Disclosures. Objectives 3/27/2017. Beki Angerstein ACNP DNP FAHA CHFN Director Advanced Practice Summa Health System

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1 Beki Angerstein ACNP DNP FAHA CHFN Director Advanced Practice Summa Health System Disclosures Previously employed by Abbott in past 12 months Objectives Review implantable device diagnostic data for risk stratification and preventing readmission. Evaluate advances in hemodynamic monitoring and its role for improving outcomes in heart failure patients 1

2 Definitions Telehealth: the use of telecommunications and virtual technology Telehealth to deliver health alone care outside is not a of traditional health-care successful facilities; includes intervention; non-clinical services Telemedicine: it is the seeks nurse s to improve intervention a patient's that health by permitting will two-way, make real the time difference interactive communication between the patient, and the physician or practitioner at the distant site. Telemonitoring: a patient management approach combining various information technologies for monitoring patients at distance Medicaid.gov J Am Med Inform Assoc May-Jun; 14(3): WHO 2017 Goal of heart failure management: slow disease progression by preventing decompensation Each Event Accelerates Downward Spiral of Myocardial Function With each subsequent HF-related admission, the patient leaves the hospital with a further decrease in cardiac function. THE GOAL: Maintain fluid volume to avoid acute decompensation and hospitalization, using proven drug and device therapies. Graph adapted from: Gheorghiade MD, et al. Am J. Cardiol

3 Psychologic Recent Admission Comorbidities Followup Social Issues Health Literacy Adherence Labs Biomarkers 7 Current HF Management: how well do current tools KEEP PATIENTS STABLE and out of the hospital? 90% of HF hospitalizations due to symptoms of pulmonary congestion 1,2 AT DISCHARGE Post-hoc analysis of 463 acute decompensated HF patients from 40% DOSE-HF and 60% CARRESS-HF moderate to severe absent or mild congestion 3 congestion 3 AT 60-DAY FOLLOW-UP TODAY S TOOLS ARE INADEQUATE at relieving congestion (inpatient) and preventing re-congestion and readmission (outpatient) 1. Adams KF, et al. Am Heart J Krum H and Abraham WT. Lancet Lala A, et al. JCF % of previously decongested patients had severe or partial recongestion 3 8 Current HF Management: clinical tools are designed to estimate pressure Parameter Symptoms (PND, orthopnea, etc.) JVP HJR S3 Rales Daily weight BNP Intrathoracic impedance Heart rate variability Surrogate for: LVEDP, RAP RAP RAP LVEDP LVEDP Body volume (LVEDP, RAP) PCWP PCWP Cardiac autonomic control THE GOAL: Recognize changing filling pressures that lead to acute decompensation. Indicates face-to-face evaluation 9 3

4 HOW DO CURRENT PARAMETERS IMPACT HEART FAILURE HOSPITALIZATION? Trial N Parameter Monitored/ Clinician Interaction Impact on HF Hospitalization Citation TELE-HF 1 1,653 Signs/symptoms, daily weights None 2010 TIM-HF Signs/symptoms, daily weights None 2011 TEN-HMS Signs/symptoms, daily weights, BP, nurse telephone support None 2005 BEAT-HF 4 1,437 Signs/symptoms, daily weights, nurse communications None 2015 Abstract INH Signs/symptoms, telemonitoring, nurse coordinated DM None 2012 DOT-HF Intrathoracic impedance with patient alert Increased 2011 Optilink 7 1,002 Intrathoracic impedance None 2011 REM-HF 8 1,650 MORE CARE Remote monitoring via ICD, CRT-D, or CRT-P Remote monitoring of advanced diagnostics via CRT-D 2016 None Abstract None 2016 Total 8,793 Multiple trials studying > 8,500 patients have demonstrated that current markers have 6. van Veldhuisen DJ, et al. Circulation, Bohm, M. et al. Eu J. Heart Fail, NO IMPROVEMENT ON HF 8. Cowie, MR. ESC Boriani G, et al. Eur J Heart Fail HOSPITALIZATION. 1. Chaudhry SI, et al. N Engl J Med, Koehler F, et al. Circulation, Cleland JG, et al. JACC, Ong MK, et al. AHA 2015 LBCT. 5. Angermann DE, et al. Circ Heart Fail, SJM-MEM (1)a(7)a Item approved for U.S. use only. 10 Patient Centered Disease Management Trial Trial design: VA Subjects with heart failure and reduced health status were randomized to a collaborative care patient-centered disease management program (n = 187) vs. usual care (n = 197). Collaborative care group (p = 0.97 between groups) Usual care group Bekelman DB, et al. JAMA Intern Med 2015;175: Results At baseline, the mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score was 37.9 points in the collaborative care group vs points in the usual care group (p = 0.48) At 1 year, the mean change in KCCQ was 13.5 points in both groups (p = 0.97 between groups) Conclusions Among patients with heart failure and reduced health status, as defined by the KCCQ, a collaborative care management program was unable to improve symptoms compared with usual care There was no significant difference in 1- year hospitalization rates between the intervention arm and the usual care arm (29.4% vs 29.9%, P =.87). Implantable Devices 4

5 Implantable Device Telemonitoring Sources in HF Cardiac Devices ICD CRT-D CRT-P PA Pressure Monitoring Cardiac Device Data Important to HF Clinician Activity log HRV Histograms/counters Thoracic Impedance Events-VT, atrial Bi-v pacing percentage Heart rate Respiratory rate Intrathoracic Impedance as a Measure of Heart Failure Clinical Status Concept Pulmonary Congestion: As fluid accumulates in the lungs, intrathoracic impedance decreases 5

6 Intrathoracic Impedance Changes The good news 3x more sensitive than weight 1 in detecting worsening heart failure PARTNERS-HF Trial did show correlation with Actionable Events 2 The bad news False positives reported 1 ½ - 2 per year More causes of decrease in impedance, e.g., pneumonia 1 Abraham, et al. CHF Whellan, et al. Am Heart J Impedance May Be Used in Risk Stratification Study High (> 100) fluid index PARTNERS-HF threshold showed identified that impedance monitoring combined with patients at a 3.9-fold risk PARTNERS-HF other device diagnostics may be a useful risk stratification tool of HF hospitalization with pulmonary congestion (p<0.0001) 2 or more criteria in 1 month had 5.5 fold increase in hospitalization in next month: *long afib, RVR, high fluid index, low activity, abnl autonomics, ICD shock or low CRT pacing, Whellan DJ, et al. JACC, What is the evolution of Hemodynamic Pressure Monitoring for Heart Failure disease management? COMPASS HF reactive approach to deviations in pressure patients with epad >25mmHg had higher event rates than those below 25, leading to hypothesis of value in driving pressures down HOMEOSTASIS introduced concept of patient self-management to keep pressures down coupled with physician dynamic prescriptions to lower pressures to target range CHAMPION HF management based on ambulatory PA pressure monitoring 6

7 CardioMEMS HF System PA Pressure Sensor on Catheter Delivery System 4.5cm 120cm Patient Home Electronics Unit PA Pressure Database Physician Access Via Secure Website CHAMPION Study Design Control Group (n=280) 550 patients Right Heart Catheterization + Sensor Implant Randomization Signs and symptoms Treatment Group (n=270) Primary endpoints analyzed when last enrolled patient reached 6 months 1. Abraham W, et al. Lancet, 2011 PA pressures uploaded without physician access PA pressures uploaded with physician access Efficacy in Reducing Heart Failure Hospitalizations Primary Endpoint Treatment Group (n=270) Control Group (n=280) Heart Failure Hospitalizations Number 6 Month Rates (hosp/pt/6 months) Hazard Ratio (95% CI) [p-value] 0.72 (28% RRR) ( ) p= Abraham W, et al. Lancet,

8 HF Hospitalization Rate 3/27/2017 Secondary Endpoints Treatment (n=270) Control (n=280) p- value Change from baseline in PA mean pressure (mean AUC [mmhg-days]) Number and proportion of patients hospitalized for heart failure (%) Days alive and out of hospital for heart failure (mean) Quality of life (Minnesota Living with Heart Failure Questionnaire) (20%) 80 (29%) Abraham W, et al. Lancet, 2011 Managing Trends of Ambulatory PA Pressures PA PRESSURE RANGES: PA Systolic mmhg PA Diastolic 8-20 mmhg PA Mean mmhg Low PA Pressure (Hypo-volemic) PA Mean Pressure trending below the normal hemodynamic range Elevated PA Pressure (Hyper-volemic) PA Mean Pressure trending above the normal hemodynamic range Poor perfusion in the absence of S&S of congestion Lower or discontinue diuretic - if on thiazide and loop diuretic, lower or D/C the thiazide diuretic - if only on loop diuretic, lower the dose or discontinue - consider liberalization of oral fluid or salt restriction Lower or hold vasodilators if postural hypotension present Re-evaluate PA pressures 2-3 days per week until PA pressures stabilize Lower or hold ACE/ARB dose if worsening renal function present with hypotension Add or increase diuretic - increase/add loop diuretic - change loop diuretic - add thiazide diuretic - IV loop diuretic Add or increase vasodilators - add or increase nitrate Re-evaluate PA pressures 2-3 days per week until PA pressures stabilize Evaluate other etiologies if PA pressures remain elevated i.e. dietary indiscretion, sleep apnea, etc. Pre-specified Subgroup Analysis Rate of HF Hospitalizations by Baseline Ejection Fraction p= RRR=24% Treatment p= RRR=46% 0.33 Control n= 208 n= 222 N=208 N=222 n= N=62 n= N=57 Reduced (EF<40%) Preserved (EF 40%) p-value from two-group t-test 1. Abraham W, et al. Lancet,

9 Number of Hospitalizations 3/27/2017 PA Pressure Monitoring Impact on 30 Day Readmissions in Medicare Eligible Patients % reduction (IRR 0.51, ) [p<0.0001] Abraham W, et al. Lancet, HF Hospitalizations Control (Standard of Care) 58% reduction (IRR 0.42, ) [p=0.0062] All Cause 30 Day Readmissions 78% reduction (IRR 0.22, ) [p=0.0027] 18 4 HF 30 Day Readmissions Treatment (PA pressure monitoring) CHAMPION TRIAL SUB-ANALYSES: HF HOSPITALIZATION RATES IN PATIENT GROUPS WITH COMMON COMORBIDITIES PURPOSE Determine if patients with common HF comorbidities and patients in important sub-groups may benefit from PA pressure monitoring. Sub-Group or Comorbidity N (control) N (treatment) Follow-up Period HF Hospitalization Rate Reduction in Treatment Group Medicare population months 49% (p < vs. control) HFpEF months 50% (p < vs. control) HFrEF following GDMT months 43% (p = vs. control) CRT-D or ICD following GDMT months 43% (p = vs. control) History of myocardial infarction months 46% (p < vs. control) COPD 6, months 41% (p = vs. control) Pulmonary hypertension months 36% (p = vs. control) AF months 41% (p < vs. control) Chronic kidney disease months 42% (p = vs. control) 1. Adamson, et al. Circ Heart Fail, Adamson, et al. Circ Heart Fail, Abraham, et al. ACC, Abraham, et al. HRS, Strickland WL, et al. JACC, Criner G, et al. Eur Respir J, Martinez F, et al. Eur Respir J, Benza R, et al. J Card Fail, Miller AB, et al. JACC, Abraham et al. J Card Fail, SJM-MEM (1)a(7)a Item approved for U.S. use only. 26 Non-Invasive Technologies 9

10 Evaluation of ReDS-guided patient management in ambulatory heart failure patients at-risk for rehospitalization. Abraham et al. ESC-HF Late Breaking Clinical Trials oral presentation. ESC HF nd World Congress on Acute Heart Failure. ReDS Technology ReDS technology for lung fluid measurement, originated in defense seethrough-wall technology, that is used to find survivors in the rubble of collapsed buildings External vest (Sensivest) placed once a day for a 90 second reading Feasibility study demonstrated an 87% reduction in hospital readmission rates Indicated for: for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications. SMILE Study-Enrolling Multi-center, randomized controlled study, to determine if a significant decrease in the rate of heart failure re-hospitalizations occurs during a follow-up period when - ReDS guided treatment is used as an adjunct to standard of care. Patients will be enrolled during an index hospitalization for ADHF and will be followed for a minimum of 3 months or a maximum of 9 months Patients will be blinded to ReDS readings values. ToSense CoVa Electrodes on the bottom of the necklace attach to the chest using an adhesive ; device is worn for about 15 minutes a day while measurements are done and recorded. FDA approved thoracic fluid index heart rate heart rate variability respiratory rate stroke volume cardiac output single lead ECG posture 10

11 Perminova CoVa necklace uses thoracic bioimpedance and ECG monitoring to determine stroke volume, blood pressure, and cardiac output CoVa is indicated for patients: i) with fluid-management problems; ii) taking diuretic medication; iii) living with heart failure; iv) living with end-stage renal disease; v) recovering from a coronary artery disease-related event; and/or vi) suffering from recurrent dehydration Joseph A. Walsh III et al. Circulation. 2014;130: Copyright American Heart Association, Inc. All rights reserved. Investigational Investigational MultiSENSE Study multicenter, international, prospective, non-randomized, feasibility study designed to evaluate the ability of multiple sensor measurements derived from a CRT-D to detect signs of worsening HF Using COMPOSITE INDEX: HeartLogic Algorithm respiration rate ratio of respiratory rate to tidal volume physiologic response to activity measured from relationships between respiration and heart rate to activity thoracic fluid measured using multivector intra-thoracic impedance heart sounds (including first & third heart sound) measured from mechanical vibrations using the device accelerometer 11

12 MultiSENSE Study Results Primary endpoint: sensitivity >40% for detecting HR events Result: sensitivity of 70% achieved Median time from alert to HF event 34 days Secondary endpoint: unexplained alert rate <2.0 per pt year Result: 1.47 Limitations: Tested in CRT-D patients only Will intervention based on the alerts impact outcomes? FDA approval Next Step: MANAGE HF AHA 2016 Boehmer Conclusions Cardiac Devices can provide meaningful data for the HF team Implantable Hemodynamic provides direct, proactive, actionable measurement of pressures with improved outcomes Noninvasive external devices are available Search continues for technologies that provide actionable data that positively improve outcomes 12

13 Q&A Thank you 13