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  • The clinical template should be used for presentation to a clinical audience and focused on clinical topics. Examples include clinical grand rounds, clinical conferences and seminars and internal clinical meetings.
  • Abraham

    1. 1. New Physician/Patient Paradigms in Heart Failure ManagementWilliam T. Abraham, MD<br />
    2. 2. Background<br />Despite current therapies and disease management approaches, the rate of heart failure hospitalization remains unacceptably high<br />> 1.1 million heart failure hospitalizations annually<br />> 25% readmission rate at 1 month; 50% at 6 months<br />> $18 billion in annual direct costs<br />Current methods for monitoring heart failure patients have not adequately addressed this issue<br />
    3. 3. Key Therapeutic Goal in Heart Failure:Maintain Optimal Volume/Pressure Status<br />Hypervolemia/Elevated Intra-cardiac and Pulmonary Artery Pressures:<br />Increased symptoms, increased risk of hospitalization, increased risk of arrhythmias, increased mortality<br />Euvolemia/Normal Intra-cardiac and Pulmonary Artery Pressures:<br />Low risk<br />Hypovolemia/Low Intra-cardiac and Pulmonary Artery Pressures:<br />Symptomatic hypotension, syncope, pre-renal azotemia<br />
    4. 4. What Do We Really Need To Monitor?<br />What do we really want to know?<br />Pulmonary congestion / left ventricular filling pressure (LVFP)<br />How do we currently assess these in patients with chronic heart failure?<br />Symptoms<br />Daily weights<br />Physical examination<br />Biomarkers<br />How well do these assessments perform?<br />Not very well<br />
    5. 5. Limitations of Available Monitoring Systems<br />Weight and Symptoms – Recent large, landmark clinical studies (Tele-HF, TIM-HF) investigating the effectiveness of telemonitoring demonstrated no benefit in reducing HF hospitalizations<br />BNP - PRIMA and other studies guided identification of patients at risk for HF events, but showed no significant reduction in HF-related admissions<br />Device-Based Diagnostics - May be useful for identifying patients that may be at higher risk for a HF hospitalization(PARTNERS-HF Study), but have not demonstrated a reduction in HF-related hospitalizations<br />Tele-HF: Yale Heart Failure Telemonitoring Study; NEJM, 2010<br />TIM-HF: Telemonitoring Intervention in Heart Failure, Eur J. Heart Failure, 2010<br />PRIMA: Can Pro-BNP guided heart failure therapy improve morbidity and mortality? J Am Coll Card, 2010<br />PARTNERS-HF: Combined Heart Failure Device Diagnostics Identify Patients at Higher Risk of Subsequent Heart Failure Hospitalizations. J Am Coll Card, 2010<br />
    6. 6. Premise of Physiological Heart Failure Monitoring (1)<br />Heart Failure Event<br />Symptoms<br />HemodynamicChanges<br />Days<br />-21<br />-14<br />- 7 <br />0 <br />Proactive<br />Reactive<br />
    7. 7. Premise of Physiological Heart Failure Monitoring (2)<br />Averted<br />Heart Failure Event<br />Medical Intervention<br />HemodynamicChanges<br />Days<br />-21<br />-14<br />- 7 <br />0 <br />Proactive<br />
    8. 8. LV Pressure Sensor<br />RV Pressure Sensors<br />PA Pressure Sensors<br />LA Pressure Sensor<br />Implantable Hemodynamic Monitors<br />
    9. 9. MEMS-based pressure sensor<br />Home electronics<br />PA Measurement database<br />The Pulmonary Artery Pressure Measurement System*<br />Catheter-based delivery system<br />*CardioMEMS Inc., Atlanta, Georgia, USA<br />
    10. 10. Primary Results of the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) Trial <br />
    11. 11. CHAMPION Study Design<br />Prospective, multi-center, randomized (1:1), controlled single-blind clinical trial<br />Treatment group received traditional HF management guided by hemodynamic information from the sensor<br />Control group received traditional HF disease management<br />550 subjects enrolled at 63 sites in the U.S. between October 2007 and September 2009<br />All subjects followed in their randomized single-blind study assignment until the last patient reached 6 months of follow-up<br />
    12. 12. Cumulative HF Hospitalizations Over Entire Randomized Follow-Up Period <br />p < 0.001, based on Negative Binomial Regression<br />Cumulative Number of HF Hospitalizations<br />Days from Implant<br />
    13. 13. Secondary Efficacy Results <br />
    14. 14. CHAMPION: Putting It Altogether<br />Pulmonary Artery Pressure<br />Medication Changes On Basis of Pulmonary Artery Pressure<br />P<0.0001<br />Pulmonary Artery Pressure Reduction<br />P=0.008<br />Heart Failure Related Hospitalization Reduction<br />P<0.0001<br />Quality of Life Improvement<br />P=0.024<br />P values for Treatment Vs Control Group<br />
    15. 15. Proximal anchor<br />7 mm<br />Distal anchor<br />Ti diaphragm <br />3 mm<br />Left Atrial Pressure Monitor*<br />Implantable Sensor Lead(ISL)<br />Sensor module<br />Implantable Communications module (ICM)<br />Sensor module features<br />Hermetic Ti housing /sensing diaphragm<br />Custom ASIC measures LAP, IEGM,Temp<br />Folding nitinol septal fixation anchors<br />Full digital waveform telemetry<br />RF power, no implanted battery<br />*St. Jude Medical, Sylmar, CA<br />
    16. 16. Physician-Directed, Patient-Self Management<br />LAP ≥28 …Very High… furosemide 80mg, call MDLAP 19-27 …High………. 40mg<br />LAP 10-18 …Optimal…… 20mg<br />LAP 6-9 …Low…………10mg<br />LAP ≤ 5 …Very Low…. hold, increase fluid intake<br />Optimal LAP makes it easier to up-titrate <br />β-Blockers and ACE-I/ARBs<br />Direct USB (in-clinic)<br />RF Telemetry<br />Remote(patient’s home)<br />Patient Advisory Module<br />Application SoftwareTrends, Waveforms, PrescriptionsPC or Web Based<br />
    17. 17. (s) carvedilol(25mg),1 tab(s) lisinopril(20mg), 1 tab*(d) furosemide(40mg),1 tab<br />HandheldPatient Advisor Module<br />PAM<br /><ul><li>Powers implant by RF
    18. 18. Atmospheric reference
    19. 19. Stores telemetry
    20. 20. Alerts patient to monitor
    21. 21. DynamicRX™
    22. 22. Meds, activity, MD contact</li></li></ul><li>Circulation 2010; 121:1086-1095<br />
    23. 23. Inclusion /Exclusionn=40<br />Implant<br />n=40<br />Observation PeriodStandard therapy without LAP-guidance for 3 monthsRHC at 3 months <br />1º Safety EndpointMACNE at 6 weeksn=40<br />Titration PeriodLAP-guided therapy rapid drug titration for 3 months<br />Stability PeriodLAP-guided therapy for ≥ 6 months<br />RHC at 12 months<br />12 month follow-upn=35, 4 deaths, 1 withdrawal<br />Longer term follow-upmedian 25 monthsn= 30, 9 deaths, 1 withdrawal<br />HOMEOSTASIS I & IIEndpoints, Design, Subject Accounting<br />Open-label, registry<br />1º Endpoint (safety)<br />Freedom from Major Adverse Cardiac and Neurological Events (MACNE) at 6 weeks<br />2º Endpoints (functionality)<br />Calibration<br />LAP vs. PCWP<br />3º Endpoints (Effectiveness surrogates)<br />Control of LAP<br />HospitalizationClinical parameters<br />
    24. 24. HF Event Rates(ADHF and All-Cause Death)Comparison of Periods with and without LAP-Guidance<br />