New Advances in the Diagnosis and Management of Acute and Chronic
Heart Failure
Deborah Budge, MD Intermountain Healthcare Heart Failure Cardiologist
Objectives: • State the updates from the ACC 2013 HF Guidelines • Describe guideline-directed medical therapy for HF
with reduced EF • Understand the mechanism of action of a new therapy
for HF and the results of the initial study
Deborah Budge, MD
Updates in Heart Failure
ACC/AHA 2013 Guideline Update &
PARADIGM
• ~ 6 million symptomatic patients, estimated 10 million in 2037
• Incidence: About 550,000 new cases/year
• More deaths from heart failure than from all forms of cancer combined
• Prevalence is 1% between the ages of 50 and 59, progressively increasing to >10% over age 80
• Over $35 billion/year (5% to 7% of total health care cost)
American Heart Association. 2012 Heart Disease and Stroke Statistical Update.
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ilure
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Heart Failure in the US
Definition of Heart Failure Classification Ejection
Fraction Description
I. Heart Failure with Reduced Ejection Fraction (HFrEF)
≤ 40% Also referred to as systolic HF. Randomized clinical trials have mainly enrolled patients with HFrEF and it is only in these patients that efficacious therapies have been demonstrated to date.
II. Heart Failure with Preserved Ejection Fraction (HFpEF)
≥ 50% Also referred to as diastolic HF. Several different criteria have been used to further define HFpEF. The diagnosis of HFpEF is challenging because it is largely one of excluding other potential noncardiac causes of symptoms suggestive of HF. To date, efficacious therapies have not been identified.
a. HFpEF, Borderline
41% to 49%
These patients fall into a borderline or intermediate group. Their characteristics, treatment patterns, and outcomes appear similar to those of patient with HFpEF.
b. HFpEF, Improved > 40% It has been recognized that a subset of patients with HFpEF previously had HFrEF. These patients with improvement or recovery in EF may be clinically distinct from those with persistently preserved or reduced EF. Further research is needed to better characterize these patients.
Yancy CW et al. Circulation. 2013;128:e240-e327.
New Approach to the Classification of Heart Failure
• Marked symptoms at rest despite maximal medical therapy (eg, those who are recurrently hospitalized or cannot be discharged from the hospital without specialized interventions)
Refractory end-stage HF D
• Known structural heart disease • Shortness of breath and fatigue • Reduced exercise tolerance
Symptomatic HF C
• Previous MI • LV systolic dysfunction • Asymptomatic valvular disease
Asymptomatic HF B
• Hypertension • CAD • Diabetes mellitus • Family history of cardiomyopathy
High risk for developing heart failure (HF) A
Patient Description Stage
Modified from Jessup M. et al. Circulation.2009
Classification of Heart Failure ACC/AHA Stage and NYHA 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 HTN 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
IV Symptomatic at rest
III Symptomatic with minimal exertion
None
Jessup M. et al. Circulation.2009 New York Heart Association/Little Brown and Company, 1964. Adapted from: Farrell MH et al.JAMA.2002.
Stage A
Diabetes Hypertension
Obesity Atherosclerosis
Stage B
MI Asymptomatic
systolic/diastolic dysfunction
Asymptomatic valvular disease
Stage C
Symptomatic HF Stage D
Advanced HF
590,000
480,000
49,000
4,900
Heart Failure Prevalence by Stage,
Utah*
*Estimates. Go AS, et al. Heart Disease and Stroke Statistics-2013 Update. Circulation 2013;127:e6-e245.
Utah Department of Health. The Impact of Heart Disease and Stroke in Utah 2012.
Stages, Phenotypes and Treatment of HF
STAGE AAt high risk for HF but without structural heart
disease or symptoms of HF
STAGE BStructural heart disease
but without signs or symptoms of HF
THERAPYGoals• 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
STAGE CStructural heart disease
with prior or current symptoms of HF
THERAPYGoals• 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
STAGE DRefractory HF
THERAPYGoals• 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
e.g., Patients with:• Known structural heart disease and• HF signs and symptoms
HFpEF HFrEF
THERAPYGoals• 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
THERAPYGoals• Control symptoms• Improve HRQOL• Reduce hospital
readmissions• Establish patient’s end-
of-life goals
Options• Advanced care
measures• Heart transplant• Chronic inotropes• Temporary or permanent
MCS• Experimental surgery or
drugs• Palliative care and
hospice• ICD deactivation
Refractory symptoms of HF at rest, despite GDMT
At Risk for Heart Failure Heart Failure
e.g., Patients with:• Marked HF symptoms at
rest • Recurrent hospitalizations
despite GDMT
e.g., Patients with:• Previous MI• LV remodeling including
LVH and low EF• Asymptomatic valvular
disease
e.g., Patients with:• HTN• Atherosclerotic disease• DM• Obesity• Metabolic syndrome orPatients• Using cardiotoxins• With family history of
cardiomyopathy
Development of symptoms of HFStructural heart
disease
Yancy CW et al. Circulation. 2013;128:e240-e327.
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Recommendations COR LOE ICD therapy is recommended for primary prevention of SCD in selected patients with HFrEF at least 40 days post-MI with LVEF ≤35%, and NYHA class II or III symptoms on chronic GDMT, who are expected to live ≥1 year*
I A
CRT is indicated for patients who have LVEF ≤35%, sinus rhythm, LBBB with a QRS ≥150 ms
I
A (NYHA class III/IV) B (NYHA class II)
ICD therapy is recommended for primary prevention of SCD in selected patients with HFrEF at least 40 days post-MI with LVEF ≤30%, and NYHA class I symptoms while receiving GDMT, who are expected to live ≥1 year*
I B
CRT can be useful for patients who have LVEF ≤35%, sinus rhythm, a non-LBBB pattern with a QRS ≥150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT.
IIa A
CRT can be useful for patients who have LVEF ≤35%, sinus rhythm, LBBB with a QRS 120 to 149 ms, and NYHA class II, III or ambulatory IV symptoms on GDMT
IIa
B
CRT can be useful in patients with AF and LVEF ≤35% on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) AV nodal ablation or rate control allows near 100% ventricular pacing with CRT
IIa B
Practical System
Patient with cardiomyopathy on GDMT for >3 mo or on GDMT and >40 d after MI, or with implantation of pacing or defibrillation device for special indications
LVEF <35%
Evaluate general health statusComorbidities and/or frailty
limit survival with good functional capacity to <1 y
Continue GDMT without implanted device
Acceptable noncardiac health
Evaluate NYHA clinical status
NYHA class I
• LVEF ≤30%• QRS ≥150 ms• LBBB pattern• Ischemic
cardiomyopathy• QRS ≤150 ms• Non-LBBB pattern
NYHA class II
• LVEF ≤35%• QRS 120-149 ms• LBBB pattern• Sinus rhythm
• QRS ≤150 ms• Non-LBBB pattern
• LVEF ≤35%• QRS ≥150 ms• LBBB pattern• Sinus rhythm
• LVEF ≤35%• QRS ≥150 ms• Non-LBBB pattern• Sinus rhythm
Colors correspond to the class of recommendations in the ACCF/AHA Table 1.
Benefit for NYHA class I and II patients has only been shown in CRT-D trials, and while patients may not experience immediate symptomatic benefit, late remodeling may be avoided along with long-term HF consequences. There are no trials that support CRT-pacing (without ICD) in NYHA class I and II patients. Thus, it is anticipated these patients would receive CRT-D unless clinical reasons or personal wishes make CRT-pacing more appropriate. In patients who are NYHA class III and ambulatory class IV, CRT-D may be chosen but clinical reasons and personal wishes may make CRT-pacing appropriate to improve symptoms and quality of life when an ICD is not expected to produce meaningful benefit in survival.
NYHA class III & Ambulatory class IV
• LVEF ≤35%• QRS 120-149 ms• LBBB pattern• Sinus rhythm
• LVEF ≤35%• QRS 120-149 ms• Non-LBBB pattern• Sinus rhythm
• LVEF ≤35%• QRS ≥150 ms• LBBB pattern• Sinus rhythm
• LVEF≤35%• QRS ≥150 ms• Non-LBBB pattern• Sinus rhythm
• Anticipated to require frequent ventricular pacing (>40%)
• Atrial fibrillation, if ventricular pacing is required and rate control will result in near 100% ventricular pacing with CRT
Special CRT Indications
Practical System
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Represents optimal medical therapy as defined by the
ACCF/AHA guideline- recommended therapies
(primarily Class I)
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Potential benefits of using risk scoring in HF: - Enables patients and families to have a
realistic expectation of prognosis - Promotes open communication between
clinicians, patients, and families to define goals of therapy
- Enables selection of therapies most likely to positively affect the quality and quantity of life
- Enables appropriate allocation of resources, including transplant, MCS, and ICD
Goldberg LR, Jessup M. Circulation 2007;116(4):360.
Risk Scoring
Risk Scores to Predict Outcomes in HF Risk Score Reference (from full-text guideline)/Link
Chronic HF All patients with chronic HF Seattle Heart Failure Model (204) / http://SeattleHeartFailureModel.org
Heart Failure Survival Score (200) / http://handheld.softpedia.com/get/Health/Calculator/HFSS-Calc-37354.shtml
CHARM Risk Score (207) CORONA Risk Score (208)
Specific to chronic HFpEF I-PRESERVE Score (202)
Acutely Decompensated HF ADHERE Classification and Regression Tree (CART) Model
(201)
American Heart Association Get With the Guidelines Score
(206) / http://www.heart.org/HEARTORG/HealthcareProfessional/GetWithTheGuidelinesHFStroke/GetWithTheGuidelinesHeartFailureHomePage/Get-With-The-Guidelines-Heart-Failure-Home- %20Page_UCM_306087_SubHomePage.jsp
EFFECT Risk Score (203) / http://www.ccort.ca/Research/CHFRiskModel.aspx
ESCAPE Risk Model and Discharge Score (215)
OPTIMIZE HF Risk-Prediction Nomogram
(216)
Yancy CW et al. Circulation. 2013;128:e240-e327.
Seattle Heart Failure Model (SHFM)
Validated multivariable risk scores can be useful to estimate subsequent risk of mortality in ambulatory or hospitalized patients with HF.
I IIa IIb III
Risk Scoring
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Natriuretic peptides: mechanisms
UpToDate
Initial diagnosis Prognosis Chronic management in the outpatient
setting
Use of Natriuretic Peptides in Chronic Heart Failure
32%
9%
Natriuretic Peptides and Prognosis in Chronic Heart Failure
Masson S, et al. Clin Chem 2006;52:1528-38 theHeart.org
Measurement of BNP or NT-proBNP is useful for establishing prognosis or disease severity in chronic HF.
I IIa IIb III
Use of Natriuretic Peptides in Chronic Heart Failure
Initial diagnosis Prognosis Chronic management in the outpatient
setting
Use of Natriuretic Peptides in Chronic Heart Failure
76-year-old man with ischemic cardiomyopathy, LVEF 25%, seen in clinic for routine evaluation
Admitted for decompensated heart failure 4 months ago, uneventful
hospitalization Reports NYHA Class II symptoms, denies congestive symptoms, says he
‘feels great’ Medications: carvedilol 12.5 mg BID, lisinopril 10 mg QD, furosemide 40
mg QD PE: BP 110/62, HR 66, JVP 6 cm, lungs clear, grade 2 MR murmur,
trace edema Labs: creatinine 1.4 mg/dL, BNP 329
Patient Example
Therapeutic inertia Differentiation responders vs non-responders Knowing if a patient is truly maximized on meds Assessing volume status Monitoring those who are ostensibly stable for
impending complications
Challenges with GDMT
Therapies which alter BNP levels
Therapy BNP Level
Diuresis
ACE-I
ARB
Beta-Blockers
Aldosterone Antagonists
CRT
Exercise
Rate control of AF
Serial NP Measurements for Prognostication in Chronic HF
Masson S, et al. J Am Coll Cardiol 2008;52:997-1003 theHeart.org
Understanding Heterogeneous Results in ‘Guided Therapy’ Trials
Motiwala SR, et al. Clin Pharm Ther 2013;93:57-67. theHeart.org
Objective: To compare a strategy of medical therapy titration aimed at achieving and maintaining an NT-proBNP target of < 1000 pg/mL (biomarker-guided therapy) to usual care in high risk patients with HFrEF
BNP- or NT-proBNP guided HF therapy can be useful to achieve optimal dosing of GDMT in select clinically euvolemic patients followed in a well-structured HF disease management program. The usefulness of serial measurement of BNP or NT-proBNP to reduce hospitalization or mortality in patients with HF is not well established.
I IIa IIb III
I IIa IIb III
Use of Natriuretic Peptides in Chronic Heart Failure
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Aldosterone Antagonist: Mechanism of Action
RALES
NEJM 1999;341:709-17. Cardiosource.com
EPHESUS
NEJM 2003;348:1309-21. Cardiosource.com
EMPHASIS-HF
NEJM 2011;364:11-21. Cardiosource.com
Aldosterone receptor antagonists are recommended in patients with NYHA class II-IV and who have LVEF of 35% or less, unless contraindicated, to reduce morbidity and mortality. Patients with NYHA class II should have a history of prior cardiovascular hospitalization or elevated plasma natriuretic peptide levels to be considered for aldosterone receptor antagonists. Aldosterone receptor antagonists are recommended to reduce morbidity and mortality following an acute MI in patients who have LVEF of 40% or less who develop symptoms of HF or who have a history of diabetes mellitus, unless contraindicated.
I IIa IIb III
Aldosterone Antagonists
I IIa IIb III
Creatinine should be 2.5 mg/dL or less in men or 2.0 mg/dL or less in women (or estimated glomerular filtration rate >30 mL/min/1.73m2) and potassium should be less than 5.0 mEq/L. Careful monitoring of potassium, renal function, and diuretic dosing should be performed at initiation and closely followed thereafter to minimize risk of hyperkalemia and renal insufficiency.
Aldosterone Antagonists
I IIa IIb III
Check potassium and renal function: - 2 to 3 days after starting therapy - 1 week after starting therapy, AND - At least monthly for the first 3
months
Fonarow G C et al. Circulation 2010;122:585-596
IMPROVE-HF
Pharmacologic Treatment for Stage C HFrEF HFrEF Stage C
NYHA Class I – IVTreatment:
For NYHA class II-IV patients. Provided estimated creatinine
>30 mL/min and K+ <5.0 mEq/dL
For persistently symptomatic African Americans, NYHA class III-IV
Class I, LOE AACEI or ARB AND
Beta Blocker
Class I, LOE CLoop Diuretics
Class I, LOE AHydral-Nitrates
Class I, LOE AAldosterone Antagonist
AddAdd Add
For all volume overload, NYHA class II-IV patients
Yancy CW et al. Circulation. 2013;128:e240-e327.
Strategies for Achieving Optimal GDMT
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions
• Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
#1 reason for hospitalization for people >65 years of age
National 30 day readmission rate 25% Mortality 50% at 5 years, 34% at 1 year
following a hospitalization ‘Many HF hospitalizations are driven by gaps in
the process of care rather than worsening pathophysiology’
Need for Improved Care Coordination
Collins SP, et al. J Am Coll Cardiol 2013;61:121-6.
Throughout the hospitalization as appropriate, before hospital discharge, at the first postdischarge visit, and in subsequent follow-up visits, the following should be addressed:
a. initiation of GDMT if not previously established and not contraindicated; b. precipitant causes of HF, barriers to optimal care transitions, and limitations in postdischarge support; c. assessment of volume status and supine/upright hypotension with adjustment of HF therapy, as appropriate; d. titration and optimization of chronic oral HF therapy; e. assessment of renal function and electrolytes, where appropriate; f. assessment and management of comorbid conditions; g. reinforcement of HF education, self-care, emergency plans, and need for adherence; and h. consideration for palliative care or hospice care in selected patients.
I IIa IIb III
Transitions of Care
Of the patients in Utah with HF, 87% have 3 or more chronic conditions, and
54% have 5 or more chronic conditions.
Multidisciplinary HF disease-management programs are recommended for patients at high risk for hospital readmission, to facilitate the implementation of GDMT, to address different barriers to behavioral change, and to reduce the risk of subsequent rehospitalization for HF. Scheduling an early follow-up visit (within 7 to 14 days) and early telephone follow-up (within 3 days) of hospital discharge is reasonable. Use of clinical risk prediction tools and/or biomarkers to identify patients at higher risk for postdischarge clinical events is reasonable.
I IIa IIb III
I IIa IIb III
I IIa IIb III
Transitions of Care
Mixed data evaluating sodium restriction in HF Observational data = association between
sodium intake and risk for hospitalization RCTs = lower sodium intake is associated
with worse outcomes in HFrEF No study has been done in optimally treated
patients
Sodium restriction is reasonable for patients with symptomatic HF to reduce congestive symptoms.
I IIa IIb III
Sodium Restriction
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Patient with cardiomyopathy on GDMT for >3 mo or on GDMT and >40 d after MI, or with implantation of pacing or defibrillation device for special indications
LVEF <35%
Evaluate general health statusComorbidities and/or frailty
limit survival with good functional capacity to <1 y
Continue GDMT without implanted device
Acceptable noncardiac health
Evaluate NYHA clinical status
NYHA class I
• LVEF ≤30%• QRS ≥150 ms• LBBB pattern• Ischemic
cardiomyopathy• QRS ≤150 ms• Non-LBBB pattern
NYHA class II
• LVEF ≤35%• QRS 120-149 ms• LBBB pattern• Sinus rhythm
• QRS ≤150 ms• Non-LBBB pattern
• LVEF ≤35%• QRS ≥150 ms• LBBB pattern• Sinus rhythm
• LVEF ≤35%• QRS ≥150 ms• Non-LBBB pattern• Sinus rhythm
Colors correspond to the class of recommendations in the ACCF/AHA Table 1.
Benefit for NYHA class I and II patients has only been shown in CRT-D trials, and while patients may not experience immediate symptomatic benefit, late remodeling may be avoided along with long-term HF consequences. There are no trials that support CRT-pacing (without ICD) in NYHA class I and II patients. Thus, it is anticipated these patients would receive CRT-D unless clinical reasons or personal wishes make CRT-pacing more appropriate. In patients who are NYHA class III and ambulatory class IV, CRT-D may be chosen but clinical reasons and personal wishes may make CRT-pacing appropriate to improve symptoms and quality of life when an ICD is not expected to produce meaningful benefit in survival.
NYHA class III & Ambulatory class IV
• LVEF ≤35%• QRS 120-149 ms• LBBB pattern• Sinus rhythm
• LVEF ≤35%• QRS 120-149 ms• Non-LBBB pattern• Sinus rhythm
• LVEF ≤35%• QRS ≥150 ms• LBBB pattern• Sinus rhythm
• LVEF≤35%• QRS ≥150 ms• Non-LBBB pattern• Sinus rhythm
• Anticipated to require frequent ventricular pacing (>40%)
• Atrial fibrillation, if ventricular pacing is required and rate control will result in near 100% ventricular pacing with CRT
Special CRT Indications
Indications for CRT in HF
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
Clinical Events and Findings Useful for Identifying Patients With Advanced HF
Repeated (≥2) hospitalizations or ED visits for HF in the past year Progressive deterioration in renal function (e.g., rise in BUN and
creatinine) Weight loss without other cause (e.g., cardiac cachexia) Intolerance to ACE inhibitors due to hypotension and/or worsening renal
function Intolerance to beta blockers due to worsening HF or hypotension Frequent systolic blood pressure <90 mm Hg Persistent dyspnea with dressing or bathing requiring rest Inability to walk 1 block on the level ground due to dyspnea or fatigue Recent need to escalate diuretics to maintain volume status, often
reaching daily furosemide equivalent dose >160 mg/d and/or use of supplemental metolazone therapy
Progressive decline in serum sodium, usually to <133 mEq/L Frequent ICD shocks
1. Does the patient have a reversible cause of heart failure? 2. Is the patient on the maximum/tolerated standard medical
HF therapy? 3. Is the patient candidate for CRT-D? If yes, will it make a
difference? 4. What is the patient’s prognosis in the next year without
MCS?(High risk for mortality ≥ 50%). 5. Does the patient have any irreversible co-morbidities that
will affect quality of life and survival after MCS implantation?
6. Does the patient have adequate financial and psychosocial support, and safe living environment?
7. Does the patient have high risk behavior?
Mechanical Circulatory Support Patient selection and Evaluation
HeartMate II - BTT Outcomes
J Am Coll Cardiol 2009;54:312–21
HeartWare (HVAD) - BTT Outcomes
Circulation. 2012; 125: 3191-3200
HeartMate II - DT Outcomes
Circ Heart Fail. 2012;5:241-48
Mechanical Circulatory Support
Area New Changes (2013) Format • Practical system
• Guideline-directed medical therapy (GDMT) • Harmonization with other guidelines, consensus documents
Content • Role of validated risk scores • Role of biomarkers
Oral pharmacologic treatment •Broader indications for aldosterone antagonists (mild to moderate HF)
Non-pharmacological interventions • Emphasis on education and transition of care • Balanced approach to Na restriction
Device therapy • Broader indications for CRT • No change for ICDs
Mechanical circulatory support • Class IIa indication for BTT, BTR, DT
ADHF • Loop diuretics – 1st-line therapy • Class IIb – low-dose dopamine • Class II – vasodilators
All-cause mortality
• Change from baseline in the clinical summary score of the Kansas City Cardiomyopathy Questionnaire at 8 months
• Time to new onset of atrial fibrillation
• Time to first occurrence of a protocol-defined decline in renal function
PARADIGM-HF: Secondary Endpoints
(all comparisons are versus
enalapril 20 mg daily, not versus placebo)
0
16
32
40
24
8
Enalapril (n=4212)
360 720 1080 0 180 540 900 1260 Days After Randomization
4187 4212
3922 3883
3663 3579
3018 2922
2257 2123
1544 1488
896 853
249 236
LCZ696 Enalapril
Patients at Risk
1117
Kap
lan-
Mei
er E
stim
ate
of
Cum
ulat
ive
Rat
es (%
)
914
LCZ696 (n=4187)
HR = 0.80 (0.73-0.87) P = 0.0000002
Number needed to treat = 21
PARADIGM-HF: Cardiovascular Death or Heart Failure Hospitalization (Primary Endpoint)
Thank You!