clinical practice guidelines - acute pulmonary embolism

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Clinical Clinical Practice Guideline Title: Management of Acute Pulmonary Embolism

Ownership: Internal Medicine Code: RH-CPG/(Internal Medicine)/001

Effective Date: April 2016 Revision Due Date: April 2017

Edition Number: 01 Revision Number: 00

Applies to: Internal Medicine, Emergency, Cardiology, Pulmonary Medicine, Intensive Care, Cardiothoracic Surgery, Radiology, Nursing Department, Pharmacy

First Edition Date: April 2016

1) Clinical Criteria Patients with clinically suspected or confirmed acute pulmonary embolism should be included in the clinical pathway of acute pulmonary embolism (PE). 1.1 Guidelines Objectives: The objectives of the guidelines are

1.1.1 Early diagnosis of acute PE 1.1.2 Proper management in concordance with the international guidelines 1.1.3 Reduction of the 30-day mortality rate and reduction of hospital length of stay 1.1.4 Proper health education of patient with acute PE 1.1.5 Organize the follow-up of patients with acute PE in outpatient clinic 1.1.6 Order follow-up radiological investigation and transthoracic echo on specific

indications 1.1.7 Issue Red Flag card to patients with acute PE on discharge from hospital 1.1.8 Write travel fitness after discharge from hospital on specific criteria

1.2 Clinical Pathway: To assist physicians from Emergency Medicine, Internal Medicine, Cardiology, Pulmonary Medicine, Intensive Care to manage acute pulmonary embolism in consistent pathway with help of multidisciplinary approach with other specialties included in the protocol

1.3 Inclusion Criteria: 1.3.1 Patient age >12 years old 1.3.2 First line physician will assess patients with symptoms and signs suggestive of

acute PE by checking a special screening sheet including the modified wells score. 1.3.3 Initiate the clinical pathway of acute PE if clinically confirmed or highly suspected

1.4 Exclusion Criteria: 1.4.1 Any patient with modified Wells score ≤4 and normal D-Dimer according to acute

PE screening sheet


2) Protocol 2.1 Definition of Acute PE: Is the presence of filling defect of the pulmonary artery or one of its branches by thrombus originated in situ or dislodged from the venous vasculature

2.1.1 Definition of Massive PE: Is acute PE with right ventricular strain which results in shock or hypotension (systolic blood pressure <90 mm Hg or drop of systolic blood pressure >40 mm Hg from baseline reading which sustains for >15 minutes) which cannot be explained by other etiologies 2.1.2 Definition of Submassive PE: Is acute PE with right ventricular strain without hemodynamics compromise

2.2 Definition of Subacute PE: Is PE which may present within days or weeks following the initial event 2.3 Definition of Chronic PE: Is PE with slowly developing symptoms of pulmonary hypertension over years 2.4 Protocol of initial evaluation and management of Acute PE: 2.4.1 Any patient with suspected symptoms and signs of acute PE will be evaluated by the physician from Emergency if the patient is in ED, 1st on-call medical physician if the patient is in the ward, intensivist if the patient is in ICU by filling the Acute PE Triage Sheet (attachment 1) 2.4.2 Suspected cases of acute PE initial evaluation and management to be at least in high dependency unit with cardiac monitoring. Provide oxygen to keep pulse oximetry >95%. Give intermittent 500 ml boluses of crystalloids for any hypotension 2.4.3 Request the following laboratory blood test for all patients with suspected acute PE (available in the SAM Special Package): CBC, Troponin, Pro BNP, Urea / electrolytes, Creatinine, LFT, PT/INR and PTT 2.4.3.1 D-Dimer is not required for high risk patients (shock or hypotension) 2.4.3.2 D-Dimer might be elevated in patients with cancer, pregnancy, trauma or surgical cases 2.4.3.3 D-Dimer can be normal in some cases with acute thrombosis 2.4.3.4 D-Dimer will be needed for outpatient follow-up to decide about stopping treatment 2.4.3.5 D-Dimer information above to be highly taken by the assessing physician and radiologist 2.4.4 Request electrocardiogram (ECG) and chest x-ray for all patients with suspected acute PE 2.4.5 Request Arterial Blood Gas (ABG) if patient’s pulse oximetry is <95% to assess the degree of hypoxemia and (A-a) gradient


2.4.6 Calculate modified Wells score if acute PE is suspected:

Clinical symptoms of DVT (leg swelling, pain with palpation) � 3.0

Other diagnosis less likely than pulmonary embolism � 3.0

Heart rate >100/minute � 1.5

Immobilization (≥3 days) or surgery in the previous four weeks � 1.5

Previous DVT/PE � 1.5

Hemoptysis � 1.0

Malignancy � 1.0

Probability Total Score:

Simplified clinical probability assessment (Modified Wells criteria)

PE likely □ >4.0 PE unlikely □ ≤ 4.0

2.4.6.1 If modified Wells score is >4, proceed for definite radiological investigation to confirm acute PE 2.4.6.2 If modified Wells score is ≤4, request D-Dimer. If D-Dimer is elevated proceed for definite radiological investigation, otherwise consider another etiology of patient symptoms

2.4.7 Start anticoagulation in all suspected or diagnosed PE unless contraindicated as per the PE triage sheet instructions 2.4.8 Radiological investigation of acute PE will be as the following: 2.4.8.1 CT pulmonary angiography is the preferred modality. The report will include the location of filling defects and severity by calculation of right ventricle (RV) diameter/ left ventricle (LV) diameter ratio. If RV/LV ration is ≥1, it indicates high-risk acute pulmonary embolism 2.4.8.2 D-Dimer is not required if the patient is high risk probability or modified Wells score >4 2.4.8.3 Timing of the exam is upon agreement between the clinician and the radiologist 2.4.8.4 In case of renal impairment/high creatinine/contrast allergy/metformin and high probability due to above criteria then ultrasound of both lower limbs to be performed to rule out DVT in Rashid Hospital radiology department plus V/Q scan to be arrange between the admitting physician and nuclear medicine unit in Dubai hospital 2.4.8.5 In case of pregnancy and high wells score, the emergency doctor will seek the opinion of the gynecologist before deciding further investigation. Ultrasound and V/Q scan will be requested choice 2.4.8.6 In case of intravenous contrast precautions or pregnancy and the physician insists on doing CT, high risk consent should be signed by them before performing the exam 2.4.8.7 When hemodynamic instability is present, proceed for Echocardiography by cardiologist and Doppler lower limbs by radiologist 2.4.8.8 In case of intravenous contrast study is required for CT pulmonary angiography, adequate hydration and possible N-Acetylcysteine to be prescribed by ordering physician if there is a risk of contrast nephropathy according to the clinical judgment


2.4.9 Calculate the Simplified Pulmonary Embolism Severity Index (SPESI) score if acute PE confirmed or highly suspected. If SPESI score is ≥1, the 30-day mortality risk is 10.9% and you consider thrombolysis of the same patient

SIMPLIFIED Acute Pulmonary Embolism Severity Index and Mortality Risk (SPESI score)

Parameter Simplified version

□ Age 1 point (if age >80 years)

□ Cancer 1 point

□ Chronic heart failure 1 point

□ Chronic pulmonary disease

□ Pulse rate ≥110/min 1 point

□ Systolic blood pressure <100 mm Hg 1 point

□ Arterial oxyhaemoglobin saturation <90% 1 point

Risk Strata (30-day mortality risk) □ 0 point: 1.0%

□ ≥ 1 point: 10.9%

2.4.10 Emergency thrombolysis to be administered by privileged ED physician or cardiologist on the following conditions: 2.4.10.1 Confirmed acute PE and cardiac arrest 2.4.10.2 Suspected acute PE and cardiac arrest if (history is highly suggestive PE + modified Wells score >4) or cardiologist report of right ventricular strain by echo or radiologist report of deep venous thrombosis by bedside Doppler lower limb 2.4.11 Activate Acute PE Clinical Pathway (attachment 2) if the diagnosis is confirmed to the concerned specialty from Internal Medicine, Cardiology 2.5 Protocol of Definitive Management of Acute PE: 2.5.1 Anticoagulation:

2.5.1.1 Anticoagulation with IV heparin alone risk of bleeding is high, invasive procedure is planned or patient hemodynamics/respiration are unstable 2.5.1.2 Anticoagulation with IV Heparin or SQ LMW Heparin plus Warfarin in the same time if the patient hemodynamics are stable 2.5.1.3 Non-vitamin K oral anticoagulation (NOAC) will be a better choice for stable patients and no contraindications 2.5.1.4 Warfarin is contraindicated in pregnancy 2.5.1.5 Consult Hematology team for patients with Heparin Induced Thrombocytopenia (HIT)


2.5.2 Thrombolysis: 2.5.2.1 Calculate early mortality risk of acute pulmonary embolism according to the table below

Early mortality risk for patients with acute pulmonary embolism (For possible thrombolysis)

Early mortality risk Risk parameters and scores

Shock or hypotension

SPESI ≥ 1 Signs of RV dysfunction on an Imaging test

Cardiac laboratory biomarker

□ High + + + +

□ Intermediate high □ Intermediate low

- + Both positive

- + Either one (or none) positive

□ Low - - Assessment optional; if assessed, both negative

2.5.2.2 Thrombolysis is indicated in case of hypotension or shock 2.5.2.3 Thrombolysis is better to be given in intermediate-high risk group for early mortality 2.5.2.4 Thrombolysis is not indicated in low risk or low-intermediate risk group for early mortality 2.5.2.5 Thrombolysis will be given according to the protocol of acute PE if no contraindication (attachment 3) 2.5.2.6 Follow intravenous heparin infusion sliding scale post-thrombolysis (attachment 3) 2.5.2.7 Repeat echo at least 24 hours post-thrombolysis to follow the RV pressure (accept <35 mm Hg) 2.5.2.8 If the patient had failure of thrombolysis in the form of clinical deterioration and RV pressure rising, consider rescue percutaneous Catheter Directed Thrombolysis (CDT) or Catheter Directed Thrombus Aspiration by Interventional Radiologist 2.5.2.9 Start oral anticoagulation post-thrombolysis once the patient is stable 2.5.3 Surgical Pulmonary Embolectomy: 2.5.3.1 Embolectomy is indicated in patients with hemodynamically unstable PE in whom thrombolytic therapy is contraindicated with the availability of cardiac surgeon, cardiopulmonary bypass machine in the operation room and Extra-Corporeal Membrane Oxygenator (ECMO) in Intensive Care Unit 2.5.3.2 It is also a therapeutic option in those who fail thrombolysis 2.5.3.3 Interventional radiologist can remove emboli by percutaneous catheter aspiration if surgical embolectomy cannot be done 2.5.4 Inferior Vena Cava (IVC) filter: 2.5.4.1 IVC filter is not routinely recommended 2.5.4.2 To be considered if any absolute contraindications for anticoagulation 2.5.4.3 In patients with acute deep venous thrombosis or PE who are treated with anticoagulants, we recommend against the use of an IVC filter according to the international guidelines 2.5.4.4 No evidence to support the use of IVC filters in patients with free-floating thrombi in proximal veins or in those scheduled for systemic thrombolysis, surgical embolectomy, or pulmonary thromboendarterctomy


3) Algorithm


4) Other Healthcare Provider Role

Responsibility

1. Most Responsible physician

• Cardiology: High or Intermediate-high early mortality risk patients who will require thrombolysis or Catheter directed intervention


• Internal Medicine: Intermediate-low or Low early mortality risk patients who do not need thrombolysis or catheter directed intervention

• Pulmonary Medicine: Acute PE in patients with obstructive lung disease, interstitial lung disease on immune-suppressive treatment, lung transplant

2. Site of care • High dependency unit: Intermediate-low or Low early mortality risk patients who do not need thrombolysis or catheter directed intervention

• Coronary Care Unit (CCU): High or Intermediate-high early mortality risk patients who will require thrombolysis or Catheter directed intervention

• Intensive Care Unit (ICU): Patients post-intubation who are not candidate for thrombolysis. Patients who require Catheter directed intervention will be in ICU.

• Emergency Department: Preferably in the Resuscitation room till further management plan is arranged

3. Triage nurse • Assess the vital signs of the patient after initial triaging

• Inform the ED physician about the possibility of acute PE

4. ED nurse • Reassess the patient according to the acute PE triage sheet

• Connect patient to cardiac monitor

• Inserts IV cannula

• Provide oxygen to keep SpO2 ≥95%

• Inform lab and ECG technician for further investigations

5. ED Physician & Nurse

• Urgent assessment of the patient clinical presentation

• Review ECG, asks for CXR and obtain ABG

• Calculate modified Wells score for suspected cases

• Follow instructions according to the acute PE triage sheet

6. ED Physician • Investigate for acute PE according to triage sheet

• Activate acute PE clinical pathway once confirmed or highly suspected

• Consult 1st on-call medical physician to assess patient for low or intermediate-low risk patients

• Consult 1st on-call cardiologist to assess patient for intermediate-high or high risk patients

• Give rescue thrombolysis for confirmed or highly suspected cases with cardiac arrest in ED

7. 1st Medical on-call • Assess the patient with acute PE on referral according to the clinical pathway

• Inform 2nd or 3rd on-call about the patient

• Will accept referrals from the wards in Rashid Hospital and Trauma Center for suspected cases


8. 1st on-call Cardiologist

• Assess the patient with acute PE on referral according to the clinical pathway

• Inform 2nd or 3rd on-call about the patient

9. CoC or ED nurse and messenger

• Responsible for mobilization of the patient from ED to high dependency unit or CCU or ICU

10. CCU/ICU/High dependency ward Nurse

• Reassessment of the patient

• Monitoring the patient as per the protocol of CCU/ICU/HDU

• Implementation of acute PE clinical pathway

11. General ward Nurse

• Implementation of acute PE clinical pathway

• Follow-up anticoagulation treatment with the treating physician

• Follow-up patient education on process

12. Dietitian • Review patient diet that might affect anticoagulation

13. Physical medicine and rehabilitation

• Assessment of physical activity with mobilization out of bed on gradual steps once patient is fit

14. Radiology Staff • CXR on presentation to ED

• Arrange CT pulmonary angiogram on maximum of 2 hours

15. Biochemistry • To carry the orders from triaging physician for CBC, Troponin, Pro BNP, Urea/electrolytes, Creatinine, LFT, PT/INR and PTT as per the pathway protocol

16. Pharmacy • Dispense the required medications particularly anticoagulation, thrombolytic after verification of the order as per the acute PE clinical pathway

17. Case management • Co-ordinate and facilitate the admission and discharge

18. Medical Record Department

• Maintenance of the records and make it available to the treating physician (as per policy)

19. Experts Panel • Emergency Department: Dr. Firas Annajjar

• Internal Medicine: Dr. Salman Abdulaziz

• Cardiology: Dr. Khalifa Omar, Dr. Juwairia Al-Ali

• ICU: Dr. Mohammed Baqer

• Expert panel members will provide medical advice for any case of acute pulmonary embolism if needed

5) Participant (Patient) Role 5.1 Encourage patient to adhere with the treatment and advices provided during the time of acute illness and while inpatient until discharge


5.2 Mobilization and bed rest as per orders in the clinical pathway 5.3 Maintain oxygen mask/ nasal prongs as deemed necessary by treating physician 5.4 Maintain ECG monitor cable and BP measuring devices attached 5.5 Be motivated on rehabilitation including healthy life style changes 5.6 Conform with hospital’s rules and regulations as per the Patients and Family Bills of Right Ensure to deposit and offset the bill/payment involved in the treatment and diagnostic procedures (invasive and non-invasive where applicable) and other payable services provided during hospitalization 6) Patient Reassessment Criteria 6.1 All acute patients in the High Dependency Units/ CCU/ICU will be re-assessed within 24 hours 6.2 Frequent reassessment of unstable patients will be required in accordance to the clinical status 6.3 Reassessment tools include focused history and examination 6.4 Follow up ECG, CXR, Echo and laboratory tests including cardiac biomarkers as needed 6.5 Stable patients in general wards will be re-assessed once in 24hrs as per hospital policy. 6.6 Early discharge (after 48 hours) criteria include: 6.6.1 SPESI score is 0 6.6.2 Normal cardiac markers 6.6.3 Health education is done properly 6.7 The treating physician will fill Acute Pulmonary Thromboembolism Discharge Orders 6.8 The treating physician will provide RED FLAG card and Patient Education Manual about acute PE, treatment, follow-up 6.9 Travel fitness for cases with Acute Pulmonary Embolism will be provided by treating physician if: 6.9.1 No fitness to fly within the first 4 days of onset 6.9.2 Medical clearance can be in less than 21 days 6.9.3 May travel after 5 days if the patient had stable anticoagulation and normal PAO2 on room air 6.10 Outpatient follow up in Rashid Hospital after 2 weeks from discharge with the following items: 6.10.1 Blood test: CBC, Coagulation profile if needed, D-Dimer, Troponin, Pro-BNP 6.10.2 Thrombophilia study after the first episode of acute PE to be requested only after 4 weeks from the end of treatment duration according to the clinical assessment 6.10.3 Pulmonary Embolism Radiology study if: recurrent symptoms and signs of pulmonary embolism, elevated D-Dimer which is persistent or recurrently elevated, right ventricular strain identified by Echo, or cardiac catheterization 6.10.4 Patients post-thrombolysis or catheter intervention will require echo follow-up on 2 weeks then 12 weeks interval to assess the pulmonary artery pressure (PAP). If persistent or continuous elevation of PAP to refer patient to specialized cardiac center for right side cardiac catheterization and possible pulmonary artery endarterectomy 7) Definitions: 7.1 Definition of Acute PE: is the presence of filling defect of the pulmonary artery or one of its branches by thrombus originated in situ or dislodged from the venous vasculature 7.1.1 Definition of Massive PE: is acute pulmonary embolism with right ventricular strain which results in shock or hypotension (systolic blood pressure <90 mm Hg or drop of systolic blood pressure >40 mm Hg from baseline reading which sustains for >15 minutes) which cannot be explained by other etiologies


7.1.2 Definition of Submassive PE: is acute pulmonary embolism with right ventricular strain without hemodynamics compromise 7.2 Definition of Subacute PE: is pulmonary embolism which may present within days or weeks following the initial event 7.3 Definition of Chronic PE: is pulmonary embolism with slowly developing symptoms of pulmonary hypertension over years

8) Tools/Attachments Forms: 8.1 Modified Wells score if acute pulmonary embolism is suspected 8.2 Simplified Acute Pulmonary Embolism Severity Index and Mortality Risk (SPESI score) 8.3 Early mortality risk for patients with acute pulmonary embolism (For possible thrombolysis) 8.4 Flow chart for management of acute pulmonary embolism 8.5 Acute Pulmonary Thromboembolism Clinical Pathway 8.6 Acute Pulmonary Embolism Red Flag Card and Patient Education Manual 8.7 Consent form 9) Performance Indicator: 9.1 Compliance of triaging physician on calculation of modified Wells score 9.2 Order time to CT pulmonary angiogram time of 2 hours by radiology technician 9.3 Simplified Acute Pulmonary Embolism Severity Index and Mortality Risk (SPESI score) and Early mortality risk for patients with acute pulmonary embolism (For possible thrombolysis) by triaging physician 9.4 Compliance of the treating team on echo indications 9.5 Compliance of the treating team on the clinical pathway 9.6 Reduction of length of stay in hospital 9.7 Reduction of mortality rate 9.6 Proper discharge summary 9.7 Red Flag Card, Patient Education Manual 9.8 Patient Satisfaction Survey 9.9 Regular and well organized long-term follow up plan 10) Search words: Acute Pulmonary Embolism Massive Pulmonary Embolism Submassive Pulmonary Embolism


11) References:

• Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016;149(2):315-352

• Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):7S-47S.

• 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69.

• Six Months vs Extended Oral Anticoagulation after a First Episode of Pulmonary Embolism the PADIS-PE Randomized Clinical Trial. JAMA. 2015;314(1):31-40.

• Acute Pulmonary Embolism. N Engl J Med 2010;363:266-74.

• Management of venous thrombo-embolism: an update. Eur Heart J. 2014 Nov 1;35(41):2855-63

• 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015; 132: S501-S518

• Evaluation of Persistent Pulmonary Hypertension after Acute Pulmonary Embolism. CHEST. 2007; 132:780–785

Prepared by:

1. Dr. Salman Abdulaziz Designation: Specialist Senior Registrar

Signature: Date: 09/02/2016

2. Dr. Laila Hussain Designation: Resident Signature: Date: 09/02/2016


3. Dr. Khalifa Omar Muhammed Designation: Specialist Senior Registrar

Signature: Date: 09/02/2016

4. Dr. Usama Al-Bastaki Designation: Consultant Signature: Date: 09/02/2016 Reviewed by:

1. Dr. Jamila Mohammed Bin Adi Designation: Head of General Medicine Department

Signature: Date:

Approved by:

1. Dr. Walid Mahmood Designation: Acting Head of Internal Medicine Dept. RH – Medical Affairs – Advisory Board

Signature: Date:

Reviewed & Acknowledged by: Designation: Head of Quality & Development Signature: Date: Authorized by: Dr. Alya Saif Al Mazrouei Designation: RH CEO

Signature: Date:

clinical practice guidelines - acute pulmonary embolism

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