Transcript Navigating the Maze of Heart Failure Treatment Options

Navigating the
Maze of Heart
Failure Treatment
Options
Acknowledgements
We acknowledge the work of Kim Newlin, RN, CNS,
NP-C, FPCNA in the development of this
presentation.
Disclosures: Consultant-Novartis
Advisor: Continuing Education Concepts, Intellyst
Presenter
Speaker
Disclosures
Objectives
1. Define the roles of pharmacotherapies and surgical
monitoring therapies in the evaluation and
treatment of heart failure.
2. Describe the implications for treatment when
monitoring blood pressure, renal function, sodium
and potassium levels in patients with heart
failure.
3. Describe how shared decision-making can improve
patient adherence to treatment plans across the
span of heart failure management.
Case Study
• PT ID: 56 year old Caucasian male
• CC: SOB, new lower extremity edema, difficulty
sleeping, gained 7 pounds in 2 weeks
• PMH: Myocardial Infarction (MI) 8 weeks ago,
hypertension
• Lifestyle Hx: Moderately active in cardiac rehab,
doesn’t smoke
• Current Medications: Atorvastatin 80 mg, Aspirin 81
mg, Metoprolol tartrate 25 mg BID, Prasugrel 10 mg
Case Study
Physical Examination
Height: 5’9”
Wt: 185 pounds
BMI: 27.3
BP: 140/86 mmHg
HR: 95 bpm
Laboratory Results
LDL: 67 mg/dl
Non-HDL: 164 mg/dl
Potassium: 4 mEq/L
Sodium 142 mEq/L
NT pro-BNP = 1200 pg/mL
Cr: 1.2 mg/dl
BUN: 23 mg/dL
GFR: >60 mL/min
Case Study
• Physical Exam
– 2+ pitting edema,
bilateral lower extremities
– Blood pressure 140/86
mmHg
– Heart Rate regular = 95
bpm
– Weight = 185 pounds
• Echo reveals EF = 33%,
normal valves
Heart Failure Statistics
• HF prevalence = 5.7 million Americans
• By 2030, estimated > 8 million
Americans
• At 40 years of age: lifetime risk of
developing HF is 20%
• Lifetime risk is double for those with BP
>160/90 mm Hg vs <140/90 mm Hg
American Heart Association. 2016 Heart and Stroke Statistical Update.
Compensatory Mechanisms
Baroreceptor
response
Brain
SNS activation
Ventricular wall tension
Goal: increase SV
R-A-A-S activation
Decreased GFR
Kidney
Renin, A-I, AII
Aldosterone
Vasoconstriction
Fluid retention
Heart Rate
Contractility
Preload
Adapted from https://quizlet.com/101258231/pathophysiology-chapter-19-heartfailure-dysrhythmias-common-sequelae-of-cardiac-diseases-flash-cards/
Heart
HR/ Contractility
Myocyte growth
Hypertrophy
Neurohormonal Forces in Opposition
RAAS
Natriuretic Peptide
System
Neurohormonal
Forces
in
Oppos
Activation of AT receptors by
ANP, BNP
angiotensin II
1
• Vasoconstriction
• Sodium retention
•  aldosterone release
•  sympathetic nervous activity
•  cellular growth
•Vasodilation
•Sodium excretion
• aldosterone levels
•Inhibition of RAAS
•Inhibition of sympathetic
nervous activity
•Antiproliferation of
vascular smooth muscle
cells
ANP = atrial natriuretic peptide; AT1 = angiotensin I; BNP = B-type natriuretic peptide;
RAAS = renin-angiotensin-aldosterone system
Burnett JC Jr. J Hypertens. 1999;17(suppl 1):S37-S43
Heart Failure Subtypes
HF with Preserved Ejection Fraction
(Formerly known as Diastolic HF)
HF with Reduced Ejection Fraction
(Formerly known as Systolic HF)
Pharmacotherapies for HFrEF
• Angiotensin Converting Enzyme Inhibitors (ACE-I)
• Angiotensin Receptor Blockers (ARB)
• Angiotensin Receptor Neprilysin Inhibitor (ARNI)*
• Beta Blockers
• Aldosterone antagonist
• Hydralazine/Nitrate
• Diuretics
• Funny-Channel Blockers
* Unfortunately, we don’t have
good data on medications
specific to HFpEF – control risk factors!
Where Do the Medications Work?
Baroreceptor
response
BetaBrain
Blockers
SNS activation
Heart Rate
Contractility
R-A-A-S activation
Decreased GFR
Ventricular wall tension
Goal: increase SV
Kidney
Funny
Heart
•ACE/ARB
HR/ Contractility
Renin, A-I, AII
Channel
•Aldosterone
Vasoconstriction
Aldosterone
Blocker
Antagonist
Fluid
•Sacubitril/ARB Myocyte growth
retention
Preload
Hypertrophy
Adapted from https://quizlet.com/101258231/pathophysiology-chapter-19-heart-failure-dysrhythmias-common-sequelae-of-cardiac-diseases-flash-cards/
Sacubitril/Valsartan (Entresto)
• Angiotensin receptor blocker (valsartan) and
neprilysin inhibitor (sacubitril)
• Neprilysin breaks down natriuretic peptides
• NYHA Class II-IV, EF ≤ 40%
• 24/26 mg, 49/51 mg, 97/103 mg twice a day
• Paradigm-HF Trial: Compared to Enalapril
– 20% reduction in CV death or HF hospitalization
– Consistent across subgroups
– Approved in USA July, 2015
Gaziano et al. June 22, 2016. JAMA Cardiology.
Ivabradine (Corlanor)
• Reduces heart rate via If “funny channel”
– Acts at the SA node, doesn’t reduce BP
• EF < 35%, Heart Rate > 70 bpm
– On maximally tolerated beta blockers
• 5 or 7.5 mg twice a day
• SHIFT study (in Europe)
– Reduced hospitalization for worsening HF or CV death
by 18% after 3 months of treatment
– Reduced risk of death from HF by 26%
– Reduced risk of hospitalization from HF by 26%
– Approved in 2015 in USA (2005 in Europe)
Gaziano et al. June 22, 2016. JAMA Cardiology.
Pharmacotherapies for Heart Failure
II
IIa
IIa
IIb
IIb
III
III
•
•
II
IIa
IIa
IIb
IIb
ACE-I are recommended for all patients
with HFrEF
ARBs are recommended in patients with
HFrEF who are ACE-I intolerant
III
III
•
Yancy et al. Circulation. 2013;128:e240-e327
Yancy et al. JACC 2016; S0735-1097; 33024-8
ARNI with beta-blockers and
aldosterone antagonists in select
patients with chronic heart failure
Pharmacotherapies for Heart Failure
II
IIa
IIa
IIb
IIb
III
III
•
Use of proven Beta Blockers is
recommended for stable patients
–
–
II
IIa
IIa
IIb
IIb
III
III
•
Ivabradine to reduce HF
hospitalization in patients with NYHA
class II-III, stable chronic HFrEF (LVEF
≤35%)
–
–
–
Yancy et al. Circulation. 2013;128:e240-e327
Yancy et al. JACC 2016; S0735-1097; 33024-8
Carvedilol
Metoprolol succinate
Sinus rhythm
HR 70 bpm or greater at rest
Beta blocker at max tolerated dose
Pharmacotherapies for Heart Failure
II
IIa
IIa
IIb
IIb
III
III
•
•
II
IIa
IIa
IIb
IIb
Aldosterone receptor antagonists are
recommended in patients with NYHA
Class II-IV who have LVEF ≤ 35%
Combination of hydralazine and
isosorbide dinitrate is recommended
for African Americans with NYHA
class III-IV HFrEF on GDMT
III
III
•
Yancy et al. Circulation. 2013;128:e240-e327
Diuretics are recommended in
patients with fluid retention
Benefits of Medications in Trials
50
45
40
35
30
25
20
15
10
5
0
Adapted from Clyde W. Yancy et al. Circulation. 2013;128:e240-e327, www.pbm.va.gov
RR Reduction in
Mortality %
RR Reduction HF
Hospitalizations %
NNT for Mortality
Reduction
Case Study - Medications
• You share with the patient he has HFrEF
• What medications would you now strongly
recommend he start and/or what changes
would you make?
1. Change metoprolol tartrate to metoprolol succinate and
increase dose due to higher heart rate
2. Add either low dose ACE or ARNI
3. Consider aldosterone antagonist
4. Add diuretic for fluid retention
Provide him with patient education……
Case Study – Next Steps
• Carvedilol 12.5 mg BID, Furosemide 40 mg daily, and
Sacubitril/Valsartan 29/31 mg started
• Encourage him to check his weight, blood pressure
and heart rate every day, same time in the morning
• Write it down on the log provided by PCNA!
• Use a STOPLIGHT tool (next slide)
• Order blood work for one week from now
• Follow up in 10 days to review labs, vital signs and
to work on up titrating him to optimal therapy
Case Study – Next Steps
Safety During Medication Changes
• Up titrate in small increments to target
dose or highest tolerated dose
– May be limited by HR, BP or labs
• Monitor renal function and electrolytes
for rising creatinine and hyperkalemia
– Certain patients may need more visits and lab
monitoring during dose titration (elderly, CKD)
– Initial rise in creatinine may be expected
Yancy et al. Circulation. 2013;128:e240-e327
Renal Function Testing
• Patients with severe heart failure may have elevated
BUN/Cr due to chronic reductions of renal blood flow
from reduced cardiac output
– Diuresing this group of patients is complex
– In some individuals, diuretics will improve renal
congestion and renal function
• In other individuals, overaggressive diuresis may
aggravate renal insufficiency from volume depletion
• ACE/ARB/ARNI or aldosterone antagonist may cause
rise in BUN/Cr
http://emedicine.medscape.com/article/163062-workup#c8
Electrolyte Testing
• Dilutional hyponatremia may occur with prolonged,
rigid sodium restriction in addition to intensive
diuretic therapy and the inability to excrete water
• Hypokalemia may occur with diuretics
• Hyperkalemia may occur with with reductions in
glomerular filtration rate (GFR) especially with
ACE/ARB/ARNI or aldosterone antagonist
• New medications being tested to address
hyperkalemia if a barrier to giving GDMT
http://emedicine.medscape.com/article/163062-workup#c8
Safety During Medication Changes
• Monitor vital signs closely before and
during up titration of medications
– Postural changes in BP and HR
• Orthostatic symptoms, bradycardia or
low systolic BP (80-100 mmHg)
• Alternate adjustments of
different medication classes
– ACE/ARB/ARNI and beta blockers
Yancy et al. Circulation. 2013;128:e240-e327
Safety During Medication Changes
• Consider temporary adjustments in
dosages during acute episodes of noncardiac illnesses
– Especially if risk of dehydration or infection
• Review other medications
– Prescription and OTC
– Scientific Statement, AHA
Yancy et al. Circulation. 2013;128:e240-e327
Page et al. Circulation; July 12, 2016, Volume 134, Issue 2
Case Study – Follow Up Visit
•
Labs and vitals stable on return visit
•
•
Cr =1.0, K = 4.2, NT pro-BNP = 370
BP 110’s/70’s, HR 70-80’s, Weight down to 174
• Decide to increase Carvedilol to 25 mg BID
• Adjust diuretics to as needed for weight gain
• Disease telemanagement team + check daily
• Follows up 2 weeks; increase
sacubitril/valsartan to 49/50 mg
• Follow up in 2 months with labs, echo
Case Study – Something More?
• Was admitted over holiday weekend with
weight gain of 10 pounds despite telephone
calls and adjustment of medications
•
•
•
Hard to tell if fluid or fat!
Limited in what he can do
NYHA Class III
• Labs show Cr =1.3, K = 4.6,
NT pro-BNP = 456
• BP = 100‘s/70’s, HR 60-70’s, EF = 38%
• He wants to know what else can be done!
Surgical Monitoring - CardioMEMS
• Sensor placed in distal pulmonary artery that
measures and monitors PA pressures
– NYHA Class III patients, HFpEF and HFrEF
– At least 1 HF hospitalization in past 12 months
Click to add text
– Outpatient, same day procedure
– Dual therapy of ASA (81 or 325 mg) for life +
Clopidogrel 75 mg for 30 days
• Home monitoring equipment (large suitcase)
– Lie down on “pillow” to transmit data daily
https://www.sjm.com/en/sjm/cardiomems
Successful Surgical Monitoring!
HF Program Leadership
• Champion adoption and implementation process
• Identify leaders and those reviewing HF data
HF Disease Management Framework
• Hospital Based Stakeholders
• Transitional Care strategy
• Process to provide emergency and urgent care (instead of
hospitalization)
Remote Patient Monitoring Infrastructure
• HF Data evaluated to manage patient/disease
• Well-developed clinical care pathway
• Develop efficient work flow
Cardiomems Impact
• Detects changes in PA pressure 4 weeks prior to
onset of HF admission
• Studies showing success:
37% ↓ HF hospitalization (15 month follow up)
8% ↓ 30 day HF readmissions in Medicare population
50% ↓ HF hospitalization HFpEF (18 month follow up)
3 fold increase in KCCQ scores from baseline
compared to no CardioMEMS
– Significant increase in 6 minute walk test distance
–
–
–
–
KCCQ = Kansas City Cardiomyopathy Questionnaire
http://www.slideshare.net/ir_stjude/2016-analyst-and-investor-day-presentation’
Amit Alam, Abstract Presentation ACC 2016. Session 903-06.
Case Study –Decision Making
• There are options for next steps:
– Changes in medications
– CardioMEMS
– Ignore everything and hope it goes away
• So how do you decide which is best for this
patient, at this time?
Patients and Health Outcomes
• Patients more actively involved in their health care
experience have better health outcomes and lower costs
• Modern health care is complex, and patients struggle to
obtain, process, communicate, and understand even
basic health information and services
• Many patients lack health literacy: true understanding of
their medical conditions
• US health care system often has seemed indifferent to
patients' desires and needs
"Health Policy Brief: Patient Engagement," Health Affairs, February 14, 2013.
Who’s in Charge?
“Patients are in control. No matter what we
as health professionals do or say, patients
are in control of these important selfmanagement decisions. When patients leave
the clinic or office, they can and do veto
recommendations their doctor makes.”
Glasgow RE, Anderson RM Diabetes Care. 1999 Dec;22(12):2090-2
Where Does Shared Decision
Making Fit?
Shared decision making (SDM) is a collaborative
process that allows patients and their providers to
make health care decisions together, taking into
account the best scientific evidence available, as
well as the patient’s values and preferences.
http://www.informedmedicaldecisions.org/
The Perspectives of 2 Experts
CLINICIAN
PATIENT/ FAMILY
Diagnosis
Personal experience of illness
Pathophysiology
How patient feels
Prognosis
Social and family context
Treatment Options
Values
Treatment Outcome
Preferences
Risk/Benefit associate with
each option
Attitudes/feelings regarding risk
http://www.informedmedicaldecisions.org/
SDM: Steps in the Process
• Invite
Invite patient
patient to
toparticipate
participate
• Both parties share Information
– Clinician introduces concept of patient participation in
decision making
– Clinician offers options and describes the associated
risks/benefits
– Patient and family expresses his/her preference/values:
What matters most or what are the priorities for the patient
and family
http://www.informedmedicaldecisions.org/
Patient Decision Aids
• When more than one option exists, decision aids
may aid in achieving consensus or agreement
–Tools that help people become involved in decision making
by making explicit the decision that needs to be made,
providing information about the options and outcomes, and
by clarifying personal values.
• They are designed to complement, rather than
replace, counseling from a health practitioner.
Ottawa Hospital Research Institute: http://decisionaid.ohri.ca/AZlist.html
Decision Aids & Training
Ottawa Hospital Research Institute: http://decisionaid.ohri.ca/AZlist.html
Decision Aids & Training
Ottawa Hospital Research Institute: http://decisionaid.ohri.ca/AZlist.html
Patient Decision Aids
Ottawa Hospital Research Institute:
https://www.healthwise.net/cochranedecisionaid/Content/StdDocument.aspx?DOCHWID=abk4103
An Under-Utilized Resource
“In our country, patients are the most underutilized resource, and they have the most at
stake. They want to be involved and they can be
involved. Their participation will lead to better
medical outcomes at lower costs with
dramatically higher patient & customer
satisfaction.”
Charles Safran, M.D.
President, American Medical Informatics Association
Testimony Before the Subcommittee on Health
of the House Committee on Ways and Means
Case Study – What Next?
• Shared decision making
discussion occurs with you and
patient and family
• Decision to implant
CardioMEMS device
• Patient continues to take GDMT
and monitor his vital signs and
weights 2-3 times a week
• Able to return to work and travel
with his family!
THANK YOU!
QUESTIONS?
Discussion Questions
• Have you used one of the new heart failure
medications (ivabradine or
sacubitril/valsartan) in your practice?
• Did you have difficulty with insurances
getting coverage for your patient(s)?
• How frequently do you monitor HF patients
during a period of medication titration? In
person or by phone?
More Discussion Questions
• Have you used the PCNA patient education
fact sheets in your practice?
– Other educational tools that you would
recommend?
• Have you used decision aids in your
practice?
– If so, which ones?
– Do you find them helpful?