NHS FIFE WIDE POLICY - HAEMATOLOGY MANAGEMENT OF ANTICOAGULATION THERAPY DURING MAJOR AND MINOR ELECTIVE SURGERY

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1 MANAGEMENT OF ANTICOAGULATION THERAPY DURING MAJOR AND MINOR ELECTIVE SURGERY The scope of this guideline is to simplify the management of patients on oral anticoagulation undergoing major and minor surgery. Decisions regarding interruption of these agents for surgical/ invasive procedures, and whether bridging therapy is advisable, should be made on an individual basis dependent on the perceived risks of bleeding and thrombosis associated with continuation of anticoagulation and discontinuation of anticoagulation, respectively, and the nature of the proposed procedure. If further advice is required, please contact the Haematologist on call via the hospital switchboard. PLEASE NOTE This is a guideline only any bridging decisions need serious consideration, as risks are involved. Whenever possible, surgery in a chronically anticoagulated patient should be undertaken on an elective basis to allow for careful planning of anticoagulant reversal. If emergency surgery is required and the patient is on an oral anticoagulant, please call the Haematologist on call for advice. All major surgery in which a body cavity is entered should be considered high risk to cause bleeding. Bleeding risk of the surgical procedure in general is as determined by the surgeon. Aspirin and antiplatelet agents Aspirin or other antiplatelet agents for the secondary prevention of cardiovascular disease, do not need to be discontinued before minor surgery with low risk of bleeding. Patients at moderate to high risk for cardiovascular events receiving these agents do not need them discontinued pre non cardiac surgery. Only patients at low risk for cardiovascular events receiving anti platelet agents should have them stopped 7 days before surgery. Rivaroxaban (all doses prophylaxis or treatment) Rivaroxaban (direct Xa inhibitor) is the new oral anticoagulant recommended for use in NHS Fife and is covered in this document. Patients on an alternative new oral anticoagulant, should be discussed with the oncall Haematologist. Rivaroxaban should be stopped prior to surgery (see timeline in relationship to surgery below) erative bridging with parenteral anticoagulation is not needed in the majority of patients. Rivaroxaban should be resumed as soon as possible after a procedure. Onset of therapeutic anticoagulation with rivaroxaban occurs within 2-4 hours. Minor surgery or procedure with low bleeding risk start hours post procedure if approved by the surgeon. Major surgery or procedure with a high bleeding risk start hours post procedure if approved by the surgeon. Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 1 of 10 1

2 TIMELINE IN RELATIONSHIP TO SURGERY 7 days pre-op Review antiplatelet agents as above *(see ACCP guidance below where coronary stents are involved) 5 days pre-op STOP warfarin Assess renal function in patients on rivaroxaban. 72 hours pre-op STOP rivaroxaban if creatinine clearance (CrCl) is 30ml/min AND surgery is of high bleeding risk (determined by surgeon) 48 hours pre-op STOP rivaroxaban if CrCl 30ml/min OR surgery is of high bleeding risk in patients with normal renal function (CrCl > 30ml/min) Patients previously on warfarin - Check INR. Recheck every 24 hours until INR <2. When INR subtherapeutic (<2) start heparin if required (see later guidance) LAST PRE-OP LOW MOLECULAR WEIGHT HEPARIN (LMWH) TREATMENT DOSE SHOULD BE 24 HOURS PRIOR TO SURGERY OR STOP IV UNFRACTIONATED HEPARIN ( IVUH) 5 HOURS PRIOR TO SURGERY. IF NORMAL RENAL FUNCTION AND NOT EXTREMES OF BODY WEIGHT, AN APTT PRE-OP IS NOT REQUIRED. 24 hours pre-op STOP rivaroxaban if minor/standard bleeding risk surgery AND normal renal function (CrCl >30ml/min) Surgery day Patients previously on warfarin - Recheck INR (if >2 on last check) If remains >2, contact Haematologist for advice If < 2, proceed (NOTE FOR SPINAL ANAESTHESIA, INR MUST BE =1). 2 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 2 of 10

3 Post op Start LMWH hours after surgery if bleeding risk low. If bleeding risk high, resume therapeutic dose LMWH hours after surgery (if unsure discuss with surgeon). Start warfarin hours post surgery at the patients previous maintenance dose, if haemodynamically stable and adequate haemostasis achieved. If high bleeding risk surgery, wait hours as above. If a catheter is in the epidural space or close to a nerve plexus do not re-introduce anticoagulation until this catheter has been removed Recheck INR on second day of re-warfarinising and daily until discharge. Stop LMWH when INR >2 for 2 consecutive days. If antiplatelet agents were stopped, restart 24 hours after surgery when there is adequate haemostasis. Anti-platelet agents should NEVER be re-introduced in the patient with a catheter in the epidural space or close to a nerve plexus if the patient is receiving thromboprophylaxis. Wait until the catheter has been removed before reintroducing anti-platelet agents. *ACCP Guideline 1 In patients with a bare metal coronary stent, surgery should be deferred for at least 6 weeks after stent replacement.. In patients with a drug eluting coronary stent, surgery should be deferred for at least 6 months after stent replacement. If surgery is required with either type of stent during these time periods, the ACCP suggest continuing dual antiplatelet therapy around the time of surgery. Surgical procedures in patients with stents should ideally be performed in hospitals where there is a 24 hour cardiac catheterisation laboratory, so patients can be treated immediately in case of perioperative atherothrombotic events. ALL THESE PATIENTS SHOULD BE DISCUSSED WITH CARDIOLOGY 3 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 3 of 10

4 WHY IS THE PATIENT ON WARFARIN? 1. Non cardiac cause (DVT, PE, arterial clot) 2. Atrial fibrillation 3. Heart valves 1. DVT / PE / Arterial Clot Avoid elective surgery in the first month after a venous or arterial thrombotic event (ideally until the patient has received 3 months of warfarin). Within 1 month (discuss with Haematologist on call. May need to consider an IVC filter) Intravenous unfractionated heparin - continued until 5 hours before start of surgery. Intravenous unfractionated heparin - re-started at a time period to suit the surgeon. Recommended minimum time period is one hour IF A BOLUS DOSE IS NOT GIVEN. If a bolus dose is given wait for 8 hours following finish of surgery. Within 2-3 months High Risk Multiple episodes VTE on lifelong warfarin Active malignancy Known AT3 deficiency / compound heterozygosity for factor V Leiden and the prothrombin gene mutation / antiphospholipid antibody syndrome / homozygosity for factor V Leiden / protein C deficiency / protein S deficiency Treatment dose LMWH - last dose given at 24 hours before start of surgery Moderate Risk Other risk factors for VTE i.e. heart failure, renal failure, acute illness, other known thrombophilias. Treatment dose LMWH - last dose given at 24 hours before start of surgery 4 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 4 of 10

5 Low Risk All other patients Nil >3months post event (majority of patients) Nil Prophylactic LMWH - restart post-op as per timeline (depends on bleeding risk of surgery) 2. Atrial Fibrillation High Risk Severe left ventricular dysfunction (ejection fraction < 25%) Clinically significant right heart disease Previous thrombotic event within 6 months Severe Left atrial enlargement Treatment dose LMWH - last dose given at 24 hours before start of surgery Low Risk All others Nil Prophylactic LMWH - restart post-op as per timeline (depends on bleeding risk of surgery) 3. Heart Valves (These patients must be discussed with a Cardiologist) Mechanical Prosthesis (any type, any position) Treatment dose LMWH - last dose given at 24 hours before start of surgery (or IVUH may be more appropriate seek advice) 5 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 5 of 10

6 Bioprosthesis (no AF) Nil Prophylactic LMWH - restart post-op as per timeline (depends on bleeding risk of surgery) Bioprosthesis (with AF) Treatment dose LMWH - last dose given at 24 hours before start of surgery (or IVUH may be more appropriate seek advice) HEPARIN DOSES IVUH (intravenous unfractionated heparin) See appendix 1 Unfractionated heparin infusion protocol LMWH (low molecular weight heparin) Treatment dose Prophylactic dose Dalteparin 200iu/kg od SC (weight based) See appendix 2 Dalteparin treatment guidelines Dalteparin 5000iu od SC Other Considerations Renal function if creatinine clearance <30ml/min, use IVUH. Do not use heparin of any type in patients with a history of heparin induced thrombocytopenia (HIT) in this instance discuss with the Haematologist on call. After spinal anaesthesia, wait 4 hours prior to administering heparin of any type. 6 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 6 of 10

7 All patients should wear graduated compression stockings (contraindicated in peripheral vascular disease) Early ambulation should be encouraged for all patients. In order to shorten hospital stays, patients could be educated in self injection of heparin, with clear written instructions and GP monitoring of INR. REFERENCES 1. Douketis JD, Spyropoulos AC, Spencer FA et al.. Perioperative management of antithrombotic therapy: American College of Chest Physicians Evidence Based Clinical Practice Guidelines (9 th Edition). Chest / 141 / Supplement. 2. Daley BJ, Taylor D. Perioperative Anticoagulation Management. SIGN Publication No Baglin TP, Keeling DM, Watson HG. Guidelines on oral anticoagulation (warfarin): third edition 2005 update. British Committee for Standards in Haematology. British Journal of Haematology, 2005, 132, Guidelines and Protocols Advisory Committee. Management of warfarin therapy during invasive procedures and surgery. BCHealth Services (Accessed online May 2010) 5. Gulseth MP, Westberg SM. SMDC Disease Management Guidelines. Anticoagulation bridging guidelines for patients on long-term warfarin anticoagulation. (Accessed online May 2010) 6. Periprocedural Anticoagulation Adult Inpatient and Ambulatory Clinical Practice Guideline. UW Health (Accessed online November 2014) 7. Steinberg BA, Peterson ED, Kim S et al. Uses and Outcomes associated with Bridging during Anticoagulation Interruption in patients with Atrial fibrillation. Circulation 2014 (Accessed online March 2015) ct 7 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 7 of 10

8 APPENDIX 1 NHS FIFE WIDE POLICY - HAEMATOLOGY UNFRACTIONATED HEPARIN INFUSION PROTOCOL A platelet count should be taken on commencement, after 24 hours, and on alternate days thereafter. If the count falls by 50% or more, falls below the normal range, or if the patient develops new thrombosis or skin allergy, Heparin Induced Thrombocytopaenia (HIT) should be considered and a haematologist should be contacted. 1. Start with an IV bolus dose of 5000units. 2. Using heparin concentration of 1000units/ml, start syringe pump at 1ml/hr. Use only the 1000 units/ml ready to use solution from ampoules and do not dilute. 3. Measure APTT (Activated Partial Thromboplastin Time) ratio six hours after bolus then at intervals indicated by the chart. Samples should be sent direct to the laboratory for separation within 45 minutes as heparin is neutralised in vitro by platelet factor 4 released from platelets. (Try to avoid out of hours tests if possible.) Keep the infusion running at the same rate until the result is received. 4. Target APTT ratio is 1.5 to 2.5 On receipt of a result, it must be documented and action taken as below by the person receiving the result. APTT Approximate Stop infusion Rate change Repeat APTT Ratio APTT (secs) (minutes) (ml/hour) <1.2 < hours hours (no change) hours hours hours hours > 5.0 > hours Rate changes are based on a heparin concentration of 1000 units/ml 8 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 8 of 10

9 APPENDIX 2 DALTEPARIN TREATMENT GUIDELINES NB: Exclude any possible contra-indications to use prior to commencing therapy DVT/PE TREATMENT Body Weight (kg) Dosage International units <46 * * * * Once daily treatment (+ oral anti- coagulant if indicated) 83+ * The dose is to be prescribed in units. *These are fixed-dose pre-filled syringes. Determine the required dose (dependant on patient s weight and assuming normal bleeding risk) and select the appropriate pre-filled syringe. Administer the full syringe contents by subcutaneous injection. Do not expel air bubble from these pre-filled syringes before administration. MAXIMUM DOSE: units once daily by subcutaneous injection ** SEEK ADVICE REGARDING USE IN SEVERE HEPATIC/ RENAL IMPAIRMENT, PREGNANCY or OBESITY ** RISK OF THROMBOCYTOPENIA: Check platelets for all patients on day of commencing therapy. For patients exposed to heparin within the last 100 days: perform baseline platelet count and repeat 24 hours after starting treatment. Surgical patients: perform platelet counts every 2 to 4 days from days 4 to 14 of treatment. If the platelet count falls by 50% or more, and/or the patient develops new thrombosis skin allergy between days 4 to14 of heparin administration, heparin induced thrombocytopenia should be considered and a clinical assessment made. Medical and obstetric patients: at low risk of developing heparin induced thrombocytopenia, therefore, do not need routine platelet monitoring. RISK OF HYPERKALAEMIA: For patients at risk of hyperkalaemia check plasma potassium before starting therapy and monitor regularly thereafter (especially if treatment continues longer than 7 days). IMPORTANT: IT IS EXPECTED THAT ALL PATIENTS WILL BE WEIGHED document weight on drug kardex. IF A PATIENT IS TOO ILL TO WEIGH, AN ESTIMATED WEIGHT CAN BE USED ALL SUCH DOSES MUST BE PRESCRIBED AS A ONCE ONLY ON THE FRONT PAGE OF THE DRUG KARDEX ON A DAILY BASIS UNTIL THE PATIENT CAN BE WEIGHED 9 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 9 of 10

10 10 Version number: 4 Implementation date: JULY 2015 Review Date: JULY 2018 Page 10 of 10