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The CardioMEMS ™ HF System

The CardioMEMS ™ HF System. 7/19/2018. Dr. Merrill Krolick. Despite Medical Advances, Heart Failure Hospitalization is a Worsening Epidemic. SIGNIFICANT INCREASE IN HF HOSPITALIZATIONS 2. SIGNIFICANT REDUCTION IN CORONARY DEATHS 1.

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The CardioMEMS ™ HF System

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  1. The CardioMEMS™ HF System • 7/19/2018 • Dr. Merrill Krolick

  2. Despite Medical Advances, Heart Failure Hospitalization is a Worsening Epidemic SIGNIFICANT INCREASE IN HF HOSPITALIZATIONS2 SIGNIFICANT REDUCTION IN CORONARY DEATHS1 Number of HF Hospitalizations with HF as Primary or Secondary Diagnosis, by 5-year Time Period Deaths/100,000 Population THE PROBLEM: Unless focused, dramatic measures are taken, the clinical and financial burden to society is only going to escalate. 1. NIH.gov, Accessed 2016. 2. Fang J, et al. J Am CollCardiol, 2008. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  3. Heart Failure is a Growing Economic Burden UNITED STATES Despite advances in medical therapies to treat heart failure, the hospitalization rate has not changed significantly from 2000. As a result, heart failure continues to be a MAJOR DRIVER OF OVERALL HEALTH CARE COSTS. *Study projections assumes HF prevalence remains constant and continuation of current hospitalization practices CDC NCHS National Hospital Discharge Survey, 2000-10. Blekcer et al. J Am CollCardiol, 2013. Yancy et al. J Am CollCardiol, 2006. Wxler DJ, et al. Am Heart J, 2001. Krumholz HM, et al. CircCardiovasQual Outcomes, 2009. Yancy CW, et al. Circulation, 2013. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  4. Heart Failure is a Growing Global Clinical Burden • UNITED STATES HIGH INCIDENCE, HIGH PREVALENCE, AND POOR PROGNOSIS despite advances in the treatment of heart failure over the past few decades. AHA 2016 Statistics at a Glance, 2016. Krumholz HM, et al. CircCardiovasQual Outcomes, 2009. Heidenreich PA, et al. Circ Heart Failure, 2013. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  5. The challenge Current Tools are Ineffective in Reducing the Clinical and Economic Burdens of HF 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  6. 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 Acute Event MYOCARDIAL FUNCTION HF HOSPITALIZATION is a valid endpoint for measuring decompensation TIME Gheorghiade MD, et al. Am J. Cardiol, 2005. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  7. Long-term Mortality Risk Increases with Multiple Hospitalizations 4th admission(n = 417) 3rdadmission(n = 1,123) 2nd admission(n = 3,358) 1st admission(n = 14,374) Kaplan-Meier cumulative mortality curve all-cause mortality after each subsequent hospitalization for HF. Setoguchi S, Stevenson LW, Schneeweiss S, Am Heart J, 2007;154:260-264. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  8. Current HF Management Tools are Not Effective at Reducing HF Hospitalizations Today’s tools are INADEQUATE 1. Adams KF, et al. Am Heart J, 2005. 2. Krum H and Abraham WT. Lancet, 2009. 3. Lala A, et al. J Cardiac Fail, 2013. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  9. Current HF Management Tools Designed to Predict Decompensation THE GOAL: Predict gradual decompensation leading to acute decompensation 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  10. Weight Change is Not a Reliable Indicator of Rising Pressure or Impending Decompensation NO CORRELATION – Daily weights do not correlate with filling pressures 1. Data based on Zile MR, et al. Circulation, 2008. Presented at FDA Advisory Panel, October 9, 2013. 2. Lewin J, et al. Eur J HF, 2005. 3. Abraham WT, et al. Cong Heart Failure, 2011. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  11. Pathogenesis of Worsening Heart FailureROLE OF HEMODYNAMIC MONITORING Vascular Resistance Fluid Retention Fluid Redistribution Increased Pulmonary Artery Pressures WORSENING DYSPNEA LEADING TO HOSPITALIZATION 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  12. Monitoring Pulmonary Artery Pressures,Proactive and Actionable GAIN IN TIME HOSPITALIZATION Clinical Congestion Hemodynamic Congestion Reactive and Inexact Symptoms Weight Change Intrathoracic Impedance Change Proactive and Actionable Autonomic Adaptation Filling Pressure Increase Hemodynamically Stable Presymptomatic Congestion Decompensation -30 -20 -10 0 Time Preceding Hospitalization (Days) Adamson PB, et al. Curr Heart Fail Reports, 2009. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  13. Introduction to CardioMEMS™ HF System A Personalized, Proactive Approach to Manage HF by Monitoring PA Pressure 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  14. CardioMEMS™ HF System Offers New Promise CLINICAL TRIAL AND EARLY COMMERCIAL USE DEMONSTRATES THAT PA-PRESSURE GUIDED THERAPY: Prevents acute decompensation Lowers hospitalization and readmission rates Effectively lowers PA pressures Improves quality of life Additionally, early commercial use offers best practices for implementation and service management. Abraham WT, Lancet, 2011. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  15. CardioMEMS™ HF System for the Management of HF • Delivers insight into the early onset of worsening HF to more proactively manage HF patients and improve outcomes PULMONARY ARTERY PRESSURE SENSOR TARGET LOCATION FOR PA PRESSURE SENSOR PATIENT ELECTRONICS SYSTEM MERLIN.NET™ PCN Abraham WT, Lancet, 2011. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  16. INDICATIONS • The CardioMEMS™ HF System is indicated for HF patients who are: • NYHA Class III, regardless of ejection fraction • At least 1 hospitalized for heart failure in the previous year. (2 midnights) 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  17. The CHAMPION Trial design Evaluating the CardioMEMS™ HF System Through Randomized and Open Access 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  18. Summary of CHAMPION Randomized Clinical Trial:550 PREVIOUSLY HOSPITALIZED NYHA CLASS III PATIENTS Pulmonary Artery Pressure • MANAGING PRESSURES TO TARGET GOAL RANGES: • PA pressure systolic 15–35 mmHg • PA pressure diastolic 8–20 mmHg • PA pressure mean 10–25 mmHg • Using diuretics and vasodilators, in addition to guideline-directed medical therapies Medication Changes Based on Pulmonary Artery Pressure (p < 0.0001) 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. • Abraham WT, et al. Lancet, 2016. • Adamson PB, et al. J Card Fail, 2010. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  19. The CHAMPION Trial results Evidence That PA-Pressure Guided Therapy Reduces HF Hospitalizations 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  20. Primary Efficacy Endpoint Met with Significantly Reduced Heart Failure Hospitalization • PART 1: RANDOMIZED ACCESS CONTROL TREATMENT p < 0.0001 Abraham W, et al. Lancet, 2016. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  21. Monitoring with CardioMEMS™ HF System Leads to Reduction in Mean PA Pressure from Baseline • PART 1: RANDOMIZED ACCESS PA Mean Pressure AUC (mmHg days) SECONDARY ENDPOINT: Targeting PA pressures and titrating medications results in reduction of mean PA pressure over time. Abraham WT, et al. Lancet, 2011. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  22. PROSPECTIVE ANALYSES: Effects of PAP pressure monitoring on: HFpEF subgroup HFrEF subgroup, HFrEF subgroup already on GDMT The CHAMPION Trial Subgroup Analyses RETROSPECTIVE SUBGROUP ANALYSES: Therapy guided by PAP alone vs. signs and symptoms Medicare-eligible populations PA-guided medical management HF patients with common comorbidities 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  23. Prospective Subgroup Analysis: HFpEF PATIENTS MANAGED WITH THE CardioMEMS™ HF SYSTEM SHOW SIGNIFICANT REDUCTION IN HF Hospitalization Avg. 18 months follow-up 50% RRR, p < 0.0001 Control Group, HFpEF 50% reduction in HF Hospitalization Treatment Group, HFpEF Adamson PB, Abraham WT, Bourge RC, et al. Circ Heart Fail, 2014 Nov;7(6):935-44. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  24. Prospective Subgroup Analysis:HFrEF PATIENTS SHOWS SIGNIFICANT REDUCTION IN HF Hospitalization AND STRONG TREND TOWARDS IMPROVED SURVIVAL* Clinical Outcomes Survival Probability 0.9 0.8 p = 0.0013 0.7 32% reduction 28% reduction 0.69 0.6 0.5 Survival Probability (%) 0.49 0.4 p = 0.06 Rates Events/Patient-yr 0.3 0.2 0.24 Control 0.1 0.18 Treatment 0 Mortality Rate HF Hospitalization Rate No. at Risk CONTROL 234 209 173 102 45 7 0 TREATMENT 222 202 161 105 62 7 0 Treatment Control Kaplan-Meier Survival Analysis *The CardioMEMS™ HF System is not labeled for a reduction in mortality Givertz M, et al. J Am CollCardiol, 2017. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  25. Managing GDMT Based on PA Pressures Alone Led to Significant Reduction in HF Hospitalization HF Hospitalization Rate (Events/year) 1.22 1.17 p < 0.05 vs. Control Patients 0.63 p = 0.0007 vs. Control Patients 67% RRR of HF Hospitalizations 0.63 0.39 - - - - - - - - - - - - - - - - - - - - - PAP Management Group - - - - - - - - - - - - - - - - - - - - Control Group Clinical Only Triggered Rx Clinical Only Triggered Rx Clinical and PAP Triggered Rx PAP Only Triggered Rx Managing medical therapy based on PA pressures, along with follow-up lab and patient assessment led to SIGNIFICANTLY BETTER OUTCOMES THAN MANAGING BASED ON CLINICAL SIGNS AND SYMPTOMS Goldberg, et al. HRS 2015. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  26. Subgroup Analysis: MEDICARE-ELIGIBLE POPULATION SHOWS SIGNIFICANT REDUCTION IN 30-DAY READMISSIONS 49% reduction 58% reduction 78% reduction p < 0.0001 p = 0.0062 p = 0.0027 STATISTICALLY SIGNIFICANT REDUCTIONS in 30-day readmission and HF Hospitalization in Medicare-eligible patients 65 years or older (n = 245), when PA pressures are monitored using the CardioMEMS™ HF System. Adamson, et al. Circ Heart Fail, 2016. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  27. Subgroup Analysis:HFrEF PATIENTS WITH CRT-D FOLLOWING GDMT 64% reduction (p = 0.028) Abraham, et al. HRS 2015. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  28. Subgroup Analysis: PA-GUIDED MEDICAL MANAGEMENT Medication changes based on PA pressure information were MORE EFFECTIVE IN REDUCING HF HOSPITALIZATIONS than using signs and symptoms alone. Costanzo, et al. J Am CollCardiol Heart Failure, 2016. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  29. Medication Increases and Decreases in Response to PAP ALL MEDICATION CHANGES VASODILATOR (NITRATE AND HYDRALAZINE) DIURETIC (LOOP AND THIAZIDE) ALDOSTERONE ANTAGONIST ACE/ARB BETA BLOCKER ✽ ✽ ✽ ✽ ✽ ✽ ✽ ✽p < 0.05 PA Pressure Guided HF Management vs. Standard of Care HF Management No Change represents where a medication was changed (ie., dose frequency, route, etc.) which resulted in no net dose equivalent change Costanzo MR, et al. J Am CollCardiol HF, 2016. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  30. The CHAMPION Trial Subgroup Analyses: REDUCTION OF HF HOSPITALIZATION IN PATIENT GROUPS WITH COMMON COMORBIDITIES Patients with common HF comorbidities and patients in important subgroups HAVE CONSISTENT REDUCTION IN HF HOSPITALIZATIONS with PA pressure-guided therapy. Adamson, et al. Circ Heart Fail, 2016. Adamson, et al. Circ Heart Fail, 2014. Abraham, et al. ACC, 2015. Abraham, et al. HRS 2015. Strickland WL, et al. J Am CollCardiol, 2011. Criner G, et al. EurRespir J, 2012. Martinez F, et al. EurRespir J, 2012. Benza R, et al. J Card Fail, 2012. Miller AB, et al. J Am Coll Cardiol, 2012. Abraham, et al. J Card Fail, 2014. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  31. NNT to Prevent One HF Hospitalization for PA Pressure Monitoring and Medical Intervention Alone • PART 1: RANDOMIZED ACCESS PA pressure monitoring led to lower NNT to prevent one hf-related hospitalization vs. other therapies 1. Packer M, et al. Circulation, 2002. 2. Pitt B, et al. N Engl J Med, 1999. 3. Cleland JG, et al. N Engl J Med, 2005. 4. Hjalmarson A, et al. JAMA, 2000. 5. The SOLVD Investigators. N Engl J Med, 1991. 6. Zannad F, et al. N Engl J Med, 2011. 7. Digitalis Investigation Group. N Engl J Med, 1997. 8. Cohn JN, et al. N Engl J Med, 2001. 9. Young JB, et al. Circulation, 2004. 10. Adamson, P. et al. HFSA, 2016. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  32. The CHAMPION Trial Sub-analysis:PATIENTS WITH PULMONARY HYPERTENSION • PURPOSE • Evaluate the effect of PA pressure monitoring in HF patients with comorbid pulmonary hypertension (PHTN, mean PA pressure > 25 mmHg, n = 314). 36% reduction 29% reduction in HF hospitalizations for HF patients with PHTN who were managed with PA pressure compared to SOC. in HF hospitalizations for PHTN patients with TPG > 15 who were managed with PA pressure compared to SOC. 0.60 vs. 0.94, HR = 0.64, 95% CI 0.51-0.81, p = 0.002 p = 0.08 REDUCTION IN HF HOSPITALIZATIONS in HF patients with comorbid pulmonary hypertension. Benza R, et al. Journal of Cardiac Failure, 2012. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  33. The CHAMPION Trial Sub-analysis: PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE • SUB-ANALYSIS #1 • Evaluate if PA pressure-guided therapy reduced HF hospitalizations in a cohort of patients with comorbid chronic obstructive pulmonary disease (COPD, n = 187).1 • SUB-ANALYSIS #2 • Determine if PA pressure monitoring impacts the number of respiratory event hospitalizations in HF patients with a medical history of (COPD, n = 187).2 PURPOSE 41% reduction 62% reduction in HF hospitalization rates in the treatment group vs. control. in respiratory event hospitalizations (REH) in the treatment group. 0.55 vs. 0.96, HR 0.59, 95% CI 0.44-0.81, p = 0.0009 0.12 vs. 0.31, HR 0.38, 95% CI 0.21-0.71, p = 0.0023 REDUCTION IN HF HOSPITALIZATIONS AND REH in HF patients with comorbid COPD. 1. Criner G, et al. EurRespir J, 2012. 2. Martinez F, et al. EurRespir J, 2012. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  34. Commercial Experience Analyzing the CardioMEMS™ HF System in a Commercial Setting 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  35. Real-world Use of the CardioMEMS™ HF System:REDUCED HF HOSPITALIZATIONS Cumulative HF Hospitalization During Period Before and After CardioMEMS™ HF System Implant 45% reductionat 6 months (p < 0.001) Pre-implant Post-implant Large (N = 1114) retrospective cohort study using the CardioMEMS™ HF System patients from CMS database Desai, AS, et al. J Am CollCardiol, 2017;69(19):2357–65. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  36. CONCLUDING SUMMARY • The CardioMEMS™ HF System is safe, reliable and clinically proven in clinical trials and real-world settings. • It provides a proactive, personalized approach to prevent acute decompensation in both HFrEF and HFpEF patients. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  37. INDICATIONS • The CardioMEMS™ HF System is indicated for HF patients who are NYHA Class III, regardless of ejection fraction, who have been hospitalized for heart failure in the previous year (needs to include 2 midnights). 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

  38. Final Points Which patients in your practice might benefit from the CardioMEMS™ HF System? Abraham W, et al. Lancet, 2011. Givertz M, et al., J Am Coll Cardiol, 2017. Ponikowski P, et al. European Heart Failure, 2016. Heywood JT, et al. Circulation, 2017;135: 1509–17. Desai AS, et al. J Am CollCardiol, 2017;69(19):2357–65. 27382-SJM-MEM-0814-0012(1)a(10) | Item approved for global use.

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