Can Comparative Effectiveness Study Tell Us
What Is The Best TherapyFor Class IV Heart Failure?
Beta blockers or LVADs?
85% 18 mo40% 18 mo
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?
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
% Pts 6 Mo SurvProportion
Crash and burn
46%0.71
Sliding fast 40%0.74
Stable on inotropes
8%0.88
Resting symptoms home on oral therapy
6%
0.77
All VADS 2006-2007Pagani at al ISHLT2008
INTERMACS Profiles and VAD Survival
Months post implant
% S
urvi
val
Level 1: n=1391Deaths=381
Level 2: n=3601Deaths=942
Level 3: n=2591Deaths=544
Levels 4-7, n=1789Deaths=405
P < .0001
Event: Death (censored at transplant and recovery)
Figure 10
7
Continuous Flow LVAD/BiVAD Implants: 2008 – 2013, n=9372
We do need a mechanicaloption before transplantationFor INTERMACS 1 and 2
AVERAGE WAIT TIME FOR URGENT PATIENTS = 5 days!
PROFILE-LEVEL Official Shorthand % Profiles
In Bridge
INTERMACS
LEVEL 1
“Crash and burn” 18%
INTERMACS
LEVEL 2
“Sliding fast” on ino 42%
INTERMACS
LEVEL 3
Stable but Ino-Dependent
Can be hosp or home
23%
INTERMACS
LEVEL 4
Resting symptoms on oral therapy at home.
12%
INTERMACS
LEVEL 5
“Housebound”,
Comfortable at rest, symptoms with minimum activity ADL
3%
INTERMACS
LEVEL 6
“Walking wounded”-ADL possible but meaningful activity limited
2%
INTERMACS
LEVEL 7
Advanced Class III
Profile 4Oral Rx home
Profile 5
Profile 6
Profile 7
How many surgeriesdo Profile 3-4 ptsreally need?
Tx after VADIs better
Tx alonebetter
Patients need supportto survive and thrivefor transplant .
When and whatintervention isfor housebound orwalking wounded?
Dead 12%
Alive (device in place) 50%Transplanted 37%
Recovery 1%
10Figure 6
Decreasing eligibility for listed pts after VAD
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?
Intermacs Profile Levels EvolveCardiac Filling Pressures Over Time
0
2
4
6
8
10
12
14
16
18
Level 1 Level 2 Level 3 Level 4
2006-102011-13
Central Venous PressureNo change in
Cardiac Index:Every level Both eras
Mean 2.1
PA Systolic PressureEvery level Both erasMean about 50 mm
Slight change in PCWBoth eras:
Level 1= 26, Level 2= 25Level 3-4 = 24 previous
= 23, 22 mm now
Intermacs and MedaMACS Cardiac Filling Pressures Over Time
0
2
4
6
8
10
12
14
16
18
Level 1 Level 3 MedaMACS
2006-102011-13
Central Venous Pressure
Intermacs and MedaMACSSystolic Blood Pressure at Implant
90
95
100
105
110
115
Level 1 Level 3 MedaMACS
2006-102011-13
Intermacs and MedaMACSSerum Creatinine Levels
11.11.21.31.41.51.61.71.81.9
2
Level
1
Level
2
Level
3
Level
4
Med
aMACS
2006-102011-13
Intermacs and MedaMACS Natriuretic Peptide Levels
0
200
400
600
800
1000
1200
Level 1 Level 3 MedaMACS
2006-102011-13
BNP Levels (Similar for NT Pro BNP
Intermacs and MedaMACSAlbumin Levels
0
0.5
1
1.5
2
2.5
3
3.5
4
Level 1 Level 3 MedaMACS
2006-102011-13
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?
What Is Likelihoodthat MedaMACS Patient
Would Need BiVAD if VAD?
Uncertain
Definite orprobable BiVADDefinite LVADOnlyProbably LeftOnly
What Is Likelihoodthat MedaMACS Patient
Would Be Transplant-Eligible?
Uncertain
Moderately orHighly UnlikelyHighly likely
ModeratelyLikely
Profiles for ComparisonLimits of Adjustment
EQ
-5D
VA
S
Pre-Implant 3 month 6 month
Months Post Implant
Best
Worst
EQ5D Visual Analog Scale (VAS) across time (± SE)
Figure 14
22
Continuous Flow LVAD/BiVAD implants: 2008 – 2013, n= 9372
12 month 18 month 24 month
Implant Eras
P values < .0001 .05 .07 .12 .48 .65
?
MedaMACS
More or less benefit?
?
INTERMACS and MedaMACS Are Not Two Arms of a Study
That requires
REMATCH
REVIVE IT
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”
