How (and Why) To Establish a Heart Failure Management Program Michael M. Givertz, M.D. Medical Director, Heart Transplant and Circulatory Assist Brigham and Women‟s Hospital Associate Professor of Medicine Harvard Medical School Boston MA, USA Heart Failure: Major Public Health Problem • Prevalence is high – 2% overall, up to 10% age 65 and older1 – HF with preserved EF more common in elderly2 • Morbidity: >1 million hospital discharges/year – length of stay 5 days (USA), 8-12 days (KSA) • Mortality: up to 50% at 5 years – 4-5% in-hospital mortality (USA and KSA) – as high as 33% at 1 year post-discharge 1AHA Heart Disease and Stroke Statistics 2011 2El Shaer et al., Cong Heart Fail 2009:15:117 HEARTS: Heart Function Assessment Registry Trial in Saudi Arabia Acute HF (N=722) High-risk chronic HF (N=368) Age 61 57 CAD 50% 42% Diabetes 61% 53% CKD 31% 28% Mod-sev LVD 73% 75% ICD 10% 29% Al Habib et al., Eur J Heart Fail 2011;13:1178 Causes of Hospital Readmission for HF Med Noncompliance 24% 16% Inappropriate Rx Diet Noncompliance 24% 19% Failure to Seek Care 17% Other: HTN, AF, infection, ETOH HF Treatment: Current Limitations • Underutilization of standard therapy – ACEIs not used in ~25% of eligible patients – Beta-blockers, aldosterone antagonists and ICDs • Overutilization of inappropriate therapy – Calcium channel blockers, antiarrhythmics – NSAIDs, thiazolidinediones, pregabalin • Inadequate patient and family education Goals of Heart Failure Therapy • Standard Care – slow disease progression – reduce morbidity and mortality – improve quality of life • Heart Failure Disease Management – address diverse needs of patient and family – improve outcomes while controlling costs Principles of HF Disease Management • Early evaluation, aggressive intervention • Close surveillance • Nurse case management – specialized HF nurse – guidelines, algorithms, critical pathways – letter, telephone, computer, clinic visit • Home health services Principles of HF Disease Management • Patient and family education – self-empowerment – “action plan” • • • • • Nutrition and drug/alcohol counseling Exercise training and risk factor modification Transportation and pharmacy Referral to advanced heart disease center End-of-life care Heart Failure Program Design Physician Director Cardiac Rehabilitation Heart Failure Nurse Cardiac Rehabilitation Home Care Home Care Inpatients Outpatients Nutrition Nutrition Social Work Primary Care Providers Social Work Keys = communication, transfer of information, documentation Proactive Telephone Call: “How are you doing?” • • • • • Assess daily weights and symptoms Assess medication and dietary compliance Review laboratories and adjust diuretics, K+ Triage urgent patients to clinic or ER Troubleshoot other medical (e.g., fever) and non-medical (e.g., psychosocial) issues • Confirm follow-up visits and tests Does HF Disease Management Work? Early Data • 10 Observational studies (1983-1993) • Patients as own controls (before-after) or historical controls • Consistent findings: – – – – – improved symptoms and functional class reduced hospitalizations (14% to 87%) and LOS improved therapy (ACEI and beta-blocker) improved patient and MD satisfaction enhanced knowledge and compliance Rich J Card Failure 1999;5:64 Does HF Disease Management Really Work? • 9 Randomized controlled trials (1993-99) – sample size: 98 to 363 – duration: 1 week to 12 months • Reduced hospitalizations (RR 0.77) – decreased LOS or total hospital days – reduced readmissions • Cost savings • No change in mortality (RR 0.94) McAlister et al., Am J Med 2001:110:378 HF Disease Management Improves Medical Therapy Before Captopril 95 mg Furosemide 48 mg Isosorbide dinatrate 39% Amiodarone 12% Type 1A 18% After 183 mg 90 mg 76% 39% 1% Calcium blocker 3% 28% Fonarow et al., JACC 1997;30:725 HF Disease Management Improves Medical Therapy Percent of Patients 100 80 * Pre 60 Post 40 * 20 0 Beta-Blocker Target Dose Whellan et al., Arch Intern Med 2001;161:2223 Peak VO2 (ml/kg/min) HF Disease Management Improves Functional Capacity * 16 14 12 10 8 6 4 2 0 Before After Fonarow et al., JACC 1997;30:725 Trends in Length of Stay and HF Readmission Rates 8.8 days 6.3 days Length of Stay 17.2% 20.1% 30-Day Readmission Rate Bueno H, et al. JAMA 2010; 303: 2141-2147 Comprehensive Discharge Instructions Six Aspects of Care • • • • • • Diet Medications (adherence and uptitration) Activity level Follow-up appointments Daily weights What to do if HF worsens? Discharge Education Improves Outcomes Education Control Koelling et al., Circulation 2005;111:179 Is a More Focused Strategy Equally Effective? • Telemonitoring now in widespread use • Electronic transmission of patient data to the health care team – Potential for an automated, centralized approach – Meta-analysis (11 trials, N=2710) • 34%  all-cause mortality (p<0.0001) • 24%  all-cause rehospitalization (p=0.008) • individual studies small, variable methodologic quality Tele-HF: Telemonitoring to Improve Heart Failure Outcomes • Hypothesis: – Compared to usual care, telemonitoring would reduce all-cause readmission and death within 180 days • Inclusion: – Hospitalization for HF within 30 days • Exclusion: – Long term nursing home resident – Unable to stand on scale, no telephone • Design: – Randomized trial Chaudhry et al., N Engl J Med 2010;363: 2301 Tele-HF: Telemonitoring Strategy • Daily toll-free calls to Interactive Voice Response System for 6 months • Questions about general health, heart failure symptoms, body weight • Predetermined responses triggered „variances‟ to flag clinicians attention Tele-HF: Clinical Intervention • 33 motivated cardiology practices selected for enthusiasm and organizational capability • Nurses at each site instructed to review telemonitoring data every business day • Required to contact subjects whose data suggested worsening clinical status • Automated patient reminders Adherence to Telemonitoring • 86% made at least 1 call • Adherence (≥ 3 calls/week) highest at beginning of study – Week 1: 90% adherent – Week 26: 55% adherent • Median 21 variances generated per patient Tele-HF: Results All-cause Readmission or Death Telemonitoring Usual Care (N=826) (N=827) Primary Endpoint 52 52 P-value 0.75 Secondary Endpoints All Cause Readmission 49 47 0.45 Death 11 11 0.88 HF readmission 28 27 0.81 Tele-HF: Conclusions • Among patients recently hospitalized for heart failure, a strategy of automated telemonitoring did not improve clinical outcomes TIM-HF: Telemedicine to Improve Mortality in Heart Failure • Inclusion: – NYHA class II-III, LVEF ≤ 35% – HF decompensation in prior 24 months – Optimally treated (i.e. ACEI/ARB, β-blocker, diuretic) • Exclusion: – Hospitalization for worsening HF within 7 days – Planned CRT implantation • Adherence: – ≥70% of possible daily transfers and no “break” > 30 days – achieved by 287 (81%) of 354 patients in RTM group Koehler et al., Circulation 2011;123:1873 Remote Telemedical Management: All-Cause Mortality Koehler et al., Circulation 2011;123:1873 Why was Telemonitoring Ineffective? • Weights and symptoms may not provide adequate warning • System may have been underutilized • Response to variances may not have been timely enough • Low control-group mortality rates, high utilization of evidence-based therapies in both arms • Telemonitoring represents a single, focused, nonpersonal approach to disease management • Other approaches may be more effective “Keep it Simple” Physician Director Cardiac Rehabilitation Heart Failure Nurse Cardiac Rehabilitation Home Care Home Care Inpatients Outpatients Nutrition Nutrition Social Work Primary Care Providers Social Work Keys = communication, transfer of information, documentation Additional Tools • Written pamphlets (e.g., www.hfsa.org) • Low-sodium cookbooks • Patient-education sessions and support groups Benefits of Disease Management in Patients with Heart Failure • • • • • Better patient outcomes Improved patient and physician satisfaction Added value to medical partners Cost savings Center of excellence Thank you for your attention