Process Improvement in Heart Failure Patient Care: Transitions From Door to Discharge and Beyond Steven Sheris, M.D., FACC, FACP Chief of Cardiology Gagnon Cardiovascular Institute at Overlook Medical Center Summit, NJ Disclosures Speakers Bureau Astra Zeneca Baxter I do not plan to discuss off-label or unapproved indications for commercial products.
30-Day Risk-adjusted, All-Cause Readmission Rates for Heart Failure Cases (MS-DRG 291-293) UHC Median Readmission Rate is 22.1% for Jul 2008-Jun 2009 while the Top Quartile is 19.6%. Discharge Year Overlook Medical Center Readmit Rate Overlook Medical Center Cases 2006 18.8% 420 2007 19.7% 502 2008 19.2% 611
30-Day All-Cause Medicare Risk-Adjusted Heart Failure Readmission Rate (publicly-reported) Lower Percentages Are Better 20% 25% 30% 35% 40% 45% 50% Overlook Medical Center US National 30 Day Readmission Rate for Heart Failure = 24.5% 23.6% No different than National Rate Number of Medicare Patients Admitted for Heart Failure Based on 890 patients 30-Day All-Cause Medicare Risk-Adjusted Heart Failure Mortality Rate (publicly-reported) Data are from Jul 05 Jun 08. Lower Percentages Are Better 9% 10% 11% 12% 13% 14% 15% Overlook Medical Center US National 30 Day Death Rate for Heart Failure = 11.1% 11.5% No different than National Rate Number of Medicaid Patients Admitted for Heart Failure Based on 800 patients
7 NAME OF PRESENTATION IN ALL CPS (INSERT IN FOOTER) Risk-adjusted Inpatient Mortality Ratios Heart Failure Cases (MS-DRG 291-293) UHC Median Mortality Ratio is 0.89 for Jul 2008-Jun 2009 while the Top Quartile is 0.56. Discharge Year Overlook Medical Center Mortality Index Overlook Medical Center Cases 2006 1.22 446 2007 1.15 525 2008 1.27 647
9 10
Admission Source for HF 2009 5% 4% 4% 1% 0% Emergency Department 9% Transfer from another facility Transfer from skilled nursing facility or ICF Non-Facility Point of Origin 78% Clinic referral Transfer from a different hospital Information not available Integrating the Continuum of Care for Heart Failure Reliable Care: Not Missing the Steps Hospital ED Dx Admit? CCU? Acute Rx Evaluation CCU Telemetry IV Meds Oral Meds Echo/Cath LV fxn Other eval Tx to floor DC Meds Other eval Pt ed Other Rx Follow up Dis mgmt Early Post DC Right meds? Titration Pt ed Continuity Device? Dis Mgmt Preemption Outpt Right meds? Right dose? Vol status Reassess EF Device selfmanagement Other issues? Fonorow GC, Rev Cardiovasc Med 2006;7:S3-11
2013 ACCF/AHA Guideline for the Management of Heart Failure Developed in Collaboration With the American Academy of Family Physicians, American College of Chest Physicians, Heart Rhythm Society, and International Society for Heart and Lung Transplantation Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation American College of Cardiology Foundation and American Heart Association, Inc. Classification of Recommendations and Levels of Evidence A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. *Data available from clinical trials or registries about the usefulness/ efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated.
Classification of Heart Failure A B C D ACCF/AHA Stages of HF At high risk for HF but without structural heart disease or symptoms of HF. Structural heart disease but without signs or symptoms of HF. Structural heart disease with prior or current symptoms of HF. Refractory HF requiring specialized interventions. None I I II III IV NYHA Functional Classification No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF. Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF. Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest. Stages, Phenotypes and Treatment of HF At Risk for Heart Failure Heart Failure STAGE A At high risk for HF but without structural heart disease or symptoms of HF STAGE B Structural heart disease but without signs or symptoms of HF STAGE C Structural heart disease with prior or current symptoms of HF STAGE D Refractory HF e.g., Patients with : HTN Atherosclerotic disease DM Obesity Metabolic syndrome or Patients Using cardiotoxins With family history of cardiomyopathy Structural heart disease e.g., Patients with : Previous MI LV remodeling including LVH and low EF Asymptomatic valvular disease Development of symptoms of HF e.g., Patients with : Known structural heart disease and HF signs and symptoms Refractory symptoms of HF at rest, despite GDMT e.g., Patients with : Marked HF symptoms at rest Recurrent hospitalizations despite GDMT HFpEF HFrEF THERAPY Goals Heart healthy lifestyle Prevent vascular, coronary disease Prevent LV structural abnormalities Drugs ACEI or ARB in appropriate patients for vascular disease or DM Statins as appropriate THERAPY Goals Prevent HF symptoms Prevent further cardiac remodeling Drugs ACEI or ARB as appropriate Beta blockers as appropriate In selected patients ICD Revascularization or valvular surgery as appropriate THERAPY Goals Control symptoms Improve HRQOL Prevent hospitalization Prevent mortality Strategies Identification of comorbidities Treatment Diuresis to relieve symptoms of congestion Follow guideline driven indications for comorbidities, e.g., HTN, AF, CAD, DM Revascularization or valvular surgery as appropriate THERAPY Goals Control symptoms Patient education Prevent hospitalization Prevent mortality Drugs for routine use Diuretics for fluid retention ACEI or ARB Beta blockers Aldosterone antagonists Drugs for use in selected patients Hydralazine/isosorbide dinitrate ACEI and ARB Digoxin In selected patients CRT ICD Revascularization or valvular surgery as appropriate THERAPY Goals Control symptoms Improve HRQOL Reduce hospital readmissions Establish patient s end - of-life goals Options Advanced care measures Heart transplant Chronic inotropes Temporary or permanent MCS Experimental surgery or drugs Palliative care and hospice ICD deactivation
Definition of Heart Failure Classification I. Heart Failure with Reduced Ejection Fraction (HFrEF) Ejection Fraction Description 40% Also referred to as systolic HF. Randomized clinical trials have mainly enrolled patients with HFrEF and it is only in these patients that efficacious therapies have been demonstrated to date. II. Heart Failure with Preserved Ejection Fraction (HFpEF) 50% Also referred to as diastolic HF. Several different criteria have been used to further define HFpEF. The diagnosis of HFpEF is challenging because it is largely one of excluding other potential noncardiac causes of symptoms suggestive of HF. To date, efficacious therapies have not been identified. a. HFpEF, Borderline 41% to 49% These patients fall into a borderline or intermediate group. Their characteristics, treatment patterns, and outcomes appear similar to those of patient with HFpEF. b. HFpEF, Improved >40% It has been recognized that a subset of patients with HFpEF previously had HFrEF. These patients with improvement or recovery in EF may be clinically distinct from those with persistently preserved or reduced EF. Further research is needed to better characterize these patients. Distribution of Patients' LVEFs Fonarow, G. C. et al. J Am Coll Cardiol 2007;50:768-777 51.2% Copyright 2007 American College of Cardiology Foundation. Restrictions may apply.
Congestion in HF: Most Admitted Patients are Wet < (ADHERE Registry. 3rd Qtr 2003 National Benchmark Report.) Initial and Serial Evaluation of the HF Patient Risk Scoring
Risk Scoring Validated multivariable risk scores can be useful to estimate subsequent risk of mortality in ambulatory or hospitalized patients with HF. Risk Scores to Predict Outcomes in HF Acutely Decompensated HF ADHERE Classification and Regression Tree (CART) Model American Heart Association Get With the Guidelines Score EFFECT Risk Score ESCAPE Risk Model and Discharge Score OPTIMIZE HF Risk-Prediction Nomogram
Predictors of In-Hospital Mortality Copyright restrictions may apply. Fonarow, G. C. et al. JAMA 2005;293:572-580. 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 43 mg/dl Systolic blood pressure < 115 mmhg Serum creatinine > 2.75 mg/dl Fonarow GC et al. JAMA 2005;293:572-80
A Multifaceted Approach to Acute HF Disposition Decision Making Collins and Storrow, Jam Coll Cardiol HF 2013; 1:273-80.
Initial and Serial Evaluation of the HF Patient Diagnostic Tests Diagnostic Tests A 12-lead ECG should be performed initially on all patients presenting with HF.
Initial and Serial Evaluation of the HF Patient Biomarkers Hospitalized/Acute Hospitalized/Acute Measurement of BNP or NT-proBNP is useful to support clinical judgment for the diagnosis of acutely decompensated HF, especially in the setting of uncertainty for the diagnosis. Measurement of BNP or NT-proBNP and/or cardiac troponin is useful for establishing prognosis or disease severity in acutely decompensated HF.
Hospitalized/Acute (cont.) The usefulness of BNP- or NT-proBNP guided therapy for acutely decompensated HF is not well-established. Measurement of other clinically available tests such as biomarkers of myocardial injury or fibrosis may be considered for additive risk stratification in patients with acutely decompensated HF. Recommendations for Biomarkers in HF Biomarker, Application Setting COR LOE Natriuretic peptides Diagnosis or exclusion of HF Prognosis of HF Guidance of acutely decompensated HF therapy Biomarkers of myocardial injury Additive risk stratification Biomarkers of myocardial fibrosis Ambulatory, Acute Ambulatory, Acute I I Acute IIb C Acute, Ambulatory I A A A Additive risk stratification Acute IIb A
Causes for Elevated Natriuretic Peptide Levels Cardiac Heart failure, including RV syndromes Acute coronary syndrome Heart muscle disease, including LVH Valvular heart disease Pericardial disease Atrial fibrillation Myocarditis Cardiac surgery Cardioversion Noncardiac Advancing age Anemia Renal failure Pulmonary causes: obstructive sleep apnea, severe pneumonia, pulmonary hypertension Critical illness Bacterial sepsis Severe burns Toxic-metabolic insults, including cancer chemotherapy and envenomation Initial and Serial Evaluation of the HF Patient Noninvasive Cardiac Imaging
Noninvasive Cardiac Imaging Patients with suspected or new-onset HF, or those 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 patients symptoms. 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. 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 GDMT, that might have had a significant effect on cardiac function; or who may be candidates for device therapy. Noninvasive Cardiac Imaging Routine repeat measurement of LV function assessment in the absence of clinical status change or treatment interventions should not be performed. No Benefit
Recommendations for Noninvasive Imaging Recommendation COR LOE Patients with suspected, acute, or new-onset HF should undergo a chest x- ray A 2-dimensional echocardiogram with Doppler should be performed for initial evaluation of HF 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 Noninvasive imaging to detect myocardial ischemia and viability is reasonable in HF and CAD Routine repeat measurement of LV function assessment should not be performed I I I IIa III: No Benefit C C C C B Initial and Serial Evaluation of the HF Patient Invasive Evaluation
Invasive Evaluation 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. 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, or systemic or pulmonary vascular resistance is uncertain; b. whose systolic pressure remains low, or is associated with symptoms, despite initial therapy; c. whose renal function is worsening with therapy; d. who require parenteral vasoactive agents; or e. who may need consideration for MCS or transplantation. Invasive Evaluation (cont.) When ischemia may be contributing to HF, coronary arteriography is reasonable for patients eligible for revascularization.
Invasive Evaluation (cont.) No Benefit Routine use of invasive hemodynamic monitoring is not recommended in normotensive patients with acute decompensated HF and congestion with symptomatic response to diuretics and vasodilators. Recommendations for Invasive Evaluation Recommendation COR LOE Monitoring with a pulmonary artery catheter should be performed in patients with respiratory distress or impaired systemic perfusion when clinical assessment is inadequate Invasive hemodynamic monitoring can be useful for carefully selected patients with acute HF with persistent symptoms and/or when hemodynamics are uncertain When coronary ischemia may be contributing to HF, coronary arteriography is reasonable Routine use of invasive hemodynamic monitoring is not recommended in normotensive patients with acute HF I IIa IIa III: No Benefit C C C B
Guideline for HF Treatment of Stages A to D Treatment of Stages A to D Stage A
I IIa IIb III Stage A Hypertension and lipid disorders should be controlled in accordance with contemporary guidelines to lower the risk of HF. I IIa IIb III 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. Treatment of Stages A to D Stage B
Recommendations for Treatment of Stage B HF Recommendations COR LOE In patients with a history of MI and reduced EF, ACE inhibitors or ARBs should be used to prevent HF I A In patients with MI and reduced EF, evidence-based beta blockers should be used to prevent HF I B In patients with MI, statins should be used to prevent HF I A Blood pressure should be controlled to prevent symptomatic HF I A ACE inhibitors should be used in all patients with a reduced EF to prevent HF Beta blockers should be used in all patients with a reduced EF to prevent HF An ICD is reasonable in patients with asymptomatic ischemic cardiomyopathy who are at least 40 d post-mi, have an LVEF 30%, and on GDMT Nondihydropyridine calcium channel blockers may be harmful in patients with low LVEF I I IIa III: Harm A C B C Treatment of Stages A to D Stage C
Treatment of Stages A to D Nonpharmacological Interventions Stage C: Nonpharmacological Interventions Patients with HF should receive specific education to facilitate HF self-care. Sodium restriction is reasonable for patients with symptomatic HF to reduce congestive symptoms.
Stage C: Nonpharmacological Interventions (cont.) Continuous positive airway pressure (CPAP) can be beneficial to increase LVEF and improve functional status in patients with HF and sleep apnea. Treatment of Stages A to D Pharmacological Treatment for Stage C HFrEF
Pharmacological Treatment for Stage C HFrEF See recommendations for stages A, B, and C LOE for LOE Measures listed as Class I recommendations for patients in stages A and B are recommended where appropriate for patients in stage C. (Levels of Evidence: A, B, and C as appropriate) GDMT as depicted in Figure 1 should be the mainstay of pharmacological therapy for HFrEF. Pharmacologic Treatment for Stage C HFrEF HFrEF Stage C NYHA Class I IV Treatment: Class I, LOE A ACEI or ARB AND Beta Blocker For all volume overload, NYHA class II-IV patients For persistently symptomatic African Americans, NYHA class III-IV For NYHA class II-IV patients. Provided estimated creatinine >30 ml/min and K+ <5.0 meq/dl Add Add Add Class I, LOE C Loop Diuretics Class I, LOE A Hydral-Nitrates Class I, LOE A Aldosterone Antagonist
Pharmacological Treatment for Stage C HFrEF (cont.) Diuretics are recommended in patients with HFrEF who have evidence of fluid retention, unless contraindicated, to improve symptoms. ACE inhibitors are recommended in patients with HFrEF and current or prior symptoms, unless contraindicated, to reduce morbidity and mortality. ARBs are recommended in patients with HFrEF with current or prior symptoms who are ACE inhibitor-intolerant, unless contraindicated, to reduce morbidity and mortality. Drugs Commonly Used for HFrEF (Stage C HF) Drug Initial Daily Dose(s) Maximum Doses(s) Mean Doses Achieved in Clinical Trials ACE Inhibitors Captopril 6.25 mg 3 times 50 mg 3 times 122.7 mg/d (421) Enalapril 2.5 mg twice 10 to 20 mg twice 16.6 mg/d (412) Fosinopril 5 to 10 mg once 40 mg once --------- Lisinopril 2.5 to 5 mg once 20 to 40 mg once 32.5 to 35.0 mg/d (444) Perindopril 2 mg once 8 to 16 mg once --------- Quinapril 5 mg twice 20 mg twice --------- Ramipril 1.25 to 2.5 mg once 10 mg once --------- Trandolapril 1 mg once 4 mg once --------- ARBs Candesartan 4 to 8 mg once 32 mg once 24 mg/d (419) Losartan 25 to 50 mg once 50 to 150 mg once 129 mg/d (420) Valsartan 20 to 40 mg twice 160 mg twice 254 mg/d (109) Aldosterone Antagonists Spironolactone 12.5 to 25 mg once 25 mg once or twice 26 mg/d (424) Eplerenone 25 mg once 50 mg once 42.6 mg/d (445)
Drugs Commonly Used for HFrEF (Stage C HF) (cont.) Drug Initial Daily Dose(s) Maximum Doses(s) Mean Doses Achieved in Clinical Trials Beta Blockers Bisoprolol 1.25 mg once 10 mg once 8.6 mg/d (118) Carvedilol 3.125 mg twice 50 mg twice 37 mg/d (446) Carvedilol CR 10 mg once 80 mg once --------- Metoprolol succinate extended release (metoprolol CR/XL) 12.5 to 25 mg once 200 mg once 159 mg/d (447) Hydralazine & Isosorbide Dinitrate Fixed dose combination (423) Hydralazine and isosorbide dinitrate (448) 37.5 mg hydralazine/ 20 mg isosorbide dinitrate 3 times daily Hydralazine: 25 to 50 mg, 3 or 4 times daily and isorsorbide dinitrate: 20 to 30 mg 3 or 4 times daily 75 mg hydralazine/ 40 mg isosorbide dinitrate 3 times daily Hydralazine: 300 mg daily in divided doses and isosorbide dinitrate 120 mg daily in divided doses ~175 mg hydralazine/90 mg isosorbide dinitrate daily --------- Pharmacological Treatment for Stage C HFrEF (cont.) ARBs are reasonable to reduce morbidity and mortality as alternatives to ACE inhibitors as first-line therapy for patients with HFrEF, especially for patients already taking ARBs for other indications, unless contraindicated. Addition of an ARB may be considered in persistently symptomatic patients with HFrEF who are already being treated with an ACE inhibitor and a beta blocker in whom an aldosterone antagonist is not indicated or tolerated.
Harm Pharmacological Treatment for Stage C HFrEF (cont.) Routine combined use of an ACE inhibitor, ARB, and aldosterone antagonist is potentially harmful for patients with HFrEF. Use of 1 of the 3 beta blockers proven to reduce mortality (i.e., bisoprolol, carvedilol, and sustained-release metoprolol succinate) is recommended for all patients with current or prior symptoms of HFrEF, unless contraindicated, to reduce morbidity and mortality. Pharmacological Treatment for Stage C HFrEF (cont.) Aldosterone receptor antagonists [or mineralocorticoid receptor antagonists (MRA)] are recommended in patients with NYHA class II-IV and who have LVEF of 35% or less, unless contraindicated, to reduce morbidity and mortality. Patients with NYHA class II should have a history of prior cardiovascular hospitalization or elevated plasma natriuretic peptide levels to be considered for aldosterone receptor antagonists. Creatinine should be 2.5 mg/dl or less in men or 2.0 mg/dl or less in women (or estimated glomerular filtration rate >30 ml/min/1.73m2) and potassium should be less than 5.0 meq/l. Careful monitoring of potassium, renal function, and diuretic dosing should be performed at initiation and closely followed thereafter to minimize risk of hyperkalemia and renal insufficiency.
Pharmacological Treatment for Stage C HFrEF (cont.) Harm Aldosterone receptor antagonists 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. Inappropriate use of aldosterone receptor antagonists is potentially harmful because of life-threatening hyperkalemia or renal insufficiency when serum creatinine greater than 2.5 mg/dl in men or greater than 2.0 mg/dl in women (or estimated glomerular filtration rate <30 ml/min/1.73m2), and/or potassium above 5.0 meq/l. Pharmacological Treatment for Stage C HFrEF (cont.) The combination of hydralazine and 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 ACE inhibitors and beta blockers, unless contraindicated. A combination of hydralazine and isosorbide dinitrate can be useful to reduce morbidity or mortality in patients with current or prior symptomatic HFrEF who cannot be given an ACE inhibitor or ARB because of drug intolerance, hypotension, or renal insufficiency, unless contraindicated.
Pharmacological Treatment for Stage C HFrEF (cont.) Digoxin can be beneficial in patients with HFrEF, unless contraindicated, to decrease hospitalizations for HF. No Benefit No Benefit Pharmacological Treatment for Stage C HFrEF (cont.) Anticoagulation is not recommended in patients with chronic HFrEF without AF, a prior thromboembolic event, or a cardioembolic source. Statins are not beneficial as adjunctive therapy when prescribed solely for the diagnosis of HF in the absence of other indications for their use. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is reasonable to use as adjunctive therapy in patients with NYHA class II-IV symptoms and HFrEF or HFpEF, unless contraindicated, to reduce mortality and cardiovascular hospitalizations.
No Benefit No Benefit Pharmacological Treatment for Stage C HFrEF (cont.) Nutritional supplements as treatment for HF are not recommended in patients with current or prior symptoms of HFrEF. Hormonal therapies other than to correct deficiencies are not recommended for patients with current or prior symptoms of HFrEF. Harm Drugs known to adversely affect the clinical status of patients with current or prior symptoms of HFrEF are potentially harmful and should be avoided or withdrawn whenever possible (e.g., most antiarrhythmic drugs, most calcium channel blocking drugs (except amlodipine), NSAIDs, or TZDs). Pharmacological Treatment for Stage C HFrEF (cont.) Harm 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 treatment (see recommendations for stage D). Calcium channel blocking drugs are not recommended as routine treatment for patients with HFrEF. No Benefit
Pharmacological Treatment for Stage C HFpEF Systolic and diastolic blood pressure should be controlled in patients with HFpEF in accordance with published clinical practice guidelines to prevent morbidity. Diuretics should be used for relief of symptoms due to volume overload in patients with HFpEF. Coronary revascularization is reasonable in patients with CAD in whom symptoms (angina) or demonstrable myocardial ischemia is judged to be having an adverse effect on symptomatic HFpEF despite GDMT. Harm Pharmacological Treatment for Stage C HFrEF (cont.) 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 treatment (see recommendations for stage D). Calcium channel blocking drugs are not recommended as routine treatment for patients with HFrEF. No Benefit
Pharmacological Therapy for Management of Stage C HFrEF Recommendations COR LOE Diuretics Diuretics are recommended in patients with HFrEF with fluid retention I C ACE Inhibitors ACE inhibitors are recommended for all patients with HFrEF I A ARBs ARBs are recommended in patients with HFrEF who are ACE inhibitor intolerant ARBs are reasonable as alternatives to ACE inhibitor as first line therapy in HFrEF The addition of an ARB may be considered in persistently symptomatic patients with HFrEF on GDMT Routine combined use of an ACE inhibitor, ARB, and aldosterone antagonist is potentially harmful I IIa IIb III: Harm A A A C Pharmacological Therapy for Management of Stage C HFrEF (cont.) Recommendations COR LOE Beta Blockers Use of 1 of the 3 beta blockers proven to reduce mortality is recommended for all stable patients Aldosterone Antagonists Aldosterone receptor antagonists are recommended in patients with NYHA class II-IV HF who have LVEF 35% Aldosterone receptor antagonists are recommended in patients following an acute MI who have LVEF 40% with symptoms of HF or DM Inappropriate use of aldosterone receptor antagonists may be harmful Hydralazine and Isosorbide Dinitrate The combination of hydralazine and isosorbide dinitrate is recommended for African-Americans, with NYHA class III IV HFrEF on GDMT A combination of hydralazine and isosorbide dinitrate can be useful in patients with HFrEF who cannot be given ACE inhibitors or ARBs I I I III: Harm I IIa A A B B A B
Medical Therapy for Stage C HFrEF: Magnitude of Benefit Demonstrated in RCTs GDMT RR Reduction in Mortality NNT for Mortality Reduction (Standardized to 36 mo) RR Reduction in HF Hospitalizations ACE inhibitor or ARB 17% 26 31% Beta blocker 34% 9 41% Aldosterone antagonist 30% 6 35% Hydralazine/nitrate 43% 7 33% Treatment of Stages A to D Treatment for Stage C HFpEF
Pharmacological Treatment for Stage C HFpEF The use of ARBs might be considered to decrease hospitalizations for patients with HFpEF. Routine use of nutritional supplements is not recommended for patients with HFpEF. No Benefit Treatment of HFpEF Recommendations COR LOE Systolic and diastolic blood pressure should be controlled according to published clinical practice guidelines I B Diuretics should be used for relief of symptoms due to volume overload Coronary revascularization for patients with CAD in whom angina or demonstrable myocardial ischemia is present despite GDMT Management of AF according to published clinical practice guidelines for HFpEF to improve symptomatic HF Use of beta-blocking agents, ACE inhibitors, and ARBs for hypertension in HFpEF ARBs might be considered to decrease hospitalizations in HFpEF Nutritional supplementation is not recommended in HFpEF I IIa IIa IIa IIb III: No Benefit C C C C B C
Treatment of Stages A to D Stage D Clinical Events and Findings Useful for Identifying Patients With Advanced Repeated ( 2) hospitalizations or ED visits for HF in the past year HF Progressive deterioration in renal function (e.g., rise in BUN and creatinine) Weight loss without other cause (e.g., cardiac cachexia) Intolerance to ACE inhibitors due to hypotension and/or worsening renal function Intolerance to beta blockers due to worsening HF or hypotension Frequent systolic blood pressure <90 mm Hg Persistent dyspnea with dressing or bathing requiring rest Inability to walk 1 block on the level ground due to dyspnea or fatigue 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 Progressive decline in serum sodium, usually to <133 meq/l Frequent ICD shocks Adapted from Russell et al. Congest Heart Fail. 2008;14:316-21.
Treatment of Stages A to D Water Restriction Water Restriction Fluid restriction (1.5 to 2 L/d) is reasonable in stage D, especially in patients with hyponatremia, to reduce congestive symptoms.
Guideline for HF The Hospitalized Patient The Hospitalized Patient Precipitating Causes of Decompensated HF
Precipitating Causes of Decompensated HF ACS precipitating acute HF decompensation should be promptly identified by ECG and serum biomarkers including cardiac troponin testing, and treated optimally as appropriate to the overall condition and prognosis of the patient. Common precipitating factors for acute HF should be considered during initial evaluation, as recognition of these conditions is critical to guide appropriate therapy. The Hospitalized Patient Maintenance of GDMT During Hospitalization
Maintenance of GDMT During Hospitalization In patients with HFrEF experiencing a symptomatic exacerbation of HF requiring hospitalization during chronic maintenance treatment with GDMT, it is recommended that GDMT be continued in the absence of hemodynamic instability or contraindications. Initiation of beta-blocker therapy is recommended after optimization of volume status and successful discontinuation of intravenous diuretics, vasodilators, and inotropic agents. Betablocker therapy should be initiated at a low dose and only in stable patients. Caution should be used when initiating beta blockers in patients who have required inotropes during their hospital course. The Hospitalized Patient Diuretics in Hospitalized Patients
Diuretics in Hospitalized Patients Patients with HF admitted with evidence of significant fluid overload should be promptly treated with intravenous loop diuretics to reduce morbidity. Therapy should begin in the emergency department or outpatient clinic without delay, as early intervention may be associated with better outcomes for patients hospitalized with decompensated HF (Level of Evidence: B). If patients are already receiving loop diuretic therapy, the initial intravenous dose should equal or exceed their chronic oral daily dose and should be given as either 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 to relieve symptoms, reduce volume excess, and avoid hypotension. Hospital Mortality, Time to Treatment, and ibnp Level Maisel, A. S. et al. J Am Coll Cardiol 2008;52:534-540 Copyright 2008 American College of Cardiology Foundation. Restrictions may apply.
Variables Predictive of In Hospital Mortality Time to IV diuretic (per h) 1.004 1.002 1.005 <0.0001 Creatinine (per mg/dl) 1.042 0.996 1.090 0.0743 BUN (per mg/dl) 1.019 1.017 1.022 <0.0001 Systolic blood pressure (per mm Hg) 0.987 0.985 0.989 <0.0001 Diastolic blood pressure (per mm Hg) 0.990 0.987 0.994 <0.0001 Serum sodium (per meq/l) 0.972 0.963 0.980 <0.0001 Pulse (per beats/min) 1.015 1.013 1.017 <0.0001 Dyspnea at rest 1.509 1.376 1.655 <0.0001 Age (per yr) 1.037 1.033 1.042 <0.0001 Maisel, A, et. al (ADHERE)J Am Coll Cardiol, 2008; 52:534-540, doi:10.1016/j.jacc.2008.05.010 Early Response of PCW but not CI Predicts Subsequent Mortality in Advanced Heart Failure Total Mortality Risk% 60 50 Total Mortality Risk% 60 50 40 30 20 10 199 257 PCW > 16 mmhg PCW < 16 mmhg P=0.001 0 0 6 12 18 24 Months 40 30 20 10 Cardiac Index > 2.6 L/min-M 2 236 220 Cardiac Index < 2.6 L/min/M 2 P=NS 0 0 6 12 18 24 Months Final hemodynamic measurement in 456 advanced HF patients after tailored vasodilator therapy (Fonarow G Circulation 1994;90:I-488)
ADHERE: Diuresis During ADHF Hospitalization Men - 3.5 kg Women -2.5 kg N=26,757 The Diuretic Factor In Heart Failure
Background Acute decompensated heart failure (ADHF) is one of the leading reasons for presentation to the Emergency Department (ED) and the leading cause of hospitalization at Overlook Medical Center In 2010 Overlook Hospital length of stay for 95 Adequate Diuretic Dosing in the ED is Associated with Reduced LOS S for ADHF ADHF was 4.72 days and 30 day re-admission was 23.6% Objective To examine diuretic dosing patterns in the Emergency Department on patients with ADHF and its impact on length-ofstay (LOS) and the 30-day readmission rate. 96 Adequate Diuretic Dosing in the ED is Associated with Reduced LOS S for ADHF
Methods Data Collection Retrospective chart review was conducted that included 250 consecutive patients presenting to the ED with ADHF from Oct 2008 Jul 2010. Initial IV diuretic dose administered in the ED and assessed if it was adequate or inadequate. Adequate diuretic dosing was defined as 1.5X the outpatient oral loop diuretic dose given as an 97 Adequate IV Diuretic bolus Dosing in the ED is Associated with Reduced LOS S for ADHF or furosemide 80 mg IV or equivalent for Determinants of Diuretic Response Maximal Response Sodium Excretion Rate Dose A Bioavailability Tubular secretory capacity Rate of absorption Time course of delivery Efficiency Threshold B Altered dose-response relationship Braking phenomenon Loop Diuretic Excretion Rate
Diuretic Management of HF at Overlook Medical Center: Emergency Department Empiric furosemide 80mg IV or 1.5 x the patient s usual oral dose (IV) whichever is greater. Expect 500cc U in the next 1 hour If <500cc, administer 2x/dose and observe. Natural Logarithm of LOS Total Number of Patients = 250 Factor Mean or PE 95% CI p-value % Constant 0.44 (-0.50,1.38) Adequate dose (yes vs. no) 26.4% -0.18 (-0.36,-0.01) 0.044 Age (per 10 years) 81.7 0.05 (-0.04,0.14) 0.24 Gender (male vs. female) 46.0% -0.28 (-0.45,-0.11) 0.002 SBP: (vs. >130 mmhg) SBP < 110 (mmhg) 9.2% 0.46 (0.18,0.74) 0.002 SBP: 111 130 (mmhg) 24.8% 0.06 (-0.13,0.25) 0.53 Serum creatinine (per 1 mg/dl) 1.5 0.16 (0.05,0.28) 0.004 Weight at admission (per 10 kg) 75.8 0.05 (0.01,0.08) 0.012 100 Adequate Diuretic Dosing in the ED is Associated with Reduced LOS S for ADHF
Predicted Average LOS N= 250 P = 0.12 101 Adequate Diuretic Dosing in the ED is Associated with Reduced LOS S for ADHF Predicted 30 Day Readmission OR = 0.38 p = 0.064 102 Adequate Diuretic Dosing in the ED is Associated with Reduced LOS S for ADHF
Conclusion Only 26% of patients admitted to the ED with ADHF received adequate diuretic dosing. Patients who received adequate diuretic dosing had a 103 significantly shorter predicted LOS and Adequate marginally Diuretic Dosing the ED is Associated with Reduced LOS S for ADHF lower 30-day readmission rate. Diuretics in Hospitalized Patients (cont.) The effect of HF treatment should be monitored with careful measurement of fluid intake and output, vital signs, body weight that is determined at the same time each day, and clinical signs and symptoms of systemic perfusion and congestion. Daily serum electrolytes, urea nitrogen, and creatinine concentrations should be measured during the use of intravenous diuretics or active titration of HF medications. When diuresis is inadequate to relieve symptoms, it is reasonable to intensify the diuretic regimen using either: a. higher doses of intravenous loop diuretics. b. addition of a second (e.g., thiazide) diuretic.
Diuretics in Hospitalized Patients (cont.) Low-dose dopamine infusion may be considered in addition to loop diuretic therapy to improve diuresis and better preserve renal function and renal blood flow. The Hospitalized Patient Renal Replacement Therapy
Renal Replacement Therapy Ultrafiltration may be considered for patients with obvious volume overload to alleviate congestive symptoms and fluid weight. Ultrafiltration may be considered for patients with refractory congestion not responding to medical therapy. The Hospitalized Patient Inpatient and Transitions of Care
Inpatient and Transitions of Care The use of performance improvement systems and/or evidence-based systems of care is recommended in the hospital and early postdischarge outpatient setting to identify appropriate HF patients for GDMT, provide clinicians with useful reminders to advance GDMT, and to assess the clinical response. Inpatient and Transitions of Care Throughout the hospitalization as appropriate, before hospital discharge, at the first postdischarge visit, and in subsequent follow-up visits, the following should be addressed: a. initiation of GDMT if not previously established and not contraindicated; b. precipitant causes of HF, barriers to optimal care transitions, and limitations in postdischarge support c. assessment of volume status and supine/upright hypotension with adjustment of HF therapy, as appropriate; d. titration and optimization of chronic oral HF therapy; e. assessment of renal function and electrolytes, where appropriate; f. assessment and management of comorbid conditions; g. reinforcement of HF education, self-care, emergency plans, and need for adherence; and h. consideration for palliative care or hospice care in selected patients.
Inpatient and Transitions of Care Multidisciplinary HF disease-management programs are recommended for patients at high risk for hospital readmission, to facilitate the implementation of GDMT, to address different barriers to behavioral change, and to reduce the risk of subsequent rehospitalization for HF. Scheduling an early follow-up visit (within 7 to 14 days) and early telephone follow-up (within 3 days) of hospital discharge is reasonable. Use of clinical risk prediction tools and/or biomarkers to identify patients at higher risk for postdischarge clinical events is reasonable. Therapies in the Hospitalized HF Patient Recommendation COR LOE HF patients hospitalized with fluid overload should be treated with intravenous diuretics HF patients receiving loop diuretic therapy, should receive an initial parenteral dose greater than or equal to their chronic oral daily dose, then should be serially adjusted HFrEF patients requiring HF hospitalization on GDMT should continue GDMT unless hemodynamic instability or contraindications Initiation of beta-blocker therapy at a low dose is recommended after optimization of volume status and discontinuation of intravenous agents Thrombosis/thromboembolism prophylaxis is recommended for patients hospitalized with HF Serum electrolytes, urea nitrogen, and creatinine should be measured during the titration of HF medications, including diuretics I I I I I I B B B B B C
Therapies in the Hospitalized HF Patient (cont.) Recommendation COR LOE When diuresis is inadequate, it is reasonable to a) Give higher doses of intravenous loop diuretics; or b) add a second diuretic (e.g., thiazide) Low-dose dopamine infusion may be considered with loop diuretics to improve diuresis Ultrafiltration may be considered for patients with obvious volume overload IIa IIb IIb B B B B Ultrafiltration may be considered for patients with refractory congestion IIb C Intravenous nitroglycerin, nitroprusside or nesiritide may be considered an adjuvant to diuretic therapy for stable patients with HF In patients hospitalized with volume overload and severe hyponatremia, vasopressin antagonists may be considered IIb IIb B B Hospital Discharge Recommendation or Indication COR LOE Performance improvement systems in the hospital and early postdischarge outpatient setting to identify HF for GDMT I B Before hospital discharge, at the first postdischarge visit, and in subsequent follow-up visits, the following should be addressed: a) initiation of GDMT if not done or contraindicated; b) causes of HF, barriers to care, and limitations in support; c) assessment of volume status and blood pressure with adjustment of HF therapy; d) optimization of chronic oral HF therapy; e) renal function and electrolytes; f) management of comorbid conditions; g) HF education, self-care, emergency plans, and adherence; and h) palliative or hospice care. I B Multidisciplinary HF disease-management programs for patients at high risk for hospital readmission are recommended A follow-up visit within 7 to 14 days and/or a telephone follow-up within 3 days of hospital discharge is reasonable Use of clinical risk-prediction tools and/or biomarkers to identify higher-risk patients is reasonable I IIa IIa B B B
Guideline for HF Coordinating Care for Patients With Chronic HF Coordinating Care for Patients With Chronic HF Effective systems of care coordination with special attention to care transitions should be deployed for every patient with chronic HF that facilitate and ensure effective care that is designed to achieve GDMT and prevent hospitalization. Every patient with HF should have a clear, detailed and evidence-based plan of care that ensures the achievement of GDMT goals, effective management of comorbid conditions, timely follow-up with the healthcare team, appropriate dietary and physical activities, and compliance with Secondary Prevention Guidelines for cardiovascular disease. This plan of care should be updated regularly and made readily available to all members of each patient s healthcare team. Palliative and supportive care is effective for patients with symptomatic advanced HF to improve quality of life.
Schematic Depiction of Comprehensive Heart Failure Care Goodlin, S. J. J Am Coll Cardiol 2009;54:386-396 Copyright 2009 American College of Cardiology Foundation. Restrictions may apply. End-of-Life Considerations It is important to ensure continuity of medical care between inpatient and outpatient settings for patients with HF at the end of life. Components of hospice care that are appropriate to the relief of suffering, including opiates, are recommended and do not preclude the options for use of inotropes and intravenous diuretics for symptom palliation for patients with HF at the end of life. All professionals working with HF patients should examine current end-of-life processes and work toward improvement in approaches to palliation and end-of-life care.
End-of-Life Considerations Ongoing patient and family education regarding prognosis for functional capacity and survival is recommended for patients with HF at the end of life. Patient and family education about options for formulating and implementing advance directives and the role of palliative and hospice care services with reevaluation for changing clinical status is recommended for patients with HF at the end of life. Discussion is recommended regarding the option of inactivating ICDs for patients with HF at the end of life. End-of-Life Considerations Aggressive procedures performed within the final days of life (including intubation and implantation of a cardioverterdefibrillator in patients with NYHA functional class IV symptoms who are not anticipated to experience clinical improvement from available treatments) are not appropriate.
Guideline for HF Quality Metrics/Performance Measures Quality Metrics/Performance Measures Performance measures based on professionally developed clinical practice guidelines should be used with the goal of improving quality of care for HF. Participation in quality improvement programs and patient registries based on nationally endorsed, clinical practice guideline-based quality and performance measures may be beneficial in improving quality of HF care.
ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set Measure Description* Care Setting 1. LVEF Percentage of patients aged 18 y with a diagnosis of HF for whom the Outpatient assessment quantitative or qualitative results of a recent or prior (any time in the 2. LVEF assessment 3. Symptom and activity assessment past) LVEF assessment is documented within a 12 mo period Percentage of patients aged 18 y with a principal discharge diagnosis of HF with documentation in the hospital record of the results of an LVEF assessment that was performed either before arrival or during hospitalization, OR documentation in the hospital record that LVEF assessment is planned for after discharge Percentage of patient visits for those patients aged 18 y with a diagnosis of HF with quantitative results of an evaluation of both current level of activity and clinical symptoms documented Level of Measurement Individual practitioner Inpatient Individual practitioner Facility Outpatien t Individual practitioner *Please refer to the complete measures for comprehensive information, including measure exception. Adapted from Bonow et al. J Am Coll Cardiol. 2012;59:1812-32. ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set (cont.) Measure Description* Care Setting 4. Symptom management Percentage of patient visits for those patients aged 18 y with a diagnosis of HF and with quantitative results of an evaluation of both level of activity AND clinical symptoms documented in which patient symptoms have improved or remained consistent with treatment goals since last assessment OR patient symptoms have demonstrated clinically important deterioration since last assessment with a documented plan of care Outpatient Level of Measurement Individual practitioner 5. Patient selfcare education 6. Beta-blocker therapy for LVSD (outpatient and inpatient setting) Percentage of patients aged 18 y with a diagnosis of HF who were provided with self-care education on 3 elements of education during 1 visits within a 12 mo period Percentage of patients aged 18 y with a diagnosis of HF with a current or prior LVEF <40% who were prescribed beta-blocker therapy with bisoprolol, carvedilol, or sustained release metoprolol succinate either within a 12 mo period when seen in the outpatient setting or at hospital discharge Outpatient Inpatient and Outpatient Individual practitioner Individual practitioner Facility
ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set (cont.) Measure Description* Care Setting Level of 7. ACE Inhibitor or ARB Therapy for LVSD (outpatient and inpatient setting) 8. Counseling regarding ICD implantation for patients with LVSD on combination medical therapy 9. Post-discharge appointment for heart failure patients Percentage of patients aged 18 y with a diagnosis of HF with a current or prior LVEF <40% who were prescribed ACE inhibitor or ARB therapy either within a 12 mo period when seen in the outpatient setting or at hospital discharge Percentage of patients aged 18 y with a diagnosis of HF with current LVEF 35% despite ACE inhibitor/arb and beta-blocker therapy for at least 3 mo who were counseled regarding ICD implantation as a treatment option for the prophylaxis of sudden death Percentage of patients, regardless of age, discharged from an inpatient facility to ambulatory care or home health care with a principal discharge diagnosis of HF for whom a follow-up appointment was scheduled and documented including location, date and time for a follow-up office visit, or home health visit (as specified) Inpatient and Outpatient Outpatient Inpatient Measurement Individual practitioner Facility Individual practitioner Facility *Please refer to the complete measures for comprehensive information, including measure exception. Test measure designated for use in internal quality improvement programs only. These measures are not appropriate for any other purpose, e.g., pay for performance, physician ranking or public reporting programs. New measure. Adapted from Bonow et al. J Am Coll Cardiol. 2012;59:1812-32. The Hospitalized Patient Monitoring and Measuring Fluid Intake and Output Effect of HF treatment should be monitored with careful measurement of fluid intake and output; vital signs; body weight, determined at the same time each day; clinical signs (supine and standing) and symptoms of systemic perfusion and congestion. Daily serum electrolytes, urea nitrogen, and creatinine concentrations should be measured during the use of intravenous diuretics or active titration of HF medications.
The Hospitalized Patient In all patients hospitalized with HF, both with preserved and low ejection fraction, transition should be made from intravenous to oral diuretic therapy with careful attention to oral diuretic dosing and monitoring of electrolytes. With all medication changes, the patient should be monitored for supine and upright hypotension and worsening renal function and HF signs/symptoms. Diuretic Management of HF at Overlook Medical Center: Inpatient Establish a quantitative clinical goal (expected daily weight loss or urine output greater than input for each 24 hour period). Initial Phase: Administer IV furosemide in bolus dose as long as the patient responds with >1L U per dose; expect to administer q8 or q12 hours to achieve goals (titrate against BP, azotemia, etc.) (Err on the side of the diuresis). If U <1L, measure spot Una; if <50meq move to additional measures. Options double furosemide (up to 4mg/hour even with renal insufficiency). Add HCTZ 50 100mg PO or chlorthiazide 500 mg PO. Consider furosemide infusion: IE rebolus with80 160mg, then 10 mg/hour, if no response increase to 20 mg/hour (can be maximized to 40mg/hour). If the patient does not respond or develops complications consultation and reassessment is recommended for possible treatment with intropes/neseritide/extracorporeal ultrafiltation.