t. Recommendations for periprocedural anticoagulation are available lhrough the American College of Chest Physicians Clinical Practice Guidelines.

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1 Name or Policy: Policy Number: Department: Approving Officer: Responsible Agent: cope: x Management of Anticoagulation with Invasive Procedures Pharmacy Chief Operating Officer Director of Phannacy University of Toledo Medical Center New policy proposal Major revision or existing polic) I HI l NIYERSI I Y IH.; TOLEDO Effective Date: 4/1/2016 Minor/technical revision of existing policy Reaffirmation of c,isting policy (A) Policy Statement: The University of Toledo Anticoagulation Clinic will follow the below management of anticoagulation therapy with invasive procedures. (8) Purpose of Policy: a. Patients receiving long tenn antithrombotic therapy who require surgery or other invasive procedure should be evaluated for individual risk of thromboembolism and bleeding prior co initiating periprocedural anticoagulation. t. Recommendations for periprocedural anticoagulation are available lhrough the American College of Chest Physicians Clinical Practice Guidelines. 11. Not all patients will need pre-operative anticoagulation or bridging therapy. (C) Procedure: r. Communication a. Surgeons should contact the clinic at least 7 days before surgery to develop a perioperative plan. b. Patients should be given written instructions (ex. Calendar) (if they arc able to come for a pre-operative appointment) outlining the perioperative plan for holding anti thrombotic therapy, the use of bridging therapy (if needed). laboratory needs, and when to restart antithrombotie therapy. c. Surgeons should communicate when anticoagulation may be restarted to the clinic by telephone or written documentation. II. Recommendations a. Evaluate the bleeding risk of the procedure/surgery. b. Identify the indication for anticoagulation and risk of thrombosis if these agents were discontinued. c. Consider other factors: patient specific factors. duration off anti thrombotic therapy. Ill. Pharmacists will make recommendations when a surgery is upcoming as noted by a patient or physician. a. Phannacist will use Procedure Anticoagulation form on 2-drive (z-drive 7 common 7 anticoag clinic 7 surgery forms) (Appendix 4) and fill out completely noting the recommendations. and reasoning behind the recommendations. b. The fonn will be scanned into EMR as a Clinical Document and put into the clinical bucket of the correct provider.

2 c. The pharmacist will close the communication gap by communicating the plan to the referring provider. provider performing the procedure, and the patient (and will document this). Aortic aneurysm repair Renal biopsy Cataract surgery Bladder surgery Resection of colon Dental procedures Bowel polypectomy polyps (dental hygiene, simple Coronary artery bypass Prostate biopsy extractions, graft (CABG) Pacemaker or restorations, Heart valve replacement defibrillator endodontics, lntracranial surgery implantation prosthetics) Major cancer surgery Major intraabdominal Cutaneous surgeries Major orthopedic surgery surgery (most) (hip or knee Major intrathoracic Laparoscopic replacement) surgery cholecystectomy or Peripheral artery bypass More invasive dental hernia repair ad other major vascular or ophthalmic Coronary angiography surgery procedures Endoscopy +/- biopsy Prostate surgery Colonoscopy +/- Reconstructive plastic biopsy surgery Spinal surgery/epidural rocedure Risk Periprocedural Risk for Thromboembolism Moderate: High: Low: Anticoagulation Anticoagulation Anticoagulation is considered on a case Advised generally not advised bv case basis Mechanica Any mechanical mitral valve Bileaflet aortic valve and 1 Bileaflet aortic valve without I Heart Older mechanical valve of the following: atrial atrial fibrillation and no other Valve model (caged ball or tilting fibrillation, prior stroke or risk factors for stroke disc) aortic valve TIA, hypertension, diabetes, Recently placed mechanical heart failure, age > 75 years valve (<3 months) Recent stroke or TIA ( <6 months\ Atrial With mechanical heart valve CHADS2 score of 4 or below, per Bridge Trial risk for Fibrillation (any position) thromboembolism is low, using of LMWH is not needed. With rheumatic valvular disease, mitral stenosis With recent stroke or TIA (<3 months) CHADS2 score of 5 or 6 refer to cardiologist to weight risk versus benefits (per Bridge trial not well represented to draw a conclusion\ Venous VTE within oast 3 months VTE 3-12 months aoo Sinqle VTE > 12 months

3 Thrombo- With severe thrombophilia Recurrent VTE ago and no other risk factors embolism (protein C, S, or With non-severe Antithrornbin Ill deficiency, thrombophilia Antiphospholipid syndrome, (heterozygous factor V Homozygous factor V Leiden mutation, Leiden mutation) heterozygous factor 11 mutation) With active cancer (treated within 6 months or palliative) *CHADS2 has not been validated for VTE risk in atrial fibrillation. It is used for risk stratification to reduce stroke risk with aspirin vs. warfarin. Risk Factors for Developing Venous Thromboembolism Age >40 years BMI >25 Swollen legs (currently) Oral contraceptive or hormone replacement therapy Acute myocardial infarction (<1 month) History of inflammatory bowel disease Leg plaster cast or brace Personal or family history of SVT, DVT/PE History of malignancy Central venous access Present cancer or treatment with chemotherapy Heart Failure exacerbation (<1 month) Serious lung diagnosis/disease (ex. Pneumonia) (<1 month) T e of sur e I rocedure Anticoagulation Considerations for Endoscopic Procedures Endoscopic Procedure High-Moderate Low Thromboembolic Risk Thromboembolic Risk Diagnostic/screening Continue warfarin management Consider holding warfarin and proceedina when INR <1.5* Low biopsy risk Continue warfarin management Consider holding warfarin and Removal of <10mm polyps with proceeding when INR <1.5* cold snare/forceps Large polyp removal (>1 Omm) Hold warfarin and bridge peri- Hold warfarin and proceed when orocedural anticoagulation INR <1.5* Sphincterotomy Hold warfarin and bridge peri- Hold warfarin and proceed when Esophageal Dilation procedural anticoagulation INR <1.5* Fine Needle Aspiration *May consider using peri-procedural anticoagulation **Diagnostic/screening, biopsy: anticoagulation may be resumed the same day ***Snare polypectomy, sphincterotomy, esophageal dilation, fine needle aspiration : anticoagulation may be resumed the next day

4 IV. Individual agent recommendations a. Warfarin Pre-Procedure INR Warfarin Discontinuation Plan I Stop warfarin 5 days (hold 4 doses) Stop warfarin 6 days (hold 5 doses) i. Check INR within 24 hours of procedure to ensure it is< 1.5 or lower if otherwise indicated ii. Restart warfarin on postoperative day 1 (24 hours after procedure) if hemostasis is achieved and if 1. May start on postoperative day O if dose given 12 hours after procedure and if b. Dabigatran i. Preoperative parenteral anticoagulation is not needed in the majority of patients receiving dabigatran Dabigatran Discontinuation Plan (CrCI) Standard Bleeding Risk High Bleeding Risk 2:50mUmin Stop dabigatran 1-2 days Stop dabigatran 2-4 days <50mUmin Stop dabigatran 3-5 days Stop dabigatran >5 days ii. Dabigatran should be resumed as soon as possible after a procedure 1. Onset of therapeutic anticoagulation with dabigatran occurs within 2 hours iii. Minor surgery or procedure with low bleeding risk: start hours if c. Rivaroxaban i. Pre-operative parenteral anticoagulation is not needed in the majority of patients receiving rivaroxaban Rivaroxaban Discontinuation Plan (CrCI) Standard Bleeding Risk High Bleeding Risk 2:30mUmin Stop rivaroxaban 24 hours Stop rivaroxaban 48 hours <30mU min Stop rivaroxaban 48 hours Stop rivaroxaban 72 hours

5 ii. Rivaroxaban should be resumed as soon as possible after a procedure 1. Onset of therapeutic anticoagulation with rivaroxaban occurs within 2-4 hours iii. Minor surgery or procedure with low bleeding risk: start hours if d. Apixaban i. Pre-operative parenteral anticoagulation is not needed in the majority of patients receiving apixaban Apixaban Discontinuation Plan (SCr) Standard Bleeding Risk High Bleeding Risk <1.Smg/dl Stop apixaban 24 hours Stop apixaban 48 hours ~1.Smg/dl Stop apixaban 48 hours Stop apixaban 72 hours ii. Apixaban should be resumed as soon as possible after a procedure 1. Onset of therapeutic anticoagulation with rivaroxaban occurs within 3-4 hours iii. Minor surgery or procedure with low bleeding risk: start hours if Approved by: ~ rctor ofph ~ Daniel Chief Operar Review/Revision Date: Review!Revls1011 Completed By: Pharmacy Policies Superseded by This Policy: Next Review Date: 04/01/2019