Maximizing Treatment Options with Congestive Heart failure

David Wolinsky FACC

Prime Care Physicians

Jan 31, 2009

CHF Magnitude in the US

5 million have CHF (prevalence)1

550,000 new cases annually (incidence)1

• HF most common cardiovascular discharge in elderly patients2

• 25% probability of dying over 2.5 years3

– 50% of these deaths occur suddenly1 American Heart Association. Heart Disease and Stroke Statistics – 2005 Update.2 NHLBI, CHF Data Fact Sheet, September 1996.3 Sweeney MO. PACE. 2001;24:871-888.

Classification of Heart Failure: ACC/AHA Stage vs NYHA Class

Heart Failure Treatment Algorithm

1 Framingham Heart Study (1948-1988) in Atlas of Heart Diseases.2 American Heart Association. Heart Disease and Stroke Statistics—2005 Update.

CHF Patients Survival Results1

100

90

80

70

60

50

40

30

20

10

0

Pro

bab

ilit

y o

f S

urv

ival

(%

)

Men (N = 237)

Time After CHF Diagnosis (Years)0 2 4 6 8 10

80% of men and 70% of women who have CHF will die within 8 years.2

Women (N = 230)

Hospitalization for Congestive Heart Failure is

a Sentinel Event

Paradigms of CHF Management

• Patient Based management

• ADHF• Chronic Heart Failure• Patient Based

approach• CORE Measures• ACC/AHA/HFSA

Guidelines

• Systems Based Approach

• Inpatient Therapy• Outpatient Therapy• Transitional Care• Measured by

Readmission and Mortality Rates

• Benchmarks?

*Adjusted for baseline age, sex, race, HF etiology, LVEF, systolic blood pressure, smoking, signs of congestion, laboratory values, discharge medications, in-hospital invasive procedures, and history of diabetes and cardiovascular, neurological, pulmonary, and renal diseases

End point LV systolic dysfunction, n=3001

Preserved LV systolic function, n=4153

Mortality 0.77 (0.68–0.87) 0.94 (0.84–1.07)

Readmission 0.89 (0.80–0.99) 0.98 (0.90–1.06)

Mortality or readmission

0.87 (0.79–0.96) 0.98 (0.91–1.06)

Hernandez AF et al. J Am Coll Cardiol 2009; 53:184-192.

Adjusted* hazard ratios (95% CI) for one-year outcomes, beta blocker therapy vs no beta blocker therapy, by LV functional status

Beyond CORE Measures

• Reduce readmission rate at 30 days• Reduce 30 day and 180 day mortality• Improve documentation• Incorporation of transitional care i.e.

redefine ‘home care”• Identlify endstage patients early on and

enroll into appropriate care algorithms• Implications of outcomes to patients,

physicians, and hospitals

RAS, renin-angiotensin system; SNS, sympathetic nervous system.

Myocardial injury to the heart (CAD, HTN, CMP, Valvular disease)

Morbidity and mortalityArrhythmiasPump failure

Peripheral vasoconstrictionHemodynamic alterations

Heart failure symptoms

Remodeling and progressiveworsening of LV function

Initial fall in LV performance, wall stress

Activation of RAAS and SNS

Fibrosis, apoptosis,hypertrophy,

cellular/molecular

alterations,myotoxicity

FatigueActivity altered Chest congestionEdemaShortness of breath

Neurohormonal Activation in Heart Failure

JCAHO: Quality-of-Care Indicators for HF

HF-1: Discharge Instructions

HF-2: Assessment of LV Function

HF-3: ACEI or ARB at Discharge in AppropriatePatients

HF-4: Smoking Cessation Advice/Counseling

www.jcaho.org

1. Daily weights 4. What to do if Sx worsen 2. 2 gram sodium diet 5. Follow-up appointment3. Activity Rx 6. List of medications

Heart Failure Core Measure Outcomes 2006-1st Q 2008

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

120.0%

Written D/C instructions (activitylevel, diet, d/c medications, f/u apt.,

wt. monitoring, worseningsymptoms)

LVF assessment ACEI/ARB Smoking cessationadvice/counseling

Quality Indicator

Pe

rce

nta

ge

1st Q 06 2nd Q 06 3rd Q 06 4th Q 06 1st Q 07 2nd Q 07 3rd Q 07 4th Q 07 1st Q 08

Heart Failure Appropriate Care Measure 2006 - 1st Q 2008

97.6%

90.8%

94.4%

90.1%

81.7%

71.8%68.0%

85.1%82.4%

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

120.0%

1st Q 06 2nd Q 06 3rd Q 06 4th Q 06 1st Q 07 2nd Q 07 3rd Q 07 4th Q 07 1st Q 08

Time Period

Perc

enta

ge

Health Grades CHF

Goals for Patients Hospitalized With HFGoals for Patients Hospitalized With HF

Relieve symptoms rapidly Reverse hemodynamic abnormalities Prevent end-organ dysfunction Initiate patient education and survival-

enhancing medications before discharge Optimize survival-enhancing oral medications

(ACE inhibitor, beta blocker, aldosterone receptor antagonist)

Optimize patient education and HF disease management

Relieve symptoms rapidly Reverse hemodynamic abnormalities Prevent end-organ dysfunction Initiate patient education and survival-

enhancing medications before discharge Optimize survival-enhancing oral medications

(ACE inhibitor, beta blocker, aldosterone receptor antagonist)

Optimize patient education and HF disease management

Case History

• 73 yo moved up from Fla and presented to SPH via car in acute CHF

• Past HX remote MI, remote CABG,Hx ICD, Hx chronic CHF, AFib EF less than 30

• COPD, OSA, DM, Hx carotid stent

• Non compliance felt to be component

• Initial BP 130/70 BUN 58 CR1.9

• ECG : Afib LBBB

Hospital Course

• Diuresed with bolus IV Bumex 2mg IV BID• Seen by cardiology for CHF x3 days• Seen by EP for evaluation of rhythm- active GI

bleed precludes TEE cardioversion. Later consider upgrade to Bivent device. Maintain rate control

• Discharged with BUN 34 and Cr 1.7• Meds Bumex 2 PO BID , Imdur 30QD, Coreg 25

BID, Hydralazine 25 TID

Readmitted 8 days later with sob

• “I told them I didn’t have enough diuretics”• Placed on hosp service boarded in PCU• Seen by cardiology 3 days later• Moved to CCU started on Nesiritide and Lasix

gtts• Diuresed 30 #, BUN 24 CR 1.4• Repeat EP evaluation BiV IVD already in place• MEDS: Lasix 80 BID, Coreg 25 BID, Coumadin,

Accupril 20,

Hospitalizations forAcute Decompensated Heart Failure

• Congestion is the primary reason for heart failure admissions

• This may be associated with systolic or diastolic dysfunction

• Low cardiac output and associated signs/ symptoms are uncommon.

• Sub-optimal weight reduction during hospitalization.

• Although appear improved clinically, many patients are discharged with persistent fluid overload (related to pulmonary congestion that is not being identified clinically).

Can we Risk Stratify Patients

• Early determination of level of care needed

• Determination of short term risk and needs

• Predict long term risk to guide adjunct therapy- ICD, CRT, Transplant , Hospice

Therapeutic Challenges

• Decongest organs • Diurese• Win the Battle with

the Kidneys

• Cardiac Decompensation urges the kidneys to play unfairly

Cardiorenal Syndrome• Worsening renal function in CHF patient who

remains congested despite increasing doses of diuretics

• Increased venous pressure with ”choked kidneys” and decreased cardiac output

• Neurohormonal activation • Decreased renal perfusion• Fluid retention• Worsening cardiac performance• POOR PROGNOSIS

Prognostic /Therapeutic Targets

• Blood Pressure

• Body Weight

• Serum Na

• Renal Function

• QRS Duration

• CAD

Fonarow GC et al. Circulation 1994; 90: I-488

High PCWP at Hospital Discharge is Associated with Higher Long-Term Mortality

Time (months)

N=199

N=257

PCWP > 16 mmHg

PCWP < 16 mmHg

Mortality (%)

0 6 12 18 240

10

20

30

40

50

60

P = 0.001

CI > 2.6 L/min/m2

CI < 2.6 L/min/m2

Mortality (%)

0 6 12 18 240

10

20

30

40

50

60

P = NS

N=236

N=220

Time (months)

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/dL

Systolic blood pressure < 115 mmHg

Serum creatinine > 2.75 mg/dL

BUN > 43 mg/dL

Systolic blood pressure < 115 mmHg

Serum creatinine > 2.75 mg/dL

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

ADHERE® CART: Predictors of Mortality

SYS BP 115SYS BP 115n=24,933n=24,933

SYS BP 115SYS BP 115n=24,933n=24,933

SYS BP 115SYS BP 115n=7,150n=7,150

SYS BP 115SYS BP 115n=7,150n=7,150

6.41%6.41%n=5,102n=5,1026.41%6.41%

n=5,102n=5,10215.28%15.28%N=2,048N=2,04815.28%15.28%N=2,048N=2,048

21.94%21.94%n=620n=620

21.94%21.94%n=620n=620

12.42%12.42%n=1,425n=1,42512.42%12.42%n=1,425n=1,425

5.49%5.49%n=4,099n=4,0995.49%5.49%

n=4,099n=4,0992.14%2.14%

n=20,834n=20,8342.14%2.14%

n=20,834n=20,834

BUN 43BUN 43N=33,324N=33,324

BUN 43BUN 43N=33,324N=33,324

Greater thanLess than

2.68%2.68%n=25,122n=25,122

2.68%2.68%n=25,122n=25,122

8.98%8.98%n=7,202n=7,2028.98%8.98%

n=7,202n=7,202

Cr 2.75Cr 2.752,0452,045

Cr 2.75Cr 2.752,0452,045

Highest to Lowest Risk CohortOR 12.9 (95% CI 10.4-15.9)

Reference: Fonarow GC, et al. Risk stratification for in-hospital mortality in heart failure using classification and regression tree(CART) methodology. JAMA. 2005;293:572-580.

Primary Prevention of Sudden Cardiac Arrest in

Heart Failure Patients with LV

Dysfunction

SCD in Heart Failure• Despite improvements in medical therapy,

symptomatic HF still confers a 20-25% risk of premature death in the first 2.5 years after diagnosis1-4

50% of these premature deaths are SCD (VT/VF)1-4

1 SOLVD Investigators. N Engl J Med 1992;327:685-691.2 SOLVD Investigators. N Engl J Med 1991;325:293-302.3 Goldman S. Circulation 1993;87:V124-V131.4 Sweeney MO. PACE. 2001;24:871-888.

Severity of Heart FailureModes of Death

1 MERIT-HF Study Group. LANCET. 1999;353:2001-2007.

12%

24%64%

CHF

Other

SuddenDeath(N = 103)

NYHA II

26%

15%

59%

CHF

Other

SuddenDeath(N = 103)

NYHA III

56%

11%

33%

CHF

Other

SuddenDeath(N = 27)

NYHA IV

14

11.6

8.47.89

8.2

4.9

7.2

0

2

4

6

8

10

12

14

16

1-17 mo 18 - 59 mo 60 - 119 mo > 120 mo

ConvICD

(n = 300) (n = 283) (n = 284) (n = 292)

Hazard Ratio .98

(p = 0.92)

0.52

(p = 0.07)

0.50

(p = 0.02)

0.62

(p = 0.09)

Wilber, D. Circulation. 2004;109:1082-1084.

Relation of Time from MI to ICD Benefit

in the MADIT-II Trial

Time from MI

% M

ort

alit

y fo

r E

ach

T

ime

Per

iod

HFSA 2006 Practice Guideline (9.1, 9.4)

Device Therapy:Prophylactic ICD Placement

In patients on optimal medical therapy (ideally 3-6 months) with or without concomitant coronary artery disease (including a prior MI > 1 month ago):

Prophylactic ICD placement should be considered in those with NYHA II-III HF (LVEF 30%)

Prophylactic ICD placement may be considered in those with NYHA II-III HF (LVEF 31-35%)

Strength of Evidence = A

Concomitant placement should be considered in NYHA III-IV patients undergoing implantation of a biventricular pacing device. Strength of Evidence = B

Adapted from: Adams KF, Lindenfeld J, et al. HFSA 2006 Comprehensive Heart Failure Guideline. J Card Fail 2006;12:e1-e122.

Disease Management Program for Congestive

Heart Failure

HFSA 2006 Practice Guideline (8.7)

Heart Failure Disease Management

Patients recently hospitalized for HF and other patients at high risk should be considered for referral to a comprehensive HF disease management program that delivers individualized care.

Strength of Evidence = A

Adapted from: Adams KF, Lindenfeld J, et al. HFSA 2006 Comprehensive Heart Failure Guideline. J Card Fail 2006;12:e1-e122.

Adams KF, Lindenfeld J, et al. HFSA 2006 Comprehensive Heart Failure Guideline. J Card Fail 2006;12:e1-e122.

1 of 2

HFSA 2006 Practice GuidelinePatient Education

Recommendation 8.1 (1 of 2)

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 in which nurses with expertise in HF management provide the majority of education and counseling, supplemented by physician input and, when available and needed, input from dietitians, pharmacists and other health care providers.

Strength of Evidence = B

Adams KF, Lindenfeld J, et al. HFSA 2006 Comprehensive Heart Failure Guideline. J Card Fail 2006;12:e1-e122.

HFSA 2006 Practice GuidelinePatient Education

Recommendation 8.6

During acute care hospitalization, only essential education is recommended, with the goal of assisting patients to understand:

Heart failure

The goals of its treatment

Post-hospitalization medication and follow up regimen.

Education begun during hospitalization should be:

Supplemented and reinforced within 1-2 weeks after discharge

Continued for 3-6 months

Reassessed periodically Strength of Evidence = B

HF Disease Management and the Risk of Readmission

Cline

J aarsma

Rich

Naylor

Stewart

Rauh

Lasater

Ekman

Venner

Fonarow0.5

0.6

0.7

0.8

0.9

1

1.1

RiskRatio

Summary RR = 0.76 (95% CI .68-.87)Summary RR for randomized only = 0.75 (CI = .60-.95)

Transitional Care for Heart Failure

• May assist in device guided monitoring of volume status

• May determine needs for supplemental oxygen therapy Involve Palliative care/ Hospice

• Effective reporting to all appropriate physicians • Goal is to reduce rehospitalization and mortality• If patient is readmitted maintain transparency of

care allocation

CHF Education and Rehab

• Cardiac Rehab not approved by CMS for CHF

• Recovery from AHDF is slower than from acute coronary event

• More likely to have repeat setbacks over first 180 days than from CAD

• Heart Failure Monitoring can be accomplished how?

Post Discharge Vulnerable Period

• Two period of neurohormonal modification which are crucial to prognosis and survival

• Changes in renal and hepatic function worsening signs and symptoms were predicitive of early events

• BEST PREDICTORS : rising BUN and rising body weight cTHESE PEOPLE NEED CLOSE

COMPETENT FOLLOWUP

MONITORING OUTPATIENT THERAPYMONITORING OUTPATIENT THERAPYTIME-CHFTIME-CHF

1.1. To compare To compare intensified BNP-guidedintensified BNP-guided therapy therapy to to standard symptom-guidedstandard symptom-guided therapy on 18-therapy on 18-month outcome.month outcome.

2.2. To assess if there is a difference in response to To assess if there is a difference in response to such therapy in patientssuch therapy in patients ≥75years of age ≥75years of age compared to those compared to those <75years of age<75years of age, , previously included in large heart failure trials.previously included in large heart failure trials.

3.3. Can monitoring of BNP reduce hospitalization Can monitoring of BNP reduce hospitalization in high risk patients?in high risk patients?

TIME-CHFTIME-CHF

Intensified, BNP-guided therapy did not improve the primary Intensified, BNP-guided therapy did not improve the primary endpoint of all-cause hospitalisation free survival overallendpoint of all-cause hospitalisation free survival overall

However, it improved the more disease-specific endpoint of However, it improved the more disease-specific endpoint of heart failure hospitalisation free survivalheart failure hospitalisation free survival

Response to therapy differed significantly between age groupsResponse to therapy differed significantly between age groups

Patients age 60-74 yearsPatients age 60-74 years Reduced mortalityReduced mortality Improved HF Improved HF

hospitalisation free hospitalisation free survivalsurvival

Patients aged ≥75 yearsPatients aged ≥75 years No benefit on outcomeNo benefit on outcome Less improvement in Less improvement in

quality of lifequality of life

Sleep Related Breathing Disorder

• Affects 40-50% of pts with systolic HF• Central sleep apnea Cheyne Stokes

respiration• Does not correlate with ejection fraction• Overnight oximetry- easy diagnostic test• Treatment with supplemental oxygen• May also need mild sleeping pills,

acetazolamide• May need Full sleep study -BiPap• Nocturnal 02 lowers BNP and catecholamine

levels

Central Sleep Apnea and CHF

• Withdrawal of central respiratory drive to respiratory muscles during sleep

• Usually more than five events per hour of more than 10 seconds of apnea

• Disrupted sleep

• Hypersomnia during the day

• CHF- often associated with hyperventilatory events- hypocapnia

Relationship of Sleep Apnea to CHF

• Epiphenomenon vs Risk predictor• Lanfranchi Apnea index of nonsurvivors

twice that of survivors • AHI> 30 worst prognosis• Treatment includes• -treat underling decompensated HF• -Positive airway pressure• -nocturnal oxygen

Impedance

Pulmonary Congestion

Impedance Monitoring Bi-V devices

As fluid accumulates in the lungs, intrathoracic impedance decreases

OptiVol Fluid Trends

OptiVol Threshold

OptiVol Fluid Index: Accumulation of the difference between the Daily and Reference Impedance

Reference Impedance adapts slowly to daily impedance changes

Daily impedance is the average of each day’s multiple impedance measurements

60

Types of Chronic Heart Failure

The use of the term “Diastolic Heart Failure” is controversial

Some experts prefer the terms “Heart Failure with Preserved Ejection Fraction” or “Heart Failure with Preserved Systolic Function”

The term diastolic heart failure is used to describe patients with the signs and symptoms of heart failure, a normal EF, and LV diastolic dysfunction

It is not simply LVH

Aurigemma N Engl J Med 355 (2006) 308-310

Treatment Options for Diastolic Heart Failure

• Diuretics

End point HR (95% CI) p

Primary end point* 0.95 (0.86–1.05) 0.35

CV mortality 1.02 (0.87–1.19) 0.85

HF death or hospitalization 1.01 (0.88–1.16) 0.89

Massie BM, Carson PE. American Heart Association 2008 Scientific Sessions; November 11, 2008; New Orleans, LA.

Hazard ratios (95% CI) for outcomes in I-PRESERVE, irbesartan vs placebo, over a mean of 50 months

*Composite of death from any cause or hospitalization for heart failure, MI, unstable angina, arrhythmia, or stroke

63

Advanced Glycation End-products (AGEs) in Heart Failure

Hartog et al. European Journal of Heart Failure 9 (2007) 1146–1155

Advanced Glycation End-products (AGEs) have been proposed as a novel factor involved in the development and progression of chronic heart failure Pathways involved include cross-linking of extra cellular matrix as well as enhanced stimulation of AGE receptors leading to (prolonged) cellular activation and release of inflammatory cytokines

The clinical and prognostic value of AGEs in patients with CHF remains largely unproven.

64

Alagebrium: Effects in Reversing Cardiac Pathology

arterial stiffness

left ventricular stiffness

end diastolic volume

diastolic compliance

stroke volume

fractional shortening

pulse wave velocity

Prevents increase in cardiac

A.G.E.s, BNP, CTGF, collagen III

Restoration of collagen solubility

Optimized ventriculo-vascular coupling

HFSA 2006 Practice Guideline (8.13)

End-of-Life Care in Heart Failure

End-of-life care should be considered in patients who have advanced, persistent HF with symptoms at rest despite repeated attempts to optimize pharmacologic and nonpharmacologic therapy, as evidenced by one or more of the following:

Frequent hospitalizations (3 or more per year)

Chronic poor quality of life with inability to accomplish activities of daily living

Need for intermittent or continuous intravenous support

Consideration of assist devices as destination therapy

Strength of Evidence = C

Adams KF, Lindenfeld J, et al. HFSA 2006 Comprehensive Heart Failure Guideline. J Card Fail 2006;12:e1-e122.

The Clinician Perspective

What the palliative careteam can do for clinicians:

Save time by helping to handle repeated, intensive patient-family communications, coordination of care across settings,

comprehensive discharge planning.

Bedside management of pain and distress of highly symptomatic and complex cases, 24/7, thus supporting the treatment plan of

the primary physician.

Promote patient and family satisfaction with the clinician’s quality of care.

The Hospital Perspective

For hospitals, a palliative care team can help -

Effectively treat the growing number of people with complex advanced illness.

Provide service excellence, patient-centered care.Increase patient and family satisfaction.

Improve staff satisfaction and retention. Meet JCAHO quality standards.

Rationalize the use of hospital resources.Increase capacity, reduce costs.

30 Day Mortality Tracking