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General Heart Failure Deck for external distribution Created 2015-09-30 SE1510388788 Instructions to the user of these slides These slides are developed to be used by and for presentation to Healthcare Professionals These slides must not be used for presentation to patients or Non-healthcare Professionals These slides are for the recipient’s personal use and are not intended for wider distribution. Changes made to the content of this slide deck will not be the responsibility of Novartis. The content of this slide deck is accurate to the best of our knowledge at the time of production. Any competitor data is based on publicly available sources. Accuracy and context at the time of presentation is the responsibility of the presenter. The recipient may use the materials for scientific discussions only, in a fair and balanced way. This slide deck may not be provided as handouts to the audience who participated during the presentation of the material, or further distributed to any additional Healthcare Professionals These slides were produced 2015-09-30 Introduction to heart failure: History 3 Our understanding of HF has evolved over time The Ancient Egyptian text, Ebers papyrus, contains some of the earliest documented observations of the syndrome of HF1,2 The term “dropsy”, derived from the Greek word for water, was used to describe a syndrome of fluid overload and the symptoms synonymous with HF for many centuries2 Changing views of HF3 A clinical syndrome Disordered fluid balance A circulatory disorder Altered architecture of the heart Abnormal hemodynamics Biochemical abnormalities Maladaptive hypertrophy Genomics Epigenetics 4 *Century in which the view of HF was first described BCE=before common era; CE=common era; HF=heart failure Century* th 5 BCE th 16 CE th 17 CE th 18 CE th 19 CE th 20 CE th 20 CE Ebers papyrus, an Egyptian medical papyrus th 20 CE st 21 CE 1. Saba et al. J Card Fail 2006;12:416–21 2. Ventura & Mehra. J Card Fail 2005;11:247–52 3. Katz. Circ: Heart Fail 2008;1:63–71 Introduction to heart failure: Definition 5 HF – abnormality of cardiac structure and/or function Abnormality of cardiac structure or function leads to failure of the heart to adequately perfuse organ systems1 Weakening or stiffening of the heart muscle over time leads to pump failure and insufficient delivery of blood around the body2 Normal heart HF Weakened heart muscle 6 HF=heart failure 1. McMurray et al. Eur Heart J 2012;33:1787–847 2. Harrison’s ‘Principles of Internal Medicine’, Seventeenth Edition p1442–55 Images from: Wilde and Behr. Nat Rev Cardiol 2013;10:571–83 A progressive condition with high mortality Clinical manifestations Increasing frequency of acute events with disease progression leads to high rates of hospitalization and increased risk of mortality With each acute event, myocardial injury may contribute to progressive LV dysfunction Chronic decline Function & quality of life (QoL) Mortality Acute episodes Disease progression LV: left ventricular Gheorghiade et al. Am J Cardiol 2005;96:11G–17G; Gheorghiade & Pang. J Am Coll Cardiol 2009;53:557–73 Chronic HF can be classified as HF with reduced or preserved ejection fraction HF with preserved ejection fraction (HFpEF)1–4 HF with reduced ejection fraction (HFrEF)1–4 Dysfunction Diastolic Systolic-diastolic LVEF >40–50% ≤35–40% LV remodeling Concentric Eccentric Characteristic • Normal end-diastolic volume • ↑ wall thickness and mass • High ratio of mass:volume Prognostic improvement with current HF therapy 8 HF=heart failure; LV=left ventricular; LVEF=left ventricular ejection fraction No • ↑ end-diastolic volume • ↓ wall thickness • Low ratio of mass:volume Yes, but morbidity and mortality remain high 1. Aurigemma. Circulation 2006;113;296–304 2. Paulus et al. Eur Heart J 2007;28:2539–50 3. Colucci (Ed.). Atlas of Heart Failure, 5th ed. Springer 2008 4. McMurray et al. Eur Heart J 2012;33:1787–847 Terminology related to left ventricular ejection fraction 9 McMurray et al. Eur Heart J 2012;33:1787–847 Figure from: http://www.cardiachealth.org/heart-information/heart-failure HFrEF vs HFpEF Systolic dysfunction Diastolic dysfunction HFrEF EF≤35–40% EF≤35–40% HFpEF HFpEF EF>40–50% EF>40–50% Echocardiography is a useful method for evaluating left ventricular ejection fraction HFrEF: heart failure with reduced ejection fraction; HFpEF: heart failure with preserved ejection fraction McMurray et al. Eur Heart J 2012;33:1787–847; Dickstein et al. Eur Heart J 2008;29:2388–442 Determing ejection fraction McMurray et al. Eur Heart J 2012;33:1787–847; Dickstein et al. Eur Heart J 2008;29:2388–442 There is a lack of consensus regarding the definition of HFpEF In patients with HFpEF, the ventricles are unable to relax properly when the heart contracts. Consequently, during filling, less blood enters the heart and the ejection fraction may be considered normal1 There is no consensus concerning the cut-off for preserved LVEF2 Approximately half of patients presenting with symptoms of HF have HFpEF2 • patients with an LVEF in the range 40–50% represent a ‘grey area’ and may have primarily mild systolic dysfunction3 Definite HFrEF (LVEF <40%)4 Uncertain (40% ≤LVEF <50%)4 50% 14% Definite HFpEF (LVEF ≥50%)4 36% Proportion of patients 12 HF=heart failure; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; LVEF=left ventricular ejection fraction 1. Hsich & Wilkoff. Clevelandclinic.org 2013. Available at: http://my.clevelandclinic.org/services/heart/disorders/heart-failure-what-is/ejectionfraction. Last accessed 9 Jan 2014; 2. Dickstein et al. Eur Heart J 2008;29:2388–442; 3. McMurray et al. Eur Heart J 2012;33:1787–847; 4. Steinberg et al. Circulation 2012;126:65–75 Pathophysiology: Risk factors Myocardial injury to the heart Initial fall in left ventricle performance Activation of RAAS and SNS to maintain cardiac output RAAS: stimulates vasoconstriction, salt and water retention SNS: stimulates vasoconstriction, increases heart rate and contractility Systemic effects of neurohormonal activation = pathophysiological ‘vicious cycle’ LV: left ventricular; RAAS: renin-angiotensin-aldosterone system, SNS: sympathetic nervous system Krum, Abraham. Lancet 2009;373:941–55; Khan. Cardiac Drug Therapy, 6th ed. 2003; Philadelphia: Saunders WB Renin Angiotensin Aldosterone System Pathophysiology ACE: angiotensin-converting-enzyme; ADH: antidiuretic hormone Sympathetic (or adrenal) Nervous System Pathophysiology Heart The SNS exerts a wide Postganglionic ANS neurons variety of cardiovascular effects: (-) • Heart rate acceleration • Increased cardiac contractility (+) Vessels - Arterial chemoreflex - CSAR Postganglionic cholinergic neurons Preganglionic ANS neurons • Peripheral vasoconstriction Spinal Cord Adrenal Preganglionic ANS neurons Prevertebral ganglia Epinephrine ANS: autonomic nervous system; CSAR: cardiac sympathetic afferent reflex; SNS: sympathetic nervous system Lymperopoulos et al. Circ Res 2013;113:739–53 - Arterial baroreflex - Cardiopulmonary reflex Paravertebral ganglia Effects of the long term neurohormonal activation Pathophysiology Risk factors Myocardial injury to the heart Initial fall in LV performance Activation of RAAS and SNS to maintain cardiac output Remodeling and progressive worsening of LV function Fibrosis, apoptosis, hypertension, hypertrophy, cellular and molecular alterations, myotoxicity Morbidity and mortality: arrhythmias, pump failure Hemodynamic alterations, salt and water retention HF symptoms: dyspnea, edema, fatigue LV: left ventricular; RAAS: renin-angiotensin-aldosterone system, SNS: sympathetic nervous system Krum, Abraham. Lancet 2009;373:941–55; Khan. Cardiac Drug Therapy, 6th ed. 2003; Philadelphia: Saunders WB Initial diagnosis of HF can be complex Initial clinical examination Assess cardiac function Evaluate cause 17 Assessment of signs and symptoms, patient history and physical examination Tests include echocardiography, chest X-ray and ECG. Other tests such as radionuclide ventriculography, MRI, computed tomography may also be carried out to provide information on the nature and severity of cardiac abnormality Laboratory tests used to assist with the identification of etiology inlcude complete blood count, urinalysis, serum electrolytes, glycohemoglobin, blood lipids and tests of renal and hepatic function, as well as BNP (or NTproBNP levels) and Troponin I or T BNP=B-type natriuretic peptide; ECG=electrocardiogram; HF=heart failure; MRI=magnetic resonance imaging; NTproBNP=N-terminal pro-B-type natriuretic peptide Dickstein et al. Eur Heart J 2008;29:2388–442 Hunt et al. J Am Coll Cardiol 2009;53:e1–90 Signs and symptoms Clinical manifestations Tiredness Shortness of breath Symptoms • Breathlessness • Orthopnea Coughing Pumping action of the heart grows weaker Fluid retention • Paroxysmal Nocturnal Dyspnea • Reduced exercise tolerance Pleural effusion • Fatigue • Ankle swelling Signs Swelling of feet, ankles, abdomen and lower back area • Elevated jugular venous pressure • Hepato-jugular reflux • Third heart sound • Laterally displaced apical impulse • Cardiac murmur McMurray et al. Eur Heart J 2012;33:1787–847 Pulmonary edema Frequency of signs and symptoms Clinical manifestations of acute heart failure 100 Signs and symptoms in 4,537 residents of Worcester, Massachusetts, USA, hospitalized for acute HF between 1995 and 2000 Patients (%) 80 60 40 20 0 Goldberg et al. Clin Cardiol 2010;33:e73–80 Frequency of signs and symptoms Clinical manifestations of chronic heart failure Signs and symptoms in a small study conducted by two cardiac outpatient centers from the US Patients (%) Frequency of signs and symptoms 70 60 50 40 30 20 10 0 Bekelman D et al. J Card fail 2007;13:643-648 Symptomatic severity of heart failure Clinical manifestations New York Heart Association functional classification based on severity of symptoms and physical activity Class I No limitation of physical activity. Ordinary physical activity does not cause undue breathlessness, fatigue, or palpitations. Class II Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue, or palpitations. Class III Marked limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue, or palpitations. Class IV Unable to carry on any physical activity without discomfort. Symptoms at rest can be present. If any physical activity is undertaken, discomfort is increased. McMurray et al. Eur Heart J 2012;33:1787–847 Clear relationship between severity of symptoms and survival Poor relationship between severity of symptoms and ventricular function Patients with mild symptoms may still have a relatively high absolute risk of hospitalization and death NYHA class is related to prognosis in chronic HF Clinical manifestations Among 411 outpatients with NYHA class II, III or IV HF, total mortality was 7.1%, 15.0% and 28.0%, respectively during a mean follow-up period of 1.4 years Survival probability according to NYHA class 1.0 NYHA II 0.9 NYHA III 0.8 NYHA IV 0.7 P<0.001 0.6 0 3 6 9 Time (months) NYHA: New York Heart Association Muntwyler et al. Eur Heart J 2002;23:1861–6 12 15 A number of diagnostic assessments support the presence of HF 23 Assessment of symptoms Compatible symptoms include breathlessness, fatigue, angina, palpitations or syncope Assessment of signs Compatible signs should include appearance, pulse, BP, fluid overload, respiratory and heart rate ECG ECG changes are common (e.g. presence of new Q waves reflecting a MI; wave abnormalities reflecting ischemia, or an arrhythmia). If the ECG is completely normal, HF, especially with systolic dysfunction, is unlikely (<10%) Laboratory analyses Elevated BNP/NT-proBNP, hyponatremia, renal dysfunction, mild elevations of troponin Chest X-ray Permits assessment of pulmonary congestion and may demonstrate important pulmonary or thoracic causes of dyspnea Echocardiography Provides extensive information on cardiac anatomy, wall motion and valvular and ventricular function; used to confirm HF diagnosis BNP=B-type natriuretic peptide; BP=blood pressure; ECG=echocardiograph; HF=heart failure; MI=myocardial infarction; NT-proBNP=N-terminal pro-B-type natriuretic peptide Dickstein et al. Eur Heart J 2008;29:2388–442 BNP and NT-proBNP measurement is useful for the diagnosis of HFrEF Clinical examination, ECG, chest X-ray, echocardiography Natriuretic peptides BNP <100 pg/mL NT-proBNP <400 pg/mL BNP 100–400 pg/mL NT-proBNP 400–2,000 pg/mL BNP >400 pg/mL NT-proBNP >2,000 pg/mL Chronic HF unlikely Uncertain diagnosis Chronic HF likely Clinical usefulness of BNP and NT-proBNP testing in patients with chronic HF: • diagnosis of chronic HF in patients with dyspnea • prognosis and risk stratification • screening for chronic HF in high-risk populations • monitoring and guiding treatment • treatment with recombinant BNP 24 BNP=B-type natriuretic peptide; ECG=electrocardiograph; HF=heart failure; HFrEF=heart failure with reduced ejection fraction; NT-proBNP=N-terminal pro-B-type natriuretic peptide Dickstein et al. Eur Heart J 2008;29:2388–442 Melanson, Lewandrowski. Am J Clin PathoI 2005;124:S122– 8 Introduction to heart failure: Epidemiology 25 HF is a common clinical condition Prevalence Approximately 1–2% of the adult population in developed countries has HF, with the prevalence rising to ≥10% among persons 70 years of age or older1 Incidence Mortality 26 HF=heart failure Over 650,000 new cases of HF are diagnosed annually in the USA2 and more than 25,000 new cases are reported every year in the UK3 The mortality rate for patients with chronic HF is as high as 50% at 5 years post-diagnosis4–5 1. McMurray et al. Eur Heart J 2012;33:1787–847; 2. Yancy et al. JACC 2013;62:e147–239 3. Townsend et al. 2012 Coronary heart disease statistics 2012 edition. Available at: https://www.bhf.org.uk/publications/statistics/coronary-heart-disease-statistics-2012 4.Roger et al. JAMA 2004;292:344–50; 5. Levy et al. NEJM 2002;347:1397–402 HF is increasing in prevalence Hospital discharges for HF by gender (USA: 1979–2006)* 700 Discharges in thousands Male 600 500 400 300 200 100 0 27 Female 79 80 85 *Hospital discharges include people discharged alive, dead and of unknown status HF=heart failure 90 Years 95 00 Lloyd-Jones et al. Circulation 2010;121:e46–e215 05 Prevalence of HFpEF is consistent worldwide Large European, USA and Asian registries have consistently demonstrated that 40–50% of patients hospitalized for acute HF have a preserved LVEF1–3 The ‘true’ overall prevalence of HFpEF in the general population has been estimated at 1.1–5.5%4 Registry Region Total patients assessed EuroHeart Failure Survey1 Europe 6,806 46% USA 52,187 50.4% Japan 1,692 42%* ADHERE2 JCARE-CARD3 HFpEF (LVEF ≥40%) *26% with LVEF ≥50%, 16% with LVEF 40–50% 28 ADHERE=Acute Decompensated Heart Failure National Registry; HF=heart failure; HFpEF=heart failure with preserved ejection fraction; JCARE-CARD=Japanese Cardiac Registry of Heart Failure in Cardiology; LVEF=left ventricular ejection fraction 1. Lenzen et al. Eur Heart J 2004;25:1214–20 2. Yancy et al. J Am Coll Cardiol 2006;47:76–84 3. Tsuchihashi-Makaya et al. Circ J 2009;73:1893–900 4. Owan, Redfield. Prog Cardiovasc Dis 2005;47:320–32 Trends show that prevalence of HFpEF is increasing Prevalence of HFpEF among patients with a discharge diagnosis of HF increased from 38% to 54% from 1987–20011 Increasing prevalence of HFpEF may be a consequence of growing recognition, population aging and increases in hypertension and obesity2 Patients with preserved ejection fraction (%) 70 60 50 40 30 20 0 1986 29 r=0.92, p<0.001 1990 1994 Data based on n=4,596 patients with LVEF measurements and a discharge diagnosis of HF from Mayo Clinic Hospitals, Minnesota, USA over a 15-year period between 1987 and 2001. HFpEF was defined as LVEF ≥50%; Solid lines represent the regression lines and the dashed line indicates 95 percent confidence intervals. HF=heart failure; HFpEF=heart failure with preserved ejection fraction; LVEF=left ventricular ejection fraction 1998 1. Owan et al. N Engl J Med 2006;355:251–9 2. Blanche et al. Swiss Med Wkly 2010;140:66–72 2002 HFpEF is more common in women than in men Distribution of LVEF amongst women (n=2,048) and men (n=3,249) enrolled in the EuroHeart Failure survey • 51% of men but only 28% of women had LVEF <40% 14.0 Women Men 12.0 Patients (%) 10.0 8.0 6.0 4.0 2.0 0 <10 10–14 15–19 20–24 25–29 30–34 35–39 40–44 45–49 50–54 55–59 60–64 65–69 70–74 75–80 LVEF (%) 30 HFpEF=heart failure with preserved ejection fraction; LVEF=left ventricular ejection fraction Cleland et al. Eur Heart J 2003;24:442–63 Rates of initial hospital admission are similar in patients with HFpEF and HFrEF In a retrospective study of 451 patients with HF in Sweden, time from diagnosis to first post-diagnosis CV- or HF-related hospitalization was not significantly different between HFpEF and HFrEF (p=0.49 and p=0.08, respectively) Time to first CV hospitalization Time to first HF hospitalization 1.00 Survival distribution function Survival distribution function 1.00 0.75 0.50 0.25 0 0.75 0.50 0.25 0 0 31 HFpEF (LVEF >45%) HFrEF (LVEF ≤45%) 200 400 600 Time (days) 800 CV=cardiovascular; HF=heart failure; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; LVEF=left ventricular ejection fraction 1,000 0 200 400 600 Time (days) Wikstrom et al. ESC 2011 Gothenburg, Sweden, May 21–24, 2011 800 1,000 Rates of hospital readmission are similar in patients with HFpEF and HFrEF In patients with new-onset HF, rates of readmission for HF and in-hospital complications do not differ substantially between HFpEF and HFrEF1 p=0.09 Percentage of patients 18 16.1 16 13.5 14 12 HFpEF 10 8 6 HFrEF p=0.66 4.5 4.9 4 2 0 30-day readmission for HF* 32 1-year readmission for HF* Patients with HFpEF are as likely as those with HFrEF to be readmitted following hospital discharge, with a re-hospitalization rate of 29% within 60–90 days,2 and a median time to re-hospitalization of 29 days3 *Readmission rates were calculated for the 2,339 patients who survived the index admission: 1,493 with HFrEF and 846 with HFpEF HF=heart failure; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction 1. Bhatia et al. N Engl J Med 2006;355:260–9 2. Fonarow et al. J Am Coll Cardiol 2007;50:768–77 3. Lenzen et al. Eur Heart J 2004;25:1214–20 Mean length of hospital stay increases with each rehospitalization for HF Length of hospital stay following hospitalization for HF Mean length of stay (days) 8.5 8.0 7.5 7.0 6.5 6.0 33 All HF HFrEF HFpEF Acute HF Chronic HF First Second Third Fourth Hospitalization 278,307 patients in the USA with ≥1 hospitalization with a HF claim were followed from first HF hospitalization for 24 months or until disenrollment or end of data availability HF=heart failure; HFrEF=heart failure with reduced ejection fraction; HFpEF= heart failure with preserved ejection fraction Fifth Korves et al. Presented at the American Heart Association Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke 2010 Scientific Sessions, Washington, D.C., May 19–21, 2010 HFpEF and HFrEF are associated with similarly high levels of mortality Survival rate among patients with a discharge diagnosis of HF in the USA was slightly higher among patients with HFpEF than those with HFrEF between 1987–20011 • respective mortality rates were 29% and 32% at 1 year and 65% and 68% at 5 years 1.0 HFrEF (LVEF <50%) HFpEF (LVEF ≥50%) Survival 0.8 0.6 0.4 0.2 p=0.03 0 0 34 1 2 Year 3 4 5 HFpEF is associated with significant morbidity and mortality, despite having a slightly higher survival rate compared with HFrEF2,3 HF=heart failure; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; LVEF=left ventricular ejection fraction 1. Owan et al. N Engl J Med 2006;355:251–9 2. Blanche et al. Swiss Med Wkly 2010;140:66–72 3. Meta-analysis Global Group in Chronic Heart Failure (MAGGIC). Eur Heart J 2012;33:1750–7 Unlike HFrEF, survival rates have not improved over time for HFpEF Survival rate among patients with a discharge diagnosis of HFpEF has not changed significantly over time Patients with HFpEF (LVEF ≥50%) 1.0 1.0 1987–1991 1992–1996 1997–2001 0.6 0.4 1987–1991 1992–1996 1997–2001 0.8 Survival 0.8 Survival Patients with HFrEF (LVEF <50%) 0.6 0.4 0.2 0.2 p=0.005 p=0.36 0 0 0 1 2 3 Year 35 HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; LVEF=left ventricular ejection fraction 4 5 0 1 2 3 Year Owan et al. N Engl J Med 2006;355:251–9 4 5 HF has a detrimental effect on QoL Patients with HF commonly report psychological distress, including1 Concepts frequently reported as important by patients with HF2 Impact of HF Number of patients reporting impact (n=15) Physical mobility 14/15 Physical activity limitations 14/15 Daily activities 12/15 Emotional impacts 11/15 Lifestyle 11/15 Self-care 3/15 Sleep disturbance 3/15 • depression • hostility and anxiety • limitation in their activities of daily living • disruption of work roles and social interaction with friends and family • reduced sexual activity and satisfaction 36 HF=heart failure; QoL=quality of life 1. Grady. Crit Care Nurs Clin North Am 1993;5:661–70 2. Gwaltney et al. Presented at the American Heart Association Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke 2010 Scientific Sessions, Washington, D.C., May 19–21, 2010 Health-related QoL is similar for patients with HFrEF and HFpEF Distribution of MLHF QoL scores reflects the wide range of health-related QoL among patients with chronic HF1 • patients with HFpEF and those with HFrEF have a similar distribution of MLHF QoL scores 16 HFpEF (LVEF >40%) HFrEF (LVEF ≤40%) Percent distribution 14 12 10 8 6 4 2 0 0–<10 10 –<20 20 –<30 30 –<40 40 –<50 50 –<60 60 –<70 70 –<80 80 –<90 Better QoL 37 MLHF summary score range Worse QoL Patients with HFpEF may have greatly reduced general and symptom-specific QoL2 Distribution of the MLHF questionnaire responses in patients (n=2709) with HFpEF and HFrEF. Scores range from 0 to 105 with a low score reflecting a better health-related QoL HF=heart failure; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; LVEF=left ventricular ejection fraction; MLHF=Minnesota Living with Heart Failure; QoL=quality of life >90 1. Lewis et al. Eur J Heart Fail 2007;9:83–91 2. Kitzman et al. JAMA 2002;288:2144-50 HF imposes a significant burden on the carer Caregiving tasks related to feelings of burden include1 • personal care, such as assisting with washing and bathing and moving in and around the house Caregiving burden in partners of patients with HF is similar to that in partners of patients with cancer1 HF caregivers report being socially isolated, physically exhausted and unprepared for the stress of the caregiver role, with sleep and anxiety issues over current and future needs, and worry over financial concerns2 Older caregivers experience decreased physiological functioning, increased risk of health problems, and increased risk of mortality3 • caregivers experiencing heightened emotional strain from caregiving also face a greatly increased mortality3 38 HF=heart failure 1. Luttik et al. Eur J Heart Fail 2007;9:695–701 2. Saunders. West J Nurs Res 2008;30:943–59 3. Schulz & Beach. JAMA 1999;282:2215–19