Can Comparative Effectiveness Study Tell Us What Is The Best Therapy For Class IV Heart Failure?...
-
Upload
gabriel-butler -
Category
Documents
-
view
214 -
download
0
Transcript of 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 TherapyFor Class IV Heart Failure?
Beta blockers or LVADs?
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
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?
?
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”