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Remote Hemodynamic Pressure Monitoring in the Management of Heart Failure 25th Annual Cardiovascular Symposium Barry S. Clemson, MD OSF Ministry Heart Failure Medical Director November 4, 2016 Heart Failure – A Growing Global Concern Prevalence and Incidence Mortality • Overall 2.1% prevalence: 5.1M heart failure patients in 20101 • For AHA/ACC stage C/D patients diagnosed with HF: • 825,000 people ≥ 45 years of age are newly diagnosed each year with HF.1 • 30% will die in the first year.3-5 • 60% will die within 5 years.5 • 15 M heart failure patients in the ESC 51-member countries2 • Overall 2-3% prevalence2 HF prevalence in the US is projected to increase 46% from 2012 to 2030, resulting in > 8M people ≥ 18 years of age with HF.6 1. 2. 3. 4. 5. 6. AHA 2014 Statistics at a Glance, 2014 The European Society of Cardiology, ESC HF Guideline, 2008 Curtis et al, Arch Intern Med, 2008. Roger et al. JAMA, 2004. Cowie et al, EHJ, 2002. Heidenreich PA et al. Circ Heart Failure 2013. 2 Heart Failure Is Associated with High Hospitalization and Readmission Rates • In 2010, there were 1 million hospitalizations in the US with HF as the principal diagnosis.1 • Hospitalization rate did not change significantly from 2000.1 • Average length of hospital stay • Approximately 5 days (US)2 • 11 days (Europe)3 • HF is also associated with high readmission rates: • ~25% all-cause readmission within 30 days4 and ~50% within 6 months5 Graph from www.health.org.uk. Bridging the gap: Heart Failure, 2010. Data from Organization for Economic Cooperation and Development, 2009. 1. 1. 2. 2. 3. 3. 4. 4. 5. 5. CDCNCHS NCHS NationalHospital Hospital DischargeSurvey, Survey, 2000-2010 CDC CDC NCHSNational National HospitalDischarge Discharge Survey,2000-2010 2000-2010 Yancy et al. JACC, 2006. Yancy Yancyetetal. al.JACC, JACC,2006. 2006. Clelandetetal. al. EuroHeart,2003. 2003. Cleland Cleland et al.EuroHeart, EuroHeart, 2003. KrumholzHM, HM,etetal. al.Circ CircCardiovas CardiovasQual Qual Outcomes2009. 2009. Krumholz Krumholz HM, et al. Circ Cardiovas QualOutcomes Outcomes 2009. WexlerDJ, DJ, et al.Am Am HeartJJ2001. 2001. Wexler Wexler DJ,etetal. al. AmHeart Heart J 2001. 3 Economic Burden of HF Will Continue to Rise Through 2030* • The AHA estimates that the total medical costs for HF are projected to increase to $70B by 2030 a 2-fold increase from 2013.1 • 50% of the costs are attributed to hospitalization.2 Graph: Heidenreich PA, et al. Circulation Heart Failure 2013. * Study projections assumes HF prevalence remains constant and continuation of current hospitalization practices 1. Heidenreich PA, et al. Circulation Heart Failure 2013. 2. Yancy CW, et al. Circulation 2013. 4 Worsening Heart Failure Leading to HF-related Hospitalizations Contributes to Disease Progression • With each subsequent HF-related admission, the patient leaves the hospital with a further decrease in cardiac function. Graph adapted from: Gheorghiade MD, et al. Am J. Cardiol. 2005 5 HF-related Hospitalizations Are a Strong Predictor of Mortality1,2 • Data from the EFFECT study, n = 9138 patients1 • Data from Setoguchi et al., n = 14,374 patients2 • • Among 1 year survivors after index EFFECT-HF discharge, the number of heart failure hospitalizations in the preceding year stratified the risk of death in crude analysis1 Each admission decreases a patient’s chance of survival. 1. Lee DS, et al. Am J of Med, 2009. 2. Setoguchi S, et al. Am Heart J, 2007. 6 KP cumulative mortality curve for all-cause mortality after each subsequent hospitalization for HF2 Current HF Management Is Inadequate for Identifying and Managing Congestion Leading to Decompensation Identifying congestion early will lead to early treatment, prevent hospitalizations and slow the progression of HF. • 90% of HF hospitalizations present with symptoms of pulmonary congestion.1,2 • Post hoc analysis of 463 acute decompensated HF patients from DOSE-HF and CARRESS-HF trials showed: • 40% of patients are discharged with moderate to severe congestion.3 • Of patients decongested at discharge, 41% had severe or partial re-congestion by 60 days.3 Congestion state at discharge Maintained decongestion Absent or mild congestion Moderate to severe congestion Congestion state of patients discharged without congestion at 60 day follow-up3 17% 40% 60% 24% Partial recongestion 59% Relapse to severe congestion 1. Adams KF, et al. Am Heart J. 2005 2. Krum H and Abraham WT. Lancet 2009 3. Lala A, et al. JCF 2013 7 Time Course of Decompensation HF management has relied on patient-reported symptoms, as well as impedance, blood pressure and weight gain changes that often manifest only after decompensation has begun. Physiologic Markers of Acute Decompensation * Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009. 8 Managing Pressures in the Heart Failure Patient Pressures When patients are stable Their pressures remain very stable over time. When patient’s decompensate Pressures increase, leading to exacerbation. The pressures return to baseline when the exacerbation is treated and volume returns to normal Managing to targeted pressure ranges Adamson PB, et al. Curr Heart Fail Reports, 2009 9 Patient Pressures reflect the underlying volume state in HF patients. Strongly supports the hypothesis that measuring those pressures frequently or continuously using implantable devices and managing those pressures may be a superior management strategy. Can reduce overall pressures and ultimately lead to a reduction in HF events. CardioMEMS™ HF System The CardioMEMS™ HF System provides ambulatory pulmonary artery (PA) pressure monitoring PA Sensor is permanently implanted in the distal pulmonary artery via a right-heart catheterization procedure. Patient-initiated sensor readings are wirelessly transmitted to an external electronics unit Data stored in a secure website for clinicians to access and review. Directly monitoring PA pressure not only enables early detection of worsening heart failure, but also allows the titration of medications for proactive and personalized patient management. 10 CHAMPION Clinical Trial: The Effect of Pulmonary Artery Pressure-Guided Therapy on HF Hospitalizations vs. Standard of Care Patients with moderate NYHA class III HF for at least 3 months, irrespective of LVEF and a HF hospitalization within the past 12 months were included in the study. 550 Pts w/CMEMS Implants All Pts Take Daily readings Treatment 270 Pts Management Based on PA Pressure +Traditional Info 26 (9.6%) Exited < 6 Months 15 (5.6%) Death 11 (4.0%) Other Control 280 Pts Management Based on Traditional Info Primary Endpoint: Rate of HF Hospitalization 26 (9.6%) Exited < 6 Months 20 (7.1%) Death 6 (2.2%) Other Secondary Endpoints: Change in PA Pressure at 6 months No. of patients admitted to hospital for HF Days alive outside of hospital QOL Abraham WT, et al. Lancet, 2011. 11 CHAMPION Clinical Trial: Managing to Target PA Pressures 550 Pts w/CMEMS Implants All Pts Take Daily readings Treatment 270 Pts Management Based on PA Pressure +Traditional Info 26 (9.6%) Exited < 6 Months 15 (5.6%) Death 11 (4.0%) Other Control 280 Pts Management Based on Traditional Info Primary Endpoint: rate of HF Hospitalization PA pressures were managed to target goal pressures by physicians with appropriate titration of HF medications. 26 (9.6%) Exited < 6 Months 20 (7.1%) Death 6 (2.2%) Other Secondary Endpoints included: Change in PA Pressure at 6 months No. of patients admitted to hospital for HF Days alive outside of hospital QOL Target Goal PA Pressures: PA Pressure Systolic 15 – 35 mmHg PA Pressure diastolic 8 – 20 mmHg PA Pressure mean 10 – 25 mmHg Abraham WT, et al. Lancet, 2011. 12 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. 13 CHAMPION Clinical Trial: Both Primary Safety Endpoints and All Secondary Endpoints Were Met at 6 months Device-related or system-related complications Treatment (n = 270) Control (n = 280) 3 (1%) 3 (1%) Primary Safety Endpoints Total 8 (1%)* Pressure-sensor failures Change from baseline in PA mean pressure (mean AUC [mm Hg x days]) Number and proportion of patients hospitalized for HF (%) Secondary Endpoints Days alive and out of hospital for HF (mean ± SD) Quality of life (Minnesota Living with Heart Failure Questionnaire, mean ± SD) P-value < 0.0001 0 0 < 0.0001 -156 33 0.008 55 (20%) 80 (29%) 0.03 174.4 ± 31.1 172.1 ± 37.8 0.02 45 ± 26 51± 25 0.02 * Total of 8 DSRCs including 2 events in Consented not implanted patients (n = 25) Abraham WT, et al. Lancet, 2011. 14 CHAMPION Clinical Trial: HF Meds Can Be More Effectively Titrated with Pulmonary Artery (PA) Pressure Information Total Medication Changes/ Patient/Month 2 P < 0.0001 1.5 0.88 < 1 incremental medication change/patient/month 1 Based on PA pressure Based on Signs and Symptoms 0.5 0.67 0.65 Treatment Control 0 Compared to the control group, patients managed with PA pressures had significantly more total medication changes, resulting in < 1 incremental medication change/month. Costanzo MR, et al. Journal of Cardiac Failure, 2011 15 CHAMPION Clinical Trial: PA Pressure-Guided Therapy Improves Outcomes in CRT Patients1 and in Patients With Preserved Systolic Function2 HF Hospitalization Reduction (6 mos follow-up) Relative Risk Reduction 60% P < 0.0001 vs. control 50% 40% P = 0.0071 vs. control P = 0.0080 vs. control with CRT without CRT 30% 20% 10% 0% HFpEF preserved EF (≥ 40%) 1. Weiner et al. Heart Rhythm, 2011 Additional data on file. 2. Adamson et al. JCF Nov 2010. 16 CHAMPION Clinical Trial: The number needed to treat (NNT) to prevent one HF-related hospitalization is improved vs. other therapies Intervention Trial Mean Duration of Randomized FollowUp Annualized Reduction in HF Hospitalization Rates NNT per year to Prevent 1 HF Hospitalization Beta-blocker COPERNICUS 10 months 33% 7 Aldosterone antagonist RALES 24 months 36% 7 CRT CARE-HF 29 months 52% 7 Beta-blocker MERIT-HF 12 months 29% 15 ACE inhibitor SOLVD 41 months 30% 15 Aldosterone antagonist EMPHASIS-HF 21 months 38% 16 Digoxin DIG 37 months 24% 17 Angiotensin receptor blocker Val-HeFT 23 months 23% 18 Angiotensin receptor blocker CHARM 40 months 27% 19 PA pressure monitoring CHAMPION 17 months 33% 4 Sub Analysis of HFpEF CHAMPION 17 months 50% 2 CHAMPION Clinical Trial: PA Pressure-Guided Therapy Benefits Patients with Common HF Comorbidities N size (control) N size (treatment) HF Hospitalization rate reduction at 15 months in treatment group History of myocardial infarction1 137 134 46% (p < 0.001 vs. control) COPD2,3 96 91 41% (p = 0.0009 vs. control) Pulmonary hypertension4 163 151 36% (p = 0.0002 vs. control) AF5 135 120 41% (p < 0.0001 vs. control) Chronic Kidney Disease6 150 147 42% (p < 0.0001 vs. control) Comorbidity 1. 2. 3. 4. 5. 6. Strickland WL, et al. JACC 2011 Criner G, et al. European Respiratory Journal, 2012 Martinez F, et al. European Respiratory Journal, 2012 Benza R, et al. Journal of Cardiac Failure, 2012 Miller AB, et al. JACC, 2012 Abraham WT, et al. HFSA, 2014 18 Summary: CHAMPION Clinical Trial Pulmonary Artery Pressure Managing pressures to target goal ranges: Medication Changes based on Pulmonary Artery Pressure (p < 0.0001) PA Pressure systolic 15–35 mmHg PA Pressure diastolic 8–20 mmHg PA Pressure mean 10–25 mmHg Pulmonary Artery Pressure Reduction (p = 0.008) Reduction in Heart Failure Hospitalizations (p < 0.0001) Quality of Life Improvement (p = 0.024) Abraham WT, et al. Lancet, 2011. 19 CHAMPION Clinical Trial: Longitudinal Results With Open Access to All Patients Confirm Effectiveness of PA Pressure Monitoring 550 Pts w/CMEMS Implants All Pts Take Daily readings Randomized Access (Part 1) Treatment Mean Follow-up 17.6 months Control 270 Pts 280 Pts Management Based on Management Based on PA Pressure +Traditional Info Traditional Info 26 (9.6%) Exited < 6 Months 15 (5.6%) Death 11 (4.0%) Other 26 (9.6%) Exited < 6 Months 20 (7.1%) Death 6 (2.2%) Other Open Access / Unblinded Control Group (Part 2) Mean follow-up 13 months Study exits: 58 31 (17.5%) Death 27 (15.2%) Other Former Treatment 177 Pts Management Based on PA Pressure + Traditional Info Former Control 170 Pts Management Based on PA Pressure + Traditional Info n = 119 n = 127 Study exits: 43 21 (12.3%) Death 22 (12.9%) Other Abraham W, et al. ACC 2014 20 CHAMPION Clinical Trial: Longitudinal results with Open Access to All Patients Confirm Effectiveness of PA Pressure Monitoring Abraham W, et al. ACC 2014 21 CardioMEMS™ HF System Work Flow Indicated for all NYHA Class III HF patients who have been hospitalized for HF in the prior year. Contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant. Identification > Implant > Lower Baseline > Maintenance 22 Pulmonary Artery Pressure Database Trend Data Reading Discrete data Systolic: 24 Mean: 19 Diastolic: 16 Heart Rate: 81 seconds 23 Elevated PA Mean Pressure Treatment Strategies Elevated PA Pressure (Hyper-volemic) PA Pressure trending above the normal hemodynamic range 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. 24 Case Studies Case Study – Subject 12-013 75-year-old female ICM EF 30-35% CM Implant 8/29/2008 MEDICAL HISTORY BASELINE HF MEDICATIONS HEMODYNAMICS AT IMPLANT Hypertension Lisinopril 5 mg QD PA 34/10 (20) Valvular heart disease Carvedilol 12.5 mg BID PCWP 25 Furosemide 40 mg QD CO 3.5 Moderate MR, Mild TR, Mild AR Atrial fibrillation Digoxin 0.125mg QD BASELINE VITALS Diabetes Chronic renal insufficiency BP 144/69 Iron deficiency anemia HR 64 Sick sinus syndrome Weight 130 lbs. BMI 23.8 s/p pacemaker Pulmonary hypertension Echo 9/2007 RSVP 50-60 mmHg BASELINE LABS SCr 1.2 GFR 47 26 Titration and Switching Loop Diuretic and Addition of Thiazide Diuretic 27 Case Study – Subject 06-010 69-year-old male ICM EF 35% CM Implant 1/11/2008 MEDICAL HISTORY BASELINE HF MEDICATIONS HEMODYNAMICS AT IMPLANT Coronary artery disease Lisinopril 20 mg QD PA 40/25(29) s/p ICD Carvedilol 6.25 mg BID PCWP 17 Mitral valve disease Furosemide 40 mg QD CO 4.0 Ventricular fibrillation Amiodarone 200 mg QD BASELINE VITALS CABGx2 Arterial stent of the kidney BP 124/88 Mitral valve repair HR 72 Thyroid disease Weight 180 lbs. Gout BMI 26.6 Acute renal failure BASELINE LABS Chronic anemia AAA repair SCr 1.3 GFR 58 28 Initiation of Long-acting Nitrates 29