1301 Punchbowl Street, Harkness Suite 225 Honolulu, Hawaii 96813 Phone (808) 691-7220 Fax: (808) 691-4099 www.queenscipn.org Policy and Procedure Phase 1 Policy Number: Effective Date: Revised: Approved by: Whitney Limm, M.D. QCIPN President & Board Chair John Houk, M.D. QCIPN Vice Chair Policy The purpose of this policy is to: I. Provide guidelines to facilitate delivery of care consistent with evidence based medical therapy for patients with heart failure AHA stage A D (see appendix A) II. Improve the quality and consistency of care by CIPN clinicians by providing education focused on evidenced based guidelines III. Differentiate treatment recommendation for heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) (see appendix B) IV. Achieve optimal guideline directed therapy for patients with heart failure by standardizing care across the continuum V. List outcome metrics to measure effectiveness of this policy Procedure I. Evidence based medical therapy per the ACC/AHA/HFSA guidelines will be used for all patient in AHA stages A D: a. Treatment in AHA stage A i. Hypertension and lipid disorders should be contributed in accordance with contemporary guidelines to lower the risk of HF. Page 1
1. Choice of antihypertensive therapy should follow guidelines with specific options tailored to concomitant medical problems (DM, CAD) please refer to the 2014 Evidence based guidelines for management of high blood pressure in adults (JNC 8 see http://jama.jamanetwork.com/article.aspx?articleid=1791497) ii. Management of 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. iii. Recognition of familial genetic risk obtain a 3 generation family history b. Treatment in AHA stage B (See appendix C) i. Referral to cardiology for evaluation ii. ACE inhibitors/arb s 1. In all patients with a recent or remote history of MI or ACS and/or reduced EF, ACEI should be used to prevent symptomatic HF and reduce mortality. In patients intolerant to ACEI, ARBs are appropriate unless contraindicated. iii. Evidence based beta blockers carvedilol, metoprolol succinate, bisoprolol 1. In all patients with recent or remote history of myocardial infarction, acute coronary syndrome and/or reduced left ventricular ejection fraction, evidence based beta blockers should be used to reduced mortality. 2. In all patients with a recent or remote history of MI or ACS, statins should be used to prevent symptomatic HF and cardiovascular events. 3. In patients with structural cardiac abnormalities, including LV hypertrophy, in the absence of a history of MI or ACS, blood pressure should be controlled in accordance with clinical practice guidelines. 4. Referral for cardiology evaluation 5. To prevent sudden cardiac death, placement of ICD is reasonable in patients with asymptomatic ischemic cardiomyopathy who are at least 40 days post MI, LVEF of 30% or less, are on appropriate medical therapy and have reasonable expectation of survival. 6. Class III: Harm a. Non dihydropyridine calcium channel blockers with negative inotropic effects may be harmful in asymptomatic patients with low LVEF and no symptoms of HF after MI. c. Treatment in AHA Stage C i. Referral to cardiology for concurrent management ii. Initial evaluation for new onset heart failure 1. Noninvasive Cardiac Imaging a. Patients with suspected or new onset HF, or presenting with acute decompensated HF, should undergo a chest x ray to assess heart size and pulmonary congestion and to detect alternative cardiac, pulmonary, and other diseases that may cause or contribute to the patient s symptoms. Page 2
Page 3 b. A 2 dimensional echocardiogram with Doppler should be performed during initial evaluation of patients presenting with HF to assess ventricular function, size, wall thickness, wall motion and valve function. c. Repeat measurement of EF and measurement of the severity of structural remodeling are useful to provide information in patients with HF who have had a significant change in clinical status; who have experienced or recovered from a clinical event; or who have received treatment, including guideline directed medical therapy, that might have had a significant effect on cardiac function; or who may be candidates for device therapy. d. Noninvasive imaging to detect myocardial ischemia and viability is reasonable in patients presenting with de novo HF, who have known CAD and no angina, unless the patient is not eligible for revascularization of any kind. e. Viability assessment is reasonable in select situations when planning revascularization in HF patients with CAD. f. Radionuclide ventriculography or magnetic resonance imaging can be useful to assess LVEF and volume when echocardiography is inadequate. g. Magnetic resonance imaging is reasonable when assessing myocardial infiltrative process or scar burden. h. NO BENEFIT: routine repeat measurement of LV function assessment in the absence of clinical status change or treatment interventions should not be performed. 2. Invasive Evaluation: a. Invasive hemodynamic monitoring with a pulmonary artery catheter should be performed to guide therapy in patients who have respiratory distress or clinical evidence of impaired perfusion in whom the adequacy or excess of intracardiac filling pressures cannot be determined from clinical assessment. 3. Invasive hemodynamic monitoring can be useful for carefully selected patients with acute HF who have persistent symptoms despite empiric adjustment of standard therapies and: a. Whose fluid status, perfusion remains low, or is associated with symptoms, despite initial therapy b. Whose renal function is worsening with therapy c. Whose systolic pressure remains low, or is associated with symptoms, despite initial therapy. d. Who require parenteral vasoactive agents, or e. Who may need consideration for MCS or transplantation
4. When ischemia may be contributing to HF, coronary arteriography is reasonable for patients eligible for revascularization. iii. Heart failure with reduced ejection fraction HFrEF 1. Non pharmacological Therapies: a. Patients with HF should receive specific education to facilitate HF selfcare. b. Exercise training is recommended as safe and effective for patients with HF who are able to participate to improve functional status. c. Sodium restriction is reasonable for patients with symptomatic HF to reduce congestive symptoms. d. Continuous positive airway pressure can be beneficial to increase LVEF and improve functional status in patients with HF and sleep apnea. e. Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, HRQOL, and mortality 2. Pharmacological Therapies: a. Measures listed in as Class I recommendations for patients in stages A and B are recommended where appropriate for patients in stage C. (ACEI/ARB and beta blockers) (See appendix D) b. Diuretics are recommended in patients with HFrEF who have evidence of fluid retention, unless contraindicated, to improve symptoms. (See appendix E) i. Initiate at low doses, with increase in dose until urine output increases and weight decreases generally by 0.5 to 1.0 kg daily. May need to increase frequency, add sequential nephron blockade with addition of Thiazide diuretic (metolazone, HCTZ or clorothiazine). > unresponsiveness to diuretic management attributed to poor bioavailability and gut absorption, renal impairment due to congestion and poor perfusion, dietary indiscretion or use of agents that block the effect of diuretics (NSAIDs, including COX 2 inhibitors) c. Aldosterone Receptor Antagonists are recommended in patients with NYHA class II IV HF and who have LVEF of 35% or less unless contraindicated, to reduce morbidity and mortality. i. Creatinine should be 2.5 mg/dl or less in men or 2.0 mg/dl or less in women, and potassium should be less than 5.0 meq/l. ii. Strategies to minimize hyperkalemia in patients treated with aldosterone antagonists include: 1. Initial dosing of spironolactone 12.5mg daily or eplerenone 25mg daily. May increase to 25mg spironolactone or 50mg eplerenone. Page 4
Page 5 2. In most cases potassium supplementation is discontinued when initiating therapy 3. Close monitoring of serum potassium is required. Check potassium levels and renal function 3 days following initiation of therapy, and at one week and monthly for at least 3 months. iii. Aldosterone receptor antagonist are recommended to reduce morbidity and mortality following an acute MI in patients who have LVEF of 40% or less who develop symptoms of HF or who have a history of diabetes mellitus, unless contraindicated. d. Hydralazine with isosorbide dinitrate is recommended to reduce morbidity and mortality for patients self described as African Americans with NYHA class III IV HFrEF receiving optimal therapy with ACEI and beta blockers, unless contraindicated. i. This combination can be used also in those patients who cannot be given ACEI or ARB because of drug intolerance, hypotension or renal insufficiency. e. Digoxin can be beneficial in patients with HFrEF unless contraindicated, to decrease hospitalizations for HF. 3. Device therapy for Stage C HFrEF a. ICD therapy is recommended for primary prevention of SCD to reduce total mortality in selected patients with NICM (DCM) or ischemic heart disease at least 40 days post MI with LVEF of 35% of less and NYHA class II III symptoms on chronic guideline directed management with a reasonable expectation of meaningful survival for >1 year. b. Cardiac Resynchronization Therapy is indicated for patients who have a LVEF of 35% or less, sinus rhythm, left bundle branch block with a QRS duration of 150 ms or greater, and NYHA class II IV symptoms on GDMT. (see Appendix F) c. ICD therapy is recommended for primary prevention of SCD to reduce total mortality in selected patients at least 40 days post MI with LVEF of 30% or less and NYHA class I symptoms while receiving guideline directed therapy, who have a reasonable expectation of meaningful survival for <1 year. 4. Medication Therapies to avoid: a. Nutritional supplements as treatment for HF are not recommended. b. Hormonal therapies other than to correct deficiencies are not recommended.
c. Drugs known to adversely affect the clinical status of patients with HFrEF, i.e most antiarrhythmic drugs, most calcium channel blockers, NSAIDS, or thiazolidinediones. d. Long term use of infused positive inotropic drugs is potentially harmful for patients with HFrEF, except as palliation for patients with end stage disease who cannot be stabilized with standard medical therapy. iv. Heart failure with preserved ejection fraction HFpEF 1. Pharmacological Treatment a. Systolic and diastolic blood pressure should be controlled in patients with HFpEF in accordance with published clinical practice guidelines to prevent morbidity. b. Diuretics should be used for relief of symptoms due to volume overload in patients with HFpEF. c. Coronary revascularization is reasonable in patients with CAD in whom symptoms or demonstrable myocardial ischemia is judged to be having an adverse effect on symptomatic HFpEF despite GMDT. d. Management of AF (atrial fibrillation) according to published guidelines. e. The use of beta blocking agents, ACEI, and ARBs in patients with hypertension is reasonable to control blood pressure. d. Stage D: Advanced HF i. Referral to cardiology for management ii. Clinical events and findings useful for identifying patients with Advance HF (See Appendix G) 1. Repeat >/=2 hospitalizations or ED visits for HF in the past year 2. Progressive deterioration in renal function (e.g. rise in BUN and Cr) 3. Weight loss without other cause (e.g cardiac cachexia) 4. Intolerance to ACEI due to hypotension and or worsening renal function 5. Intolerance to beta blockers due to worsening HF or hypotension 6. Frequent systolic blood pressure <90 mmhg 7. Persistent dyspnea with dressing or bathing requiring rest 8. Inability to walk 1 bock on the level ground due to dyspnea or fatigue 9. Recent need to escalate diuretics to maintain volume status, often reaching daily furosemide equivalent dose >160 mg /d and or use of supplemental metolazone therapy. 10. Progressive decline in serum sodium, usually <133 meq/l 11. Frequent ICD shocks iii. Treatment options in stage D heart failure 1. Inotropic Support: a. Until definitive therapy (e.g. coronary revascularization, MCS, heart transplantation) or resolution of the acute precipitating problem, Page 6
patients with cardiogenic shock should receive temporary intravenous inotropic support to maintain systemic perfusion and preserve end organ performance. b. Continuous intravenous inotropic support is reasonable as bridge therapy in patients with stage D HF refractory to GDMT and device therapy who are eligible for and awaiting MCS or cardiac transplantation. 2. Mechanical Circulatory Support a. MCS is beneficial in carefully selected patients with stage D HFrEF in whom definitive management (e.g. cardiac transplantation) or cardiac recovery is anticipated or planned. b. Nondurable MCS, including the use of percutaneous and extracorporeal ventricular assist device (VADs) is reasonable as a bridge to recovery or bridge to decision for carefully selected patients with HFrEF with acute profound hemodynamic compromise. c. Durable MCS is reasonable to prolong survival for carefully selected patients with stage D HFrEF. 3. Cardiac Transplantation a. Evaluation for cardiac transplantation is indicated for carefully selected patients with stage D HF despite GDMT, device, and surgical management. 4. Palliative care a. Supportive care referral i. Increased assistance in the home for symptomatic improvement for patients with frequent hospitalizations b. Hospice referral i. End of life care e. Treatment of the acutely decompensated patient in the hospitalized setting i. Identify the precipitating cause of decompensated HF 1. Eevaluate for possible ACS with ECG and serum cardiac biomarkers. 2. Other common precipitating factors should be considered such as medication or dietary noncompliance, uncorrected high blood pressure, AF or other arrhythmias, recent addition of negative inotropic drugs (CCB s or beta blockers), initiation of drugs that increase salt retention (steroids, NSAIDs or thiazolidinediones), excessive alcohol or illicit drug use, endocrine abnormalities (DM or thyroid), concurrent infection or additional acute cardiovascular disorders (valvular disease, myopericarditis or aortic dissection). ii. Biomarkers: 1. BNP or NT probnp: useful to support clinical judgment for the diagnosis of acutely decompensated HF, especially in the setting of uncertainty for the diagnosis. 2. Measurement of BNP or NT probnp and or cardiac troponin is useful for establishing prognosis or disease severity in acutely decompensated HF. iii. Forrester Classification: Page 7
iv. v. Maintenance of guideline directed medical therapy during hospitalization 1. In patients with HFrEF experiencing a symptomatic exacerbation of HF requiring hospitalization during chronic treatment with guideline directed medical therapy, it is recommended that therapy be continued in the absence of hemodynamic instability or contraindications. 2. With holding of, or reduction in, beta blocker therapy should be considered only in patients hospitalized after recent initiation or increase in dose, or with marked volume overload or marginal/low cardiac output. Those with worsening renal function should be considered for temporary discontinuation of ACEI/ARB and or aldosterone antagonist. vi. Initiation of beta blocker therapy is recommended after optimization of volume status and successful discontinuation of intravenous diuretics, vasodilators, and inotropic agents. Beta blocker therapy should be initiated at a low dose and only in stable patients. vii. Diuretics in Hospitalized Patients: 1. Patients with HF admitted with evidence of significant fluid overload should be promptly treated with intravenous loop diuretics to reduce morbidity. 2. If patients are already receiving loop diuretic therapy, the initial intravenous dose should be equal or exceed their chronic oral daily dose and should be given in intermittent boluses or continuous infusion. Urine output and signs and symptoms of congestion should be serially assessed, and the diuretic dose should be adjusted accordingly. 3. When diuresis is inadequate to relieve symptoms, it is reasonable to intensify the diuretic regimen (double to dose or add a second thiazide diuretic). viii. Renal Replacement Therapy: Ultrafiltration 1. Ultrafiltration may be considered for patients with refractory congestion not responding to medical therapy. ix. Recommendations for discharge 1. Before hospital discharge, at the first post discharge visit and subsequent followups the following should be addressed Page 8
II. III. IV. a. Initiation of guideline directed therapy b. Cause of heart failure, barriers to care, limitations in support c. Assessment of volume status and blood pressure with adjustment of therapy d. Optimization of chronic oral HF therapy e. Renal function an electrolytes f. Management of comorbid conditions g. HF eduation, self care, emergency plans, adherence h. Palliative care or hospice care 2. Follow up visit scheduled within 7 14 days or telephone call within 3 days Achieve optimal guideline directed therapy for patients with heart failure by standardizing care across the continuum a. Up titrate medications in small increments to the highest tolerated target dose b. Specific sub populations (ie. elderly, chronic kidney disease) may require more frequent office visits and laboratory monitoring during medication titration c. Monitor vital signs closely with mediation titration d. Alternate adjustment of different medication classes (ie. ACE/ARB and beta blockers) e. Monitor renal function and electrolytes for changes in creatinine f. Patients may report symptoms of fatigue and weakness with dose increases. If patients are stable otherwise, these symptoms are likely transient g. Discourage sudden spontaneous discontinuation of therapy h. Carefully review all medications prior to dose adjustments i. Consider temporary adjustments in dosages with acute non cardiac illness (respiratory infection, risk of dehydration) j. Educate patients and families regarding the benefits of guideline directed medical therapy including myocardial reverse remodeling, increased survival, improved functional status and quality of life. Web based module education for review and reference by the physicians in the CIPN List outcome metrics to measure effectiveness of this policy a. Heart failure admission rates for patients in the CIPN b. Use of guideline directed therapy Page 9
APPENDIX A ACCF/AHA Stages and NYHA Classifications APPENDIX B DEFINITIONS OF HEART FAILURE APPENDIX C TREATMENT FOR HEART FAILURE STAGE B Page 10
APPENDIX D Diuretics for use in Chronic Heart Failure Stage C Page 11
APPENDIX E Drugs commonly used in HFrEF stage C APPENDIX F Indication for CRT therapy Page 12
APPENDIX G Advanced heart failure profiles References 1. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2013; 128:1810. Page 13