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Detection and management of preclinical heart failure Director, Menzies Research Institute Tasmania Tom Marwick.

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Presentation on theme: "Detection and management of preclinical heart failure Director, Menzies Research Institute Tasmania Tom Marwick."— Presentation transcript:

1 Detection and management of preclinical heart failure Director, Menzies Research Institute Tasmania Tom Marwick

2 Overt heart failure (Stages C and D) Risk factors including social determinants and behaviour (Stage A) Preclinical disease Stage B EARLY HEART FAILURE Preclinical heart failure

3 Hunt SA, et al. J Am Coll Cardiol 2009;53:e1-e90 EARLY HEART FAILURE HF stages Stage B Structural heart disease but without signs or symptoms of HF Stage B Structural heart disease but without signs or symptoms of HF Stage A At high risk for HF without structural heart disease or symptoms Stage A At high risk for HF without structural heart disease or symptoms Stage C Structural heart disease with prior or current symptoms of HF Stage C Structural heart disease with prior or current symptoms of HF Stage D Refractory HF requiring specialized intervention Stage D Refractory HF requiring specialized intervention Patient with: -Previous MI -LV remodeling including LVH and low EF -Asymptomatic valvular disease Patient with: -Previous MI -LV remodeling including LVH and low EF -Asymptomatic valvular disease Patient with: -Hypertension -Atherosclerosis -Diabetes -Metabolic syndrome -Cardiotoxins -With FHx CM Patient with: -Hypertension -Atherosclerosis -Diabetes -Metabolic syndrome -Cardiotoxins -With FHx CM

4 1.Why - The epidemiology of heart failure 2.Detection - is HF screening an option? a.Right population b.Right test c.Rx strategy d.Measuring outcomes e.Quantifying risk, FP and FN results 3.Proof of Principle – TasELF study 4.Lessons about community-based RCTs EARLY HEART FAILURE TCF funding – Rural HF project

5 EARLY HEART FAILURE What is heart failure? Acute heart failure Chronic heart failure

6 Australia (National Heart Foundation of Australia-HF guideline) Prevalence: 10% (> 65 yrs); 50% (> 85 yrs ) Annual Incident HF: 30,000 Annual admissions: 100,000 Annual cost of care: $411 million (0.4% ) USA (Hunt SA,2009) Prevalence: 5,800,000 Incident rate: 500,000 /year Annual cost of care: 39 billion (1-2%) Worldwide ( McMurray JJ 1998) Prevalence: 23,000,000 EARLY HEART FAILURE Magnitude of the Problem

7 EARLY HEART FAILURE The heart failure epidemic Hospital admissions per 1,000 population per year for heart failure (Kannel WG. Br Heart J 1994) Why is HF increasing? - Aging - Survival from heart attack - Risk factors -BP -diabetes -obesity Chance of getting HF? - About 30% HF IS THE SINGLE MOST EXPENSIVE DIAGNOSIS IN HEALTH SYSTEM

8 Wellcome Museum, London EARLY HEART FAILURE Metabolic drivers of the HF epidemic

9 EARLY HEART FAILURE HF – Survival rate at 5 years Stewart S, et al. More malignant than cancer? Five-year survival following a first admission for heart failure in Scotland. European Journal of Heart Failure 3 (2001)

10 Juenger J et al. Health related quality of life in patients with congestive heart failure: comparison with other chronic disease and relation to functional variables. Heart 2001; 87: 235 EARLY HEART FAILURE Heart Failure - Quality of Life Lynn J. JAMA 1997; 277: PF: Physical function RP: Role limitation BP: Body pain GH: General health perceptions VT: Vitality SF: Social function RE: Emotional Problems MH: Mental Health

11 Focus on early disease to change trajectory EARLY HEART FAILURE HF is bad! What can we do about it?

12 1.Why - The epidemiology of heart failure 2.Detection - is HF screening an option? a.Right population b.Right test c.Rx strategy d.Measuring outcomes e.Quantifying risk, FP and FN results 3.Proof of Principle – TasELF study 4.Lessons about community-based RCTs EARLY HEART FAILURE TCF funding – Rural HF project

13 EARLY HEART FAILURE Screening for HF Prevalence: 10% (> 65 yrs) At June 2010, there were 79,100 people aged 65 years and over in Tasmania % of the population Can we afford to screen ~80,000 people in order to find ~8,000 with HF?

14 EARLY HEART FAILURE What’s wrong with screening? – The risk of false positive results Lead to further unnecessary diagnostic testing, over- treatment, some can be invasive – Cause psychological distress and anxiety in asymptomatic people – Need of evidence that screening and detection changes management outcomes Screening for Heart Failure has not been recommended by the US Preventive Services Task Force

15 EARLY HEART FAILURE Essentials of screening Thomas Bayes, Choosing the right population 2.Having the right test 3.Absolute vs relative risk 4.Defining the phenotype 5.Having a treatment strategy 6.Knowing how to manage false positive and false negative tests

16 1.Why - The epidemiology of heart failure 2.Detection - is HF screening an option? a.Right population b.Right test c.Rx strategy d.Measuring outcomes e.Quantifying risk, FP and FN results 3.Proof of Principle – TasELF study EARLY HEART FAILURE Rural HF project

17 EARLY HEART FAILURE Shrink the haystack

18 Framingham HF Risk Score EARLY HEART FAILURE Framingham HF Risk Score

19 Health ABC HF Score EARLY HEART FAILURE Health ABC HF Score

20 EARLY HEART FAILURE ARIC HF Risk Score

21 EARLY HEART FAILURE PRISMA- A Meta Analysis Total articles identified (n=2947) Articles reviewed by title or abstract (n=1974) Articles included for meta- analysis (n=23) Articles included in systematic review (n=29) 18 additional articles from bibliographies included. Articles for full text review (n=111) Articles eligible for review (n=94) Excluded duplicates (n=973) Excluded by title or abstract (n=1880) Excluded articles not reporting characteristics of inclusion criteria (n=83) Excluded articles reporting risk inconsistent with inclusion criteria (n=6) Inclusion: 1)Study in unselected population, community 2)Reporting risk effect size in RR/OR/HR 3)Outcome: incident heart failure Inclusion: 1)Study in unselected population, community 2)Reporting risk effect size in RR/OR/HR 3)Outcome: incident heart failure

22 EARLY HEART FAILURE Studies included AuthorStudy (Trial) Total (n) F-U (year) HF (n) 1 Ho; Kannel ; Ho et al Framingham study (Framingham and Offspring) Butler Kalogeroul Health ABC study (Health Aging and Body Composite Study) HeNHANES (National Health Nutrition Examination Survey ErikssonMen born in 1913 (Sweden) AgarwalARIC (The Atherosclerosis Risk in Communities) GoyalOne Million Person-Year DunlayPopulation based CC-Mayo BahramiMESA (Multi-Ethnic Study of Atherosclerosis) Gottdiener; Mujib Cardio Vascular Health Chen YT EPESE (Established Population for Epidemiologic Studies of the Elderly program) WilhelmsenMPPS (Sweden) Bibbins-D CARDIA (Coronary Artery Risk Development in Young Adults) IngelssonULSAM Wang JKuopio (Finland) AronowMt Sinai Smith JGMDCS (Sweden) KenchaiahPhysician’s heart (US) BrouwersPREVEND (Netherlands)

23 EARLY HEART FAILURE Risk variables identified Clinical RisksClin Risks (uncontrollable)Lab risk markers AgeGender (male)Fasting Glucose ObesitySmoking, COPDC-reactive protein DiabetesLow Physical ActivityRenal dysfunction Family HistoryCoffee, AlcoholAlbumin HypertensionSleep disorderDyslipidemia Education, raceAbnormal ECG (LVH) Resting Heart RateNT-proBNP, BNP Atrial FibrillationTroponin Valvular Heart diseaseLVEF (echo, MRI) Coronary artery disease (CAD)BP medication CVA or TIAOther medication

24 Risk Variable -Hypertension

25 EARLY HEART FAILURE Inclusion/ Exclusion > 65 years Diabetes High blood pressure /on treatment Overweight Family history of heart failure Past history of chemotherapy Past history of heart disease < 65 years > Moderate valve disease History of heart failure Already on BB and ACEi Contraindications to BB or ACEi Oncologic life expectancy <12 month Inability to acquire adequate images Inclusion Exclusion

26 1.Why - The epidemiology of heart failure 2.Detection - is HF screening an option? a.Right population b.Right test c.Rx strategy d.Measuring outcomes e.Quantifying risk, FP and FN results 3.Proof of Principle – TasELF study 4.Lessons about community-based RCTs EARLY HEART FAILURE Rural HF project

27 myocyte preproBNP (134 aa) proBNP (108 aa)signal peptide (26 aa) secretion NT-proBNP (1-76)BNP (77-108) EARLY HEART FAILURE BNP release from Cardiac Myocytes

28 EARLY HEART FAILURE BNP to ER presentation with dyspnea Maisel A. J Am Coll Cardiol 2001 N=139N=14N=97

29 EARLY HEART FAILURE Preclinical disease and BNP n=101 apparently normal diabetic subjects (asymptomatic, normal EF) BNP in LVH pts was higher than those without LVH But only 4 had elevated BNP (using age and gender-specific normal ranges) - only 1 had low velocity/strain BNP is not a good marker of subclinical disease (no substitute for the echo lab!) Fang ZY. Am Heart J 2005 p<0.05 NT-proBNP (pg/ml) Taylor A. Am Heart J 2006

30 EARLY HEART FAILURE Echo is essential in HF diagnosis Siemens SC2000 Philips ie33 GE Vivid e9

31 EARLY HEART FAILURE Progressive miniaturization

32 LA volume 32ml/m 2 EARLY HEART FAILURE Early HF – Standard tests normal

33 EARLY HEART FAILURE Measurement of strain

34 1.3 S S -1 EARLY HEART FAILURE Strain and sick heart muscle

35 EARLY HEART FAILURE Other diagnostic markers? Central Blood Pressure ECG 6 Minute-walk Test (6MW) Assessment of Activity and quality of life –Minnesota MLHFQ score –Charlson comorbidity index –Duke Activity Status Index (DASI) –EQ5D –SOF frailty score

36 1.Why - The epidemiology of heart failure 2.Detection - is HF screening an option? a.Right population b.Right test c.Rx strategy d.Measuring outcomes e.Quantifying risk, FP and FN results 3.Proof of Principle – TasELF study EARLY HEART FAILURE Rural HF project

37 Stage B Heart failure cardio-protective Treatment (SOLVD trial) SOLVD – Prevention Trial Study of Left Ventricular Dysfunction percentage of event, defined as death or hospitalization for congestive Heart Failure, occurring in the placebo and Enalapril (ACEi) Groups

38 Cardio-protective Treatment of Stage B Heart failure (SAVE trial) SAVE Trial - Captopril Study of Survival and Ventricular Enlargement Trial

39 1.Why - The epidemiology of heart failure 2.Detection - is HF screening an option? a.Right population b.Right test c.Rx strategy d.Measuring outcomes e.Quantifying risk, FP and FN results 3.Proof of Principle – TasELF study EARLY HEART FAILURE Rural HF project

40 EARLY HEART FAILURE Stage B HF - Progression to overt HF Natural history of SBHF – Olmsted County study (n=1760) – LV dysfunction in T2DM – 25% HF in 2 years, 36.9% in 5 years, twice the rate of HF in patients without LV dysfunction Aaron M. From et al. The development of Heart Failure in Patients with Diabetes Mellitus and Preclinical Diastolic Dysfunction: A Population Based Study. JACC ; 55(4)

41 EARLY HEART FAILURE TASELF Process Measures (n)

42 1.Why - The epidemiology of heart failure 2.Detection - is HF screening an option? a.Right population b.Right test c.Rx strategy d.Measuring outcomes e.Quantifying risk, FP and FN results 3.Proof of Principle – TasELF study EARLY HEART FAILURE Rural HF project

43 “55113 – Cardiac M-mode and 2 dimensional real time echocardiographic examination of the heart … for the investigation of symptoms or signs of cardiac failure, or suspected or known ventricular hypertrophy or dysfunction, or chest pain” DHHS THOs Tasmania Medicare Local Medicare EARLY HEART FAILURE Changes needed

44 EARLY HEART FAILURE Research Questions 1. What is the prevalence of Stage B Heart Failure (LVSD & LVDD) in at risk population in Tasmanian community 2. How does functional capacity (6MW test) correlates with echo systolic and diastolic parameters 3. How does central blood pressure associate with diastolic dysfunction and LV mass 4. What is a better echo marker LVEF, GLS and diastology in stage B heart failure. 5. How does screening and early treatment affect quality of life? 6. Is community screening cost effective? 7. What are the main constrains of a community screening model? Main constrains of treatment delivery.

45 TASELF - Study design Title Tasmanian Study of Echocardiographic detection of Left ventricular dysfunction Trial acronymTAS-ELF (H ) Trial IDACTRN Study TypeInterventional (Prospective Randomized Open Blinded Endpoint-Probe) AllocationRandomized Controlled (Adaptive) Sample size 400 x 400 (  =0.044, β=0.8; 7.8% annual loss); 25% versus 12.5% in 2 yrs Random seq. Masking/blind Enrollment followed by randomization (central web-based program). Masked: those involved in recruiting, randomization, analyzing data. ParticipantsEligibility: (>65 year, Stage A[ACC/AHA guideline]); Exclusion: BB + ACEi Recruitment18 months. Self-referred (by advertising and recommendation by GP) Follow UpPhone tracking on 1 st, 6 th,12 th,18 th,24 th month. Repeat assessment: 24 th month. Primary Secondary New onset of heart failure; 6 minutes walk test distance

46 TASELF Planned sites Hobart Huonville Oatlands Geeveston Longford Deloraine Launceston Smithton Ulverstone George Town Devonport New Norfolk Sorrell Kingston Scottdale Queenstown St Helen’s

47 EARLY HEART FAILURE How we will screen for HF

48 EARLY HEART FAILURE Planned protocol Apparently healthy subject with HF risk Exclusion of known HF, co-morbidities, CAD Subclinical LVD – start ACEi and BB (n=120) Normal LV 2 year follow-up for HF and functional capacity Clinically suitable for randomization Clinical questionnaires Usual care Exclusion of reduced EF (<40%), valve disease, CAD BNP in borderline Baseline echo Randomize 1:1 (n=800) Echo strain, diastology HF 25% HF 10% HF 5% Aim to study 800 subjects in the 1st year (400 subjects with HF screening and therapy vs 400 controls) ~16 studies per week (ie 2 trips/week)

49 Venn diagram TASELF risk profile HYT Missing T2DM – Chemo : 3 Chemo- T2DM- Obe: 3 T2D M Obe se Chemo DM31% Obese49% HTN87% Chemo10% FHx Ht37% Past Ht dis12% Total (n=220)

50 TASELF Registry – updated May 2014

51 At June 2010, there were 79,100 people aged 65 years and over in Tasmania % of the population The prevalence of people in this age group with diabetes (T2DM), obesity, high blood pressure, past cancer therapy or known cardiac disease is about 50% - roughly 40,000 people (100 times the number in the study) An effective program on a state-wide basis would avoid/delay heart failure in 2,400 people. EARLY HEART FAILURE The Big Picture

52 StakeholderImpact of project on stakeholders Prof Marwick and Ms YangSupport of their research activities Menzies Research Institute Tasmania Leadership of a community-based initiative that aligns with the mission of the Institute Rural GPsAccess to diagnostic testing that may help identify and avoid patients developing a potential problem with heart failure Rural communitiesAccess to a service that will reduce the risk of serious illness and hospital admission far away from their family/social support Consultants/hospitalsReduction of urgent heart failure admissions Wider communityIf successful, the proposed strategy will be of value in all practices and not restricted to the rural community EARLY HEART FAILURE Stakeholders

53 ItemAmountSource Contribution to Echo equipment$150,000Tas Community Fund Contribution to Echo equipment$105,000Siemens Sonographer PhD scholarship$75,000National Heart Foundation Supervision – Principal investigator, cardiologists, GPs $50,000+Menzies, THO-S, practices Support of travel, research assistants$50,000 $40,000 Diabetes Australia vTAHSP Total~$500k EARLY HEART FAILURE Support

54 Thank you

55 1.Why - The epidemiology of heart failure 2.Detection - is HF screening an option? a.Right population b.Right test c.Rx strategy d.Measuring outcomes e.Quantifying risk, FP and FN results 3.Proof of Principle – TasELF study 4.Lessons about community-based RCTs EARLY HEART FAILURE Rural HF project

56 EARLY HEART FAILURE Time frame TasksResponsible personStart dateDue dateMilestones Communication with GPs, advertising to communities Prof Tom Marwick, Dr Michael Lees 1st July th June 2014Recruitment of ~10 communities Ethics applicationProf Tom Marwick1st July th July 2014Approval Screening and imaging in communities Ms Hilda Yang, other members of Prof Tom Marwick’s team 1st July th June 2014Screening of 800 subjects in 12 months Treatment of patients with undiagnosed disease Dr Michael Lees, GPs in other communities, supported by Dr Jeff Evans, Prof Marwick, RHH and LGH cardiologists 1st July th July 2016Appropriate management of identified patients Follow-up at 12, 24, 36 months Ms Hilda Yang, other members of Prof Tom Marwick’s team 1st July th June 2016Follow-up of screened subjects Data analysisProf Tom Marwick, Hilda Yang 1st July th July 2016Complete analysis Dissemination of resultsProf Tom Marwick, Hilda Yang 30th July 2016December 2016Submission to Australian and international symposia and publication Translation of science to practice Prof Tom Marwick30th July 2016December 2016Implementation of screening programme Statewide

57 RiskLikelihoodSeriousnessMitigation plan Failure to recruit practices in other towns LowSeriousContacts already being made Failure to recruit appropriate patients LowSeriousDirect approaches to communities Loss of patients to follow-upLowSeriousDirect approaches to communities Less then expected incidence of eligible pts fitting screening criteria LowModerateIncrease recruitment Less incidence of early stage HF than expected Low Very unlikely - that would be an excellent outcome! Lower success than anticipated in reducing % that develop late stage HF Low None – this would be a negative study. The community still have the benefit of vascular screening. Lack of buy-in from Government Agencies to implement programme Moderate if the effect is less than anticipated SeriousInvolvement of the Heart Foundation and Diabetes Australia to help make our case with government. HEART FAILURE IN RURAL COMMUNITIES Risk evaluation

58 1,760 diabetic pts with assessment of cardiac function; 411 (23%) abnormal Every 1-U increase in E/e' ratio a/w increase of HF hazard ratio of 3% Diastolic dysfunction a/w HF after adjustment for age, sex, BMI, HT, CAD and echo parameters (HR: 1.61; p = 0.003). From AM et al. J Am Coll Cardiol 2010 EARLY HEART FAILURE Implications of Early HF


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