Transcript The Value of Remote Monitoring

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
Disclosures
• CONSULTING FEES/HONORARIA
• Medtronic Inc
• Boeringer
• SPEAKER'S BUREAU
• Medtronic
• Sanofi
• RESEARCH/RESEARCH GRANTS
• Medtronic
• St Jude
• Sanofi
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
Study Design
Patient signs Informed Consent/HIPAA Authorization
implanted with a study device and randomized
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)
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
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.
Required Study Programming
Remote
Medtronic CareLink® Home Monitor
In-office
Provided
Not Provided
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 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
Clinical Management Alerts
Lead / Device Integrity Alerts
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
Required Study Programming
Remote
Medtronic CareLink® Home Monitor
In-office
Provided
Not Provided
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 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
Clinical Management Alerts
Lead / Device Integrity Alerts
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
Study Demographics
Patient Characteristics
Remote (n=1014)
In-office (n=983)
70.5%
71.7%
65.2 ± 12.4
64.9 ± 11.9
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%
Male
Age (years)
CRT-D
Primary Endpoint
Median time in the Remote
arm was 4.6 days vs. 22 days
in the In-office arm
25
Event to Clinical Decision (median time)
(per patient with at least one event)
22
20
Number of Days
Time from event to clinical
decision in the Remote Arm
was significantly shorter
than in the In-office Arm
(p<0.001)
15
10
5
4.6
0
Remote Arm (N=172 pts)
In-office Arm (N=145 pts)
Note: Data includes events for patients who crossed over, were noncompliant or had alerts occur prior to home monitor setup
Time from Event to Decision by Alert Type
(median days)
Device Event
No. of Events
(No. of Patients)
No. of Days from Event Onset To
Clinical Decision
Median (Interquartile Range)
Remote
In-office
Remote
In-office
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)
1 (1)
1 (1)
30
0
575 (172)
391 (145)
3 (0, 13)
20 (4, 52)
AT/AF burden at least 12 hrs
Low battery
Overall
Results of Clinician Alert Transmissions
Clincian alert unable
to transmit due to
other reasons
(patient not home,
monitor not plugged
in, etc.)
9%
Clinician alert
unable to transmit
due to home
monitor not set up
25%
Patient seen inoffice prior to
clincian alert
transmission
13%
(Remote Arm)
Successful clinician
alert transmission &
device data viewed
prior to clinicial
decision
41%
Successful clinician
alert transmission
but decision made
prior to viewing data
12%
Clinician Alert Transmissions
Mean Time From Event to Decision by Alert Type (Remote arm)
Mean Number of Days (mean ± SE)
8
7
Time from Viewing to Decision
6
Time from Event to Viewing
5
4
3
2
1
0
AT/AF Burden
(N=104)
Fast V Rate
(N=16)
All Therapies
Exhausted
(N=4)
2+ Shocks
(N=13)
Lead
Impedance
(N=7)
VF Detection
OFF (N=1)
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)
7
Annualized Rate Per Patient Year
6.27
6
Remote Arm
5
In-office Arm
4.33
3.92
4
3
2.24
2
1.68
1.94
1
0
Scheduled Visits
Unscheduled Visits
All Clinic Visits
Health Care Utilization Visits
by Treatment Arm
Remote Arm
Annualized Rate Per Patient Year
3.00
p=0.10
2.50
In-office Arm
2.24
1.95
2.00
1.50
1.00
p=0.52
p=0.33
0.50
0.50
0.47
0.24
0.21
0.00
CV Hospitalization
Emergency Department Unscheduled Clinic Visit *
* Includes Urgent Care Visits
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
Mean Length of Stay Per Hospitalization
Remote Arm
5
In-office Arm = 4 days
per hospitalization
Estimated savings per
hospitalization $1,659*
Number of Days
4
Mean reduction 18%
3
In-office Arm
4.7
3.6
4.0
3.8
3.3
3.0
2
1
0
ICD
CRT-D
Overall
(p = 0.002)
* Estimated using the Medicare Limited Data Set - Standard Analytic Files from 2002-2007
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