searched and combined with terms University Bochum, Germany; #Cardiac Anesthesia, WRHA/SBGH Car-diac Sciences Program, Winnipeg, MB Canada; **Glenfield Hospital, for blood, red blood cells, fresh-frozen plasma, platelets, transfusion, University of Leicester, Leicester, UK; ††Department of Anesthesiology, and allogeneic exposure. The American Heart Association/American Virginia Commonwealth University/Medical College of Virginia, College of Cardiology system was used to label the level of evidence Richmond VA USA; and ‡‡Cardiac Surgery, Inova Heart and Vascular and class of each recommendation.
Institute, Falls Church, VA USA.
Results and Recommendations: Database search identified more Supported by the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), which has received unrestricted educational grants from than 6900 articles, with 4423 full-text randomized controlled trials industries that produce surgical technologies and from the Department of An- assessed for eligibility, and the final 125 systematic reviews and esthesia & Perioperative Medicine, Western University, London, ON Canada.
meta-analyses were used in the consensus conference. The results of Disclosure: John J. Freedman, MD, is a speaker and receives consultant fees the consensus conference, including the evidence-based statements for Ethicon Biosurgery, Markham, ON Canada; Gavin J. Murphy is a con- and the recommendations, are outlined in the text, with references sultant to Novo Nordisk, Bagsvaerd, Denmark and Ethicon Biosurgery, given for the relevant evidence that formed the basis for the state- Somerville, NJ USA; Niv Ad, MD, is a speaker and receives consulting feesfor Medtronic, Inc., Minneapolis, MN USA, AtriCure, Inc., West Chester, ments and recommendations.
OH USA, and Estech, Inc., San Ramon, CA USA. Alan H. Menkis, MD, Recommendations for Antifibrinolytics: Janet Martin, PharmD, MSc (HTA), Davy C.H. Cheng, MD, David C.
h The lysine analogs ?-aminocaproic acid (Amicar) and tra- Fitzgerald, CCP, Changqing Gao, MD, Andreas Koster, MD, PhD, G. Scott nexamic acid (TA) reduce exposure to allogeneic blood in MacKenzie, MD, and Bruce Spiess, MD, declare no conflict of interest.
patients undergoing on-pump cardiac surgery. These agents are Address correspondence and reprint requests to Davy C.H. Cheng, MD, recommended to be used routinely as part of a blood conser- FRCPC, Department of Anesthesia and Perioperative Medicine, LHSC- vation strategy especially in patients at risk of undergoing on- University Hospital, 339 Windermere Rd, London, ON Canada N6A 5A5.
pump cardiac surgery (Class I, Level A).
h It is importarnt not to exceed maximum TA total dosages (50Y100 Copyright * 2012 by the International Society for Minimally Invasive Car- diothoracic Surgery mg/kg) because of potential neurotoxicity in the elderly and open-heart procedures (Class IIb, Level C).
Innovations & Volume 7, Number 4, July/August 2012 Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 h Aprotinin is not recommended in adult cardiac surgery until Recommendations for Retrograde Autologous Priming: further studies on its safety profile have been performed (Class h Retrograde autologous priming is recommended as a blood con- III, Level A).
servation modality to reduce allogeneic blood transfusion for on- Recommendations for TA in Off-Pump Coronary Artery Bypass: pump cardiac surgery (Class I, Level A).
h Tranexamic acid may be recommended as part of a blood con- Recommendations for Cell Salvage: servation strategy in high risk patients undergoing off-pump h Routine use of cell salvage is recommended in operations where coronary artery bypass (OPCAB) surgery (Class I, Level A).
an increased blood loss is expected (Class 1, Level A).
h Tranexamic acid dosing in OPCAB surgery needs further study h Cell salvage should be used throughout the entire operation and particularly with regard to possible neurotoxicity such as seizures.
not merely as a replacement for CPB cardiotomy suction (Class In addition, the benefit-risk ratio in OPCAB needs further elu- IIa, Level A).
dication because of the lower inherent risk for bleeding in this Recommendations: Biocompatible CPB Circuits: group (Class IIb, Level C).
h The routine use of biocompatible coated CPB circuitry may be considered as part of a multimodal blood conservation program.
Recommendations for DDAVP: However, the heterogeneity of surface-modified products, antic- h DDAVP can be considered for prophylaxis in coronary artery oagulation management, and CPB technique does not signifi- bypass grafting (CABG) surgery, in particular, for patients on cantly impact surgical blood loss and transfusion needs (Class IIb, ASA within 7 days or prolonged CPB more than 140 minutes (Class IIa, Level A).
h Caution should be used with the DDAVP infusion rate to avoid Recommendations for Miniaturized Extracorporeal Cardiopul- significant systemic hypotension (Class I, Level A).
monary Circuit Versus Conventional Extracorporeal Cardiopul- Recommendations for Topical Hemostatics: h The routine use of topical antifibrinolytics in cardiac surgery is h Miniaturized extracorporeal cardiopulmonary circuit can be not recommended (Class IIa, Level A).
considered as a blood conservation technique to reduce alloge- h Topical fibrin sealants may be considered in clinical situations neic blood exposure (Class IIa, Level A); however, issues related where conventional approaches of surgical and medical im- to heparinization management and biocompatible coatings re- provement of hemostasis are not effective, that is, with bleeding main to be clarified.
problems more local than generalized, bearing in mind the black Recommendations for Ultrafiltration (Continuous or Modified): box warning of bovine thrombin by the US Food and Drug h Ultrafiltration may be considered for blood conservation (Class Administration (Class IIb, Level C).
IIb, Level A); however, the impact on clinically relevant out-comes remains unknown.
Recommendations for FVIIa: h Prophylactic use of FVIIa cannot be recommended because of a Recommendations for Platelet Plasmapheresis: significant increase in the risk of thromboembolic events and h It is reasonable to recommend platelet plasmapheresis for blood stroke (Class IIa, Level A).
management in cardiac surgery (Class IIa, Level A), although the h Factor VIIa may be considered in clinical situations where con- impact on clinically relevant outcomes remains unknown.
ventional approaches of surgical and pharmacologic hemostasis Recommendations for Point-of-Care Monitoring: h The evidence is too premature to recommend point-of-care have failed and uncontrollable hemorrhage poses a high risk of technology for routine use because its use has not been shown to severe and life-threatening outcomes (Class IIb, Level B).
impact clinical outcome (Class IIb, Level A).
Recommendations for Erythropoietin Plus Iron: Recommendations for Surgical Techniques for OPCAB, Mini- h It is reasonable to administer erythropoietin preoperatively to mally Invasive Sternotomy for Aortic Valve Surgery, Minimally increase red blood cell mass in patients who are anemic or refuse Invasive Sternotomy for Mitral Valve Surgery, and Transcatheter blood products (such as for Jehovah's Witness faith) or who are Aortic Valve Implantation: likely to have postoperative anemia (Class IIa, Level A).
h Although these minimally invasive procedures are not primarily Recommendations for Antiplatelets Before Cardiac Surgery: selected for the purpose of blood management, the reduced al- h Acetylsalicylic acid may be continued until surgery (Class IIa, logeneic blood exposure should be considered in the balance of benefits and risks when selecting the appropriate surgery for h For stable elective CABG procedures with no drug-eluting stent, stop clopidogrel 5 days before surgery (Class I, Level A).
h For stable elective CABG procedures with drug-eluting stents less Key Words: Blood management, Cardiac surgery, Consensus than 1 year old, consider continuing clopidogrel or heparin as a bridge to surgery (Class IIb, Level C).
h Direct-acting P2Y12 receptor antagonists may be a better (Innovations 2012;7: 229Y241) alternative than clopidogrel in acute coronary syndromepatients undergoing CABG surgery (Class IIa, Level B).
Recommendations for Antiplatelets After Cardiac Surgery: Blood loss during and after cardiac surgery is one of h In stable CABG surgery (nonYacute coronary syndrome patients), the routine use of postoperative clopidogrel with ASA the most common causes of allogeneic blood product use.1Y3 is not warranted (Class IIb, Level B).
Blood transfusions are administered during cardiac surgery Recommendations for Acute Normovolemic Hemodilution: to manage or prevent hemodynamic instability and ischemia- h Acute normovolemic hemodilution can be considered in selected related injury to the heart, kidneys, brain, and other vital patients with adequate preoperative hemoglobin to reduce post- organs. Administration of red blood cells (RBCs) may im- CPB bleeding (Class IIa, Level A).
prove oxygen delivery when the existing RBC mass has been h The routine use of acute normovolemic hemodilution is not depleted. Other blood product fractions including plasma, recommended (Class IIb, Level B).
cryoprecipitate, and platelets may reduce coagulopathies.4Y7 Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 Perioperative Blood Management Consensus Statement 2011 However, oxygen delivery and coagulopathies are not hard were performed by members of the group for publication in outcomes per se, and it is the prevention of clinically relevant the peer-reviewed literature. The de novo systematic reviews adverse outcomes such as death, stroke, myocardial infarction, were performed in accordance with recent guidelines for evi- renal failure, infection, and blood loss requiring intervention dence synthesis.30 MEDLINE, Cochrane Library, and Embase that would be of greater clinical relevance. Whether transfu- databases were searched from their date of inception to May sions adequately prevent these clinically relevant outcomes to a 2011, and supplemental hand searches were also performed.
degree that matter, and with sufficient magnitude that the benefits Detailed methodology and search strategies are outlined in outweigh the inherent risks that accompany blood product each of the subsequently published systematic reviews. In transfusion, remains a relevant and timely question.7,8 general, all relevant synonyms for drugs (antifibrinolytic, A myriad of studies (observational studies and ran- aprotinin [AP], ?-aminocaproic acid [EACA], tranexamic acid domized trials) have demonstrated an adverse and dose-related [TA], desmopressin, anticoagulants, heparin, antiplatelets, anti- association between blood product transfusion and serious Xa agents, adenosine diphosphate inhibitors, acetylsalicylic morbidity and mortality in surgical and critical care patients.7,9Y11 acid [ASA, aspirin], factor VIIa [FVIIa]), technologies (cell As a result, uncertainty remains regarding the rightful place salvage [CS], miniaturized cardiopulmonary bypass [CPB] for blood product transfusions (in whom, at what threshold, circuits, biocompatible circuits, ultrafiltration), and techniques and after failing which alternatives?).12Y14 Clearly, the risks of (transfusion thresholds, minimally invasive cardiac or aortic blood product administration, considered together with the surgery) were searched and were combined with terms for uncertain benefits, significant costs, and limited supply of blood, RBCs, fresh-frozen plasma (FFP), platelets, transfu- blood products, suggest that blood administration should not sion, and allogeneic exposure.
be considered lightly and conservation practices need to be Identification, selection, and quality assessment of rele- ascertained and agreed on.
vant studies (meta-analyses, systematic reviews, randomized Whereas the clinically appropriate place of blood prod- trials, and if needed, based on lack of higher levels of evi- uct transfusion has been uncertain in the world of conventional dence, observational studies) was performed by at least two cardiac surgery, it remains even less certain within the world reviewers based on predefined inclusion criteria (published in of minimally invasive cardiac surgery where the risk for blood any language, with relevant patient population, intervention, loss and hemodilution is likely to be inherently less than in comparator, and outcomes for the prespecified clinical ques- conventional surgery. The International Society of Minimally tions). Noncomparative studies were not considered. Data Invasive Cardiothoracic Surgery (ISMICS) sponsored this were extracted and double checked by a team of systematic consensus conference to specifically address the evidence for reviewers. Meta-analysis was performed using the random blood conservation in cardiac surgery, with special emphasis effects model when heterogeneity across studies was expected on minimally invasive cardiac surgery. This consensus state- to be significant or using the fixed effect model when hetero- ment was convened to add to existing guidelines on cardiac geneity was not statistically significant. Using Review Man- surgical blood management strategies7,15Y20 because previous ager 5, Stata, or Comprehensive Meta-Analysis v2.0, the guidelines have not specifically addressed blood management weighted mean differences (WMDs) and 95% confidence for minimally invasive cardiac surgery.
intervals (95% CIs) for continuous data and the rate ratio (95%CI) for dichotomous data were calculated. Meta-regressions were performed when dose-response relationships were in The objectives of this consensus conference were twofold: question or when time-dependent outcomes were in question.
1. To evaluate the evidence for efficacy and safety of perioperative Heterogeneity across studies was estimated using the I2 sta- drugs, technologies, and techniques to reduce allogeneic blood tistic, whereby an I2 exceeding 50% was considered moder- transfusion for adults undergoing cardiac surgery, with em- ately heterogeneous and I2 exceeding 75% was considered phasis on minimally invasive cardiac surgery.
2. To develop evidence-based recommendations for perioperative blood management in cardiac surgery, with emphasis on min- LEVELS OF EVIDENCE AND GRADES OF imally invasive cardiac surgery.
The methodology used to support the evidence identifi- As described in previous ISMICS consensus state- cation, retrieval, synthesis, and interpretation for this consensus ments,21Y29 the evidence used in consideration for each re- panel was similar to previous published ISMICS consensus spective clinical question and any related subquestions was conferences.21Y29 This represents the eighth consensus con- classified according to the American Heart Association (AHA)/ ference supported by ISMICS. Previous consensus statements American College of Cardiology (ACC) levels of evidence are freely available at www.ismics.org.
and grades of recommendation (Tables 1 and 2). The AHA/ACCclassification categorizes evidence levels primarily based on con- SEARCH STRATEGY AND EVIDENCE RETRIEVAL siderations of study design where the highest level of evidence For each aspect of perioperative blood management to (Level A) consists of two or more randomized controlled trials.
be addressed during the consensus conference, we searched We also include meta-analyses of randomized trials as Level A for existing high-quality systematic reviews of the literature to evidence. The higher the level of evidence has presumably, the objectively inform the consensus panel. If high-quality pub- lesser the likelihood for bias caused by trial design limita- lished systematic reviews were not found or if they did not tions.31,32 However, it is also important to consider that there include the most recent studies, de novo systematic reviews are additional forms of bias beyond the study design alone, Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 which should be considered when applying evidence to make TABLE 2. Classes of Recommendations While other systems of grading evidence exist, the Conditions for which there is evidence and/or general AHA/ACC system was used to maintain consistency with agreement that a given procedure or treatment is useful previous consensus statements21Y29 and to allow comparability with other AHA/ACC statements in the field of cardiology Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a and cardiac surgery. Labeling the level of evidence for each procedure or treatment statement and classifying the recommendations derived from Weight of evidence/opinion is in favor of usefulness/efficacy the evidence statements were performed collaboratively with Usefulness/efficacy is less well established by evidence/opinion the consensus panel using a democratic process after full Conditions for which there is evidence and/or general discussion of the strengths and limitations of the evidence.
agreement that the procedure/treatment is NOT The highest existing level of evidence was considered when useful/effective and, in some cases, may be harmful making recommendations to inform the clinical questions,whereby systematic reviews and meta-analyses of randomized statements and the recommendations, are outlined below, with trials (Level A) were considered preferentially over singular references given for the relevant evidence that formed the randomized trials or observational studies (Level B). When basis for the statements and recommendations. Readers are no relevant clinical trials could be found after systematically encouraged to consult the original publications for the sys- reviewing the literature, expert opinion from the consensus tematic reviews and meta-analyses for the detailed discussion panel was considered but was labeled explicitly as such so of outcomes and implications for each of the drugs, technol- the reader will interpret it flexibly in full light of the lack of ogies, and techniques discussed below.
evidence and reliance on opinion (Level C evidence). Recom-mendations with highest levels of evidence should be inter- preted with more confidence than recommendations based onlower levels of evidence. The former recommendations may The following categories of drugs were addressed: sys- represent a list of priorities for implementation into practice temic antifibrinolytics, desmopressin, topical hemostatics.
after consideration of local contextual factors, whereas thelatter (Level B and Level C) should be considered to be impor- Systemic Antifibrinolytics: AP, TA, EACA tant priorities for future research programs to clarify the existing Relevant Evidence gaps in the evidence to move beyond reliance on opinion.
Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, Fergusson DA, Ker K. Antifibrinolytic agents for use in SELECTION OF TOPICS FOR REVIEW minimising allogeneic blood transfusion [Review]. Cochrane The consensus panel short-listed the topics for review Database Syst Rev. 2011 Mar 16;(3):CD001886.
from a comprehensive list of potential drugs, devices, tech- Gagne J, Griesdale DE, Schneeweiss S. Aprotinin and nologies, and techniques. The process of short-listing was risk of death and renal dysfunction in patients undergoing based on the practical need to prioritize and focus on the areas cardiac surgery: a meta-analysis of epidemiologic studies.
of highest importance to cardiac surgeons, anesthesiologists, Pharmacoepi Drug Saf. 2009;18:259Y268.
perfusionists, hematologists, and allied health care involved in Ma SC, Brindle W, Burton G, Gallacher S, Cheng Hong the management of patients who undergo cardiac surgery F, Manelius I, et al. Tranexamic acid is associated with less whether through the conventional or the minimally invasive blood transfusion in off-pump coronary artery bypass graft approach. The purpose of this consensus conference was to surgery: a systematic review and meta-analysis. J Cardi- give an overview of the role of drugs, technologies, and othorac Vasc Anesth. 2011;25:26Y35.
techniques for blood management in the setting of minimallyinvasive and conventional cardiac surgery.
Statements for Antifibrinolytics in Cardiac Surgery 1. Antifibrinolytics reduce the risk of allogeneic blood transfusion (Level A) in patients undergoing on-pump cardiac Database search identified more than 6900 articles, with 4423 full-text randomized controlled trials (RCTs) assessed 2. Aprotinin may increase the risk of in-hospital all-cause mor- for eligibility, and the final 125 systematic reviews and meta- tality compared with TA/EACA (relative risk [RR], 1.39; 95% analyses were used in the consensus conference. The results of CI, 1.02Y1.89; Level A) in patients undergoing cardiac surgery.
3. Aprotinin may increase short-term (RR, 1.39; 95% CI, the consensus conference, including the evidence-based 1.02Y1.89; Level A) and longer term mortality versus TA/EACA (hazard ratio [HR], 1.22; 95% CI, 1.08Y1.39; Level B) inpatients undergoing cardiac surgery.
TABLE 1. Levels of Evidence 4. Meta-analysis of RCTs suggests no increase in risk of renal Level of Evidence A Data derived from multiple randomized dysfunction with AP versus placebo (Level A) in patients un- dergoing cardiac surgery, although non-RCT evidence has been Level of Evidence B Data derived from a single randomized trial or nonrandomized studies 5. Tranexamic acid reduces the risk of allogeneic blood exposure Level of Evidence C Consensus opinion of experts (RR, 0.67; 95% CI, 0.52Y0.86), and EACA reduces the risk of Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 Perioperative Blood Management Consensus Statement 2011 TABLE 3. Summary of Recommendations Lysine Analogs in Cardiac Surgery The lysine analogs ?-aminocaproic acid (Amicar) and tranexamic acid (TA) reduce exposure to allogeneic blood in patients undergoing CPB cardiac surgery.
These agents are recommended routinely as part of a blood conservation strategy in patients undergoing cardiac surgery (Class I, Level A).
It is important not to exceed maximum recommended TA dosages (50Y100 mg/kg) because of potential neurotoxicity, particularly in elderly and open-heart procedures (Class IIb, Level C).
Aprotinin is not recommended in adult cardiac surgery until further studies on its safety profile (Class III, Level A).
TA is recommended as part of a blood conservation strategy in patients undergoing OPCAB surgery (Class I, Level A).
TA dosing in OPCAB surgery needs further study particularly with regard to possible neurotoxicity such as seizures (Class IIb, Level C).
DDAVP may be considered for prophylaxis in CABG surgery, in particular, for patients on ASA within 7 days or prolonged CPB more than 140 minutes (Class IIa, Level A).
Use caution with DDAVP infusion rate to avoid significant hypotension (Class I, Level A).
Topical Hemostatics Routine use of topical antifibrinolytics in cardiac surgery is not recommended (Class IIa, Level A).
Topical fibrin sealant may be considered in clinical situations where conventional approaches of surgical and medical improvement of hemostasis are not effective, that is, with bleeding problems more local than generalized (Class IIb, Level C).
Prophylactic use of FVIIa cannot be recommended because of a significant increase in the risk of thromboembolic events and stroke (Class IIa, Level A).
FVIIa may be considered in clinical situations where conventional approaches of surgical/pharmacologic hemostasis failed and uncontrollable hemorrhage poses a high risk of adverse outcome (Class IIb, Level B).
It is reasonable to administer EPO preoperatively (2Y4 weeks) to increase red blood cell mass in patients who are anemic or refuse blood products (Jehovah's Witness) or as a blood management strategy (Class IIa, Level A).
Antiplatelet Agents Before Cardiac Surgery ASA may be continued until surgery (Class IIa, Level B).
In stable elective CABG with no DES, clopidogrel should be discontinued 5 days preoperatively (Class I, Level A).
In stable elective CABG with DES less than 1 year old, consider continuing clopidogrel or heparin as a bridge to surgery (Class IIb, Level C).
Direct-acting P2Y12 receptor antagonist may be a better alternative than clopidogrel in ACS patients undergoing CABG surgery (Class IIa, Level B).
Antiplatelet Agents After Cardiac Surgery In stable CABG surgery (non-ACS patients), the routine use of postoperative clopidogrel with ASA is not warranted (Class IIb, Level B).
ANH can be considered in selected patients (adequate preoperative hemoglobin level) to reduce post-CPB bleeding (Class IIa, Level A).
Routine use of ANH in unselected patients cannot be recommended (Class IIb, Level B).
RAP can be recommended as a blood conservation modality to reduce allogeneic blood transfusion in cardiac surgery (Class I, Level A).
Routine use of CS is recommended in operations where an increased blood loss is expected (Class I, Level A).
CS should be used throughout the entire operation and not merely as a replacement for CPB cardiotomy suction (Class IIa, Level A).
Biocompatible Coated CPB Circuit The routine use of biocompatible coated CPB circuitry may be considered as part of a multimodal blood conservation program. However, the heterogeneity of surface-modified products, anticoagulation management, and CPB technique does not significantly impact surgical blood loss and transfusion needs(Class IIb, Level A).
Miniaturized CPB Circuit MECC can be considered as a blood conservation technique to reduce allogeneic blood exposure (Class IIa, Level A); however, issues related to heparinization management and biocoat remain to be clarified.
The use of ultrafiltration may be considered for blood conservation; however, impact on clinically relevant outcomes remains unproven and issues related to different technologies and timing of ultrafiltration remain to be clarified (Class IIb, Level A).
Platelet Plasmapheresis It is reasonable to consider platelet plasmapheresis for blood management in cardiac surgery (Class IIa, Level A).
The evidence is too premature to recommend POC technology for routine use because its use has not been shown to impact clinical outcome (Class IIb, Level A).
Minimally Invasive Techniques Whereas minimally invasive cardiac procedures are not primarily selected for blood management, the reduced allogeneic blood exposure should be considered in the balance of benefits and risks when selecting the appropriate surgery for the patients (Class IIa, Level A).
ACS indicates acute coronary syndrome; ANH, acute normovolemic hemodilution; ASA, acetylsalicylic acid; CABG, coronary artery bypass grafting; CPB, cardiopulmonary bypass; CS, cell salvage; DES, drug-eluting stent; EPO, erythropoietin; FVIIa, factor VIIa; MECC, miniaturized extracorporeal circuit; OPCAB, off-pump coronary artery bypass;POC, point of care; TA, tranexamic acid; RAP, retrograde autologous priming; Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 blood exposure (RR, 0.70; 95% CI, 0.52Y0.93) in patients Statements for DDAVP undergoing cardiac surgery (Level A), although the impactversus placebo or no antifibrinolytic on clinically relevant 1. DDAVP prophylaxis has been shown to reduce blood loss; outcomes such as thromboembolic, acute myocardial infarction however, its effect on need for blood transfusion does not reach (AMI), stroke, and death remains uncertain (Level A) in patients conventional significance and the effect is heterogeneous across undergoing cardiac surgery.
trials (Level A).
6. Preliminary evidence from case series has raised considerations 2. In coronary artery bypass grafting (CABG) surgery, DDAVP about potential neurotoxicity with TA (seizures, particularly infusion reduces intraoperative and postoperative blood loss exceeding the higher doses); further research about safe dosing (WMD, j117 mL; 95% CI, j173 to j61), RBC unit trans- levels remains to be addressed in valid studies (Level C).
fused (WMD, j0.4 units; 95% CI, j0.8 to j0.01), and allo-geneic blood exposure (RR, 0.85; 95% CI, 0.73-0.99; Level A).
Recommendations for Antifibrinolytics 3. In patients on ASA less than 7 days, DDAVP infusion reduces blood loss (WMD, j110 mL; 95% CI, j200 to j19; Level A), h The lysine analogs EACA (Amicar) and TA (Cyklokapron) although it does not reduce blood transfusion rate.
reduce exposure to allogeneic blood in patients undergoing on- 4. In prolonged CPB more than 140 minutes, DDAVP infusion pump cardiac surgery. These agents are recommended to be reduces blood loss (WMD, j345 mL; 95% CI, j479 to j211; used routinely as part of a blood conservation strategy es- pecially in patients at risk undergoing on-pump cardiac sur- 5. DDAVP infusion causes hypotension requiring intervention gery (Class I, Level A).
with fluid T vasopressor (37% vs 10%; RR, 2.81; 95% CI, h It is important not to exceed maximum TA dosages (50Y100 mg/ 1.50Y5.27; Level A).
kg) because of potential neurotoxicity in the elderly and open-heart procedures (Class IIb, Level C).
Recommendations for DDAVP h Aprotinin is not recommended in adult cardiac surgery until further studies on its safety profile (Class III, Level A).
h DDAVP can be considered for prophylaxis in CABG Statements for TA in Off-Pump Coronary surgery, in particular, for patients on ASA within 7 daysor prolonged CPB more than 140 minutes (Class IIa, Level A).
h Use caution with DDAVP infusion rate to avoid significant hypotension (Class I, Level A).
1. Tranexamic acid reduces RBC exposure (RR, 0.51; 95% CI, 0.36Y0.71) and overall blood product exposure (RR, 0.47; 95%CI, 0.33 Recommendations for Further Research Y0.66) beyond the effect of CS compared with no TA or placebo in patients undergoing off-pump coronary artery ) Is there a role for DDAVP for patients presenting for surgery bypass (OPCAB) (Level A). The impact of TA on AMI, stroke, while on antiplatelet agents? or death is unknown (Level A).
) Is there a role for DDAVP in patients with refractory 2. Tranexamic acid has not been shown to increase thromboem- bolic rates (Level A), although the studies have been small andof short duration.
Topical Hemostatics Recommendations for TA in OPCAB Relevant Evidence Abrishami A, Chung F, Wong J. Topical application of h Tranexamic acid may be recommended as part of a antifibrinolytic drugs for on-pump cardiac surgery: a systematic blood conservation strategy in high-risk patients undergoingOPCAB surgery (Class I, Level A).
review and meta-analysis. Can J Anaesth. 2009;56:202Y212.
h Tranexamic acid dosing in OPCAB surgery needs further study Carless DA, Henry PA, Anthony DM. Fibrin sealant use particularly with regard to possible neurotoxicity such as sei- for minimising perioperative allogeneic blood transfusion.
zures. In addition, the benefit-risk ratio in OPCAB needs further Cochrane Database Syst Rev. 2003:CD004171.
eludication because of the lower inherent risk for bleeding in thisgroup (Class IIb, Level C).
Statements for Topical Hemostatics Recommendations for Further Research 1. Topical antifibrinolytics (TA or AP) and topical fibrin sealants may reduce postoperative chest tube blood loss (È200 mL); ) Does TA or EACA reduce the risk of clinically relevant outcomes however, the impact on RBC exposure did not reach conven- such as death, stroke, MI, renal failure (RF), infections, and tional significance and there is significant heterogeneity across neurologic outcomes? trials (Level A).
) In which specific risk groups should antifibrinolytics be used? 2. Impact on other clinically relevant outcomes (AMI, stroke, ) What is the optimal dose for TA or EACA in on-pump bypass death) is unknown, and safety data are sparse.
) What is the optimal dose for TA or EACA in off-pump bypass Recommendations for Topical Hemostatics h Routine use of topical antifibrinolytics in cardiac surgery is not Relevant Evidence recommended (Class IIa, Level A).
h Topical fibrin sealants may be considered in clinical situations Carless PA, Stokes BJ, Moxey AJ, Henry DA. Desmo- where conventional approaches of surgical and medical im- pressin use for minimising perioperative allogeneic blood trans- provement of hemostasis are not effective, that is, with bleeding fusion. Cochrane Database Syst Rev. 2008;(1):CD001884.
problems more local than generalized, bearing in mind the black Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 Perioperative Blood Management Consensus Statement 2011 box warning of bovine thrombin by the US Food and Drug allogeneic blood transfusion in cardiac surgery? A systematic Administration (Class IIb, Level C) review and meta-analysis. J Card Surg. 2006;21:320Y326.
Recommendations for Further Research Statements for Erythropoietin Plus Iron ) Does topical fibrin sealant result in clinically significant impact on outcomes when systemic antifibrinolytics have been used? 1. Erythropoietin (EPO) reduces the risk of allogeneic RBC ex- ) What are the risks of using topical fibrin sealant? posure (OR, 0.26; 95% CI, 0.15Y0.44; number needed to treat, ) Do the clinically meaningful benefits of topical fibrin sealant out- 4) in cardiac surgery undergoing PAD and in patients not un- weigh the risks? If so, in which patient risk groups? dergoing PAD for cardiac surgery (Level A); however, its impacton AMI, RF, cerebrovascular accident (CVA), and death is 2. Although the impact may be greater when EPO is initiated 2 to 4 Relevant Evidence weeks before surgery, emerging evidence suggests that EPO Ponschab M, Landoni G, Biondi-Zoccai G, Bignami E, initiated on the day of surgery may also reduce the need for Frati E, Nicolotti D, et al. Recombinant activated factor VII transfusion (Level A).
increased stroke in cardiac surgery: a meta-analysis. J Cardi- 3. In OPCAB, EPO (high-dose, short-term) reduced the risk of othorac Vasc Anesth. 2011;25:804Y810.
RBC transfusion (Level B); however, its impact on AMI, RF, Lin Y, Stanworth S, Birchall J, Doree C, Hyde C. Re- CVA, and death is unknown.
4. Reports of improvement in neurologic outcomes and reduced combinant factor VIIa for the prevention and treatment of acute kidney injury (Level B) are encouraging, but more study is bleeding in patients without haemophilia. Cochrane Database Syst Rev. 201116;CD005011.
Statements for FVIIa Recommendations for EPO Plus Iron h It is reasonable to administer EPO preoperatively to increase red 1. Factor VIIa reduces blood exposure in patients refractory to blood cell mass in patients who are anemic or refuse blood conventional hemostatic management (Level B).
products (such as for Jehovah's Witness faith) or who are likely to 2. Factor VIIa is associated with a significant increased risk stroke have postoperative anemia (Class IIa, Level A).
(odds ratio [OR], 3.69; 95% CI, 1.10Y12.38; Level B), and thereis a trend toward increased thromboembolic events (OR, 1.84; Recommendations for Further Research 95% CI, 0.82Y4.09; Level B).
3. No impact on mortality has been shown (OR, 0.96; 95% CI, ) Does EPO significantly reduce clinically relevant outcomes (re- 0.50Y1.86; Level B), but studies have largely been non- duced death, stroke, MI, kidney failure, and neurologic perfor- randomized and retrospective and of short duration.
mance) without undue risk of adverse events? ) Is the routine use of erythropoietin warranted, and if so, in which Recommendations for FVIIa patient risk groups (elderly, small stature, preexisting renal dys-function, severity of preoperative anemia)? ) What is the optimal dose, route, time of initiation, and duration h Prophylactic use of FVIIa cannot be recommended because of a for EPO and accompanying iron supplementation? What should be significant increase in the risk of thromboembolic events and the target hemoglobin or hematocrit level? stroke (Class IIa, Level A).
) Does the role of EPO differ for on- versus off-pump cardiac h Factor VIIa may be considered in clinical situations where conven- tional approaches of surgical and pharmacologic hemostasis havefailed and uncontrollable hemorrhage poses a high risk of severeand life-threatening outcomes (Class IIb, Level B).
ANTIPLATELETS BEFORE CARDIAC SURGERY Relevant Evidence Recommendations for Further Research Sun JCJ, Whitlock R, Cheng J, Eikeboom JW, Thabane L, Crowther MA, Teoh KHT. The effect of preoperative aspi- ) In refractory hemorrhage, at what point along the continuum of risk toward life-threatening or severe adverse events is the benefit rin on bleeding, transfusion, myocardial infarction, and mor- of FVIIa worthy of the risks? tality in coronary artery bypass surgery: a systematic review of ) What dose of FVIIa is recommended to maximize the benefit- randomized and observational studies. Eur Heart J. 2008;29: Nijjer S. Safety of clopidogrel being continued until the ERYTHROPOIETIN (PLUS IRON) time of coronary artery bypass grafting in patients with acutecoronary syndrome: a meta-analysis of 34 studies. Euro Heart Relevant Evidence J. 2011 (Epub ahead of print).
Martin JE, Lal A, Bainbridge D, Cheng D. Does perio- Held C, Asenblad N, Bassand JP, Becker RC, Cannon perative erythropoietin benefit patients undergoing cardiac CP, Claeys MJ, Harrington RA, Horrow J, et al. Ticagrelor surgery? A meta-analysis with meta-regression of randomized versus clopidogrel in patients with acute coronary syndrome trials. Submitted 2012.
undergoing coronary artery bypass surgery. Results from the Alghamdi AA, Albanna MJ, Guru V, Brister SJ. Does PLATO (Platelet inhibition and Patient Outcomes) Trial. J Am the use of erythropoietin reduce the risk of exposure to Coll Cardiol. 2011;57:672Y684.
Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 Statements for Antiplatelets Before (ANH), retrograde autologous priming (RAP), CS, biocom- patible CPB circuit, miniaturized extracorporeal circuit(MECC), and point-of-care (POC) monitoring.
1. Continuation of ASA up to the time of surgery (or D/C G7 days) increases blood loss (È100 mL on average) (Level A).
Acute Normovolemic Hemodilution 2. Increased reoperation for bleeding (Level A).
Davies L, Brown TJ, Haynes S, Payne K, Elliott RA, 3. Continuation of clopidogrel + ASA in the week before surgery McCollum C. Cost-effectiveness of cell salvage and alternative increases blood loss, need for transfusion, and reoperation for methods of minimising perioperative allogeneic blood trans- bleeding (Level B).
fusion: a systematic review and economic model.
4. Optimal timing of discontinuation of clopidogrel in elective surgery is 5 days (Level B).
Assess. 2006;10(44): iiiYiv, ixYx, 1Y210.
5. Ticagrelor (D/C 24Y72 hours) compared with clopidogrel (D/C Martin JE, Lal A, Bainbridge D, Cheng DC. Acute 5 days) is associated with a lower total mortality (4.7% vs 9.7%; normovolemic hemodilution versus none in cardiac surgery.
HR, 0.49; 95% CI, 0.32Y0.77) and cardiovascular mortality Submitted 2012.
(4.1% vs 7.9%; HR, 0.52; 95% CI, 0.32Y0.85) without exces- Statements for ANH sive risk of bleeding in CABG surgery (Level B).
Recommendations for Antiplatelets Before 1. Acute normovolemic hemodilution reduces bleeding and RBC volume transfused post-CPB (Level A), with a trend in reducing allogeneic RBC exposure (Level A).
2. No impact on AMI, CVA, and death has been shown. Issues of h ASA may be continued until surgery (Class IIa, Level B).
safety remain to be determined (hemodilution risks).
h Stable elective CABG with no drug-eluting stent (DES), stop clopidogrel 5 days preoperatively (Class I, Level A).
Recommendations for ANH h Stable elective CABG with DES less than 1 year old, consider continuing clopidogrel or heparin as a bridge to surgery (Class h Acute normovolemic hemodilution can be considered in selected IIb, Level C).
patients (adequate preoperative hemoglobin) to reduce post-CPB h Direct-acting P2Y12 receptor antagonist may be a better alter- bleeding (Class IIa, Level A).
native than clopidogrel in acute coronary syndrome (ACS) h Routine use of ANH cannot be recommended (Class IIb, Level B).
patients undergoing CABG surgery (Class IIa, Level B).
Recommendations for Further Research ANTIPLATELETS AFTER CARDIAC SURGERY ) Adequately powered RCTs comparing ANH versus none should Relevant Evidence be conducted in cardiac surgery settings, including in the min-imally invasive setting, to determine whether ANH reduces the Patel JH, Stoner JA, Owora A, Mathew ST, Thadani U.
risk of clinically relevant adverse events without undue risk (ie, Evidence for using clopidogrel alone or in addition to aspirin what is the risk of bleeding complications, RF, stroke, MI, post coronary artery bypass surgery patients. Am J Cardiol.
) The role of colloids versus crystalloids for ANH and the ap- propriate dose and duration remain to be explored.
Statements for Antiplatelets After Retrograde Autologous Priming 1. Post-CABG use of clopidogrel with ASA is associated with Relevant Research increased trend for major and minor bleeding but no clearbenefits on clinical outcomes (MI, stroke, death) after CABG Martin JE, Lal A, Bainbridge D, Cheng DC. Retrograde surgery in on-pump and OPCAB patients (Level B).
autologous prime versus control: a meta-analysis and sys-tematic review. Submitted 2012.
Recommendations for Antiplatelets After Statements for RAP 1. Retrograde autologous priming in cardiac surgery reduces the h In stable CABG surgery (non-ACS patients), the routine use of risk of allogeneic blood product exposure (RR, 0.31; 95% CI, postoperative clopidogrel with ASA is not warranted (Class IIb, 0.19Y0.51; Level A).
2. Retrograde autologous priming reduces the mean volume of Recommendations for Future Research on blood product exposure (j0.4 units; 95% CI, j0.6 to j0.2 Antiplatelets after Cardiac Surgery units; Level A).
Recommendations for RAP ) What is the place of newer antiplatelet agents in patients un- dergoing on-pump cardiac surgery? h Retrograde autologous priming is recommended as a blood ) What is the place of newer antiplatelet agents in patients un- conservation modality to reduce allogeneic blood transfusion for dergoing off-pump cardiac surgery? on-pump cardiac surgery (Class I, Level A).
The following were considered under the category of Relevant Evidence technologies used to prevent or reduce exposure to allogeneic Carless PA, Henry DA, Moxey AJ, O'Connell D, Brown T, blood product transfusion: acute normovolemic hemodilution Fergusson DA. Cell salvage for minimising perioperative Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 Perioperative Blood Management Consensus Statement 2011 allogeneic blood transfusion. Cochrane Database Syst Rev.
) A number of existing studies did not clearly define membrane 2010 Apr 14;(4):CD001888.
‘‘biocompatibility,' and existing trials have tested heteroge- Wang G, Bainbridge D, Martin J, Cheng D. The effi- neous biocompatible membranes. Studies need to clarify the cacy of intraoperative cell saver during cardiac surgery: a membrane and the concomitant therapies (ie, coated oxygenator meta-analysis of randomized trials. Anesth Analg. 2009;109: only or whole circuit? which biocoat? open vs closed reservoir?differences in heparinization?) and will need to adequately evaluate which characteristics provide best outcomes.
Statements for CS Minimized Extracorporeal Cardiopulmonary 1. The use of CS throughout cardiac surgery significantly reduces exposure to allogeneic RBC (OR, 0.63; 95% CI, 0.43Y0.94; Relevant Evidence Level A). However, no impact on AMI, RF, infection rates, Harling L, Warren OJ, Martin A, Kemp PR, Evans PC, CVA, and death was shown (Level A).
Darzi A, Athanasiou T. Do miniaturized extracorporeal cir- 2. The benefit for washed CS is greater than for unwashed blood salvaging technique (Level A).
cuits confer significant clinical benefit without compromising 3. Replacing cardiotomy suction with CS only has no significant safety? A meta-analysis of randomized controlled trials.
impact on blood conservation and increases FFP need (Level A).
ASAIO J. 2011;57:141Y151.
Zangrillo A, Garozzo FA, Biondi-Zoccai G, Pappalardo Recommendations for CS F, Monaco F, Crivellari M, Bignami E, Nuzzi M, Landoni G.
h Routine use of CS is recommended in operations where Miniaturized cardiopulmonary bypass improves short-term an increased blood loss is expected (Class 1, Level A).
outcome in cardiac surgery: a meta-analysis of randomized h Cell salvage should be used throughout the entire operation and controlled studies. J Thorac Cardiovasc Surg. 2010;139: not merely as a replacement for CPB cardiotomy suction (Class IIa, Level A).
Harling L, Warren OJ, Rogers PL, Watret AL, Choong Recommendations for Future Research AM, Darzi A, Angelini GD, Athanasiou T. How minimalizedextracorporeal circulation compares with the off-pump tech- ) The impact of CS on neurologic outcomes and on the risk of nique in coronary artery bypass grafting. ASAIO J. 2010;56: death, stroke, MI, and RF should be ascertained in adequately powered randomized trials.
) The risk-benefit of reinfusing washed or unwashed cells should Statements for MECC Versus Conventional be further addressed in future randomized trials.
Extracorporeal Cardiopulmonary Circuit ) The cost-effectiveness of different forms of CS should be MECC Versus Conventional ExtracorporealCardiopulmonary Circuit Biocompatible CPB Circuit 1. MECC (reservoir-less, coated circuits, reduced prime volume) Relevant Evidence for CABG significantly reduces risk of allogeneic blood ex- Ranucci M, Balduini A, Ditta A, Boncilli A, Brozzi S. A posure (OR, 0.42; 95% CI, 0.28Y0.63; Level A). In addition,neurologic events have been shown to be reduced (OR, 0.30; 95% systematic review of biocompatible cardiopulmonary bypass CI, 0.12-0.73; Level A). However, impact on AMI, stroke, and circuits and clinical outcome. Ann Thorac Surg. 2009;87: death is unproven.
MECC Versus OPCAB Statements for Biocompatible CPB Circuit 1. Miniaturized extracorporeal cardiopulmonary circuit and 1. Using biocompatible CPB circuit has an uncertain impact on OPCAB provide similar risks of blood loss and allogeneic blood loss and transfusion needs (RR, 0.88; 95% CI, 0.72Y1.1; transfusion. Clinical outcomes have not been shown to differ Level A) and has not been shown to impact AMI, CVA, and between MECC and OPCAB (Level A [two small RCTs; four Recommendations: Biocompatible Coated Recommendations for MECC Versus Conventional Extracorporeal Cardiopulmonary Circuit h Miniaturized extracorporeal cardiopulmonary circuit can be h The routine use of biocompatible coated CPB circuitry may be considered as a blood conservation technique to reduce allo- considered as part of a multimodal blood conservation program.
geneic blood exposure (Class IIa, Level A); however, issues However, the heterogeneity of surface-modified products, antic- related to heparinization management and biocoat remain to be oagulation management, and CPB technique does not signifi- cantly impact surgical blood loss and transfusion needs (Class IIb,Level A).
Recommendations for Future Research Recommendations for Future Research ) Does MECC have sufficient impact on clinically relevant out- ) Randomized trials of homogeneously defined biocompatible comes (death, stroke, AMI, kidney failure, neurologic outcomes, circuits are required, with adequate power to measure clinically severe bleeding) to warrant its routine use? relevant outcomes such as death, stroke, MI, neurologic out- ) There was significant heterogeneity in the biocoats used in trials comes, and bleeding.
of MECC. More research is required to determine the role of Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 MECC versus the role of the specific biocoat used within the ) There was significant heterogeneity in heparinization.
Relevant Evidence More research is required to determine appropriate heparinization Urwyler N, Trelle S, Theiler L, Juni P, Staub LP, Luyet when using MECC.
C, Alberio L, Stricker L, Stricker K, Greif R. Does point ofcare prothrombin time measurement reduce the transfusion of fresh frozen plasma in patients undergoing major surgery? Relevant Evidence The POC-OP randomized-controlled trial [Study protocol] Martin J, Lal A, Cheng D. Does ultrafiltration improve outcomes in patients undergoing cardiac surgery? A meta- Afshari A, Wikkelsø A, Brok J, Møller AM, Wetterslev J.
analysis of randomized trials. Submitted 2012.
Thromboelastography (TEG) or thromboelastometry (ROTEM) Boodhwani M, Williams K, Babaev A, Gill G, Saleem to monitor haemotherapy versus usual care in patients N, Rubens FD. Ultrafiltration reduces blood transfusions fol- with massive transfusion. Cochrane Database Syst Rev. 2011; lowing cardiac surgery: a meta-analysis. Eur J CardioThorac Statements: POC Monitoring Statements for Ultrafiltration (Continuous 1. Despite benefits shown for thromboelastography/thromboelas- tometry for reduced blood subcomponent transfusion, the resultsare heterogeneous and no benefit has been shown for clinically 1. Ultrafiltration significantly reduces blood loss (j70 mL; 95% relevant outcomes (Level A).
CI, j118 to j21 mL) and volume of blood product transfused 2. The technologies for POC are still evolving, and adequate ex- (j0.73 units; 95% CI, j1.13 to j0.31 units) (Level A).
perience and evidence from clinical trials are required. In ad-dition, the initial evidence that platelet testing impacts on Recommendations for Ultrafiltration (Continuous decision making also requires confirmation of positive clinical impact (Level C).
h Ultrafiltration may be considered for blood conservation (Class Recommendations for POC Monitoring IIb, Level A); however, the impact on clinically relevant out-comes remains unknown.
h The evidence is too premature to recommend POC technology Recommendations for Future Research for routine use because its use has not been shown to impactclinical outcome (Class IIb, Level A).
) Does ultrafiltration significantly reduce the risk of clinically relevant adverse outcomes (death, stroke, AMI, RF, and neuro- Recommendations for Future Research Related to ) Does ultrafiltration add significantly to CS and antifibrinolytics?) Which filtration approach is superior (continuous vs modified ) Randomized controlled trials that are adequately powered to measure clinically relevant outcomes such as death, stroke, MI,interventions for bleeding, and cost-effectiveness are required.
Platelet Plasmapheresis ) Further studies should aim for consistency in which monitor is used and how they are used to direct decision making (ie, when and how Statements for Platelet Plasmapheresis frequently to measure platelet function perioperatively? When dothe results add to standard anticoagulant monitoring? What actions 1. Platelet plasmapheresis significantly reduces exposure to allo- should be taken based on the results of the POC monitoring? geneic RBCs by 30% (RR, 0.70; 95% CI, 0.55Y0.88) and ) Is one monitoring system superior to another? How do the newer platelets by 51% (RR, 0.49; 95% CI, 0.25Y0.85) and also anticoagulants and antiplatelet agents impact the monitoring reduces volume of allogeneic RBCs (j0.44 units; 95% CI, j0.65 to j0.22 units) and allogeneic platelets transfused (j1.0units; 95% CI, j1.6 to j0.4 units) (Level A).
SURGICAL TECHNIQUES 2. Impact on AMI, stroke, RF, and death remains uncertain.
Because less invasive surgical procedures may reduce Recommendations for Platelet Plasmapheresis the risk of blood loss, the role of the following surgical tech-niques in blood management was considered: OPCAB; mini- h It is reasonable to recommend platelet plasmapheresis for blood mally invasive sternotomy for aortic valve surgery (mini-AVR); management in cardiac surgery (Class IIa, Level A), although the minimally invasive sternotomy for mitral valve surgery (mini- impact on clinically relevant outcomes remains unknown.
MVR); thoracic endovascular aortic regurgitation (TEVAR);transcatheter aortic valve implantation (TAVI). One overarch- Recommendations for Future Research Related to ing statement is provided for all techniques reviewed in this Platelet Plasmapheresis ) Adequately powered randomized trials to measure clinically relevant outcomes for platelet plasmapheresis should beencouraged.
Relevant Evidence ) The cost-effectiveness of routine or universal platelet plas- Puskas J, Cheng D, Knight J, Angelini G, Decannier D, mapheresis should be the focus of future studies in this area.
Diegeler A, Dullum M, Martin J, Ochi M, Patel N, Sim E, Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 Perioperative Blood Management Consensus Statement 2011 Trehan N, Zamvar V. Off-Pump versus conventional coronary Statements for TEVAR artery bypass grafting: a meta-analysis and consensus state-ment from the 2004 ISMICS Consensus Conference. Innova- 1. Thoracic endovascular aortic repair (may reduce risk of allogeneic RBC exposure (OR, 0.01; 95% CI, 0.002Y0.04; Level B) and tions. 2005;1:3Y27.
reexploration for bleeding (OR, 0.26; 95% CI, 0.11Y0.62) com- Cheng DC, Bainbridge D, Martin JE, Novick RJ; pared with open thoracic aortic repair (Level B).
Evidence-Based Perioperative Clinical Outcomes Research 2. Thoracic endovascular aortic repair may reduce renal insuffi- Group. Does off-pump coronary artery bypass reduce mor- ciency (OR, 0.40; 95% CI, 0.25Y0.63), early mortality (OR, tality, morbidity, and resource utilization when compared with 0.44; 95% CI, 0.33Y0.59), and permanent paraplegia (OR, 0.30; conventional coronary artery bypass? A meta-analysis of 95% CI, 0.14Y0.62; Level B) compared with open thoracic randomized trials. Anesthesiology. 2005;102:188Y203.
aortic repair, although the reduction in risk of stroke did notreach significance (OR, 0.75; 95% CI, 0.50Y1.13) (Level B).
Statements for OPCAB Versus Conventional CABG 3. Survival benefit for TEVAR versus open repair beyond 1 year remains unproven (1-year mortality OR, 0.73; 95% CI, 1. Off-pump coronary artery bypass significantly reduces alloge- neic blood exposure versus CABG across risk groups (OR, 0.42; 95% CI, 0.34Y0.51; Level A). However, the impact on Transcatheter Aortic Valve Implantation AMI, stroke, and death is less certain.
2. Off-pump coronary artery bypass suffers from lack of stan- Relevant Evidence dardization of anticoagulation strategies (what should be the Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, ACT target, protamine reversal dose) (Level C). Despite this, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar OPCAB has shown advantages in blood exposure reduction.
RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani Minimally Invasive Sternotomy for Aortic VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Valve Replacement Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investi-gators. Transcatheter versus surgical aortic-valve replacement Relevant Evidence in high-risk patients. N Engl J Med. 2011;364:2187Y2198.
Brown ML, McKellar SH, Sundt TM, Schaff HV. Min- Statements for TAVI isternotomy versus conventional sternotomy for aortic valvereplacement: a systematic review and meta-analysis. J Thorac 1. Transcatheter aortic valve implantation reduces a risk of major Cardiovasc Surg. 2009;137:670Y679.
bleeding compared with open AVR (9.3% vs 19.5%; Level B; Statements for Mini-AVR 2. However, the balance of benefits and risks with respect to other 1. Mini-AVR reduces blood loss (WMD, j79 mL; 95% CI, j136 clinically relevant outcomes is of key interest. There was similar to j23 mL; Level A); however, impact on allogeneic blood 30-day and 1-year mortality but increased risk of stroke at exposure remains uncertain. Advantages for AMI, RF, stroke, 30 days (5.5% vs 2.4%) and 1 year (8.3% vs 4.3%) (Level B, and death have not been shown.
Minimally Invasive Sternotomy for Mitral Recommendations for Surgical Techniques for Valve Replacement OPCAB, Mini-AVR, Mini-MVR, and TAVI Relevant Evidence h Whereas these minimally invasive procedures are not primarily Cheng DCH, Martin J, Lal A, Diegler A, Folliguet TA, selected for the purpose of blood management, the reduced al- Nifong W, Perier P, Raanani E, Smith M, Seegurger J, Falk V.
logeneic blood exposure should be considered in the balance of Minimally invasive versus conventional open mitral valve benefits and risks when selecting the appropriate surgery forpatients.
surgery: a meta-analysis and systematic review. Innovations.
2011;6:84Y103.
Recommendations for Future Research Related to OPCAB, Mini-AVR, Mini-MVR, and TAVI Statements for Mini-MVR ) Further randomized studies with adequate power to measure 1. Mini-MVR reduces RBC volume transfused (WMD, j1.85 clinically relevant outcomes beyond blood conservation should units; 95% CI, j2.48 to j1.22; Level B).
be encouraged for mini-AVR, mini-MVR, and TAVI.
2. However, impact on risk of allogeneic RBC exposure did not reach ) Future randomized evidence should explore the learning curve significance (OR, 1.00; 95% CI, 0.47Y2.14; Level A).
in minimally invasive surgery and its impact on the need for 3. Advantages for AMI, RF, and death have not been shown; the risk transfusions and clinically relevant outcomes.
of stroke may be increased (OR, 1.79; 95%, 1.35Y2.38; Level B) Thoracic Endovascular Aortic Replacement Relevant Evidence A number of drugs, technologies, and techniques have Cheng D, Martin J, Dunning J, Shennib H, Muneretto C, been shown to reduce the need for allogeneic blood transfu- Schueler S, von Segesser, Sergeant P, Turina M, on behalf of sion and should be routinely considered as part of a program the ad hoc EACTS/ESCVS Committee. Endovascular versus to reduce exposure to allogeneic blood, including lysine ana- open surgical repair of thoracic aortic disease: a systematic logs, discontinuing antiplatelets in non-ACS patients and in review and meta-analysis of comparative studies. J Am Coll patients without recent DESs, RAP, and use of CS through- out surgery (see summary in Table 3). The benefits of other Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
Innovations & Volume 7, Number 4, July/August 2012 strategies remain less clear, and definitive recommenda- Cost-effectiveness, Availability, and Local tions for routine use would be premature (ie, topical hemo- statics, DDAVP, FVIIa in refractory bleeding, EPO, ANH, This consensus panel did not specifically address issues biocom patible CPB circuits, MECC, ultrafiltration, platelet of cost-effectiveness, and this should not be interpreted to plasmapheresis, POC platelet function testing). Furthermore, suggest that costs and resource considerations are not impor- the role of the minimally invasive approach to surgery may be tant. Because cost-effectiveness and resource considerations part of a program to reduce blood loss; however, there are more are context-sensitive, these issues should be considered locally important considerations for choosing between minimally in- before decisions are made about the relative appropriateness vasive and conventional approaches to cardiac surgery.
of the different drugs, technologies, and techniques. In addi- It is notable that none of these approaches to blood tion, local considerations regarding the availability of the conservation has been proven in RCTs to significantly im- drugs and technologies will be an important driver for decid- prove clinically important outcomes such as death, stroke, or ing which is most important. Lastly, local expertise and skill organ failure in randomized trials. Furthermore, few of these sets should be considered carefully when deciding which type approaches to blood conservation have been adequately of surgical technique is appropriate, given that the learning addressed to determine their impact when applied singularly curve can be a significant driver of adverse clinical outcomes, versus in combination as a multimodal approach to conser- including a higher risk for bleeding.
vation. If the primary purpose of blood conservation strategiesis to reduce the risk of clinically meaningful adverse eventscaused by blood exposure (presumably, increased risk of death, morbidities, immunologic reactions, and infections) A number of strategies have been shown to reduce the while balancing the risk of anemia (death, stroke, MI, organ need for allogeneic blood transfusion in patients undergoing failure), then it is surprising that so few randomized trials have conventional cardiac surgery (antifibrinolytics such as lysine addressed these outcomes. Most RCTs have measured expo- analogs, discontinuation of clopidogrel preoperatively in non- sure to allogeneic blood, or volume of blood transfused, rather ACS patients without recent DESs, RAP, intraoperative CS), than measuring the ultimate outcomes that matter most to and these should be encouraged for routine blood conserva- patients. While conserving blood because of limitations in tion management. A number of strategies to conserve blood supply is important, it is not the ultimate outcome per se, and remain nondefinitive because of lack of consistent evidence future research is imperative to address whether strategies to (topical hemostatics, DDAVP, FVIIa in refractory bleeding, reduce blood transfusion result in comparable or improved EPO, ANH, biocompatible CPB circuits, MECC, ultrafiltra- rates of death, stroke, MI, RF, neurologic function, graft pa- tion, platelet plasmapheresis, POC platelet function testing). A tency, and overall serious adverse events.
number of strategies not addressed in this review should be If there has been a dearth of evidence for clinically rel- the focus of future consensus, including anticoagulation strate- evant outcomes in conventional cardiac surgery, there has gies, colloids versus crystalloids, restrictive transfusion thresh- been an even greater lack of evidence addressing these im- olds, transfusion protocols, and effective implementation of portant questions for minimally invasive cardiac surgery. The multifaceted blood conservation programs. Few blood man- latter represents an important call to action for surgeons, agement strategies have been specifically tested in minimally anesthesiologists, perfusionists, intensivists, and other health invasive cardiac surgery. The lack of high-level evidence to care professionals to prioritize research on these most impor- address the impact on clinical outcomes such as infection, tant questions. More than 1 million cardiac surgeries are per- incompatibility immunologic reactions, kidney failure, MI, formed globally every year, and still a paucity of research stroke, and death remains a significant barrier to determining exists to support evidence-based decision making for patient which drugs, technologies, and techniques provide worthy care in safety and cost-effectiveness in blood management.
improvements in clinically important outcomes for patientsundergoing cardiac surgery whether conventional or mini-mally invasive. Given the volume of cardiac surgery that is Areas Not Addressed performed around the world and the significant consumption A number of important areas related to blood conser- of blood that occurs during cardiac surgery, future large-scale vation were not addressed during this consensus conference, research should be conducted to address these questions.
recognizing that future consensus processes may address theseareas, such as the role of colloids versus crystalloids for fluid management, restrictive versus standard or liberal transfusion The authors acknowledge the support for extensive thresholds, role of transfusing different blood fractions (FFP, literature searches and article retrievals from Brieanne platelets, cryoprecipitate), role of different anticoagulation McConnell, MLIS. In addition, Avtar Lal, MD, PhD, and strategies (different doses of heparin, different ACT targets, Junseok Jeon, MD, PhD, provided data analysis for a number protamine reversal strategies, and different classes of anti- of systematic review updates from the Western University.
coagulants such as bivalirudin for anticoagulation during car- The authors also acknowledge the organizational support of diac surgery, whether for on-pump or off-pump surgery). In Aurelie Alger and Elizabeth Chouinard from ISMICS to facili- addition, the role of formal blood management programs at tate distribution of the collected literature and the face-to-face the institutional and regional level was not specifically ad- meeting for the consensus panel. This consensus conference dressed during this consensus conference.33Y36 was cochaired by Dr Alan H. Menkis and Dr Niv Ad.
Copyright * 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery Copyright 2012 by the International Society for Minimally Invasive Cardiothoracic Surgery. Unauthorized reproduction of this article is prohibited.
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Medical Technology SA Volume 25 No. 1 June 2011 Peer reviewed rEviEW PATHOGENESIS AND FUTURE TREATMENTS OF SYSTEMIC LUPUS ERYTHEMATOSUS: THE ROLE OF CYTOKINES AND ANTI-CYTOKINES?W. J. MauleUniversity of Johannesburg, Department of Biomedical Technology, Faculty of Health Sciences, South Africa.email: warrenm@uj.ac.za tel: +27 (0)11 559 6265 fax: +27 (0)11 559 6558

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