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Navigating the Maze of Heart Failure Treatment Options Acknowledgements We acknowledge the work of Kim Newlin, RN, CNS, NP-C, FPCNA in the development of this presentation. Disclosures: Consultant-Novartis Advisor: Continuing Education Concepts, Intellyst Presenter Speaker Disclosures Objectives 1. Define the roles of pharmacotherapies and surgical monitoring therapies in the evaluation and treatment of heart failure. 2. Describe the implications for treatment when monitoring blood pressure, renal function, sodium and potassium levels in patients with heart failure. 3. Describe how shared decision-making can improve patient adherence to treatment plans across the span of heart failure management. Case Study • PT ID: 56 year old Caucasian male • CC: SOB, new lower extremity edema, difficulty sleeping, gained 7 pounds in 2 weeks • PMH: Myocardial Infarction (MI) 8 weeks ago, hypertension • Lifestyle Hx: Moderately active in cardiac rehab, doesn’t smoke • Current Medications: Atorvastatin 80 mg, Aspirin 81 mg, Metoprolol tartrate 25 mg BID, Prasugrel 10 mg Case Study Physical Examination Height: 5’9” Wt: 185 pounds BMI: 27.3 BP: 140/86 mmHg HR: 95 bpm Laboratory Results LDL: 67 mg/dl Non-HDL: 164 mg/dl Potassium: 4 mEq/L Sodium 142 mEq/L NT pro-BNP = 1200 pg/mL Cr: 1.2 mg/dl BUN: 23 mg/dL GFR: >60 mL/min Case Study • Physical Exam – 2+ pitting edema, bilateral lower extremities – Blood pressure 140/86 mmHg – Heart Rate regular = 95 bpm – Weight = 185 pounds • Echo reveals EF = 33%, normal valves Heart Failure Statistics • HF prevalence = 5.7 million Americans • By 2030, estimated > 8 million Americans • At 40 years of age: lifetime risk of developing HF is 20% • Lifetime risk is double for those with BP >160/90 mm Hg vs <140/90 mm Hg American Heart Association. 2016 Heart and Stroke Statistical Update. Compensatory Mechanisms Baroreceptor response Brain SNS activation Ventricular wall tension Goal: increase SV R-A-A-S activation Decreased GFR Kidney Renin, A-I, AII Aldosterone Vasoconstriction Fluid retention Heart Rate Contractility Preload Adapted from https://quizlet.com/101258231/pathophysiology-chapter-19-heartfailure-dysrhythmias-common-sequelae-of-cardiac-diseases-flash-cards/ Heart HR/ Contractility Myocyte growth Hypertrophy Neurohormonal Forces in Opposition RAAS Natriuretic Peptide System Neurohormonal Forces in Oppos Activation of AT receptors by ANP, BNP angiotensin II 1 • Vasoconstriction • Sodium retention • aldosterone release • sympathetic nervous activity • cellular growth •Vasodilation •Sodium excretion • aldosterone levels •Inhibition of RAAS •Inhibition of sympathetic nervous activity •Antiproliferation of vascular smooth muscle cells ANP = atrial natriuretic peptide; AT1 = angiotensin I; BNP = B-type natriuretic peptide; RAAS = renin-angiotensin-aldosterone system Burnett JC Jr. J Hypertens. 1999;17(suppl 1):S37-S43 Heart Failure Subtypes HF with Preserved Ejection Fraction (Formerly known as Diastolic HF) HF with Reduced Ejection Fraction (Formerly known as Systolic HF) Pharmacotherapies for HFrEF • Angiotensin Converting Enzyme Inhibitors (ACE-I) • Angiotensin Receptor Blockers (ARB) • Angiotensin Receptor Neprilysin Inhibitor (ARNI)* • Beta Blockers • Aldosterone antagonist • Hydralazine/Nitrate • Diuretics • Funny-Channel Blockers * Unfortunately, we don’t have good data on medications specific to HFpEF – control risk factors! Where Do the Medications Work? Baroreceptor response BetaBrain Blockers SNS activation Heart Rate Contractility R-A-A-S activation Decreased GFR Ventricular wall tension Goal: increase SV Kidney Funny Heart •ACE/ARB HR/ Contractility Renin, A-I, AII Channel •Aldosterone Vasoconstriction Aldosterone Blocker Antagonist Fluid •Sacubitril/ARB Myocyte growth retention Preload Hypertrophy Adapted from https://quizlet.com/101258231/pathophysiology-chapter-19-heart-failure-dysrhythmias-common-sequelae-of-cardiac-diseases-flash-cards/ Sacubitril/Valsartan (Entresto) • Angiotensin receptor blocker (valsartan) and neprilysin inhibitor (sacubitril) • Neprilysin breaks down natriuretic peptides • NYHA Class II-IV, EF ≤ 40% • 24/26 mg, 49/51 mg, 97/103 mg twice a day • Paradigm-HF Trial: Compared to Enalapril – 20% reduction in CV death or HF hospitalization – Consistent across subgroups – Approved in USA July, 2015 Gaziano et al. June 22, 2016. JAMA Cardiology. Ivabradine (Corlanor) • Reduces heart rate via If “funny channel” – Acts at the SA node, doesn’t reduce BP • EF < 35%, Heart Rate > 70 bpm – On maximally tolerated beta blockers • 5 or 7.5 mg twice a day • SHIFT study (in Europe) – Reduced hospitalization for worsening HF or CV death by 18% after 3 months of treatment – Reduced risk of death from HF by 26% – Reduced risk of hospitalization from HF by 26% – Approved in 2015 in USA (2005 in Europe) Gaziano et al. June 22, 2016. JAMA Cardiology. Pharmacotherapies for Heart Failure II IIa IIa IIb IIb III III • • II IIa IIa IIb IIb ACE-I are recommended for all patients with HFrEF ARBs are recommended in patients with HFrEF who are ACE-I intolerant III III • Yancy et al. Circulation. 2013;128:e240-e327 Yancy et al. JACC 2016; S0735-1097; 33024-8 ARNI with beta-blockers and aldosterone antagonists in select patients with chronic heart failure Pharmacotherapies for Heart Failure II IIa IIa IIb IIb III III • Use of proven Beta Blockers is recommended for stable patients – – II IIa IIa IIb IIb III III • Ivabradine to reduce HF hospitalization in patients with NYHA class II-III, stable chronic HFrEF (LVEF ≤35%) – – – Yancy et al. Circulation. 2013;128:e240-e327 Yancy et al. JACC 2016; S0735-1097; 33024-8 Carvedilol Metoprolol succinate Sinus rhythm HR 70 bpm or greater at rest Beta blocker at max tolerated dose Pharmacotherapies for Heart Failure II IIa IIa IIb IIb III III • • II IIa IIa IIb IIb Aldosterone receptor antagonists are recommended in patients with NYHA Class II-IV who have LVEF ≤ 35% Combination of hydralazine and isosorbide dinitrate is recommended for African Americans with NYHA class III-IV HFrEF on GDMT III III • Yancy et al. Circulation. 2013;128:e240-e327 Diuretics are recommended in patients with fluid retention Benefits of Medications in Trials 50 45 40 35 30 25 20 15 10 5 0 Adapted from Clyde W. Yancy et al. Circulation. 2013;128:e240-e327, www.pbm.va.gov RR Reduction in Mortality % RR Reduction HF Hospitalizations % NNT for Mortality Reduction Case Study - Medications • You share with the patient he has HFrEF • What medications would you now strongly recommend he start and/or what changes would you make? 1. Change metoprolol tartrate to metoprolol succinate and increase dose due to higher heart rate 2. Add either low dose ACE or ARNI 3. Consider aldosterone antagonist 4. Add diuretic for fluid retention Provide him with patient education…… Case Study – Next Steps • Carvedilol 12.5 mg BID, Furosemide 40 mg daily, and Sacubitril/Valsartan 29/31 mg started • Encourage him to check his weight, blood pressure and heart rate every day, same time in the morning • Write it down on the log provided by PCNA! • Use a STOPLIGHT tool (next slide) • Order blood work for one week from now • Follow up in 10 days to review labs, vital signs and to work on up titrating him to optimal therapy Case Study – Next Steps Safety During Medication Changes • Up titrate in small increments to target dose or highest tolerated dose – May be limited by HR, BP or labs • Monitor renal function and electrolytes for rising creatinine and hyperkalemia – Certain patients may need more visits and lab monitoring during dose titration (elderly, CKD) – Initial rise in creatinine may be expected Yancy et al. Circulation. 2013;128:e240-e327 Renal Function Testing • Patients with severe heart failure may have elevated BUN/Cr due to chronic reductions of renal blood flow from reduced cardiac output – Diuresing this group of patients is complex – In some individuals, diuretics will improve renal congestion and renal function • In other individuals, overaggressive diuresis may aggravate renal insufficiency from volume depletion • ACE/ARB/ARNI or aldosterone antagonist may cause rise in BUN/Cr http://emedicine.medscape.com/article/163062-workup#c8 Electrolyte Testing • Dilutional hyponatremia may occur with prolonged, rigid sodium restriction in addition to intensive diuretic therapy and the inability to excrete water • Hypokalemia may occur with diuretics • Hyperkalemia may occur with with reductions in glomerular filtration rate (GFR) especially with ACE/ARB/ARNI or aldosterone antagonist • New medications being tested to address hyperkalemia if a barrier to giving GDMT http://emedicine.medscape.com/article/163062-workup#c8 Safety During Medication Changes • Monitor vital signs closely before and during up titration of medications – Postural changes in BP and HR • Orthostatic symptoms, bradycardia or low systolic BP (80-100 mmHg) • Alternate adjustments of different medication classes – ACE/ARB/ARNI and beta blockers Yancy et al. Circulation. 2013;128:e240-e327 Safety During Medication Changes • Consider temporary adjustments in dosages during acute episodes of noncardiac illnesses – Especially if risk of dehydration or infection • Review other medications – Prescription and OTC – Scientific Statement, AHA Yancy et al. Circulation. 2013;128:e240-e327 Page et al. Circulation; July 12, 2016, Volume 134, Issue 2 Case Study – Follow Up Visit • Labs and vitals stable on return visit • • Cr =1.0, K = 4.2, NT pro-BNP = 370 BP 110’s/70’s, HR 70-80’s, Weight down to 174 • Decide to increase Carvedilol to 25 mg BID • Adjust diuretics to as needed for weight gain • Disease telemanagement team + check daily • Follows up 2 weeks; increase sacubitril/valsartan to 49/50 mg • Follow up in 2 months with labs, echo Case Study – Something More? • Was admitted over holiday weekend with weight gain of 10 pounds despite telephone calls and adjustment of medications • • • Hard to tell if fluid or fat! Limited in what he can do NYHA Class III • Labs show Cr =1.3, K = 4.6, NT pro-BNP = 456 • BP = 100‘s/70’s, HR 60-70’s, EF = 38% • He wants to know what else can be done! Surgical Monitoring - CardioMEMS • Sensor placed in distal pulmonary artery that measures and monitors PA pressures – NYHA Class III patients, HFpEF and HFrEF – At least 1 HF hospitalization in past 12 months Click to add text – Outpatient, same day procedure – Dual therapy of ASA (81 or 325 mg) for life + Clopidogrel 75 mg for 30 days • Home monitoring equipment (large suitcase) – Lie down on “pillow” to transmit data daily https://www.sjm.com/en/sjm/cardiomems Successful Surgical Monitoring! HF Program Leadership • Champion adoption and implementation process • Identify leaders and those reviewing HF data HF Disease Management Framework • Hospital Based Stakeholders • Transitional Care strategy • Process to provide emergency and urgent care (instead of hospitalization) Remote Patient Monitoring Infrastructure • HF Data evaluated to manage patient/disease • Well-developed clinical care pathway • Develop efficient work flow Cardiomems Impact • Detects changes in PA pressure 4 weeks prior to onset of HF admission • Studies showing success: 37% ↓ HF hospitalization (15 month follow up) 8% ↓ 30 day HF readmissions in Medicare population 50% ↓ HF hospitalization HFpEF (18 month follow up) 3 fold increase in KCCQ scores from baseline compared to no CardioMEMS – Significant increase in 6 minute walk test distance – – – – KCCQ = Kansas City Cardiomyopathy Questionnaire http://www.slideshare.net/ir_stjude/2016-analyst-and-investor-day-presentation’ Amit Alam, Abstract Presentation ACC 2016. Session 903-06. Case Study –Decision Making • There are options for next steps: – Changes in medications – CardioMEMS – Ignore everything and hope it goes away • So how do you decide which is best for this patient, at this time? Patients and Health Outcomes • Patients more actively involved in their health care experience have better health outcomes and lower costs • Modern health care is complex, and patients struggle to obtain, process, communicate, and understand even basic health information and services • Many patients lack health literacy: true understanding of their medical conditions • US health care system often has seemed indifferent to patients' desires and needs "Health Policy Brief: Patient Engagement," Health Affairs, February 14, 2013. Who’s in Charge? “Patients are in control. No matter what we as health professionals do or say, patients are in control of these important selfmanagement decisions. When patients leave the clinic or office, they can and do veto recommendations their doctor makes.” Glasgow RE, Anderson RM Diabetes Care. 1999 Dec;22(12):2090-2 Where Does Shared Decision Making Fit? Shared decision making (SDM) is a collaborative process that allows patients and their providers to make health care decisions together, taking into account the best scientific evidence available, as well as the patient’s values and preferences. http://www.informedmedicaldecisions.org/ The Perspectives of 2 Experts CLINICIAN PATIENT/ FAMILY Diagnosis Personal experience of illness Pathophysiology How patient feels Prognosis Social and family context Treatment Options Values Treatment Outcome Preferences Risk/Benefit associate with each option Attitudes/feelings regarding risk http://www.informedmedicaldecisions.org/ SDM: Steps in the Process • Invite Invite patient patient to toparticipate participate • Both parties share Information – Clinician introduces concept of patient participation in decision making – Clinician offers options and describes the associated risks/benefits – Patient and family expresses his/her preference/values: What matters most or what are the priorities for the patient and family http://www.informedmedicaldecisions.org/ Patient Decision Aids • When more than one option exists, decision aids may aid in achieving consensus or agreement –Tools that help people become involved in decision making by making explicit the decision that needs to be made, providing information about the options and outcomes, and by clarifying personal values. • They are designed to complement, rather than replace, counseling from a health practitioner. Ottawa Hospital Research Institute: http://decisionaid.ohri.ca/AZlist.html Decision Aids & Training Ottawa Hospital Research Institute: http://decisionaid.ohri.ca/AZlist.html Decision Aids & Training Ottawa Hospital Research Institute: http://decisionaid.ohri.ca/AZlist.html Patient Decision Aids Ottawa Hospital Research Institute: https://www.healthwise.net/cochranedecisionaid/Content/StdDocument.aspx?DOCHWID=abk4103 An Under-Utilized Resource “In our country, patients are the most underutilized resource, and they have the most at stake. They want to be involved and they can be involved. Their participation will lead to better medical outcomes at lower costs with dramatically higher patient & customer satisfaction.” Charles Safran, M.D. President, American Medical Informatics Association Testimony Before the Subcommittee on Health of the House Committee on Ways and Means Case Study – What Next? • Shared decision making discussion occurs with you and patient and family • Decision to implant CardioMEMS device • Patient continues to take GDMT and monitor his vital signs and weights 2-3 times a week • Able to return to work and travel with his family! THANK YOU! QUESTIONS? Discussion Questions • Have you used one of the new heart failure medications (ivabradine or sacubitril/valsartan) in your practice? • Did you have difficulty with insurances getting coverage for your patient(s)? • How frequently do you monitor HF patients during a period of medication titration? In person or by phone? More Discussion Questions • Have you used the PCNA patient education fact sheets in your practice? – Other educational tools that you would recommend? • Have you used decision aids in your practice? – If so, which ones? – Do you find them helpful?
