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• W3041103613 abstract "ACTIVATED CLOTTING time (ACT) is regarded as the gold standard for measurements of heparin anticoagulation during cardiopulmonary bypass (CPB). ACT is a widely available, inexpensive point-of-care (POC) test and can be performed by nonlaboratory staff with minimal training.12nd Hessel EA What's new in cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2019; 33: 2296-2326Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar,2Thompson TZ Kunak RL Savage NM et al.Intraoperative monitoring of heparin: Comparison of activated coagulation time and whole blood heparin measurements by different point-of-care devices with heparin concentration by laboratory-performed plasma anti-Xa assay.Lab Med. 2019; 50: 348-356Crossref PubMed Scopus (9) Google Scholar Despite its routine use since the 1970s,3Bull BS Huse WM Brauer FS et al.Heparin therapy during extracorporeal circulation.II. The use of a dose-response curve to individualize heparin and protamine dosage. J Thorac Cardiovasc Surg. 1975; 69: 685-689Google Scholar optimal ACT target remains unclear due to the lack of high-level evidence. Recent international surveys consistently reported that many institutions use ACT targets between 400 and 500 seconds for safe CPB management,4Lobato RL Despotis GJ Levy JH et al.Anticoagulation management during cardiopulmonary bypass: A survey of 54 North American institutions.J Thorac Cardiovasc Surg. 2010; 139: 1665-1666Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar, 5Miles LF Coulson TG Galhardo C et al.Pump priming practices and anticoagulation in cardiac surgery: Results from the global cardiopulmonary bypass survey.Anesth Analg. 2017; 125: 1871-1877Crossref PubMed Scopus (33) Google Scholar, 6Sniecinski RM Bennett-Guerrero E Shore-Lesserson L Anticoagulation management and heparin resistance during cardiopulmonary bypass: A survey of society of cardiovascular anesthesiologists members.Anesth Analg. 2019; 129: e41-e44Crossref PubMed Scopus (16) Google Scholar but a relevant number of cardiac centers aim for ACT values <400 or >500 seconds. Such variations in ACT targets among institutions are partly explained by (1) device use instructions; (2) different coagulation activators (kaolin, celite, etc) and different technologies of ACT analyzers; and (3) types of CPB circuits (eg, surface coating, use of cardiotomy suction) and potential invasiveness of surgery. Of note, fluctuating coagulation factor levels, platelet count and function, and temperature may yield variable ACT values at the same heparin activity.7Levy JH Sniecinski RM Activated clotting times, heparin responses, and antithrombin: Have we been wrong all these years?.Anesth Analg. 2010; 111: 833-835Crossref PubMed Scopus (13) Google Scholar,8Bosch YP Weerwind PW Nelemans PJ et al.An evaluation of factors affecting activated coagulation time.J Cardiothorac Vasc Anesth. 2012; 26: 563-568Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar In this issue of the Journal of Cardiothoracic and Vascular Anesthesia, Falter et al. compared the results of 2 POC cartridge-based ACT analyzers, Hemochron (Werfen, Bedford, MA) and iSTAT (Abbott, Princeton, NJ), at several time points during elective cardiac surgery in 33 patients.9Falter F MacDonald S Matthews C et al.Evaluation of point-of-care ACT coagulometers and anti-Xa activity during cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2020; 34: 2921-2927Abstract Full Text Full Text PDF Scopus (8) Google Scholar ACT values from the 2 devices were also compared with anti-Xa activity. The authors found an acceptable correlation between anti-Xa and Hemochron ACT (r = 0.82, 95% confidence interval [CI] 0.757-0.868), as well as between anti-Xa and iSTAT ACT (r = 0.81, 95% CI 0.738-0.858). Interestingly, the correlation between the 2 ACT devices was lower (r = 0.77, 95% CI 0.707-0.828). The authors concluded that the ACT results from different devices are not interchangeable and that target values for safe anticoagulation on CPB should be determined specifically for each device and potentially adapted with change of the device. In the original methodologic description of ACT measurements for heparin anticoagulation on CPB, Bull et al. wrote that, “blood was placed into a glass tube containing celite and then the tube was inverted once a second for the first 30 seconds to mix the content. The tube was then place in a heat block over a 40-watt light bulb and rocked slowly until clotting occurred. The time clock was stopped manually when the first clearly defined clot was visible” (by eye-balling).3Bull BS Huse WM Brauer FS et al.Heparin therapy during extracorporeal circulation.II. The use of a dose-response curve to individualize heparin and protamine dosage. J Thorac Cardiovasc Surg. 1975; 69: 685-689Google Scholar Using this method, the authors determined a “safety zone” of heparin anticoagulation during CPB between 300 and 600 seconds, but an ACT level of 480 seconds (ie, 8 minutes) was chosen as an optimal target, without further explanation.12nd Hessel EA What's new in cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2019; 33: 2296-2326Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar,3Bull BS Huse WM Brauer FS et al.Heparin therapy during extracorporeal circulation.II. The use of a dose-response curve to individualize heparin and protamine dosage. J Thorac Cardiovasc Surg. 1975; 69: 685-689Google Scholar Today, ACT values are read out by automated or cartridge-based systems with improved precisions. Nonetheless, the study by Falter et al. pointed out that ACT measurement still has large variability, and its validity for exact determination of heparin activity is limited.9Falter F MacDonald S Matthews C et al.Evaluation of point-of-care ACT coagulometers and anti-Xa activity during cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2020; 34: 2921-2927Abstract Full Text Full Text PDF Scopus (8) Google Scholar The technology behind each ACT device might, at least partially, explain the low correlation between results. The Hemochron device exerts forward and backward oscillations inside a small capillary and detects reductions in flow rate of the added blood sample by light-emitting diode optical sensors. The test endpoint occurs when oscillating movements slow down to a predetermined rate due to clot formation.10Ojito JW Hannan RL Burgos MM et al.Comparison of point-of-care activated clotting time systems utilized in a single pediatric institution.J Extra Corpor Technol. 2012; 44: 15-20PubMed Google Scholar In contrast to this mechanical detection of clot formation, iSTAT uses an electrical sensor that amperometrically monitors the increase of a specific split product, mimicking the reaction of thrombin with fibrinogen. Detection of conversed thrombin substrate (H-D-phenylalanyl-pipecolyl-arginine-p-amino-p-methodydiphenylamine) stops the test.2Thompson TZ Kunak RL Savage NM et al.Intraoperative monitoring of heparin: Comparison of activated coagulation time and whole blood heparin measurements by different point-of-care devices with heparin concentration by laboratory-performed plasma anti-Xa assay.Lab Med. 2019; 50: 348-356Crossref PubMed Scopus (9) Google Scholar,9Falter F MacDonald S Matthews C et al.Evaluation of point-of-care ACT coagulometers and anti-Xa activity during cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2020; 34: 2921-2927Abstract Full Text Full Text PDF Scopus (8) Google Scholar,10Ojito JW Hannan RL Burgos MM et al.Comparison of point-of-care activated clotting time systems utilized in a single pediatric institution.J Extra Corpor Technol. 2012; 44: 15-20PubMed Google Scholar It seems obvious that well-known influencing factors of the ACT measurements, such as diluted coagulation factors, hypothermia, low platelet count, or impaired platelet function,7Levy JH Sniecinski RM Activated clotting times, heparin responses, and antithrombin: Have we been wrong all these years?.Anesth Analg. 2010; 111: 833-835Crossref PubMed Scopus (13) Google Scholar,8Bosch YP Weerwind PW Nelemans PJ et al.An evaluation of factors affecting activated coagulation time.J Cardiothorac Vasc Anesth. 2012; 26: 563-568Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar might differently affect the 2 devices, leading to variable test results, especially with high heparin dosages11Maslow A Chambers A Cheves T et al.Assessment of heparin anticoagulation measured using i-STAT and Hemochron activated clotting time.J Cardiothorac Vasc Anesth. 2018; 32: 1603-1608Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar or prolonged CPB.12Williams B Wehman B Mazzeffi MA et al.Acute intracardiac thrombosis and pulmonary thromboembolism after cardiopulmonary bypass: A systematic review of reported cases.Anesth Analg. 2018; 126: 425-434Crossref PubMed Scopus (22) Google Scholar Technical differences between the ACT devices support the conclusion that Hemochron and iSTAT are not interchangeable.9Falter F MacDonald S Matthews C et al.Evaluation of point-of-care ACT coagulometers and anti-Xa activity during cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2020; 34: 2921-2927Abstract Full Text Full Text PDF Scopus (8) Google Scholar They might further explain the variable behavior of ACT changes during CPB as reported in the present study.9Falter F MacDonald S Matthews C et al.Evaluation of point-of-care ACT coagulometers and anti-Xa activity during cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2020; 34: 2921-2927Abstract Full Text Full Text PDF Scopus (8) Google Scholar However, it does not fully explain why Hemochron ACT was higher at all stages during CPB as compared with iSTAT ACT,9Falter F MacDonald S Matthews C et al.Evaluation of point-of-care ACT coagulometers and anti-Xa activity during cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2020; 34: 2921-2927Abstract Full Text Full Text PDF Scopus (8) Google Scholar which was in agreement with 2 recent studies.10Ojito JW Hannan RL Burgos MM et al.Comparison of point-of-care activated clotting time systems utilized in a single pediatric institution.J Extra Corpor Technol. 2012; 44: 15-20PubMed Google Scholar,11Maslow A Chambers A Cheves T et al.Assessment of heparin anticoagulation measured using i-STAT and Hemochron activated clotting time.J Cardiothorac Vasc Anesth. 2018; 32: 1603-1608Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar Interestingly, another study suggested the higher ACT values with the iSTAT when compared with the ACT Plus system (Medtronic, Minneapolis, MN). The latter device uses an electromechanical detection of clot formation.13Falter F Razzaq N John M et al.Clinical evaluation of measuring the ACT during elective cardiac surgery with two different devices.J Extra Corpor Technol. 2018; 50: 38-43PubMed Google Scholar Nonetheless, it remains unclear which ACT device provides “best” results. Falter et al. reported the higher sensitivity and specificity for specific anti-Xa levels with iSTAT.9Falter F MacDonald S Matthews C et al.Evaluation of point-of-care ACT coagulometers and anti-Xa activity during cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2020; 34: 2921-2927Abstract Full Text Full Text PDF Scopus (8) Google Scholar However, as long as ACT values remain within the suggested therapeutic range during CPB, the higher sensitivity and lower variation of the iSTAT might not lead to better outcome. It seems rather unrealistic to find clinically relevant outcome differences between ACT devices, due to existing variability in heparin products, heparin dosing schemes, and CPB circuits.5Miles LF Coulson TG Galhardo C et al.Pump priming practices and anticoagulation in cardiac surgery: Results from the global cardiopulmonary bypass survey.Anesth Analg. 2017; 125: 1871-1877Crossref PubMed Scopus (33) Google Scholar,6Sniecinski RM Bennett-Guerrero E Shore-Lesserson L Anticoagulation management and heparin resistance during cardiopulmonary bypass: A survey of society of cardiovascular anesthesiologists members.Anesth Analg. 2019; 129: e41-e44Crossref PubMed Scopus (16) Google Scholar,14Bojan M Fischer A Narayanasamy A et al.Postoperative bleeding after change in heparin supplier: A cardiothoracic center experience.J Cardiothorac Vasc Anesth. 2017; 31: 1603-1610Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar,15Lax M Pesonen E Hiippala S et al.Heparin dose and point-of-care measurements of hemostasis in cardiac surgery - results of a randomized controlled trial.J Cardiothorac Vasc Anesth. 2020; (2020 Jan 7;S1053-0770(20)30020-3. [e-pub ahead of print])https://doi.org/10.1053/j.jvca.2019.12.050Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Alternatives to conventional ACT measurements have been suggested. Results from heparin-protamine titration system, (also called heparin monitoring systems) might better reflect the real heparin activity than common ACT devices.16Raymond PD Ray MJ Callen SN et al.Heparin monitoring during cardiac surgery. Part 1: Validation of whole-blood heparin concentration and activated clotting time.Perfusion. 2003; 18: 269-276Crossref PubMed Scopus (74) Google Scholar,17Ural K Pro Owen C. The Hepcon HMS should be used instead of traditional activated clotting time (ACT) to dose heparin and protamine for cardiac surgery requiring cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2016; 30: 1727-1729Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar In addition, they have been shown to reduce postoperative bleeding risk and transfusion requirements.18Boer C Meesters MI Milojevic M et al.EACTS/EACTA guidelines on patient blood management for adult cardiac surgery.J Cardiothorac Vasc Anesth. 2017; 32: 88-120Abstract Full Text Full Text PDF PubMed Scopus (208) Google Scholar,19Boer C Meesters MI Veerhoek D et al.Anticoagulant and side-effects of protamine in cardiac surgery: A narrative review.Br J Anaesth. 2018; 120: 914-927Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar However, they also are based on ACT measurements and might, therefore, have similar limitations to conventional ACT devices.20Gilly G Trusheim J. Con: The Hepcon HMS should not be used instead of traditional activated clotting time to dose heparin and protamine for cardiac surgery requiring cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2016; 30: 1730-1732Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar,21Abuelkasem E Mazzeffi MA Henderson RA et al.Clinical impact of protamine titration-based heparin neutralization in patients undergoing coronary bypass grafting surgery.J Cardiothorac Vasc Anesth. 2019; 33: 2153-2160Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar The intrinsic clotting time with and without heparinase in ROTEM (TEM International, Munich, Germany) is able to detect residual heparin activity after protamine reversal,22Willems A Savan V Faraoni D et al.Heparin reversal after cardiopulmonary bypass: Are point-of-care coagulation tests interchangeable?.J Cardiothorac Vasc Anesth. 2016; 30: 1184-1189Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar but its usefulness to assess adequate heparin levels during CPB is poorly investigated. The same limitation applies to reaction (R) time as assessed by the TEG (Haemonetics, Boston, MA) assay with and without heparinase. Importantly, this TEG assay is activated by kaolin and tissue factor, which might limit its sensitivity for heparin activity.20Gilly G Trusheim J. Con: The Hepcon HMS should not be used instead of traditional activated clotting time to dose heparin and protamine for cardiac surgery requiring cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2016; 30: 1730-1732Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar Further, the activated partial thromboplastin time could be performed as a POC test, but its correlation with heparin activity is limited and the test is not applicable with heparin blood concentrations higher than 1 U/L. Potentially, the anti-Xa assay would provide the only alternative to ACT measurements during CPB. Anti-Xa measurements are thought to assess heparin concentrations most adequately, and several studies, including the present one have demonstrated a lack of good correlation between heparin levels as assessed by anti-Xa activity and ACT during CPB.9Falter F MacDonald S Matthews C et al.Evaluation of point-of-care ACT coagulometers and anti-Xa activity during cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2020; 34: 2921-2927Abstract Full Text Full Text PDF Scopus (8) Google Scholar,16Raymond PD Ray MJ Callen SN et al.Heparin monitoring during cardiac surgery. Part 1: Validation of whole-blood heparin concentration and activated clotting time.Perfusion. 2003; 18: 269-276Crossref PubMed Scopus (74) Google Scholar,23Despotis GJ Summerfield AL Joist JH et al.Comparison of activated coagulation time and whole blood heparin measurements with laboratory plasma anti-Xa heparin concentration in patients having cardiac operations.J Thorac Cardiovasc Surg. 1994; 108: 1076-1082Abstract Full Text PDF PubMed Scopus (184) Google Scholar However, anti-Xa measurements are not available as POC tests and specifically trained lab personnel are needed to run such tests.19Boer C Meesters MI Veerhoek D et al.Anticoagulant and side-effects of protamine in cardiac surgery: A narrative review.Br J Anaesth. 2018; 120: 914-927Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar Of note, even if the anti-Xa activity would be available as a POC test, it is unclear which target we should aim for during CPB. In contrast to venous thromboembolism therapy and prevention,24Kearon C Kahn SR Agnelli G et al.Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition).Chest. 2008; 133: 454S-545SAbstract Full Text Full Text PDF PubMed Scopus (1874) Google Scholar evidence for optimal anti-Xa activity during CPB is scarce.11Maslow A Chambers A Cheves T et al.Assessment of heparin anticoagulation measured using i-STAT and Hemochron activated clotting time.J Cardiothorac Vasc Anesth. 2018; 32: 1603-1608Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar About 10 years ago, Dr Jobes suggested in this journal that, “learning optimal factor Xa inhibition for CPB along with a corresponding POC test might prove (most) fruitful.”25Jobes D It is a tough ACT to follow.J Cardiothorac Vasc Anesth. 2011; 25: 393-394Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar Unfortunately, we have not accumulated much more evidence since 2011, and the present study, despite interesting and relevant, might not provoke fundamental changes. In summary, heparin remains the drug of choice for mandatory anticoagulation during CPB, but optimal dosing to achieve best patient outcomes is unclear.12nd Hessel EA What's new in cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2019; 33: 2296-2326Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar,15Lax M Pesonen E Hiippala S et al.Heparin dose and point-of-care measurements of hemostasis in cardiac surgery - results of a randomized controlled trial.J Cardiothorac Vasc Anesth. 2020; (2020 Jan 7;S1053-0770(20)30020-3. [e-pub ahead of print])https://doi.org/10.1053/j.jvca.2019.12.050Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Similarly, ACT has a long track record as the preferred monitoring system of heparin activity during CBP despite the lack of strong evidence or optimal targets in relation to clinical outcomes. It is supposed that ACT will remain the most common assessment of adequate heparin effects during CPB in the near future.17Ural K Pro Owen C. The Hepcon HMS should be used instead of traditional activated clotting time (ACT) to dose heparin and protamine for cardiac surgery requiring cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2016; 30: 1727-1729Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar The findings by Falter et al. suggested that the responsibility of evaluating safety and efficacy of heparin anticoagulation monitoring, such as ACT targets, falls on both the practice and institution. In particular, heparin levels may not be adequately maintained when ACT values go out of range due to complex coagulopathy during prolonged CPB of more than 4 hours.12Williams B Wehman B Mazzeffi MA et al.Acute intracardiac thrombosis and pulmonary thromboembolism after cardiopulmonary bypass: A systematic review of reported cases.Anesth Analg. 2018; 126: 425-434Crossref PubMed Scopus (22) Google Scholar However, in the absence of real alternatives, we must rely on internationally suggested ACT values as a gold standard. The current practice of anticoagulation and its monitoring during CPB is supported by our daily experiences and recommendations that a heparin bolus of 300- to- 400 U/kg, leading to an ACT between 400 and 500 seconds evaluated with different devices, is generally accepted safe enough to inhibit clot formation during CPB.12nd Hessel EA What's new in cardiopulmonary bypass.J Cardiothorac Vasc Anesth. 2019; 33: 2296-2326Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar A switch from ACT to anti-Xa monitoring cannot be recommended in cardiac surgery with CPB at the moment. There are no conflicts of interest. Evaluation of Point-of-Care ACT Coagulometers and Anti-Xa Activity During Cardiopulmonary BypassJournal of Cardiothoracic and Vascular AnesthesiaVol. 34Issue 11PreviewObjective: The activated clotting time (ACT) is used worldwide to confirm safe heparin anticoagulation for cardiopulmonary bypass. For the present study, the performances of 2 commonly used ACT devices were compared with each other and with anti-Xa levels throughout the surgical procedure in order to understand whether they can be used interchangeably.Design: Prospective study.Setting: Tertiary care center.Participants: The study comprised 33 elective adult cardiac surgical patients.Interventions: Blood samples were taken at standard times throughout the surgery (after induction, after heparin bolus, 4 samples at 30-minute intervals during cardiopulmonary bypass, after protamine), and ACTs and anti-Xa levels were analyzed. Full-Text PDF" @default.
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• W3041103613 title "Toward Optimal Anticoagulation Monitoring During Cardiopulmonary Bypass: It Is Still A Tough “ACT”" @default.
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