An Intelligent Platform for Personalized Remote Monitoring of the Cardiac Patients with Electronic Implant Devices Catherine

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()

September 23, 2009

23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215

WG7 3

Cardiac Implantable Electronic Devices Pacemaker (PM) Implantable Cardioverter-Defibrillator (ICD) Cardiac Resynchronization Therapy (CRT) Implantable Loop recorder (ILR) Implantable Hemodynamic Monitoring (IHM()

September 23, 2009


WG7 4

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


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Device Telemonitoring: opportunities


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Device Telemonitoring: opportunities


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Management from home-ICD opportunities

September 23, 2009


WG7 9

Status of Affairs in interoperability

September 23, 2009

23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7 11

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


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

September 23, 2009 23rd Plenary HL7 WG Meeting, Atlanta,

IEEE 11073, ISO TC215 WG7 1717

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iCARDEA Architecture

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WG7

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

September 23, 2009 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215

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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


WG723

iCARDEA consortium


WG724

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

September 23, 2009 25


WG7

Thank very much you for your attention

http://www.srdc.com.tr/icardea/

Documents

An Intelligent Platform for Personalized Remote Monitoring of the Cardiac Patients with Electronic Implant Devices Catherine