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Controversies in the management of Pulmonary Embolism

Controversies in the management of Pulmonary Embolism. Joel Frankel, MD, FACP, FCCP Plantation General Hospital February 27, 2014. Clinical Case. 62 y.o . male presents to ED with 48 hours of worsening dyspnea after returning from a 3 day business trip to China

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Controversies in the management of Pulmonary Embolism

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  1. Controversies in the management of Pulmonary Embolism Joel Frankel, MD, FACP, FCCP Plantation General Hospital February 27, 2014

  2. Clinical Case • 62 y.o. male presents to ED with 48 hours of worsening dyspnea after returning from a 3 day business trip to China • Vitals: BP 110/60, P 102, O2 sat 86% on RA • PE: Distended neck veins, RR w/o murmur, lungs clear, normal LE exam • D Dimer = 2496 • CT chest multiple thrombi in PA and dilated right ventricle • Management?

  3. Questions • Which form of Heparin? • Lovenox (1 mg/kg SC) • Unfractionated Heparin • (80 U/kg bolus; 18 U/kg drip) • Disposition • ICU • Medicine • Home

  4. Very Simple Goals • Remember atypical cases • Know why PE is missed • Make your chart bullet proof

  5. Why is the diagnosis delayed or missed? • Not considering the diagnosis • Presentation too atypical • PE looks like many diseases • The obvious miss • Misinterpretation of studies • Reliance on normal VS

  6. Elevated troponin • Not just in MI !!! • Myocarditis, tachycardia • CHF, pericarditis, stroke, sepsis • Pulmonary embolism

  7. Who do we miss the diagnosis in? • Obese females on OCP • Patients with medical comorbidities

  8. The Pulmonary Embolism Rule-Out Criteria (PERC) rule • Less than 2% chance of PE if clinician pre-test probability < 15% and all of the following: • Age < 50 • HR < 100 • SpO2 > 96% • No unilateral leg swelling • No hemoptysis • No recent trauma • No h/o VTE/PE • No OCP/exogenous estrogen use

  9. PE myths • All patients with PE are tachycardic • About 50% • Hypoxia is usually present • Most patients have risk factors • 20-25 % with risk factors • Classic presentation common

  10. Protective documentation • Thought process • Leg exam, Homan’s sign • Risk factor analysis • Clinical gestalt • Clinical decision rule

  11. The chart • Any patient with cardiopulmonary symptoms • VTE risk factors • Attention to the VS • Leg exam • Evidence that you thought about VTE

  12. Epidemiology • PE is common • 600,000-900,000 patients annually in US • PE has high morbidity and mortality • Mortality rate 10 – 17.5% overall • Likely responsible for over 50,000 deaths annually • Optimal management can improve these outcomes

  13. Questions for Discussion • Which is the optimal form of heparin to be used in the treatment of PE? • Do all patients with a new diagnosis of PE need to be admitted? • When are thrombolytics indicated in the management of PE?

  14. Which is the optimal form of heparin to be used in the treatment of PE? • Options for bridging anticoagulation in acute PE • Unfractionated heparin (UFH) • Low-molecular weight heparin (LMWH) • LMWH has multiple potential advantages over UFH • Use of LMWH for most patients is standard of care and recommended by multiple professional societies

  15. Evidence Supporting Use • Multiple RCTs have established efficacy and safety between LMWH and UFH for the treatment of PE • 3 month recurrence of VTE: 3.0% vs. 4.4 % (NS) • Major bleeding: 1.3% vs. 2.1 % (NS)

  16. Other Considerations • LMWH is renally cleared – use with caution with poor renal function • UFH preferred in hemodynamically unstable patients, especially if considering thrombolysis • No clear difference in efficacy or safetey when comparing once a day (1.5 mg/kg) vs. twice a day (1 mg/kg) dosing regimens

  17. Do all patients with a new diagnosis of PE need to be admitted? • Current standard of care is outpatient management for DVT • 30-40% of patients with DVTs have been found to have asymptomatic PEs • Although DVT and PE have different outcomes, they exist on the same spectrum of disease (VTE) • Likely there is some group of low-risk patients with PE that can be managed similarly to DVT

  18. Aujesky et al 2011 • Open-label, multi-center, international, non-inferiority, RCT • 339 adult patients with confirmed acute PE randomized to inpatient vs. outpatient management • Outpatients treated with 1 mg/kg LMWH BID until INR > 2.0 for > 2 days • Primary end-point was recurrent VTE • Secondary end-points included • Major bleeding • All cause mortality

  19. Inclusion/Exclusion Pulmonary Embolus Severity Score of I or II (<86 points) • Patients excluded if any of the following • O2 sat < 90% • SBP < 100 mmHg • Chest pain requiring IV opiates • Active bleeding • Stroke within 10 days • GI bleed within 14 days • < 75,000 platelets • Cr Clearance < 30 • Extreme obesity (>150 kg) • History of HIT • Already being treated with oral anticoagulant • Any barriers to follow up

  20. Outcomes *P-value represents one-sided p-value for non-inferiority

  21. Erkens et al 2010 • Retrospective cohort study of consecutive patients with confirmed acute PE • Decision for outpatient treatment by treating physician based on hospital protocol • SPB > 100 mmHG • O2 sat > 92% • No contraindication to LMWH • Does not need admission for other reasons • Outpatients treated with LMWH • Patient followed-up at 14 days and 90 days

  22. Outcomes

  23. Are there other factors that can help risk stratify patients? • Troponin is a predictor of complicated clinical course or death • NPV for death 96-97% • NPV for complicated clinical course 92-94% • Pro-BNP is a predictor of mortality or adverse outcomes • NPV for death 99% • NPV for adverse outcome 95% • RV dysfunction on CT • NPV for PE related death 100%

  24. Take Home Message • Outpatient management of PE is not common practice currently, but feasible and safe in selected low-risk patients with acute PE • Standard of care is likely to shift in the near future given pressures to lower resource utilization • It is reasonable to offer outpatient management in the patient with low PE severity index, normal BP, normal O2 sats, normal EKG, normal troponin, normal pro-BNP, and no evidence of RV dysfunction • An informed discussion with the patient and careful documentation are necessary to attempt this approach

  25. When are thrombolyticsindicated in the management of PE? • Risk of Bleeding with Thrombolysis in PE • Fatal Hemorrhage: 0.5 % • Intracranial Hemorrhage : 1.8-3.0 % • Major Hemorrhage: 9-13 % • Potential Benefits of Decreasing • Mortality • PE recurrence • Pulmonary Hypertension • In-Hospital Complications

  26. Differences in Outcomes • The mortality of patients with PE vary depending on the clinical circumstances • Cardiac Arrest: 66-95% • Massive PE: 22-53% • Submassive PE: 8-13% • Uncomplicated PE: 1-4% • The clinical circumstances should drive decision making with the use of thrombolytics

  27. Contraindications to Fibrinolytics • Active internal bleeding • Recent intracranial bleeding • Intracranial tumor or seizure history • Ischemic stroke within 2 months • Neurosurgery within the past 1 month • Surgery within the past 10 days • Puncture of non-compressible vessel within past 10 days • Trauma within 15 days • Uncontrolled HTN (SBP > 180; DBP > 100) • Hemorrhagic disorder or thrombocytopenia (<100,000) • Impaired hepatic or renal function • GI bleeding within 10 days • Pregnancy

  28. Cardiac Arrest • 10-20% of all PE cases • Dismal outcomes with 66-95% mortality • No RCTs address this clinical scenario • 3 major studies show significant increase in ROSC rate and trend toward increased survival in cardiac arrest • Overall bleeding complication rare is low when used in cardiac arrest • Multiple professional societies have supported use of thrombolytics in this clinical situation

  29. Bottiger et al 2001 • 90 patients with out-of-hospital cardiac arrest undergoing CPR without ROSC within 15 minutes • 40 patients received 50 mg tPA and 5000 U of heparin as bolus vs. 50 patients with standard ACLS • ROSC: 68% vs. 58% (p=0.026) • Survival to ICU admission: 58% vs. 44% (p=0.009) • 24 hr Survival: 35% vs. 22% (p=0.171) • Hospital Discharge: 15% vs. 8% (NS) • No CPR related bleeding complications

  30. Lederer et al 2001 • 324 patients with out-of-hospital cardiac arrest undergoing CPR • 108 received 50 mg tPA as bolus vs. 216 with standard ACLS (retrospective) • ROSC: 70.4% vs. 51.0% (p=0.001) • 24 hr Survival: 48.1% vs. 32.9% (p=0.003) • Hospital Discharge: 25% vs. 15.3% (p=0.048) • Bleeding complications low • ICH 0.9% vs. 0.9% (NS) • Major Hemorrhage 4.6% vs. 2.3% (NS)

  31. Bozeman et al 2006 • 163 patients in cardiac arrest undergoing CPR not responding to standard ACLS (prospective) • 50 received 30-50 mg tPA bolus vs. 113 controls with standard ACLS • ROSC: 26% vs. 12.4% (p=0.04) • Survival to ICU admission: 12% vs. 0% (p=0.0007) • 24 hr Survival: 4% vs. 0% (NS) • Hospital Discharge: 4%vs. 0% (NS) • 1 patient with ICH in tPA group (2%)

  32. Take Home Message • Although not definitely studied in patients with PE, likely benefit > risk to giving tPA in cardiac arrest with PE is suspected cause • Consider historical factors or bedside ultrasonography to guide decision making • When given, administer 50 mg tPA and 5000 U UFH as IV bolus • May repeat if no ROSC after 15 minutes • If ROSC occurs, start continuous infusion of UFH at 18 U/kg/hr

  33. Massive PE • 5% of all PE cases • Mortality 22-53% • 5 RCTs that included hemodynamically unstable patients suggest benefit • Meta-analysis of RCTs showed significant benefit • 2 retrospective studies show trend to benefit • Bleeding complications low in selected patients • Multiple professional societies recommend use of thrombolytics in this scenario

  34. Wan et al 2004 • Meta analysis of 11 RCTs comparing thrombolysis + heparin vs. heparin alone • Subgroup analysis of 5 RCTs that included hemodynamicallyunstable patients • 128 patients received thrombolysis, 126 received heparin alone • Efficacy Outcomes • Mortality: 6.2% vs. 12.7% (NS) • Recurrent PE: 3.9% vs. 7.1% (NS) • Recurrent PE or Death: 9.4% vs. 19% (p<0.05) • Bleeding outcomes: 21.9% vs. 11.9% (p=0.05)

  35. Take Home Message • Data regarding benefit not definitive, but benefit:risk ratio likely to support use in hemodynamically unstable patients • Consider use in select patients with CONFIRMED PE and hemodynamic instability keeping in mind patient risk for bleeding complications • When given, infuse 10 mg tPA as bolus followed by 90 mg infusion over 2 hours • Should be followed by 80 U/kg bolus of heparin followed by 18 U/kg/hr infusion

  36. Submassive PE • 23-40% of all PE cases • Increased mortality when compared to hemodynamically stable patients without RV dysfunction (9.3% vs. 0.4%) • Multiple studies have definitely shown improvement in hemodynamic or radiographic parameters, though improvement in clinical outcomes remains mixed

  37. Take Home Message • Treatment of patients with submassive PE with thrombolytics is highly controversial • Current evidence is conflicting and filled with multiple flaws • Use of thrombolytics in this situation does not carry overall support from professional societies and is not standard of care • Use of thrombolytics may be considered in select patients with support from sub-specialists

  38. Future Directions • The Pulmonary EmbolIsmTHrOmbolysis (PEITHO) trial is a multi-center international RCT (double-blinded, placebo controlled) currently underway • Includes patients with • Confirmed acute PE • RV dysfunction on Echo or CT chest • Elevated Troponin • Treatment Protocol • Thrombolysis Group: tPA + UFH • Control Group: UFH only • Outcomes • Primary: Composite of Death or Hemodynamic Collapse < 7 days • Secondary: Death, Hemodynamic Collapse, Recurrent PE, ICH, Major Bleeding

  39. Follow-up on Initial Questions • Which is the optimal form of heparin to be used in the treatment of PE? • LMWH in most cases • Do all patients with a new diagnosis of PE need to be admitted? • There may be a group of very low risk patients that can be managed primarily as outpatients • When are thrombolytics indicated in the management of PE? • Clearly indicated in cardiac arrest from PE and massive PE without contraindication to fibrinolytics • Utility in submassive PE unclear • Not indicated in uncomplicated PE

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