2020 Symposia Series 1 The Pivotal Role of Primary Care Clinicians - - PowerPoint PPT Presentation

2020 Symposia Series 1

The Pivotal Role of Primary Care Clinicians in the Management of Heart Failure

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• Implement current evidence-based recommendations in the management of

patients with heart failure (HF)

• Differentiate the roles and responsibilities of team members involved in managing

patients with HF who are transitioning from the hospital to the community for continued care

• Develop strategies to manage patients with HF who present with acute illnesses
• r comorbidities

Learning Objectives

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• Complex syndrome in which the heart cannot pump blood at a rate commensurate with metabolic needs of the tissues, or can do

so only with high pressures

• Results from structural or functional impairment of ventricular filling (HFpEF, or diastolic HF) or ejection (HFrEF, or systolic HF) of

blood

• The term “heart failure” is preferred over “congestive heart failure”; some patients present without signs or symptoms of volume
• verload

Definition and Nomenclature of HF

EF = ejection fraction; ESC = European Society of Cardiology; HFmrEF = heart failure with mid-range ejection fraction; HFpEF = heart failure with preserved ejection fraction; HFrEF = heart failure with reduced ejection fraction. Kalogeropoulos AP, et al. JAMA Cardiol. 2016;1:510-518; Ponikowski P, et al. Eur Heart J. 2016;37:2129-2200; Yancy CW, et al. J Am Coll Cardiol. 2013;62:e147-e239.

HFrEF (EF ≤40%) Decreased pumping function of the heart—systolic HF Result: shortness of breath, fluid in lungs—symptomatic HF HFpEF (EF ≥50%) Major symptoms: shortness of breath and exercise intolerance HFpEF more common than HFrEF, but medical therapies proven effective only for HFrEF HFmrEF (EF 40%-49%) Epidemiologically more like HFpEF and usually treated as such

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• Prevalence in US

‒ >6.2 million people currently ‒ >8 million by 2030

• >1 million new cases/year
• 1 in 8 deaths due to HF
• Mortality ~50% within 5 years of diagnosis
• Higher incidence in blacks than in whites

when <75 years of age

• HF costs, 2012:

‒ Total: $30.7 billion ‒ Direct: $21 billion

Epidemiology and Burden of HF

SNF = skilled nursing facility. Benjamin EJ, et al. Circulation. 2019;139:e56-e66; Heidenreich PA, et al. Circ Heart Fail. 2013;6:606-619; Sieck S. Curr Emerg Hosp Med Rep. 2017;5:76-82.

Distribution of Direct Costs in HF

Inpatient Drug Outpatient SNF ED Hospice Other

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• GDMT for HF often not

prescribed to eligible patients who do not have contraindications to therapy

• Patients who do receive GDMT

are frequently underdosed

• Treating with GDMT and dosing

to target has a large impact on morbidity and mortality

CHAMP-HF: Suboptimal Real-world Use of GDMT in HF

GDMT = guideline-directed medical therapy; MRA = mineralocorticoid receptor antagonist. Greene SJ, et al. J Am Coll Cardiol. 2018;72:351-366. 60 13 72 67 33 39 86 26 33 66 0% 20% 40% 60% 80% 100% ACEI/ARB ARNI ACEI/ARB/ARNI Beta-Blocker MRA

Use of GDMT in Patients With HFrEF

With Contraindication Treated Without Contraindication and Not Treated % % % % % % % % % %

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Pathophysiology of HF

RAAS = renin-angiotensin-aldosterone system; SNS = sympathetic nervous system. Adapted from: Eichhorn EJ, et al. Circulation. 1996;94:2285-2296.

Cardiac injury Increased load Activation of RAAS, SNS, and cytokines Reduced systemic perfusion Direct toxicity Ischemia and energy depletion Growth and remodeling Altered gene expression Cell death Apoptosis Necrosis

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Case Study: Charles, 52-year-old data analyst

History

• 2 months of general fatigue and shortness of breath with minimal activity
• T2DM, hyperlipidemia, and hypertension; admits to “off and on” adherence

with medications and dietary changes

• Nonsmoker; 10 to 15 alcoholic drinks/month

Physical examination

• Height: 5 ft 11 in; weight: 238 lb (108 kg); BMI: 33.2 kg/m2
• Blood pressure: 157/95 mm Hg; heart rate: 108 beats/min; respiratory rate:

18 breaths/min; temperature: 98.7°F

• 2+ pitting edema feet; S3 heart sound; bilateral rales at lung bases

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Case Study (cont’d)

Laboratory findings

• Total cholesterol 156 mg/dL, LDL-C 74 mg/dL
• A1C 7.8%
• Potassium 4.1 mmol/L, creatinine 0.8 mg/dL
• ECG: no arrhythmias
• Chest x-ray: cardiomegaly and mild bilateral pleural effusions
• TTE 35% EF

Medications

• HCTZ 25 mg/d, atenolol 100 mg/d, atorvastatin 40 mg/d,

metformin 2000 mg/d, empagliflozin 25 mg/d

A1C = glycated hemoglobin; ECG = electrocardiogram; LDL-C = low-density lipoprotein cholesterol; HCTZ = hydrochlorothiazide; TTE = transthoracic echocardiogram.

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Classification of HF

*Patients should be treated to prevent progression and reduce morbidity and mortality; **patients should be treated to reduce symptoms or referred for advanced therapies or hospice. Yancy CW, et al. Circulation. 2013;128:1810-1852.

ACCF/AHA Stage (course of disease)* NYHA Functional Classification (symptoms at that moment)**

A At high risk for HF but without structural heart disease or symptoms of HF None B Structural heart disease but without signs or symptoms of HF I No limitation of physical activity; ordinary physical activity does not cause HF symptoms C Structural heart disease with prior or current symptoms of HF I No limitation of physical activity; ordinary physical activity does not cause HF symptoms II Slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in HF symptoms III Marked limitation of physical activity; comfortable at rest, but less than ordinary activity causes HF symptoms IV Unable to carry on any physical activity without HF symptoms, or symptoms at rest D Refractory HF requiring specialized interventions IV Unable to carry on any physical activity without HF symptoms, or symptoms at rest

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Elevated Natriuretic Peptide Levels Are a Biomarker for HF

Yancy CW, et al. Circulation. 2013;128:1810-1852.

• In ambulatory patients with dyspnea, measurement of BNP or NT-proBNP

is useful to support the diagnosis of HF

• BNP >100 pg/mL, NT-proBNP >300 pg/mL: HF very likely
• Measurement of BNP or NT-proBNP is also useful for establishing

prognosis or disease severity in chronic HF

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Cardiac Noncardiac

• HF, including RV syndromes
• ACS
• Heart muscle disease, including LVH
• Valvular heart disease
• Pericardial disease
• AF
• Myocarditis
• Cardiac surgery
• Cardioversion
• Advancing age
• Anemia
• Renal failure
• Pulmonary causes: obstructive sleep apnea, severe

pneumonia, pulmonary hypertension

• Critical illness
• Bacterial sepsis
• Severe burns
• Toxic metabolic insults, including cancer chemotherapy

and envenomation

• COVID-19

Causes of Elevated Natriuretic Peptide Levels

ACS = acute coronary syndrome; AF = atrial fibrillation; LVH = left ventricular hypertrophy; RV = right ventricular. Liu, et al. Circulation. 2020; [Epub ahead of print]; Yancy CW, et al. Circulation. 2013;128:1810-1852.

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Case Study (cont’d)

• Charles has stage C and NYHA class III HF because he has structural HF

with symptoms triggered by minimal activity

• You counsel him that:

‒ good blood pressure control is important for reducing his risk of complications from HF ‒ a low-salt diet will help reduce congestive symptoms ‒ regular exercise, such as walking 30 minutes for 5 days a week is important ‒ lifestyle changes can help manage his diabetes, weight, and HF, and you refer him to a dietitian ‒ various strategies can improve his medication adherence

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• Improve symptoms and QoL
• Prolong life by slowing disease progression
• Optimize patient education, adherence, referral
• Recognize patients who will benefit from specialized care, including ventricular

assist device and heart transplant

Goals of HF Management

QoL = quality of life. Yancy CW, et al. Circulation. 2013;128:1810-1852.

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• Patient and family education on self-care
• Regular, suitable physical activity
• Sodium restriction if congestive symptoms
• Cardiac rehabilitation for clinically stable patients
• Smoking cessation, weight loss
• Shared decision-making aligned with patient’s goals, values, preferences
• Enhanced patient education—refer to HF management program for at least one hour of

education with a qualified educator or AHA interactive workbook ⎻ www.heart.org/idc/groups/heart- public/@private/@wcm/@hcm/@gwtg/documents/downloadable/ucm_428949.pdf

Strategies for Optimal Management of HF in Primary Care: Nonpharmacologic Interventions

Allen LA, et al. Circulation. 2012;125:1928-1952; Gibbs CR, et al. BMJ. 2000;320:366-369.

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2017 ACC/AHA/HFSA Focused Update: New Target Blood Pressure Levels in HF

HFSA = Heart Failure Society of America. Yancy CW, et al. J Card Fail. 2017;23:628-651.

• <130 mm Hg systolic in patients with HFrEF and hypertension
• <130 mm Hg in patients with HFpEF and persistent hypertension

despite volume control

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Common Comorbidities of HF

TIA = transient ischemic attack. Hollenberg, et al. J Am Coll Cardiol. 2019;74:1966-2011.

Cardiovascular

• Acute coronary syndrome
• Aortic stenosis
• Atrial fibrillation/flutter
• Cerebrovascular disease, TIA/stroke
• Coronary artery disease
• Hypertension
• Mitral regurgitation
• Peripheral vascular disease

Systemic

• Acute worsening of kidney function
• Acute exacerbation of chronic lung disease
• Amyloidosis
• Anemia/iron deficiency
• Cancer
• Chronic kidney disease
• Diabetes mellitus
• Infection
• Liver disease
• Rheumatologic diseases, including gout
• Sleep apnea
• Thyroid disorders

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Guidelines for Managing Comorbidities in HF

ACC 2019 Expert Consensus Decision Pathway on Heart Failure provides links to guidelines for managing the many comorbidities in patients with HF

Hollenberg, et al. J Am Coll Cardiol. 2019;74:1966-2011.

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Prevention of HF/Treatment of Stage A HF

Yancy CW, et al. Circulation. 2013;128:1810-1852.

Goal: prevent myocardial injury

• Primary care clinicians can have the biggest impact in preventing HF
• Treat hypertension and dyslipidemia using current guidelines
• Other conditions/agents that may lead to or contribute to HF should be

controlled or avoided (eg, obesity, diabetes, tobacco use, known cardiotoxic agents)

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Therapies for HF: Stages B-D/Classes I-IV

Severity of HF Stage B C D Class I I II III IV Class IV ACE inhibitor or ARB      All stage C treatments, plus:

• Inotropic agents, vasodilators
• Experimental drugs/surgery
• ICD deactivation
• Transplant
• Mechanical circulatory support
• Palliative care, hospice

β-blocker      Diuretic (improves symptoms, not outcomes)    ARNI (sacubitril/valsartan)   Ivabradine   Aldosterone antagonist    ISDN/hydralazine*     Digoxin    CRT, ICD   

*ISDN/hydralazine is indicated in African Americans with class III-IV HF or in patients of any functional class unable to take ACE inhibitor/ARB. CRT = cardiac resynchronization therapy; ISDN = isosorbide dinitrate. Yancy CW, et al. Circulation. 2013;128:1810-1852; Yancy CW, et al. Circulation. 2016;134:e282-e293.

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Palliative carec (COR I) Transplantc (COR I) LV assist devicec (COR IIa) Investigational studiesd Refractory NYHA class III-IV (stage D) Symptoms improved Aldosterone antagonist (COR I) Discontinue ACE inhibitor

• r ARB; initiate ARNI

(COR I) Hydral-Nitratesb,c (COR I) ICDc (COR I) CRT or CRT-Dc (COR I) Ivabradine (COR IIa) NYHA class II-IV, provided est. CrCI >30 mL/min and K+ <5.0 mEq/L NYHA class II-III, adequate blood pressure on ACE inhibitor or ARBa; no C/I to ARB or sacubitril NYHA class III-IV in black patients NYHA class II-III, LVEF ≤35% (caveat: >1 y survival, >40 d post MI) NYHA class II-IV, LVEF ≤35%, NSR and QRS ≥150 ms with LBBB pattern NYHA class II-III, NSR, heart rate ≥70 bpm on maximally tolerated dose β-blocker HFrEF NYHA class I-IV (stage C) ACE inhibitor or ARB and GDMT β-blocker: diuretics as needed (COR I)

Treatment of HFrEF Stage C and D

aFull guidelines give important information about administration; but the combination of ISDN/HYD with ARNI has not been robustly tested; bblood pressure

response should be carefully monitored; csee 2013 HF guideline; dparticipation in investigational studies is also appropriate for stage C, NYHA class II-III HF. C/I = contraindication; COR = class of recommendation; CrCl = creatinine clearance; CRT-D = cardiac resynchronization therapy-device; LV = left ventricle; LVEF = left ventricular ejection fraction; K+ = potassium; LBBB = left bundle-branch block; MI = myocardial infarction; NSR = normal sinus rhythm. Yancy CW, et al. J Am Coll Cardiol. 2017;70:776-803.

Step 1: Establish Dx of HFrEF: assess volume; initiate GDMT Step 2: Consider following patient scenarios Step 3: Implement GDMT Choices not mutually exclusive, no order implied Step 4: Reassess Step 5: Consider additional therapy

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Palliative carec (COR I) Transplantc (COR I) LV assist devicec (COR IIa) Investigational studiesd Refractory NYHA class III-IV (stage D) Symptoms improved Aldosterone antagonist (COR I) Discontinue ACE inhibitor

• r ARB; initiate ARNI

(COR I) Hydral-Nitratesb,c (COR I) ICDc (COR I) CRT or CRT-Dc (COR I) Ivabradine (COR IIa) NYHA class II-IV, provided est. CrCI >30 mL/min and K+ <5.0 mEq/L NYHA class II-III, adequate blood pressure on ACE inhibitor or ARBa; no C/I to ARB or sacubitril NYHA class III-IV in black patients NYHA class II-III, LVEF ≤35% (caveat: >1 y survival, >40 d post MI) NYHA class II-IV, LVEF ≤35%, NSR and QRS ≥150 ms with LBBB pattern NYHA class II-III, NSR, heart rate ≥70 bpm on maximally tolerated dose β-blocker HFrEF NYHA class I-IV (stage C) ACE inhibitor or ARB and GDMT β-blocker: diuretics as needed (COR I)

Treatment of HFrEF Stage C and D

aFull guidelines give important information about administration; but the combination of ISDN/HYD with ARNI has not been robustly tested; bblood pressure

response should be carefully monitored; csee 2013 HF guideline; dparticipation in investigational studies is also appropriate for stage C, NYHA class II-III HF. C/I = contraindication; COR = class of recommendation; CrCl = creatinine clearance; CRT-D = cardiac resynchronization therapy-device; LV = left ventricle; LVEF = left ventricular ejection fraction; K+ = potassium; LBBB = left bundle-branch block; MI = myocardial infarction; NSR = normal sinus rhythm. Yancy CW, et al. J Am Coll Cardiol. 2017;70:776-803.

Step 1: Establish Dx of HFrEF: assess volume; initiate GDMT Step 2: Consider following patient scenarios Step 3: Implement GDMT Choices not mutually exclusive, no order implied Step 4: Reassess Step 5: Consider additional therapy

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Palliative carec (COR I) Transplantc (COR I) LV assist devicec (COR IIa) Investigational studiesd Refractory NYHA class III-IV (stage D) Symptoms improved Aldosterone antagonist (COR I) Discontinue ACE inhibitor

• r ARB; initiate ARNI

(COR I) Hydral-Nitratesb,c (COR I) ICDc (COR I) CRT or CRT-Dc (COR I) Ivabradine (COR IIa) NYHA class II-IV, provided est. CrCI >30 mL/min and K+ <5.0 mEq/L NYHA class II-III, adequate blood pressure on ACE inhibitor or ARBa; no C/I to ARB or sacubitril NYHA class III-IV in black patients NYHA class II-III, LVEF ≤35% (caveat: >1 y survival, >40 d post MI) NYHA class II-IV, LVEF ≤35%, NSR and QRS ≥150 ms with LBBB pattern NYHA class II-III, NSR, heart rate ≥70 bpm on maximally tolerated dose β-blocker HFrEF NYHA class I-IV (stage C) ACE inhibitor or ARB and GDMT β-blocker: diuretics as needed (COR I)

Treatment of HFrEF Stage C and D

aFull guidelines give important information about administration; but the combination of ISDN/HYD with ARNI has not been robustly tested; bblood pressure

response should be carefully monitored; csee 2013 HF guideline; dparticipation in investigational studies is also appropriate for stage C, NYHA class II-III HF. C/I = contraindication; COR = class of recommendation; CrCl = creatinine clearance; CRT-D = cardiac resynchronization therapy-device; LV = left ventricle; LVEF = left ventricular ejection fraction; K+ = potassium; LBBB = left bundle-branch block; MI = myocardial infarction; NSR = normal sinus rhythm. Yancy CW, et al. J Am Coll Cardiol. 2017;70:776-803.

Step 1: Establish Dx of HFrEF: assess volume; initiate GDMT Step 2: Consider following patient scenarios Step 3: Implement GDMT Choices not mutually exclusive, no order implied Step 4: Reassess Step 5: Consider additional therapy

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Palliative carec (COR I) Transplantc (COR I) LV assist devicec (COR IIa) Investigational studiesd Refractory NYHA class III-IV (stage D) Symptoms improved Aldosterone antagonist (COR I) Discontinue ACE inhibitor

• r ARB; initiate ARNI

(COR I) Hydral-Nitratesb,c (COR I) ICDc (COR I) CRT or CRT-Dc (COR I) Ivabradine (COR IIa) NYHA class II-IV, provided est. CrCI >30 mL/min and K+ <5.0 mEq/L NYHA class II-III, adequate blood pressure on ACE inhibitor or ARBa; no C/I to ARB or sacubitril NYHA class III-IV in black patients NYHA class II-III, LVEF ≤35% (caveat: >1 y survival, >40 d post MI) NYHA class II-IV, LVEF ≤35%, NSR and QRS ≥150 ms with LBBB pattern NYHA class II-III, NSR, heart rate ≥70 bpm on maximally tolerated dose β-blocker HFrEF NYHA class I-IV (stage C) ACE inhibitor or ARB and GDMT β-blocker: diuretics as needed (COR I)

Treatment of HFrEF Stage C and D

aFull guidelines give important information about administration; but the combination of ISDN/HYD with ARNI has not been robustly tested; bblood pressure

response should be carefully monitored; csee 2013 HF guideline; dparticipation in investigational studies is also appropriate for stage C, NYHA class II-III HF. C/I = contraindication; COR = class of recommendation; CrCl = creatinine clearance; CRT-D = cardiac resynchronization therapy-device; LV = left ventricle; LVEF = left ventricular ejection fraction; K+ = potassium; LBBB = left bundle-branch block; MI = myocardial infarction; NSR = normal sinus rhythm. Yancy CW, et al. J Am Coll Cardiol. 2017;70:776-803.

Step 1: Establish Dx of HFrEF: assess volume; initiate GDMT Step 2: Consider following patient scenarios Step 3: Implement GDMT Choices not mutually exclusive, no order implied Step 4: Reassess Step 5: Consider additional therapy

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Palliative carec (COR I) Transplantc (COR I) LV assist devicec (COR IIa) Investigational studiesd Refractory NYHA class III-IV (stage D) Symptoms improved Aldosterone antagonist (COR I) Discontinue ACE inhibitor

• r ARB; initiate ARNI

(COR I) Hydral-Nitratesb,c (COR I) ICDc (COR I) CRT or CRT-Dc (COR I) Ivabradine (COR IIa) NYHA class II-IV, provided est. CrCI >30 mL/min and K+ <5.0 mEq/L NYHA class II-III, adequate blood pressure on ACE inhibitor or ARBa; no C/I to ARB or sacubitril NYHA class III-IV in black patients NYHA class II-III, LVEF ≤35% (caveat: >1 y survival, >40 d post MI) NYHA class II-IV, LVEF ≤35%, NSR and QRS ≥150 ms with LBBB pattern NYHA class II-III, NSR, heart rate ≥70 bpm on maximally tolerated dose β-blocker HFrEF NYHA class I-IV (stage C) ACE inhibitor or ARB and GDMT β-blocker: diuretics as needed (COR I)

Treatment of HFrEF Stage C and D

aFull guidelines give important information about administration; but the combination of ISDN/HYD with ARNI has not been robustly tested; bblood pressure

response should be carefully monitored; csee 2013 HF guideline; dparticipation in investigational studies is also appropriate for stage C, NYHA class II-III HF. C/I = contraindication; COR = class of recommendation; CrCl = creatinine clearance; CRT-D = cardiac resynchronization therapy-device; LV = left ventricle; LVEF = left ventricular ejection fraction; K+ = potassium; LBBB = left bundle-branch block; MI = myocardial infarction; NSR = normal sinus rhythm. Yancy CW, et al. J Am Coll Cardiol. 2017;70:776-803.

Step 1: Establish Dx of HFrEF: assess volume; initiate GDMT Step 2: Consider following patient scenarios Step 3: Implement GDMT Choices not mutually exclusive, no order implied Step 4: Reassess Step 5: Consider additional therapy

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• NSAIDs

‒ Increase risk of hospitalization ‒ May antagonize effects of ACE inhibitor therapy ‒ May increase blood pressure and promote sodium and water retention

• Calcium channel blockers (non-dihydropyridine—verapamil, diltiazem)

‒ Increase risk of hospital readmission due to HF exacerbation ‒ Negative inotropic effects may be harmful in asymptomatic patients with low EF and no HF symptoms after MI ‒ No evidence of benefit with newer calcium channel blockers but may not be harmful (amlodipine and felodipine)

Medications to Avoid in HFrEF

NSAID = nonsteroidal anti-inflammatory drug. Yancy CW, et al. Circulation. 2013;128:1810-1852.

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Target Dosing for ACE Inhibitors, ARBs, and β-blockers

XL = extended release. *FDA recall of some ARB lots: www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan- and-irbesartan. Yancy CW, et al. Circulation. 2013;128:e240-e327; Yancy CW, et al. J Am Coll Cardiol. 2018;71:201-230; Yancy CW, et al. J Card Fail. 2017;23:628-651.

Drug Initial Daily Dose Target (Maximum) Daily Dose ACE Inhibitors Captopril 6.25 mg 3 times 50 mg 3 times Enalapril 2.5 mg twice 10 to 20 mg twice Lisinopril 2.5 to 5 mg once 20 to 40 mg once Ramipril 1.25 to 2.5 mg once 10 mg once ARBs* Candesartan 4 to 8 mg once 32 mg once Losartan 25 to 50 mg once 50 to 150 mg Valsartan 20 to 40 mg twice 160 mg twice β-blockers Bisoprolol 1.25 mg once 10 mg once Carvedilol 3.125 mg twice 25 mg twice (<85 kg) 50 mg twice (≥85 kg) Metoprolol succinate CR/XL 12.5 to 25 mg once 200 mg once

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ISDN/Hydralazine: Use in African American Patients

• Use of ISDN/hydralazine is associated with lower mortality rates in African American

patients with HFrEF—but may be underused

• Consider:

⎻ Establish therapy with ACE inhibitor/ARB, -blocker, and aldosterone antagonist, then switch to ARNI (after discontinuing ACE inhibitor for ≥36 hours); if stable, follow with ISDN/hydralazine if persistent class III-IV symptoms ⎻ OR ⎻ Establish therapy with ACE inhibitor/ARB, -blocker, and aldosterone antagonist, then proceed with ISDN/hydralazine if persistent class III-IV symptoms; if stable, follow with ARNI substitution for ACE inhibitor/ARB (after discontinuing ACE inhibitor for ≥36 hours)

Golwala HB, et al. J Am Heart Assoc. 2013;2:e000214; Yancy CW, et al. J Am Coll Cardiol. 2018;71:201-230.

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• Evaluated in patients with NYHA class II-IV HFrEF
• Neprilysin (enzyme) inhibitor + ARB; increases peptides (eg, BNP) usually

degraded by neprilysin to counter maladaptive mechanisms

• In patients with chronic symptomatic HFrEF NYHA class II-III who tolerate ACE

inhibitor or ARB, replacement with ARNI such as sacubitril/valsartan recommended to further reduce morbidity and mortality

• Approval based on PARADIGM-HF trial versus enalapril

Newer Medication Option in HF: Sacubitril/Valsartan

Entresto [prescribing information]. Novartis; 2015.

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• Lower rates of discontinuation with

sacubitril/valsartan due to AE (P = .03) or renal impairment (P = .002)

• More symptomatic hypotension with

sacubitril/valsartan (P <.001)

• Similar rates of angioedema, but:

‒ Do not use with history of angioedema ‒ Discontinue ACE inhibitor for ≥36 hours before starting sacubitril/valsartan

PARADIGM-HF: Reduction in Cardiovascular Death or HF Hospitalization With Sacubitril/Valsartan

AE = adverse event; CI = confidence interval; HR = hazard ratio. McMurray JJ, et al. N Engl J Med. 2014;371:993-1004; Yancy CW, et al. Circulation. 2016;134:e282-e293. 1.0 0.0 0.4 0.8 0.6 0.2 360 720 1080 180 540 900 1260

Days After Randomization Sacubitril/valsartan (n = 4187) Enalapril (n = 4212) HR, 0.80 (95% CI, 0.73-0.87) P <.001 Trial stopped early due to

• verwhelming

benefit of sacubitril/valsartan

0.3 0.7 0.5 0.1 0.9

Cumulative Probability

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PARADIGM-HF: Improvements in All-Cause Mortality and Quality

• f Life Measurements With Sacubitril/Valsartan

McMurray JJV et al. N Engl J Med. 2014;371:993-1004.

Reduction in HF symptoms and physical limitations as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

• 2.99
• 4.63
• 5
• 4.5
• 4
• 3.5
• 3
• 2.5
• 2
• 1.5
• 1
• 0.5

Enalapril Sacubitril/valsartan

Decrease in KCCQ Score

HR, 1.64 (95% CI, 0.63-2.65) P = 0.001 0.0 0.4 1.0 0.6 0.2 360 720 1080 180 540 900 1260

Days After Randomization Cumulative Probability Sacubitril/valsartan (n = 4187) Enalapril (n = 4212) HR, 0.84 (95% CI, 0.76-0.93) P <.001

0.3 0.5 0.1

↓16%

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Warnings and Precautions Contraindications Common AEs

• Fetal toxicity: discontinue if pregnant
• Monitor for angioedema and hypotension
• Monitor renal function and potassium in

susceptible patients

• Initiate ≥36 hours since last ACE inhibitor

dose

• Hypersensitivity to sacubitril or valsartan
• History of angioedema with ACE inhibitor
• r ARB use
• Concurrent use with ACE inhibitors
• Concurrent use with aliskiren in patients

with diabetes

• Hypotension
• Hyperkalemia
• Cough
• Dizziness
• Renal failure

Sacubitril/Valsartan: Practical Considerations and Safety

Entresto [prescribing information]. Novartis; 2018. Ponikowski P, et al. Eur Heart J. 2016;37:2129-2200; Yancy CW, et al. Circulation. 2016;134:e282-e293.

• Use with β-blocker
• Patients on moderate/high ACE inhibitor/ARB dose:

⎻ Start at 49/51 mg twice daily ⎻ After 2 to 4 weeks double to 97/103 mg twice daily, as tolerated

• Patients on low dose or no ACE inhibitor/ARB:

⎻ Start at 24/26 mg twice daily ⎻ Double every 2 to 4 weeks to target 97/103 mg twice daily, as tolerated

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• Ivabradine

‒ Inhibits the If “funny” (pacemaker) current in the sinoatrial node to decrease heart rate but does not impact contractility

• Dose adjusted to achieve heart rate of

50 to 60 beats/min or max dose of 7.5 mg twice daily

• Treatment effect driven by hospitalization

for HF

Newer Medication Option in HF: Ivabradine

Swedberg K, et al. Lancet. 2010;376:875-885. 6 12 18 24 30 40 30 20 10

Cumulative Frequency (%) ↓ 18% HR, 0.82 (95% CI, 0.75-0.90) P <.0001 Placebo (n = 3290) Ivabradine (n = 3268) Months

SHIFT: Reduction in Cardiovascular Death or HF Hospitalization

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• Can reduce HF hospitalization in patients with stable chronic HFrEF (LVEF ≤35%)

NYHA class II-III who are receiving GDMT, including maximally tolerated β- blocker, and who are in sinus rhythm with heart rate ≥70 beats/min

Ivabradine: Practical Considerations and Safety

AV = atrioventricular. Corlanor [prescribing information]. Amgen; 2017; Ponikowski P, et al. Eur Heart J. 2016;37:2129-2200; Yancy CW, et al. Circulation. 2016;134:e282-e293.

Warnings and Precautions Contraindications AEs

• Fetal toxicity: women should use

effective contraception

• Monitor for decreases in HR and

bradycardia symptoms

• Monitor for AF
• Not recommended in 2nd degree AV

block

• Acute decompensated HF
• Blood pressure <90/50 mm Hg
• Sick sinus syndrome, sinoatrial block, 3rd degree

AV block (unless pacemaker present)

• Resting heart rate <60 beats/min
• Severe hepatic impairment
• Pacemaker dependence
• Concurrent use of strong cytochrome CYP3A4

inhibitors

• Bradycardia
• Hypertension
• AF
• Phosphenes

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DPP-4 = dipeptidyl peptidase-4; GLP-1 RAs = glucagon-like peptide-1 receptor agonists; SGLT2 = sodium glucose cotransporter 2. Diabetes Care 2020;43(Suppl 1):S98-S110; Diabetes Care 2020;43(Suppl 1):S111–S134; Nassif, et al. Am J Cardiol 2019;124:S12−S19.

Class Effect on Outcomes in HF Weight Change Biguanides Neutral: metformin Neutral (potential for modest loss) SGLT2 Inhibitors Studies ongoing: canagliflozin, empagliflozin Benefit with or without T2DM, recently FDA-approved: dapagliflozin Loss GLP-1 RAs Neutral: dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide Loss DPP-4 Inhibitors Potential risk: alogliptin, linagliptin, saxagliptin, sitagliptin Neutral Thiazolidinediones Increased risk, black box warning: pioglitazone, rosiglitazone Gain Sulfonylureas (second generation) Neutral: glimepiride, glipizide, glyburide Gain

Effect of Antidiabetic Agents on HF Outcomes in Patients With T2DM

36

DAPA-HF: Dapagliflozin Reduced Risk of Worsening HF in Patients With HF, With or Without Diabetes

eGFR = estimated glomerular filtration rate. Adapted from: McMurray JJV, et al. N Engl J Med. 2019;381:1995-2008.

Subgroup Dapagliflozin (N = 2373) Placebo (N = 2371) Hazard Ratio (95% Cl) All patients Age ≤65 years >65 years NYHA class II III or IV T2DM at baseline Yes No Baseline eGFR (mL/min/1.73 m2) <60 ≥65 years 386/2373 162/1032 224/1341 190/1606 196/767 215/1075 171/1298 191/962 195/1410 502/2371 196/998 306/1373 289/1597 213/774 271/1064 231/1307 254/964 248/1406 0.74 (0.65-0.85) 0.78 (0.63-0.96) 0.72 (0.60-0.85) 0.63 (0.52-0.75) 0.90 (0.74-1.09) 0.75 (0.63-0.90) 0.73 (0.60-0.88) 0.72 (0.59-0.86) 0.76 (0.63-0.92)

0.5 0.8 1.0 1.2 Dapagliflozin Better Placebo Better

• no. of patients/total no.

37

Shared Decision-Making: A Patient-Centered Approach to HF Management

• Share information with patients and family
• Include patients and family in making treatment decisions
• Discuss difficult topics early on to simplify difficult decisions in the future
• Establish goals for outcomes that focus on more than just survival

(eg, symptom burden, quality of life)

• Reassess prognosis, goals of care, and advance care planning annually and

with significant events (eg, hospitalization for HF)

• Initiate timely planning for end-of-life care that aligns with patient’s goals,

values, preferences

Allen LA, et al. Circulation. 2012;125:1928-1952.

38

Case Study (cont’d)

• Charles has trouble adhering to his medication regimen and diet while
• n vacation, and is admitted to the hospital with blood pressure of

190/120 mm Hg and blurred vision

• In the hospital, his blood pressure is reduced with IV hydralazine

treatment

• Before discharge, he and his wife receive education about his

medication regimen and adherence, and a dietitian counsels him on strategies to maintain his heart healthy diet when away from home

• The first follow-up appointment is scheduled for 1 week after Charles

goes home

39

Successful Discharge Planning Requires Continuous Assessment and Optimization

Hollenberg, et al. J Am Coll Cardiol. 2019;74:1966-2011.

• In-hospital transition to oral therapies triggers multiple discharge

planning considerations ‒ Optimize medications ‒ Coordinate care with outpatient team

• Continuity of care—outpatient team must be able to access information
• n hospital course, planned therapies, and monitoring, etc
• Post-discharge appointment should be in 7 days

40

First follow-up visit

• Volume status
• Hemodynamic stability
• Kidney function and electrolytes
• Regimen of recommended therapies
• Patient understanding
• Adherence challenges (including insurance/coverage issues)
• Goals of care

Post-Discharge Follow-up Is Essential to Improved Outcomes

Hollenberg, et al. J Am Coll Cardiol. 2019;74:1966-2011.

41

Education and Communication to Patient, Family, and Care Team Is Important at Hospital Discharge

Hollenberg, et al. J Am Coll

• Cardiol. 2019;74:1966-2011.

2019 ACC Expert Consensus Decision Pathway on Risk Assessment, Management, and Clinical Trajectory of Patients Hospitalized With Heart Failure Checklists for

• Patient/Family/Caregiver

Education

• Communication to

Continuing Care Providers

EDUCATION TO PATIENT/FAMILY/CAREGIVER THAT IS CULTURALLY APPROPRIATE DELIVERED VERBALLY AND IN WRITTEN FORM ❑ Current meds

• Dose/frequency
• Potential side effects

❑ Activity level ❑ Dietary sodium restriction. _____ mg/day ❑ Fluid restriction ❑ Yes_____L/day or ❑ No ❑ Daily weight monitoring

• Has scale

❑ Yes ❑ No

• Logbook

❑ Yes ❑ No ❑ Assessment for peripheral edema ❑ Smoking cessation counseling for current or recent smokers ❑ Substance use counseling, if applicable ❑ List of warning signs of decompensation ❑ What to bring to each outpatient appointment

• List of meds
• Recordings of daily weights

❑ Who to call for increased weight/worsening symptoms/ICD discharge _______________________________________________________ ❑ Plans for continuation of care

• Cardiologist follow-up appointment

/ / .

• Primary care follow-up appointment

/ / .

• HF disease management program

/ / .

• Cardiac rehabilitation

/ / .

• Anticoagulation services follow-up,

if applicable / / ___ COMMUNICATION TO CONTINUING CARE PROVIDERS HOSPITAL COURSE ❑ Reason for admission ❑ Sentinel symptoms ❑ Congestion status

• Admission, discharge, and target weight
• Admission and discharge kidney function

❑ Unexpected events PLANNED THERAPIES AND MONITORING ❑ Plan for initiation, titration, and optimization of GDMT

• ACE inhibitor/ARB
• Beta blockers
• Aldosterone antagonists

❑ Plan to monitor electrolytes and kidney function ❑ Follow-up for pending or planned diagnostic tests ❑ Plan for EP consult if sudden death risk or potential candidate for device therapy ❑ Recommendations for when to assess response to therapy ❑ Pneumovax and Influenza vaccination FOLLOW-UP RELATED TO COMORBIDITIES ❑ Kidney function ❑ Diabetes ❑ Sleep-disordering breathing PSYCHOSOCIAL ISSUES RELEVANT TO INGOING ADHERENCE CONTINGENCY PLAN

• Diagnostic uncertainty
• What could go wrong and expected action plan

ADVANCE CARE PLANNING OR GOALS OF CARE DISCUSSIONS

• Indication
• Potential adherence issues
• Diuretic dosing
• Rescue dosing
• ARNI
• Ivabradine
• Hydralazine/isosorbide

❑ Depression ❑ Anemia ❑ Other

42

The Patient Is at the Center of Team-Based Care in HF

VNA = Visiting Nurse Association. Brush JE, et al. J Am Coll Cardiol. 2015;65:2118-36.

Primary Care Family/ Care Givers Community Resources VNA

HF Patient

Pharmacy Physical Therapy Palliative Care Hospice Acute Rehab/SNF/ Cardiac Rehab Nutrition Home Care Social Work/Clinical Resource Management

43

I Intravenous inotropes N NYHA class IIIB/IV or persistently elevated natriuretic peptides E End-organ dysfunction E EF ≤35% D Defibrillator shocks H Hospitalizations >1 for HF in past 12 months E Edema despite escalating diuretics L Low systolic BP ≤90 mm Hg, high heart rate P Prognostic medication; progressive intolerance or down-titration of GDMT

Indications to Refer to Advanced HF Program: “I NEED HELP”

Yancy, et al. J Am Coll Cardiol. 2018;71:201-230.

44

Case Conclusion

• At 3-month follow-up appointment, Charles’ symptoms have stabilized, and he

now has dyspnea only when walking across a large parking lot

• He reports no AEs on the regimen of HCTZ, carvedilol, ISDN/hydralazine,

spironolactone, and sacubitril/valsartan

• Charles has lost 16 pounds (7 kg) and his A1C decreased to 7.0%
• Potassium and creatinine levels are normal
• You continue him on the current regimen and schedule a follow-up appointment

and lab work in 1 month

• You also order a repeat TTE; he may need an ICD if EF remains ≤35%
• Charles may need to see a cardiologist in the future for advanced HF therapies if

his symptoms worsen

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PCE Action Plan

✓ Measure NT-proBNP or BNP to establish diagnosis and prognosis ✓ For enhanced patient education, refer patients to a comprehensive HF management program to improve outcomes ✓ Apply 2017 updated recommendations for target blood pressure in patients with HF ✓ Follow guidelines to reduce risk factors in Stage A HF ✓ Select guideline-directed medications for HF based on HF severity; titrate to target ✓ Consider use of ISDN/hydralazine in African American patients with HFrEF ✓ Use a patient-centered approach to involve patients in decision-making about HF therapy

PCE Promotes Practice Change

2020 Symposia Series 1