advanced heart failure - iowaheartfoundation.org · advanced heart failure improving outcomes with...
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Advanced Heart Failure Improving Outcomes with Current Therapies
Ravinder Kumar, MD, FACC
Feb 10, 2018
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Disclosure
• Employee-Iowa Heart Center/Mercy-Des Moines
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Learning Objectives
• Burden of Heart Failure
• Staging of HF
• Overview of therapies available for various stages of HF
• Advances in Heart Failure therapy
• Advanced Heart Failure – Definition
– Risk stratification
– Therapies
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Burden of HF
• 5.7 million Americans ≥20 years of age have HF • Projected prevalence of HF will increase 46% from
2012 to 2030 • Lifetime risk of developing HF is 20% for Americans ≥40
years of age • 870,000 new HF cases annually • In 2013, HF costs in the United States exceeded $30
billion • Most common cause of hospitalization
– Primary diagnosis in >1 million hospital discharges – Readmission rates 20-25%
Clyde W. Yancy et al. Circulation. 2013;128:e240-e327
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Definition of HF
• HF is a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood
• The cardinal manifestations of HF
– dyspnea and fatigue leading to limited exercise tolerance
– fluid retention leading to pulmonary and/or splanchnic congestion and/or peripheral edema
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Classification of HF
Clyde W. Yancy et al. Circulation. 2013;128:e240-e327
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Stages of HF and NYHA functional class
Clyde W. Yancy et al. Circulation. 2013;128:e240-e327
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Stages in the development of HF and recommended therapy by stage.
Clyde W. Yancy et al. Circulation. 2013;128:e240-e327
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Clyde W. Yancy et al. JACC 2017;70:776-803
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Heart Failure Pathway Writing Committee et al. JACC
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Trial Evidence for Mortality Benefit of Drugs in HF
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Beta blocker
Mineralocorticoid receptor
antagonist ACE
inhibitor
Angiotensin receptor blocker
Drugs that inhibit the renin-angiotensin system have modest effects on
survival
Based on results of SOLVD-Treatment, CHARM-Alternative,
COPERNICUS, MERIT-HF, CIBIS II, RALES and EMPHASIS-HF
10%
20%
30%
40%
0%
% D
ec
rea
se
in
Mo
rta
lity
Drugs That Reduce Mortality in Heart
Failure With Reduced Ejection Fraction
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PARADIGM-HF
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RAAS and Natriuretic peptide system
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RAAS and Natriuretic peptide system
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Angiotensin receptor Neprilysin Inhibitor
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2 weeks 1-2 weeks 2-4 weeks
Single-blind run-in period Double-blind period
(1:1 randomization)
Enalapril
10 mg BID
100 mg BID
200 mg BID
Enalapril 10 mg BID
LCZ696 200 mg BID
Randomization
LCZ696
PARADIGM-HF Study Design
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McMurray JJV et al. N Engl J Med 2014;371:993-1004
PARADIGM-HF
McMurray et al. NEJM 2014
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10%
20%
30%
40%
ACE inhibitor
Angiotensin receptor blocker
0%
% D
ec
rea
se
in
Mo
rta
lity
18%
20%
Effect of ARB vs placebo derived from CHARM-Alternative trial
Effect of ACE inhibitor vs placebo derived from SOLVD-Treatment trial
Effect of LCZ696 vs ACE inhibitor derived from PARADIGM-HF trial
Angiotensin neprilysin inhibition
15%
LCZ696 Doubles Effect on CV Mortality
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10%
20%
30%
40%
ACE inhibitor
Angiotensin receptor blocker
0%
% D
ec
rea
se
in
Mo
rta
lity
18%
20%
Effect of ARB vs placebo derived from CHARM-Alternative trial
Effect of ACE inhibitor vs placebo derived from SOLVD-Treatment trial
Effect of LCZ696 vs ACE inhibitor derived from PARADIGM-HF trial
Angiotensin neprilysin inhibition
15%
LCZ696 Doubles Effect on CV Mortality
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NNT to Reduce any cause Mortality
Jessup M. N Engl J Med 2014;371:1062-1064.
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Lancet 2010; 376: 875–85
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SHIFT Trial
Lancet 2010; 376: 875–85
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2017 ACC/AHA/HFSA update
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Lancet 2011; 377: 658–66
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Device Therapy - ICD & CRT
Clyde W. Yancy et al. Circulation. 2013;128:e240-e327
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Advanced HF/Stage D HF
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ESC Definition of Advanced HF
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Identifying Patients With Advanced HF
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INTERMACS Profiles
Modifiers: Frequent flyer: for Profile 3-6 Arrhythmia TCS(temporary circulatory support) for profile 1-3
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Tools for Prognostication
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When “optimal medical therapy” fails, what are the options?
• Inotropes
• Mechanical circulatory support
• Heart Transplant
• Clinical Trials
• Palliative Care
D Refractory
Heart
Failure
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ACT - Advanced Cardiac Therapies
Yancy C, et. al. Circ. 2013;128:e240-e327
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Milrinone: Bridge to Transplant
• 60 milrinone-dependent patients, listed for transplant • 76% successfully bridged with milrinone (waited 59 days for txp) • 24% required LVAD (waited 93 days for txp) • 5 died (waited 130 days for txp)
J. Cardiac Failure 2008; 14(10): 839-843
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Continuous Outpatient Support with Inotropes: Palliation
• 36 patients – Inotrope-dependent
– Refused/ineligible for transplant
• Rehospitalizations infrequent
• Infection/sepsis common
• Survival 3.4 months – Most died at home
J. Cardiac Failure 2003; 9(3): 180-187
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Chronic inotrope infusion associated with high mortality
• OPTIME-CHF and PROMISE
• Randomized, double blinded
• 1000 patients/ea randomized to milrinone or placebo
• High rates of hypotension, arrhythmia, syncope
• 53% increase in mortality – Pts not “wet and cold”
– Inotropic therapy was not considered essential for management
JAMA 2002; 287(12): 1541-1547
NEJM 1991; 325: 1468-1475
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Heart Transplant COR I
• Cardiac transplantation is considered the gold standard for the treatment of refractory end-stage HF.
• First successful cardiac transplantation in 1967
• Over last 50 years post transplant survival has improved
• Post transplant survival at 1-, 3-, and 5-year is 87.8%, 78.5%, and 71.7% in adults, respectively
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Heart Transplant
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Status at time of transplant impacts post-transplant survival
Barge-Caballero Circ Heart Failure. 2013
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Heart Transplant Trends
JHLT 2011 Oct; 30(10): 1071-1132
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Unmet Need in Advanced HF
• 150,000-300,000 patients 2000 heart transplants
+ 1500 VAD implants
• --------------------------------
= more pts need referrals!
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HM III LVAD
Heartmate II (axial flow) HVAD
Syncardia TAH
MCS • BTT • Bridge to recovery • Destination therapy
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Improvement in Survival with LVADs
N Engl J Med 2009;361:2241-51
N Engl J Med 2001;345:1435-43
REMATCH
2001
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HVAD ADVANCE BTT Trial
Keith D. Aaronson et al. Circulation. 2012;125:3191-3200
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Quality of Life
Rogers JG, Aaronson KD, Boyle AJ et al, JACC, 2010;55:1826-34.
Change in NYHA Class After HMII
Six Month
Follow-up for
BTT Patients
Two Year
Follow-up for
DT Patients
Change in Quality of Life
After HeartMate II:
MLWHF*
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Survival Post LVAD implant
2017 INTERMACS Report. J HeartLungTransplant2017;36:1080–1086
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J HeartLungTransplant2015;34:1495–1504
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Optimal timing of ACT referral
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J Am Coll Cardiol 2015;66:1747–61
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INTERMACS Profiles
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ROADMAP study
1 2 3 4 5 6 7 INTERMACS Profiles
CMS Coverage: Class IV
FDA Approval: Class IIIB/IV
Currently Not Approved Limited Adoption Acceptance
NYHA Class III Class
IIIB
Class IV
(Ambulatory)
Class IV
(On Inotropes)
1.0% 1.4% 3.0% 14.6% 29.9% 36.4% 14.3% Percent of current
implants in INTERMACS
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ROADMAP Study
Jerry D. Estep et al. JACC 2015;66:1747-1761
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Jerry D. Estep et al. JACC 2015;66:1747-1761
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Common VAD complications
Events/100 pt months • Bleeding (17-24) • Thromboembolism
(1.5-2.5) • Neurologic events (2-
4) • Infection (11-28) • Mechanical failure
(0.8-3) • Right heart failure
(2.2-3.1)
Kirklin et. al. Second INTERMACs annual report. JHLT 29 (1), 2009
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N Engl J Med 2014;370:33-40
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LVAD Thrombosis
N Engl J Med 2014;370:33-40
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HeartMate III LVAD
N Engl J Med 2017;376:440-50.
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Contraindications to Advanced Heart Failure Therapies
• Irreversible kidney, liver, neurologic dz
• Uncorrectable, severe PVD
• Active infection
• Severe psychosocial concerns
– Inadequate social support system
– Ongoing alcohol or substance abuse
• Medical nonadherence
• Other life-limiting disease
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Contraindications to Heart Transplant (but not DT VAD)
• Advanced age (> 70-75)
• Morbid obesity (BMI > 40)
• Substance abuse
• PVR > 5
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Goals of an assessment of candidacy for ACT
• Identify medical appropriateness (is the pt sick enough?)
• Identify social appropriateness
• Identify contraindications, opportunities for management
• Estimate prognosis
• Risk stratify
– Intermacs profile, DT risk score, MELD
• Determine which therapy is right for the individual patient
– Inotropes, VAD, heart transplant, palliative care, something else
• Educate
• Informed consent – shared decision making
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Eur Heart J. 2015;36(48):3467-3470
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Eur Heart J. 2015;36(48):3467-3470.
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Summary
• Heart failure prevalence/incidence is increasing
• Post transplant survival has improved over last 50 years
• Scarcity of donors led to development of durable MCS devices
• Durable MCS devices have improved survival and quality of life in patients with advanced heart failure
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Thank you