Transcript Commander

Pre-Activity Assessment/
Evaluation Form
Pre-Activity Assessment
• Please take a moment to complete the pre-activity
assessment prior to the start of the activity.
Evaluation Form
• Please take a moment at the conclusion of the activity
to complete the evaluation form in the back of the
workbook.
• The on-site staff will collect the pre-activity assessment
and evaluation forms at the conclusion of the activity.
Thursday, September 15, 2016
11:00am-12:00pm
Houston Marriott Westchase
2900 Briarpark Drive
Houston, TX 77042
Faculty
Michael B. Bottorff, PharmD, FCCP, FNLA, CLS
Professor and Chair
Department of Pharmacy Practice
Manchester College of Pharmacy
Fort Wayne, IN
Connie Commander, RN-BC, MBA, CCM, ABDA CPUR
President/CEO
Commander’s Premier Consulting Corporation
Hockley, TX
Program Agenda
5 minutes
Welcome and Introductions
10 minutes
Epidemiology of HF in the US
10 minutes
Pathophysiology and risk factors of HF
10 minutes
New frontiers in workup, monitoring, and
treatment of HF
20 minutes
The Role of the Case Manager as a Member of
the Team
5 minutes
Conclusions and Q&A
CE Information
Nursing Education Purpose Statement
The purpose of this activity is to improve the knowledge and
competence of nurse case managers concerning the treatment and
management of patients with heart failure (HF).
Target Audience
This educational activity was developed for case managers involved
in the management and care of patients with HF.
Provider
This activity is provided by Medical Learning Institute, Inc.
Commercial Support Acknowledgment
This activity is supported by an educational grant from Novartis
Pharmaceuticals Corporation.
Learning Objectives
Upon completion of this activity, the participant will be able to:
• Describe the high incidence and burden of HF and the factors that
may contribute to the “HF paradox”– increases in HF despite
better management of HF risk factors
• Explain the complex pathophysiology and risk factors for HF
• Plan to incorporate novel electronic monitoring technologies to
guide medication adjustment during follow-up
• Prepare the case manager for the introduction of a new class of
pharmacologic agents for HF, the angiotensin-neprilysin inhibitors
• Discuss the role of the case manager as patient advocate and
liaison between the clinician and the patient
Disclosure
Before the activity, all faculty and anyone who is in a position to have control over the content
of this activity and their spouse/life partner will disclose the existence of any financial interest
and/or relationship(s) they might have with any commercial interest producing healthcare
goods/services to be discussed during their presentation(s): honoraria, expenses, grants,
consulting roles, speakers bureau membership, stock ownership, or other special relationships.
Presenters will inform participants of any off-label discussions. All identified conflicts of
interest are thoroughly vetted by Medical Learning Institute Inc for fair balance, scientific
objectivity of studies mentioned in the materials or used as the basis for content, and
appropriateness of patient care recommendations.
The associates of Medical Learning Institute Inc, the accredited provider for this activity do not
have any financial relationships or relationships to products or devices with any commercial
interest related to the content of this CE activity for any amount during the past 12 months.
Name of Planner/Manager
Company
Susan Rogers, RN-BC, MSN, CCM Peer Reviewer
Reported Financial Relationship
Has nothing to disclose.
Faculty Disclosures
Michael B. Bottorff, PharmD, FCCP, FNLA, CLS, is on the
Speakers' Bureau for BMS, Boehringer Ingelheim, Pfizer,
and Sanofi/Regeneron. He does not intend to discuss
any non-FDA-approved or investigational use of any
products/devices.
Connie Commander, RN-BC, MBA, CCM, ABDA CPUR
has nothing to disclose. She does not intend to discuss
any non-FDA-approved or investigational use of any
products/devices.
Disclaimer
The information provided at this CE activity is for
continuing education purposes only and is not meant to
substitute for the independent medical judgment of a
healthcare provider relative to diagnostic and treatment
options of a specific patient’s medical condition.
Recommendations for the use of particular therapeutic
agents are based on the best available scientific evidence
and current clinical guidelines. No bias towards or
promotion for any agent discussed in this activity should be
inferred.
Michael B. Bottorff
PharmD, FCCP, FNLA, CLS
Professor and Chair
Department of Pharmacy Practice
Manchester College of Pharmacy
Risk Factors for Heart Failure
• Coronary artery
disease
• Diabetes
• Hypertension (LVH)
• Other:
• Congenital heart defects
• Valvular heart disease
• Alcoholism
• Infection (viral)
CAD=coronary artery disease; LVH=left ventricular hypertrophy.
–
–
–
–
Obesity
Age
Smoking
High or low hematocrit
level
– Obstructive Sleep Apnea
– Toxins
Epidemiology of Heart Failure
in the US
Heart Failure Patients in US
(Millions)
12
10
10
• 550,000 new cases/year
8
• 1 in 9 deaths in 2009 listed heart
failure as a contributing cause
5.7
6
4
• More deaths from heart failure
than from all forms of cancer
combined
4.7
3.5
• Estimated costs exceed $30
billion each year
• The “Paradox”:
2
0
1991
2000
2016
2037*
*Rich M. J Am Geriatric Soc. 1997;45:968–974.
American Heart Association. 2001 Heart and Stroke Statistical Update.
American Heart Association. 2016 Heart and Stroke Statistical Update.
Heidenreich PA et al. Circulation. 2011;123(8):933–44.
– Increasing age of population
– Increase in risk factors
– Improved post MI survival
HF Hospitalization Burden
• Predominant reason for hospital admissions in
patients with HF = worsening HF
• High readmission rate after initial hospitalization
– 20% within one month
– 50% within six months
– 17% are readmitted two or more times
• Hospitalization = the major contributor to the
cost of HF care
Centers for Medicare and Medicaid Services. 2000 MedPAR data. DRG 127; Fonarow, GC. Rev Cardiovasc Med. 2002;3
(suppl 4):S3; Krumholz HM et al. R Arch Intern Med. 1997 Jan 13;157(1):99-104; Roger VL, Circulation. 2012;125(1):e2-e220.
Economic Burden of Chronic HF
Post-discharge
outpatient visits
Primary
Care
2%
Hospital
admissions
6%
Outpatient
referral
5%
18% Drug
69%
Hospitalization accounts for most CHF-associated costs
Stewart S, et al. Eur J Heart Fail. 2002;4:361-71
treatment
Co-morbid Conditions Contribute to
Readmission Risk in HF
JAGS 2016
Pathophysiology
Pathologic Progression of
CV Disease
Coronary artery
disease
Hypertension
Diabetes
Sudden Death
Myocardial
injury
Pathologic
remodeling
Low ejection
fraction
Death
Cardiomyopathy
Pump
failure
Valvular disease
• Neurohormonal
stimulation
• Myocardial
toxicity
Adapted from Cohn JN. N Engl J Med. 1996;335:490–498.
Symptoms:
• Dyspnea
• Fatigue
• Edema
Chronic
heart
failure
Compensatory Mechanisms
Renin-Angiotensin-Aldosterone System
Beta
Stimulation
• CO
• Na+
Renin + Angiotensinogen
Angiotensin I
Angiotensin II
ACE
Kaliuresis
Aldosterone Secretion
Peripheral
Vasoconstriction
Fibrosis
Salt & Water Retention
 Plasma Volume
  Afterload
  Preload
 Cardiac Output
 Cardiac Workload
Heart Failure
Edema
Classification of HF
Comparison Between ACC/AHA HF Stage and
NYHA Functional Class
ACC/AHA HF Stage1
NYHA Functional Class2
A At high risk for heart failure but without
structural heart disease or symptoms
of heart failure (eg, patients with
hypertension or coronary artery disease)
B Structural heart disease but without
symptoms of heart failure
C Structural heart disease with prior or
current symptoms of heart failure
D Refractory heart failure requiring
specialized interventions
I
Asymptomatic
II Symptomatic with moderate exertion
III Symptomatic with minimal exertion
IV Symptomatic at rest
Hunt SA et al. J Am Coll Cardiol. 2001;38:2101–2113.
New York Heart Association/Little Brown and Company, 1964. Adapted from: Farrell MH et al. JAMA. 2002;287:890–897.
Heart Failure
Terminology
• Treatment guidelines focus on HFrEF, where
numerous outcome studies have been conducted
ESC Heart Failure Guidelines 2016
Evidence-Based Therapy
for HFrEF
Lifestyle Changes
What
Why
• Eat a low-sodium, low-fat
diet
• Sodium is bad for high blood pressure,
causes fluid retention
• Lose weight
• Extra weight can put a strain
on the heart
• Stay physically active
• Exercise can help reduce stress
and blood pressure
• Reduce or eliminate
alcohol and caffeine
• Alcohol and caffeine can weaken an
already damaged heart
• Quit Smoking
• Smoking can damage blood vessels and
make the heart beat faster
Rationale for HF Medications
(Why does my doctor have me on so many pills?)
• Improve Survival
– Beta-blockers
– ACE-inhibitors
– Mineralocorticoid
receptor antagonists
(MRA)
– Angiotensin receptor
blockers (ARB’s)
– ARNI
• Improve Symptoms
– Diuretics
– Digoxin
Drugs Commonly Used for HFrEF
(Stage C HF)
Drug
Initial Daily Dose(s)
ACE Inhibitors
Captopril
6.25 mg 3 times
Enalapril
2.5 mg twice
Fosinopril
5 to 10 mg once
Lisinopril
2.5 to 5 mg once
Perindopril
2 mg once
Quinapril
5 mg twice
Ramipril
1.25 to 2.5 mg once
Trandolapril
1 mg once
ARBs
Candesartan
4 to 8 mg once
Losartan
25 to 50 mg once
Valsartan
20 to 40 mg twice
Aldosterone Antagonists
Spironolactone
12.5 to 25 mg once
Eplerenone
25 mg once
Maximum Doses(s)
Mean Doses Achieved in
Clinical Trials
50 mg 3 times
10 to 20 mg twice
40 mg once
20 to 40 mg once
8 to 16 mg once
20 mg twice
10 mg once
4 mg once
122.7 mg/d (421)
16.6 mg/d (412)
--------32.5 to 35.0 mg/d (444)
---------------------------------
32 mg once
50 to 150 mg once
160 mg twice
24 mg/d (419)
129 mg/d (420)
254 mg/d (109)
25 mg once or twice
50 mg once
26 mg/d (424)
42.6 mg/d (445)
Drugs Commonly Used for HFrEF
(Stage C HF)
Drug
Initial Daily Dose(s)
Beta Blockers
Bisoprolol
1.25 mg once
Carvedilol
3.125 mg twice
Carvedilol CR
10 mg once
Metoprolol succinate
extended release
12.5 to 25 mg once
(metoprolol CR/XL)
Hydralazine & Isosorbide Dinitrate
37.5 mg hydralazine/
Fixed dose
20 mg isosorbide
combination (423)
dinitrate 3 times
daily
Hydralazine and
Hydralazine: 25 to 50
isosorbide dinitrate
mg, 3 or 4 times
(448)
daily and isorsorbide
dinitrate:
20 to 30 mg
3 or 4 times daily
Maximum Doses(s)
Mean Doses Achieved in
Clinical Trials
10 mg once
50 mg twice
80 mg once
8.6 mg/d (118)
37 mg/d (446)
---------
200 mg once
159 mg/d (447)
75 mg hydralazine/
40 mg isosorbide
dinitrate 3 times
daily
Hydralazine: 300
mg daily in divided
doses and
isosorbide dinitrate
120 mg daily in
divided doses
~175 mg hydralazine/90 mg
isosorbide dinitrate daily
---------
Recommendations for Treatment
of Stage B HF
Recommendations
In patients with a history of MI and reduced EF, ACE inhibitors or ARBs
should be used to prevent HF
In patients with MI and reduced EF, evidence-based beta blockers
should be used to prevent HF
In patients with MI, statins should be used to prevent HF
Blood pressure should be controlled to prevent symptomatic HF
ACE inhibitors should be used in all patients with a reduced EF to
prevent HF
Beta blockers should be used in all patients with a reduced EF to
prevent HF
An ICD is reasonable in patients with asymptomatic ischemic
cardiomyopathy who are at least 40 d post-MI, have an LVEF ≤30%,
and on GDMT
Nondihydropyridine calcium channel blockers may be harmful in
patients with low LVEF
COR
LOE
I
A
I
B
I
A
I
A
I
A
I
C
IIa
B
III: Harm
C
Stage C
Nonpharmacological Interventions
I IIa IIb III
Patients with HF should receive specific education to
facilitate HF self-care
I IIa IIb III
I IIa IIb III
Exercise training (or regular physical activity) is
recommended as safe and effective for patients with
HF who are able to participate to improve functional
status
Sodium restriction is reasonable for patients with
symptomatic HF to reduce congestive symptoms
Stage C
Nonpharmacological Interventions (continued)
I IIa IIb III
I IIa IIb III
Continuous positive airway pressure (CPAP)
can be beneficial to increase LVEF and
improve functional status in patients with
HF and sleep apnea
Cardiac rehabilitation can be useful in
clinically stable patients with HF to improve
functional capacity, exercise duration,
HRQOL, and mortality
Pharmacological Therapy for
Management of Stage C HFrEF
Recommendations
Diuretics
Diuretics are recommended in patients with HFrEF with fluid
retention
ACE Inhibitors
ACE inhibitors are recommended for all patients with HFrEF
ARBs
ARBs are recommended in patients with HFrEF who are ACE
inhibitor intolerant
ARBs are reasonable as alternatives to ACE inhibitor as first
line therapy in HFrEF
The addition of an ARB may be considered in persistently
symptomatic patients with HFrEF on GDMT
Routine combined use of an ACE inhibitor, ARB, and
aldosterone antagonist is potentially harmful
COR
LOE
I
C
I
A
I
A
IIa
A
IIb
A
III: Harm
C
Pharmacologic Therapy for
Management of Stage C HFrEF
(continued)
Recommendations
COR
Digoxin
Digoxin can be beneficial in patients with HFrEF
IIa
Anticoagulation
Patients with chronic HF with permanent/persistent/paroxysmal AF and an
I
additional risk factor for cardioembolic stroke should receive chronic
anticoagulant therapy*
The selection of an anticoagulant agent should be individualized
I
Chronic anticoagulation is reasonable for patients with chronic HF who have
IIa
permanent/persistent/paroxysmal AF but without an additional risk factor for
cardioembolic stroke*
Anticoagulation is not recommended in patients with chronic HFrEF without AF,
III: No Benefit
prior thromboembolic event, or a cardioembolic source
Statins
Statins are not beneficial as adjunctive therapy when prescribed solely for HF
III: No Benefit
Omega-3 Fatty Acids
Omega-3 PUFA supplementation is reasonable to use as adjunctive therapy in
HFrEF or HFpEF patients
IIa
LOE
B
A
C
B
B
A
B
Diuretics in Heart Failure
• Thiazide diuretics possible for mild congestion
• Loop diuretics preferred for most patients
– Furosemide for the majority of patients
– Torsemide has better, more reliable absorption
• Less hospitalizations, lower cost of care (Clin Therapeutics 1999, ASCPT 2000)
– Metolazone reserved for apparent diuretic resistance
• Diuretic advantages
– Necessary for fluid control (MONITOR PATIENT WEIGHTS)
– Synergistic effect with ACE-inhibitors
• Diuretic disadvantages
– Electrolyte disturbances (arrhythmogenic, dig toxicity)
– Hypovolemia, hypotension, renal dysfunction
DIGOXIN
Clinical Uses
• AF with rapid ventricular response
• CHF refractory to other drugs
• Should be combined with other drugs
ACEI
ADVANTAGES
•
•
Inhibit LV remodeling post-MI
Modify the progression of chronic CHF
–
–
–
•
•
Benefits may be exclusive of symptom improvement
Relative contraindications
–
–
–
•
- Survival
- Hospitalizations
Improve the quality-of-life
Hypotension
Hyperkalemia
Renal insufficiency
Absolute contraindication
–
Angioedema
Yancy CW, Jessup M, Bozkurt B, Butler J, Casey Jr DE, , et al. 2016 ACC/AHA/HFSA Focused Update on New
Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure, Journal of the
American College of Cardiology (2016), doi: 10.1016/ j.jacc.2016.05.011.
Pharmacological Therapy for
Management of Stage C HFrEF
(continued)
Recommendations
Beta Blockers
Use of 1 of the 3 beta blockers proven to reduce mortality is
recommended for all stable patients
Aldosterone Antagonists
Aldosterone receptor antagonists are recommended in patients with
NYHA class II-IV HF who have LVEF ≤35%
Aldosterone receptor antagonists are recommended in patients
following an acute MI who have LVEF ≤40% with symptoms of HF or
DM
Inappropriate use of aldosterone receptor antagonists may be
harmful
Hydralazine and Isosorbide Dinitrate
The combination of hydralazine and isosorbide dinitrate is
recommended for African-Americans, with NYHA class III–IV HFrEF on
GDMT
A combination of hydralazine and isosorbide dinitrate can be useful in
patients with HFrEF who cannot be given ACE inhibitors or ARBs
COR
LOE
I
A
I
A
I
B
III: Harm
B
I
A
IIa
B
Pharmacological Therapy for
Management of Stage C HFrEF
(continued)
Recommendations
Other Drugs
Nutritional supplements as treatment for HF are not
recommended in HFrEF
Hormonal therapies other than to replete deficiencies are not
recommended in HFrEF
Drugs known to adversely affect the clinical status of patients with
HFrEF are potentially harmful and should be avoided or
withdrawn
Long-term use of an infusion of a positive inotropic drug is not
recommended and may be harmful except as palliation
Calcium Channel Blockers
Calcium channel blocking drugs are not recommended as routine
in HFrEF
COR
III: No
Benefit
III: No
Benefit
LOE
B
C
III: Harm
B
III: Harm
C
III: No
Benefit
A
Which Beta-blockers Are
Recommended for Use in HF?
Initial and Target Doses for
B-Blockers with Proven Benefit
for Systolic Heart Failure*
Agent
Initial dose
TOPROL-XL®†
(metoprolol
succinate)‡
25 mg QD for NYHA Class II
patients
12.5 mg QD for more severe
heart failure patients
Carvedilol
3.125 mg BID
Bisoprolol
1.25 mg QD
Target Dose
200 mg200
QD mg
or QD
highest tolerated dose
25 mg BID for patients < 85 kg
50 mg BID for patients > 85 kg
10 mg QD
Uptitrate by doubling the dose every 2 weeks unless
patients decompensate (see next slide)
*Temporary suspension/reduction of therapy does not preclude success of b-blocker therapy during management of uptitration.
Management of B-Blocker Therapy in
Heart Failure Patients During Uptitration
• In patients with fluid retention
– Increase diuretic dosage
• In patients with hypotension
– Reduce diuretic/ACE inhibitor dosage
• In patients with worsening heart failure
–
–
–
–
Stop uptitration until clinical conditions stabilize
Adjust concomitant medications
If symptoms don’t resolve, down-titrate b-blocker dose*
Avoid abrupt cessation of b-blocker therapy
*Temporary suspension/reduction of therapy does not preclude success of b-blocker therapy during management of uptitration.
Eichhorn EJ. Clinical use of b-blockers in patients with heart failure. J Cardiac Fail. 2000;6:40-46; Consensus Recommendations for the
Management of Chronic Heart Failure. Am J Cardiol. 1999;83:1A-80A.
Management of B-Blocker Therapy in
Heart Failure Patients During Uptitration
• The majority of patients will not decompensate
during uptitration
– Patients should weigh themselves daily to detect early
signs of decompensation
– Patients who note weight gain of 2-3 pounds should be
instructed to call their physicians
• It may take 8-12 weeks for improvement to become
evident
• Most patients can be managed without discontinuing
b-blocker therapy
Eichhorn EJ. Clinical use of b-blockers in patients with heart failure. J Cardiac Fail. 2000;6:40-46.
Randomized Aldactone Evaluation Study
(RALES)
• 1663 patients with Class IV HF in last six months
– EF <35%, on ACEI and loop diuretic +/- digoxin
• R, DB, PC with spironolactone 25 mg QD
– Could be increased to 50 mg or reduced to 25 mg QOD
• Exclusion criteria included a serum creatinine of > 2.5 mg/dL
• Results
– 30% reduction in mortality
– 30% reduction in hospitalizations
Pitt et al. NEJM 1999; Sept. 2
A-Heft Trial
1,050 African-American patients with advanced heart failure
New York Heart Association (NYHA) class 3-4 for > 3 months
LV function < 35% (< 40% if LV dilated per echo)
90% receiving diuretics, 69% ACE-inhibitor, 17% angiotensin receptor blocker, 74% beta-blocker
Isosorbide dinitrate (ISDN) plus
hydralazine
Tablet containing 20 mg ISDN and 37.5 mg
hydralazine (BiDil®, NitroMed) 3X daily.
Dosage could be doubled by enrolling
physician.
n=518
44.2% female
44.8% diabetic
Placebo
n=532
36.1% female
37.0% diabetic
Primary Endpoint:

Weighted composite of all-cause death, first hospitalization for heart failure,
and change in quality of life at a mean follow-up of 10 months
Presented at AHA 2004
A-Heft Trial
Primary Endpoint
All individual components of the primary composite endpoint were significantly improved
with ISDN-hydralazine therapy, namely death, first hospitalization for heart failure, and
change in the quality-of-life score (a larger negative score indicates a better quality-of-life).
All-Cause Mortality
p=0.02
12
25
10.2
Change in quality-of-life
score at 6 months
p=0.02
-6
-5.5
20
9
-5
16.4
15
-4
6
%
%
6.2
%
First HF Hospitalization
p=0.00124.4
10
3
-2
5
-1
0
0
ISDN-Hydralazine
Presented at AHA 2004
Placebo
-2.7
-3
0
ISDN-Hydralazine
Selective Invasive
ISDN-Hydralazine
Placebo
Drugs That Reduce Mortality in
Heart Failure With Reduced
Ejection Fraction
% Decrease in Mortality
0%
Angiotensin
receptor
blocker
ACE
inhibitor
Beta
blocker
Mineralocorticoid
receptor
antagonist
10%
20%
30%
Drugs that inhibit the
renin-angiotensin system
have modest effects on
survival
40%
Based on results of SOLVD-Treatment, CHARM-Alternative, COPERNICUS, MERIT-HF, CIBIS II, RALES and EMPHASIS-HF
AHA HF Update 2016
One Enzyme — Neprilysin — Degrades
Many Endogenous Vasoactive Peptides
Endogenous
vasoactive peptides
(natriuretic peptides, adrenomedullin,
bradykinin, substance P,
calcitonin gene-related peptide)
Neprilysin
Inactive metabolites
Neprilysin Inhibition Potentiates Actions
of Endogenous Vasoactive Peptides That
Counter Maladaptive Mechanisms in HF
Endogenous
vasoactive peptides
(natriuretic peptides, adrenomedullin,
bradykinin, substance P,
calcitonin gene-related peptide)
Neprilysin
Inactive metabolites
Neurohormonal
activation
Vascular tone
Cardiac fibrosis,
hypertrophy
Sodium retention
Neprilysin
inhibition
Sacubitril and Valsartan
Angiotensin Receptor Neprilysin Inhibition
Sacubitril and Valsartan
Angiotensin
receptor blocker
Inhibition of
neprilysin
Aim of the PARADIGM-HF Trial
Prospective comparison of ARNI with ACEI to
Determine Impact on Global Mortality and morbidity
in Heart Failure trial (PARADIGM-HF)
LCZ696
400 mg daily
Enalapril
20 mg daily
SPECIFICALLY DESIGNED TO REPLACE CURRENT USE
OF ACE INHIBITORS AND ANGIOTENSIN RECEPTOR BLOCKERS AS THE
CORNERSTONE OF THE
TREATMENT OF HEART FAILURE
PARADIGM-HF
Effect of LCZ696 vs Enalapril on
Primary Endpoint and Its Components
LCZ696
(n=4187)
Enalapril
(n=4212)
Hazard Ratio
(95% CI)
P
Value
Primary endpoint
914
(21.8%)
1117
(26.5%)
0.80
(0.73-0.87)
0.0000002
Cardiovascular
death
558
(13.3%)
693
(16.5%)
0.80
(0.71-0.89)
0.00004
Hospitalization
for heart failure
537
(12.8%)
658
(15.6%)
0.79
(0.71- 0.89)
0.00004
PARADIGM-HF
Summary of Findings
In heart failure with reduced ejection fraction, when compared with
recommended doses of enalapril:
LCZ696 was more effective than enalapril in . . .
•
•
•
•
•
Reducing the risk of CV death and HF hospitalization
Reducing the risk of CV death by incremental 20%
Reducing the risk of HF hospitalization by incremental 21%
Reducing all-cause mortality by incremental 16%
Incrementally improving symptoms and physical limitations
LCZ696 was better tolerated than enalapril . . .
•
•
•
•
Less likely to cause cough, hyperkalemia or renal impairment
Less likely to be discontinued due to an adverse event
More hypotension, but no increase in discontinuations
Not more likely to cause serious angioedema
Optimal Implementation of ARNI
in Heart Failure
• Inevitable delay for implemention into practice
of newly established therapies
• Estimated 84% of U.S. patients with HFrEF as
candidates for ARNI therapy
• Optimal implementation would:
– Prevent 28,484 deaths per year
– 12 month NNT 80
Fonarow GC et al. JAMA 2016
From: Cost-effectiveness Analysis of Sacubitril/Valsartan vs Enalapril in Patients With Heart Failure and Reduced Ejection
Fraction
JAMA Cardiol. Published online June 22, 2016. doi:10.1001/jamacardio.2016.1747
Figure Legend:
Tornado DiagramUnivariate sensitivity analyses evaluating the effect of each variable’s uncertainty on an overall cost-effectiveness ratio. The
central black line represents the base-case analysis. None of the analyses lead to an incremental cost-effectiveness ratio greater than $150 000
per quality-adjusted life-year (QALY). HR indicates hazard ratio.
Copyright © 2016 American Medical Association. All rights reserved.
Date of download: 7/14/2016
Angiotensin Neprilysin Inhibition With
LCZ696 Doubles Effect on Cardiovascular
Death of Current Inhibitors of the
Renin-Angiotensin System
% Decrease in Mortality
0%
10%
Angiotensin
receptor
blocker
Angiotensin
neprilysin
inhibition
ACE
inhibitor
15%
18%
20%
20%
30%
40%
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
Ivabradine
Mechanism of Action
Systolic Heart failure treatment with the
If inhibitor ivabradine Trial
Main Results
Swedberg K, et al. Lancet. 2010;376(9744):875-885
www.shift-study.com
Primary Objective
To evaluate whether the If inhibitor ivabradine
improves cardiovascular outcomes in patients with:
• Moderate to severe chronic heart failure
• Left ventricular ejection fraction 35%
• Heart rate 70 bpm in sinus rhythm
• Best recommended therapy
Swedberg K, et al. Eur J Heart Fail. 2010;12:75-81
www.shift-study.com
Effect of Ivabradine
on Outcomes
Endpoints
Hazard ratio
95% CI
p value
0.82
[0.75;0.90]
p<0.0001
All-cause mortality
0.90
[0.80;1.02]
p=0.092
Death from heart failure
0.74
[0.58;0.94]
p=0.014
All-cause hospital admission
0.89
[0.82;0.96]
p=0.003
Any CV hospital admission
0.85
[0.78;0.92]
p=0.0002
CV death/hospital admission for HF
or non-fatal MI
0.82
[0.74;0.89]
p<0.0001
Primary composite endpoint
(CV death or hospital admission for worsening HF)
Swedberg K, et al. Lancet. 2010;376(9744):875-885
www.shift-study.com
In Summary….
• Heart failure is common and has high mortality
• Drug therapy improves survival
– Beta-blockers, ACE-I, aldosterone antagonists, ARNI
• Newer device therapies are showing promise for
symptom relief and improved survival
– Biventricular pacing, ICD’s
• Transplants remain rare, but technology for
mechanical assist devices continues to improve
Your Patient
• Mr. B is a 58 yo former welder who retired
early two years ago from ill health
• In the last two years he has had several
admissions for IHD, type II diabetes, HTN and
heart failure
• He was first admitted for HF in August 2014
with increasing SOB and chest tightness
• He had bilateral thigh edema, elevated JVP,
orthopnea, PND and a dry, hacking cough
Your Patient
(continued)
• His medications included HCTZ 12.5mg QD,
simvastatin 40mg QHS, metformin 500mg BID
• After a 6 day admission, he was discharged on
– Furosemide 40mg BID
– Lisinopril 5mg QD
– Atenolol 50mg QD
– Metformin 500mg BID
– Simvastatin 40mg QD
Your Patient
(continued)
• He is now being discharged after an
admission for poorly controlled HTN and is on
the above meds plus nifedipine 10mg QD
• What are the key elements of your care plan
for the patient?
– Understanding of heart failure and ability to be
involved in their own care
– Drug therapy regimen
Your Patient
Guideline-Directed Evaluation
and Management (GDEM)
• Non-pharmacologic interventions
– HF-specific patient education, Na restriction, consider cardiac
rehab/exercise training
• Diuretic therapy
– Monitor patient weights, symptoms and adjust as needed
• ACEI and Beta-blocker therapy
– Titrate to target doses
– Use evidence-based beta-blocker
• Consider MRA
– Caution with renal function, hyperkalemia
• Consider ARNI
– Stable class II, III patients without history of angioedema
Drugs that May Cause or Exacerbate HF
AHA Scientific Statement 2016
The American Heart Association
• Common drugs to avoid
– COX-2 inhibitors, NSAIDS
– TZDs, DPP-4 inhibitors
– Type 1 antiarrhythmics (propafenone, disopyramide,
flecainide), sotalol and dronedarone
– CCBs, esp. diltiazem and verapamil
– Anthracyclines
– Cilostazol
– bosentan
AHA Scientific Statement 2016
The Case Manager’s Role in
Supporting the Individual
with Heart Failure
Challenges and Critical Elements for Success!
Connie Commander, RN-BC,
MBA, CCM, ABDA CPUR
President/CEO
Commander’s Premier Consulting
Corporation
Hockley, TX
Guiding Principles of the
2016 CMSA Standards
• Client-centric, collaborative partnership approach
• Implement evidence-based care guidelines
• Foster navigation through the health care system to
enhance access to services achievement of successful
outcomes
Case Managers Philosophy
From CMAG 2012
• Case managers enable and support a patient-centered
approach to care that by itself is a significant means for
promoting adherence
• Case managers recognize the importance of the
patient’s involvement in their own care and actively
engage the patient as the primary decision maker and
goal setter
• Case managers believe in the principles of advocacy,
collaboration, shared-decision making, and education
to promote effective patient engagement and
adherence with evidence-based care and treatment
plans
Establishing an Individual
Plan of Care
• Based upon the needs of the patient
• Developed with the individual patient and their
identified caregiver
• Including the professional recommendations of the
members of the multidisciplinary team
• Built on collaboration with community-based support
• Developed with a strong and effective “warm handover” across each transitional opportunity
Assessments
• Initially, throughout, and routinely re-evaluated and revised
• Developed with the individual patient and their caregiver(s)
• Based upon the needs of the patient
–
–
–
–
–
Physical and behavioral health needs
Financial needs and coverage parameters
Cultural and religious beliefs
Cognitive abilities and language barriers
Access to care
Advocating for the Individual
• Evaluating what the patient and caregiver
understand about heart failure
• Discussion of managing heart failure
• Tools they currently have and educational
support they require
• Willingness to modify daily routines (diet to low
sodium, medication regimen, exercise program)
Across Disciplines
• Participation in formal heart failure programs
–
–
–
–
Payer supported
Hospital or clinics
Community-based
Links to internet-based web programs
• Developing and communicating the accepted plan of care with all
members of the multidisciplinary team
• Always sharing with the individual the transitional
communications
• Medication reconciliation and educational linkage with
Pharmacists specific to individual
• Post-discharge MTM
• Specific follow-up with collaboration between Hospitalists,
Primary Care Physicians, and Specialists
MTM= medical therapy management
Identifying Community
Collaboration
•
•
•
•
•
•
•
•
•
Cardiologist
Home Health Care Team
Care Transition Team
Cardiac Rehabilitation
Primary Care Physician
Case Manager in community
Nutritional and dietician collaboration
Pharmacist/Community-based
Palliative Care programs to manage chronic conditions
Patient-Focused
Dietary
Changes
Monitoring
Weight
Managing
other
co-morbid
conditions
Reduce
alcohol
and
caffeine
Importance
of
medication
DME
Needs
Patient
Healthy
Lifestyle
Choices
and
changes
Monitoring
and
tracking
Lab values
Participating
in support
networks
Routine
Physician and
Health care
team follow-up
visits
Hospital Providers
Patient
Community Providers
Help
Outpatient clinic
Case Manager/
Discharge Planner
Pharmacist
The Complexity of HF Management
Cardiologist
Geriatrician
Pharmacist
HF Nurse
Physiotherapist
Heart Failure Clinic
Case Manager
Psychologist
District Nurse
Dietician
Social Services
General Practitioner
J Cardiovasc Nursing 2009
Education Specific to
Exacerbations
• Symptom management
– Dyspnea
– Fatigue
– Increasing edema
• Identifying when symptoms are progressing
–
–
–
–
Asymptomatic
Symptomatic with moderate exertion
Symptomatic with minimal exertion
Symptomatic at rest
• Medication effectiveness may take > 8 weeks to be obvious
to the patient
Collaborative Challenges
• Sharing the individual plan of care across multiple
platforms (paper, electronic, telephonic)
• Supporting identified preferences for educating,
supporting, and revising plan of care
• Holistic approach
• Implementing tools for individual self-motivation to
sustain change in lifestyle
• Implementing tools for individual to manage
effective self care
Effective Tools and
Evidenced-Based Practices for
Case Managers
• Assessment tools
• Discharge and Transitional Checklist
– Inclusive of detailed instructions after a readmission
• Medication Adherence Tools
• Readiness to Change tools
• Teach Back Methods
• Self Motivational Methods
• Continually re-assess throughout patient’s care to
measure understanding, adherence, and introduction
of new interventions
Success Will Be Based Upon:
• Relationship you have built with your patient
• Patient’s understanding of their disease process and
what they are responsible to manage
• Effectively addressing the identified barriers
• Working with the individual patient to set their own
personal goals to achieve
• Subsequent follow-up meetings with patient should
be shared by all health care providers with assessing
their individual outcomes and revising plans as
appropriate
Resources
Mechanisms of Progression in
Heart Failure
Myocardial or vascular
stress or injury
Increased activity or response
to maladaptive
mechanisms
Decreased activity or
response to adaptive
mechanisms
Evolution and progression
of heart failure
Stages, Phenotypes and
Treatment of HF
At Risk for Heart Failure
Heart Failure
STAGE A
STAGE B
STAGE C
At high risk for HF but
without structural heart
disease or symptoms of HF
Structural heart disease
but without signs or
symptoms of HF
Structural heart disease
with prior or current
symptoms of HF
e.g., Patients with:
· HTN
· Atherosclerotic disease
· DM
· Obesity
· Metabolic syndrome
or
Patients
· Using cardiotoxins
· With family history of
cardiomyopathy
Structural heart
disease
e.g., Patients with:
· Previous MI
· LV remodeling including
LVH and low EF
· Asymptomatic valvular
disease
Development of
symptoms of HF
e.g., Patients with:
· Known structural heart disease and
· HF signs and symptoms
HFpEF
THERAPY
Goals
· Heart healthy lifestyle
· Prevent vascular,
coronary disease
· Prevent LV structural
abnormalities
Drugs
· ACEI or ARB in
appropriate patients for
vascular disease or DM
· Statins as appropriate
THERAPY
Goals
· Prevent HF symptoms
· Prevent further cardiac
remodeling
Drugs
· ACEI or ARB as
appropriate
· Beta blockers as
appropriate
In selected patients
· ICD
· Revascularization or
valvular surgery as
appropriate
STAGE D
Refractory HF
THERAPY
Goals
· Control symptoms
· Improve HRQOL
· Prevent hospitalization
· Prevent mortality
Strategies
· Identification of comorbidities
Treatment
· Diuresis to relieve symptoms
of congestion
· Follow guideline driven
indications for comorbidities,
e.g., HTN, AF, CAD, DM
· Revascularization or valvular
surgery as appropriate
Refractory
symptoms of HF
at rest, despite
GDMT
e.g., Patients with:
· Marked HF symptoms at
rest
· Recurrent hospitalizations
despite GDMT
HFrEF
THERAPY
Goals
· Control symptoms
· Patient education
· Prevent hospitalization
· Prevent mortality
Drugs for routine use
· Diuretics for fluid retention
· ACEI or ARB
· Beta blockers
· Aldosterone antagonists
Drugs for use in selected patients
· Hydralazine/isosorbide dinitrate
· ACEI and ARB
· Digoxin
In selected patients
· CRT
· ICD
· Revascularization or valvular
surgery as appropriate
THERAPY
Goals
· Control symptoms
· Improve HRQOL
· Reduce hospital
readmissions
· Establish patient’s endof-life goals
Options
· Advanced care
measures
· Heart transplant
· Chronic inotropes
· Temporary or permanent
MCS
· Experimental surgery or
drugs
· Palliative care and
hospice
· ICD deactivation
Digoxin in HFrEF
No Survival Benefit
OVERALL MORTALITY
50
40
30
Placebo (n=3403)
%
p = 0.8
20
10
0
0
DIG
N Engl J Med 1997;336:525
DIGOXIN (n=3397)
12
24
Months
36
48
When Would You Consider an
ARB in a HF Patient?
• Not for ACEI intolerance due to
– Hyperkalemia, hypotension, renal dysfunction
• Mostly for intolerance to cough or angioedema
• Not in combination
Recent Trials of Beta-blockers
in HF
Recent Trials of Beta-Blockers in Heart Failure
Beta-blocker
Placebo
35
*
% Mortality
30
25
20
*
*
15
*
10
5
0
CIBIS-II
Bisoprolol
* P<0.05
MERIT-HF
Metoprolol
CAPRICORN
Carvedilol
COPERNICUS
Carvedilol
BEST
Bucindolol