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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 Pacemaker (PM) Implantable Cardioverter-Defibrillator (ICD) Cardiac Resynchronization Therapy (CRT) Implantable Loop recorder (ILR) Implantable Hemodynamic Monitoring (IHM()
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Cardiac Implantable Electronic Devices Pacemaker (PM) Implantable Cardioverter-Defibrillator (ICD) Cardiac Resynchronization Therapy (CRT) Implantable Loop recorder (ILR) Implantable Hemodynamic Monitoring (IHM()
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The number of cardiac implants in increasing.. Expected exponential increase over the next
years 2 million patients worldwide 2007:
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Pacemakers ICDs CRTs
North America
564.074 234780 148092
Europe 683472 87747 61010
Telemonitoring technology in the EU
September 23, 2009 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7
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Device Telemonitoring: opportunities
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Device Telemonitoring: opportunities
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Management from home-ICD opportunities
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Status of Affairs in interoperability
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iCardea Objectives 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
CIED electronic and software complexity have widen their function and application
However, due to their limited processing capabilities restricted by their size, CIEDs need to be supported with software running on the data centers
Currently, the data center processing is standalone with their custom software and proprietary interfaces 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
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CIED Data Exposure Module
iCARDEA aims to expose CIED data through standard interfaces based: 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... 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
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Personalized Adaptive Care Planner for CIED Recipients
Personalized follow-up of CIED patients will be coordinated through a “care plan” 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
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
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Interoperability Infrastructure for EHRs, PHRs and Code Systems 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
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
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Data Analysis and Correlation Tool For detection of further complications such as
contraindications and co-morbidities Analogical reasoning will be used
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
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Patient Empowerment Framework iCARDEA will provide a Web based Personal Health Record (PHR)
system 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 Tools for patient education and feedback will be provided
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 Privacy will be managed by the patient himself through the Patient
Consent Editor
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iCARDEA Architecture
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iCARDEA Pilot Application 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:
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
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iCardea Data Sources Cardiovascular Implantable Electronic Devices
Pace Maker Implantable cardioverter defibrillators (ICD) Cardiac Resynchronization Therapy (CRT) device
EHR Previous or ongoing healthcare problems Medications Family History
PHR Dietary Daily usage of medications Allergies Physical Activities
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Example Data to be used in Decision Support 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
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An Example: the Prognosis of Heart Failure Predictors come from different sources From EHR and PHR:
Demographics Body Weight, Physical Activity The medications (including angiotensin-converting enzyme inhibitors and beta-
blockers) Problems: Hypotension, Diabetes, Anaemia, Chronic obstructive pulmonary
disease, Depression, Sleep related breathing disorders From CIED
Electrophysiological: Tachycardia, Complex Ventricular Arrhythmias, Atrial Fibrillation, Heart Rate Variability 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
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Foreseen Decision Making Processes An Example
A patient with ischemic cardiomyopathy is discharged with a ICD implantation 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 Change in drug therapy by considering
Comorbidities Intolerances to certain drugs Current medications
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iCARDEA consortium
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Partner no Partner name Partner org. short name
EHR-profiles Software Research and Development and Consultancy Ltd.
SRDC, Turkey
Research OFFIS e.V. (OFFIS) OFFIS, Germany
Research Salzburg Research Forschungsgesellschaft m.b.H
SRFG, Austria
interoperabilityFoundation for Research and Technology Hellas – Institute of Computer Science
FORTH, Greece
HospitalSalzburger Landeskliniken BetriebsgesmbH
SALK, Austria
ICD manufacturerSt. Jude Medical Medizintechnik Ges.m.b.H
SJM, Austria
ICD manufacturer Medtronic Österreich GmbH Medtronic, Austria
hospital Hospital Clinic I Provincial de Barcelona HCPB, Spain
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iCARDEA Architecture
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Thank very much you for your attention
http://www.srdc.com.tr/icardea/