Download N0268_iCardeaObjectives_2009

An Intelligent Platform for Personalized
Remote Monitoring of the Cardiac Patients
with Electronic Implant Devices
http://www.srdc.com.tr/icardea/
Catherine Chronaki
On behalf of SRDC and the iCardea
Consortium
Credit: J. Brugada
Causes of death in heart failure
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO
TC215 WG7
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Cardiac Implantable Electronic Devices
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Pacemaker (PM)
Implantable Cardioverter-Defibrillator (ICD)
Cardiac Resynchronization Therapy (CRT)
Implantable Loop recorder (ILR)
Implantable Hemodynamic Monitoring (IHM()
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta,
IEEE 11073, ISO TC215 WG7
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Cardiac Implantable Electronic Devices
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Pacemaker (PM)
Implantable Cardioverter-Defibrillator (ICD)
Cardiac Resynchronization Therapy (CRT)
Implantable Loop recorder (ILR)
Implantable Hemodynamic Monitoring (IHM()
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta,
IEEE 11073, ISO TC215 WG7
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The number of cardiac implants in
increasing..
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Expected exponential increase over the next
years
2 million patients worldwide
2007:
Pacemakers ICDs
CRTs
North
America
564.074
234780
148092
Europe
683472
87747
61010
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23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073,
ISO TC215 WG7
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Telemonitoring technology in the EU
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ISO TC215 WG7
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Device Telemonitoring: opportunities
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23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073,
ISO TC215 WG7
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Device Telemonitoring: opportunities
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11073, ISO TC215 WG7
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Management from home-ICD
opportunities
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23rd Plenary HL7 WG Meeting, Atlanta,
IEEE 11073, ISO TC215 WG7
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Status of Affairs in interoperability
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23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073,
ISO TC215 WG7
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iCardea Objectives
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There has been an exponential growth in the number of cardiac
implantable devices: 800.000 CIED patients in EU with 5.8 million
follow-up visits
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CIED electronic and software complexity have widen their function and
application
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However, due to their limited processing capabilities restricted by their
size, CIEDs need to be supported with software running on the data
centers
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Currently, the data center processing is standalone with their custom
software and proprietary interfaces
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Patient and device data is stored in data centres operated by the
vendors
Presented via secure Web-sites to the access of responsible healthcare
professionals
Access to follow-up information often requires clinicians to use multiple
vendor specific systems and interfaces, reducing efficiency
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
11073, ISO TC215 WG7
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CIED Data Exposure Module
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iCARDEA aims to expose CIED data through standard interfaces based:
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International standards such as HL7, ISO/IEEE 11073 (Point of Care Medical
Device Communication Standards)
Standard profiles such as Integrating the Healthcare Enterprise (IHE) Implantable
Device Cardiac Observations (IDCO) Profile
Standard transport protocols such as Web Services
iCARDEA will provide the necessary authentication, authorization and
secure transfer of data mechanisms based on solid standards and profiles
As a result...
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CIED data will be ready to be integrated into the automated clinical follow-up
workflows
By exposing CIED data through standard interfaces, interoperability of data
coming from CIEDs from different vendors will be made achievable
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
11073, ISO TC215 WG7
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Personalized Adaptive Care Planner for
CIED Recipients
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Personalized follow-up of CIED patients will be coordinated through
a “care plan”
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An executable definition of a care pathway that consists of computer
interpretable clinical guideline models
Control flow of the care plan will be dynamically adapted based on the
patient’s context
Personalized Adaptive Care Planner Engine
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Care plan will be constructed through re-usable building blocks to be
personalized for each patient
Subscribe to necessary context variables provided by the data source
services
Interact with the existing healthcare institutions for operations like scheduling
in-clinic follow-up with the responsible physician
Check the existing healthcare records from EHR systems
Provide reminder and personalized guidance services to the patient to
enable improved compliance with the follow-up
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
11073, ISO TC215 WG7
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Interoperability Infrastructure for
EHRs, PHRs and Code Systems
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Follow-up of CIED patients requires access to medical history and other clinical
information of the patients that are stored in EHR and PHR systems
iCARDEA will develop Interoperability Infrastructure for EHRs
 Enable the legacy EHR systems of the end-users (in whatever format they
are) to expose EHR using HL7 CDA as the EHR content standard and HL7
Web Services Profile as the transport protocol standard
 Interoperability Infrastructure for Personal Health Records
 IHE Exchange of Personal Health Record Content (XPHR) Profile will be
implemented in iCARDEA
 Code Mapping API
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Handle automatic mapping of coded terms from different code systems by
implementing HL7 Common Terminology Services (CTS) interfaces
Unified Medical Language System Knowledge Source Server (UMLSKS)
The implementation will be exposed as Web Services as defined by the CTS
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
11073, ISO TC215 WG7
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Data Analysis and Correlation Tool
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For detection of further complications such as
contraindications and co-morbidities
Analogical reasoning will be used
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Analyze patients’ various physiological parameters such as blood
pressure, pulse and electrocardiogram (ECG) gathered via CIED
Data Exposure Module together with the patient data extracted
from electronic healthcare records or patient health records
Correlate the data with the data stored in established biomedical
knowledge bases, such as PhysioNET, to extract hidden patterns
and trends in data which leverages the quality and effectiveness
of decision making and to alert doctors in an unusual situation or
unexpected profile deviations
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
11073, ISO TC215 WG7
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Patient Empowerment Framework
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iCARDEA will provide a Web based Personal Health Record (PHR)
system
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Patients will be able to view their medical history, CIED data, and
manage their medication summaries, daily nutrition information
iCARDEA targets high acceptance of patients and gain the
maximum clinical and social benefit
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Tools for patient education and feedback will be provided
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Static and dynamic educative materials such as written guidelines and
interactive demos
Facilitate connection with the responsible healthcare professional for
enabling patients to send and retrieve feedback about their health status
Patient controlled and configurable privacy mechanisms and
enhanced security mechanisms will be provided
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Privacy will be managed by the patient himself through the Patient
Consent Editor
September 23, 2009
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11073, ISO TC215 WG7
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iCARDEA Architecture
September 23, 2009
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IEEE 11073, ISO TC215 WG7
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iCARDEA Pilot Application
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Deployment will be in Salzburg Clinics in Austria with two groups of patients
First group of ICD patients with ordinary post-surgical control (twice per
year),
Second group of ICD patients with iCARDEA-enhanced remote monitoring,
each group between 20-50 persons
The aspects of evaluation and validation will include:
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Possible medical risks which could be detected earlier
Management of symptoms
Time and pathway from patient symptoms to clinical decision in response to the
symptom
Indicators on how remote iCARDEA monitoring can reduce risks for the patients
(concerning the device and medical risks)
Usability and acceptance (patients, medical experts)
Patient well-being
Current barriers and limits; perspectives for future developments
Adequacy of the iCARDEA security and privacy measures
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
11073, ISO TC215 WG7
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iCardea Data Sources
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Cardiovascular Implantable Electronic Devices
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EHR
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Pace Maker
Implantable cardioverter defibrillators (ICD)
Cardiac Resynchronization Therapy (CRT) device
Previous or ongoing healthcare problems
Medications
Family History
PHR
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Dietary
Daily usage of medications
Allergies
Physical Activities
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
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Example Data to be used in Decision
Support
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History of non-cardiac conditions
Detailed information about severity of each
condition (e.g., specifics of therapy for the
condition)
The medications
The non-cardiac conditions denoting
contraindications to the proposed therapies
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
11073, ISO TC215 WG7
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An Example: the Prognosis of Heart
Failure
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Predictors come from different sources
From EHR and PHR:
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Demographics
Body Weight, Physical Activity
The medications (including angiotensin-converting enzyme inhibitors and betablockers)
Problems: Hypotension, Diabetes, Anaemia, Chronic obstructive pulmonary
disease, Depression, Sleep related breathing disorders
From CIED
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Electrophysiological: Tachycardia, Complex Ventricular Arrhythmias, Atrial
Fibrillation, Heart Rate Variability
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The onset of atrial fibrillation has also shown to be a predictor sudden cardiac death
An increase in mean heart rate has been shown to predict an increase in cardiac
mortality
Accumulation of consecutive day-to-day differences between the daily and reference
impedance can predict heart failure
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073,
ISO TC215 WG7
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Foreseen Decision Making Processes
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An Example
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A patient with ischemic cardiomyopathy is discharged with a ICD
implantation
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Data followed: diagnostic data on heart rhythm, atrial, and ventricular
arrhythmias accompanied by IECG (VT, VF, SVF Detection,
Ventricular Episodes, Mode Switch episode duration, Ventricular
Rhythm, Mean Ventricular Rate, Mean Ventricular Extrasistole, %
CRT Pacing )
From this data, atrial and ventricular arrhythmia development is
detected (Early detection of Asymptomatic clinical event)
Combining this data with data coming from the patient’s EHR and
PHR, the following becomes possible
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Change in drug therapy by considering
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September 23, 2009
Comorbidities
Intolerances to certain drugs
Current medications
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
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iCARDEA consortium
Partner no
EHR-profiles
Research
Research
interoperability
Partner name
Software Research and Development and
SRDC, Turkey
Consultancy Ltd.
OFFIS e.V. (OFFIS)
Salzburg Research
Forschungsgesellschaft m.b.H
Foundation for Research and Technology
Hellas – Institute of Computer Science
Salzburger Landeskliniken
BetriebsgesmbH
St. Jude Medical Medizintechnik
ICD manufacturer
Ges.m.b.H
Hospital
ICD manufacturer Medtronic Österreich GmbH
hospital
September 23, 2009
Partner org. short name
Hospital Clinic I Provincial de Barcelona
23rd Plenary HL7 WG Meeting, Atlanta, IEEE
11073, ISO TC215 WG7
OFFIS, Germany
SRFG, Austria
FORTH, Greece
SALK, Austria
SJM, Austria
Medtronic, Austria
HCPB, Spain
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iCARDEA Architecture
September 23, 2009
23rd Plenary HL7 WG Meeting, Atlanta,
IEEE 11073, ISO TC215 WG7
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Thank very much you for
your attention
http://www.srdc.com.tr/icardea/