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>
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
Implanted
Device Diagnostics
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
Acute Exacerbations Contribute to the Progression
of the Heart Failure
Clinical Status
With each event, hemodynamic
alterations/myocardial injury
contribute to progressive
ventricular dysfunction
Acute event
Heart failure progression
may be accelerated by the
aggressive therapies
initiated during hospitalization
Time
Jain P et al. Am Heart J. 2003;145:S3-S17.
Congestive Heart Failure
Congestion
(as measured by increased intracardiac
end diastolic pressures)

 Symptoms and  Survival
Physiological Premise of Monitor Guided Care (1)
Heart Failure Event
Symptoms
Pressure Changes
-21
-14
-7
Proactive
0
Days
Reactive
Physiological Premise of Monitor Guided Care
Medical Intervention
Averted
Heart Failure Event
Pressure Changes
-21
-14
Proactive
-7
0
Days
TEN-HMS: Patients Baseline Characteristics
Variable
Number Patients
Mean Age (years)
% Patients age >70
Women (%)
NYHA I & II (%)
NYHA III & IV (%)
Mean Weight (kg)
BP (mmHg)
Mean LVEF (%)
Median NT-proBNP
(pg/ml)
IQR
UC
85
68
49
18
54
46
80
115/69
24
2,309
NTS
HTM
173
168
67
67
47
54
28
20
61
66
39
34
75
77
116/69 112/69
25
25
2,909
3,873
[1,057 to
6,935]
[1,116 to
6,140
[1,607 to
7,518]
p
ns
ns
ns
ns
ns
0,05
ns
ns
ns
7
TEN-HMS
Days Dead or Hospitalized over 240 days
20
18
16
14
12
%
10
8
6
4
2
0
UC
NTS
HTM
NB HTM reduced
Average length of stay
Days. in
Hospital
Days. in
Hospital
For HF
Death or
.
Days in
Hospital
(All-cause)
Death
. or
Hospital Days
for Heart Failure
Mortality
TransEuropean Home Telemonitoring Study
Mortality
Reduction in Mortality
NTS or HTM v UC
Absolute 16.4%
Relative 36 %
p < 0,05
Cleland et al JACC 2005
Effect of Structured Telephone Support on
All-Cause Mortality
Clark RA et al. BMJ 2007
Effect of Home Telemonitoring
On hospitalization
On mortality
Clark RA, BMJ 2007
Chronicle IHM - Lead Positioning
Pressure
Sensor
Capsule
Chronicle Pressure Measurements
EGM
1 = RVDP at QRS detection
2
2 = RVSP at peak of waveform
3
3 = ePAD at maximal dP/dt
1
RVP
dP/dt
Efficacy in NYHA Class III Patients
Control
(n = 122)
# of Pts with
Events
35
51
Total HF Related
Events
58
99
50
86
Emergency
Department Visits
6
11
Urgent Clinic Visits
2
3
0. 54
0.85
Hospitalizations
Event Rate /
6months
1
% Reduction in
Event Rate
1.
2.
Cumulative Events
120
100
Events
Chronicle
(n =112)
Chronicle
Control
80
60
40
20
0
2
36% (p=0.0061;
p=0.0582)
4
6
Months
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
HF-related Hospitalization – NYHA
Class III
Time to Event Analysis
Freedom from HF-related
hospitalization
100%
80%
Chronicle
Control
60%
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
CO= 30 x(P 1st-P ES)x(STI-PEI)/RR
AP=P SYS-P 1st
Implanted Monitor Derived
Hemodynamics in PAH
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
P 1st
40
Q max
mmHg
ePAD
P ES
SV
SV
ED
T 1st
0
PEI
STI
RR
dP/dtmax
0
mmHg/s
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
P sys
dP/dtmin
-1000
500 ms
6
500
4
300
200
2
mmHg
L/min/m2
400
100
0
0
Measured (L/min/m2)
Implanted Monitor Derived Hemodynamics in Pulmonary
Arterial Hypertension
Cardiac Index
6
5
4
Y=X, r2=0.95
3
2
1
0
0
1
2
3
4
5
6
Estimated
Measured
Dose
L/min/m2
6
4
2
0
01
03
05
06
07
09
31
34
Difference (L/min/m2)
Estimated (L/min/m2)
1.0
+95% CI=0.37 L/min/m2
0.5
Mean=0.0 L/min/m2
0.0
-95% CI=0.37 L/min/m2
-0.5
Bland - Altman Plot
-1.0
0
1
2
3
4
5
2
Average (L/min/m )
Fig 6 & 7, Karamanoglu, M, et al, Chest 2007, 132:37-43
6
CardioMEMS Wireless Heart Failure Sensor
HF Sensor technology based on clinically proved commercially
available system for abdominal aneurysms repair monitoring
AAA Sensor
HF Sensor
Externally powered – no battery
CardioMEMS System in Diastolic Dysfunction
CHAMPION
CardioMEMS Heart Sensor Allows Monitoring of Pressure to
Improve Outcomes in NYHA Class III heart failure patients
• 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
550 Pts
w/ CM Implants
All Pts Take Daily
Readings
Treatment
275 Pts
Management Based on
Hemodynamics + Traditional Info
Control
275 Pts
Management Based on
Traditional Info
Primary Endpoint: HF Hospitalizations at 6 Months
• Cost Effectiveness
Sub-Study
Additional Analysis: HF Hospitalizations at All Days (~18 M mean F/U)
Multiple Secondary Endpoints
21
Edible Electronic Monitors
Ingestible sensor chip 1mm
square and 200 microns thick
attached to pills with a biocompatible glue
External band-aid-like patch.
When swallowed the chips
send a signal to the patch
tracking heart rate,
respiratory rate, temperature
and activity.
The Potential for TeleMedicine in the
Care of Patients with Cardiovascular Disease
Implanted
Monitors
-arrhythmia
-hemodynamics
-labs
1
Development of Integrated Tele-Medicine
for 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
Summary
< bbourge@uab.edu >
Summary
< bbourge@uab.edu >
Summary
< bbourge@uab.edu >
Summary
< bbourge@uab.edu >