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Ultrasound Assisted Thrombolysis for Massive and Submassive Pulmonary Embolism

Ultrasound Assisted Thrombolysis for Massive and Submassive Pulmonary Embolism. Scott M Lilly, MD PhD Interventional Cardiology Fellows School August 15 th , 2014. Acknowledgements . Peter Bittenbender , MD Ray Magorien , MD Michael Bray, EKOS Corporation. Outline .

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Ultrasound Assisted Thrombolysis for Massive and Submassive Pulmonary Embolism

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  1. Ultrasound Assisted Thrombolysis for Massive and Submassive Pulmonary Embolism Scott M Lilly, MD PhD Interventional Cardiology Fellows School August 15th, 2014

  2. Acknowledgements • Peter Bittenbender, MD • Ray Magorien, MD • Michael Bray, EKOS Corporation

  3. Outline • Background and Definitions • How to Determine Risk • Treatment of High Risk patients • Practical Points and Program Experience

  4. Background and Definitions • 300k-600k per year • 1-2 per 1000 people, or as high as 1 in 100 if > 80 • 10-30% overall 30 day mortality • Sudden death is presenting symptom in ~ 25% • 2012: 166,665 primary admissions for PE • In-hospital mortality ~ 3% • Most commonly from lower extremity DVT • Evidence of DVT in > 50% cdc.gov; Agency for Healthcare Research and Quality

  5. Background and Definitions • RV dysfunction • RV/LV ratio > 0.9 or RV systolic dysfunction on echo • RV/LV ratio > 0.9 on CT • Elevation of BNP (>90 pg/mL) • Elevation of NTpro-BNP (>500 pg/mL) • ECG changes: • new complete or incomplete RBBB • anteroseptal ST elevation or depression • anteroseptal T-wave inversion RV LV Jaff et al. Circulation 2011;123(16):1788-1830. Jaff et al. Circulation 2011;123(16):1788-1830.

  6. Background and Definitions Massive PE [High risk] 5% PE population Massive PE [High risk] 5% PE population Minor PE [Low risk] 55% PE population Minor PE [Low risk] 55% PE population Submassive PE [Moderate risk] 40% PE population

  7. Outline • Background and Definitions • How to Determine Risk • Treatment of High Risk patients • Practical Points and Program Experience

  8. How to Determine Risk ? Mortality In hospital ~ 25% (MAPPET) 90-day ~ 50% (ICOPER) Jaff et al. Circulation 2011;123(16):1788-1830.

  9. How to Determine Risk Jaff et al. Circulation 2011;123(16):1788-1830.

  10. How to Determine Risk • Registry of 1,416 patients • Mortality rate: 1.9% if RV/LV ratio < 0.9 6.6% if RV/LV ratio ≥ 0.9 Fremont et al. CHEST 2008;133:358-362

  11. How to Determine Risk • Retrospective analysis of 120 patients with hemodynamically stable PE based on chest CT • PE-related mortality at 3 months: • 17% if RV/LV ≥ 1.5 • 8% if 1.0 ≤ RV/LV < 1.5 • 0% if RV/LV < 1.0 Van der Meer et al. Radiology 2005; 235:798-803.

  12. How to Determine Risk • Retrospective analysis of 63 patients with chest CT • Adverse event rate at 30 days: • 80.3% if RV/LV ratio > 0.9 • 51.3%if RV/LV ratio ≤ 0.9 Quiroz et. al. Circulation. 2004;109:2401-2404

  13. Risk Stratification *ACC/AHA Guidelines 2011 Circulation 2006;113:577-82

  14. Outline • Background and Definitions • How to Determine Risk • Treatment of High Risk patients • Practical Points and Program Experience

  15. Treatment of High Risk patients 20% risk of major bleeding 3% risk of intracranial hemorrhage *ACC/AHA Guidelines 2011 Circulation 2006;113:577-82

  16. Treatment of High Risk patients *ACC/AHA Guidelines 2011 Circulation 2006;113:577-82

  17. Treatment of High Risk patients

  18. Treatment of High Risk patients Status of Trials

  19. Treatment of High Risk patients The ULTIMA TrialA Prospective, Randomized, Controlled Study of Ultrasound Accelerated Thrombolysis for the Treatment of Acute Pulmonary Embolism Annual Meeting of the American College of Cardiology, March 9, 2013

  20. Treatment of High Risk patients The ULTIMA Trial ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism Hypothesis: Ultrasound-assisted, catheter-directed thrombolysis is superior to treatment with heparin alone for reversing RV enlargement within 24 hours 22

  21. Treatment of High Risk patients The ULTIMA Trial Enrollment Criteria • Symptoms < 14 days • No hemodynamic collapse at presentation • No active bleeding • Acute symptomatic PE confirmed by contrast-enhanced chest CT with embolus located in at least one main or proximal lower lobe pulmonary artery • RV/LV ratio > 1 on echocardiography

  22. Treatment of High Risk patients The ULTIMA Trial Nils Kutcher, ACC.13 24

  23. Treatment of High Risk patients The ULTIMA Trial 1 1 1 1 • Pulmonaryocclusion score1 • Multiply score pointsfor non-occlusiveembolusbyone • Multiply score pointsforocclusiveembolusbytwo • Maximum score is 40. 1 1 3 3 10 10 1 1 2 2 20 5 5 1 1 1 1 1Qanadli Am J Roentgenology 2001;176:1415-20 1 1 1 1 1 1 1 1 1 Nils Kutcher, ACC.13 25

  24. Treatment of High Risk patients The ULTIMA Trial Nils Kutcher, ACC.13 26

  25. Treatment of High Risk patients RV/LV Ratio (Echocardiography) The ULTIMA Trial Heparin Alone EKOS + Heparin Nils Kutcher, ACC.13 27

  26. Treatment of High Risk patients The ULTIMA Trial Right Ventricular Dysfunction Nils Kutcher, ACC.13

  27. Treatment of High Risk patients The ULTIMA Trial • rehospitalization and death from advanced pancreatic cancer • ** two patients with transient mild hemoptysis without medical intervention, • one patient with groin hematoma requiring manual compression • § one patient with transient anal bleeding following endoscopic removal of colon polyp 29

  28. Systemic Lytics vs EKOS

  29. Treatment of High Risk patients The SEATTLE II Trial A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism (SEATTLE II)

  30. Treatment of High Risk patients The SEATTLE II Trial A prospective, single-arm, multicenter trial to: Evaluate the efficacy of ultrasound-facilitated, catheter-directed low-dose fibrinolysis to reverse RV dysfunction as measured by CT-determined RV/LV diameter ratio in patients with acute massive and submassive PE Assess the safety of ultrasound-facilitated, catheter-directed low-dose fibrinolysis in patients with acute massive and submassive PE

  31. Treatment of High Risk patients The SEATTLE II Trial Main Inclusion Criteria: • Proximal PE on CT (filling defect in ≥ 1 main, lobar, or segmental pulmonary artery) AND • Age ≥ 18 years AND • PE symptom duration ≤ 14 days AND • Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR • Submassive PE (RV/LV diameter ≥ 0.9 on contrast-enhanced chest CT) Main Exclusion Criteria: • Stroke/TIA, head trauma, or intracranial or intraspinal disease within 1 year • Active or recent (within 1 month) bleeding from a major organ • Major surgery within 7 days • Hematocrit < 30%, platelets < 100k/μL, INR > 3, aPTT > 50 seconds on no anticoagulation • Serum creatinine > 2 mg/dL • Clinician-determined high-risk for catastrophic bleeding • Hemodynamic instability despite medical therapy • Pregnancy

  32. Treatment of High Risk patients The SEATTLE II Trial

  33. Treatment of High Risk patients The SEATTLE II Trial *N = 150 patients (1 patient died before devices could be placed) **N = 285 devices attempted ***N = 278 devices placed

  34. Treatment of High Risk patients The SEATTLE II Trial *Patients could have received more than one anticoagulant.

  35. Treatment of High Risk patients The SEATTLE II Trial RV to LV Ratio

  36. Treatment of High Risk patients The SEATTLE II Trial p = 0.31 p = 0.61 0.51 14.3 0.43 12.6

  37. Treatment of High Risk patients The SEATTLE II Trial *All death, serious adverse, and bleeding events were adjudicated by an independent safety monitor. **N = 149 (1 patient lost to follow-up)

  38. Treatment of High Risk patients The SEATTLE II Trial

  39. Treatment of High Risk patients Lysisvs Placebo 13 placebo controlled, randomized trials of lysisvs placebo Minority for massive PE, total 480 patients. Variable drugs, dosing, timing and adjunctive therapies No independent mortality effect Meta-analyses reduction in death/recurrent PE Improvement in RV size/function, mPA pressures EKOS v Heparin No study large enough to evaluate death/recurrent PE Improved RV size/function at 24hrs, catch up at 90days Improved RV function at 90 days Status of Trials

  40. Outline • Background and Definitions • How to Determine Risk • Treatment of High Risk patients • Practical Points, Program Experience

  41. Who is an EKOS Candidate? Large, Central PE – symptoms <14 days SBP<90 (not responsive to fluids) Need for inotrope HR<40 w/ s/s Shock PEA (after return of circulation) RV:LV ratio > 1.0 (CTPE) RV:LV ratio > 1.0 (TTE) Signs of RV dysfxn (TTE) MASSIVE SUBMASSIVE Activate a PE Alert by dialing the Transfer Center Hotline phone number: 366-8111

  42. The PE Guideline is Located on One Source Listed under “Venous Thromboembolism” 44

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