Catherine Chronaki On behalf of SRDC and the iCardea Consortium

1. 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

2. Causes of death in heart failure 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() 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

4. Cardiac Implantable Electronic Devices • Pacemaker (PM) • Implantable Cardioverter-Defibrillator (ICD) • Cardiac Resynchronization Therapy (CRT) • Implantable Loop recorder (ILR) • Implantable Hemodynamic Monitoring (IHM() 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

5. The number of cardiac implants in increasing.. • Expected exponential increase over the next years • 2 million patients worldwide • 2007: 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

6. Telemonitoring technology in the EU 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

7. Device Telemonitoring: opportunities 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

8. Device Telemonitoring: opportunities 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

9. Management from home-ICD opportunities 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

10. Status of Affairs in interoperability 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

12. 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

13. 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 14 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

14. 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

15. 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

16. 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 17 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

17. iCARDEA Architecture 18 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

18. 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

19. 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

20. 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

21. 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

22. 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 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

23. iCARDEA consortium 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

24. iCARDEA Architecture 25 23rd Plenary HL7 WG Meeting, Atlanta, IEEE 11073, ISO TC215 WG7

25. Thank very much you for your attention http://www.srdc.com.tr/icardea/