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AHA Scientific Statement
Management of Massive and
Submassive Pulmonary Embolism,
Iliofemoral Deep Vein Thrombosis, and
Chronic Thromboembolic Pulmonary
Hypertension
Circulation 2011, 123:1788-1830
Management of Massive & Submassive Pulmonary Embolism
Massive, Submassive, and
Low-Risk PE
Definition for Massive PE
Acute PE with with at least 1 of the following:
1. Sustained hypotension
   SBP <90 mmHg for at least 15 minutes or
   requiring inotropic support, not due to a
   cause other than PE, such as arrhythmia,
   hypovolemia, sepsis, or LV dysfunction
2. Pulselessness
3. Persistent profound bradycardia
   heart rate <40 bpm with signs or symptoms
   of shock
In the International Cooperative Pulmonary
  Embolism Registry (ICOPER), the 90-day
  mortality rate for patients with acute PE
  and SBP < 90 mmHg at presentation (108
  patients) was 52.4% (95% CI 43.3% to
  62.1%) versus14.7% (95% CI 13.3% to
  16.2%) in the remainder of the cohort.
                 Circulation. 2006;113:577–582.
In the Germany-based Management
  Strategy and Prognosis of Pulmonary
  Embolism Registry (MAPPET) of 1001
  patients with acute PE, in-hospital
  mortality was 8.1% for hemodynamically
  stable patients versus 25% for those
  presenting with cardiogenic shock and
  65% for those requiring CPR.
         J Am Coll Cardiol. 1997;30: 1165–1171.
Definition for Submassive PE
Acute PE without systemic hypotension (SBP >90 mm
  Hg) but with either RV dysfunction or myocardial
  necrosis.
• RV dysfunction means the presence of at least 1 of the
  following:
   – Echo: RV dilation (apical 4-chamber RV diameter divided by LV
     diameter >0.9), or RV systolic dysfunction
   – CT: RV dilation (4-chamber RV diameter divided by LV diameter
     > 0.9)
   – BNP > 90 pg/mL or N-terminal pro-BNP > 500 pg/mL
   – ECG changes: New complete or incomplete RBBB, anteroseptal
     ST elevation or depression, or anteroseptal T-wave inversion
• Myocardial necrosis is defined as either of the following:
   – Troponin I > 0.4 ng/mL, or Troponin T > 0.1 ng/mL
Midright ventricular diameter measured in apical 4-chamber
view at level of left ventricular papillary muscles.

                           J Am Soc Echocardiogr 2005;18:1440-1463.
Measurement of the
short axes of the RV
and LV on a
reformatted four-
chamber CT image
Measurement of the short
axes of the RV and LV on a
reformatted four-chamber
CT image obtained in a 54-
year-old patient with non-
severe PE.
CT images of the heart are
rotated to obtain the four-
chamber image. The short
axes of the RV and LV are
44.7 mm and 45.6 mm,
respectively, resulting in a
normal RV/LV diameter
ratio of less than 1.

                               January 2006 RadioGraphics, 26, 23-39.
Moderate acute
dilatation of the RV in a
55-year-old man with
massive PE.

Four-chamber CT image
shows measurements for
the short axes of the RV
and LV, resulting in an
RV/LV diameter ratio of 1.7.



  Note the PE in the right
  lower lobe PA (arrow).




                               January 2006 RadioGraphics, 26, 23-39.
Definition for Low-Risk PE
Acute PE and the absence of the clinical
 markers of adverse prognosis that define
 massive or submassive PE.
Therapy for Acute Massive,
Submassive, and Low-Risk PE
• Heparin passive reduction of thrombus size.
• Thrombolytic agents actively promote the
  hydrolysis of fibrin molecules.
• At 24 hours, patients treated with heparin
  have no substantial improvement in
  pulmonary blood flow, whereas patients
  treated with adjunctive fibrinolysis manifest
  a 30% to 35% reduction in total perfusion
  defect. However, by 7 days, blood flow
  improves similarly (65% to 70% reduction in
  total defect).
Management of Massive & Submassive Pulmonary Embolism
Recommendations for Initial
Anticoagulation for Acute PE
1. Therapeutic anticoagulation with subcutaneous
   LMWH, intravenous or subcutaneous UFH with
   monitoring, unmonitored weight-based
   subcutaneous UFH, or subcutaneous
   fondaparinux should be given to patients with
   objectively confirmed PE and no contraindications
   to anticoagulation (Class I; Level of Evidence A).
2. Therapeutic anticoagulation during the diagnostic
   workup should be given to patients with
   intermediate or high clinical probability of PE and
   no contraindications to anticoagulation (Class I;
   Level of Evidence C).
Pharmacological Profile of Plasminogen-
Activating Fibrinolytic Agents
                FDA Indication
Fibrinolytic                     Fibrinolytic Dose
                for PE?
                                 250 000-IU IV bolus followed by
Streptokinase        Yes
                                 100 000-IU/h infusion for 12–24 h
                                 4400-IU/kg bolus, followed by 4400
Urokinase            Yes
                                 IU.kg-1.h-1 for 12–24 h
Alteplase            Yes         100-mg IV infusion over 2 h
Reteplase             No         Double 10-U IV bolus 30 min apart
                                 Weight-adjusted IV bolus over 5 s
Tenecteplase          No         (30–50 mg with a 5-mg step every
                                 10 kg from <60 to >90 kg)
Right ventricular systolic pressures at diagnosis and 6
months after acute submassive pulmonary embolism.
Left Panel, Patients initially treated with heparin and alteplase.
Right Panel, Patients who received heparin alone. Plots for patients
with a net increase in systolic pressure are highlighted in red.
                                                 Chest. 2009;136:1202–1210.
Recommendations for
Fibrinolysis for Acute PE
1.   Fibrinolysis is reasonable for patients with massive acute
     PE and acceptable risk of bleeding complications (Class IIa;
     Level of Evidence B).
2.   Fibrinolysis may be considered for patients with
     submassive acute PE judged to have clinical evidence of
     adverse prognosis (new hemodynamic instability,
     worsening respiratory insufficiency, severe RV
     dysfunction, or major myocardial necrosis) and low risk
     of bleeding complications (Class IIb; Level of Evidence C).
3.   Fibrinolysis is not recommended for patients with low-risk
     PE (Class III; Level of Evidence B) or submassive acute PE
     with minor RV dysfunction, minor myocardial necrosis, and
     no clinical worsening (Class III; Level of Evidence B).
4.   Fibrinolysis is not recommended for undifferentiated cardiac
     arrest (Class III; Level of Evidence B).
Probability of PE above treatment threshold

Submassive without RV       Submassive with RV strain               Systolic blood pressure
Strain (Low risk PE)        (Abnormal echo or biomarkers)           < 90 mmHg for >15 min


Heparin Anticoagulation         Heparin Anticoagulation             Heparin Anticoagulation

              Assess for evidence of increased severity that suggests
              potential for benefit of fibrinolysis

              1. EVIDENCE OF SHOCK OR RESPIRATORY FAILURE:
                  • Any hypotension (SBP<90 mm Hg) OR
                  • Shock index >1.0 OR
                  • Respiratory distress (SaO2 <95% with Borg score >8, or
                    altered mental status, or appearance of suffering)
              2. EVIDENCE OF MODERATE TO SEVERE RV STRAIN:
                  • RV dysfunction (RV hypokinesis or estimated RVSP> 40
                    mmHg) OR
                  • Clearly elevated biomarker values (e.g., troponin above
                    borderline value, BNP >100 pg/mL or pro-BNP >900 pg/mL)


                          No contraindications to fibrinolysis

                             Alteplase 100 mg over 2 h IV
Catheter-Based Interventions
Goals of Catheter-Based Therapy
1. Rapidly reducing pulmonary artery
   pressure, RV strain, and pulmonary
   vascular resistance
2. Increasing systemic perfusion
3. Facilitating RV recovery
Three General Categories of
Percutaneous Intervention
1. Aspiration thrombectomy
2. Thrombus fragmentation
3. Rheolytic thrombectomy
Surgical Embolectomy
Representative pulmonary
endarterectomy specimens
A, Type 1 disease (25% of cases of thromboembolic
pulmonary hypertension): Fresh thrombus in the main
or lobar pulmonary arteries. B, Type 2 disease (40%
of cases): Intimal thickening and fibrosis with or
without organized thrombus proximal to segmental
arteries. In these cases, only thickened intima can be
seen on initial dissection into the pulmonary arteries,
occasionally with webs in the main or lobar arteries.
C, Type 3 disease (30% of cases): Fibrosis, intimal
webbing, and thickening with or without organized
thrombus within distal segmental and subsegmental
arteries only. No occlusion of vessels can be seen
initially.
Recommendations for Catheter Embolectomy
and Fragmentation or Surgical Embolectomy
1. Depending on local expertise, either catheter
   embolectomy and fragmentation or surgical
   embolectomy is reasonable for patients with massive
   PE and contraindications to fibrinolysis (Class IIa;
   Level of Evidence C).
2. Catheter embolectomy and fragmentation or surgical
   embolectomy is reasonable for patients with massive
   PE who remain unstable after receiving
   fibrinolysis (Class IIa; Level of Evidence C).
3. For patients with massive PE who cannot receive
   fibrinolysis or who remain unstable after fibrinolysis, it
   is reasonable to consider transfer to an institution
   experienced in either catheter embolectomy or
   surgical embolectomy if these procedures are not
   available locally and safe transfer can be achieved
   (Class IIa; Level of Evidence C).
Recommendations for Catheter Embolectomy
and Fragmentation or Surgical Embolectomy
4. Either catheter embolectomy or surgical
   embolectomy may be considered for patients with
   submassive acute PE judged to have clinical
   evidence of adverse prognosis (new
   hemodynamic instability, worsening respiratory
   failure, severe RV dysfunction, or major
   myocardial necrosis) (Class IIb; Level of
   Evidence C).
5. Catheter embolectomy and surgical
   thrombectomy are not recommended for
   patients with low-risk PE or submassive acute
   PE with minor RV dysfunction, minor myocardial
   necrosis, and no clinical worsening (Class III;
   Level of Evidence C).
Inferior Vena Cava Filters
Recommendations on IVC Filters
in the Setting of Acute PE
1. Adult patients with any confirmed acute PE (or
   proximal DVT) with contraindications to
   anticoagulation or with active bleeding complication
   should receive an IVC filter (Class I; Level of
   Evidence C).
2. Anticoagulation should be resumed in patients with
   an IVC filter once contraindications to anticoagulation
   or active bleeding complications have resolved
   (Class I; Level of Evidence B).
3. Patients who receive retrievable IVC filters should be
   evaluated periodically for filter retrieval within the
   specific filter’s retrieval window (Class I; Level of
   Evidence C).
4. For patients with recurrent acute PE despite
   therapeutic anticoagulation, it is reasonable to place
   an IVC filter (Class IIa; Level of Evidence C).
Recommendations on IVC Filters
in the Setting of Acute PE
5.   For DVT or PE patients who will require permanent IVC
     filtration (eg, those with a long-term contraindication to
     anticoagulation), it is reasonable to select a permanent IVC
     filter device (Class IIa; Level of Evidence C).
6.   For DVT or PE patients with a time-limited indication for an
     IVC filter (eg, those with a short-term contraindication to
     anticoagulation therapy), it is reasonable to select a
     retrievable IVC filter device (Class IIa; Level of Evidence C).
7.   Placement of an IVC filter may be considered for patients with
     acute PE and very poor cardiopulmonary reserve, including
     those with massive PE (Class IIb; Level of Evidence C).
8.   An IVC filter should not be used routinely as an adjuvant to
     anticoagulation and systemic fibrinolysis in the treatment of
     acute PE (Class III; Level of Evidence C).

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Management of Massive & Submassive Pulmonary Embolism

  • 1. AHA Scientific Statement Management of Massive and Submassive Pulmonary Embolism, Iliofemoral Deep Vein Thrombosis, and Chronic Thromboembolic Pulmonary Hypertension Circulation 2011, 123:1788-1830
  • 4. Definition for Massive PE Acute PE with with at least 1 of the following: 1. Sustained hypotension SBP <90 mmHg for at least 15 minutes or requiring inotropic support, not due to a cause other than PE, such as arrhythmia, hypovolemia, sepsis, or LV dysfunction 2. Pulselessness 3. Persistent profound bradycardia heart rate <40 bpm with signs or symptoms of shock
  • 5. In the International Cooperative Pulmonary Embolism Registry (ICOPER), the 90-day mortality rate for patients with acute PE and SBP < 90 mmHg at presentation (108 patients) was 52.4% (95% CI 43.3% to 62.1%) versus14.7% (95% CI 13.3% to 16.2%) in the remainder of the cohort. Circulation. 2006;113:577–582.
  • 6. In the Germany-based Management Strategy and Prognosis of Pulmonary Embolism Registry (MAPPET) of 1001 patients with acute PE, in-hospital mortality was 8.1% for hemodynamically stable patients versus 25% for those presenting with cardiogenic shock and 65% for those requiring CPR. J Am Coll Cardiol. 1997;30: 1165–1171.
  • 7. Definition for Submassive PE Acute PE without systemic hypotension (SBP >90 mm Hg) but with either RV dysfunction or myocardial necrosis. • RV dysfunction means the presence of at least 1 of the following: – Echo: RV dilation (apical 4-chamber RV diameter divided by LV diameter >0.9), or RV systolic dysfunction – CT: RV dilation (4-chamber RV diameter divided by LV diameter > 0.9) – BNP > 90 pg/mL or N-terminal pro-BNP > 500 pg/mL – ECG changes: New complete or incomplete RBBB, anteroseptal ST elevation or depression, or anteroseptal T-wave inversion • Myocardial necrosis is defined as either of the following: – Troponin I > 0.4 ng/mL, or Troponin T > 0.1 ng/mL
  • 8. Midright ventricular diameter measured in apical 4-chamber view at level of left ventricular papillary muscles. J Am Soc Echocardiogr 2005;18:1440-1463.
  • 9. Measurement of the short axes of the RV and LV on a reformatted four- chamber CT image Measurement of the short axes of the RV and LV on a reformatted four-chamber CT image obtained in a 54- year-old patient with non- severe PE. CT images of the heart are rotated to obtain the four- chamber image. The short axes of the RV and LV are 44.7 mm and 45.6 mm, respectively, resulting in a normal RV/LV diameter ratio of less than 1. January 2006 RadioGraphics, 26, 23-39.
  • 10. Moderate acute dilatation of the RV in a 55-year-old man with massive PE. Four-chamber CT image shows measurements for the short axes of the RV and LV, resulting in an RV/LV diameter ratio of 1.7. Note the PE in the right lower lobe PA (arrow). January 2006 RadioGraphics, 26, 23-39.
  • 11. Definition for Low-Risk PE Acute PE and the absence of the clinical markers of adverse prognosis that define massive or submassive PE.
  • 12. Therapy for Acute Massive, Submassive, and Low-Risk PE
  • 13. • Heparin passive reduction of thrombus size. • Thrombolytic agents actively promote the hydrolysis of fibrin molecules. • At 24 hours, patients treated with heparin have no substantial improvement in pulmonary blood flow, whereas patients treated with adjunctive fibrinolysis manifest a 30% to 35% reduction in total perfusion defect. However, by 7 days, blood flow improves similarly (65% to 70% reduction in total defect).
  • 15. Recommendations for Initial Anticoagulation for Acute PE 1. Therapeutic anticoagulation with subcutaneous LMWH, intravenous or subcutaneous UFH with monitoring, unmonitored weight-based subcutaneous UFH, or subcutaneous fondaparinux should be given to patients with objectively confirmed PE and no contraindications to anticoagulation (Class I; Level of Evidence A). 2. Therapeutic anticoagulation during the diagnostic workup should be given to patients with intermediate or high clinical probability of PE and no contraindications to anticoagulation (Class I; Level of Evidence C).
  • 16. Pharmacological Profile of Plasminogen- Activating Fibrinolytic Agents FDA Indication Fibrinolytic Fibrinolytic Dose for PE? 250 000-IU IV bolus followed by Streptokinase Yes 100 000-IU/h infusion for 12–24 h 4400-IU/kg bolus, followed by 4400 Urokinase Yes IU.kg-1.h-1 for 12–24 h Alteplase Yes 100-mg IV infusion over 2 h Reteplase No Double 10-U IV bolus 30 min apart Weight-adjusted IV bolus over 5 s Tenecteplase No (30–50 mg with a 5-mg step every 10 kg from <60 to >90 kg)
  • 17. Right ventricular systolic pressures at diagnosis and 6 months after acute submassive pulmonary embolism. Left Panel, Patients initially treated with heparin and alteplase. Right Panel, Patients who received heparin alone. Plots for patients with a net increase in systolic pressure are highlighted in red. Chest. 2009;136:1202–1210.
  • 18. Recommendations for Fibrinolysis for Acute PE 1. Fibrinolysis is reasonable for patients with massive acute PE and acceptable risk of bleeding complications (Class IIa; Level of Evidence B). 2. Fibrinolysis may be considered for patients with submassive acute PE judged to have clinical evidence of adverse prognosis (new hemodynamic instability, worsening respiratory insufficiency, severe RV dysfunction, or major myocardial necrosis) and low risk of bleeding complications (Class IIb; Level of Evidence C). 3. Fibrinolysis is not recommended for patients with low-risk PE (Class III; Level of Evidence B) or submassive acute PE with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening (Class III; Level of Evidence B). 4. Fibrinolysis is not recommended for undifferentiated cardiac arrest (Class III; Level of Evidence B).
  • 19. Probability of PE above treatment threshold Submassive without RV Submassive with RV strain Systolic blood pressure Strain (Low risk PE) (Abnormal echo or biomarkers) < 90 mmHg for >15 min Heparin Anticoagulation Heparin Anticoagulation Heparin Anticoagulation Assess for evidence of increased severity that suggests potential for benefit of fibrinolysis 1. EVIDENCE OF SHOCK OR RESPIRATORY FAILURE: • Any hypotension (SBP<90 mm Hg) OR • Shock index >1.0 OR • Respiratory distress (SaO2 <95% with Borg score >8, or altered mental status, or appearance of suffering) 2. EVIDENCE OF MODERATE TO SEVERE RV STRAIN: • RV dysfunction (RV hypokinesis or estimated RVSP> 40 mmHg) OR • Clearly elevated biomarker values (e.g., troponin above borderline value, BNP >100 pg/mL or pro-BNP >900 pg/mL) No contraindications to fibrinolysis Alteplase 100 mg over 2 h IV
  • 21. Goals of Catheter-Based Therapy 1. Rapidly reducing pulmonary artery pressure, RV strain, and pulmonary vascular resistance 2. Increasing systemic perfusion 3. Facilitating RV recovery
  • 22. Three General Categories of Percutaneous Intervention 1. Aspiration thrombectomy 2. Thrombus fragmentation 3. Rheolytic thrombectomy
  • 24. Representative pulmonary endarterectomy specimens A, Type 1 disease (25% of cases of thromboembolic pulmonary hypertension): Fresh thrombus in the main or lobar pulmonary arteries. B, Type 2 disease (40% of cases): Intimal thickening and fibrosis with or without organized thrombus proximal to segmental arteries. In these cases, only thickened intima can be seen on initial dissection into the pulmonary arteries, occasionally with webs in the main or lobar arteries. C, Type 3 disease (30% of cases): Fibrosis, intimal webbing, and thickening with or without organized thrombus within distal segmental and subsegmental arteries only. No occlusion of vessels can be seen initially.
  • 25. Recommendations for Catheter Embolectomy and Fragmentation or Surgical Embolectomy 1. Depending on local expertise, either catheter embolectomy and fragmentation or surgical embolectomy is reasonable for patients with massive PE and contraindications to fibrinolysis (Class IIa; Level of Evidence C). 2. Catheter embolectomy and fragmentation or surgical embolectomy is reasonable for patients with massive PE who remain unstable after receiving fibrinolysis (Class IIa; Level of Evidence C). 3. For patients with massive PE who cannot receive fibrinolysis or who remain unstable after fibrinolysis, it is reasonable to consider transfer to an institution experienced in either catheter embolectomy or surgical embolectomy if these procedures are not available locally and safe transfer can be achieved (Class IIa; Level of Evidence C).
  • 26. Recommendations for Catheter Embolectomy and Fragmentation or Surgical Embolectomy 4. Either catheter embolectomy or surgical embolectomy may be considered for patients with submassive acute PE judged to have clinical evidence of adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV dysfunction, or major myocardial necrosis) (Class IIb; Level of Evidence C). 5. Catheter embolectomy and surgical thrombectomy are not recommended for patients with low-risk PE or submassive acute PE with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening (Class III; Level of Evidence C).
  • 28. Recommendations on IVC Filters in the Setting of Acute PE 1. Adult patients with any confirmed acute PE (or proximal DVT) with contraindications to anticoagulation or with active bleeding complication should receive an IVC filter (Class I; Level of Evidence C). 2. Anticoagulation should be resumed in patients with an IVC filter once contraindications to anticoagulation or active bleeding complications have resolved (Class I; Level of Evidence B). 3. Patients who receive retrievable IVC filters should be evaluated periodically for filter retrieval within the specific filter’s retrieval window (Class I; Level of Evidence C). 4. For patients with recurrent acute PE despite therapeutic anticoagulation, it is reasonable to place an IVC filter (Class IIa; Level of Evidence C).
  • 29. Recommendations on IVC Filters in the Setting of Acute PE 5. For DVT or PE patients who will require permanent IVC filtration (eg, those with a long-term contraindication to anticoagulation), it is reasonable to select a permanent IVC filter device (Class IIa; Level of Evidence C). 6. For DVT or PE patients with a time-limited indication for an IVC filter (eg, those with a short-term contraindication to anticoagulation therapy), it is reasonable to select a retrievable IVC filter device (Class IIa; Level of Evidence C). 7. Placement of an IVC filter may be considered for patients with acute PE and very poor cardiopulmonary reserve, including those with massive PE (Class IIb; Level of Evidence C). 8. An IVC filter should not be used routinely as an adjuvant to anticoagulation and systemic fibrinolysis in the treatment of acute PE (Class III; Level of Evidence C).