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Can Comparative Effectiveness Study Tell Us What Is The Best Therapy For Class IV Heart Failure?

Can Comparative Effectiveness Study Tell Us What Is The Best Therapy For Class IV Heart Failure?. Beta blockers or LVADs?. 85% 18 mo. 40% 18 mo. Triage Guided By INTERMACS Profiles. Importance of comparing a fruit to a fruit Shifting away from Profile 1 over time

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Can Comparative Effectiveness Study Tell Us What Is The Best Therapy For Class IV Heart Failure?

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  1. Can Comparative Effectiveness Study Tell UsWhat Is The Best TherapyFor Class IV Heart Failure? Beta blockers or LVADs?

  2. 85% 18 mo 40% 18 mo

  3. Triage Guided By INTERMACS Profiles • Importance of comparing a fruit to a fruit • Shifting away from Profile 1 over time • Device before Transplant vs Direct Transplant without Device vs Device Only • Evolution of INTERMACS Profiles • INTERMACS patients compared to MedaMACS • Line up by disease severity • Line up by intent • Transplant eligibility • Likelihood of RV failure? • Patient preferences?

  4. REMATCH “Class IV” • 19 unstable on > 2 inotropic agents • 8 patients on 2 agents, couldn’t wean first agent • 3 patients unsuccessful switch of one agent for another • 34 unsuccessful wean due to hypotension or increased dyspnea • 27 met VO2 < 12 criterion on inotropic therapy and did not attempt wean • 38 patients oral therapy only met PkVO2 criteria

  5. INTERMACS Profiles and VAD Survival All VADS 2006-2007 Pagani at al ISHLT 2008

  6. Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372 Levels 4-7, n=1789 Deaths=405 Level 1: n=1391 Deaths=381 Level 3: n=2591 Deaths=544 % Survival Level 2: n=3601 Deaths=942 P < .0001 Event: Death (censored at transplant and recovery) Months post implant Figure 10

  7. We do need a mechanical option before transplantation For INTERMACS 1 and 2 AVERAGE WAIT TIME FOR URGENT PATIENTS = 5 days!

  8. Patients need support to survive and thrive for transplant . Tx after VAD Is better How many surgeries do Profile 3-4 pts really need? Tx alone better Profile 4 Oral Rx home When and what intervention is for housebound or walking wounded? Profile 5 Profile 6 Profile 7

  9. Decreasing eligibility for listed pts after VAD Alive (device in place) 50% Transplanted 37% Dead 12% Recovery 1% Figure 6

  10. Triage Guided By INTERMACS Profiles • Importance of comparing a fruit to a fruit • Shifting away from Profile 1 over time • Device before Transplant vs Direct Transplant without Device vs Device Only • Evolution of INTERMACS Profiles • MedaMACS compared to INTERMACS patients • Line up by disease severity • Line up by intent • Transplant eligibility • Likelihood of RV failure? • Patient preferences?

  11. Intermacs Profile Levels EvolveCardiac Filling Pressures Over Time Central Venous Pressure No change in Cardiac Index: Every level Both eras Mean 2.1 PA Systolic Pressure Every level Both eras Mean about 50 mm Slight change in PCW Both eras: Level 1= 26, Level 2= 25 Level 3-4 = 24 previous = 23, 22 mm now

  12. Intermacs and MedaMACS Cardiac Filling Pressures Over Time Central Venous Pressure

  13. Intermacs and MedaMACSSystolic Blood Pressure at Implant

  14. Intermacs and MedaMACSSerum Creatinine Levels

  15. Intermacs and MedaMACS Natriuretic Peptide Levels BNP Levels (Similar for NT Pro BNP

  16. Intermacs and MedaMACSAlbumin Levels

  17. Triage Guided By INTERMACS Profiles • Importance of comparing a fruit to a fruit • Evolution of INTERMACS Profiles • Device before Transplant vs Direct Transplant without Device vs Device Only • MedaMACS compared to INTERMACS patients • Line up by disease severity • Line up by intent • Transplant eligibility • Likelihood of RV failure? • Patient preferences?

  18. What Is Likelihoodthat MedaMACS Patient Would Need BiVAD if VAD?

  19. What Is Likelihoodthat MedaMACS Patient Would Be Transplant-Eligible?

  20. Profiles for ComparisonLimits of Adjustment

  21. Continuous Flow LVAD/BiVAD implants: 2008 – 2013, n= 9372 EQ5D Visual Analog Scale (VAS) across time (± SE) Best Implant Eras More or less benefit? ? MedaMACS EQ-5D VAS ? Worst Pre-Implant 3 month 6 month 12 month 18 month 24 month P values < .0001 .05 .07 .12 .48 .65 Months Post Implant Figure 14

  22. INTERMACS and MedaMACS Are Not Two Arms of a Study That requires REMATCH REVIVE IT

  23. Triage Guided By INTERMACS Profiles • Importance of comparing a fruit to a fruit • Evolution of INTERMACS Profiles • Triage for transplant and devices • MedaMACS compared to INTERMACS patients • Line up by disease severity • Line up by intent • Transplant eligibility • Likelihood of RV failure? • Patient preferences? • We cannot ever say what would have happened with different therapy: • Our answers will be in the form of “These patients had these outcomes”

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