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

• 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

• 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.

• 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.

Orthopedic Procedures

Procedural Risk Stratification

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

Dental Procedures

Procedural Risk Stratification

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

Gastrointestinal Procedures

Procedural Risk Stratification

Minor Bleed Risk Contested Major Bleed Risk Gastrointestinal endoscopy +/- biopsy

Endoscopy ultrasound (EUS) without fine-needle 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

• 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)

• 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 peri-procedurally

• 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

– 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)

• 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?

• The Process • Recognize that there are instances where clinical

judgement needs to prevail • Attempt to give guidance that is procedure-specific

• 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