Advanced Heart Failure: Patient Identification and ... · Advanced Heart Failure: Patient Identification and Treatment Options Donald Haas, MD, MPH Abington - Jefferson Health Abington,
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Advanced Heart Failure: Patient Identification and Treatment
Options
Donald Haas, MD, MPH
Abington - Jefferson Health
Abington, PA
Disclosures
• I have received honoraria from Thoratec Corporation/St. Jude Medical, manufacturer of Heartmate II and Heartmate 3 left ventricular assist devices
• I will not discuss any off label products or devices
Advanced Heart Failure Considerations
• Heart failure is associated with extremely high mortality rates
“Walking Dead”
Among HF outpatients
– One year mortality 20%
– Five year mortality 50%
Among HF inpatients
– One year risk adjusted mortality 30%
Chen J. JAMA 2011;306:1669 Donahoe SM. JAMA 2007;298:765
Among HF outpatients
– One year mortality 20%
– Five year mortality 50%
Among HF inpatients
– One year risk adjusted mortality 30%
Chen J. JAMA 2011;306:1669 Donahoe SM. JAMA 2007;298:765
Heart failure is associated with very high mortality rates
One year mortality among myocardial infarction patients
is only 7%
Five-year Mortality following Hospitalization for ADHF
Shahar E, et al. J Card Fail 2004;10: 2148-59
Perc
en
t su
rviv
al
Survival of Stage D Heart Failure
Patients with Optimal Medical Therapy
Projected Mortality for Advanced Heart Failure
on Par Other Terminal Diseases
0
10
20
30
40
50
60
70
80
90
AIDS Leukemia Lung Cancer Pancreatic Cancer End-stage Heart
Failure with Optimal
Medical Management Diagnosis
Mort
alit
y e
xpecta
tion %
at
One Y
ear
Rose EA, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J
Med. 2001 Nov 15;345(20):1435-43.
Heart Failure: Scope of the Problem
• Estimated 7 million patients with HF 1
• 50% have HFpEF or diastolic HF 1,2
(1) Miller LW, Circulation. 2011;123:1522-58.
(2) AbouEzzeddine OF, et al. Congest Heart Fail. 2011;17:160-8.
(3) Bhatia RS. N Engl J Med. 2006; 355: 260-9.
Pulmonary Hypertension
J Am Coll Cardiol 2012 Jan 17;59(3):222-31. Heart. 2012; 98(24): 1805–1811.
Advanced Heart Failure Considerations
• Heart failure is associated with extremely high mortality rates
• Generally, advanced heart failure do not receive appropriate therapy
Stages of Heart Failure
Jessup M, Brozena S. N Engl J Med. 2003;348:2007-18.
Functional Class
• NYHA Class
– Class I: no functional impairment
– Class II: SOB at moderate exertion
– Class III: SOB at minimal – mild exertion
– Class IV: SOB at rest
Why stages?
• NYHA Class
– Class I: no functional impairment
– Class II: SOB at moderate exertion
– Class III: SOB at minimal – mild exertion
– Class IV: SOB at rest
Why stages?
• NYHA Class
– Class I: no functional impairment
– Class II: SOB at moderate exertion
– Class III: SOB at minimal – mild exertion
– Class IV: SOB at rest
- NYHA Class changes
- Inadequate as stand
alone descriptor
of natural history
Stages of Heart Failure
Jessup M, Brozena S. N Engl J Med. 2003;348:2007-18.
Stage A: high risk for HF without structural
heart disease or symptoms
– Hypertension
– Atherosclerotic heart disease
– Diabetes
– Obesity
– Metabolic syndrome
– Cardiotoxins (eg, doxorubicin, EtOH)
– Family history of cardiomyopathy
Stages of Heart Failure
Jessup M, Brozena S. N Engl J Med. 2003;348:2007-18.
Stage B: Structural heart disease without the
development of HF
– Prior myocardial infarction
– Depressed LV ejection fraction
– Left ventricular hypertrophy
– Asymptomatic valvular heart disease
Stages of Heart Failure
Jessup M, Brozena S. N Engl J Med. 2003;348:2007-18.
Stage C: Structural heart disease with
current or prior symptoms
“Needs Lasix” Heart Failure
Syndrome
CARDIOMYOPATHY IS NOT
SYNONYMOUS WITH
HEART FAILURE
Stages of Heart Failure
Jessup M, Brozena S. N Engl J Med. 2003;348:2007-18.
Stage D: refractory symptoms requiring
special intervention
• What constitutes refractory symptoms?
– Repeated HF hospitalizations?
– Inability to complete activities of daily living?
– Severe sodium/fluid restriction and high diuretic
requirement?
Stages of Heart Failure
Jessup M, Brozena S. N Engl J Med. 2003;348:2007-18.
• The routine use of inotropes as heart failure therapy is not indicated in either the short- or long-term setting
• The use of inotropes as a treatment of cardiogenic shock, diuretic/ACE inhibitor–refractory heart failure decompensations, or as a short-term bridge to definitive treatment, such as revascularization or cardiac transplantation, is potentially appropriate
• Inotropes may be appropriate as a palliative measure in patients with truly end-stage heart failure as part of hospice care
Guideline Recommendations: Role of Inotropic Therapy in Patients
with Heart Failure
Hershberger RE et al. J Card Fail 2003; 9:188-91.
COSI* Survival
*Continuous Outpatient Support with Inotropes
IV Inotropic Agents During Hospitalization for Decompensated Heart Failure
* without cardiogenic shock
Cuffe MS et al. JAMA. 2002;287:1541–1547.
Treatment Failure From Adverse Event (48 h)
Sustained Hypotension
Acute MI Mortality
Milrinone
Placebo
Afib
P < 0.001 P < 0.001
P = 0.18
P = 0.004 P = 0.19
12.6
2.1
10.7
3.2
1.5 0.4
4.6
1.5
3.8
2.3
0
5
10
15
20
OPTIME-CHF: In-hospital Adverse Events
• The routine use of inotropes as heart failure therapy is not indicated in either the short- or long-term setting
• The use of inotropes as a treatment of cardiogenic shock, diuretic/ACE inhibitor–refractory heart failure decompensations, or as a short-term bridge to definitive treatment, such as revascularization or cardiac transplantation, is potentially appropriate
• Inotropes may be appropriate as a palliative measure in patients with truly end-stage heart failure as part of hospice care
Guideline Recommendations: Role of Inotropic Therapy in Patients
with Heart Failure
Stage D: refractory symptoms requiring
special intervention
– Need for inotropes
– Treatments
• Transplant
• MCS/LVAD
• Hospice
MCS Candidate
Transplant Candidate
Hospice
Treatment Options for Stage D Heart Failure Patients
MCS Candidate
Transplant
Candidate
Hospice
Treatment Options for Stage D
Heart Failure Patients
“Care as usual”
is not an option
Scope of the Problem • Estimated 7 million patients with HF 1
• 50% have HFrEF or systolic HF 1,2
• 10% have stage D HF
– Estimates vary between 5-20% 1,2
• ~2200 transplants in US annually 6
• ~4000 LVAD implants in US 2015 7
• 16% referred to hospice
– Estimates vary between 12-20% (conservative)2,3,4,5
(1) Miller LW, Circulation. 2011;123:1522-58.
(2) AbouEzzeddine OF, et al. Congest Heart Fail. 2011;17:160-8.
(3) Setoguchi S, et al. Am Heart J. 2010;160:139-44.
(4) Connor SR, et al. J Pain Symptom Manage. 2007;34:277-85.
(5) Givens JL, et al. Arch Intern Med. 2010;170:427-32.
(6) Taylor DO, et al. J Heart Lung Transplant. 2009;28:1007-22.
(7) Personal communication, Thoratec, INTERMACS
Scope of the Problem • Estimated 7 million patients with HF 1
• 50% have HFrEF or systolic HF 1,2
• 10% have stage D HF
– Estimates vary between 5-20% 1,2
• ~2200 transplants in US annually 6
• ~4000 LVAD implants in US 2013 7
• 16% referred to hospice
– Estimates vary between 12-20% (conservative)2,3,4,5
(1) Miller LW, Circulation. 2011;123:1522-58.
(2) AbouEzzeddine OF, et al. Congest Heart Fail. 2011;17:160-8.
(3) Setoguchi S, et al. Am Heart J. 2010;160:139-44.
(4) Connor SR, et al. J Pain Symptom Manage. 2007;34:277-85.
(5) Givens JL, et al. Arch Intern Med. 2010;170:427-32.
(6) Taylor DO, et al. J Heart Lung Transplant. 2009;28:1007-22.
(7) Personal communication, Thoratec, INTERMACS
350,000 HFrEF Stage D
Most advanced HF patients do not receive stage D therapies
18% of patients receive advanced HF therapies
Untreated N =288,300
LVAD N = 3,500
Transplant N = 2,200
Hospice N = 56,000
Death with HF
Characteristic All deaths
(n=160)
Outpt
deaths
(n=80)
Inpt deaths
(n=80)
CHF clinic (mos) 24.7 23.1 26.6
CHF duration (yrs) 5.0 4.6 5.4
Age (yrs) 59.9 57.9 61.1
Male (%) 74 75 74
NYHA III (%) 14 13 14
NYHA IV (%) 79 74 83
ICD (%) 37 30 46
CRT (%) 5 7 5
EF (%) 20 22 19
Teuteberg et al. J Card Fail 2006;12:47
Deaths from 1/1/00-10/20/03
HF Patients (%) Cancer Patients (%)
Hospice prior to death 20.4 50.8
Died <3 days after hospice enrollment
22.8 11.0
Opiates < 60 days before death 22.2 45.6
Opiates in those dying in hospital 19.1 43.7
Opiates in those dying outside hospital
26.8 48.0
ER visits <30 days before death 60.1 38.9
Hospitalized <7 days before death
30.3 15.9
Hospitalized <30 days before death
64.2 45.3
ICU <30 days before death 19.0 7.2
Adm SNF before death 60.6 38.3
Death in acute care hospital 39.1 21.0
Setoguchi S, et al. Am Heart J. 2010;160:139-44.
HF Patients (%) Cancer Patients (%)
Hospice prior to death 20.4 50.8
Died <3 days after hospice enrollment
22.8 11.0
Opiates < 60 days before death 22.2 45.6
Opiates in those dying in hospital 19.1 43.7
Opiates in those dying outside hospital
26.8 48.0
ER visits <30 days before death 60.1 38.9
Hospitalized <7 days before death
30.3 15.9
Hospitalized <30 days before death
64.2 45.3
ICU <30 days before death 19.0 7.2
Adm SNF before death 60.6 38.3
Death in acute care hospital 39.1 21.0
Setoguchi S, et al. Am Heart J. 2010;160:139-44.
HF Patients (%) Cancer Patients (%)
Hospice prior to death 20.4 50.8
Died <3 days after hospice enrollment
22.8 11.0
Opiates < 60 days before death 22.2 45.6
Opiates in those dying in hospital 19.1 43.7
Opiates in those dying outside hospital
26.8 48.0
ER visits <30 days before death 60.1 38.9
Hospitalized <7 days before death
30.3 15.9
Hospitalized <30 days before death
64.2 45.3
ICU <30 days before death 19.0 7.2
Adm SNF before death 60.6 38.3
Death in acute care hospital 39.1 21.0
Setoguchi S, et al. Am Heart J. 2010;160:139-44.
Hospitalizations Predict Mortality
Russell SD, et al. Congest Heart Fail 2008;14:316-21
Hospitalizations Predict Mortality
Russell SD, et al. Congest Heart Fail 2008;14:316-21
Any heart failure admission
is a red flag!!
Impact of Hospitalizations on Mortality J Am Coll Cardiol. 2013;61(12):1209-1221. doi:10.1016/j.jacc.2012.08.1029
Median Survival Decreases Progressively After Each Hospitalization for HF
Hospital admissions not only decrease quality of life, but they are also associated with shorter longevity.
Figure Legend:
Presence of JVD
Drazner MH, et al. N Engl J Med 2001; 345:574-581.
Improvement of Congestion Predicts Survival in
Patients With Class IV Symptoms of ADHF
• 146 Patients hospitalized with class IV HF
• Assessed 4 to 6 weeks after hospitalization for congestion
• Patients with persistent orthopnea (n=33)
– 2-year survival: 38%
• Patients with resolution of orthopnea (n=113)
– 2-year survival: 77% (P=.0001)
0
10
20
30
40
50
60
70
80
2 yr survival
Orthop
Noorthop
Lucas C et al. Am Heart J. 2000;140:840-847.
Failure to achieve euvolemia
is a poor prognostic sign
N=46,218
No mention
10%
Asymptomatic
51%
Improved
(but still symptomatic)
39%
1. ADHERE Registry. 3rd Quarter. 2003 National Benchmark Report. http://www.adhereregistry.com/national_BMR/index.html.
2. Fonarow GC, for ADHERE Scientific Advisory Committee. Rev Cardiovasc Med. 2003;4(suppl 7):S21.
ADHERE®1,2: Patients Discharged From September 1, 2002, to October 30, 20031
No change <1%
Not applicable <1%
Worse <1%
Persistent Symptoms of Congestion at Discharge
in Large Fraction of Patients Admitted for HF
Diuretics and Mortality
0%
25%
50%
75%
100%
0 1 2 3
4+ mg/kg
3-4 mg/kg
2-3 mg/kg
1-2 mg/kg
0.5-1 mg/kg
<0.5 mg/kg
Levy W, Mozaffariun D, Linker D, et al. The Seattle heart failure model. Circulation. 2006;113:1424-33.
Years
p<0.0001
KM Survival - Daily Diuretic Dose mg/kg
Predictors of Acute Mortality for
Patients Admitted with Acute CHF
SBP 115 mm Hg
n=7150
15.28%
n=2048
SCr 2.75 mg/dL
n=2045
6.41%
n=5102
12.42%
n=1425
21.94%
n=620
2.14%
n=20,834
5.49 %
n=4099
SBP 115 mm Hg
n=24,933
2.68%
n=25,122
8.98%
n=7202
BUN 43 mg/dL
N=33,046
Less than Greater than
or equal to
Greater than or
equal to
Greater than or
equal to
Greater than
or equal to
Less than
Less than Less than
Fonarow GC et al. JAMA 2005;293:572-580.
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0 250 500 750 1000 1250
Pro
port
ion s
urv
ival
Pro
po
rtio
n s
urv
ival
Days
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.0
>76 59-76 44-58 <44
>30 26-30 20-25 <20
GFR (mL/min)
LVEF (%)
GFRc=glomerular filtration rate estimated from serum creatinine, LVEF=left ventricular ejection fraction
Hillage HL et al. Circulation 2000; 102:203-210.
Diagnostic Value of Glomerular Filtration Rate in
Patients With Heart Failure
• Two or more HF hospitalizations in 6 months
• Intolerant of ACE-I/ARB/Beta blocker
• Unable to walk 1 block or 1 flight of stairs without
dyspnea – (< 300 m 6MWT)
• Renal insufficiency (especially BUN)
• Increasing diuretic requirement
Clues to Identifying the Potential Stage D Heart Failure Patient
Russell SD, et al. Congest Heart Fail 2008;14:316-21
• Two or more HF hospitalizations in 6 months
• Intolerant of ACE-I/ARB/Beta blocker
• Unable to walk 1 block or 1 flight of stairs without
dyspnea – (< 300 m 6MWT)
• No clinical improvement with CRT or no CRT and QRS > 140ms
Clues to Identifying the Potential Stage D Heart Failure Patient
Russell SD, et al. Congest Heart Fail 2008;14:316-21
AC
E/A
RB
B
eta
Blo
cke
rs
Ald
ost
ero
ne
an
tago
nis
ts
Loo
p d
iuretics
Meto
lazon
e
J Am Coll Cardiol. 2014;63(7):661-671.
Figure Legend:
NYHA III-IV NYHA II
Triggers for Referral to Advanced HF Program
Swedish HF Registry2000-2013
~10000 patients NYHA III-IV (~9000 NYHA II)
Age < 80 years
• SBP <90 mmHg
• Creatinine >1.8mg/dL
• Hemoglobin <12 g/dL
• No beta blocker
• No RAS antagonist
J Am Coll Cardiol. 2014;63(7):661-671.
Figure Legend:
NYHA III-IV NYHA II
Triggers for Referral to Advanced HF Program
Advanced Heart Failure Considerations
• Heart failure is associated with extremely high mortality rates
• Generally, advanced heart failure do not receive appropriate therapy
• The crucial role of RHC in the management of heart failure
Rapid Assessment of Hemodynamic Status
Congestion at Rest
Low
Perfusion
at Rest
No
No Yes
Yes
Warm & Dry Warm & Wet
Cold & Wet Cold & Dry
Signs/symptoms
of congestion
• Orthopnea/PND
• JV distension
• Ascites
• Edema
• Rales (rare in chronic HF)
Possible evidence of low perfusion • Narrow pulse pressure • Sleepy/obtunded • Low serum sodium
• Cool extremities • Hypotension with ACE inhibitor • Renal dysfunction (one cause)
PND = paroxysmal nocturnal dyspnea; JV = jugular venous.
Stevenson LW. Eur J Heart Fail. 1999;1:251–257.
How do you diagnose shock? Who needs an inotrope?
How do you diagnose shock? Who needs an inotrope?
PA catheter
How do you diagnose shock? Who needs an inotrope?
PA catheter
ESCAPE
Clinical Outcomes in ESCAPE
Six-month end points PAC,
n=215
(%)
Clinical,
n=218
(%)
Days dead or
hospitalized (mean)
38 36
Mortality 20.9 17.4
Rehospitalizations/
patient (mean)
2.1 2.1
Days in hospital (median) 11 11
*No significant differences PAC=pulmonary artery catheterization; clinical=clinically guided therapy only
Evaluation Study of Congestive Heart Failure and
Pulmonary Artery Catheterization Effectiveness: The
ESCAPE Trial
– 26 experienced transplant cardiology centers
– Study of decongestion
• Exclusion included
– creatinine >3.5 mg/dl
– Prior use of dobutamine, milrinone
• Inotropes discouraged
– Sick cohort
• BP 105
• EF < 30%
JAMA. 2005;294(13):1625-1633
O2 consumption ----------------------------------- [hgb][13.6][Ao sat – PA sat]
O2 consumption ----------------------------------- [hgb][13.6][Ao sat – PA sat]
Dehmer, GJ, et al. Clin Cardiol 1982; 5: 436-440
What is the O2 consumption?
108 consecutive patients
Mean : 126 ml/min/m2
Wide variability: 65-250ml/min/m2
CO 6, HGB 15, PA sat 70%
CO 6, HGB 15, PA sat 70% CO 6, HGB 10, PA sat 60%
CO 6, HGB 15, PA sat 70% CO 6, HGB 10, PA sat 60% CO 3, HGB 15, PA sat 50%
CO 6, HGB 15, PA sat 70% CO 6, HGB 10, PA sat 60% CO 3, HGB 15, PA sat 50% CO 3, HGB 10, PA sat 40%
Destination Therapy survival improvement
over time1
1. Jorde UP, Khushwaha SS, Tatooles AJ, et al. Two-Year Outcomes in the
Destination Therapy Post-FDA-Approval Study with a Continuous Flow
Left Ventricular Assist Device: A Prospective Study Using the
INTERMACS Registry. Presented at the ISHLT annual meeting, April 25,
2013.
INTERMACS PROFILES
Stevenson LW, Pagani FD, Young JB, et al. INTERMACS profiles of advanced heart failure: the current picture. J Heart Lung Transplant. 2009;28:535-41.
INTERMACS PROFILES AND OTHER CLASSIFICATION SYSTEMS
Profile # Description NYHA Class Time to MCS therapy AHA/ACC
Stage
INTERMACS
1 Crashing and burning IV Within hours D
INTERMACS
2
Progressive decline on inotropic
support IV Within a few days D
INTERMACS
3 Stable but inotrope dependent IV Within a few weeks D
INTERMACS
4
Recurrent advanced heart failure;
resting symptoms at home on oral
therapy
Ambulatory IV Within weeks to
months D
INTERMACS
5 Exertion intolerant Ambulatory IV Variable D
INTERMACS
6 Exertion limited or walking wounded Ambulatory IV Variable C-D
INTERMACS
7 Advanced NYHA III IIIB Variable C
Source: The Journal of Heart and Lung Transplantation 2013; 32:141-156 (DOI:10.1016/j.healun.2012.12.004 )
Copyright © 2013 International Society for Heart and Lung Transplantation Terms and Conditions
Interaction of Age and INTERMACS Level
on Survival following CF-LVAD Implantation
Clinical Outcomes Based on INTERMACS Profile
Less acutely ill, ambulatory patients in INTERMACS profiles 4-7 had better survival and
reduced length of stay compared to patients who were more acutely ill in profiles 1-3.
Length of Stay Post-VAD Actuarial Survival Post-VAD
Boyle, Ascheim, Russo,
et.al. JHLT. 30:4, 2011.
“It’s better to refer a month too early
than a week too late”
Transplant
LVAD
Hospice
End Stage Cancer
End Stage Heart Failure
74% receive ICD shock
within days of death
ADLER ED 2010
75
76
77
78
79
80
81
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