Major Medical Decisions in
Advanced Heart Failure
G. Michael Felker, MD, MHS, FACC, FAHA
Chief, Heart Failure Section
Duke University School of Medicine
Disclosures
• Grant Support and/or Consulting
–
–
–
–
–
–
–
–
–
NIH/NHLBI
Novartis
Amgen
Trevena
Roche Diagnostics
Otsuka
Celladon
St Judes
Singulex
Allen, LA et al. Circulation, 2012
Variable Clinical Course of Heart Failure
Allen L A et al. Circulation 2012
Defining Options
 Medical decision making is not a menu where the
patient choses from among all available treatment
options
 Clinicians are responsible for defining the range of
medically appropriate options.
 Presentation of options should include:
 alternative approaches
 range of anticipated outcomes, including QoL
 “what if?” scenarios
Typical Medical Decisions in
Advanced Heart Failure
• Should we place an ICD?
• Should we list for heart transplant?
• Should we place a ventricular assist
device as destination therapy?
• Should we involve palliative care?
ICDs in Chronic HF
30.0%
Control
Therapy
28.8%
P=0.007
% Mortality
25.0%
20.0%
22.0%
19.8%
P=0.016
19.0%
P=0.004
14.2%
15.0%
12.0%
14.1%
P=0.065
7.9%
10.0%
5.0%
0.0%
MADIT II
COMPANION
HF Etiology
Ischemic: 100%
Ischemic:59%
Non-ischemic:41%
NYHA Class
I/II/III
(35%/35%/30%)
III/IV
(87%/13%)
I/II/III
(20%/60%/20%)
II/III
(71%/29%)
< 30%
< 35%
< 35%
< 35%
1232
1520
458
2521
2 months
12 months
24 months
45 months
17
14
17
14
0.69
0.64
0.66
0.77
LVEF
No. Pts
Follow-Up
NNT
Hazard Ratio
DEFINITE
Non-ischemic:
100%
SCD-HeFT
Ischemic: 52%
Non-ischemic:48%
Device Therapy for Stage C HFrEF
I IIa IIb III
ICD therapy is recommended for primary prevention of SCD to
reduce total mortality in selected patients with nonischemic DCM
or ischemic heart disease at least 40 days post-MI with LVEF of
35% or less, and NYHA class II or III symptoms on chronic
GDMT, who have reasonable expectation of meaningful survival
for more than 1 year.
I IIa IIb III
ICD therapy is recommended for primary prevention of SCD to
reduce total mortality in selected patients at least 40 days postMI with LVEF less than or equal to 30%, and NYHA class I
symptoms while receiving GDMT, who have reasonable
expectation of meaningful survival for more than 1 year.
Device Therapy for Stage C HFrEF
I IIa IIb III
The usefulness of implantation of an ICD is of uncertain
benefit to prolong meaningful survival in patients with a
high risk of nonsudden death as predicted by frequent
hospitalizations, advanced frailty, or comorbidities such as
systemic malignancy or severe renal dysfunction.
*Counseling should be specific to each individual patient and should include
documentation about the potential for sudden death and non-sudden death from HF or
non-cardiac conditions. Information should be provided about the efficacy, safety, and
potential complications of an ICD and the potential for defibrillation to be inactivated if
desired in the future, notably when a patient is approaching the end of life.
Primary Prevention ICD in context
• Out of 100 patients with an ICD implanted for
primary prevention and followed for 4 years:
– 70 will never receive a shock
– Of the 30 who do receive a shock, 13 of those shocks will
be inappropriate
– 17 will have an appropriate shock that prevents SCD
– 10 of those pts will go onto die of something else
– 7 lives will be saved by implanting an ICD
• 14 ICD’s will be implanted to save 1 life (NNT = 14)
Extrapolated from SCD-HeFT results
ICD Take Home Message
• ICD clearly improve survival in well defined groups
of patients with heart failure
• Data on ICD therapy in patients with more advanced
HF is very limited
• Important limitations of ICD therapy
– ICDs do not improve symptoms or QOL
– ICDs may decrease QOL (frequent shocks)
– ICDs are designed to identify and treat a specific type of
mortal event (ventricular tachy-arrhythmias)
Typical Medical Decisions in
Advanced Heart Failure
• Should we place an ICD?
• Should we list for heart transplant?
• Should we place a ventricular assist
device as destination therapy?
• Should we involve palliative care?
ADULT HEART TRANSPLANTS
Kaplan-Meier Survival by Era
(Transplants: January 1982 - June 2010)
100
1982-1992 vs. 1993-2002: p < 0.0001
1982-1992 vs. 2003-6/2010: p <0.0001
1993-2002 vs. 2003-6/2010: p <0.0001
Survival (%)
80
60
1982-1992 (N = 25,138)
1993-2002 (N = 37,193)
40
2003-6/2010 (N = 24,021)
20
HALF-LIFE 1982-1992: 8.5 years; 1993-2002: 10.9 years; 2003-6/2010: NA
0
0
1
2
3
4
5
6
7
8
9
Years
ISHLT
2012
J Heart Lung Transplant. 2012 Oct; 31(10): 1045-1095
10
11
12
13
14
15
POST-HEART TRANSPLANT MORBIDITY FOR ADULTS
Cumulative Morbidity Rates in Survivors within 1, 5 and 10 Years PostTransplant (Follow-ups: January 1995 – June 2011)
Within
1 Year
Total N with
known
response
Within
5 Years
Total N with
known
response
Hypertension*
72.8%
(N = 25,542)
92.6%
(N = 11,853)
–
Renal Dysfunction
26.7%
(N = 27,478)
53.0%
(N = 13,481)
68.2%
Outcome
Total N
Within
with known
10 Years
response
18.3%
33.2%
37.5%
Creatinine > 2.5 mg/dl
6.6%
15.8%
21.1%
Chronic Dialysis
1.5%
2.9%
6.1%
Renal Transplant
0.3%
1.2%
3.6%
Abnormal Creatinine < 2.5 mg/dl
Hyperlipidemia*
60.2%
(N = 26,810)
88.0%
(N = 13,191)
–
Diabetes*
26.5%
(N = 27,474)
38.0%
(N = 13,306)
–
Cardiac Allograft Vasculopathy
7.9%
(N = 24,790)
30.4%
(N = 9,819)
49.7%
ISHLT
2012
J Heart Lung Transplant. 2012 Oct; 31(10): 1045-1095
(N = 4,339)
(N = 2,482)
* Data are not available 10 years post
transplant
Cardiac Transplantation
I IIa IIb III
Evaluation for cardiac transplantation is indicated
for carefully selected patients with stage D HF
despite GDMT, device, and surgical
management.
Cardiac Transplantation Evaluation
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Complete history and physical examination
CBC, BMP, LFT, coags, UA
Serologic testing for syphilis, HIV, hepatitis B & C,
CMV,EBV, VZV, toxo
Tb skin testing
ABO, HLA typing, panel reactive antibody screening
12 lead ECG
Echocardiogram
Chest xray
Cardiopulmonary exercise testing
Right heart catheterization with vasodilator challenge if
appropriate
Age appropriate cancer screening
PFTS
Carotid ultrasound
VQ scan
Dental evaluation
Psychosocial evaluation
Social work evaluation
Nutrition consult
Financial Evaluation
Transplant is Epidemiologically Trivial
300 million
2.6% w/ HF (7 milllion)
50% sys HF
25% NYHA III
5% NYHA IV (150200K)
10% NYHA IIIB (300350K)
IIIB+IV (250-300K) [<75
yrs]
~2300 transplant/year
Miller LW. Circulation 2011
Typical Medical Decisions in
Advanced Heart Failure
• Should we place an ICD?
• Should we list for heart transplant?
• Should we place a ventricular assist
device as destination therapy?
• Should we involve palliative care?
Improving Survival with Continuous Flow LVAD
100
90
HM II BTT Starling JACC 2011
Percent Survival
80
HM II BTT Pagani JACC 2009
70
HM II BTT Miller NEJM 2007
60
HM II DT Slaughter NEJM 2009
50
40
VE DT LVAD REMATCH Rose NEJM 2001
30
XVE DT LVAD Slaughter NEJM 2009
20
Novacor DT LVAD INTrEPID Rogers JACC 2007
10
OMM REMATCH Rose NEJM 2001
OMM INTrEPID Rogers JACC 2007
0
0
6
12
Months
18
24
Improvement in Functional
Capacity with Mechanical Support
Rogers, JG et al. JACC 2010
Changing Landscape of Mechanical Support
Stewart and Stevenson. Circulation 2011;123:1559-68.
Landscape of potential VAD patients
AHA/ACC
classification
NYHA
classifications
Stage C
Class III
INTERMACS
Profiles
Stage D
Class IIIb/IV
7
6
Class IV
5
Range of HM II DT Approval and CMS Coverage
4
3
2
Approved
General Range of Market Adoption
Not Broadly Adopted
Generally Accepted
Ambulatory Class IIIB and IV
INTERMACS 6: Walking
Wounded
INTERMACS 5: Exertion
intolerant
INTERMACS 4: Resting
symptoms on oral therapy
at home
Less Sick
ROADMAP
Sick
1
Limitations of of LVAD Therapy
•
•
•
•
•
•
•
Right heart failure
Pump thrombosis
Stroke
Recurrent GI bleeding
Arrhythmias
Aortic insufficiency
Drive line infections
Mechanical Circulatory Support
I IIa IIb III
MCS use is beneficial in carefully selected* patients with
stage D HFrEF in whom definitive management (e.g.,
cardiac transplantation) or cardiac recovery is anticipated
or planned.
I IIa IIb III
Nondurable MCS, including the use of percutaneous and
extracorporeal ventricular assist devices (VADs), is
reasonable as a “bridge to recovery” or a “bridge to
decision” for carefully selected* patients with HFrEF with
acute, profound hemodynamic compromise.
I IIa IIb III
Durable MCS is reasonable to prolong survival for carefully
selected* patients with stage D HFrEF.
Re-hospitalizations after LVAD
Total Readmissions
Hospital Days
Smedira, N. et al. JACC-Heart Failure, 2013
The Importance of Frailty Patient Selection for
Advanced Heart Failure Therapy
Flint, KM. Circ Heart Fail 2012;5:286-93
“…it is challenging to locate the
intersection of patients who face high
mortality without LVAD and yet can look
forward to good outcomes with LVAD.”
Stewart and Stevenson. Circulation 2011.
LVAD Take Home
• Destination LVAD therapy can provide substantial
improvement in survival and functional capacity in
selected patients with advanced heart failure
• It is also associated with a multiple major morbidities
and a high risk of unplanned rehospitalization
• Patient selection with attention to those
comorbidities likely to be improved by VAD therapy
vs. those not is key
Other Important Considerations
• Even non-cardiac procedures may lead to
progressive heart failure and cardiogenic shock
• Many ‘temporary’ forms of support may be
associated with failure to wean and ‘dependence’
–
–
–
–
Cardiopulmonary bypass
Inotropic therapy
IABP
Mechanical Ventilation
• Need for discussion of “what if” outcomes where
feasible in advance
Typical Medical Decisions in
Advanced Heart Failure
• Should we place an ICD?
• Should we list for heart transplant?
• Should we place a ventricular assist
device as destination therapy?
• Should we involve palliative care?
Palliative Care is:
• Specialized medical care for people with serious illness
• Relief from symptoms, pain and stress – whatever the
diagnosis
• Improve quality of life for both patient and family
• A team that provides an extra layer of support
• Appropriate at any age and at any stage of illness
– Can be provided together with curative treatment
Diagnosis of Serious
Illness
Palliative Care Models
End of
Life
Life Prolonging Care
Life Prolonging
Care
Palliative Care
Medicare
Hospice
Benefit
Hospice Care
Old
New
Shared Decision Making
“The process through
which clinicians and
patients share information
with each other and work
toward decisions about
treatment chosen from
medically reasonable
options aligned with
patients’ values, goals,
and preferences.”