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Bridge Therapy: Peri-operative Anticoagulation Management Amjad AlMahameed, MD, MPH Division of Cardiology Beth Israel Deaconess Medical Center Boston. mechanical heart valves. A Fib w risk factors for emboli. recent VTE (< 3 months). hypercoaguable states. RATIONALE FOR BRIDGING.

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slide1

Bridge Therapy: Peri-operative Anticoagulation

Management

Amjad AlMahameed, MD, MPH

Division of Cardiology

Beth Israel Deaconess Medical Center

Boston

slide2

mechanical

heart valves

A Fib w risk factors

for emboli

recent VTE

(< 3 months)

hypercoaguable

states

RATIONALE FOR BRIDGING

Cross Coverage to

Therapeutic INR

Requiring AC but have

not achieved

Therapeutic INR

Already Rxed w

chronic AC and

now documented

drop in INR

Peri-procedural:

benefits supporting need for bridge therapy
BENEFITSSupporting Need for Bridge Therapy
  • high daily risk estimate for thrombosis when patients remain unprotected for several days peri-procedure
  • Subtherapeutic INR offers little or no protection
  • Possible rebound hypercoaguable state, especially when warfarin reinitiated leading to thrombosis
  • Bleeding complications can be controlled while CVA or PE may have lasting effect
  • New drugs and new data offer increased ease of therapy
safe surgery choosing the best approach
SAFE SURGERY:Choosing the Best Approach

Must Answer three basic questions

1- What is the risk of bleeding with AC based upon the type of procedure and patient’s history?

2- What is the risk of thrombosis if AC reduced or stopped?

3- Which is the best bridging strategy (bridging medication, timing, outpatient vs. inpatient)

safe surgery what is the risk of pei operative thrombosis
SAFE SURGERYWhat is the Risk of pei-operative Thrombosis?

DEFICIENCIES IN CURRENT EVIDENCE

  • From descriptive studies and clinical experience
  • Does not account for:

- the added risk of thrombosis during surgery

- the rebound theory

- the heterogeneity in patients’ characteristics

- the post-operative clinical course

safe surgery what is the optimal upper inr level
SAFE SURGERYWhat is the Optimal Upper INR Level?
  • Type of Surgery
  • Patients’ Characteristics
  • Integrity of the hemostasis/coagulation system
  • Technical/intraoperative factor
current standard in bridge therapy
Current Standard in Bridge Therapy

Prospective Randomized Controlled Trials

Expert Opinion/Consensus

prospective randomized trials bridge therapy
Prospective Randomized Trials (Bridge Therapy)

None available, but some in progress and others

in the planning phase

expert opinion on bridge therapy
Expert Opinion on Bridge Therapy
  • British Society of Hematology
  • American College of Chest Physicians (ACCP)
  • Kearon and Hirsh article; NEJM, May, 1997
  • Pregnancy and Prosthetic Valve Clinical Consensus (PPCR)
  • Douketis article
slide10

British Society of Haematology

3

2

1.3

1

Therapeutic INR range

INR

Normal INR Range 1-1.3

Procedure

Procedure

Pre-Op Day 3 2 1

UFH

when

INR < 2

Stop

Warfarin

+/- Vit K

slide11

American College of Chest Physicians

3

2

1.3

1

Therapeutic INR range

INR

Normal INR Range 1-1.3

Procedure

Procedure

Pre-Op Day 5 4 3 1

Low or full dose

UFH or LMWH

when INR < 2

Stop

Warfarin

+/- Vit K

kearom and hirsh recommendations nejm may 1997
Kearom and Hirsh RecommendationsNEJM, May, 1997

Indication Before After

VTE

1 monthIV UFH IV UFH

Month 2-3 No Heparin IV Heparin

Recurrent No Heparin SC Heparin

Arterial 1 month IV Heparin IV Heparin

Mechanical ValveNo Heparin SC Heparin

A Fib No Heparin No Heparin

Kearon C, Hirsh J. NEJM 1997336:1506-1511

limitations of kearon and hirsh recommendations
Limitations of Kearon and Hirsh Recommendations
  • Discounts rebound phenomena
  • Estimate 100-fold  in VTE risk but no  in ATE risk [versus Wahl’s review (5 of 493 patients had ATE , 4 died)]
  • Low estimate ATE risk off warfarin (4.5 %/ year A fib, 8% /year mechanical valve)
  • Estimate heparin bleeding risk of 3% per 2 days
  • Recommends SC vitamin K, does not utilize LMWH
  • Does not focus on patients’ characteristics (type of valve, risk factors for ATE in A Fib)
  • SC (or no) heparin in A fib and mechanical valves??!!
douketis article thrombosis research 108 2003 3 13
Douketis ArticleThrombosis Research, 108 (2003) 3-13
  • Better risk stratification of:

- risk of post-procedural bleed

- risk of peri procedure thrombotic

complications

  • Advocates normal or near normal INR at the time of surgery (earlier withdrawal of warfarin)
  • Includes practical algorithms that guide perioperative management of AC
slide15

Bleeding Risk Classification and Postoperative AC

Bleeding Risk

Type of Procedure

Post-op AC

High Risk

NSG, Prostate/bladder, OHS, major vascular,

renal Bx, polypectomy, major CA surgery

Low-dose LMWH: POD 1-2

Warfarin: evening POD 1-2

Full dose LMWH: POD 2-3 h

Moderate Risk

Major abd, thoracic, and orthopedic

PPM insertion

Low-dose LMWH & warfarin evening of OR day

Full dose LMWH: POD 1-2

Low Risk

Catarct, cutaneous, laparascopic choly/hernia repai, cardiac cath

Low-dose LMWH & warfarin evening of OR day

Full dose LMWH: POD 1

J.D. Douketis, Thrombosis Research; 108 (2003) 3-13

slide16

Perioperative AC Rx in Patients With Mechanical Valves

Thromboembolism Risk Category

Patient

Characteristics

Suggested Management

High

Stroke or TIA < 1 mo

Any MV

Caged-ball or single leaflet tilting disc AV

Bridging strongly recommended

Star-Edwards

Bjork-Shiley

Medtronic-Hall

Omnicarbon

A Fib, CVA, TIA, emboli, LV dysfxn, >75 y/o, HTN, DM

Moderate

Bileaflet tilting disc AV and > 2 stroke RF

Bridging should be considered

St. Jude

Carbomedics

Low

Bileaflet tilting disc AV and < 2 stroke RF

Bridging is optional

J.D. Douketis, Thrombosis Research; 108 (2003) 3-13

slide17

Perioperative AC Rx in Patients With Chronic A Fib

Thromboembolism Risk Category

Patient

Characteristics

Suggested Management

High

Stroke or TIA < 1 mo

Any MV

Rheumatic MV Disease

Bridging strongly recommended

A Fib, CVA, TIA, emboli, LV dysfxn, >75 y/o, HTN, DM

Moderate

Chronic A Fib and > 2 stroke RF

Bridging should be considered

Low

Chronic A Fib and < 2 stroke RF

Bridging is optional

J.D. Douketis, Thrombosis Research; 108 (2003) 3-13

slide18

Regardless of thromboembolism risk category,

patient’s characteristics take precedent!

  • A Fib
  • CVA
  • TIA
  • arterial emboli
  • LV dysfxn
  • >75 y/o
  • HTN
  • DM

Bridging strongly recommended

J.D. Douketis, Thrombosis Research; 108 (2003) 3-13

slide19

Perioperative AC Rx in Patients With VTE

VTE Recurrence Risk

Patient

Characteristics

Suggested Management

High

Recent VTE (< 3 wks)

Active CA

APL Ab or LA

Major comorbid disease

Bridging strongly recommended

VTE < 6 months

VTE with previous AC

interruption

Bridging should be considered

Moderate

Low

None of the above

Bridging is optional

J.D. Douketis, Thrombosis Research; 108 (2003) 3-13

emergency surgery in the anticoagulated patient
Emergency Surgery in the Anticoagulated Patient
  • D/C all anticoagulants
  • If INR >2.5: plasma or factor concentrate (+/- Vit k)
  • Prepare PRBC, platelet, and FFP
  • Consider PRBC transfusion to “augment hematocrit” especially in pts with cardiac disease
  • Watch for volume overload, dilutional thrombocytopenia and coagulaopathy
available anticoagulants
Available Anticoagulants
  • UFH: Discovered 1916, clinical use 1935
  • Vitamin K antagonists: discovered 1940, clinical use 1960s, clinical trials 1990s
  • LMWHs: Discovered 1976, clinical trials started in 1980s and ongoing …
  • Parenteral DTIs: Lepirudin (recombinant Hirudin) and Argatroban approved for Rx of HIT/HIT-T (3/1998 and 6/2000). Bivalirudin (modified Hirudin), for patients with ACS undergoing PCI
new anticoagulants
New Anticoagulants
  • Oral Small-Molecule DTIs: Ximelagatran. No FDA approval
  • Pentasaccharide: Fondaparinux (anti Xa activity), FDA approval for VTE prophylaxis in orthopaedic surgery 12/2001. Idraparinux: Being evaluated for chronic treatment of VTE
choosing the best bridging medication
Choosing the Best Bridging Medication
  • Depends on patient characteristics:

- Recent bleed

- Renal function

- Actual body weight

- Pre-op INR

- Baseline coagulation tests

- History of Heparin-Induced Thrombocytopenia

  • Available data, clinical experience, and Douketis advocate bridging with LMWH if possible
slide24

“BRIDGING” STRATEGY

Prophylactic

Dose LMWH

Start full

Dose LMWH

Resume full

dose LMWH

Hold

Coumadin

Coumadin

Resume

Coumadin

Surgery

Day -7 -5 -3 -1 +1 +2 +3 +5

√INR

√CBC

√INR

√ INR

# Days post-op

# Days pre-op

J.D. Douketis, Thrombosis Research; 108 (2003) 3-13