The Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision (CONNECT) Trial The Value of Remote Monitoring

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
Study Purpose

• 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

4
Study Design

• 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)

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
Nov156(5)840-6. Epub 2008 Sep 11.
5
Required Study Programming
Remote In-office
Medtronic CareLink Home Monitor Provided Not Provided
Clinical Management Alerts
AT/AF Burden Automatic Clinician Alert, 12 hrs/day Off
Fast V. Rate during AT/AF Automatic Clinician Alert, 120 bpm x 6 hrs AT/AF /day Off
Number of Shocks Delivered Automatic Clinician Alert, 2 Shocks Delivered Off
All Therapies Exhausted in a Zone Automatic Clinician Alert Off
Lead / Device Integrity Alerts
Lead Impedance Out of Range Automatic Clinician and Audible Patient Alert Audible Patient Alert
VF Detection / Therapy Off Automatic Clinician and Audible Patient Alert Audible Patient Alert
Low Battery Voltage Automatic Clinician and Audible Patient Alert Audible Patient Alert
Excessive Charge Time Automatic Clinician and Audible Patient Alert Audible Patient Alert
6
Required Study Programming
Atrial fibrillation
Atrial fibrillation
7
Required Study Programming
Remote In-office
Medtronic CareLink Home Monitor Provided Not Provided
Clinical Management Alerts
AT/AF Burden Automatic Clinician Alert, 12 hrs/day Off
Fast V. Rate during AT/AF Automatic Clinician Alert, 120 bpm x 6 hrs AT/AF /day Off
Number of Shocks Delivered Automatic Clinician Alert, 2 Shocks Delivered Off
All Therapies Exhausted in a Zone Automatic Clinician Alert Off
Lead / Device Integrity Alerts
Lead Impedance Out of Range Automatic Clinician and Audible Patient Alert Audible Patient Alert
VF Detection / Therapy Off Automatic Clinician and Audible Patient Alert Audible Patient Alert
Low Battery Voltage Automatic Clinician and Audible Patient Alert Audible Patient Alert
Excessive Charge Time Automatic Clinician and Audible Patient Alert Audible Patient Alert
8
Study Methods

• 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

9
Study Demographics
Patient Characteristics Remote (n1014) In-office (n983)
Male 70.5 71.7
Age (years) 65.2 12.4 64.9 11.9
CRT-D 36.4 35.3
LVEF () 28.6 10.0 29.2 10.3
NYHA No HF Class I Class II Class III Class IV 5.3 3.9 40.9 48.5 1.5 6.7 4.7 39.5 47.5 1.5
10
Primary Endpoint
Time from event to clinical decision in the
Remote Arm was significantly shorter than in the
In-office Arm (plt0.001) 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)
Device Event No. of Events (No. of Patients) No. of Events (No. of Patients) No. of Days from Event Onset To Clinical Decision Median (Interquartile Range) No. of Days from Event Onset To Clinical Decision Median (Interquartile Range)
Device Event Remote In-office Remote In-office
AT/AF burden at least 12 hrs 437 (107) 280 (105) 3 (1, 15) 24 (7, 57)
Fast V rate at least 120 bpm during at least 6 hrs AT/AF 41 (26) 47 (37) 4 (2, 13) 23 (5, 40)
At least 2 shocks delivered in an episode 44 (35) 32 (23) 0 (0, 1.5) 0 (0, 2)
Lead impedances out of range 26 (18) 12 (6) 0 (0, 9) 17 (5.5, 45)
All therapies in a zone exhausted for an episode 16 (12) 11 (6) 0 (0, 1) 9 (0, 36)
VF detection/therapy off 10 (10) 8 (8) 0 (0, 0) 0 (0, 84)
Low battery 1 (1) 1 (1) 30 0
Overall 575 (172) 391 (145) 3 (0, 13) 20 (4, 52)
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 (p0.002)

• 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
Conclusions
In this study monitoring patients remotely with
automatic clinician alerts showed

• 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