Robert C. Bourge, MD Professor of Medicine, Radiology, and Surgery

1. The Potential of Telemedical Devices to Monitor and Enhance Patient Health:-----------------------------------------Focus on Cardiovascular Disease Robert C. Bourge, MD Professor of Medicine, Radiology, and Surgery Director, Division of Cardiovascular Disease The University of Alabama at Birmingham <bbourge@uab.edu>

2. TeleMedicine • Patient Access • Physically remote from a nurse or doctor • Actively engaged in monitoring health • ‘Long-distance’ communication link • Telephone / Wired or Wireless • Broadband Internet • (GPS) • Monitoring methodology • Questionnaires, Verbal / Video • Non-invasive – patient/carer/technician operated • Implanted - +/- patient operated • Patient Interaction / Feedback • Patient Directed – Per Patient Specific Rx • Verbal / Video – Health Professional Directed • Automated – Per Patient Specific Rx Adapted for J.G.Cleland, 2009, with permission

3. Heart Failure Management Report Heart Failure Management Report AT/AF total h/day OptiVol fluid index V. rate during AT/AF, bmp Patient activity h/day Thoracic impedance Average V. rate, bpm Implanted Device Diagnostics

4. Acute event Clinical Status Acute Exacerbations Contribute to the Progression of the Heart Failure With each event, hemodynamic alterations/myocardial injury contribute to progressive ventricular dysfunction Heart failure progression may be accelerated by the aggressive therapiesinitiated during hospitalization Time Jain P et al. Am Heart J. 2003;145:S3-S17.

5. Congestive Heart Failure Congestion (as measured by increased intracardiac end diastolic pressures)   Symptoms and  Survival

6. Physiological Premise of Monitor Guided Care (1) Heart Failure Event Symptoms Pressure Changes Days -21 -14 - 7 0 Proactive Reactive

7. Physiological Premise of Monitor Guided Care Averted Heart Failure Event Medical Intervention Pressure Changes Days -21 -14 - 7 0 Proactive

9. TEN-HMSDays Dead or Hospitalized over 240 days % NB HTM reduced Average length of stay Days in Hospital Days in Hospital For HF Death or Hospital Days for Heart Failure Death or Days in Hospital (All-cause)

10. TransEuropean Home Telemonitoring Study Mortality Reduction in Mortality NTS or HTM v UC Absolute 16.4% Relative 36 % Mortality p < 0,05 Cleland et al JACC 2005

11. Effect of Structured Telephone Support on All-Cause Mortality Clark RA et al. BMJ 2007

12. Effect of Home Telemonitoring On hospitalization On mortality Clark RA, BMJ 2007

13. Chronicle IHM - Lead Positioning Pressure Sensor Capsule

14. EGM 2 3 1 RVP dP/dt Chronicle Pressure Measurements 1 = RVDP at QRS detection 2 = RVSP at peak of waveform 3 = ePAD at maximal dP/dt

15. Efficacy in NYHA Class III Patients Cumulative Events 120 Chronicle 100 Control 80 Events 60 40 20 0 2 4 6 Months 1 • Poisson model - Scaled Deviance = 1.7 • Negative Binomial model - Scaled Deviance = 0.8 Bourge, RC, et al. J Am Coll Cardiol 2008;51:1073-9

16. HF-related Hospitalization – NYHA Class IIITime to Event Analysis 100% 80% Chronicle Control 60% Freedom from HF-related hospitalization 40% RR = 0.62 (95%CI = 0.39 - 0.98) p=0.04 20% 0% 0 50 100 150 200 Days Bourge, RC, et al. J Am Coll Cardiol 2008;51:1073-9

17. Implanted Monitor Derived Hemodynamics in PAH The basic features of the RV pressure waveform and the identification of these feature points using the first derivative of the RV pressure waveform. Three of these points identify the turning points of the PA flow waveform (in mmHg), PEI, T1st and STI, where PEI = time of dP/dtmax, T1st = time of the early shoulder of the RV pressure waveform, and STI = time of dP/dtmin. The area of the triangle (shaded area) = (P1st-Pes)x ED/2 corresponds to estimated stroke volume (SV). RR = R-R interval The augmented pressure (AP) caused by the presence of wave reflection is the difference between the late systolic pressure (Psys) and the early systolic shoulder (P1st). Fig 1, Karamanoglu, M, et al, Chest 2007, 132:37-43

18. Implanted Monitor Derived Hemodynamics in Pulmonary Arterial Hypertension Fig 6 & 7, Karamanoglu, M, et al, Chest 2007, 132:37-43

19. AAA Sensor HF Sensor CardioMEMS Wireless Heart Failure Sensor HF Sensor technology based on clinically proved commercially available system for abdominal aneurysms repair monitoring Externally powered – no battery

20. CardioMEMS System in Diastolic Dysfunction

21. CHAMPIONCardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III heart failure patients 550 Pts w/ CM Implants All Pts Take Daily Readings • Enrollment completed early October, 2009 • Final Data May 2010 • I/E: • Class III HF with 1 hosp in previous year • No EF or QRS criteria • Cost Effectiveness Sub-Study Treatment 275 Pts Management Based on Hemodynamics + Traditional Info Control 275 Pts Management Based on Traditional Info Primary Endpoint: HF Hospitalizations at 6 Months Additional Analysis: HF Hospitalizations at All Days (~18 M mean F/U) Multiple Secondary Endpoints 21

22. Edible Electronic Monitors Ingestible sensor chip 1mm square and 200 microns thick attached to pills with a bio-compatible glue External band-aid-like patch. When swallowed the chips send a signal to the patch tracking heart rate, respiratory rate, temperature and activity.

23. The Potential for TeleMedicine in the Care of Patients with Cardiovascular Disease • Implanted • Monitors • arrhythmia • hemodynamics • labs 1

24. Development of Integrated Tele-Medicinefor Heart Failure Improved sensor and communication technology Evidence! Adequate preparatory work (health services not ready) Intelligent Study Design and Funding Clinician-led models of service Development of clinical pathways Decision-support software Replace existing care patterns Proper business and health-economic models Adapted for J.G.Cleland, 2009, with permission

25. Summary < bbourge@uab.edu >

26. Summary < bbourge@uab.edu >

27. Summary < bbourge@uab.edu >

28. Summary < bbourge@uab.edu >