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PERIOPERATIVE MANAGEMENT OF PATIENTS ON ANTI THROMBOTIC THERAPY DR. V. R. Hemanth Kumar Asst prof MGMC&RI American College of Chest Physicians Guidelines-2008 Douketis etal American Society of Regional Anaesthesia guidelines 2009 Horlocker etal Summary of Recommendations Grade 1A Strong recommendation, high-quality evidence, Desirable effects clearly outweigh undesirable effects, or vice versa Consistent evidence from RCTs without important limitations or exceptionally strong evidence from observational studies Recommendation can apply to most patients in most circumstances; further research is very unlikely to change our confidence in the estimate of effect Grade 1B Strong recommendation, moderate-quality evidence, Desirable effects clearly outweigh undesirable effects, or vice versa Evidence from RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence from observational studies Recommendation can apply to most patients in most circumstances; higher quality research may well have an important impact on our confidence in the estimate of effect and may change the estimate Grade 1C Strong recommendation, low or very low-quality evidence, Desirable effects clearly outweigh undesirable effects, or vice versa Evidence for at least one critical outcome from observational studies, case series, or from RCTs with serious flaws or indirect evidence Recommendation can apply to most patients in many circumstances; higherquality research is likely to have an important impact on our confidence in the estimate of effect and may well change the estimate Grade 2A Weak recommendation, high-quality evidence, Consistent evidence from RCTs without important limitations or exceptionally strong evidence from observational studies The best action may differ depending on circumstances or patient or society values; further research very unlikely to change our confidence in the estimate Desirable effects closely is balanced with undesirable effects of effect Grade 2B Weak recommendation, moderate-quality evidence, Desirable effects closely balanced with undesirable effects Evidence from RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence from observational studies Best action may differ depending on circumstances or patient or society values ; higher-quality research may well have an important impact on our confidence in the estimate of effect and may change the estimate Grade 2C Weak recommendation, low or very low-quality evidence, Desirable effects closely balanced with undesirable effects Evidence for at least one critical outcome from observational studies, case series, or from RCTs with serious flaws or indirect evidence Other alternatives may be equally reasonable; higher-quality research is likely to have an important impact on our confidence in the estimate of effect and may well change the estimate ACCP recommend stopping warfarin approximately 5 days before surgery to allow adequate time for the INR to normalize (Grade 1B). ACCP recommend resuming warfarin approximately 12 to 24hrs after surgery (Grade 1C). In patients whose INR is still elevated (ie, > 1.5) 1 to 2 days before surgery. what to do? ACCP suggest administering low-dose (ie, 1 to 2 mg) oral vitamin K to normalize the INR (Grade 2C). Choice of Bridging anticoagulants Based on risk for thromboembolism Three subsets Patients With a Mechanical Prosthetic Heart Valve With Chronic Atrial Fibrillation Patients With Prior VTE Patients With a Mechanical Prosthetic Heart Valve High Risk a mitral valve prosthesis an older-generation aortic valve prosthesis Moderate Risk Bi leaflet aortic valve prosthesis and one of the following 1.AF, 2.Prior stroke or TIA within 6 months stroke or TIA Low Risk Bi leaflet aortic valve prosthesis without atrial fibrillation No other risk factors for stroke. 3.other stroke risk factors (hypertension, diabetes, congestive heart failure, age 75 years With Chronic Atrial Fibrillation High Risk CHADS2 score of 5 or 6; within 3 months stroke or TIA rheumatic valvular heart disease Moderate Risk CHADS2 score of 3 or 4, Low Risk CHADS2 score of 0 to 2 No prior stroke or transient ischemic attack Patients With Prior VTE High Risk Moderate Risk Low Risk Prior VTE within 3 months prior VTE within the past 3 to 12 months VTE occurred 12 months ago severe thrombophilic conditions non severe thrombophilic conditions no risk factors active cancer LMWH Prophylactic LMWH- Dalteparin5000U SC OD OR Enoxaparin 40mg SC od Therapautic dose- enoxaparin 1mg/kg every 12 hrs, enoxaparin 1.5 mg/kg daily, dalteparin 120 U/kg every 12 hrs, dalteparin 200 U/kg daily, tinzaparin 175 U/kg daily UFH Prophylactic dose UFH-5000U SC BD /TID Therapautic dose-5,000 U IV bolus followed by 32,000 U q24h by IV infusion or 35,000 to 40,000 U q24h sc, adjusted to maintain APTT in the therapeutic range1.5 times control Bridging anticoagulant of choice for high risk cases? ACCP recommend bridging anticoagulation with therapeuticdose SC LMWH or IV UFH (Grade 1C). therapeutic-dose SC LMWH is preferred over IV UFH (Grade 2C). Bridging anticoagulant of choice for moderate risk cases? ACCP suggest bridging anticoagulation with therapeutic-dose SC LMWH, therapeutic-dose IV UFH, or low-dose SC LMWH (Grade 2C);ACP suggest therapeutic-dose SC LMWH over other management options (Grade 2C) Bridging anticoagulant of choice? for low risk cases ACCP suggest lowdose SC LMWH or no bridging (Grade 2C). Values and preferences In patients at high or moderate risk for thrombo embolism, the recommendations reflect a relatively high value on preventing thrombo embolism and a relatively low value is on preventing bleeding; in patients at low risk for thrombo embolism, the recommendations reflect a relatively high value on preventing bleeding and a relatively low value on preventing thrombo embolism. Cost containment perspective ACCP recommend the use of SC LMWH administered in an outpatient setting where feasible instead of inpatient administration of IV UFH (Grade 1C) When to stop bridging anticoagulant – therapeutic dose LMWH administer the last dose of LMWH 24 h before surgery (Grade 1C); last preoperative dose of LMWH is approximately half the total daily dose In patients who are receiving bridging anticoagulation with therapeutic-dose IV UFH, ACCP recommend stopping UFH approximately 4 h before surgery (Grade 1C). When to restart therapeutic dose LMWH In patients undergoing a minor surgical procedure and who are receiving bridging anticoagulation with therapeutic- dose LMWH, ACCP recommend resuming this regimen approximately 24 h after the procedure (Grade 1C). In patients undergoing major surgery for whom postoperative therapeutic-dose LMWH/UFH is planned, ACCP recommend either 1. delaying the initiation of therapeutic-dose LMWH/UFH for 48 to 72 h after surgery when hemostasis is secured, or 2. administering low-dose LMWH/UFH after surgery when hemostasis is secured, or 3.completely avoiding LMWH or UFH after surgery (Grade 1C) Is it necessary to monitor anticoagulant effect of LMWH with anti-factor Xa levels ACCP suggest against the routine use of anti-factor Xa levels to monitor the anticoagulant effect of LMWHs (Grade 2C). When to stop asprin and clopidogrel if required? In patients who require temporary interruption of aspirin or clopidogrel-containing drugs before surgery, ACCP suggest stopping this treatment 7 to 10 days before the procedure (Grade 2C). ACCP suggest resuming aspirin and clopidogrel approximately 24 h after surgery when there is adequate hemostasis (Grade 2C). Is it necessary to monitor antithrombotic activity of asprin or clopidogrel ACCP suggest against the routine use of platelet function assays to monitor the antithrombotic effect of aspirin or clopidogrel (Grade 2C). What are Not at increased risk for cardiovascular events drugs for Primary prevention of MI or Stroke What are at increased risk for cardiovascular events recent placement of bare metal stent or drug eluting stent and MI with in 3 months Guidelines for not high risk & high risk For patients who are not at high risk for cardiac events, ACCP recommend interruption of antiplatelet drugs (Grade 1C). For patients at high risk of cardiac events scheduled for non cardiac surgery, ACCP suggest continuing aspirin up to and beyond the time of surgery (Grade 2C); if patients are receiving clopidogrel, we suggest interrupting clopidogrel at least 5 days and, preferably, within 10 days prior to surgery (Grade 2C). Recommendations for CABG and PCI In patients scheduled for CABG, ACCP recommend continuing aspirin up to and beyond the time of CABG (Grade 1C); if aspirin is interrupted(some institutions for increased risk of mediastinal bleeding), ACCP recommend it be reinitiated between 6 h and48 h after CABG (Grade 1C). Stop clopidogrel at least 5 days and, preferably, 10days prior to surgery (Grade 1C). In patients scheduled for PCI, ACCP suggest continuing aspirin up to and beyond the time of the procedure; (better to continue clopidogrel but no recommendation) if clopidogrel is interrupted prior to PCI, ACCP suggest resuming clopidogrel after PCI with a loading dose of 300 to 600 mg (Grade 2C). Recommendations for bare metal and drug eluting stent In patients with a bare metal coronary stent who require surgery within 6 weeks of stent placement, ACCP recommend continuing aspirin and clopidogrel in the perioperative period (Grade 1C). In patients with a drug-eluting coronary stent who require surgery within 12 months of stent placement, ACCP recommend continuing aspirin and clopidgrel in the perioperative period (Grade 1C). Is bridging therapy required after stopping antiplatelet drugs? ACCP suggest against the routine use of bridging therapy with UFH, LMWH, direct thrombin inhibitors, or glycoprotein IIb/IIIa inhibitors (Grade 2C). In patients who are undergoing minor procedures and are receiving warfarin, ACCP recommend continuing warfarin around the time of the procedure co administering an oral prohemostatic agent (Grade 1B for dental and Grade 1C for dermatological and cataract surgeries In patients who are undergoing minor procedures and are receiving aspirin, ACCP recommend continuing aspirin around the time of the procedure (Grade1C). In patients who are undergoing minor procedures and are receiving clopidogrel, continuation or stopping is based on situation. patients on warfarin coming as emergency For less immediate reversal of the anticoagulant effect, ACCP recommend treatment with low-dose (2.5 to 5.0 mg) IV or oral vitamin K (Grade 1C). For more immediate reversal of the anticoagulant effect, ACCP suggest treatment with fresh-frozen plasma or another prothrombin concentrate in addition to low-dose IV or oral vitamin K (Grade 2C). Perioperatively life threatening bleeding occurs in patients on aspirin and clopidogrel ACCP suggest platelet transfusion or prohemostatic agents (Grade 2C). Recent guidelines focused not only on neuraxial blocks and anticoagulants but also focussed on thromboprophylaxis perioperatively. And also focused on peripheral blockade. Regional anaesthesia given –for how many days fibrinolytic drugs are avoided avoid fibrinolytic drugs for 10 days after puncture of non compressible vessels (Grade 1A). Fibrinolytic drugs given-for how many days regional anesthesia is avoided ASRA recommend against performance of spinal or epidural anesthetics except in highly unusual circumstances(Grade 1A). Data are not available to clearly outline the length of time neuraxial puncture should be avoided after discontinuation of these drugs. who have received neuraxial blocks at or near the time of fibrinolytic therapy - postoperative management neurological monitoring should be continued . epidural catheter infusion, should be limited to drugs minimizing sensory and motor block to facilitate assessment of neurologic function (Grade 1C). Any recommendation to remove catheter There is no definitive recommendation for removal of neuraxial catheters in patients who unexpectedly receive fibrinolytic therapy during a neuraxial catheter infusion. how to evaluate residual thrombolytic effect in such cases ASRA suggest for the measurement of fibrinogen level (one of the last clotting factors to recover) 1. To evaluate the presence of residual thrombolytic effect 2.For appropriate timing of catheter removal (Grade 2C). For Patients receiving prophylactic dose of <10000 U SC UFH daily no contraindication for neuraxial technique (Grade 1C). For Patients receiving >10000 U SC UFH may have an increased risk of surgical-related bleeding. But unclear whether there is an increased risk of spinal hematoma. techniques to facilitate detection of new/progressive neurodeficits like neurologic monitoring and neuraxial solutions to minimize sensory and motor block should be applied (Grade 2C). Patients coming for surgery after receiving heparin for more than 4 days Because of risk of heparininduced thrombocytopenia, platelet count should be assessed before neuraxial block and catheter removal (Grade 1C). Combining neuraxial techniques with intraoperative anticoagulation with intravenous UFH during vascular surgery is acceptable with the following recommendations (Grade 1A) IV UFH-4 hrs-neuraxial procedure-1 hr- IV UFH 1.Needle placement and /or catheter putting or removal should be done 2 to 4 hrs after the last heparin dose 2.assess the patient’s coagulation status 3.re-heparin 1 hr after neuraxial technique. bloody or difficult neuraxial needle placement. cancellation of case? there is no data to support mandatory cancellation of a case. Direct communication with the surgeon and a specific risk-benefit decision about proceeding in each case is warranted. Postoperative monitoring in such cases Monitor the patient postoperatively to provide early detection of motor blockade consider use of minimal concentration of local anesthetics to enhance the early detection of a spinal hematoma. Pre op single daily dosing needle placement should occur at least 10 to 12 hrs after the prophylactic /single LMWH dose (Grade 1C). Pre op twice daily dosing needle placement should occur at least 24 h after the therapeutic LMWH twice daily dose (Grade 1C). POSTOP LMWH single daily dosing The first postoperative LMWH dose should be administered 6 to 8 hrs postoperatively. The second postoperative dose should occur no sooner than 24 hrs after the first dose. However, the catheter should be removed after a minimum of 10 to 12 hrs after the last dose of LMWH. Subsequent LMWH dosing should occur after a minimum of 2 hrs after catheter removal. Postoperative LMWH twice daily dosing This dosage regimen is associated with an increased risk of spinal hematoma. The first dose of LMWH should be administered no earlier than 24 hrs postoperatively, the epidural catheter must be removed before the first dose of LMWH. Administration of LMWH should be delayed for 2 hrs after catheter removal. prophylactic LMWH-12 hrs-neuraxial technique -6hrs-1st post op prophylactic LMWH dose-24 hrs-2nd dose LMWH-12 hrs- Catheter removal-2hrsLMWH Therapeutic LMWH-24 hrs-neuraxial technique-22 hrs-catheter removal-2hrsTherapeutic LMWH monitoring of the anti-Xa level. is it necessary? ASRA recommend against the routine use of monitoring of the anti-Xa level (Grade 1A). The presence of blood during needle and catheter placement. does it necessitate postponement of surgery? No. Initiation of LMWH therapy in this setting should be delayed for 24 hrs postoperatively this consideration should be discussed with the surgeon (Grade 2C). Warfarin to be stopped ideally 4 to5 days before the planned procedure and the INR must be normalized before initiation of neuraxial block (Grade 1B). NSAID including asprin no contraindication for neuraxial block-(Grade 1A). Contradiction to ACCP guidelines where surgical bleed was discussed and so aspirin stopped 7-10 days before Discontinue clopidogrel 7 days before neuraxial block(Grade 1C). Platelet GP IIb/IIIa inhibitors Neuraxial techniques should be avoided until platelet function has recovered ie 24 to 48 hrs for abciximab 4 to 8 hrs for eptifibatide and tirofiban Although GP IIb/IIIa antagonists are contraindicated within 4 weeks of surgery, should one be administered in the postoperative period (after a neuraxial technique), patient should be carefully monitored neurologically Herbal medications Should we stop herbal medications preoperatively ASRA recommend against mandatory discontinuation of these medications (Grade 1C). Same recommendations applied for neuraxial techniques can be applied (Grade 1C). Thank you