Reducing I will NOT discuss off label/ investigational use of - PDF document

12/1/17 Financial Relationship Disclosure Reducing Readmissions in Heart Failure Reducing I will NOT discuss off label/ investigational use of products. Liviu Klein MD, MS Readmissions Associate Professor The following financial relationships exist: Director, Mechanical Consultant: Abbott, Boston Scientific, Medtronic. Circulatory Support and in Heart Failure Heart Failure Device Programs Liviu.Klein@ucsf.edu 2 Heart Failure Hospitalizations High Post Discharge Mortality Solomon SD et al. Circulation. 2007; 116: 1482-1487. Benjamin EJ et al. Circulation. 2017; 135: e146-e603. 3 4 1

12/1/17 Heart Failure ReHospitalizations Heart Failure ReHospitalizations Dharmarajan K et al. JAMA. 2013; 309: 355-363. Dharmarajan K et al. JAMA. 2013; 309: 355-363. 6 Heart Failure Costs CMS Heart Failure Readmission Reduction Program : A Success! Physicians professional fees ($3 billion) 10% Drugs/ Medical Durables Hospital stay ($4 billion) 12% ($21 billion) 68% 23.5% 21.4% Home Health ($3 billion) 10% Total Costs = $31 billion in 2012 -> $70 billion in 2030 Benjamin EJ et al. Circulation. 2017; 135: e146-e603. Dharmarajan K et al. JAMA. 2017; 318: 270-278. 7 8 2

12/1/17 CMS Heart Failure Readmission CMS HFRRP and the Standard Reduction Program : A Success? of Care for Heart Failure in 2017 30-day risk adjusted readmissions: 20.0% -> 18.4% -1.6 30-day risk adjusted mortality: 7.2% -> 8.6% +1.4 1 year risk adjusted readmissions: 57.2% -> 56.3% -0.9 1 year risk adjusted mortality: 31.3% -> 36.3% +5.0 Gupta A et al. JAMA Cardiol. 2017; in print. 9 Weights and Heart Failure Weights and Non Heart Failure Hospitalizations Hospitalizations Chaudhry SI et al. Circulation. 2007; 116: 1549-1554. Chaudhry SI et al. Circulation. 2007; 116: 1549-1554. 11 12 3

12/1/17 Weights and Heart Failure Telemonitoring and Heart Hospitalizations: WISH Trial Failure Hospitalizations Lynga P et al. Eur J Heart Fail. 2012; 14: 438-444. Pandor A et al. Heart. 2013;99:1717-1726. 13 14 Telemonitoring and Heart Failure Telemonitoring and Heart Failure Hospitalizations: BEAT HF Hospitalizations: BEAT HF Ong MK et al. JAMA Intern Med. 2016;176:310-318. Ong MK et al. JAMA Intern Med. 2016;176:310-318. 4

12/1/17 Telemonitoring and Main Reasons for Broken Care Readmissions Patient Symptoms worsen Doesn’t recognize early signs and symptoms Readmission Limited time Limited staff MD Office Limited diagnostics Limited monitoring Limited intervention Limited patient education Hospitalization Symptoms Pressure on length ED worsen of stay shortens time to test new Only alternative medication regimen ED MD with no patient relationship or educate Safest route medically and legally Heart Failure Signs/ Symptoms Congestion Precedes Most Heart Failure Hospitalizations in Hospitalized Patients Admission Discharge Symptoms (%) Dyspnea on exertion 79 58 Dyspnea at rest 42 5 Orthopnea 50 12 PND 33 4 Fatigue 53 57 Signs (%) JVP > 8 cm 33 6 Rales 57 13 S3 gallop 20 6 Edema > 2+ 50 13 Zile MR et al. Circulation. 2008; 118: 1433-1441. Gattis WA et al. J Am Coll Cardiol. 2004; 43: 1534-1540. 20 5

12/1/17 Congestion Precedes Most Heart Ability to Predict High PWP Failure Hospitalizations Sens. Spec. PPV NPV Dyspnea on exertion 66 52 45 27 Orthopnea 66 47 61 37 Edema 46 73 79 46 JVD 70 79 85 62 S3 73 42 66 44 CXR Cardiomegaly 97 10 61 --- Redistribution 60 68 75 52 Interstitial edema 60 73 78 53 Pleural effusion 43 79 76 47 Adapted from Chakko S. et al. Am J Med. 1991; 90: 353-358. Zile MR et al. Circulation. 2008; 118: 1433-1441. Adapted from Butman SM. Et al. J Am Coll Cardiol. 1993; 22: 968-975. 21 The Congestion Iceberg in Heart Failure HF Diagnostics in a Device Systemic congestion Package (Leg edema; JVD; Hepatomegaly) S ­ RV + RA Pressure Y Abnormal lung mechanics Dyspnea Respiratory muscle ­ PA Pressure M dysfunction Other factors P Alveolar edema ­ Hydrostatic pressure ­ Oncotic pressure T ­ Permeability Redistribution in pulmonary vascular Lymphatic drainage capacity bed + interstitial edema O Alveolar-capillary membrane integrity Hemodynamic congestion (Increased PWP) M Neurohormonal activation => ­ Blood volume S ­ LV diastolic pressure Abnormal LV function (Sys and/or Dia) Cowie MR et al. Eur Heart J. 2013;34:2472-2480. 6

12/1/17 HF Diagnostics in a Package Proof is the Pudding (REM HF)... Cowie MR et al. Eur Heart J. 2013;34:2472-2480. Cowie MR et al. ESC Congress 2016 A New Logic? HeartLogic TM A New Logic? HeartLogic TM MULTISENSE Boehmer JP et al. AHA Scientific Sessions 2016 Boehmer JP et al. AHA Scientific Sessions 2016 7

12/1/17 Hemodynamic vs. Clinical Issues with CIED in HF Patients Congestion in Heart Failure • Current devices are used for arrhythmia treatment • HF Diagnostics are indirect physiological assessment and a byproduct of CIED • Only 20-25% of heart failure patients qualify for an implantable device • 5-10% complication rate for the implant procedures • Costly ~ $ 30,000 per device Heart Rate Variability • Newer implantable devices target diagnostics Resting heart rate Activity level – Cost ? Respiration rate Intrathoracic fluid – Complications? Adapted from Adamson P. Curr Heart Fail Rep. 2009;6:287-292. CardioMEMS™ HF System Hemodynamics and Outcomes PA Sensor and Delivery System 4.5 cm 120 cm Patient Electronics PA Pressure Database System Physician Access Via Secure Website Zile MR et al. Circ Heart Fail. 2017;10:e3594-e3604. 8

12/1/17 CHAMPION Trial – Long Term CHAMPION Trial – Readmissions Abraham WT et al. Lancet. 2016;387:453-461. Adamson PB et al. Circ Heart Fail. 2016;9:e2600-e2610. 9

12/1/17 Success of a CHAMPION: CardioMeMS Hospitalizations: Treatment Algorithm Real World Experience Desai AS et al. J Am Coll Cardiol. 2016;69:2357-2365. Costanzo MR et al. J Am Coll Cardiol HF. 2016;4:333-344. Reasons for Medication CHAMPION Trial: Medications Changes in CHAMPION Trial Changes 3000 2517 2500 during Primary Endpoint Period Number of medication changes 2000 ~1 per patient month 1404 1500 1113 1061 1061 1000 500 0 NA 0 Based on Total Total Based on signs Pressure-based Non-pressure knowledge & symptoms based Abraham WT et al. Lancet. 2016;387:453-461. of PA pressures Costanzo MR et al. J Am Coll Cardiol HF. 2016;4:333-344. 10

12/1/17 CHAMPION Trial: Diuretic CHAMPION Trial: Vasodilator Changes by PA Pressures Changes by PA Pressures Costanzo MR et al. J Am Coll Cardiol HF. 2016;4:333-344. Costanzo MR et al. J Am Coll Cardiol HF. 2016;4:333-344. HFrEF Mortality Benefit with HFrEF: Best Neurohormonal and Hemodynamic Management Hemodynamic Management Givertz MM et al. J Am Coll Cardiol. 2017;70:1875-1886. Givertz MM et al. J Am Coll Cardiol. 2017;70:1875-1886. 11

12/1/17 HFrEF: Best Neurohormonal and CHAMPION Trial: Symptoms vs. Hemodynamic Management PAP Management Givertz MM et al. J Am Coll Cardiol. 2017;70:1875-1886. Goldberg LR et al. HRS 2015 Management Goals During Identifying Triggers for Hospitalization Hospitalization • Improve symptoms – ↓ filling pressures, ↓ volume, ? ↑ CO without further myocardial, renal and liver damage • Identify triggering events – Ischemia, hypertensive emergency, arrhythmias (AF), worsening CKD, infections, compliance • Change substrate (heart, kidney) • Initiate life saving therapies • Address the “vulnerable phase” • Palliative care/ hospice where appropriate Fonorow GC et al. Arch Intern Med. 2008; 168: 847-854. 12

12/1/17 Diuresis: How Far to Go – Assessing Readiness for Discharge Check CVP! • Symptoms significantly improved – Assess exertional dyspnea! • Test exercise capacity – 6MWD > 1000 feet • Volume management achieved – Stable on oral diuretics (euvolemic) > 24 hrs. • Education achieved – Teach back techniques! • Guideline directed medical therapy implement – ACE-I/ ARB; BB; MRB; Diuretics • Post discharge follow-up within a week – PCP/ Cardiologist, Home Health Thalhammer C et al. J Am Coll Cardiol. 2007; 50: 1584-1589. Mortality After Hospitalization Readmission After Hospitalization Harikrishnan S et al. Eur J Heart Fail. 2015; 17: 794-800. Harikrishnan S et al. Am Heart J. 2017; 189: 193-199. 13