General Statement on UPMC Health Plan Clinical Practice Guidelines: UPMC Health Plan develops clinical practice guidelines to support the practice of evidence-based medicine. The guidelines are from recognized sources and are updated annually. They are intended as quick reference guides to assist physicians and non-physician providers in the diagnosis and management of selected conditions. They summarize key points but are not comprehensive overviews; Web links to appropriate national guidelines or other key literature sources are included for greater depth of information. Availability of UPMC Clinical Practice guidelines: The guidelines are available to participating providers on the Web at http://www.upmchealthplan.com/providers/guidelines.html. Providers receive notification of the new or updated guidelines via their credentialing/re-credentialing letters and in the physician newsletter at different times through the year. Hard copies are available upon request. General Guideline Limitations: Guidelines may not apply to every patient or clinical situation; some variation from guidelines is expected. Provider judgment and knowledge of an individual patient supersedes clinical guidelines. Guidelines do not determine insurance coverage of health care services or products. Coverage decisions are based on member eligibility, contractual benefits, and determination of medical necessity. UPMC Health Plan Clinical Practice Guideline on Heart Failure with Left Ventricular Systolic Dysfunction Relevance to Population: Heart failure (HF) is a major public health problem in the United States. According to statistics, approximately 5.1 million people in this country have heart failure and this number is expected to increase 25% by the year 2030. More than 670,000 new cases are diagnosed annually and costs the nation an estimate $32 billion each year. This total includes the cost of health care services, medications to treat heart failure, and missed days of work. Heart failure is the primary cause of more than 56,000 deaths each year and is mentioned as a contributing cause in more than 275,000 deaths. Survival after heart failure diagnosis has improved over time; however, 50% of people diagnosed with heart failure die within five years. 1 In 2006, the UPMC Health Plan Congestive Heart Failure program was expanded to a Cardiovascular Health Management Program, automatically enrolling all members who are diagnosed with heart failure, coronary artery disease, hypertension, and hyperlipidemia. The program utilizes a team approach to collaborate with physicians to educate members and empower them to take control of their disease and improve their quality of life. Definition: Heart failure is a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood. Heart failure with reduced left ventricular ejection fraction (HFrEF) is referred to as systolic heart failure and is associated with a LVEF < 40%. Heart failure with preserved LVEF (HFpEF) is referred to as diastolic heart failure and is associated with a LVEF > 50%. Heart Failure Management: The current 2013 ACCF/AHA Guideline Management of Heart Failure at http://content.onlinejacc.org/article.aspx?articleid=1695825&resultclick=3. Page 1
Comparison of Functional Classifications: The American College of Cardiology Foundation/American Heart Association (ACCF/AHA) stages of HF emphasize the development and progression of disease and can be used to describe individuals and populations. The New York Heart Association (NYHA) classes focus on exercise capacity and the symptomatic status of the disease ACCF/AHA Stage NYHA Functional Class Stage Description Class Description A Patients at high risk of developing HF but without structural heat disease or symptoms of HF None B Patients who have structural heart disease but without signs or symptoms of HF I No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. C Patients with structural heart disease with prior or current symptoms of HF I No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. II Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF. III Marked limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in symptoms of HF IV Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest. D Patients with refractory HF requiring specialized interventions IV Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest. Page 2
Applying Classification of Recommendation and Level of Evidence: Page 3
Recommendations for Initial Evaluation of the HF Patient in addition to a complete history and physical exam: CBC, complete chemistry profile, fasting lipid profile and TSH. (Class I; Level of Evidence(LOE): C) 12-lead electrocardiogram. (Class I; LOE: C) For patients with idiopathic dilated cardiomyopathy (DCM), a 3-generational family history should be obtained to aid in establishing the diagnosis of familial DCM. (Class I; LOE: C) Chest x-ray to assess heart size and pulmonary congestion, and other contributing diseases (Class I; LOE: C) 2-D Echo with Doppler to assess ventricular function, size, wall thickness, wall motion, and valves. (Class I; LOE: C) Radionuclide ventriculography or MRI can be useful to assess LVEF and volume when echocardiography is inadequate. (Class IIa; LOE:C) Measurement B-type Natriuretic Peptide or N-terminal pro-b-type natriuretic peptide (collectively referred to as BNP): o Supports a HF diagnosis when there is dyspnea in a setting of uncertainty. (Class I; LOE:A) o Helps establish disease prognosis/severity in chronic or decompensated HF. (Class I; LOE:A) o Can be useful in achieving optimal dosing in select clinically euvolemic patients followed in a wellstructured HF disease management program. (Class IIa; LOE:B) o The usefulness of BNP guided therapy for acutely decompensated HF is not well established. (Class IIb; LOE:C) Noninvasive imaging to detect myocardial ischemia and viability is reasonable in HF and CAD. ((Class IIa; LOE:C) Cardiac viability assessment is reasonable before revascularization in HF patients with CAD. (Class IIa; LOE:B) When coronary ischemia may be contributing to HF, coronary arteriography is reasonable. (Class IIa; LOE:C) Testing for hemochromatosis, HIV, rheumatologic diseases, amyloidosis or pheochromcytoma are reasonable in patients presenting with HF in whom there is a clinical suspicion of these diseases. (Class IIa; LOE:C) Invasive pulmonary artery hemodynamic monitoring is useful in patients with respiratory distress or impaired systemic perfusion when clinical assessment is inadequate. (Class I; LOE:C) Routine use of invasive monitoring is not recommended in normotensive patients with acute decompensated HF with symptomatic response to diuretics and vasodilators. (Class III; LOE:B) Recommendations for Follow-up Evaluation of the HF Patient: Volume status and vital signs should be assessed at each patient encounter, including serial assessment of weight, estimates of jugular venous pressure, presence of peripheral edema, and orthopnea. (Class I; LOE: B) Serial monitoring of serum electrolytes and renal function, when indicated. (Class I; LOE:C) Repeat measurement of EF is useful in patients with HF who have had a significant change in clinical status or received treatment that might affect cardiac function, or for consideration of device therapy. (Class I; LOE:C) Routine repeat measurement of LV function assessment should not be performed. (Class III; LOE: B) The usefulness of serial measurement of BNP to reduce hospitalization or mortality is not well established. (Class IIb; LOE:B) o Serial BNP testing used to reduce hospitalization is not well established. (Class IIb; LOE: B) o Use of BNP-guided therapy for acutely decompensated HF is not well established. (Class IIb; LOE: C) Page 4
Development of HF and Recommended Therapy by Stage (Each stage includes and builds upon the treatment of the previous stages): Key Points of Recommended Treatment/Management of Stage A HF: Hypertension and lipid disorders should be controlled in accordance with contemporary guidelines to lower the risk of HF. (Class I; LOE:A) Other conditions that may lead to or contribute to HF, such as obesity, diabetes mellitus, tobacco use, and known cardiotoxic agents, should be controlled or avoided. (Class I; LOE:C) Key Points of Recommended Treatment/Management of Stage B HF: (UNLESS CONTRAINDICATED) In patients with recent or remote history of MI or acute coronary syndrome (ACS) and reduced EF, ACE inhibitors (ACE-I) or ARBs should be used to prevent symptomatic HF and reduce mortality. (Class I; LOE:A) In patients without a history of MI/ACS and with reduced EF, ACE-I or ARBs should be used to prevent symptomatic HF. (Class I; LOE:A) ACE inhibitors should be used in all patients with a reduced EF to prevent HF. (Class I; LOE:A) In patients with history of MI/ACS and reduced EF, evidence-based beta blockers (B-blockers) should be used to prevent HF (carvedilol, metoprolol, or bisoprolol). (Class I; LOE:B) Page 5
Beta blockers should be used in all patients with a reduced EF to prevent HF. (Class I; LOE:C) In patients with MI, statins should be used to prevent HF and symptomatic CV events. (Class I; LOE:A) Blood pressure should be controlled to prevent symptomatic HF, especially in the presence of left ventricular hypertrophy (LVH). (Class I; LOE:A)An ICD is reasonable in patients with asymptomatic ischemic cardiomyopathy who are at least 40 days post-mi, have an LVEF <30%, are on appropriate guideline-directed medical therapy (GDMT), and have reasonable expectation of survival with good functional status for more than one year. (Class IIa; LOE:B) Nondihydropyridine calcium channel blockers with negative inotropic effects may be harmful in asymptomatic patients with low LVEF and no symptoms of HF after an MI. (Class III; LOE:C) Key Points of Recommended Treatment/Management of Stage C HFrEF: (UNLESS CONTRAINDICATED) Nonpharmacological Interventions Patients with HF should receive specific education to facilitate HF self-care. (Class I; LOE: B) Exercise training (or regular physical activity) is recommended as safe and effective for patients with HF who are able to participate to improve functional status. (Class I; LOE: A) Sodium restriction is reasonable for symptomatic HF to reduce congestive symptoms. (Class IIa; LOE: C) Continuous positive airway pressure (CPAP) can be beneficial to increase LVEF and improve functional status in patients with HF and sleep apnea. (Class IIa; LOE: B) Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, health-related quality of life, and mortality. (Class IIa; LOE: B) Pharmacological Treatment [Pharmacologic treatment listed as Class I recommendations for patients in stages A and B are recommended. (Level of Evidence: A/B/C); GDMT should be the mainstay of pharmacological therapy for HFrEF. (Level of Evidence: A)] Diuretics Diuretics are recommended in patients with HFrEF with fluid retention. (Class I; LOE: C) ACE Inhibitors ACE-I are recommended for all patients with HFrEF. (Class I; LOE: A) ARBs ARBs are recommended in patients with HFrEF who are ACE inhibitor intolerant. (Class I; LOE: A) ARBs are reasonable as alternatives to ACE inhibitor as first line therapy in HFrEF, especially for patients already taking ARBs for other indications. (Class IIa; LOE: A) Addition of an ARB may be considered in persistently symptomatic patients with HFrEF, who are already on an ACE-I and B-blocker in whom an aldosterone antagonist is not indicated or tolerated. (Class IIb; LOE: A) Routine concurrent use of an ACE inhibitor, ARB, and aldosterone antagonist is potentially harmful. (Class III: HARM; LOE: C) Beta Blockers Use of 1 of the 3 beta blockers proven to reduce mortality (carvedilol, metoprolol, or bisoprolol) is recommended in all stable patients. (Class I; LOE: A) Page 6
Aldosterone Antagonists Aldosterone receptor antagonists are recommended in patients with NYHA class II-IV who have LVEF <35%, unless contraindicated, to reduce both morbidity and mortality. (Class I; LOE: A) o Patients with NYHA class II HF should have a Hx of prior CV hospitalization or elevated BNP to be considered for aldosterone receptor antagonists (Aldo-RA). o Creatinine should be 2.5 mg/dl or less in men or 2.0 mg/dl or less in women (or estimated GFR >30 ml/min/1.73 m2). o Potassium should be less than 5.0 meq/l. o Initial and serial monitoring of K +, renal function, and diuretic dosing should be performed. Aldosterone receptor antagonists are recommended in patients following an acute MI who have LVEF <40% with symptoms of HF or DM. (Class I; LOE: B) Inappropriate use of aldosterone receptor antagonists may be harmful when creatinine > 2.5 mg/dl in men or > 2.0 in women (or estimated GFR >30 ml/min/1.73 m2), and/or potassium greater than 5.0 meq/l, due to potentially life-threatening hyperkalemia or renal insufficiency. (Class III: HARM; LOE: B) Hydralazine and Isosorbide Dinitrate Digoxin The combination of hydralazine and isosorbide dinitrate is recommended for African-Americans with NYHA class III-IV HFrEF on GDMT. (Class I; LOE: A) A combination of hydralazine and isosorbide dinitrate can be useful in patients with HFrEF who cannot be given ACE inhibitors or ARBs. (Class IIa; LOE: B) Digoxin can be beneficial in patients with HFrEF to reduce hospitalizations. (Class IIa; LOE: B) Anticoagulation Patients with chronic HF with permanent/persistent/paroxysmal AF and an additional risk factor for cardioembolic stroke should receive chronic anticoagulant therapy. (Class I; LOE: A) The selection of an anticoagulant agent should be individualized. (Class I; LOE: C) Statins Chronic anticoagulation is reasonable for patients with chronic HF who have permanent/persistent/ paroxysmal AF but without an additional risk factor for cardioembolic stroke. (Class IIa; LOE: B) Anticoagulation is not recommended in patients with chronic HFrEF without AF, prior thromboembolic event or a cardioembolic source. (Class III: NO BENEFIT; LOE: B) Statins are not beneficial as adjunctive therapy when prescribed solely for HF. (Class III: NO BENEFIT; LOE: A) Omega-3 Fatty Acids Omega-3 PUFA supplementation is reasonable to use as adjunctive therapy in patients with NYHA Class II-IV symptoms and HFrEF or HFpEF patients. (Class IIa; LOE: B) Other Drugs Nutritional supplements as treatment for HF are not recommended in HFrEF. (Class III: NO BENEFIT; LOE: B) Hormonal therapies other than to replete deficiencies are not recommended in HFrEF. (Class III: NO BENEFIT; LOE: C) Drugs known to adversely affect the clinical status of patients with HFrEF are potentially harmful and should be avoided or withdrawn. (Class III: HARM; LOE: B) Long-term use of an infusion of a positive inotropic drug is not recommended and may be harmful except as palliation. (Class III: HARM; LOE: C) Page 7
Calcium Channel Blockers Calcium channel blocking drugs are not recommended as routine treatment for HFrEF. (Class III: NO BENEFIT; LOE: A) Device Therapy for Stage C HFrEF Implantable Cardioverter Defibrillator ICD is recommended for primary prevention of sudden cardiac death to reduce total mortality in selected patients with nonischemic dilated cardiomyopathy or ischemic heart disease at least 40 days post-mi and with reasonable expectation of survival for more than one year, with: o LVEF of 35% or less and NYHA class II or III symptoms on chronic GDMT (Class I; LOE: A) o LVEF of 30% or less and NYHA class I symptoms while receiving GDMT ICD placement is of uncertain benefit to prolong meaningful survival in patients with a high risk of nonsudden death as predicted by frequent hospitalizations, advanced frailty, or comorbidities. (Class IIb; LOE: B) ICD placement is of uncertain benefit to prolong meaningful survival in patients with a high risk of nonsudden death as predicted by frequent hospitalizations, advanced frailty, or comorbidities. (Class IIb; LOE: B) Cardiac Resynchronization Therapy (CRT) CRT is indicated for patients who have LVEF of 35% or less, sinus rhythm, left bundle-branch block (LBBB) with a QRS duration of 150 ms or greater, and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Class I; LOE: A for NYHA class III/IV; LOE: Class I; LOE: B for NYHA class II) CRT can be useful for patients with LVEF of 35% or less, sinus rhythm, a non-lbbb pattern with a QRS duration of 150 ms or greater, and NYHA class III/ambulatory class IV symptoms on GDMT. (Class IIa; LOE: A) CRT can be useful for patients with LVEF of 35% or less, sinus rhythm, LBBB with a QRS duration of 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Class IIa; LOE: B) CRT can be useful in patients with AF and LVEF of 35% or less on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) atrioventricular nodal ablation or pharmacological rate control will allow near 100% ventricular pacing with CRT. (Class IIa; LOE: B) CRT can be useful for patients on GDMT who have LVEF of 35% or less and are undergoing placement of a new or replacement device with anticipated requirement for >40% ventricular pacing. (Class IIa; LOE: C) CRT may be considered for patients who have LVEF of 35% or less, sinus rhythm, a non-lbbb pattern with a QRS duration of 120 to 149 ms, and NYHA class III/ambulatory class IV on GDMT. (Class IIb; LOE: B) CRT may be considered for patients who have LVEF of 35% or less, sinus rhythm, a non-lbbb pattern with a QRS duration of 150 ms or greater, and NYHA class II symptoms on GDMT. (Class IIb; LOE: B) CRT may be considered for patients who have LVEF of 30% or less, ischemic etiology of HF, sinus rhythm, LBBB with a QRS duration of 150 ms or greater, and NYHA class I symptoms on GDMT. (Class IIb; LOE: C) CRT is not recommended for patients with NYHA class I or II symptoms and non-lbbb pattern with a QRS duration of less than 150 ms. (Class III: NO BENEFIT; LOE: B) CRT is not indicated for patients whose comorbidities and/or frailty limit survival with good functional capacity to less than 1 year. (Class III: NO BENEFIT; LOE: C) Page 8
Indications for CRT therapy algorithm Key Points of Recommended Treatment/Management of Stage C HFpEF: (UNLESS CONTRAINDICATED) Systolic and diastolic BP should be controlled according to evidence-based guidelines. (Class I; LOE: B) Use of B-blockers, ACE-I, and ARBs is reasonable to control HBP in patients with HFpEF. (Class IIa; LOE: C) ARBs might be considered to decrease hospitalizations for patients with HFpEF. (Class IIb; LOE: B) Diuretics should be used for symptom relief of volume overload in patients with HFpEF. (Class I; LOE: C) Coronary revascularization is reasonable in patients with symptomatic ischemic CAD judged to have an adverse effect on symptomatic HFpEF despite GDMT. (Class IIa; LOE: C) GDMT of AF in patients with HFpEF is reasonable to improve symptomatic HF. (Class IIa; LOE: C) Routine use of nutritional supplements is not recommended for patients with HFpEF. (Class III: No Benefit; LOE: C) Key Points of Recommended Treatment/Management of Stage D HF: (UNLESS CONTRAINDICATED) Fluid Restriction Fluid restriction (1.5 to 2 L/d) is reasonable in stage D HF, especially with hyponatremia, to reduce congestive symptoms. (Class IIa; LOE: C) Page 9
Intravenous (IV) Inotropic Therapy Temporary IV Inotropic therapy should be used in patients with cardiogenic shock to maintain perfusion and preserve end-organ function pending definitive therapy (e.g., CABG, mechanical circulatory support (MCS), or heart transplant). (Class I; LOE: C) Evaluation for cardiac transplantation is indicated for carefully selected patients with stage D HF despite GDMT, device, and surgical management. (Class I; LOE: C) Continuous IV inotropic support as bridge therapy is reasonable for stage D HF refractory to GDMT and device therapy who are eligible and waiting for MCS or cardiac transplant (Class IIa; LOE: B) Long-term, continuous IV inotropic support may be used as palliative therapy in stage D HF despite optimal GDMT/device therapy, in patients not eligible for MCS or cardiac transplant. (Class IIb: LOE: B) Short-term, continuous IV inotropic support may be reasonable in hospitalized patients presenting with severe systolic dysfunction, low BP, and significantly depressed cardiac output. (Class IIb; LOE: B) Continuous or intermittent, IV positive inotropic agents for HF, in the absence of specific indications or for reasons other than palliative care, is potentially harmful. (Class III: HARM; LOE: B) IV inotropic agents in hospitalized patients without documented severe systolic dysfunction, low BP, impaired perfusion, and significantly depressed cardiac output is potentially harmful. (Class III: HARM; LOE: B) Mechanical Circulatory Support (MCS) MCS is beneficial in carefully selected patients with Stage D HF (remains under investigation, but generally includes those with LVEF <25% and NYHA class III IV functional status despite GDMT, with high predicted 1- to 2-year mortality. (Class IIa; LOE: B) Nondurable MCS may be used as a bridge to recovery or bridge to decision in select patients with stage D HFrEF and acute, profound hemodynamic compromise. (Class IIa; LOE: B) Durable MCS may be used to prolong survival for in selected patients with stage D HFrEF. (Class IIa; LOE: B) Cardiac Transplantation Evaluation for cardiac transplantation is indicated for carefully selected patients with stage D HF despite GDMT, device, and surgical management. (Class I; LOE: C) Recommended Treatment/Management of Hospitalized Patients: For recommended treatment and management of the patient requiring acute hospitalization planning for discharge back to ambulatory management, please refer to the published guidelines at: http://circ.ahajournals.org/content/128/16/e240 Clinical practice guidelines are designed to assist clinicians by providing a framework for the evaluation and treatment of patients. The heart failure management guideline is based on the most current recommendations from the American College of Cardiology/American Heart Association 2009 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation in addition to the scientific evidence sources referenced below. The current ACC/AHA Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult is available at http://www.sciencedirect.com/science/article/pii/s0735109708038023. Page 10
Additional Resources for UPMC Health Plan Members MyHealth Advice Line is staffed by experienced Registered Nurses and is available 24/7 to provide telephone support to members. Call 1-866-918-1591. TTY/TDD users should call 1-866-918-1593. Health Coach Programs provide intensive case management for members with specific chronic illnesses or conditions. The programs are built upon best practices and accepted clinical guidelines and include: Diabetes Asthma/COPD Behavioral Health Depression Anxiety ADHD Substance Abuse Cardiovascular Heart failure Coronary artery disease Hypertension Hyperlipidemia. Low Back Pain Members and providers can obtain additional information about the health coach programs by calling 1-866-778-6073. Online interactive preventive health programs and resources are available in partnership with WebMD at www.upmchealthplan.com. MyHealth OnLine Tobacco Cessation Program MyHealth OnLine Physical Activity Program MyHealth OnLine Nutrition Program MyHealth OnLine Weight Management Program MyHealth OnLine Stress Management Program MyHealth OnLine Emotional Health Program Scientific Evidence Sources: 1. Yancy CW, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128:e240-e327, published online before print June 5 2013, doi:10.1161/cir.0b013e31829e8776 http://circ.ahajournals.org/content/early/2013/06/03/cir.0b013e31829e8776.citation 2. Sidney S, et al. Heart Disease and Stroke Statistics - 2013 Update: A Report From the American Heart Association. Circ 2013;127:e6-e245 3. Bonow RO et al. ACCF/AHA/AMA-PCPI 2011 Performance Measures for Adults With Heart Failure. Circulation 2012;125:2382-2401. (http://circ.ahajournals.org/content/125/19/2382.full) 4. 2009 Focused Update Incorporated Into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults. J Am Coll Cardiol 2009; 53(15):e1-e90. 5. Lindenfeld J, et al. Executive Summary: HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010;16:475-539. 6. Pinkerman C, et al. Institute for Clinical Systems Improvement, Heart Failure in Adults. Updated July 2013. Accessed online: https://www.icsi.org/guidelines more/catalog_guidelines_and_more/catalog_guidelines/catalog_cardiovascular_guideli nes/heart_failure/ Page 11
7. Beller GA. Tests that may be overused or misused in cardiology: the Choosing Wisely campaign. J Nucl Cardiol 2012;19:401-403. 8. Messerli FH, et al. Is An ACE Inhibitor Plus An ARB More Effective Than Either Drug Alone? Cleveland Clinic Journal of Medicine, 2009 December;76(12):693-696 9. Taylor, et al. The African-American Heart Failure Trial investigators. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. New England Journal of Medicine 2004; 351:2049-2057. 10. Epstein A, et al. 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation 2013;127:e283-e352. 11. Riegel B, et al. State of the Science: Promoting Self-Care in Persons With Heart Failure: A Scientific Statement From the American Heart Association. Circulation 2009;120(12):1141-1163. Page 12