robert c. bourge, md professor of medicine, radiology, and surgery
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
The Potential of Telemedical Devices to Monitor and Enhance Patient Health:
-----------------------------------------Focus on Cardiovascular Disease
Robert C. Bourge, MDProfessor of Medicine, Radiology, and Surgery
Director, Division of Cardiovascular DiseaseThe University of Alabama at Birmingham
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
ImplantedDevice Diagnostics
Patient activity h/day
AT/AF total h/day
V. rate during AT/AF, bmp
Average V. rate, bpm
Heart Failure Management Report
OptiVol fluid index
Thoracic impedance
Heart Failure Management Report
Acute Exacerbations Contribute to the Progression of the Heart Failure
TimeTime
Cli
nic
al S
tatu
sC
lin
ical
Sta
tus
Acute eventAcute event
With each event, hemodynamic With each event, hemodynamic alterations/myocardial injury alterations/myocardial injury contribute to progressive contribute to progressive ventricular dysfunctionventricular dysfunction
Heart failure progression may be accelerated by the aggressive therapiesinitiated during hospitalization
Jain P et al. Jain P et al. Am Heart JAm Heart J. 2003;145:S3-S17. . 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)
-21-21 -14-14 - 7 - 7 DaysDays
ReactiveReactiveProactiveProactive
0 0
SymptomsSymptoms
Pressure ChangesPressure Changes
Heart Failure EventHeart Failure Event
Physiological Premise of Monitor Guided Care
-21 -14 - 7 Days
ProactiveProactive
0
Pressure ChangesPressure Changes
Medical InterventionMedical Intervention AvertedAvertedHeart Failure EventHeart Failure Event
7
TEN-HMS: Patients Baseline Characteristics
0,05777580Mean Weight (kg)
ns3,873 [1,607 to
7,518]
2,909 [1,116 to
6,140
2,309 [1,057 to
6,935]
Median NT-proBNP(pg/ml)
ns252524Mean LVEF (%)ns112/69116/69115/69BP (mmHg)
ns343946NYHA III & IV (%)ns666154NYHA I & II (%)ns202818Women (%)ns544749% Patients age >70ns676768Mean Age (years)
16817385Number PatientspHTMNTSUCVariable
IQR
TEN-HMSDays Dead or Hospitalized over 240 days
02468
101214161820
. . . .
UCNTSHTM
%
Death or Days in
Hospital (All-cause)
Death or Hospital Days
for Heart Failure
Days in Hospital
Days in HospitalFor HF
NB HTM reduced Average length of stay
p < 0,05
Mo
rtal
ity
Cleland et al JACC 2005
TransEuropean Home Telemonitoring Study Mortality
Reduction in MortalityNTS or HTM v UCAbsolute 16.4%Relative 36 %
Effect of Structured Telephone Support on All-Cause Mortality
Clark RA et al. BMJ 2007
Effect of Home Telemonitoring
Clark RA, BMJ 2007
On hospitalization
On mortality
Chronicle IHM - Lead Positioning
PressureSensorCapsule
Chronicle Pressure Measurements
1 = RVDP at QRS detection
13
2
EGM
RVP
dP/dt
2 = RVSP at peak of waveform
3 = ePAD at maximal dP/dt
Efficacy in NYHA Class III Patients
Cumulative Events
0
20
40
60
80
100
120
1
Eve
nts
Chronicle(n =112)
Control(n = 122)
# of Pts with Events 35 51
Total HF Related Events 58 99
Hospitalizations 50 86
Emergency Department Visits 6 11
Urgent Clinic Visits 2 3
Event Rate / 6months 0. 54 0.85
% Reduction in Event Rate
36% (p=0.0061; p=0.0582)
Chronicle
Control
642Months
1. Poisson model - Scaled Deviance = 1.7
2. 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
Days
Fre
edo
m f
rom
HF
-re
late
d
ho
spit
aliz
atio
n
0 50 100 150 200
0%
20%
40%
60%
80%
100%
RR = 0.62 (95%CI = 0.39 - 0.98)p=0.04
Chronicle
Control
Bourge, RC, et al. J Am Coll Cardiol 2008;51:1073-9
Implanted Monitor Derived Hemodynamics in PAH
Fig 1, Karamanoglu, M, et al, Chest 2007, 132:37-43
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
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).
CO= 30 x(P1st-PES)x(STI-PEI)/RR AP=PSYS-P1st
0
40
mm
Hg
SV
ED
PES
P1st
0
500 ms -1000
mm
Hg
/s
dP/dtmax
dP/dtmin
ePAD
T1st
PEI
STI
Psys
RR
Qmax
SV
CO= 30 x(P1st-PES)x(STI-PEI)/RR AP=PSYS-P1st
0
40
mm
Hg
SV
ED
PES
P1st
0
500 ms -1000
mm
Hg
/s
dP/dtmax
dP/dtmin
ePAD
T1st
PEI
STI
Psys
RR
Qmax
SV
Implanted Monitor Derived Hemodynamics in Pulmonary Arterial Hypertension
Fig 6 & 7, Karamanoglu, M, et al, Chest 2007, 132:37-43
0 1 2 3 4 5 6
Estimated (L/min/m2)
0
1
2
3
4
5
6
Mea
sure
d (
L/m
in/m
2 )
Y=X, r2=0.95
Cardiac Index
0 1 2 3 4 5 6
Average (L/min/m2)
-1.0
-0.5
0.0
0.5
1.0
Dif
fere
nce
(L
/min
/m2 )
+95% CI=0.37 L/min/m2
-95% CI=0.37 L/min/m2
Mean=0.0 L/min/m2
Bland - Altman Plot
0 1 2 3 4 5 6
Estimated (L/min/m2)
0
1
2
3
4
5
6
Mea
sure
d (
L/m
in/m
2 )
Y=X, r2=0.95
Cardiac Index
0 1 2 3 4 5 6
Average (L/min/m2)
-1.0
-0.5
0.0
0.5
1.0
Dif
fere
nce
(L
/min
/m2 )
+95% CI=0.37 L/min/m2
-95% CI=0.37 L/min/m2
Mean=0.0 L/min/m2
Bland - Altman Plot
0
2
4
6
L/m
in/m
2
0
100
200
300
400
500
mm
Hg
0
2
4
6
L/m
in/m
2
01 0907060503 3431
EstimatedMeasuredDose
CardioMEMS Wireless Heart Failure Sensor
Externally powered – no battery
HF Sensor technology based on clinically proved commercially available system for abdominal aneurysms repair monitoring
AAA Sensor
HF Sensor
CardioMEMS System in Diastolic Dysfunction
550 Ptsw/ CM Implants
All Pts Take Daily Readings
Treatment275 Pts
Management Based onHemodynamics + Traditional Info
Control275 Pts
Management Based onTraditional Info
Primary Endpoint: HF Hospitalizations at 6 Months
Additional Analysis: HF Hospitalizations at All Days (~18 M mean F/U)
• Enrollment completed early October, 2009
• Final Data May 2010
• I/E:Class III HF with 1 hosp in previous yearNo EF or QRS criteria
• Cost Effectiveness Sub-Study
CHAMPIONCardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III heart failure patients
21Multiple Secondary Endpoints
Edible Electronic Monitors
Ingestible sensor chip 1mm
square and 200 microns thick
attached to pills with a bio-
compatible glue
External band-aid-like patch.
When swallowed the chips
send a signal to the patch
tracking heart rate,
respiratory rate, temperature
and activity.
1
Implanted Monitors-arrhythmia-hemodynamics-labs
The Potential for TeleMedicine in the Care of Patients with Cardiovascular Disease
Development of Integrated Tele-Medicinefor 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
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