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

The Value of Remote Monitoring

George H. Crossley, MDPresident, Mid-State Cardiology, a unit of St. Thomas Heart

Clinical Professor of Medicine, University of Tennessee College of MedicineACC 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

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 Arm1014 pts

Enrollment

In-office Arm983 pts

1 Month Office F/U

Patient signs Informed Consent/HIPAA Authorization implanted with a study device and randomized

Enrollment

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 ProgrammingRemote In-office

Medtronic CareLink® Home Monitor Provided Not Provided

Clinical Management AlertsAT/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 AlertsLead 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

Required Study Programming

MidnightDay 1

MidnightDay 2

MidnightDay 3

MidnightDay 1

MidnightDay 2

MidnightDay 3

Atrial fibrillation

Atrial fibrillation

Required Study ProgrammingRemote In-office

Medtronic CareLink® Home Monitor Provided Not Provided

Clinical Management AlertsAT/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 AlertsLead 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

• 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

Study DemographicsPatient Characteristics Remote (n=1014) In-office (n=983)

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%

Primary EndpointEvent to Clinical Decision (median time)

(per patient with at least one event)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

Note: Data includes events for patients who crossed over, were non-compliant or had alerts occur prior to home monitor setup

4.6

22

0

5

10

15

20

25

Remote Arm (N=172 pts) In-office Arm (N=145 pts)

Nu

mb

er

of D

ays

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

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 0Overall 575 (172) 391 (145) 3 (0, 13) 20 (4, 52)

Results of Clinician Alert Transmissions (Remote Arm)

Successful clinician alert transmission & device data viewed

prior to clinicial decision

41%

Successful clinician alert transmission but decision made

prior to viewing data12%

Patient seen in-office prior to clincian alert transmission

13%

Clinician alert unable to transmit

due to home monitor not set up

25%

Clincian alert unable to transmit due to

other reasons (patient not home,

monitor not plugged in, etc.)

9%

Clinician Alert Transmissions

0

1

2

3

4

5

6

7

8

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)

Mea

n N

umbe

r of

Day

s (m

ean

±SE

)

Mean Time From Event to Decision by Alert Type (Remote arm)

Time from Viewing to Decision

Time from Event to Viewing

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)

1.68

2.24

3.924.33

1.94

6.27

0

1

2

3

4

5

6

7

Scheduled Visits Unscheduled Visits All Clinic Visits

Annu

alize

d Ra

te P

er P

atien

t Yea

r

Remote Arm

In-office Arm

Health Care Utilization Visits by Treatment Arm

* Includes Urgent Care Visits

0.50

0.24

2.24

0.47

0.21

1.95

0.00

0.50

1.00

1.50

2.00

2.50

3.00

CV Hospitalization Emergency Department Unscheduled Clinic Visit *

Annu

aliz

ed R

ate

Per P

atien

t Yea

r

Remote Arm

In-office Arm

p=0.52p=0.33

p=0.10

Impact of Remote Management

Remote Arm = 3.3 days per hospitalization

In-office Arm = 4 days per hospitalization

Mean reduction 18%

Estimated savings per hospitalization $1,659*

3.0

3.8

3.33.6

4.7

4.0

0

1

2

3

4

5

ICD CRT-D Overall

Num

ber o

f Day

s

Mean Length of Stay Per HospitalizationRemote Arm

In-office Arm

This study showed the Remote Arm had significantly shorter hospitalization length of stays than In-office Arm (p=0.002)

(p = 0.002)

* Estimated using the Medicare Limited Data Set - Standard Analytic Files from 2002-2007

Conclusions

• 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

In this study monitoring patients remotely with automatic clinician alerts showed: