Expert Consensus Decision Pathway on Peri- Procedural Management of Anticoagulation

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1 Expert Consensus Decision Pathway on Peri- Procedural Management of Anticoagulation John U Doherty, MD, FACC Anticoagulation Consortium Roundtable Heart House October 24, 2015

2 Peri-Procedural Management of Anticoagulation Consensus Document/Pathway/App Writing Group John U Doherty, MD, FACC Ty Gluckman, MD, FACC William Hucker, MD, PhD, FIT James Januzzi, MD, FACC Thomas Ortel, MD Sherry Saxonhouse, MD, FACC Sarah Spinler, PharmD, AACC ACC Staff: Lea Binder, Veronica Wilson

3 Peri-Procedural Management of Anticoagulation in Non-Valvular Atrial Fibrillation: The Problem 35 million prescriptions written annually in the United States for oral anticoagulation (OAC) 15-20% have or potentially have interruption of OAC therapy in a given year placing them at risk of thrombo-embolic events (TE), bleeding, or death Management of such patients is spread across providers with poor coordination in decision making across these clinicians.

4 Risk stratification in informing such decisions is performed inconsistently (ORBIT-AF) Management depends upon patient related factors (risk of TE), procedure related risk of bleeding, education of providers, coordination of care with proceduralists.

5 Procedural Risk Stratification Orthopedic Procedures Minor Bleed Risk Contested Major Bleed Risk Foot surgery Shoulder surgery Hand surgery Arthrocentesis Hip replacement Arthroscopy Knee replacement (single or bilateral) Joint arthroplasty Spine surgery Laminectomy Major orthopedic surgery Joint Replacement

6 Procedural Risk Stratification Dental Procedures Minor Bleed Risk Contested Major Bleed Risk Dental surgery or other dental procedure Minor oral surgery Tooth extractions Endodontic (root canal) procedures Periodontal surgery* Implant positioning* Incision of abscess* mucosal flap excision of cysts Prosthodontics (construction of dentures) Scaling including subgingival Polishing Fillings Crowns Bridges Local anesthesia (infiltrations inferior alveolar nerve block mandibular blocks) Biopsies None Reconstructive procedures

7 Procedural Risk Stratification Gastrointestinal Procedures Minor Bleed Risk Contested Major Bleed Risk Gastrointestinal endoscopy +/- biopsy Endoscopy ultrasound (EUS) without fineneedle aspiration (FNA) Capsule endoscopy Endoscopy without surgery* Upper and lower endoscopy without biopsy Endoscopic retrograde cholangiopancreatography (ERCP) without sphincterotomy Diagnostic endoscopic retrograde cholangiopancreatography (ERCP) Luminal self-expanding stent placement (controversial) Biliary/pancreatic stent without sphincterotomy Enteral stent deployment (without dilation) Colonoscopy with or without biopsy Diagnostic procedures +/- biopsy Diagnostic esophagogastroduodenoscopy (EGD) with or without biopsy Flexible sigmoidoscopy with or without biopsy Nonthermal (cold) snare removal of small Enteroscopy Therapeutic balloon-assisted enteroscopy Endoscopy (including balloon enteroscopy) with or without mucosal biopsy Enteroscopy and diagnostic balloon-assisted enteroscopy Colonic polyp resection Colonic polyp resection < cm safe without bridging Resection of large colon polyp (>- cm) Catheter exchange through well formed tracts (e.g. gastrostomy nephrostomy cholecystostomy tubes) Gastrostomy tube placement (initial) Percutaneous endoscopic gastrostomy Treatment of esophageal/gastric varices Treatment of varices Variceal band ligation (controversial) Coagulation or ablation of tumors or vascular lesions Tumor ablation by any technique Endoscopic sphincterotomy (.-% risk of bleeding) Biliary sphincterotomy Pancreatic sphincterotomy Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy Abdominal procedure Polypectomy Polypectomy (> cm) Colonoscopic polypectomy (-.% risk of bleeding) Gastric polypectomy (% risk of bleeding) Endoscopic mucosal or submucosal dissection Percutaneous liver biopsy Endosonographic (EUS) guided fine needle aspiration Endoscopy ultrasound (EUS) with fine-needle aspiration (FNA) or needle biopsy Endoscopic hemostasis Cystogastrostomy Endoscopic mucosal resection

8 What We Know and What We Don t Guidelines are limited: ACCP and ACC/AHA AF Guidelines suggest continuation of anticoagulation for procedures with low bleeding risk, bridging for patients at high risk of TE that require interruption, and clinical judgment for those at intermediate risk. For certain procedures, continuation of warfarin is associated with lower risk of bleeding and equivalent TE risk to interruption with bridging (BRUISE Control)

9 What We Know and What We Don t How Should DOACs Be Managed Peri- Procedurally? Not informed with RCTs. Europace article provides practical recommendations for managing DOACs periprocedurally

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12 Defining the Algorithm Assumptions: An area of clinical variability and incomplete knowledge Common problem with care across many providers with variable knowledge Proceeding without interruption often not considered Use of a parenteral agent probably too frequent DOACs, if dosed properly, seldom need to be bridged Peri-procedural management with DOACs needs to follow a different path than warfarin

13 The risk of a TE with an interruption averages 0.52% for interruption without bridging and 0.94% for those interrupted and bridged based on pooled data (0.4% and 0.3% respectively in BRIDGE trial)

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17 The Process Should the patient be anti-coagulated in the first place? Assess TE risk of interruption (patient specific) Assess risk of bleeding (procedure specific) Are some procedures such low risk that clinicians can fast track decision not to interrupt Are there procedures of sufficient bleeding risk that we would always interrupt?

18 The Process Recognize that there are instances where clinical judgement needs to prevail Attempt to give guidance that is procedure-specific

19 When to restart anticoagulant? It s Not Just 1 Decision! Decide to stop Decide when to stop informed by labs, creatinine clearance Use a parenteral agent prior to procedure Use a parenteral agent post-procedure: when and what dose When to stop parenteral agent

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