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June 2020

Bleeding risk assessment for bedside and interventional radiology guided procedures: Consensus guidelines and beyond

Aditi Khandelwal MDCM FRCPC, Internal Medicine and Adult Hematology Fellow, Transfusion Medicine, University of Toronto & Canadian Blood Services

Assessment of patients for peri-procedural bleeding risk involves consideration of both the unique procedure related risk as well as their underlying condition, co-morbidities and medications. Practice standards were updated in 2019 with endorsement from Canadian Association for Interventional Radiology (CAIR)1,2. This article will allow clinicians to apply the guidelines to their practice and identify individuals at risk of bleeding:

  1. Determine bleeding risk associated with procedure and relevant laboratory parameters

  1. Identify individuals at higher risk of bleeding due to an acquired or congenital bleeding diathesis

  1. Minimize bleeding risk imparted by prescription and non-prescription medications

Procedure related risk of bleeding 

To assist with risk-stratification of interventional procedures, Table 1 provides a list with selected interventional radiology procedures informed by both Thrombosis Canada and CAIR2,3.

Table 1: Risk stratification of common bedside or interventional radiology guided procedures2,3

Procedure Type 

Bleeding risk  

Low risk ( <1%) 

Moderate to high risk 

Vascular Procedures

Central line removal

Dialysis access

IVC filter placement

Non-tunneled venous catheter

PICC placement

Transjugular liver biopsy* 

Tunneled venous catheter

Venography

Arterial interventions (sheath ≤7 Fr)

Chemoembolization

Complex venous interventions

Radioembolization

Subcutaneous port device placement

Transjugular intrahepatic portosystemic shunt

Uterine fibroid embolization

Non-vascular procedures

Arthrocentesis + joint injection

Bone marrow aspiration without biopsy

Catheter exchange

Chest tube placement (non-tunneled)

Dental extraction (up to 2)

Endoscopy without biopsy

Lumbar Puncture

Pacemaker insertion

Paracentesis

Peripheral nerve block

Superficial aspiration

Superficial drainage

Superficial skin biopsy

Thoracentesis

Thyroid biopsy

Biliary interventions (new tract)

Bone marrow biopsy

Cervical cone biopsy

Cholecystostomy

Colonic polypectomy

Complex dental procedures

Deep abscess drainage

Deep non-organ biopsy

Endoscopy with biopsy

Lymph node biopsy

Nephrostomy tube placement

Neuraxial anesthesia

Percutaneous enteric tube (new tract)

Pericardiocentesis

Prostate biopsy

Radiofrequency ablation

Solid organ biopsy

Spinal procedures

Urinary tract interventions

* see Table 2 for laboratory parameters suggested in individuals with liver disease

Role of laboratory testing 

For low-risk procedures, routine laboratory testing is not recommended, no discontinuation of anticoagulation is required, and no correction of INR is required. Thresholds for correction or transfusion are provided in Table 22,4 for individuals with and without liver disease.

Two special situations need further discussion:

  1. Patients with liver dysfunction or cirrhosis have re-balanced physiological coagulation. Despite prolonged aPTT, PT and low fibrinogen or platelet counts, patients with liver dysfunction are not at an increased risk of bleeding. In fact, they are susceptible to thrombosis at a rate twice as high as the general population. Bleeding is rare in patients with chronic liver disease, and often unrelated to the abnormalities observed on laboratory testing, including platelet counts below 50 x 109/L.

  1. Neuraxial procedures are considered higher risk due to risk of severe neurologic impairment from spinal bleeding. Generally, experts recommend a safe platelet count over 70 x 109/L2. The ESA and British guidelines recommend an INR ≤1.4, which can usually be achieved by patients stopping their warfarin 5 days prior to planned procedure7. For patients undergoing neuraxial anesthesia, direct-oral anticoagulants (DOACs) should be held for 2 days prior to the procedure7. Use of reversal agents, such as vitamin K or prothrombin complex concentrates, should be based on an individual risk-benefit assessment.

Table 2: Laboratory parameters suggested by consensus guidelines for procedures in those with and without cirrhosis2,4

Parameter 

Individuals without chronic liver disease 

Individuals with liver disease 

Low  Risk 

High Risk 

Low Risk 

High Risk 

INR

Not routinely recommended

If on Warfarin, ensure within therapeutic range

< 1.8

N/A

<2.5

PTT (s)

Not routinely recommended

Not routinely recommended

Not routinely recommended

Not routinely recommended

Platelet count (x109/L)

If checked, transfuse if <20

Transfuse if <50,

<70 for neuraxial anesthesia

>20

>30 for liver biopsy

>30

Fibrinogen (g/L)

Not routinely recommended

Not routinely recommended

>1

>1

The accepted indications for coagulation testing are presented in Table 3. Laboratory coagulation testing, especially  prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR), were not designed nor validated to screen for hemostatic defects in unselected patients5. Hence, they do not provide an accurate and reliable assessment of the patient’s in vivo coagulation capacity and bleeding or thrombotic risk5. In fact, a normal PT/INR and aPTT test may impart a false sense of security, as bleeding disorders, for example vonWillebrand disease or platelet dysfunction, may not show any perturbations in routinely performed coagulation tests.

Table 3: Accepted indications for common coagulation tests4,6

PT/INR 

aPTT 

Both PT/INR and aPTT 

Fibrinogen 

Warfarin monitoring

Liver disease

Risk factors for vitamin K deficiency

IV heparin monitoring

IV argatroban monitoring

Suspected hemophilia A or B, Factor XI deficiency or severe vonWillebrand disease

Bleeding patient

Suspected DIC

Active trauma patient

Massive hemorrhage

Awaiting thrombolysis

Suspected DIC

Massive hemorrhage

Post-partum hemorrhage

Severe liver dysfunction

Cardiac bypass surgery

Acute leukemia

Identifying patients with bleeding disorders 

The guidelines recommend use of the HASBLED score to risk-stratify patients2. The HASBLED score has been validated for assessment of bleeding risk for individuals prescribed anticoagulation for atrial fibrillation. Although it has not been studied for peri-procedural risk stratification, HASBLED score has been widely adopted. Table 4 presents an approach to bleeding risk assessment in those undergoing interventional radiology guided procedures.

A thorough history, guided by a validated bleeding assessment tool (BAT), helps identify individuals with possible underlying bleeding diathesis8. BATs are designed for use in an unselected population as screening for congenital bleeding disorders, such as vonWillebrand disease, the most common inherited bleeding disorder. On the MCMDM-1 BAT (reproduced in Figure 1), a score of ≥4 has a sensitivity of 100%, specificity of 87%,and a negative predictive value of 100% for diagnosis of vonWillebrand disease8. If there is a suspicion of underlying coagulopathy based on initial assessment, patients should be referred to a specialist and/or a Hemophilia Treatment Center for further assessment.

Table 4: Risk factors for bleeding and assessment of bleeding risk in individuals undergoing interventional radiology procedures2,8

Situation 

Bleeding assessment recommendation 

Screening for congenital bleeding disorders

  • Known coagulopathy or platelet dysfunction

  • Utilize a BAT e.g. condensed MCMDM-1 score (score ≥4 predictive of underlying bleeding disorder)

Screening for acquired bleeding disorders related to medication use or co-morbidities

  • HAS-BLED Score (Score >3 predictive of bleeding events)

  • Other factors:

  • Bleeding within prior 3 months

  • Bleeding with similar procedures previously

  • INR above therapeutic range at the time of procedure if individual on Warfarin

  • Previous bleeding with bridging therapy

  • Mechanical heart valve

  • Active cancer

  • Platelet count lower than 20 x 109/L

  • Medication review (see Tables 5 and 6)

Figure 1: The scoring chart for condensed MCMDM-1 bleeding assessment tool reproduced from Bloody Easy Coagulation Simplified 2nd ed8,9

Medications as a risk factor for bleeding 

A complete list of prescription medications, over the counter medications and herbal products should be obtained. The impact of herbal products on hemostasis is underappreciated10. For procedures with moderate to high bleeding risk, herbal medication should be stopped 7 – 14 days prior10,11.

Table 5: Complementary and alternative medications known to cause increased bleeding10,11

Ajoene

Birch bark

Cayenne

Chinese black tree fungus

Cumin

Echinacea

Evening primrose oil

Feverfew

Garlic

Ginger

Ginkgo biloba

Ginseng

Grapeseed extract

Milk thistle

Onion extract

St. John’s wort

Turmeric

Vitamins E

The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) cohort study7 and the CAIR endorsed guidelines1,2 have helped simplify the peri-procedural management for patients on DOACs, as shown in Table 6. Using this approach, the 30-day postoperative rate of major bleeding was below 2%7.

Table 6: Peri-procedural DOAC management based on recent evidence2,7

DOAC 

Low to Moderate risk 

High risk  

Rivaroxaban

Apixaban

Edoxaban

Dabigatran (CrCl >50 mL/min)

In most cases, no need to interrupt

If interrupted, 1 day off (last dose 2 days before procedure); resume 1 day after procedure

2 days off

Resume 2 – 3 days after procedure

Dabigatran

(CrCl ≤ 50mL/min)

In most cases, no need to interrupt

If interrupted, 2 days off, resume 1 day after procedure

4 days off

Resume 2 – 3 days after procedure

Routine laboratory testing for measuring DOAC levels is not recommended. There are certain peri-procedural situations where coagulation testing, include PT/INR, aPTT, drug-specific anti-Xa level, thrombin time (TT) and diluted TT, may be helpful. When an urgent intervention associated with a high bleeding risk is required, an anti-factor Xa level or dilute thrombin time below 30 ng/mL is safe to proceed with the intervention12. Situations where lab testing in patients on DOACs may be beneficial include12:

  1. Need for urgent/emergent intervention where information on last dose of DOAC cannot be obtained

  1. Need for urgent/emergent surgery when patient has taken DOAC within 24 hours

  1. Severe renal failure in a patient on a DOAC awaiting intervention

Timing of discontinuation of other anticoagulants and antiplatelet medications is informed by balancing both the dose and indication with risk of bleeding2. A general approach is shown in Table 7. If the patient has a high risk of thrombosis (recurrent thrombosis, recent venous thrombosis, atypical thrombosis, mechanical mitral valve etc), bridging may need to be discussed. These decisions should be made in collaboration with specialists managing anticoagulation. For patients with recent percutaneous cardiac intervention with stent placement, all non-urgent procedures should be postponed a minimum of 1 month.

Table 7: Management of other commonly used  anticoagulants and antiplatelets2,3

Medication/Procedure Bleeding risk 

Low 

High 

Warfarin

No need to interrupt

Hold 5 days (INR <1.4)

Heparin

Therapeutic aPTT acceptable

Hold 4 – 6 hours, aPTT </= 1.5x control range

LMWH therapeutic

No need to interrupt

Hold 24 hours or hold 2 doses

LMWH prophylactic

No need to interrupt

Hold 12 hours or hold 1 dose

Aspirin

No need to interrupt

hold 3 – 5 days

NSAIDs

No need to interrupt

Short acting (ibuprofen, diclofenac, indomethacin) hold 24 hours,

Intermediate-acting (naproxen, celecoxib), hold 2 – 3 days, long acting (meloxicam) hold 10 days

Clopidogrel

No need to interrupt

hold 5 days

Ticagrelor

No need to interrupt

hold 5 days

Conclusion 

A careful history, judicious use of laboratory testing and a review of medications can help determine the bleeding risk of a patient. When combined with the risk associated with the procedure being offered, it can help identify those at increased risk of bleeding. Once identified, patients with higher risk of bleeding can benefit from correction of certain laboratory abnormalities, liberal use of tranexamic acid and timely discontinuation of dangerous medications. A multidisciplinary approach, with advice from a hematologist or transfusion specialist, can also be helpful to determine strategies to reduce bleeding.

References:

  1. Davidson JC, Rahim S, Hanks SE et al. Society of interventional radiology consensus guidelines for the periprocedural management of thrombotic and bleeding risk in patients undergoing percutaneous image-guided interventions – Part I: review of anticoagulation agents and clinical considerations. J Vasc interv Radiol 2019; 30:1155-1167.

  1. Patel IJ, Rahim S, Davidson JC et al. Society of interventional radiology consensus guidelines for the periprocedural management of thrombotic and bleeding risk in patients undergoing percutaneous image-guided interventions – Part II: recommendations. J Vasc interv Radiol 2019; 30:1155-1167.

  1. Thrombosis Canada Clinical Guide. Perioperative Management of Antiplatelet Therapy. Last updated 2019/Feb 11 . Available at: https://thrombosiscanada.ca/clinicalguides/# (accessed 11 March, 2020).

  1. Fralick M et al. Reduce unnecessary coagulation testing in the emergency department (REDUCED). BMJ Quality. 2017;6:u221651.w8161.

  1. Levy JH, Szlam F, Wolberg AS et al. Clinical use of the activated partial thromboplastin time and prothrombin time for screening: a review of the literature and current guidelines for testing. Clin Lab Med. 2014; 34(3):453-77.

  1. CAS and Choosing Wisely Canada. Anesthesiology – five things physicians and patients should question. Available at URL: https://choosingwiselycanada.org/anesthesiology/ (accessed March 11, 2020)

  1. Douketis JD, Spyropoulos AC, Duncan J, et al. Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant (PAUSE). JAMA Intern Med. 2019;179(11):1469-1478.

  1. Bowman M, Mundell G, Grabell J et al. Generation and validation of the condensed MCMDM-1 bleeding questionnaire for von Willebrand disease. J Thromb Haemost 2008;6:2062-6.

  1. Black L, Selby R, Brnjac E et al. Bloody easy coagulation simplified 2nd ed. ORBCoN Feb 2019. Available at URL: https://transfusionontario.org/en/documents/?cat=bloody_easy (Accessed 24 March, 2020).

  1. Ang-Lee M, Moss J, Yuan CS. Herbal medicines and peri-operative care. JAMA. 2001;286(2):208-216.

  1. Hodges PJ, Kam PC. The peri-operative implications of herbal medicines. Anaesthesia. 2002;57(9):889-99.

  1. Cuker A et al. Laboratory measurement of the anticoagulant activity of the non‐vitamin K oral anticoagulants. J Am Coll Cardiol 2014;64(11):1128‐1139.

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