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Pre-Activity Assessment/ Evaluation Form Pre-Activity Assessment • Please take a moment to complete the pre-activity assessment prior to the start of the activity. Evaluation Form • Please take a moment at the conclusion of the activity to complete the evaluation form in the back of the workbook. • The on-site staff will collect the pre-activity assessment and evaluation forms at the conclusion of the activity. Thursday, September 15, 2016 11:00am-12:00pm Houston Marriott Westchase 2900 Briarpark Drive Houston, TX 77042 Faculty Michael B. Bottorff, PharmD, FCCP, FNLA, CLS Professor and Chair Department of Pharmacy Practice Manchester College of Pharmacy Fort Wayne, IN Connie Commander, RN-BC, MBA, CCM, ABDA CPUR President/CEO Commander’s Premier Consulting Corporation Hockley, TX Program Agenda 5 minutes Welcome and Introductions 10 minutes Epidemiology of HF in the US 10 minutes Pathophysiology and risk factors of HF 10 minutes New frontiers in workup, monitoring, and treatment of HF 20 minutes The Role of the Case Manager as a Member of the Team 5 minutes Conclusions and Q&A CE Information Nursing Education Purpose Statement The purpose of this activity is to improve the knowledge and competence of nurse case managers concerning the treatment and management of patients with heart failure (HF). Target Audience This educational activity was developed for case managers involved in the management and care of patients with HF. Provider This activity is provided by Medical Learning Institute, Inc. Commercial Support Acknowledgment This activity is supported by an educational grant from Novartis Pharmaceuticals Corporation. Learning Objectives Upon completion of this activity, the participant will be able to: • Describe the high incidence and burden of HF and the factors that may contribute to the “HF paradox”– increases in HF despite better management of HF risk factors • Explain the complex pathophysiology and risk factors for HF • Plan to incorporate novel electronic monitoring technologies to guide medication adjustment during follow-up • Prepare the case manager for the introduction of a new class of pharmacologic agents for HF, the angiotensin-neprilysin inhibitors • Discuss the role of the case manager as patient advocate and liaison between the clinician and the patient Disclosure Before the activity, all faculty and anyone who is in a position to have control over the content of this activity and their spouse/life partner will disclose the existence of any financial interest and/or relationship(s) they might have with any commercial interest producing healthcare goods/services to be discussed during their presentation(s): honoraria, expenses, grants, consulting roles, speakers bureau membership, stock ownership, or other special relationships. Presenters will inform participants of any off-label discussions. All identified conflicts of interest are thoroughly vetted by Medical Learning Institute Inc for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations. The associates of Medical Learning Institute Inc, the accredited provider for this activity do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this CE activity for any amount during the past 12 months. Name of Planner/Manager Company Susan Rogers, RN-BC, MSN, CCM Peer Reviewer Reported Financial Relationship Has nothing to disclose. Faculty Disclosures Michael B. Bottorff, PharmD, FCCP, FNLA, CLS, is on the Speakers' Bureau for BMS, Boehringer Ingelheim, Pfizer, and Sanofi/Regeneron. He does not intend to discuss any non-FDA-approved or investigational use of any products/devices. Connie Commander, RN-BC, MBA, CCM, ABDA CPUR has nothing to disclose. She does not intend to discuss any non-FDA-approved or investigational use of any products/devices. Disclaimer The information provided at this CE activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition. Recommendations for the use of particular therapeutic agents are based on the best available scientific evidence and current clinical guidelines. No bias towards or promotion for any agent discussed in this activity should be inferred. Michael B. Bottorff PharmD, FCCP, FNLA, CLS Professor and Chair Department of Pharmacy Practice Manchester College of Pharmacy Risk Factors for Heart Failure • Coronary artery disease • Diabetes • Hypertension (LVH) • Other: • Congenital heart defects • Valvular heart disease • Alcoholism • Infection (viral) CAD=coronary artery disease; LVH=left ventricular hypertrophy. – – – – Obesity Age Smoking High or low hematocrit level – Obstructive Sleep Apnea – Toxins Epidemiology of Heart Failure in the US Heart Failure Patients in US (Millions) 12 10 10 • 550,000 new cases/year 8 • 1 in 9 deaths in 2009 listed heart failure as a contributing cause 5.7 6 4 • More deaths from heart failure than from all forms of cancer combined 4.7 3.5 • Estimated costs exceed $30 billion each year • The “Paradox”: 2 0 1991 2000 2016 2037* *Rich M. J Am Geriatric Soc. 1997;45:968–974. American Heart Association. 2001 Heart and Stroke Statistical Update. American Heart Association. 2016 Heart and Stroke Statistical Update. Heidenreich PA et al. Circulation. 2011;123(8):933–44. – Increasing age of population – Increase in risk factors – Improved post MI survival HF Hospitalization Burden • Predominant reason for hospital admissions in patients with HF = worsening HF • High readmission rate after initial hospitalization – 20% within one month – 50% within six months – 17% are readmitted two or more times • Hospitalization = the major contributor to the cost of HF care Centers for Medicare and Medicaid Services. 2000 MedPAR data. DRG 127; Fonarow, GC. Rev Cardiovasc Med. 2002;3 (suppl 4):S3; Krumholz HM et al. R Arch Intern Med. 1997 Jan 13;157(1):99-104; Roger VL, Circulation. 2012;125(1):e2-e220. Economic Burden of Chronic HF Post-discharge outpatient visits Primary Care 2% Hospital admissions 6% Outpatient referral 5% 18% Drug 69% Hospitalization accounts for most CHF-associated costs Stewart S, et al. Eur J Heart Fail. 2002;4:361-71 treatment Co-morbid Conditions Contribute to Readmission Risk in HF JAGS 2016 Pathophysiology Pathologic Progression of CV Disease Coronary artery disease Hypertension Diabetes Sudden Death Myocardial injury Pathologic remodeling Low ejection fraction Death Cardiomyopathy Pump failure Valvular disease • Neurohormonal stimulation • Myocardial toxicity Adapted from Cohn JN. N Engl J Med. 1996;335:490–498. Symptoms: • Dyspnea • Fatigue • Edema Chronic heart failure Compensatory Mechanisms Renin-Angiotensin-Aldosterone System Beta Stimulation • CO • Na+ Renin + Angiotensinogen Angiotensin I Angiotensin II ACE Kaliuresis Aldosterone Secretion Peripheral Vasoconstriction Fibrosis Salt & Water Retention Plasma Volume Afterload Preload Cardiac Output Cardiac Workload Heart Failure Edema Classification of HF Comparison Between ACC/AHA HF Stage and NYHA Functional Class ACC/AHA HF Stage1 NYHA Functional Class2 A At high risk for heart failure but without structural heart disease or symptoms of heart failure (eg, patients with hypertension or coronary artery disease) B Structural heart disease but without symptoms of heart failure C Structural heart disease with prior or current symptoms of heart failure D Refractory heart failure requiring specialized interventions I Asymptomatic II Symptomatic with moderate exertion III Symptomatic with minimal exertion IV Symptomatic at rest Hunt SA et al. J Am Coll Cardiol. 2001;38:2101–2113. New York Heart Association/Little Brown and Company, 1964. Adapted from: Farrell MH et al. JAMA. 2002;287:890–897. Heart Failure Terminology • Treatment guidelines focus on HFrEF, where numerous outcome studies have been conducted ESC Heart Failure Guidelines 2016 Evidence-Based Therapy for HFrEF Lifestyle Changes What Why • Eat a low-sodium, low-fat diet • Sodium is bad for high blood pressure, causes fluid retention • Lose weight • Extra weight can put a strain on the heart • Stay physically active • Exercise can help reduce stress and blood pressure • Reduce or eliminate alcohol and caffeine • Alcohol and caffeine can weaken an already damaged heart • Quit Smoking • Smoking can damage blood vessels and make the heart beat faster Rationale for HF Medications (Why does my doctor have me on so many pills?) • Improve Survival – Beta-blockers – ACE-inhibitors – Mineralocorticoid receptor antagonists (MRA) – Angiotensin receptor blockers (ARB’s) – ARNI • Improve Symptoms – Diuretics – Digoxin Drugs Commonly Used for HFrEF (Stage C HF) Drug Initial Daily Dose(s) ACE Inhibitors Captopril 6.25 mg 3 times Enalapril 2.5 mg twice Fosinopril 5 to 10 mg once Lisinopril 2.5 to 5 mg once Perindopril 2 mg once Quinapril 5 mg twice Ramipril 1.25 to 2.5 mg once Trandolapril 1 mg once ARBs Candesartan 4 to 8 mg once Losartan 25 to 50 mg once Valsartan 20 to 40 mg twice Aldosterone Antagonists Spironolactone 12.5 to 25 mg once Eplerenone 25 mg once Maximum Doses(s) Mean Doses Achieved in Clinical Trials 50 mg 3 times 10 to 20 mg twice 40 mg once 20 to 40 mg once 8 to 16 mg once 20 mg twice 10 mg once 4 mg once 122.7 mg/d (421) 16.6 mg/d (412) --------32.5 to 35.0 mg/d (444) --------------------------------- 32 mg once 50 to 150 mg once 160 mg twice 24 mg/d (419) 129 mg/d (420) 254 mg/d (109) 25 mg once or twice 50 mg once 26 mg/d (424) 42.6 mg/d (445) Drugs Commonly Used for HFrEF (Stage C HF) Drug Initial Daily Dose(s) Beta Blockers Bisoprolol 1.25 mg once Carvedilol 3.125 mg twice Carvedilol CR 10 mg once Metoprolol succinate extended release 12.5 to 25 mg once (metoprolol CR/XL) Hydralazine & Isosorbide Dinitrate 37.5 mg hydralazine/ Fixed dose 20 mg isosorbide combination (423) dinitrate 3 times daily Hydralazine and Hydralazine: 25 to 50 isosorbide dinitrate mg, 3 or 4 times (448) daily and isorsorbide dinitrate: 20 to 30 mg 3 or 4 times daily Maximum Doses(s) Mean Doses Achieved in Clinical Trials 10 mg once 50 mg twice 80 mg once 8.6 mg/d (118) 37 mg/d (446) --------- 200 mg once 159 mg/d (447) 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 --------- Recommendations for Treatment of Stage B HF Recommendations In patients with a history of MI and reduced EF, ACE inhibitors or ARBs should be used to prevent HF In patients with MI and reduced EF, evidence-based beta blockers should be used to prevent HF In patients with MI, statins should be used to prevent HF Blood pressure should be controlled to prevent symptomatic HF 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 COR LOE I A I B I A I A I A I C IIa B III: Harm C Stage C Nonpharmacological Interventions I IIa IIb III Patients with HF should receive specific education to facilitate HF self-care I IIa IIb III I IIa IIb III 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 Sodium restriction is reasonable for patients with symptomatic HF to reduce congestive symptoms Stage C Nonpharmacological Interventions (continued) I IIa IIb III I IIa IIb III Continuous positive airway pressure (CPAP) can be beneficial to increase LVEF and improve functional status in patients with HF and sleep apnea Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, HRQOL, and mortality Pharmacological Therapy for Management of Stage C HFrEF Recommendations Diuretics Diuretics are recommended in patients with HFrEF with fluid retention ACE Inhibitors ACE inhibitors are recommended for all patients with HFrEF 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 COR LOE I C I A I A IIa A IIb A III: Harm C Pharmacologic Therapy for Management of Stage C HFrEF (continued) Recommendations COR Digoxin Digoxin can be beneficial in patients with HFrEF IIa Anticoagulation Patients with chronic HF with permanent/persistent/paroxysmal AF and an I additional risk factor for cardioembolic stroke should receive chronic anticoagulant therapy* The selection of an anticoagulant agent should be individualized I Chronic anticoagulation is reasonable for patients with chronic HF who have IIa permanent/persistent/paroxysmal AF but without an additional risk factor for cardioembolic stroke* Anticoagulation is not recommended in patients with chronic HFrEF without AF, III: No Benefit prior thromboembolic event, or a cardioembolic source Statins Statins are not beneficial as adjunctive therapy when prescribed solely for HF III: No Benefit Omega-3 Fatty Acids Omega-3 PUFA supplementation is reasonable to use as adjunctive therapy in HFrEF or HFpEF patients IIa LOE B A C B B A B Diuretics in Heart Failure • Thiazide diuretics possible for mild congestion • Loop diuretics preferred for most patients – Furosemide for the majority of patients – Torsemide has better, more reliable absorption • Less hospitalizations, lower cost of care (Clin Therapeutics 1999, ASCPT 2000) – Metolazone reserved for apparent diuretic resistance • Diuretic advantages – Necessary for fluid control (MONITOR PATIENT WEIGHTS) – Synergistic effect with ACE-inhibitors • Diuretic disadvantages – Electrolyte disturbances (arrhythmogenic, dig toxicity) – Hypovolemia, hypotension, renal dysfunction DIGOXIN Clinical Uses • AF with rapid ventricular response • CHF refractory to other drugs • Should be combined with other drugs ACEI ADVANTAGES • • Inhibit LV remodeling post-MI Modify the progression of chronic CHF – – – • • Benefits may be exclusive of symptom improvement Relative contraindications – – – • - Survival - Hospitalizations Improve the quality-of-life Hypotension Hyperkalemia Renal insufficiency Absolute contraindication – Angioedema Yancy CW, Jessup M, Bozkurt B, Butler J, Casey Jr DE, , et al. 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure, Journal of the American College of Cardiology (2016), doi: 10.1016/ j.jacc.2016.05.011. Pharmacological Therapy for Management of Stage C HFrEF (continued) Recommendations 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 COR LOE I A I A I B III: Harm B I A IIa B Pharmacological Therapy for Management of Stage C HFrEF (continued) Recommendations Other Drugs Nutritional supplements as treatment for HF are not recommended in HFrEF Hormonal therapies other than to replete deficiencies are not recommended in HFrEF Drugs known to adversely affect the clinical status of patients with HFrEF are potentially harmful and should be avoided or withdrawn Long-term use of an infusion of a positive inotropic drug is not recommended and may be harmful except as palliation Calcium Channel Blockers Calcium channel blocking drugs are not recommended as routine in HFrEF COR III: No Benefit III: No Benefit LOE B C III: Harm B III: Harm C III: No Benefit A Which Beta-blockers Are Recommended for Use in HF? Initial and Target Doses for B-Blockers with Proven Benefit for Systolic Heart Failure* Agent Initial dose TOPROL-XL®† (metoprolol succinate)‡ 25 mg QD for NYHA Class II patients 12.5 mg QD for more severe heart failure patients Carvedilol 3.125 mg BID Bisoprolol 1.25 mg QD Target Dose 200 mg200 QD mg or QD highest tolerated dose 25 mg BID for patients < 85 kg 50 mg BID for patients > 85 kg 10 mg QD Uptitrate by doubling the dose every 2 weeks unless patients decompensate (see next slide) *Temporary suspension/reduction of therapy does not preclude success of b-blocker therapy during management of uptitration. Management of B-Blocker Therapy in Heart Failure Patients During Uptitration • In patients with fluid retention – Increase diuretic dosage • In patients with hypotension – Reduce diuretic/ACE inhibitor dosage • In patients with worsening heart failure – – – – Stop uptitration until clinical conditions stabilize Adjust concomitant medications If symptoms don’t resolve, down-titrate b-blocker dose* Avoid abrupt cessation of b-blocker therapy *Temporary suspension/reduction of therapy does not preclude success of b-blocker therapy during management of uptitration. Eichhorn EJ. Clinical use of b-blockers in patients with heart failure. J Cardiac Fail. 2000;6:40-46; Consensus Recommendations for the Management of Chronic Heart Failure. Am J Cardiol. 1999;83:1A-80A. Management of B-Blocker Therapy in Heart Failure Patients During Uptitration • The majority of patients will not decompensate during uptitration – Patients should weigh themselves daily to detect early signs of decompensation – Patients who note weight gain of 2-3 pounds should be instructed to call their physicians • It may take 8-12 weeks for improvement to become evident • Most patients can be managed without discontinuing b-blocker therapy Eichhorn EJ. Clinical use of b-blockers in patients with heart failure. J Cardiac Fail. 2000;6:40-46. Randomized Aldactone Evaluation Study (RALES) • 1663 patients with Class IV HF in last six months – EF <35%, on ACEI and loop diuretic +/- digoxin • R, DB, PC with spironolactone 25 mg QD – Could be increased to 50 mg or reduced to 25 mg QOD • Exclusion criteria included a serum creatinine of > 2.5 mg/dL • Results – 30% reduction in mortality – 30% reduction in hospitalizations Pitt et al. NEJM 1999; Sept. 2 A-Heft Trial 1,050 African-American patients with advanced heart failure New York Heart Association (NYHA) class 3-4 for > 3 months LV function < 35% (< 40% if LV dilated per echo) 90% receiving diuretics, 69% ACE-inhibitor, 17% angiotensin receptor blocker, 74% beta-blocker Isosorbide dinitrate (ISDN) plus hydralazine Tablet containing 20 mg ISDN and 37.5 mg hydralazine (BiDil®, NitroMed) 3X daily. Dosage could be doubled by enrolling physician. n=518 44.2% female 44.8% diabetic Placebo n=532 36.1% female 37.0% diabetic Primary Endpoint: Weighted composite of all-cause death, first hospitalization for heart failure, and change in quality of life at a mean follow-up of 10 months Presented at AHA 2004 A-Heft Trial Primary Endpoint All individual components of the primary composite endpoint were significantly improved with ISDN-hydralazine therapy, namely death, first hospitalization for heart failure, and change in the quality-of-life score (a larger negative score indicates a better quality-of-life). All-Cause Mortality p=0.02 12 25 10.2 Change in quality-of-life score at 6 months p=0.02 -6 -5.5 20 9 -5 16.4 15 -4 6 % % 6.2 % First HF Hospitalization p=0.00124.4 10 3 -2 5 -1 0 0 ISDN-Hydralazine Presented at AHA 2004 Placebo -2.7 -3 0 ISDN-Hydralazine Selective Invasive ISDN-Hydralazine Placebo Drugs That Reduce Mortality in Heart Failure With Reduced Ejection Fraction % Decrease in Mortality 0% Angiotensin receptor blocker ACE inhibitor Beta blocker Mineralocorticoid receptor antagonist 10% 20% 30% Drugs that inhibit the renin-angiotensin system have modest effects on survival 40% Based on results of SOLVD-Treatment, CHARM-Alternative, COPERNICUS, MERIT-HF, CIBIS II, RALES and EMPHASIS-HF AHA HF Update 2016 One Enzyme — Neprilysin — Degrades Many Endogenous Vasoactive Peptides Endogenous vasoactive peptides (natriuretic peptides, adrenomedullin, bradykinin, substance P, calcitonin gene-related peptide) Neprilysin Inactive metabolites Neprilysin Inhibition Potentiates Actions of Endogenous Vasoactive Peptides That Counter Maladaptive Mechanisms in HF Endogenous vasoactive peptides (natriuretic peptides, adrenomedullin, bradykinin, substance P, calcitonin gene-related peptide) Neprilysin Inactive metabolites Neurohormonal activation Vascular tone Cardiac fibrosis, hypertrophy Sodium retention Neprilysin inhibition Sacubitril and Valsartan Angiotensin Receptor Neprilysin Inhibition Sacubitril and Valsartan Angiotensin receptor blocker Inhibition of neprilysin Aim of the PARADIGM-HF Trial Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF) LCZ696 400 mg daily Enalapril 20 mg daily SPECIFICALLY DESIGNED TO REPLACE CURRENT USE OF ACE INHIBITORS AND ANGIOTENSIN RECEPTOR BLOCKERS AS THE CORNERSTONE OF THE TREATMENT OF HEART FAILURE PARADIGM-HF Effect of LCZ696 vs Enalapril on Primary Endpoint and Its Components LCZ696 (n=4187) Enalapril (n=4212) Hazard Ratio (95% CI) P Value Primary endpoint 914 (21.8%) 1117 (26.5%) 0.80 (0.73-0.87) 0.0000002 Cardiovascular death 558 (13.3%) 693 (16.5%) 0.80 (0.71-0.89) 0.00004 Hospitalization for heart failure 537 (12.8%) 658 (15.6%) 0.79 (0.71- 0.89) 0.00004 PARADIGM-HF Summary of Findings In heart failure with reduced ejection fraction, when compared with recommended doses of enalapril: LCZ696 was more effective than enalapril in . . . • • • • • Reducing the risk of CV death and HF hospitalization Reducing the risk of CV death by incremental 20% Reducing the risk of HF hospitalization by incremental 21% Reducing all-cause mortality by incremental 16% Incrementally improving symptoms and physical limitations LCZ696 was better tolerated than enalapril . . . • • • • Less likely to cause cough, hyperkalemia or renal impairment Less likely to be discontinued due to an adverse event More hypotension, but no increase in discontinuations Not more likely to cause serious angioedema Optimal Implementation of ARNI in Heart Failure • Inevitable delay for implemention into practice of newly established therapies • Estimated 84% of U.S. patients with HFrEF as candidates for ARNI therapy • Optimal implementation would: – Prevent 28,484 deaths per year – 12 month NNT 80 Fonarow GC et al. JAMA 2016 From: Cost-effectiveness Analysis of Sacubitril/Valsartan vs Enalapril in Patients With Heart Failure and Reduced Ejection Fraction JAMA Cardiol. Published online June 22, 2016. doi:10.1001/jamacardio.2016.1747 Figure Legend: Tornado DiagramUnivariate sensitivity analyses evaluating the effect of each variable’s uncertainty on an overall cost-effectiveness ratio. The central black line represents the base-case analysis. None of the analyses lead to an incremental cost-effectiveness ratio greater than $150 000 per quality-adjusted life-year (QALY). HR indicates hazard ratio. Copyright © 2016 American Medical Association. All rights reserved. Date of download: 7/14/2016 Angiotensin Neprilysin Inhibition With LCZ696 Doubles Effect on Cardiovascular Death of Current Inhibitors of the Renin-Angiotensin System % Decrease in Mortality 0% 10% Angiotensin receptor blocker Angiotensin neprilysin inhibition ACE inhibitor 15% 18% 20% 20% 30% 40% Effect of ARB vs placebo derived from CHARM-Alternative trial Effect of ACE inhibitor vs placebo derived from SOLVD-Treatment trial Effect of LCZ696 vs ACE inhibitor derived from PARADIGM-HF trial Ivabradine Mechanism of Action Systolic Heart failure treatment with the If inhibitor ivabradine Trial Main Results Swedberg K, et al. Lancet. 2010;376(9744):875-885 www.shift-study.com Primary Objective To evaluate whether the If inhibitor ivabradine improves cardiovascular outcomes in patients with: • Moderate to severe chronic heart failure • Left ventricular ejection fraction 35% • Heart rate 70 bpm in sinus rhythm • Best recommended therapy Swedberg K, et al. Eur J Heart Fail. 2010;12:75-81 www.shift-study.com Effect of Ivabradine on Outcomes Endpoints Hazard ratio 95% CI p value 0.82 [0.75;0.90] p<0.0001 All-cause mortality 0.90 [0.80;1.02] p=0.092 Death from heart failure 0.74 [0.58;0.94] p=0.014 All-cause hospital admission 0.89 [0.82;0.96] p=0.003 Any CV hospital admission 0.85 [0.78;0.92] p=0.0002 CV death/hospital admission for HF or non-fatal MI 0.82 [0.74;0.89] p<0.0001 Primary composite endpoint (CV death or hospital admission for worsening HF) Swedberg K, et al. Lancet. 2010;376(9744):875-885 www.shift-study.com In Summary…. • Heart failure is common and has high mortality • Drug therapy improves survival – Beta-blockers, ACE-I, aldosterone antagonists, ARNI • Newer device therapies are showing promise for symptom relief and improved survival – Biventricular pacing, ICD’s • Transplants remain rare, but technology for mechanical assist devices continues to improve Your Patient • Mr. B is a 58 yo former welder who retired early two years ago from ill health • In the last two years he has had several admissions for IHD, type II diabetes, HTN and heart failure • He was first admitted for HF in August 2014 with increasing SOB and chest tightness • He had bilateral thigh edema, elevated JVP, orthopnea, PND and a dry, hacking cough Your Patient (continued) • His medications included HCTZ 12.5mg QD, simvastatin 40mg QHS, metformin 500mg BID • After a 6 day admission, he was discharged on – Furosemide 40mg BID – Lisinopril 5mg QD – Atenolol 50mg QD – Metformin 500mg BID – Simvastatin 40mg QD Your Patient (continued) • He is now being discharged after an admission for poorly controlled HTN and is on the above meds plus nifedipine 10mg QD • What are the key elements of your care plan for the patient? – Understanding of heart failure and ability to be involved in their own care – Drug therapy regimen Your Patient Guideline-Directed Evaluation and Management (GDEM) • Non-pharmacologic interventions – HF-specific patient education, Na restriction, consider cardiac rehab/exercise training • Diuretic therapy – Monitor patient weights, symptoms and adjust as needed • ACEI and Beta-blocker therapy – Titrate to target doses – Use evidence-based beta-blocker • Consider MRA – Caution with renal function, hyperkalemia • Consider ARNI – Stable class II, III patients without history of angioedema Drugs that May Cause or Exacerbate HF AHA Scientific Statement 2016 The American Heart Association • Common drugs to avoid – COX-2 inhibitors, NSAIDS – TZDs, DPP-4 inhibitors – Type 1 antiarrhythmics (propafenone, disopyramide, flecainide), sotalol and dronedarone – CCBs, esp. diltiazem and verapamil – Anthracyclines – Cilostazol – bosentan AHA Scientific Statement 2016 The Case Manager’s Role in Supporting the Individual with Heart Failure Challenges and Critical Elements for Success! Connie Commander, RN-BC, MBA, CCM, ABDA CPUR President/CEO Commander’s Premier Consulting Corporation Hockley, TX Guiding Principles of the 2016 CMSA Standards • Client-centric, collaborative partnership approach • Implement evidence-based care guidelines • Foster navigation through the health care system to enhance access to services achievement of successful outcomes Case Managers Philosophy From CMAG 2012 • Case managers enable and support a patient-centered approach to care that by itself is a significant means for promoting adherence • Case managers recognize the importance of the patient’s involvement in their own care and actively engage the patient as the primary decision maker and goal setter • Case managers believe in the principles of advocacy, collaboration, shared-decision making, and education to promote effective patient engagement and adherence with evidence-based care and treatment plans Establishing an Individual Plan of Care • Based upon the needs of the patient • Developed with the individual patient and their identified caregiver • Including the professional recommendations of the members of the multidisciplinary team • Built on collaboration with community-based support • Developed with a strong and effective “warm handover” across each transitional opportunity Assessments • Initially, throughout, and routinely re-evaluated and revised • Developed with the individual patient and their caregiver(s) • Based upon the needs of the patient – – – – – Physical and behavioral health needs Financial needs and coverage parameters Cultural and religious beliefs Cognitive abilities and language barriers Access to care Advocating for the Individual • Evaluating what the patient and caregiver understand about heart failure • Discussion of managing heart failure • Tools they currently have and educational support they require • Willingness to modify daily routines (diet to low sodium, medication regimen, exercise program) Across Disciplines • Participation in formal heart failure programs – – – – Payer supported Hospital or clinics Community-based Links to internet-based web programs • Developing and communicating the accepted plan of care with all members of the multidisciplinary team • Always sharing with the individual the transitional communications • Medication reconciliation and educational linkage with Pharmacists specific to individual • Post-discharge MTM • Specific follow-up with collaboration between Hospitalists, Primary Care Physicians, and Specialists MTM= medical therapy management Identifying Community Collaboration • • • • • • • • • Cardiologist Home Health Care Team Care Transition Team Cardiac Rehabilitation Primary Care Physician Case Manager in community Nutritional and dietician collaboration Pharmacist/Community-based Palliative Care programs to manage chronic conditions Patient-Focused Dietary Changes Monitoring Weight Managing other co-morbid conditions Reduce alcohol and caffeine Importance of medication DME Needs Patient Healthy Lifestyle Choices and changes Monitoring and tracking Lab values Participating in support networks Routine Physician and Health care team follow-up visits Hospital Providers Patient Community Providers Help Outpatient clinic Case Manager/ Discharge Planner Pharmacist The Complexity of HF Management Cardiologist Geriatrician Pharmacist HF Nurse Physiotherapist Heart Failure Clinic Case Manager Psychologist District Nurse Dietician Social Services General Practitioner J Cardiovasc Nursing 2009 Education Specific to Exacerbations • Symptom management – Dyspnea – Fatigue – Increasing edema • Identifying when symptoms are progressing – – – – Asymptomatic Symptomatic with moderate exertion Symptomatic with minimal exertion Symptomatic at rest • Medication effectiveness may take > 8 weeks to be obvious to the patient Collaborative Challenges • Sharing the individual plan of care across multiple platforms (paper, electronic, telephonic) • Supporting identified preferences for educating, supporting, and revising plan of care • Holistic approach • Implementing tools for individual self-motivation to sustain change in lifestyle • Implementing tools for individual to manage effective self care Effective Tools and Evidenced-Based Practices for Case Managers • Assessment tools • Discharge and Transitional Checklist – Inclusive of detailed instructions after a readmission • Medication Adherence Tools • Readiness to Change tools • Teach Back Methods • Self Motivational Methods • Continually re-assess throughout patient’s care to measure understanding, adherence, and introduction of new interventions Success Will Be Based Upon: • Relationship you have built with your patient • Patient’s understanding of their disease process and what they are responsible to manage • Effectively addressing the identified barriers • Working with the individual patient to set their own personal goals to achieve • Subsequent follow-up meetings with patient should be shared by all health care providers with assessing their individual outcomes and revising plans as appropriate Resources Mechanisms of Progression in Heart Failure Myocardial or vascular stress or injury Increased activity or response to maladaptive mechanisms Decreased activity or response to adaptive mechanisms Evolution and progression of heart failure Stages, Phenotypes and Treatment of HF At Risk for Heart Failure Heart Failure STAGE A STAGE B STAGE C 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 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 HFpEF 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 STAGE D Refractory HF 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 Refractory symptoms of HF at rest, despite GDMT e.g., Patients with: · Marked HF symptoms at rest · Recurrent hospitalizations despite GDMT HFrEF 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 endof-life goals Options · Advanced care measures · Heart transplant · Chronic inotropes · Temporary or permanent MCS · Experimental surgery or drugs · Palliative care and hospice · ICD deactivation Digoxin in HFrEF No Survival Benefit OVERALL MORTALITY 50 40 30 Placebo (n=3403) % p = 0.8 20 10 0 0 DIG N Engl J Med 1997;336:525 DIGOXIN (n=3397) 12 24 Months 36 48 When Would You Consider an ARB in a HF Patient? • Not for ACEI intolerance due to – Hyperkalemia, hypotension, renal dysfunction • Mostly for intolerance to cough or angioedema • Not in combination Recent Trials of Beta-blockers in HF Recent Trials of Beta-Blockers in Heart Failure Beta-blocker Placebo 35 * % Mortality 30 25 20 * * 15 * 10 5 0 CIBIS-II Bisoprolol * P<0.05 MERIT-HF Metoprolol CAPRICORN Carvedilol COPERNICUS Carvedilol BEST Bucindolol