An Intelligent Platform for Personalized Remote Monitoring of the Cardiac Patients with Electronic Implant Devices http://www.srdc.com.tr/icardea/

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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
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Causes of death in heart failure
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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

Pacemakers ICDs CRTs
North America 564.074 234780 148092
Europe 683472 87747 61010
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Telemonitoring technology in the EU
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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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Device-Centric Diagnostics
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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 patients 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
  patients 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
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
interoperability Foundation for Research and Technology Hellas Institute of Computer Science FORTH, Greece
Hospital Salzburger Landeskliniken BetriebsgesmbH SALK, Austria
ICD manufacturer St. 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/