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Pulmonary Embolism Management – Adult – Ambulatory – Emergency Department Clinical Practice Guideline (CPG)

Cover Sheet

Target Population: Adult patients diagnosed with pulmonary embolism in the Emergency Department

CPG Contact for Content Questions: Name: Nikki Pernot Phone Number: (608) 890-6695 Email address: npernot@uwhealth.org CPG Contact for Document Changes: Name: Nikki Pernot/Lee Vermeulen Phone Number: (608) 262-7537 Email address: lc.vermeulen@hosp.wisc.edu Guideline Author(s): Nikki Pernot Coordinating Team Members: Jeff Pothof, Rob Hoffman,

Sarah Ahrens, Linda Harsy, Jayne McGrath, Anne Rose, Cindy Gaston, Jeffrey Kanne, Scott Nagle, Joe Halfpap, Eliot Williams

Review Individuals/Bodies: Pharmacy and Therapeutics Committee and CKM Council Committee Approvals/Dates: 12/20/2012 Release Date: 12/26/2012

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Executive Summary

Guideline Title: Outpatient Pulmonary Embolism Management – Adult –

Ambulatory – Emergency Department Clinical Practice Guideline

Guideline Overview Recommendations for outpatient treatment and management of pulmonary embolism in

adult patients in the emergency department. Practice Recommendations Eligibility Criteria for Outpatient Pulmonary Embolism management:

• ≥ 18 years of age • Diagnosis of acute pulmonary embolism • Able and willing to comply with home care • Able to obtain necessary medications

If patient meets the eligibility criteria, calculate the PESI score based on table included in the guideline. If PESI score is ≥ 86, hospitalize the patient. If PESI score is ≤ 85, continue to the exclusion criteria: Exclusion Criteria:

• Intracardiac or central vein thrombus • Central PE (main pulmonary artery) • Requires admission for reasons other than acute PE/DVT • Not appropriate for long term anticoagulation (fall risk, unreliable, or unable to comply

with follow up) • Any stroke in the last 6 weeks • Brain, spinal, or ophthy surgery in the last 6 weeks • Non-cutaneous surgery in the last 2 weeks • GI bleed in the last 2 weeks • Active major bleeding • History of HIT or heparin “allergy” • Theraputic anticoagulation at the time of diagnosis (e.g. INR ≥ 2) • Thrombocytopenia (< 75,000) • Other coagulopathy • Creatinine clearance , 30 mL/min • Hypoxia (< 90% at any time in the ED) • Hypotension (SBP , 100mmHg at any time in the ED) • RV strain on echocardiogram (if obtained) • Treated with thrombolytics in the ED • Pregnant • > 150 kg • BMI < 18

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If no to all exclusion criteria, then the patient may be discharged with proper home care instructions. Companion Documents

ED order set, patient education materials (will hyperlink these once they are created) Pertinent UWHC Policies & Procedures None identified

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Scope

Disease/Condition(s): Pulmonary Embolism (PE) Clinical Specialty: Emergency Department (ED) Intended Users: Emergency Department Clinicians CPG objective(s): To assist clinician by providing a framework for the evaluation and outpatient

treatment of adult PE patients.

Target Population: Adult patients diagnosed with PE in the ED.

Major Outcomes Considered: Number of patients with PE admitted versus treated as outpatients. Number of readmissions or complications in the outpatient treatment population.

Methodology

Description of Methods Used to Collect/Select the Evidence: (1) completing a comprehensive literature search of electronic databases; (2) conducting an in-depth review of relevant abstracts and articles; (3) conducting thoughtful discussion and interpretation of findings; (4) ranking strength of evidence underlying the current recommendations that are made.

Methods Used to Assess the Quality and Strength of the Evidence: Comprehensive review of literature from 1998 to 2011 Rating Scheme for the Strength of the Evidence: A modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) developed by the American Heart Association and American College of Cardiology (Figure 1) has been used to assess the Quality and Strength of the Evidence in this Clinical Practice Guideline.1

Figure 1. Quality of Evidence and Strength of Recommendation Grading Matrix

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Definitions: Pulmonary Embolism: embolism of a pulmonary artery or one of its branches that is produced by foreign matter and most often a blood clot originating in a vein of the leg or pelvis and that is marked by labored breathing, chest pain, fainting, rapid heart rate, cyanosis, shock, and sometimes death.

Introduction This guideline contains strategies and recommendations designed to assist clinicians in delivering and

supporting effective outpatient treatment for pulmonary embolism.

Recommendations

1. Eligibility Criteria for Outpatient Pulmonary Embolism management: • ≥ 18 years of age1 • Diagnosis of acute pulmonary embolism1 • Able and willing to comply with home care • Able to obtain necessary medications

(Class IIa, Level of Evidence B)

2. If patient meets the eligibility criteria, calculate the PESI score1 (Class IIa, Level of Evidence B) :

Calculate the PESI  Age  + 1 per year  Male  + 10 

Any history of malignancy*  + 30  Any history of Heart Failure  + 10 

Any history of Chronic Lung Disease  + 10  Triage HR > 110  + 20  Triage SBP < 100  + 30  Triage Temp < 36C  + 20  Triage RR > 29  + 20 

Triage Oxygen sat < 90%  + 20  Altered Mental Status  + 60 

* Any diagnosis of cancer other than basal‐cell or squamous‐cell carcinoma of the skin, within the prior six months, any treatment for cancer in the previous six months, or recurrent or metastatic cancer3

3. If PESI score is ≥ 86, hospitalize the patient1

If PESI score is ≤ 85, continue to the exclusion criteria1

(Class IIa, Level of Evidence B)

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4. Exclusion Criteria: • Intracardiac or central vein thrombus • Central PE (main pulmonary artery) • Requires admission for reasons other than acute PE/DVT4 • Not appropriate for long term anticoagulation (fall risk, unreliable, or unable to comply with follow up)4 • Any stroke in the last 6 weeks4 • Brain, spinal, or ophthy surgery in the last 6 weeks • Non-cutaneous surgery in the last 2 weeks4 • GI bleed in the last 2 weeks1,4 • Active major bleeding1 • History of HIT or heparin “allergy”1,4 • Theraputic anticoagulation at the time of diagnosis (e.g. INR ≥ 2)1 • Thrombocytopenia (< 75,000)1,4 • Other coagulopathy1 • Creatinine clearance , 30 mL/min1,4 • Hypoxia (< 90% at any time in the ED)1,4 • Hypotension (SBP < 100mmHg at any time in the ED)1,4 • RV strain on echocardiogram (if obtained) • Treated with thrombolytics in the ED • Pregnant1,4 • > 150 kg1 • BMI < 18

If no to all exclusion criteria, then the patient may be discharged with proper home care instructions (Class IIa, Level of Evidence B).

Companion/Collateral documents (algorithm, tables, and forms):

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Exclusion criteria No Yes

Intracardiac or central vein thrombus

Central PE (main pulmonary artery)

Requires admission for reasons other than acute PE/DVT

Not appropriate for long term anticoagulation (Fall risk, unreliable, or unable to comply with follow up)

Any stroke in the last 6 weeks

Brain, spinal, or ophthy surgery in the last 6 weeks

Non‐cutaneous surgery in the last 2 weeks

GI bleed in the last 2 weeks

Active major bleeding

History of HIT or heparin “allergy”

Therapeutic anticoagulation at the time of diagnosis (e.g. INR ≥ 2)

Thrombocytopenia ( < 75,000)

Other coagulopathy

Creatinine clearance < 30mL/min

Hypoxia (< 90% at any time in the ED)

Hypotension (SBP < 100mmHg at any time in the ED)

RV strain on echocardiogram (if obtained)

Treated with thrombolytics in the ED

Pregnant

Weight  > 150 kg

BMI < 18

Calculate the PESI

Age + 1 per year

Male  + 10

Any history of malignancy* + 30

Any history of Heart Failure + 10

Any history of Chronic Lung Disease + 10

Triage HR > 110 + 20

Triage SBP < 100 + 30

Triage Temp < 36C + 20

Triage RR > 29 + 20

Triage Oxygen sat < 90% + 20

Altered Mental Status  + 60

Consider outpatient management of PE if:

Diagnosis of acute PE

Age ≥ 18

Able and willing to comply with home care

Able to obtain necessary medications

If PESI score ≥ 86Hospitalize

If PESI ≤ 85

If Yes to any of the exclusion criteria, then patient must be hospitalized.

If No to all of the exclusion criteria, then patient may be discharged.

University of Wisconsin Hospital and ClinicsEmergency Department

Outpatient treatment of acute Pulmonary Embolism with Low Molecular Weight Heparin

* Any diagnosis of cancer other than basal-cell or squamous-cell carcinoma of the skin, within the prior six months, any treatment for cancer in the previous six months, or recurrent or metastatic cancer

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Pulmonary Embolism Outpatient Treatment Algorithm

Eligible for Outpatient Treatment

Give first dose of LMWH and Warfarin in ED prior to discharge: □ Enoxaparin 1 mg / kg SQ x 1 (round to nearest syringe size) □ Warfarin 5 mg orally x 1

Provide patient education on the following prior to discharge: □ Pulmonary embolism disease state □ Injection technique □ Warfarin and LMWH □ Follow up/outpatient management plan

Patient should discharge from the ED with: □ First doses of anticoagulation administered

□ Prescription for warfarin and LMWH (may be phoned to a pharmacy) □ Understanding of dose, administration, and follow up/outpatient

management plan □ Educational material

Outpatient anticoagulation treatment: (select one from each category) □ Warfarin 5 mg Take as Directed per INR □ Warfarin 2.5 mg Take as Directed per INR (sensitive patients)* AND □ Enoxaparin 1 mg/kg SQ every 12 hours for 10 days (enoxaparin once daily is not recommended) □ Dalteparin 100 units/kg SQ every 12 hours for 10 days

Physicians: □ Contact (via telephone) patient’s PCP or on call provider if

after hours to establish outpatient management □ Schedule a follow up INR 2-3 days after ED discharge

(an INR should not be checked on the weekend)

Potential for warfarin sensitivity: □ Baseline INR > 1.5 □ Age > 65 □ Actual body weight < 45 kg □ Significant drug interactions □ Current antiplatelet therapy □ Chronic diarrhea □ Alcohol abuse history □ Decompensated heart failure □ Malnourished or NPO > 3 days

Pharmacist will contact patient 2-3 days after ED discharge to ensure follow up with PCP has occurred.

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References for Supporting Evidence 1. Aujesky D, et al. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an

international, open-label, randomized, non-inferiority trail. Lancet 2011; 378; 41-48. 2. Aujesky D, et al. Cost-Effectiveness of Low-Molecular-Weight Heparin for Treatment of Pulmonary

Embolism. Chest 2005; 128; 1601-1610. 3. Lee A, et al. Low Molecular-Weight Heparin versus a Coumarin for the Prevention of Recurrent Venous

Thromboembolism in Patients with Cancer. New England Journal of Medicine 2003; 349; 146-153 4. Zondag I, et al. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. Thromb

Haemost 2011; 9; 1500-1507 5. Jimenez D, et al. Prognostic Models for Selecting Patients with Acute Pulmonary Embolism for Initial

Outpatient Therapy. Chest 2007; 132; 24-30. 6. Lim A, et al. Early discharge and home supervision of patients with pulmonary embolism treated with low-

molecular weight heparin. European Journal of Internal Medicine 2003; 14; 89-93. 7. Kovacs MJ, et al. Outpatient Treatment of Pulmonary Embolism with Dalteparin. Thromb Haemost 2000; 83;

209-211. 8. Wells PS, et al. Expanding Eligibility for Outpatient Treatment of Deep Vein Thrombosis and Pulmonary

Embolism With Low-Molecular-Weight Heparin. Arch Internal Medicine 1998; 158; 1809-1812. 9. Squizzato A, et al. Outpatient treatment and early discharge of symptomatic pulmonary embolism: a

systematic review. European Respiratory Journal 2009; 33; 1148-1155. 10. Hull RD. Treatment of pulmonary embolism: The use of low-molecular-weight heparin in the inpatient and

outpatient settings. Thromb Haemost 2008; 99; 502-510. 11. American College of Emergency Physicians Clinical Policies Subcommittee. Critical Issues in the Evaluation

and Management of Adult Patients Presenting to the Emergency Department With Suspected Pulmonary Embolism. Annals of Emergency Medicine 2011; 57; 628-652

Benefits/Harms of Implementation

Potential Benefits: cost savings, shorter length of stay, higher patient satisfaction Potential Harms: recurrent pulmonary embolism, patient non-adherence, possible higher

readmission rate

Implementation Strategy This guideline will be housed on UConnect in a dedicated folder for Clinical Practice Guidelines.

Links to this guideline will be created in appropriate Health Link tools.

Implementation Tools/Plan ED Physician Responsibilities

• Diagnosis of Pulmonary Embolism • Evaluation of eligibility criteria • Review of eligibility with pharmacist • Completion of Outpatient Pulmonary Embolism order set with dosing recommendations

from pharmacist • Identification of responsible party as contact for the following business day • Ensure patient has PCP follow up plan established

ED Nurse Responsibilities

• Administer first dalteparin or warfarin dose • Provide preliminary injection teaching • Supply patient with warfarin patient information sheets • Reinforce instructions to return the next business day to PCP

ED Pharmacist Responsibilities

• Ensure appropriate baseline labs are drawn • Review potential for drug interactions with home medications • Review discharge prescriptions for LMWH and warfarin • Review patient insurance coverage

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• Patient medication teaching for LMWH and warfarin Disclaimer

Guidelines are designed to assist clinicians by providing a framework for the evaluation and treatment of patients. This guideline outlines the preferred approach for most patients. It is not intended to replace a clinician’s judgment or to establish a protocol for all patients. It is understood that some patients will not fit the clinical condition contemplated by a guideline and that a guideline will rarely establish the only appropriate approach to a problem.