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Guideline methodology

Guideline methodology

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Guideline methodology

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  1. Guideline methodology • Every topic is supported by a structured review • Review is published as a ‘Best Evidence Topic‘ in the ICVTS • A summary recommendation is given in the guideline • Each recommendation is graded, based on the strength of evidence to support that recommendation 2007 EACTS guidelines

  2. Best Evidence Topics • Follows a structured protocol • Answers a single narrowly phrased clinical question • Performed by Clinicians throughout Europe • Evidence supported by : • Second author check • Information scientist search check • Journal Club evidence check • Web-based comments on ICVTS website • Then publication 2007 EACTS guidelines

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  7. Perioperative management of anticoagulation and anti-platelet therapy in cardiac surgery Dose of aspirin after coronary arterial bypass grafting Timing of aspirin after coronary arterial bypass grafting Clopidogrel for the optimisation of graft patency. Clopidogrel cessation prior to urgent coronary bypass grafting. 2007 EACTS guidelines

  8. Perioperative management of anticoagulation and anti-platelet therapy in cardiac surgery Anticoagulation after mechanical valve replacement Warfarin after bioprosthetic valve replacement Aspirin in addition to warfarin for patients with a mechanical valve replacement Warfarin and mitral valve repair Anticoagulation for patients with de novo AF after cardiac surgery 2007 EACTS guidelines

  9. Perioperative management of anticoagulation and anti-platelet therapy in cardiac surgery Aprotinin to reduce perioperative bleeding Aprotinin and stroke risk for cardiothoracic surgery Tranexamic acid to reduce perioperative bleeding Topical tranexamic acid to reduce perioperative bleeding Protamine administration post cardiac surgery Hepcon for minimisation of blood and blood product usage Thromboelastography to guide blood and blood product usage. Recombinant Factor VIIa for intractable bleeding after cardiac surgery Low molecular weight heparin for deep vein thrombosis prophylaxis 2007 EACTS guidelines

  10. Dose of aspirin after CABG :Recommendation Aspirin should be given post-operatively to all patients without contra-indications after coronary artery bypass grafting in order to improve the long term patency of venous grafts. The dose given should be 150-325mg. (Grade A recommendation based on Level 1a and 1b studies) There is no evidence to promote the use of aspirin after coronary arterial bypass grafts to improve the patency of arterial grafts. However aspirin may be recommended on the basis of improved survival of patients in general who have atherosclerotic disease. (Grade E recommendation based on expert consensus) 2007 EACTS guidelines

  11. Dose of aspirin after CABG :Evidence • Fremes(1993) meta-analysis of 12 studies showing benefit of low or medium dose aspirin over high dose aspirin • Veterans and antiplatelet trialists meta-analyses unable to differentiate between doses of aspirin. • Mangano(2002) in 5065 CABG pts showed mortality benefit for aspirin, NNT 30 • Lim(2003) comparative meta-analysis showed highest risk reduction with 300-325mg compared to 75-150mg of aspirin (P=NS) • ACCP 6th consensus conference(2001) recommended 325mg of aspirin • ACCP 7th consensus conference(2004) recommended 75mg-162mg per day (both graded as level 1a evidence) • ACC/AHA 2004 Dosing regimes from 100mg to 325mg seem efficacious Dunning J, Das S. What is the optimal dose of aspirin after discharge following coronary bypass surgery. ICVTS 2003;(4):427-30. 2007 EACTS guidelines

  12. Timing of aspirin after CABG :Recommendation Aspirin should be commenced within 24 hours after coronary artery bypass grafting. (Grade A recommendation based on Level 1a and 1b studies) There is a trend towards maximal benefit of aspirin the sooner it is given post-operatively. Giving aspirin at 6 hours or when bleeding has ceased may therefore be the optimal strategy. (Grade B recommendation based on individual Level 1a and 1b studies) 2007 EACTS guidelines

  13. Timing of aspirin after CABG :Evidence • Fremes(1993) 12 study meta-analysis showed maximal risk reduction if aspirin given <6hrs (p=NS) • Gavaghan(1991) 237pts showed largest risk reduction with aspirin at 1hr but increased re-operation rate • Sharma(1983) showed no benefit if aspirin started at 48hrs • ACCP 7th consensus conference recommend aspirin at 6 hrs post-operatively (grade 1a evidence). • ACC/AHA guidelines 2004 : Prospective controlled trials have demonstrated a graft patency benefit when aspirin was started 1, 7, or 24 hours after operation Musleh G, Dunning J. Does aspirin 6 h after coronary artery bypass grafting optimise graft patency? ICVTS 2003;(4):413-5 2007 EACTS guidelines

  14. Clopidogrel in addition to aspirin :Recommendation 1 Clopidogrel (75mg) is an acceptable alternative to aspirin for the optimisation of graft patency post coronary arterial bypass grafting. (Grade B recommendation based on individual Level 1b studies) The superiority of clopidogrel over aspirin for optimising graft patency after coronary arterial bypass grafting has not yet been established and thus aspirin should be regarded as the first drug of choice. (Grade B recommendation based on individual Level 1b studies) 2007 EACTS guidelines

  15. Clopidogrel in addition to aspirin :Recommendation 2 In patients having cardiac surgery for acute coronary syndrome, clopidogrel should be considered for 9-12 months in addition to aspirin. ( Grade B recommendation based on sub-analyses of level 1b studies) Clopidogrel may further improve the patency of saphenous vein grafts when given in addition to aspirin, but this will be at the expense of an increase in bleeding complications (Grade B recommendation based on individual level 1a and 1b studies) In patients having coronary bypass surgery with a coronary stent in situ, clopidogrel should be continued if the stent has not been covered by a graft. ( Grade E recommendation based on expert consensus) 2007 EACTS guidelines

  16. Clopidogrel in addition to aspirin :Evidence • ACCP 7th consensus conference 2004 : Grade 1C recommendation For patients who undergo CABG for non–ST segment elevation acute coronary syndrome(ACS), Clopidogrel, 75 mg/d should be given for 9 to 12 months following the procedure in addition to treatment with aspirin. • CAPRIE ( Aspirin vs Clopidogrel 19,185pts) 1480 pts had CABG, RRR 39% death, 38% MI. • CURE ( Clopidogrel plus aspirin, 12,562pts) 2072pts had subsequent CABG, 11% RRR in MACE , 18% if CABG was same admission • CREDO (Clopidogrel plus aspirin after PCI, 2116pts) 320 CABG - RRR 17% • CASCADE(Clopidogrel After Surgery for Coronary Artery DiseasE) – 100pt RCT Kunadian B, Babu N, Dunning J. Should High Risk Patients Receive Clopidogrel as well as Aspirin post Coronary Arterial Bypass Grafting? ICVTS 2006 – web prepublication Nagarajan DV, Lewis PS, Dunning J. Is clopidogrel beneficial following coronary bypass surgery? ICVTS 2004;(2):311-3. 2007 EACTS guidelines

  17. Clopidogrel cessation pre-CABG:Recommendation Patients requiring urgent coronary arterial bypass grafting should have their clopidogrel omitted for 5-7 days prior to their surgery if their clinical condition allows. The benefits in terms of the reduction in perioperative blood loss, reduced risk of re-exploration and reduction of blood product usage is at the expense of a 1% increase in the risk of MI while awaiting surgery (Grade B recommendation based on individual Level 1a and 1b studies) 2007 EACTS guidelines

  18. Clopidogrel cessation pre-CABG :Evidence • Purkayastha (2006) 11 study meta-analysis: Mean increase in blood loss of 323mls, a 6-fold increase in the odds of re-exploration, an increase in adverse events and ventilation time,no difference in hospital length-of-stay or mortality • PCI-CURE study(2001) 2,658pts having clopidogrel or placebo prior to PCI at day 6, 5.1% MI without clopidogrel , vs 3.6% with clopidogrel while waiting for PCI • ACC/AHA guideline : stop clopidogrel 5-7 days prior to CABG (grade B) • ACCP guideline : stop clopidogrel 5-7 days prior to CABG (grade 2A) Kunadian B, Thornley AR, Tanos M, Dunning J. Should Clopidogrel be stopped prior to urgent cardiac surgery? ICVTS 2006 web prepublication. 2007 EACTS guidelines

  19. INR after mechanical valve replacement: Recommendation We recommend that European Cardiothoracic Surgeons follow the guidelines provided by the European Society of Cardiology. These guidelines are both up to date, detailed and will be kept up to date by the European Society of Cardiology in the future. 2007 EACTS guidelines

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  22. Warfarin after bioprosthesis:Recommendation Patients post-mitral bioprosthesis should have heparinisation and warfarin for 3 months with an INR of 2-3. For patients post-aortic bioprosthesis without additional risk factors, antiplatelet therapy alone is adequate. (Grade B recommendation based on Level 2b and 3b studies) 2007 EACTS guidelines

  23. Warfarin after bioprosthesis :Evidence • ESC(2005) due to the absence of studies that demonstrate the safety of omitting anticoagulation for 3-months post-bioprosthesis, warfarinisation with a target INR of 2.5 or 3.0 in higher risk patients should be given. • ACCP(2004) Bioprosthetic valves in the mitral position should receive warfarin for the first 3 months ( Grade 1C+) and also in the aortic position( grade 2C) • ACC/AHA (1998) warfarin is recommended although in several centres only aspirin is used. • SIGN(1999) 3 months of warfarin in the aortic position( grade C) and the mitral position (grade A) • BSH (1998, 2005) warfarin in the aortic position is not required although many centres anticoagulate for 3-6 months. Mitral bioprosthesis should receive warfarin for 3-6 months (grade A) • Surveys in UK and USA show that 60% of surgeons do not anticoagulate aortic bioprostheses • No primary studies show convincing evidence in favour of anticoagulating aortic valves. El-Husseiny M, Salhiyyah K, Raja SG, Dunning J. Should warfarin be routinely prescribed for the first three months after a biprosthetic valve replacement? ICVTS 2006 web prepublication 2007 EACTS guidelines

  24. Aspirin in addition to warfarin for mechanical valves: Recommendation Low dose aspirin (80-100 mg daily) in addition to warfarin in patients with prosthetic heart valves reduces all cause mortality (NNT=19), with significant reductions in thromboembolism despite an increase in bleeding. (Grade A recommendation based on Level 1a and 1b studies) 2007 EACTS guidelines

  25. Aspirin in addition to warfarin for mechanical valves: Evidence • 11 trials found and 12 meta-analyses or guidelines • Massel (2001) meta-analysis of 11 studies 2428 patients. significant reduction of all cause mortality from 9% to 5.2% significant increase in major bleeding of 5.4% to 8.5% • ACC/AHA (1998) 80mg-100mg aspirin in addition to warfarin (Grade 2A) • ACCP(2004) patients who suffer systemic embolism despite warfarin aspirin should be added ( Grade 1C) • ESC (2005) Aspirin in addition to warfarin only for patients with arterial disease, systemic embolisation or stenting. Nagarajan DV, Lewis PS, Botha P, Dunning J. Is addition of anti-platelet therapy to warfarin beneficial to patients with prosthetic heart valves? ICVTS 2004;(3):450-5 2007 EACTS guidelines

  26. Warfarin for mitral valve repair: Recommendation There is an absence of studies demonstrating the safety of omitting warfarin for patients undergoing mitral valve repair. In addition, due to higher atrial fibrillation and thromboembolic episodes in the early postoperative period a period of 6 weeks to 3 months of anticoagulation may be regarded as current best practise. (Grade C recommendation based on an absence of studies demonstrating the safety of omission and level 2b and 3b studies ) 2007 EACTS guidelines

  27. Warfarin for mitral valve repair: Evidence • The European Society of Cardiology state that there are no randomized controlled trials to support the safety of omitting warfarin after mitral repair. They recommend 3 months of warfarin at a target INR of 2.5 or 3.0. • No other guidelines make recommendations • Vaughan UK survey – 64% of consultants use warfarin post-mitral valve repair • Carpentier 29 year follow up series demonstrate very low rates of thromboembolism ( Warfarin for 2 months) • Jovin – of 181 patients post-repair who were discharged in sinus rhythm, 36% had an episode of AF post discharge. Asopa S, Patel A, Dunning J. Is short term anticoagulation necessary after mitral valve repair? ICVTS 2006;Accepted for publication. 2007 EACTS guidelines

  28. DVT prophylaxis for cardiac surgery: Recommendation The incidence of thromboembolism after cardiac surgery is similar to the incidence in patients undergoing high risk general surgery. (Grade B recommendation based on Level 2b studies) The ACCP guidelines recommend heparin prophylaxis for this risk group and we conclude that patients post-cardiac surgery should be treated equivalently, with prophylaxis using heparin or LMWH starting on the first post-operative day. (Grade B recommendation based on Level 1b and 2b studies) 2007 EACTS guidelines

  29. DVT prophylaxis for cardiac surgery: Evidence • Shammas(2000) review of 8 studies including over 18,000 patients post cardiac surgery. Incidence of proximal DVT was 18%, PE 0.8%, 29 fatal PEs identified. • Ramos(1996) PRCT of 2551 patients undergoing cardiac surgery using heparin 5000sc +/- TEDS. Incidence of PE was 3% • Systematic reviews in many specialties demonstrate the efficacy of LMWH and the safety with regard to bleeding complications • Malouf et al – patients with immediate heparin and warfarinisation post surgery had a 32% pericardial effusion rate with 12 delayed tamponades. • Kulik(2006) systematic reviews of anticoagulation strategies- 4% bleed rate with LMWH, 8% with full dose heparin. Close V, Purohit M, Tanos M, Hunter S. Should patients post cardiac surgery be given low molecular weight heparin for deep vein thrombosis prophylaxis? ICVTS 2006;In press 2007 EACTS guidelines

  30. Aprotinin to reduce perioperative bleeding: Recommendation Aprotinin clearly reduces blood loss, requirement for blood transfusion, and the risk of reoperation for bleeding, but probably does increase the risk of saphenous vein graft occlusion. (Grade A recommendation based on Level 1a and 1b studies) 2007 EACTS guidelines

  31. Aprotinin to reduce perioperative bleeding: Evidence Kalkat M, Levine A, Dunning J. Does use of aprotinin in coronary artery bypass graft surgery affect graft patency? ICVTS 2004;(1):124-8. Ronald A, Dunning J. Does use of Aprotinin decrease the incidence of stroke and neurological complications in adult patients undergoing Cardiac Surgery? ICVTS 2006 web pre-publication 2007 EACTS guidelines

  32. Tranexamic acid to reduce perioperative bleeding: Recommendation Tranexamic acid reduces blood loss, requirement for blood transfusion, and the risk of reoperation for bleeding (Grade A recommendation based on Level 1b studies) No study has yet looked directly at vein graft patency with tranexamic acid, but equally no randomized studies have raised concerns over its safety (Grade B recommendation based on individual Level 1b studies) 2007 EACTS guidelines

  33. Tranexamic acid to reduce perioperative bleeding: Evidence • 10 PRCTs and one meta-analysis found • 5 PRCTS of Tranexamic acid versus placebo – 4/5 demonstrated significant reductions in bleeding • Casati 2001 (Aprotinin vs Tranexamic acid) 1040 primary elective CABG patients. No difference in bleeding, re-operation for bleeding, transfusion or outcome. Thiagarajamurthy S, Levine A, Dunning J. Does prophylactic tranexamic acid safely reduce bleeding without increasing thrombotic complications in patients undergoing cardiac surgery? ICVTS 2004;(3):489-94. 2007 EACTS guidelines

  34. Topical Tranexamic acid to reduce perioperative bleeding: Recommendation Only 1 RCT exists to answer this question, which demonstrated a clinically small benefit in favour of topical tranexamic acid in low risk patients. Further RCTs should be performed prior to any further use of topical tranexamic acid as a strategy to reduce postoperative bleeding. (Grade B recommendation based on a single Level 1b study) 2007 EACTS guidelines

  35. Topical Tranexamic acid to reduce perioperative bleeding: Evidence De Bonis (2001) 40 patients undergoing CABG. 36% reduction in bleeding at 2 hours, 25% at 24 hours. NB new abstract presented at this meeting – to await full paper Hanif M, Nourei SM, Dunning J. Does the use of topical tranexamic acid in cardiac surgery reduce the incidence of post-operative mediastinal bleeding? ICVTS 2004;(4):603-5 2007 EACTS guidelines

  36. Protamine post-cardiac surgery: Recommendation High doses of protamine can cause increased bleeding and impaired platelet function, but these effects have never been demonstrated below a ratio of 2.6:1 protamine to heparin. (Grade B recommendation based on Level 1b and 2b studies) 2007 EACTS guidelines

  37. Protamine post-cardiac surgery: Evidence • Carr (1994) and Moshizuki(1998) provide convincing evidence that at protamine to heparin ratios above 5:1 cause platelet aggregation and function does become impaired. • Moshizuki - levels above 2.6:1 the ACT significantly increases • Butterworth(2002)– protamine half life is 7 mins and is fully eliminated in 20-30 mins Mclaughlin KE, Dunning J. In patients post cardiac surgery do high doses of protamine cause increased bleeding? ICVTS 2003;(4):424-6 2007 EACTS guidelines

  38. Hepcon to reduce blood product usage: Recommendation Hepcon monitoring is associated with higher heparin and lower protamine doses and may decrease activation of the coagulation and inflammatory cascades. Some studies have shown this may be associated with decreased postoperative bleeding and blood component therapy requirement. Larger trials are required to investigate this further. (Grade B recommendation based on Level 1b and 2b studies) Aziz KAA, Masood O, Hoschtitzky A, Ronald A. Does use of the Hepcon decrease bleeding and blood and blood product requirements in patients undergoing cardiac surgery? ICVTS 2006;5:469-82. 2007 EACTS guidelines

  39. TEG to guide blood product usage: Recommendation Thromboelastography may be used to guide transfusion in the post-operative period and studies have demonstrated a reduction in blood and blood product usage if used in conjunction with a treatment algorithm. Further studies are required before Thromboelastography can be recommended as the standard of care for post-operative transfusion management. (Grade B recommendation based on Level 2b studies) Ronald A, Dunning J. Can the use of thromboelastography predict and decrease bleeding and blood and blood product requirements in adult patients undergoing cardiac surgery? ICVTS 2005;(5):456-63. 2007 EACTS guidelines

  40. Factor VIIa for intractable bleeding: Recommendation For patients with intractable bleeding post cardiac surgery refractory to conventional haemostatic interventions, factor VIIa is recommended and its complication rates are low. (Grade C recommendation based on Level 2b, 3b and level 4 studies) 2007 EACTS guidelines

  41. Factor VIIa for intractable bleeding: Evidence • Roberts(2004) over 400,000 usages of Factor VIIa across all specialties recorded adverse event risk around 1% • Diprose – PRCT in cardiac surgery 20pts, halved blood loss • At least 160 case reports of use in Cardiothoracic surgery, • with a 1% risk of serious thrombosis Tanos M, Dunning J. Is recombinant activated factor VII useful for intractable bleeding after cardiac surgery? ICVTS 2006;5:493-8. 2007 EACTS guidelines

  42. Future EACTS guidelines 2008 Guidelines : The Indications for Coronary Artery Bypass Grafting 2007 EACTS guidelines

  43. Any Questions ? To get involved in writing the 2008 EACTS guidelines and Best Evidence Topics : www.icvts.org joeldunning@doctors.org.uk 2007 EACTS guidelines