Heart Failure Guideline Recommendations for Device Therapy

and Ejection Fraction (EF) Measurement

ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult (www.acc.org and www.americanheart.org). Copyright 2005 The American College of Cardiology Foundation and American Heart Association, Inc. Permission granted for limited use. Further reproduction is not permitted without permission of the ACC/AHA.

ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic HF

in the Adult• Developed in collaboration with:

– American College of Chest Physicians

– International Society for Heart and Lung Transplantation

• Endorsed by Heart Rhythm Society

• Full text posted on ACC and AHA websites

ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic HF

• 1995: first guidelines

• 2001: guidelines revised

• 2005: guidelines revised due to:

– Development of new pharmacological and device therapies for HF

– Availability of new published study results on HF therapies

– Increased recognition of HF in patients with normal EF

ACC/AHA Task Force on Practice Guidelines

• Role: develop and revise important cardiovascular practice guidelines

• Process: a formal literature review and evaluation of evidence

• Recommendations: classes and level of evidence categories

Heart Failure Background

• Symptomatic Disorder– NYHA Class I: symptoms that limit normal individuals

– NYHA Class II: symptoms on ordinary exertion

– NYHA Class III: symptoms on less-than-ordinary exertion

– NYHA Class IV: symptoms at rest

• Progressive Disorder– Clinical syndrome characterized by:

Specific symptoms (dyspnea and fatigue) in the medical history

Signs (edema, rales) on the physical examination

Heart Failure Background

At Risk for Heart Failure Heart FailureStage A

At high risk of HF but without structural heart disease or HF symptoms

Stage C

Structural heart disease with prior or current HF symptoms

Stage B

Structural heart disease but without signs or symptoms of HF

Stage D

Refractory HF requiring specialized interventions

At high risk for HF but without structural heart disease or symptoms of HF: Patients with hypertension, atherosclerotic disease, diabetes, obesity, or metabolic syndrome OR patients using cardiotoxins or have family history of cardiomyopathy

Structural heart disease but without signs or symptoms of HF: Patients with previous MI, LV remodeling including LVH and low EF, or asymptomatic valvular disease

Structural heart disease with prior or current symptoms of HF: Known structural heart disease, shortness of breath and fatigue or reduced exercise tolerance

Refractory HF requiring specialized interventions: Patients who have marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions)

Stage A

Stage B

Stage C

Stage D

2005 Heart Failure Guideline Update Diagnosis and Management of Chronic HF in Adults

- Devices in Selected Patients -

• Updated guidelines recommend ICDs for primary prevention of Sudden Cardiac Arrest (SCA) in selected HF patients for the first time.

• Updated guidelines recommend Cardiac Resynchronization Therapy for reduction in mortality and improvement in quality of life in selected HF patients for the first time.

Stage B:

• ICD Therapy (Class IIa)

• ICD Therapy (Class IIb)

Stage C:

• ICD Therapy (Class I)

• ICD Therapy (Class IIa)

• Cardiac Resynchronization Therapy (Class I)

2005 Heart Failure Guideline Update Diagnosis and Management of Chronic HF in Adults

- Devices in Selected Patients -

ACC/AHA Classification of Recommendations

• Class I:– Conditions for which there is evidence and/or general agreement that a

given procedure or treatment is beneficial, useful, and effective

• Class II:– Conditions for which there is conflicting evidence and/or a divergence

of opinion about the usefulness/efficacy of a procedure or treatment

– Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy

– Class IIb: Usefulness/efficacy is less well established by evidence/opinion

• Class III:– Conditions for which there is evidence and/or general agreement that a

procedure/treatment is not useful/effective and in some cases may be harmful

ACC/AHA Level of Evidence

• Level A: Data derived from multiple randomized clinical

trials or meta-analyses

• Level B: Data derived from a single randomized trial, or nonrandomized studies

• Level C: Only consensus opinion of experts, case studies, or standard-of-care

Stage B: ICD GuidelineClass IIa, Level of Evidence B

• 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 is reasonable in patients with

Supporting Clinical Trials 1. MADIT: Moss AJ. N Engl J Med 1996;335:1933-1940.2. MADIT-II: Moss AJ. N Engl J Med 2002;346:877-883.3. MUSTT: Buxton AE. N Engl J Med 1999;341:1882-1892.

Stage B: ICD Guideline Class IIb, Level of Evidence C

• 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.

Placement of an ICD might be considered in patients

Supporting Clinical Trial

1. DEFINITE: Kadish A. N Engl J Med 2004;350:2151-2158.

Stage C: ICD GuidelineClass I, Level of Evidence A

• current or prior symptoms of HF and reduced LVEF who have

• a history of cardiac arrest, ventricular fibrillation, or hemodynamically destabilizing ventricular tachycardia.

Supporting Clinical Trials 1. AVID: The AVID Investigators. N Engl J Med 1997;337:1576-15832. CIDS: Connolly S. Circ 2000;101:1297-1302.3. CASH: Kuck K. Circ 2000;102:784-754.

An implantable cardioverter-defibrillator is recommended as secondary prevention to prolong survival in patients with

Stage C: ICD GuidelineClass I, Level of Evidence A

• 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.

Supporting Clinical Trials 1. MADIT-II: Moss AJ. N Engl J Med 2002;346:877-883.2. SCD-HeFT: Bardy GH. N Engl J Med 2005;352:225-237.

Implantable cardioverter-defibrillator therapy is recommended for primary prevention to reduce total mortality by a reduction in sudden cardiac death in patients with

Stage C: ICD GuidelineClass I, Level of Evidence B

• 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.

Supporting Clinical Trials 1. SCD-HeFT: Bardy GH. N Engl J Med 2005;352:225-237.2. DEFINITE: Kadish A. N Engl J Med 2004;350:2151-2158.

Implantable cardioverter-defibrillator therapy is recommended for primary prevention to reduce total mortality by a reduction in sudden cardiac death in patients with

Stage C: ICD GuidelineClass IIa, Level of Evidence B

• 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.

Supporting Clinical Trials 1. SCD-HeFT: Bardy GH. N Engl J Med 2005;352:225-237.2. DEFINITE: Kadish A. N Engl J Med 2004;350:2151-2158.

Placement of an implantable cardioverter-defibrillator is reasonable in patients with

Stage C: CRT GuidelineClass I, Level of Evidence A

• 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,

Supporting Clinical Trials 1. MIRACLE: Abraham WT. N Engl J Med 2002;346:1845-1853.2. COMPANION: 2 Bristow M. N Engl J Med 2004;350:1140-1150. 3. CARE-HF: Cleland JGF. N Engl J Med 2005;352:1539-1549.

Patients with

should receive cardiac resynchronization therapy unless contraindicated.

Assessment of Patients: EF Measurement Class I, Level of Evidence C

• during initial evaluation of patients presenting with HF

• to assess LVEF, LV size, wall thickness, and valve function.

• to assess LVEF and volumes.

Two-dimensional echocardiography with Doppler should be performed

Radionuclide ventriculography can be performed

Assessment of Patients: EF Measurement Class IIa, Level of Evidence C

• who have had a change in clinical status

• or who have experienced or recovered from a clinical event

• or received treatment that might have had a significant effect on cardiac function.

Repeat measurement of EF and the severity of structural remodeling can provide useful information in patients with HF

Stage A: EF MeasurementClass I, Level of Evidence C

• a strong family history of cardiomyopathy

• or in those receiving cardiotoxic interventions.

Healthcare providers should perform a noninvasive evaluation of LV function (i.e., LVEF) in patients with

ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult (www.acc.org and www.americanheart.org). Copyright 2005 The American College of Cardiology Foundation and American Heart Association, Inc. Permission granted for limited use. Further reproduction is not permitted without permission of the ACC/AHA.