George H. Crossley, MD President, Mid-State Cardiology, a unit of St. Thomas Heart Clinical Professor of Medicine, Unive

1. The Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision (CONNECT) Trial The Value of Remote Monitoring George H. Crossley, MD President, Mid-State Cardiology, a unit of St. Thomas Heart Clinical Professor of Medicine, University of Tennessee College of Medicine ACC Governor, Tennessee

2. Disclosures • CONSULTING FEES/HONORARIA • Medtronic Inc • Boeringer • SPEAKER'S BUREAU • Medtronic • Sanofi • RESEARCH/RESEARCH GRANTS • Medtronic • St Jude • Sanofi

3. To demonstrate that remote monitoring with automatic clinician notifications reduces the time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular disease progression, and device issues as compared to standard in-office care. Rates of cardiovascular health care utilization (HCU) between treatment groups Study Purpose

4. Randomized, multi-center prospective study N = 1,997 newly implanted CRT-D and DR-ICD patients 136 US centers Remote management system vs. standard In-office care Patients followed remotely for 12 months (Remote Arm) Patient signs Informed Consent/HIPAA Authorizationimplanted with a study device and randomized Remote Arm 1014 pts In-office Arm 983 pts Enrollment Enrollment 1 Month Office F/U 1 Month Office F/U 3 Month Remote F/U 3 Month Office F/U 6 Month Remote F/U 6 Month Office F/U 9 Month Remote F/U 9 Month Office F/U 12 Month Remote F/U 12 Month Office F/U 15 Month Office F/U 15 Month Office F/U Study Design Crossley G, Boyle A, Vitense H, Sherfesee L, Mead RH. Trial design of the clinical evaluation of remote notification to reduce time to clinical decision: the Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study. Am Heart J. 2008 Nov;156(5):840-6. Epub 2008 Sep 11.

5. Required Study Programming

6. Required Study Programming Atrial fibrillation Midnight Day 1 Midnight Day 2 Midnight Day 3 Atrial fibrillation Midnight Day 1 Midnight Day 2 Midnight Day 3

7. Required Study Programming

8. All events that did or would have triggered alerts if device programmed accordingly included Events that triggered alerts: the center logged date of clinical decision Events that did not trigger alerts: date of decision was date of first device interrogation following event Time to decision determined for each event, and for each subject with an event, these times were averaged Due to skewness of data, nonparametric test used to compare time to decision per patient between arms For health care utilization, multiple events proportional hazards models used to compare rates of each of the following between arms: Cardiovascular hospitalizations ED visits Unscheduled clinic visits, including urgent care visits Study Methods

9. Study Demographics

10. Primary Endpoint Time from event to clinical decision in the Remote Arm was significantly shorter than in the In-office Arm (p<0.001) Median time in the Remote arm was 4.6 days vs. 22 days in the In-office arm Event to Clinical Decision (median time) (per patient with at least one event) Note: Data includes events for patients who crossed over, were non-compliant or had alerts occur prior to home monitor setup

11. Time from Event to Decision by Alert Type (median days)

12. Results of Clinician Alert Transmissions(Remote Arm)

13. Clinician Alert Transmissions

14. Clinic Visits (Scheduled and Unscheduled) By replacing routine clinic visits with remote monitoring, the observed rate of total clinic visits per patient year was Remote (3.92) vs. In-office (6.27)

15. Health Care Utilization Visits by Treatment Arm * Includes Urgent Care Visits

16. Impact of Remote Management This study showed the Remote Arm had significantly shorter hospitalization length of stays than In-office Arm (p=0.002) Remote Arm = 3.3 days per hospitalization In-office Arm = 4 days per hospitalization Mean reduction 18% Estimated savings per hospitalization $1,659* (p = 0.002) * Estimated using the Medicare Limited Data Set - Standard Analytic Files from 2002-2007

17. A significant reduction in time from onset of events to clinical decisions in response to arrhythmias, and device issues Replacement of routine in-clinic visits with remote transmissions did not significantly increase other health care utilizations (cardiovascular hospitalizations, emergency department, and unscheduled clinic visits) A significant reduction in mean length of stay per cardiovascular hospitalization Conclusions In this study monitoring patients remotely with automatic clinician alerts showed: