2013 Heart Failure Guideline Data Supplements

2013 Heart Failure Guideline Data Supplements

(Section numbers correspond to the full-text guideline.)

Table of Contents

Data Supplement 1. HFpEF (Section 2.2)............................................................................................................................... 3

Data Supplement 2. NYHA and AHA/ACC Class (Section 3) .............................................................................................. 4

Data Supplement 3. Prognosis ? Mortality (Section 4.1)........................................................................................................ 5

Data Supplement 4. Health-Related Quality of Life and Functional Capacity (Section 4.4) ................................................. 7

Data Supplement 5. Stress Testing (Initial and Serial Evaluation) of the HF Patient (Section 6.1.1) .................................. 11

Data Supplement 6. Clinical Evaluation ? History (Orthopnea) (Section 6.1.1) .................................................................. 13

Data Supplement 7. Clinical Evaluation ? Examination (Section 6.1.1) .............................................................................. 13

Data Supplement 8. Clinical Evaluation ? Risk Scoring (Section 6.1.2).............................................................................. 16

Data Supplement 9. Imaging Echocardiography (Section 6.4)............................................................................................. 18

Data Supplement 10. Biopsy (Section 6.5.3) ........................................................................................................................ 21

Data Supplement 11. Stage A: Prevention of HF (Section 7.1)............................................................................................ 22

Data Supplement 12. Stage B: Preventing the Syndrome of Clinical HF With Low EF (Section 7.2) ................................ 28

Data Supplement 13. Stage C: Factors Associated With Outcomes, All Patients (Section 7.3)........................................... 30

Data Supplement 14. Nonadherence (Section 7.3.1.1) ......................................................................................................... 38

Data Supplement 15. Treatment of Sleep Disorders (Section 7.3.1.4) ................................................................................. 47

Data Supplement 16. Cardiac Rehabilitation-Exercise (Section 7.3.1.6) ............................................................................. 49

Data Supplement 17. Diuretics Versus Ultrafiltration in Acute Decompensated HF (Section 7.3.2.1) ............................... 60

Data Supplement 18. ACE Inhibitors (Section 7.3.2.2) ........................................................................................................ 76

Data Supplement 19. ARBs (Section 7.3.2.3)....................................................................................................................... 82

Data Supplement 20. Beta Blockers (Section 7.3.2.4).......................................................................................................... 85

Data Supplement 21. Anticoagulation (Section 7.3.2.8.1).................................................................................................... 89

Data Supplement 22. Statin Therapy (Section 7.3.2.8.2)...................................................................................................... 94

Data Supplement 23. Omega 3 Fatty Acids (Section 7.3.2.8.3) ......................................................................................... 101

Data Supplement 24. Antiarrhythmic Agents to Avoid in HF (7.3.2.9.2) .......................................................................... 104

Data Supplement 25. Calcium Channel Blockers to Avoid in HF (Section 7.3.2.9.3) ....................................................... 105

Data Supplement 26. NSAIDs Use in HF (Section 7.3.2.9.4) ............................................................................................ 106

Data Supplement 27. Thiazolidinediones in HF (Section 7.3.2.9.5)................................................................................... 107

Data Supplement 28. Device-Based Management (Section 7.3.4) ..................................................................................... 108

Data Supplement 29. CRT (Section 7.3.4.2)....................................................................................................................... 109

Data Supplement 30. Therapies, Important Considerations (Section 7.4.2) ....................................................................... 114

Data Supplement 31. Sildenafil (Section Section 7.4.2) ..................................................................................................... 120

? American College of Cardiology Foundation and American Heart Association, Inc.

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Data Supplement 32. Inotropes (Section 7.4.4) .................................................................................................................. 123 Data Supplement 33. Inotropic Agents in HF (Section 7.4.4) ............................................................................................ 135 Data Supplement 34. Mechanical Circulatory Support (Section 7.4.5) .............................................................................. 136 Data Supplement 35. LVADs (Section 7.4.5)..................................................................................................................... 138 Data Supplement 36. Transplantation (Section 7.4.6) ........................................................................................................ 149 Data Supplement 37. Comorbidities in the Hospitalized Patient (Section 8.1) .................................................................. 159 Data Supplement 38. Worsening Renal Function, Mortality and Readmission in Acute HF (Section 8.5) ....................... 161 Data Supplement 39. Nesiritide (Section 8.7)..................................................................................................................... 165 Data Supplement 40. Hospitalized Patients ? Oral Medications (Section 8.8)................................................................... 177 Data Supplement 41. Atrial Fibrillation (Section 9.1) ........................................................................................................ 186 Data Supplement 42. HF Disease Management (Section 11.2) .......................................................................................... 187 Data Supplement 43. Telemonitoring (Section 11.2) ......................................................................................................... 189 Data Supplement 44. Quality Metrics and Performance Measures (Section 12)................................................................ 191 References........................................................................................................................................................................... 192

? American College of Cardiology Foundation and American Heart Association, Inc.

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Data Supplement 1. HFpEF (Section 2.2)

Study Name,

Aim of Study

Study Type

Author, Year

Study Size

Patient Population

Endpoints

Statistical Analysis (Results)

Study Limitations

Findings/ Comments

Masoudi JACC 2003;41:217223 12535812 (1)

To assess factors associated with preserved LVSF in pts with HF

Cross sectional cohort study

19,710

Owan NEJM 2006;355:251259 16855265 (2)

Define temporal trends in prevalence of HF with preserved LVEF over 15 y period

Retrospective 4,596 cohort study

Bhatia NEJM 2006;355:260269 16855266 (3)

Evaluate the epidemiological features and outcomes of pts with HFpEF vs. HFrEF

Retrospective 2,802 cohort study

Lee Circulation 2009;119:30703077 19506115 (4)

Assess the contribution of risk factors and disease pathogenesis to HFpEF

Retrospective 534 cohort study

Inclusion Criteria

Exclusion Criteria

Medicare beneficiary; hospitalized with principal discharge diagnosis of HF; acute care hospitalization; hospitalized between 4/1998-3/1999

Consecutive pts admitted to Mayo Clinic hospitals; Discharge code for HF; 1987-2001

No documentation of LVEF

No documentation of LVEF

Pts admitted to 103 Ontario hospitals; 4/1999-3/2001; discharge diagnosis of HF

No documentation of LVEF

Framingham

N/A

participants; incident HF

Preserved LVSF

Multivariable logistic regression to assess factors associated with preserved LVSF

Limited to Medicare population; limited to hospitalized pts; missing LVEF in a portion of the population

Factors associated with preserved LVSF, which included gender, advanced age, HTN, AF; and absence of coronary disease

Proportion of pts with Linear regression and

preserved LVSF;

survival analysis

survival

Death within 1 y; readmission for HF

Multivariable survival analysis

Factors associated with HFpEF; Mortality

Multivariable logistic regression (risk factors); multivariable survival analysis (mortality)

Limited to Olmsted County, MN; limited to hospitalized pts; missing LVEF in a portion of the population

Overall, more than half the population had preserved LVSF; this proportion increased overtime; survival in pts with HFpEF was only slightly better than for those with HFrEF (HR:0.96)

Limited to Ontario; limited to hospitalized pts; missing LVEF in a portion of the population

Limited to Framingham cohort; relatively small sample size

31% had HFpEF; HFpEF more often female, older, with AF, and HTN; Unadjusted mortality similar (22% for HFpEF vs. 26% for HFrEF); adjusted mortality also similar (aHR:1.13); readmission rates also similar between groups. Factors associated with HFpEF included female gender; elevated SBP; AF; and absence of CAD. Longterm prognosis equally poor (overall cohort median survival of 2.1 y; 5-y mortality 74%).

? American College of Cardiology Foundation and American Heart Association, Inc.

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Kane JAMA Measure changes in Retrospective 2042

Random sample from N/A

Diastolic function

Multivariable survival Limited to Olmsted County, In 4 y between baseline and

2011;306:856- diastolic function and cohort study

Olmsted County MN in

grade; incident HF analysis

MN; limited to those

follow-up, prevalence of

863

assess the

1997; age 45;

following up for 2nd

diastolic dysfunction

21862747 (5) relationship between

participating in baseline

examination

increased from 23.8% to

diastolic

and follow up

39.2%. Diastolic dysfunction

abnormalities and HF

assessments

associated with incident HF

risk

(HR:1.81)

AF indicates atrial fibrillation; CAD, coronary artery disease; HF, heart failure; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; HTN, hypertension; LVEF, left ventricular ejection fraction; LVSF, left ventricular

systolic function; MN, Minnesota; N/A, not applicable; pts, patients, and SBP, systolic blood pressure.

Data Supplement 2. NYHA and AHA/ACC Class (Section 3)

Study Name, Author, Year

Aim of Study

Study Type

Study Size

Patient Population

Endpoints

Statistical Analysis (Results)

Study Limitations

Findings/ Comments

Madsen BK, 1994 Predict CHF mortality 8013501 (6)

Longitudinal 190 registry

Inclusion Criteria

N/A

Exclusion Criteria

Must be ambulatory

Primary Endpoint

Death

Secondary Endpoint

N/A

Kaplan-Meier

N/A

Mortality increased with

increased NYHA class and

with decreased EF

Conducted primarily outside U.S.

Holland R, 2010 20142027 (7)

Predict CHF mortality using self-assessed NYHA class

Longitudinal 293 registry

Adults with CHF N/A after CHF admission

Readmission over 6 mo

MLHF

Survival analysis

questionnaire and Readmission rate increased

death

with higher NYHA class

No clinician assessment to compare to pt assessment

Conducted primarily outside U.S.

Anmar KA, 2007 17353436 (8)

Measure association of HF stages with mortality

Crosssectional cohort

2,029 Residents of

N/A

Olmsted Co, MN

5-y survival rates BNP

Survival analysis

Retrospective

N/A

HF stages associated with classification of stage

progressively worsening 5-y

survival rates

Goldman L, 1981 Reproducibility for

Longitudinal 75

7296795 (9)

assessing CV functional registry

class

All those referred N/A for treadmill testing

Reproducibility N/A testing

NYHA classification

N/A

Reproducibility only 56%

BNP indicates B-type natriuretic peptide; CHF, congestive heart failure; CV, cardiovascular; EF, ejection fraction; HF, heart failure; MLHF, Minnesota Living with Heart Failure; N/A, not applicable; NYHA, New York Heart Association; and pt, patient.

? American College of Cardiology Foundation and American Heart Association, Inc.

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Data Supplement 3. Prognosis - Mortality (Section 4.1)

Study Name, Author, Year

Aim of Study

Study Type

Study Size

The Seattle HF Model: Prediction of Survival in HF Levy, Wayne Circ 2006 16534009 (10)

Develop and validate a risk model for 1,2,and 3-y mortality

Cohort

Derivation: 1,125 Validation: 9,942

Predicting Mortality Among Pts Hospitalized with HF (EFFECT) Lee, Douglas JAMA 2003 14625335 (11)

Develop and validate a risk model for 30-d and 1-y mortality

Cohort

Derivation: 2,624 Validation: 1,407

Predictors of Mortality After Discharge in pts Hospitalized w/ HF (OPTIMIZEHF) O'Connor, Christopher AHJ 2008 18926148 (12)

Develop models predictive of 60 and 90 d mortality

Cohort study/registry

4,402

Patient Population

Inclusion Criteria

Exclusion Criteria

Derivation Cohort: EF

N/A

2.5 mg/dL; nonfatal

nonfatal MI;

C index of 0.80;

6

Validity - assessed by bootstrapping

Risk prediction nomogram: age, HR, SBP, sodium, Cr, primary cause for admit, LVSD

Used a clinical trial population; limited to ischemic etiology

Elderly pts on contemporary HF therapy; NTproBNP added

incremental value evaluate the

ischemic etiology; EF

chronic muscle disease or stroke (time death from any all-cause mortality

predictive

of apolipoprotein relative

40% (or 35% if NYHA II) unexplained CK >2.5x ULNl; to event)

cause or

or HF

information

A-1, high-

prognostic

TSH >2x ULN; any condition

hospitalization hospitalization: C

sensitivity C-

significance of

substantially reducing life

for HF

index of 0.701 (all

reactive peptide new

expectancy

models included

and NT proBNP biomarkers

NT-proBNP)

Wedel, Hans

EJHF 2009

19168876 (17)

Comparison of Examine the Cohort

33,533

Pts with primary ICD-9

N/A

Inhospital

N/A

Inhospital

N/A

N/A

Variability

Four Clinical

performance

discharge diagnosis of HF

mortality; in-

mortality: 4.5%;

among rules in

Prediction Rules of 4 clinical

admitted at one of 2

hospital

Inhospital mortality

the number of

for Estimating

prediction

Pennsylvania hospitals

mortality or

or serious medical

pts assigned to

Risk in HF

rules

from the ED

serious

complication:

risk groups and

Auble, Thomas E (ADHERE

complication;

11.2%; 30-d

the observed

Annals of

decision tree,

30-d mortality

mortality: 7.9%

mortality within

Emergency

ADHERE

ADHERE rules

risk group.

Medicine 2007 regression

could not be used

EFFECT

17449141 (18) model,

in 4.1% because

identified pts at

EFFECT,

BUN or SCr were

the lowest risk,

Brigham and

N/A.

ADHERE tree

Women's

identified largest

Hospital rule)

proportion of pts

for inpatient

in the lowest risk

death, 30-d

group

death, and

inhospital

death or

serious

complications

ADHERE indicates Acute Decompensated Heart Failure National Registry; AHA, American Heart Association; BUN, blod urea nitrogen; CHARM, Candesartan in Heart Failure: Assessment of Reduction in Mortality and morbidity; COPD, chronic obstructive

pulmonary disease; CORONA, Controlled Rosuvastatin Multinational Trial in HF; CV, cardiovascular; CVD, cardiovascular disease; ED, emergency department; EF, ejection fraction; EFFECT, Enhanced Feedback for Effective Cardiac Treatment; GWTG, Get

With the Guidelines; HF, heart failure; Hgb, hemoglobin; HR, heart rate; ICD-9, international classification of diseases; LVSD, left ventricular systolic dysfunction; MI, myocardial infarction; Na, sodium, N/A, not applicable; NT-proBNP; n-terminal pro-B-type

natriuretic peptide; NYHA, New York Heart Association; OPIMIZE-HF, Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure; pts, patients; RAD, reactive airway disease; ROC, receiver operating characteristic curve;

SBP, systolic blood pressure; SCr, serum creatinine; TSH, thyroid stimulating hormone; ULN, upper limit of normal.

Data Supplement 4. Health-Related Quality of Life and Functional Capacity (Section 4.4)

Study Name, Author, Year

Aim of Study

Study Type

Study Size

Patient Population

Inclusion

Exclusion

? American College of Cardiology Foundation and American Heart Association, Inc.

Endpoints

Primary

Secondary

7

Statistical Analysis (Results)

Study Limitations

Findings/Comments

Improvement in To determine the Secondary 425

HRQoL after

frequency,

analysis of

hospitalization durability, and data from the

predicts event- prognostic

ESCAPE trial

free survival in significance of

pts with advanced improved

HF. Moser et al HRQoL after

2009

hospitalization for

19879462 (19) decompensated

HF.

QoL and

To examine

Secondary 781

depressive

whether there are analysis of

symptoms in the differences in

COACH trial

elderly: a

QoL and

data plus

comparison

depressive

enrollment of

between pts with symptoms

a community

HF and age and between HF pts sample from

gender matched and an age and Netherlands

community

gender matched

controls. Lesman- group of

Leegte et al,

community-

2009.

dwelling elderly

19181289 (20) and determine

how chronic

comorbid

conditions qualify

the answer

Criteria

Hospitalized for NYHA class IV, at least 1 sign of fluid overload EF ................
................

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