ACC Heart Failure Guidelines Slide Deck Based on the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult January 2006

Supported by Medtronic, Inc. Medtronic, Inc. was not involved in the development of this slide deck and in no way influenced its contents.

William T. Abraham, MD, FACC, FAHA Marshall H. Chin, MD, MPH, FACP Arthur M. Feldman, MD, PhD, FACC, FAHA Gary S. Francis, MD, FACC, FAHA Theodore G. Ganiats, MD Mariell Jessup, MD, FACC, FAHA Marvin A. Konstam, MD, FACC Sharon Ann Hunt, MD, FACC, FAHA, Chair Donna M. Mancini, MD Keith Michl, MD, FACP John A. Oates, MD, FAHA Peter S. Rahko, MD, FACC, FAHA Marc A. Silver, MD, FACC, FAHA Lynne Warner Stevenson, MD, FACC, FAHA Clyde W. Yancy, MD, FACC, FAHA ACC/AHA 2005 Guideline Update for the Management of Patients With Chronic Heart Failure in the Adult Writing Committee Members

Class I Benefit >>> Risk Procedure/ Treatment SHOULD be performed/ administered Class IIa Benefit >> Risk Additional studies with focused objectives needed IT IS REASONABLE to perform procedure/administer treatment Class IIb Benefit ≥ Risk Additional studies with broad objectives needed; Additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED Class III Risk ≥ Benefit No additional studies needed Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL should is recommended is indicated is useful/effective/ beneficial is reasonable can be useful/effective/ beneficial is probably recommended or indicated may/might be considered may/might be reasonable usefulness/effectiveness is unknown /unclear/uncertain or not well established is not recommended is not indicated should not is not useful/effective/beneficial may be harmful Applying Classification of Recommendations and Level of Evidence

Level A Multiple (3-5) population risk strata evaluated General consistency of direction and magnitude of effect Class I Recommen- dation that procedure or treatment is useful/ effective Sufficient evidence from multiple randomized trials or meta- analyses Class IIa Recommen- dation in favor of treatment or procedure being useful/ effective Some conflicting evidence from multiple randomized trials or meta- analyses Class IIb Recommen- dation’s usefulness/ efficacy less well established Greater conflicting evidence from multiple randomized trials or meta- analyses Class III Recommen- dation that procedure or treatment not useful/effectiv e and may be harmful Sufficient evidence from multiple randomized trials or meta- analyses Applying Classification of Recommendations and Level of Evidence

Level B Limited (2-3) population risk strata evaluated Class I Recommen- dation that procedure or treatment is useful/effecti ve Limited evidence from single randomized trial or non- randomized studies Class IIa Recommen- dation in favor of treatment or procedure being useful/ effective Some conflicting evidence from single randomized trial or non- randomized studies Class IIb Recommen- dation’s usefulness/ efficacy less well established Greater conflicting evidence from single randomized trial or non- randomized studies Class III Recommen- dation that procedure or treatment not useful/effectiv e and may be harmful Limited evidence from single randomized trial or non- randomized studies Applying Classification of Recommendations and Level of Evidence

Level C Very limited (1- 2) population risk strata evaluated Class I Recommen- dation that procedure or treatment is useful/ effective Only expert opinion, case studies, or standard-of- care Class IIa Recommen- dation in favor of treatment or procedure being useful/effectiv e Only diverging expert opinion, case studies, or standard-of- care Class IIb Recommen- dation’s usefulness/ efficacy less well established Only diverging expert opinion, case studies, or standard-of- care Class III Recommend- ation that procedure or treatment not useful/effectiv e and may be harmful Only expert opinion, case studies, or standard-of- care

Heart Failure is a Major and Growing Public Health Problem in the U.S.  Approximately 5 million patients in this country have HF  Over 550,000 patients are diagnosed with HF for the first time each year  Primary reason for 12 to 15 million office visits and 6.5 million hospital days each year  In 2001, nearly 53,000 patients died of HF as a primary cause

Heart Failure is Primarily a Condition of the Elderly  The incidence of HF approaches 10 per 1000 population after age 65  HF is the most common Medicare diagnosis- related group  More dollars are spent for the diagnosis and treatment of HF than any other diagnosis by Medicare

Guideline Scope Document focuses on :  Prevention of HF  Diagnosis and management of chronic HF in the adult

Definition of Heart Failure HF is a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood.

“Heart Failure” vs. “Congestive Heart Failure” Because not all patients have volume overload at the time of initial or subsequent evaluation, the term “heart failure” is preferred over the older term “congestive heart failure.”

Causes of HF in Western World For a substantial proportion of patients, causes are: 1. Coronary artery disease 2. Hypertension 3. Dilated cardiomyopathy

Stages of Heart Failure At Risk for Heart Failure: STAGE A High risk for developing HF STAGE B Asymptomatic LV dysfunction Heart Failure: STAGE C Past or current symptoms of HF STAGE D End-stage HF

Stages of Heart Failure Designed to emphasize preventability of HF Designed to recognize the progressive nature of LV dysfunction

Stages of Heart Failure COMPLEMENT, DO NOT REPLACE NYHA CLASSES NYHA Classes - shift back/forth in individual patient (in response to Rx and/or progression of disease) Stages - progress in one direction due to cardiac remodeling

Stage A Patients at High Risk for Developing Heart Failure

Stage A Therapy Recommended Therapies to Reduce Risk Include: Treating known risk factors (hypertension, diabetes, etc.) with therapy consistent with contemporary guidelines Avoiding behaviors increasing risk (i.e., smoking excessive consumption of alcohol, illicit drug use) Periodic evaluation for signs and symptoms of HF Ventricular rate control or sinus rhythm restoration Noninvasive evaluation of LV function Drug therapy – Angiotensin Converting Enzyme Inhibitors (ACEI) Angiotensin Receptor Blockers (ARBs)

Stage A Therapy In patients at high risk for developing HF, systolic and diastolic hypertension should be controlled in accordance with contemporary guidelines. In patients at high risk for developing HF, lipid disorders should be treated in accordance with contemporary guidelines. Using Therapy Consistent with Contemporary Guidelines

Stage A Therapy In patients at high risk for developing HF who have known atherosclerotic vascular disease, healthcare providers should follow current guidelines for secondary prevention. For patients with diabetes mellitus (who are all at high risk for developing HF), blood sugar should be controlled in accordance with contemporary guidelines. Using Therapy Consistent with Contemporary Guidelines

Stage A Therapy Thyroid disorders should be treated in accordance with contemporary guidelines in patients at high risk for developing HF. Using Therapy Consistent with Contemporary Guidelines

Stage A Therapy Patients at high risk for developing HF should be counseled to avoid behaviors that may increase the risk of HF (e.g., smoking, excessive alcohol consumption, and illicit drug use). Avoiding Behaviors That Increase Risk

Stage A Therapy Healthcare providers should perform periodic evaluation for signs and symptoms of HF in patients at high risk for developing HF. Periodic Evaluation for Signs and Symptoms

Stage A Therapy Ventricular rate should be controlled or sinus rhythm restored in patients with supraventricular tachyarrhythmias who are at high risk for developing HF. Ventricular Rate Control or Sinus Rhythm Restoration I I I IIa IIb III I I I IIa IIb III I I I IIa IIb III IIa IIb IIa IIb III IIb III

Stage A Therapy Healthcare providers should perform a noninvasive evaluation of LV function (i.e., LVEF) in patients with a strong family history of cardiomyopathy or in those receiving cardiotoxic interventions. Noninvasive Evaluation of LV Function

Stage A Therapy ACEI can be useful to prevent HF in patients at high risk for developing HF who have a history of atherosclerotic vascular disease, diabetes mellitus, or hypertension with associated cardiovascular risk factors. Angiotensin Converting Enzyme Inhibitors (ACEI)

Stage A Therapy ARBs can be useful to prevent HF in patients at high risk for developing HF who have a history of atherosclerotic vascular disease, diabetes mellitus, or hypertension with associated cardiovascular risk factors. Angiotension Receptor Blockers (ARBs)

Stage A Therapy Routine use of nutritional supplements solely to prevent the development of structural heart disease should not be recommended for patients at high risk for developing HF. Therapies NOT Recommended

Stage B Patients with Asymptomatic LV Dysfunction

Stage B Therapy Recommended Therapies: General Measures as advised for Stage A Drug therapy for all patients ACEI or ARBs Beta-Blockers ICDs in appropriate patients Coronary revascularization in appropriate patients Valve replacement or repair in appropriate patients

Stage B Therapy All Class I recommendations for Stage A should apply to patients with cardiac structural abnormalities who have not developed HF. (Levels of Evidence: A, B, and C as appropriate) Patients who have not developed HF symptoms should be treated according to contemporary guidelines after an acute MI. General Measures

Stage B Therapy Beta-blockers and ACEIs should be used in all patients with a recent or remote history of MI regardless of EF or presence of HF. ACEI should be used in patients with a reduced EF and no symptoms of HF, even if they have not experienced MI. ACEI or ARBs can be beneficial in patients with hypertension and LVH and no symptoms of HF. Angiotensin Converting Enzyme Inhibitors (ACEI)

Stage B Therapy An ARB should be administered to post-MI patients without HF who are intolerant of ACEIs and have a low LVEF. ACEIs or ARBs can be beneficial in patients with hypertension and LVH and no symptoms of HF. ARBs can be beneficial in patients with low EF and no symptoms of HF who are intolerant of ACEIs. Angiotensin Receptor Blockers (ARBs)

Stage B Therapy Beta-blockers and ACEIs should be used in all patients with a recent or remote history of MI regardless of EF or presence of HF. Beta-blockers are indicated in all patients without a history of MI who have a reduced LVEF with no HF symptoms. Beta-Blockers

Stage B Therapy Placement of an ICD is reasonable in patients with ischemic cardiomyopathy who are at least 40 days post-MI, have an LVEF of 30% or less, are NYHA functional class I on chronic optimal medical therapy, and have reasonable expectation of survival with a good functional status for more than 1 year. Placement of an ICD might be considered in patients without HF who have nonischemic cardiomyopathy and an LVEF less than or equal to 30% who are in NYHA functional class I with chronic optimal medical therapy and have a reasonable expectation of survival with good functional status for more than 1 year. Internal Cardioverter Defibrillator (ICD)

Stage B Therapy Coronary revascularization should be recommended in appropriate patients without symptoms of HF in accordance with contemporary guidelines (see ACC/AHA Guidelines for the Management of Patients With Chronic Stable Angina). Coronary Revascularization

Stage B Therapy Valve replacement or repair should be recommended for patients with hemodynamically significant valvular stenosis or regurgitation and no symptoms of HF in accordance with contemporary guidelines. Valve Replacement/Repair

Stage B Therapy Digoxin should not be used in patients with low EF, sinus rhythm, and no history of HF symptoms, because in this population, the risk of harm is not balanced by any known benefit. Use of nutritional supplements to treat structural heart disease or to prevent the development of symptoms of HF is not recommended. Calcium channel blockers with negative inotropic effects may be harmful in asymptomatic patients with low LVEF and no symptoms of HF after MI. Therapies NOT Recommended

Stage C Patients with Past or Current Symptoms of Heart Failure

Recommended Therapies: General measures as advised for Stages A and B Drug therapy for all patients Diuretics for fluid retention ACEI Beta-blockers Drug therapy for selected patients Aldosterone Antagonists ARBs Digitalis Hydralazine/nitrates ICDs in appropriate patients Cardiac resynchronization in appropriate patients Exercise Testing and Training Stage C Therapy (Reduced LVEF with Symptoms)

Measures listed as Class I recommendations for patients in stages A and B are also appropriate for patients in Stage C. (Levels of Evidence: A, B, and C as appropriate) Drugs known to adversely affect the clinical status of patients with current or prior symptoms of HF and reduced LVEF should be avoided or withdrawn whenever possible (e.g., nonsteroidal anti-inflammatory drugs, most antiarrhythmic drugs, and most calcium channel blocking drugs). General Measures Stage C Therapy (Reduced LVEF with Symptoms)

Diuretics and salt restriction are indicated in patients with current or prior symptoms of HF and reduced LVEF who have evidence of fluid retention. Diuretics Stage C Therapy (Reduced LVEF with Symptoms)

ACEIs are recommended for all patients with current or prior symptoms of HF and reduced LVEF, unless contraindicated. Routine combined use of an ACEI, ARB, and aldosterone antagonist is not recommended for patients with current or prior symptoms of HF and reduced LVEF. Angiotensin Enzyme Converting Inhibitors (ACEIs) Stage C Therapy (Reduced LVEF with Symptoms)

ARBs approved for the treatment of HF are recommended in patients with current or prior symptoms of HF and reduced LVEF who are ACEI- intolerant (see full text guidelines for information regarding patients with angioedema). ARBs are reasonable to use as alternatives to ACEIs as first-line therapy for patients with mild to moderate HF and reduced LVEF, especially for patients already taking ARBs for other indications. Angiotensin Receptor Blockers (ARBs) Stage C Therapy (Reduced LVEF with Symptoms)

The addition of an ARB may be considered in persistently symptomatic patients with reduced LVEF who are already being treated with conventional therapy. Routine combined use of an ACEI, ARB, and aldosterone antagonist is not recommended for patientswith current or prior symptoms of HF and reduced LVEF. ARBs (cont’d) Stage C Therapy (Reduced LVEF with Symptoms)

Addition of an aldosterone antagonist is recommended in selected patients with moderately severe to severe symptoms of HF and reduced LVEF who can be carefully monitored for preserved renal function and normal potassium concentration. Creatinine should be less than or equal to 2.5 mg/dL in men or less than or equal to 2.0 mg/dL in women and potassium should be less than 5.0 mEq/L. Under circumstances where monitoring for hyperkalemia or renal dysfunction is not anticipated to be feasible, the risks may outweigh the benefits of aldosterone antagonists. Routine combined use of an ACEI, ARB, and aldosterone antagonist is not recommended for patients with current or prior symptoms of HF and reduced LVEF. Aldosterone Antagonists Stage C Therapy (Reduced LVEF with Symptoms)

Beta-blockers (using 1 of the 3 proven to reduce mortality, i.e., bisoprolol, carvedilol, and sustained release metoprolol succinate) are recommended for all stable patients with current or prior symptoms of HF and reduced LVEF, unless contraindicated. Beta-Blockers Stage C Therapy (Reduced LVEF with Symptoms)

Digitalis can be beneficial in patients with current or prior symptoms of HF and reduced LVEF to decrease hospitalizations for HF. Digitalis Stage C Therapy (Reduced LVEF with Symptoms)

The addition of a combination of hydralazine and a nitrate is reasonable for patients with reduced LVEF who are already taking an ACEI and beta- blocker for symptomatic HF and who have persistent symptoms. A combination of hydralazine and a nitrate might be reasonable in patients with current or prior symptoms of HF and reduced LVEF who cannot be given an ACEI or ARB because of drug intolerance, hypotension, or renal insufficiency. Hydralazine and Isosorbide Dinitrate Stage C Therapy (Reduced LVEF with Symptoms)

An ICD is recommended as secondary prevention to prolong survival in patients with current or prior symptoms of HF and reduced LVEF who have a history of cardiac arrest, ventricular fibrillation, or hemodynamically destabilizing ventricular tachycardia. ICD therapy is recommended for primary prevention to reduce total mortality by a reduction in sudden cardiac death in patients with ischemic heart disease who are at least 40 days post-MI, have an LVEF less than or equal to 30%, with NYHA functional class II or III symptoms while undergoing chronic optimal medical therapy, and have reasonable expectation of survival with a good functional status for more than 1 year. Implantable Cardioverter- Defibrillators (ICDs) Stage C Therapy (Reduced LVEF with Symptoms)

ICD therapy is recommended for primary prevention to reduce total mortality by a reduction in sudden cardiac death in patients with nonischemic cardiomyopathy who have an LVEF less than or equal to 30%, with NYHA functional class II or III symptoms while undergoing chronic optimal medical therapy, and who have reasonable expectation of survival with a good functional status for more than 1 year. Placement of an ICD is reasonable in patients with LVEF of 30% to 35% of any origin with NYHA functional class II or III symptoms who are taking chronic optimal medical therapy and who have reasonable expectation of survival with good functional status of more than 1 year. ICDs (cont’d) Stage C Therapy (Reduced LVEF with Symptoms)

Patients with LVEF less than or equal to 35%, sinus rhythm, and NYHA functional class III or ambulatory class IV symptoms despite recommended, optimal medical therapy and who have cardiac dyssynchrony, which is currently defined as a QRS duration greater than 120 ms, should receive cardiac resynchronization therapy unless contraindicated. Cardiac Resynchronization Stage C Therapy (Reduced LVEF with Symptoms)

Maximal exercise testing with or without measurement of respiratory gas exchange is recommended to facilitate prescription of an appropriate exercise program for patients presenting with HF. Exercise training is beneficial as an adjunctive approach to improve clinical status in ambulatory patients with current or prior symptoms of HF and reduced LVEF. Exercise Testing and Training Stage C Therapy (Reduced LVEF with Symptoms)

Unproven/Not Recommended Drugs and Interventions for HF Nutritional Supplements Hormonal Therapies Intermittent Intravenous Positive Inotropic Therapy Stage C Therapy (Reduced LVEF with Symptoms)

Long-term use of an infusion of a positive inotropic drug may be harmful and is not recommended for patients with current or prior symptoms of HF and reduced LVEF, except as palliation for patients with end-stage disease who cannot be stabilized with standard medical treatment (see recommendations for Stage D). Use of nutritional supplements as treatment for HF is not indicated in patients with current or prior symptoms of HF and reduced LVEF. Unproven/Not Recommended Drugs and Interventions Stage C Therapy (Reduced LVEF with Symptoms)

Calcium channel blocking drugs are not indicated as routine treatment for HF in patients with current or prior symptoms of HF and reduced LVEF. Hormonal therapies other than to replete deficiencies are not recommended and may be harmful to patients with current or prior symptoms of HF and reduced LVEF. Routine combined use of an ACEI, ARB, and aldosterone antagonist is not recommended for patientswith current or prior symptoms of HF and reduced LVEF. Unproven/Not Recommended Drugs and Interventions Stage C Therapy (Reduced LVEF with Symptoms)

Recommended Therapies for Routine Use: Treating known risk factor (hypertension) with therapy consistent with contemporary guidelines Ventricular rate control for all patients Drugs for all patients - Diuretics Drugs for appropriate patients – ACEI ARBs Beta-Blockers Digitalis Coronary revascularization in selected patients Restoration/maintenance of sinus rhythm in appropriate patients Stage C Therapy (Normal LVEF with Symptoms)

Differential Diagnosis in Patient with HF and Normal LVEF with Symptoms Incorrect diagnosis of HF Inaccurate measurement of LVEF Primary valvular disease Restrictive (infiltrative) cardiomyopathies Amyloidosis, sarcoidosis, hemochromatosis Pericardial constriction Episodic or reversible LV systolic dysfunction Severe hypertension, myocardial ischemia HF associated with high metabolic demand (high- output states) Anemia, thyrotoxicosis, arteriovenous fistulae Chronic pulmonary disease with right HF Pulmonary hypertension associated with pulmonary vascular disorders Atrial myxoma Diastolic dysfunction of uncertain origin Obesity

Physicians should control systolic and diastolic hypertension in patients with HF and normal LVEF, in accordance with published guidelines. Treating known risk factors - Hypertension Stage C Therapy (Normal LVEF with Symptoms)

Physicians should control ventricular rate in patients with HF and normal LVEF and atrial fibrillation. Ventricular Rate Control Stage C Therapy (Normal LVEF with Symptoms)

Physicians should use diuretics to control pulmonary congestion and peripheral edema in patients with HF and normal LVEF. Diuretics Stage C Therapy (Normal LVEF with Symptoms)

Coronary revascularization is reasonable in patients with HF and normal LVEF and coronary artery disease in whom symptomatic or demonstrable myocardial ischemia is judged to be having an adverse effect on cardiac function. Coronary Revascularization Stage C Therapy (Normal LVEF with Symptoms)

Restoration and maintenance of sinus rhythm in patients with atrial fibrillation and HF and normal LVEF might be useful to improve symptoms. Restoration/Maintenance of Sinus Rhythm Stage C Therapy (Normal LVEF with Symptoms)

The use of beta-adrenergic blocking agents, ACEIs, ARBs, or calcium antagonists in patients with HF and normal LVEF and controlled hypertension might be effective to minimize symptoms of HF. Angiotensin Enzyme Converting Inhibitors (ACEIs) Stage C Therapy (Normal LVEF with Symptoms)

The use of beta-adrenergic blocking agents, ACEIs, ARBs, or calcium antagonists in patients with HF and normal LVEF and controlled hypertension might be effective to minimize symptoms of HF. Angiotensin Receptor Blockers (ARBs) Stage C Therapy (Normal LVEF with Symptoms)

The use of beta-adrenergic blocking agents, ACEIs, ARBs, or calcium antagonists in patients with HF and normal LVEF and controlled hypertension might be effective to minimize symptoms of HF. Beta-Blockers Stage C Therapy (Normal LVEF with Symptoms)

The usefulness of digitalis to minimize symptoms of HF in patients with HF and normal LVEF is not well established. Digitalis Stage C Therapy (Normal LVEF with Symptoms)

Stage D Patients with Refractory End-Stage HF

Stage D Therapy Recommended Therapies Include: Control of fluid retention Referral to a HF program for appropriate pts Discussion of options for end-of-life care Informing re: option to inactivate defibrillator Device use in appropriate patients Surgical therapy – Cardiac transplantation Mitral valve repair or replacement Other Drug Therapy – Positive inotrope infusion as palliation in appropriate patients

Stage D Therapy Meticulous identification and control of fluid retention is recommended in patients with refractory end-stage HF. Control of Fluid Retention

Stage D Therapy Referral of patients with refractory end-stage HF to an HF program with expertise in the management of refractory HF is useful. Referral to an HF Program

Stage D Therapy Options for end-of-life care should be discussed with the patient and family when severe symptoms in patients with refractory end-stage HF persist despite application of all recommended therapies. Discussion of Options for End-of-Life Care

Stage D Therapy Patients with refractory end-stage HF and implantable defibrillators should receive information about the option to inactivate defibrillation. Inform on option to inactivate defibrillation

Stage D Therapy Referral for cardiac transplantation in potentially eligible patients is recommended for patients with refractory end-stage HF. The effectiveness of mitral valve repair or replacement is not established for severe secondary mitral regurgitation in refractory end-stage HF. Surgical Therapy

Stage D Therapy Consideration of an LV assist device as permanentor “destination” therapy is reasonable in highly selected patients with refractory end-stage HF and an estimated 1-year mortality over 50% with medical therapy. Pulmonary artery catheter placement may be reasonable to guide therapy in patients with refractory end-stage HF and persistently severe symptoms. Device Use

Stage D Therapy Continuous intravenous infusion of a positive inotropic agent may be considered for palliation of symptoms in patients with refractory end-stage HF. Routine intermittent infusions of positive inotropic agents are not recommended for patients with refractory end-stage HF. Medical Therapy

Stage D Therapy Partial left ventriculectomy is not recommended inpatients with nonischemic cardiomyopathy and refractory end-stage HF. Routine intermittent infusions of positive inotropic agents are not recommended for patients with refractory end-stage HF. Therapies NOT Recommended