Disclosures. Preventing Heart Failure Re-admissions in Deaths Due to Cardiovascular Disease (United States: ) Heart Failure

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29 th Annual Cardiology for Clinicians Spring Symposium Workshop #3 Alumni Hallway, Northeastern Conference Room, 1-9525 Thursday, May 5, 2016 Preventing Heart Failure Re-admissions in 2016 Leway Chen, MD, MPH, FACC, FACP, FAHA, FHSFA Director, Program in Heart Failure and Transplantation Associate Professor of Medicine Division of Cardiology Strong Memorial Hospital - University of Rochester Medical Center Disclosures I will discuss investigational agents/devices Consultant- Thoratec Site PI for Thoratec studies: ROADMAP and RESIST (completed) Site PI for Thoratec HeartMate 3 (MOMENTUM 3) study (in process) Site PI for Novartis RELAX-AHF2 study (in process) Leway_Chen@URMC.Rochester.edu Heart Failure/Transplant/MCS Office: 585-273-3760 Mobile: 585-747-3303 3 4 Heart Failure Deaths Due to Cardiovascular Disease (United States: 1900-2010) The situation when the heart is incapable of maintaining a cardiac output adequate to accommodate metabolic requirements and the venous return." E. Braunwald 5 6 1

Why is this topic important? Currently $38 billion annually 43% of Medicare spending; 14% of Medicare beneficiaries 25% of patients hospitalized for HF will be readmitted within 30 days of discharge #1 reason for readmission in Medicare FFS patient population is HF https://www.healthcatalyst.com/reduce-heart-failure-readmissions-with-healthcare-analytics/ 7 8 Cost of HF Circ Heart Failure, Online 04/24/2013 9 10 11 12 2

But, does reducing HF readmissions REALLY result in better outcomes? LOS? 30-day mortality? 13 14 Lower HF Hospitalization Rate Higher 1-year Mortality Rate Balance 30-Day Readmission Patient Satisfaction Rates Emergency Department (ED) visits Observation Stays Length of Stays Mortality Chen J, et al, JAMA 2011 16 Hospitals: JCAHO HF Performance Improvement Measures HF-1: Discharge Instructions (Activity, Diet, Follow-up, Medications, Symptoms Worsening, Weight Monitoring) HF-2: Assessment of Left Ventricular Systolic Function (Before, during, or planned for after discharge) HF-3: LVEF < 40% Prescribed ACEI* (or ARB) at Discharge HF-4: Smoking Cessation Advice/Counseling *Originally ACEI only; ARB later added as option 17 18 3

SMH Heart Failure Compliance with Indicators 2Q 2005 to 4Q 2010 100% 90% 80% 70% 60% 50% 40% 30% HF-1: D/C Instructions HF-2: LVSF Assessment HF-3: ACE/ARB for LSVD HF-4: Smoking Cessation 20% 10% 0% 2Q05 4Q05 2Q06 4Q06 2Q07 4Q07 2Q08 4Q08 2Q09 4Q09 19 http://www.hospitalcompare.hhs.gov/hospital/search/comparehospitals.asp: Accessed 2010-06-21 20 Mortality Comparison Rate of Unplanned Readmissions for Heart Failure Patients http://www.hospitalcompare.hhs.gov/hospital/search/comparehospitals.asp: Accessed 2010-06-21 21 22 Death Rate for Heart Failure Patients New Inpatient Core Measure Requirements January 2014 LVEF Assessment Lowest EF documented in chart on patient is the EF that triggers the EF <40% ACE Inhibitor/ARB for LVEF <40% Beta Blocker for LVEF <40% Must be bisoprolol, carvedilol or metoprolol succinate Reasons acceptable for exclusion: Allergy or Heart Block or provider clearly links deleterious effect Inpatients Excluded from reporting sample: comfort measures only is clearly documented, Hospice, In Clinical Trial, pt left AMA or pt was transferred to another hospital 23 4

New Inpatient Core Measure Requirements January 2014 New Inpatient Core Measure Requirements January 2014 Post DC Appointment made for Heart Failure Patients DC to home (not skilled facility) Appointment must be within 7 days 7 Calendar Days and Day 1 is the day after DC Appointment has to have location, date and time on DC paperwork Inpatient Exclusions: Patient refusal or patient was only visiting from long distance and not returning to area Care Record Transmitted Within 7 days of Discharge and must contain ALL these data points: Reason for hospitalization (CC) Procedures Performed during stay Treatment received/services DC Meds: dose and clear indication for all meds (what is the purpose of use in this patient) Follow-up plan and services needed at time of discharge Only if discharged to home Care Record must be clearly transmitted to the key providers who are going to provide HF care in followup Hospital must define which documents are included in Care Transmission ***Must be a yes to each of these in order to get credit for this Core Measure Advance Directives/Advanced care Planning: DISCUSSION One time discussion with Provider or Social Worker If DNR order or Advanced Directive placed or filed in chart, then automatically get credit for this core measure. Advance Directive Executed: Need Legal Document Uncommon to have 100% here. Would need to have discussion and then something like a MOLST is complete as result of the above documented Advance Directive discussion Post DC Evaluation Must occur within 72 hours of discharge Can occur via: email, telephone, home health nursing visit, clinic visit This INCLUDES patients even if they sign out AMA Strongly Recommended Outpatient Measure Requirements January 2014 Outpatient Beta Blocker Therapy for LVSD Outpatient ACE/ARB for LVSD Outpatient Aldosterone Receptor Antagonist for LVSD NYHA Assessment Outpatient Activity Recommendations: Description: Outpatients who have received a document describing individualized activity recommendations including type of activity, duration and intensity, tailored to their needs. This document must be present in the outpatient record. Outpatient Discussion of Advance Directives/Advance Care Planning: Description: Outpatients who have documentation in the medical record of a one-time discussion of advance directives/advance care planning with a healthcare provider. Outpatient Advanced Directives Executed 28 Sacubitril Valsartan: July 7, 2015 PARADIGM-HF: presented at European Society of Cardiology Meeting August 30, 2014 Dec 2009 March 2014, 1043 centers 47 countries 8442 Patients EF <40, class II-IV LCZ696 200mg BID (Sacubitril + Valsartan 160mg BID) or enalapril 10mg BID Primary endpoint: Combined CV mortality and hospitalization for HF Secondary endpoint: Overall mortality, Kansas City Cardiomyopathy Questionnaire EARLY TERMINATION: At 27 months, when the primary outcome had occurred in 914 (21.8%) in the LCZ696 group and 1117 (26.5%) in the enalapril group. NNT 21 N Engl J Med Volume 371(11):993-1004 September 11, 2014 N Engl J Med Volume 371(11):993-1004 September 11, 2014 5

Numbers of Patients with Heart Failure Who Would Need to Be Treated to Reduce Any-Cause Mortality in Seven Clinical Trials. Jessup M. N Engl J Med 2014;371:1062-1064. 32 Ivabradine: April 15, 2015 SHIFT study Systolic Heart failure treatment with the I f inhibitor ivabradine Trial Swedberg K, Lancet. 2010; 376(9744):875-885. February 2012 European Medicine Agency granted indication of ivabradine in chronic heart failure (NYHA Class II-IV, SR, Heart rate 75 bpm) May 2012 ESC guidelines for the diagnosis and management of heart failure included ivabradine in the algorithm for the treatment of chronic heart failure (NYHA Class II-IV, SR, heart rate 70 bpm) http://www.shift-study.com/shift/shift-study/overvieaw-of-shift/ 33 34 35 36 6

CHAMPION Clinical Trial: PA Pressure-guided Therapy Reduces HF Hospitalizations Patients managed with PA pressure data had significantly fewer HF hospitalizations as compared to the control group. Abraham WT, et al. Lancet, 2011. 37 Lancet; February 19, 2011. 377:658-665 38 CardioMEMS HF System PA Pressure Sensor on Catheter Delivery System 4.5cm 120cm Hospital and Patient Home Electronics Unit PA Pressure Database Physician Access Via Secure Website 40 A Life of Heart Failure Important Outpatient Considerations? What do I recommend? Treat the WHOLE patient. Address co-morbidities HF patients often have many other important medical conditions Address: Etiology Class/Stage Optimize medications Identify precipitating factors Identify co-morbidities that worsen/amplify Involve an Interdisciplinary Team in the outpatient setting Involve family/friends Goodlin S. JACC 2009;54:386-96. 41 42 7

HF Continuity of Care: My Ideal Education and Prevention Keep HF from occurring Tackle obesity, inactivity, etc. Optimal Outpatient Management Guideline recommendations ARE reasonable Target research proven doses Cardiac resynchronization therapies Disease management programs Telemonitoring? Noninvasive Invasive Timely referral to Advanced HF Program HF Continuity of Care: My Ideal Hospital Quality Targets: HF QI, 30-day hospitalization, 30-day mortality Care does NOT end at discharge Safe Transitions Multidisciplinary team approach Discharge planning Access to medications Home health agencies Insurer disease management programs Adequate follow up Proper utilization of rehabilitation and SNF Proper utilization of Palliative Care and Hospice 43 44 What have we done at SMH? HF Quality Indicators as mandated by CMS Monitor data HF patients labeled high risk extra attention Discharge appointments made AT TIME OF DISCHARGE Medicine reconciliation AVS and discharge summary at time of discharge Contact PCP and/or referring doctors Next? Goals are to decrease costs and improve outcomes Changing health care landscape Accountable Care Organizations Patient Centered Medical Home CMS Demonstration Projects HF Bundled Payment (90 day Highland and URMC) Outpatient Heart Failure Management may benefit Rationale implementation of evidence-based care Phone call to patient the next day Goal: patient seen within 3 days (by a provider) Rapid Heart Failure Clinic (option available) 45 46 47 48 8