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lICENSE To Treat Failure: An updated approach. CDR Timothy Murray CHF Clinic Manager Internal Medicine Team Inpatient Pharmacy Clinical Coordinator Claremore Indian Hospital Clinical Assistant Professor University of Oklahoma Primary Care Cardiology Update April 9, 2011. Case #1. - PowerPoint PPT Presentation
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LICENSE TO TREAT FAILURE: AN UPDATED APPROACH CDR Timothy Murray CHF Clinic Manager Internal Medicine Team Inpatient Pharmacy Clinical Coordinator Claremore Indian Hospital Clinical Assistant Professor University of Oklahoma Primary Care Cardiology Update April 9, 2011
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Page 1: lICENSE To Treat Failure:  An updated approach

LICENSE TO TREAT FAILURE: AN UPDATED APPROACH

CDR Timothy MurrayCHF Clinic Manager

Internal Medicine TeamInpatient Pharmacy Clinical Coordinator

Claremore Indian HospitalClinical Assistant Professor

University of Oklahoma

Primary Care Cardiology UpdateApril 9, 2011

Page 2: lICENSE To Treat Failure:  An updated approach

Case #1 PT is a 37 yo white male whom is being consulted to the Internal

Medicine service today secondary to an CHF exacerbation. JS presented to the ER with a 5 day history of increased shortness of breath and 10 lb weight increase.

Symptoms started after a recent trip where a “poor” diet was consumed.

Family Hx: DM, CAD Social Hx: negative PMH: HTN, CAD Medication prior to admission:

Atenolol 25mg BID, aspirin 81mg daily, fish oil 1000mg daily, tamsulosin 0.4mg daily, KCL 8meq daily, furosemide 20mg daily

Page 3: lICENSE To Treat Failure:  An updated approach

Case #1

Vitals: BP- 152/77, HR-101, WT- 177lbs

Page 4: lICENSE To Treat Failure:  An updated approach

Case #1 Physical Exam: CHEST/LUNGS: Chest: Nontender Lungs: RALES Bilateral mostly at right base, no wheezing

CARDOVASCULAR: Cardiac: regular rate, regular rhythm, No murmur Pulses: Equal, DIMINISHED Very diminished at feet. Carotid: No bruit JVD: + distended Abd aorta: No Bruit

Lower ext: BILATERAL Edema of both legs mostly right side 3/4 and 2/4 at left.

Page 5: lICENSE To Treat Failure:  An updated approach

Case #1 PT is treated in the hospital for 3 days. Weight has decreased 15

lbs and he feels much better. PT is to be seen in the CHF clinic in 2weeks for medication adjustment, dietary education, and monitoring. Completed echocardiogram reveals an ejection fraction of 25%

PT returns to CHF clinic in 2wks with the following labs:

PNBP: 3200

Page 6: lICENSE To Treat Failure:  An updated approach

Case #1 Based upon the above case what type of interventions would you

have expected to have been performed? (during admission or in clinic)

A. Continue all medications prior to admissionB. Increase Atenolol, start an ace-inhibitor, & start an aldosterone

antagonistC. DC atenolol, start metoprolol succinate, & start an ace-inhibitorD. DC atenolol, start carvedilol, & start an ace-inhibitorE. Just give up and discharge patient from clinic!!!

Page 7: lICENSE To Treat Failure:  An updated approach

Heart Failure Background

Heart failure (HF) is a major public health problem resulting in substantial morbidity and mortality

Major cost-driver of HF is high incidence of hospitalizations1,2

JCAHO has initiated HF quality care indicators for hospitalized HF patients

1American Heart Association. 2003 Heart and Stroke Statistical Update. Dallas, Tex: American Heart Association; 2002.

Population Group

Prevalence

Incidence

Mortality

Hospital Discharge

s CostTotal population 4,900,000 550,000 51,546 999,000 $24.3

billion

1

Page 8: lICENSE To Treat Failure:  An updated approach

Estimated Direct and Indirect Costs of Heart Failure in US

8%8% 10%

7%

14%

53%

Hospitalization$13.6

Lost Productivity/Mortality*

$2.1Home Healthcare

$2.1

Drugs/Other Medical Durables

$2.7

Physicians/Other Professionals

$1.8

Nursing Home$3.5

*Lost future earnings of persons who will die in 2004, discounted by 3%AHA. Heart Disease and Stroke Statistics—2004 Update

Total Cost$25.8 billion

Page 9: lICENSE To Treat Failure:  An updated approach

Causes of Hospital Readmission for Congestive Heart Failure

17%Other

19%Failure to Seek

Care

16%Inappropriate Rx

Rx Noncompliance 24%

Diet Noncompliance24%

Annals of Internal Medicine 122:415-21, 1995

Over 2/3 of HF Hospitalizations Preventable

Page 10: lICENSE To Treat Failure:  An updated approach

Why a Hospital-based System for HF Management?

Patients Patient capture point Have patient’s/family’s attention:

“teachable moment” Predictor of care in community

Hospital structure Standardized processes / protocols / teams Accrediting bodies for standards of care Centers for Medicare and Medicaid

Services—peer review organization

Page 11: lICENSE To Treat Failure:  An updated approach

• Improved use of evidence- based therapy

• Improved symptom status and functional capacity

• Improved QOL• Reduction in

hospitalization• Decrease in total

medical costs

Benefits & Drawbacks of HF Disease Management Programs

Benefits Drawbacks

96%

4%

Usual Care

HF Disease Management

Program

Moser DK, Mann DL. Circulation. 2002;105:2810–2812.

Page 12: lICENSE To Treat Failure:  An updated approach

How did we get into this CHF mess??

Where did our process break down and why no reduction in hospitalizations or re-hospitalizations? Sub-optimal utilization of guidelines No standardization of care (standing orders) No team approach to treating CHF No increase in intensity of HF care after hospital

discharge

Page 13: lICENSE To Treat Failure:  An updated approach

How to get out of this CHF mess?? National registry Develop a treatment plan (protocol) Utilize a team approach to treating CHF Provide a comprehensive service to monitor & make

clinical alterations with patient’s treatment plan Provide patient education & training to involve patients

in their treatment plan Follow-up on patients discharged after a CHF

admission to avoid re-admission: CHF Clinic!!!!!! Implement & utilize national standards of care for CHF GET UP TO DATE WITH THE CHF GUIDELINES! Document – Document - Document!

Page 14: lICENSE To Treat Failure:  An updated approach

CMS Center of Medicaid & Medicare Services

Compliance rates for discharging CHF pts

Joint Commission/ACC/AHA CHF Performance Measures

Page 15: lICENSE To Treat Failure:  An updated approach

CMS CHF Core Measures

1. Documentation of discharge instructions

2. Left ventricular function assessment

3. Use of ACE-I or ARB in pts with left ventricular systolic failure

4. Documentation of smoking cessation

Page 16: lICENSE To Treat Failure:  An updated approach

CMS Hospitals should strongly consider

implementing a process of care to ensure these measures are obtained and proper documentation occurs.

The principal outcome measure of the ADHERE Registry was to assess overall hospital adherence to each of these measures for participating hospitals.

Page 17: lICENSE To Treat Failure:  An updated approach

CMS CMS 2009 Documentation privileges for

pharmacists!

Electronic Health Record advantages

GIPRA Measures/Performance Improvements

2010 CMS 30 day readmission policy changes

Beta Blockers?

Page 18: lICENSE To Treat Failure:  An updated approach

Medications Ace-Inhibitors Beta-Blockers Aldosterone Antagonists ARBs ISDN/Hydralazine Diuretics Digitalis Antiplatelets Statins Fish Oils Calcium Channel Blockers

Page 19: lICENSE To Treat Failure:  An updated approach

Guidelines Never Die CHF care driven by two sets of national

guidelines

American College of Cardiology/American Heart Association

Heart Failure Society of America

Page 20: lICENSE To Treat Failure:  An updated approach

Guidelines Never Die Both organizations provide a set of detailed

treatment guidelines for practitioners in an effort to optimize the management of chronic CHF.

Treatment guidelines provide an approach to

practice evidence based medicine.

Page 21: lICENSE To Treat Failure:  An updated approach

CHF National Guidelines Heart Failure Society of America

www.hfsa.org Last update: June 2010

American College of Cardiology/American Heart Association http://circ.ahajournals.org Last update: April 2009

Page 22: lICENSE To Treat Failure:  An updated approach

Guidelines 2009 ACC/AHA recommendation for: “implementation of practice based guidelines utilizing multidisciplinary disease-management programs in efforts to assist in the treatment of patients with CHF”.

Page 23: lICENSE To Treat Failure:  An updated approach

Guidelines 2010 HFSA recommendation for:“patients recently hospitalized for HF & other patients at high risk for HF decompensation should be considered for comprehensive HF disease management.”

Page 24: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (3.2)

HF Risk Factor Treatment GoalsRisk Factor GoalHypertension Generally < 130/80Diabetes See ADA guidelines1

Hyperlipidemia See NCEP guidelines2

Inactivity 20-30 min. aerobic 3-5 x wk.Obesity Weight reduction < 30 BMIAlcohol Men ≤ 2 drinks/day, women ≤ 1Smoking CessationDietary Sodium Maximum 2-3 g/day

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 25: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (3.3-3.4)Prevention—ACEI and Beta Blockers

ACE inhibitors are recommended for prevention of HF in patients at high risk for this syndrome, including those with: Coronary artery disease Peripheral vascular disease Stroke Diabetes and another major risk factor

Strength of

Evidence = A

ACE inhibitors and beta blockers are recommended for all patients with prior MI.

Strength of Evidence = A

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 26: lICENSE To Treat Failure:  An updated approach

Management of Patients with Known Atherosclerotic Disease But No HF

Treatment with ACE inhibitors decreases the risk of CV death, MI, stroke, or cardiac arrest.

NEJM 2000;342:145-53 (HOPE)Lancet 2003;362:782-8 (EUROPA)

0

5

10

15

20

0 1 2 3 4

Years

% MI,Stroke,

CV Death

0

3

6

9

12

15

0 1 2 3 4 5

Years

% MI, CV Death,

Cardiac Arrest

Placebo

Ramipril

Placebo

Perindopril

20% rel. risk red. p = .0003

22% rel. risk red. p < .001

HOPE

EUROPA

Page 27: lICENSE To Treat Failure:  An updated approach

Treatment of Post-MI Patients with Asymptomatic LV Dysfunction (LVEF ≤ 40%)

SAVE Study

All-cause mortality ↓19%

CV mortality ↓21% HF development ↓37% Recurrent MI ↓25%

0

0.1

0.2

0.3

0 0.5 1 1.5 2 2.5 3 3.5 4

Placebo

Captopril

Years

MortalityRate

19% rel. risk reduction p = 0.019

Pfeffer et al. NEJM 1992;327:669-77

Page 28: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.1, 7.7)Pharmacologic Therapy: ACE Inhibitors

ACE inhibitors are recommended for symptomatic and asymptomatic patients with an LVEF ≤ 40%.

Strength of Evidence = A

ACE inhibitors should be titrated to doses used in clinical trials (as tolerated during uptitration of other medications, such as beta blockers). Strength of Evidence = C

ACE inhibitors are recommended as routine therapy for asymptomatic patients with an LVEF ≤ 40%. Post MI Strength of Evidence = B Non Post-MI Strength of Evidence = C

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 29: lICENSE To Treat Failure:  An updated approach

ACE Inhibitors in Heart Failure: From Asymptomatic LVD to Severe HF

SOLVD Prevention (Asymptomatic LVD) 20% death or HF hosp. 29% death or new HF

CONSENSUS (Severe Heart Failure) 40% mortality at 6

mos. 31% mortality at 1 year 27% mortality at end of

study

SOLVD Investigators. N Engl J Med 1992;327:685-91SOLVD Investigators. N Engl J Med 1991;325:293-302CONSENSUS Study Trial Group. N Engl J Med 1987;316:1429-35

(Chronic Heart Failure)SOLVD Treatment

16% mortality

Page 30: lICENSE To Treat Failure:  An updated approach

ACE Inhibitors Used in Clinical Trials

Generic Name Trade Name Initial Daily Dose

Target Dose Mean Dose in Clinical Trials

Captopril Capoten 6.25 mg tid 50 mg tid 122.7 mg/day

Enalapril Vasotec 2.5 mg bid 10 mg bid 16.6 mg/day

Fosinopril Monopril 5-10 mg qd 80 mg qd N/A

Lisinopril Zestril, Prinivil

2.5-5 mg qd 20 mg qd 4.5 mg/day, 33.2 mg/day*

Quinapril Accupril 5 mg bid 80 mg qd N/A

Ramipril Altace 1.25-2.5 mg qd 10 mg qd N/A

Trandolapril Mavik 1 mg qd 4 mg qd N/A

*No mortality difference between high and low dose groups, but 12% lower risk of death or hospitalization in high dose group vs. low dose group.

Page 31: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.2)Pharmacologic Therapy: Substitutes for ACEI

It is recommended that other therapy be substituted for ACE inhibitors in the following circumstances: In patients who cannot tolerate ACE inhibitors due to cough,

ARBs are recommended. Strength of Evidence = A

The combination of hydralazine and an oral nitrate may be considered in such patients not tolerating ARBs. Strength of Evidence = C

Patients intolerant to ACE inhibitors from hyperkalemia or renal insufficiency are likely to experience the same side effects with ARBs. In these cases, the combination of hydralazine and an oral nitrate should be considered.

Strength of Evidence = C

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 32: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.6, 7.7)Pharmacologic Therapy: Beta Blockers

Beta blockers shown to be effective in clinical trials are recommended for symptomatic and asymptomatic patients with an LVEF ≤ 40%.

Strength of Evidence = A

Beta blockers are recommended as routine therapy for asymptomatic patients with an LVEF ≤ 40%. Post MI Strength of Evidence = B Non Post-MI Strength of Evidence = C

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 33: lICENSE To Treat Failure:  An updated approach

Effect of Beta Blockade on Outcome in Patients With HF and Post-MI LVD

Study Drug

HF Severity

Target Dose (mg)

Outcome

US Carvedilol1 carvedilol mild/ moderate

6.25- 25 BID

↓48% disease progression (p= .007)

CIBIS-II2 bisoprolol moderate/ severe

10 QD ↓34% mortality (p <.0001)

MERIT-HF3 metoprolol succinate

mild/ moderate

200 QD ↓34% mortality (p = .0062)

COPERNICUS4 carvedilol severe 25 BID ↓35% mortality (p = .0014)

CAPRICORN5 carvedilol post-MI LVD

25 BID ↓23% mortality (p =.031)

1Colucci WS et al. Circulation 1196;94:2800-6. 2CIBIS II Investigators. Lancet 1999;353:9-13.3MERIT-HF Study Group. Lancet 1999;353:2001-7. 4Packer M et al. N Engl J Med 2001;3441651-8. 5The CAPRICORN Investigators. Lancet 2001;357:1385-90.

Page 34: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.8) Pharmacologic Therapy: Beta Blockers

Beta blocker therapy is recommended for patients with a recent decompensation of HF after optimization of volume status and successful discontinuation of IV diuretics and vasoactive agents.

Whenever possible, beta blocker therapy

should be initiated in the hospital at a low dose prior to discharge of stable patients.

Strength of Evidence = B

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 35: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.11)

Pharmacologic Therapy: Beta Blockers

Continuation of beta blocker therapy is recommended in most patients experiencing a symptomatic exacerbation of HF during chronic maintenance treatment, unless they develop cardiogenic shock, refractory volume overload, or symptomatic bradycardia. Strength of Evidence = C

Temporary dose reduction may be considered Avoid abrupt discontinuation Reinstate or gradually increase prior to discharge Titrate dose to previously tolerated dose as soon as

possible

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 36: lICENSE To Treat Failure:  An updated approach

IMPACT-HF Primary End Point:Patients Receiving Beta Blocker at 60 Days

91%

73%

0%

25%

50%

75%

100%

Patie

nts

P <.0001

CarvedilolPredischarge Initiation

(n=185)

Physician DiscretionPostdischarge

Initiation*(n=178)

18%Improvement

Gattis WA et al. JACC 2004;43:1534-41

Page 37: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.9)

Pharmacologic Therapy: Beta Blockers

CONCOMITANT DISEASE

Beta blocker therapy is recommended in the great majority of patients with HF and reduced LVEF—even if there is concomitant diabetes, chronic obstructive lung disease or peripheral vascular disease. Use with caution in patients with:

Diabetes with recurrent hypoglycemia Asthma or resting limb ischemia.

Use with considerable caution in patients with marked bradycardia (<55 bpm) or marked hypotension (SBP < 80 mmHg).

Not recommended in patients with asthma with active bronchospasm. Strength of Evidence = C

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 38: lICENSE To Treat Failure:  An updated approach

Diabetes and the Use of Beta Blockers for HF: Relative Risk for Mortality and Hospitalization for Heart Failure

0 0.5 1.0 1.5 2.0

COPERNICUS (carvedilol)1

With diabetes Without diabetesMERIT-HF (ER metoprolol succinate)2

With diabetes Without diabetes

Mohacsi. Circulation. 2001;104(17):abstr 3551.Hjalmarson. JAMA. 2000;283(10):1295.

Page 39: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (11.8, 15.2)

Pharmacologic Therapy: Beta BlockersPRESERVED LVEF Beta blocker treatment is recommended in patients with HF and

preserved LVEF who have: Prior MI Strength of Evidence = A Hypertension Strength of Evidence = B Atrial fib. requiring control of ventricular rate

Strength of Evidence = B

THE ELDERLY Beta-blocker and ACE inhibitor therapy is recommended as

standard therapy in all elderly patients with HF due to LV systolic dysfunction. Strength of Evidence = B

In the absence of contraindications, these therapies are also recommended in the very elderly (age > 80 years).

Strength of Evidence = C

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 40: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline

Pharmacologic Therapy: Beta Blocker Overview*

General considerations

Initiate at low doses

Up-titrate gradually, generally no sooner than at 2 week intervals

Use target doses shown to be effective in clinical trials

Aim to achieve target dose in 8-12 weeks

Maintain at maximum tolerated doseIf symptoms worsen or other side effects appear

Adjust dose of diuretic or concomitant vasoactive med.

Continue titration to target after symptoms return to baseline

If up-titration continues to be difficult

Prolong titration interval

Reduce target dose

Consider referral to a HF specialist

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 41: lICENSE To Treat Failure:  An updated approach

Beta Blockers Used in Clinical Trials

Generic Name Trade Name Initial Daily Dose

Target Dose Mean Dose in Clinical Trials

Bisoprolol Zebeta 1.25 mg qd 10 mg qd 8.6 mg/day

Carvedilol Coreg 3.125 mg bid 25 mg bid 37 mg/day

Carvedilol Coreg CR 10 mg qd 80 mg qd

Metoprolol succinate CR/XL

Toprol XL 12.5-25 mg qd 200 mg qd 159 mg/day

Page 42: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.3)

Pharmacologic Therapy: Angiotensin Receptor Blockers

ARBs are recommended for routine administration to symptomatic and asymptomatic patients with an LVEF ≤ 40% who are intolerant to ACE inhibitors for reasons other than hyperkalemia or renal insufficiency.

Strength of Evidence = A

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 43: lICENSE To Treat Failure:  An updated approach

ARBS in Patients Not Taking ACE Inhibitors: Val-HeFT & CHARM-Alternative

50

60

70

80

90

100

0 3 6 9 12 15 18 21 24 270

10

20

30

40

50

0 9 18 27 36

Val-HeFT

Valsartan

Placebo

p = 0.017

Months

Surv

ival

%

CV D

eath

or

HF

Hos

p %

Placebo

Candesartan

CHARM-Alternative

HR 0.77, p = 0.0004

Months

Maggioni AP et al. JACC 2002;40:1422-4Granger CB et al. Lancet 2003;362:772-6

Page 44: lICENSE To Treat Failure:  An updated approach

Angiotensin Receptor Blockers Used in Clinical Trials

Generic Name Trade Name Initial Daily Dose

Target Dose Mean Dose in Clinical Trials

Candesartan Atacand 4-8 mg qd 32 mg qd 24 mg/day

Losartan Cozaar 12.5-25 mg qd 150 mg qd 129 mg/day

Valsartan Diovan 40 mg bid 160 mg bid 254 mg/day

Page 45: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.14-7.15) Pharmacologic Therapy: Aldosterone Antagonists

An aldosterone antagonist is recommended for patients on standard therapy, including diuretics, who have:

NYHA class IV HF (or class III, previously class IV) HF from reduced LVEF (≤ 35%)

One should be considered in patients post-MI with clinical HF or diabetes and an LVEF < 40% who are on standard therapy, including an ACE inhibitor (or ARB) and a beta blocker.

Strength of Evidence = A

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 46: lICENSE To Treat Failure:  An updated approach

Aldosterone Antagonists in HF

0.40

0.50

0.60

0.70

0.80

0.90

1.00

0 3 6 9 12 15 18 21 24 27 30 33 360.40

0.50

0.60

0.70

0.80

0.90

1.00

0 3 6 9 12 15 18 21 24 27 30 33 36

RALES (Advanced HF) EPHESUS (Post-MI)

Spironolactone

Placebo

Months

RR = 0.70P < 0.001

Eplerenone

Placebo

RR = 0.85P < 0.008

Pitt B. N Engl J Med 1999;341:709-17Pitt B. N Engl J Med 2003;348:1309-21

Prob

abili

ty o

f Sur

viva

l

Page 47: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.16-7.18) Aldosterone Antagonists and Renal Function

Aldosterone antagonists are not recommended when: Creatinine > 2.5mg/dL (or clearance < 30 mL/min) Serum potassium> 5.0 mmol/L Therapy includes other potassium-sparing diuretics

Strength of Evidence = A It is recommended that potassium be measured at

baseline, then 1 week, 1 month, and every 3 months Strength of Evidence = A

Supplemental potassium is not recommended unless potassium is < 4.0 mmol/L Strength of Evidence = A

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 48: lICENSE To Treat Failure:  An updated approach

EMPHASIS-HF Trial of 2737 patients with NYHA class 2 heart failure and an

ejection fraction of no more than 35%.

Patients were randomized to eplerenone (up to 50mg daily) or placebo in addition to recommended therapy.

Measured outcomes included: cardiovascular death/heart-failure hospitalization, cardiovascular death, heart-failure hospitalization, and hospitalization for hyperkalemia.

Trial was stopped early at 21months.

Page 49: lICENSE To Treat Failure:  An updated approach

EMPHASIS-HF EMPHASIS-HF Major results

Results in a 37% reduction in the primary end point of the composite of death from cardiovascular causes or hospitalization for heart failure!!

Hyperkalemia occurring in 11.8% of eplerenone patients vs 7.2% of those in placebo group!!!

Outcome Eplerenone (%)

Placebo (%) Adjusted hazard ratio

(95% CI)

P

Cardiovascular death/heart-failure hospitalization

18.3 25.9 0.63 (0.54-0.74)

< 0.001

Cardiovascular death

10.8 13.5 0.76 (0.61-0.94)

0.01

Heart-failure hospitalization

12.0 18.4 0.58 (0.47-0.70)

< 0.001

Hospitalization for hyperkalemia

0.3 0.2 1.15 (0.25-5.31)

0.85

Page 50: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.19)

Pharmacologic Therapy:Hydralazine and Oral Nitrates

A combination of hydralazine and isosorbide dinitrate is recommended as part of standard therapy, in addition to beta-blockers and ACE-inhibitors, for African Americans with HF and reduced LVEF: NYHA III or IV HF Strength of Evidence = A NYHA II HF Strength of Evidence = B

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 51: lICENSE To Treat Failure:  An updated approach

A-HeFT Outcomes

End point

ISDN-HDZN (n=518)

Placebo (n=532)

p

Primary end point composite score

-0.1 -0.5 0.01

All-cause mortality (%) 6.2 10.2 0.02

1st HF hospitalization (%) 16.4 24.4 0.001

Change in quality-of-life score at 6 months**

-5.5 -2.7 0.02

Taylor AL et al. N Engl J Med 2004; 351;2049-57

Page 52: lICENSE To Treat Failure:  An updated approach

A-HeFT All-Cause Mortality

85

90

95

100

0 100 200 300 400 500 600

Survival %

Days Since Baseline Visit

43% Decrease in Mortality

Fixed Dose ISDN/HDZN

Placebo

P = 0.01

Taylor AL et al. N Engl J Med 2004;351:2049-57

Page 53: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.23)

Pharmacologic Therapy: Diuretics

Diuretic therapy is recommended to restore and maintain normal volume status in patients with clinical evidence of fluid overload, generally manifested by: Congestive symptoms Signs of elevated filling pressures

Strength of Evidence = A

Loop diuretics rather than thiazide-type diuretics are typically necessary to restore normal volume status in patients with HF.

Strength of Evidence = B

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 54: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (7.24) Pharmacologic Therapy: Diuretics

Restoration of normal volume status may require multiple adjustments.

Once a diuretic effect is achieved with short-acting loop diuretics, increase frequency to 2-3 times a day if necessary, rather than increasing a single dose.

Strength of Evidence = B Oral torsemide may be considered in patients exhibiting

poor absorption of oral medication or erratic diuretic effect. Strength of Evidence = C

IV administration of diuretics may be necessary. Strength of Evidence = A

Diuretic refractoriness may represent patient nonadherence, a direct effect of diuretic use on the kidney, or progression of underlying dysfunction.

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 55: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (9.1, 9.4)

Device Therapy:Prophylactic ICD Placement

Prophylactic ICD placement should be considered in patients with an LVEF ≤35% and mild to moderate HF symptoms:

Ischemic etiology Strength of Evidence = A Non-ischemic etiology Strength of Evidence = B

In patients who are undergoing implantation of a biventricular pacing device, use of a device that provides defibrillation should be considered.

Strength of Evidence = B

Decisions should be made in light of functional status and prognosis based on severity of underlying HF and comorbid conditions, ideally after 3-6 mos. of optimal medical therapy. Strength of Evidence = C

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 56: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (12.5-12.20) Overview of Treatment Options for Patients with Acute

Decompensated HF

Fluid and sodium restriction Diuretics, especially loop diuretics Ultrafiltration/renal replacement therapy

(in selected patients only) Parenteral vasodilators *

(nitroglycerin, nitroprusside, nesiritide) Inotropes * (milrinone or dobutamine)

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 57: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (12.25, Table 12.7)Discharge Criteria for Hospitalized ADHF Patients

Recommended prior to discharge for all patients with HF: Exacerbating factors addressed Near optimum fluid status and pharmacologic therapy achieved Transition from IV to oral diuretic completed Patient education completed with clear discharge instructions Follow-up clinic visit scheduled, usually 7-10 days

Should be considered prior to discharge for patients with advanced HF or a history of recurrent admissions: Oral regimen stable for 24 hours No IV inotrope or vasodilator for 24 hours Ambulation before discharge to assess functional capacity Plans for post-discharge management Referral for disease management, if available

Strength of Evidence =C

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 58: lICENSE To Treat Failure:  An updated approach

Predictors of Mortality Based on Analysis of ADHERE Database

Classification and Regression Tree (CART) analysis of ADHERE data shows:

Three variables are the strongest predictors of mortality in hospitalized ADHF patients:

BUN > 43 mg/dLSystolic blood pressure < 115 mmHg

Serum creatinine > 2.75 mg/dL

Fonarow GC et al. JAMA 2005;293:572-80

Page 59: lICENSE To Treat Failure:  An updated approach

HFSA 2010 Practice Guideline (8.1)Heart Failure Patient Education

It is recommended that patients with HF and their family members or caregivers receive individualized education and counseling that emphasizes self-care.

This education and counseling should be delivered by providers using a team approach.

Teaching should include skill building and target behaviors.

Strength of Evidence = B

Journal of Cardiac Failure Vol. 16 No. 6 2010

Page 60: lICENSE To Treat Failure:  An updated approach

Evidence-Based Treatment Across the Continuum of Systolic LVD and HF

Control Volume Improve Clinical Outcomes

DiureticsRenal ReplacementTherapy*

Digoxin

-BlockerACEIor ARB

AldosteroneAntagonist

or ARB

Treat Residual Symptoms

CRT an ICD*

HDZN/ISDN**In selected patients

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Antiplatelets For years the discussion has been which

antiplatelet regimen is ideal for CHF pts? ASA Warfarin Plavix

WASH Trial WATCH Trial

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Risk Stratification

CHADS2

Congestive Heart Failure

Hypertension

Age > 75

Diabetes

Stroke or TIA (2 points)

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Risk Stratification CHA2DS2-VAS ScoreCongestive heart failure/LV 1 dysfunctionHypertension1Age > 75 years 2Diabetes mellitus 1Stroke/TIA 2Vascular disease (prior MI, peripheral 1 vascular disease)Age 65-75 years 1Female sex 1

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Selecting an Antiplatelet “Gadget”

Patient Factors

ASA Plavix Warfarin

Myocardial Infarction <12months ago

X X

Stent <12months ago

X X

Atrial Fibrillation (CHADS2 score 0-1)

X

Atrial Fibrillation (CHADS2 score >2)

X or Dabigatran

Diabetes XBYPASS Hx X

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Selecting an Antiplatelet “Gadget”

Patient Factors

ASA Plavix Warfarin

EF% < 30% X Systolic Failure w/ EF% >30%

X

Diastolic Failure XSevere CAD (no surgery option)

X X

LVAD X X X

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HFSA 2010 Practice Guidelines New RecommendationVTE prophylaxsis with low dose unfractionated heparin, LMWH, or fondaparinux to prevent proximal deep venous thrombosis and pulmonary embolism is recommended for patients who are admitted to the hospital with ADHF and who are not already anticoagulated & have no contraindication.

(Strength of Evidence=B)

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A View To A Trial IMPROVE-HF

Yancy CW, Fonarow GC, Albert NM, et al. Influence of patient age and sex on delivery of guideline-recommended heart failure care in the outpatient cardiology practice setting: Findings from IMPROVE HF. American Heart Journal. 2009;157:754-762.

Omega-3 (PUFAs) Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of n-3 polyunsaturated fatty acids in patients with

chronic heart failure (the GISSI-HF trial): a randomized, double-blind, placebo-controlled trial. Lancet 2008;372:1231-1239.

SELECT Trial Zebrack J, Munger M, MacGregor J, et al. B-Receptor Selectivity of Carvedilol and Metoprolol Succinate

in Patients with Heart Failure (SELECT Trial): A randomized Dose-Ranging Trial. Pharmacotherapy. 2009;29(8):883-890.

Irbesartan Massie b, Carson P, et al. Irbesartan in Patients with Heart Failure & Preserved Ejection Fraction (I-

Preserve Trial). NEJM. 2008;359(23):2456-2467 HFSA “The Heart Failure Clinic A Consensus Statement”

J Card Fail. 2008;14:801-815. Centers for Medicare and Medicaid Services 30 day congestive heart failure readmission

rates. http://www.hospitalcompare.hhs.gov

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No significant differences in the patients’ global assessment of symptoms or in changes from baselinerenal function with either bolus as compared with continuous infusion of intravenous furosemide orwith a low-dose strategy as compared with a highdose strategy.

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Hospital Quality Compare

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Hospital Quality Compare

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From Seattle With Love

Teaching tool to utilize with CHF patients Provides 5yr survival rate for patients based

upon clinical history and no intervention as compared to rate after intervention.

User friendly Internet based http://depts.washington.edu/shfm/

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From Seattle With Love

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From Seattle With Love

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Case #1 Based upon the above case what type of interventions would you

have expected to have been performed? (during admission or in clinic)

A. Continue all medications prior to admissionB. Increase Atenolol, start an ace-inhibitor, & start an aldosterone

antagonistC. DC atenolol, start metoprolol succinate, & start an ace-inhibitorD. DC atenolol, start carvedilol, & start an ace-inhibitorE. Just give up and discharge patient from clinic!!!


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