Implantable Device Cardiac Observations (IDCO) Profile

1. Implantable Device Cardiac Observations (IDCO) Profile Tim Becker, PhD Univ- Hospital Schleswig-Holstein, Campus Kiel

2. Implantable Cardiac Devices • Pacemakers – therapy for heart rate problems • Defibrillators – therapy for life threatening heart rhythms • Cardiac Resynchronization – therapy for congestive heart failure

3. IDCO - Programmer Vendor specific ‚Programmers‘ used to communicate with implanted devices

4. Impl. Cardiac Device Follow-up • Electrophysiologists follow patients with implantable cardiac devices from multiple vendors • For each patient follow-up information that is stored in the implantable device is electronically collected by an “interrogating” device • In-Clinic – Programmer • Remote – Communicator / Data Collector • Each “interrogating” device is vendor proprietary

5. Impl. Cardiac Device Follow-up • The follow-ups can occur in-clinic or remotely in the home healthcare environment • Access to follow-up information often requires clinicians to use multiple vendor specific systems and interfaces, complicating efficiency and quality of workflows • Most of the interrogation devices are (portable) stand-alone systems without network interface • Aggregation of data into a central EMR or device clinic management systems requires manual and paper processes

6. IDCO Value Proposition • Enable management of follow-up information in a central system such as an Device Clinic Management System or EMR • Improve efficiency and quality of related clinical processes • Single point of access for information • Automation of current manual processes for data collection, aggregation and analysis • Standardization of workflow processes • Enabling of analytics

7. IDCO Profile Approach • Existing messing and nomenclature standards • HL7 Therapeutic Device Domain – Implantable Device Cardiac messaging standards • ISO/IEEE 11073 Point of Care Medical Device Communication Standards nomenclature • Define actors, transactions and constraints consistent with existing and evolving IHE profiles and contexts • Align with future EP Workflow and other related profiles • Keep it simple for first year – trial implementation

8. IDCO Profile Use Cases • In-Clinic Implants or Follow-ups • Patients present themselves in-clinic for implantation or follow-ups • Information is collected using vendor specific “programmers” • Information is sent from interrogation system to a central Device Clinic Management System or EMR • Remote Follow-ups • Patients devices are interrogated in the home health care environment • Information is collected using vendor specific communication devices and systems • Information is sent from interrogation system to a central Device Clinic Management System or EMR

9. IDCO Profile Use Cases • Case I1: In-Clinic Followup • Case I2: In-Clinic Followup with Networked Programmer that Translates Information • Case I3: Remote Followup • Case I4: Third Party Value-Added Services

10. IDCO Actors • Observation Creator - A system that creates and transmits diagnostic or therapeutic observational data. • Observation Processor and Repository – Systems that receive clinical observations and further process them or store them for retrieval and display. • Grouped with PIX and PAM actors for patient identification and demographics management.

11. IDCO Actors • Alternative Actor configuration • HL7 Router - A system that receives HL7 messages, routes them to one or more configured actors, and handles transport level acknowledgements. • Router will manage patient identification cross-referencing

12. Transaction CARD 12 • CARD-12 • Unsolicited HL7 v2.5 ORU message • OBX contains XML payload based on HL7 v3 IDC message • XML payload coded using ISO/IEEE 11073.1.1.3 IDC nomenclature containing Device Observations, Patient Observations, Device Therapy Settings • Options for standard v2.5 OBX and embedded PDF report • Audit Trail and Node Authentication (ATNA) profile recommended for remote follow-ups across non-trusted networks • Attention ! Changes in Year 4 • OBX containing HL7 v2.5 will be required • OBX containing HL7 v3 will be an option

13. I1: In-Clinic Followup Device Proprietary Protocol Translator Device Programmer Proprietary Protocol Obvservation Creator Send Observation [CARD-12] Obvservation Processor Obvservation Repository • No standardized communication between programmer and Observation Creator

14. I2: In-Clinic Followup with Networked Programmer that Translates Information Translator Device Programmer Obvservation Creator Send Observation [CARD-12] Obvservation Processor Obvservation Repository • Programmer assumes role of the Observation Creator

15. I3: Remote Followup Translator Obvservation Creator ATNA: Secure Node Clinic A Send Observation [CARD-12] untrusted network Clinic B ATNA: Secure Node Obvservation Processor Obvservation Repository ATNA: Secure Node • Use of ATNA to secure communication for remote followup

16. I4: Third Party Value-Added Systems Value Added Systems Translator Obvservation Creator Analysis Send Observation [CARD-12]incl. rendered data as PDF Obvservation Processor Obvservation Repository • Observation Creator is implemented as a third party service (e.g. monitor service) • Povides additional functions such as analysis, trending, statistical reports • Additional data can be sent as a PDF attachment

17. Example Transaction Flow

18. Patient Identification • Implanted Device does not carry any information about patient identifikation • Make use of ITI – Patient Identifier Cross-referencing Profile Patient Identy Source PIX Query [ITI-9] Patient Identity Feed [ITI-8] Obvservation Processor PIX Update Notification [ITI-10] Patient Identifier Cross Reference Manager Patient Identifier Cross Reference Consumer Obvservation Repository HL/ Message Router Asigning Authority: Device Manufacturer Patient Identifier: Model device model number + device serial number

19. Potential Extended Actor Groupings Basic IDCO Report Display using Retrieve Information for Display Profile (RID) IDCO Data Incorporation into a Report using Displayable Reports Profile (DRPT) IDCO Discrete Data Storage using Evidence Documents Profile (ED) IDCO Submission to an EHR using Cross Domain Document Sharing Profile (XDS)

20. What’s Next? • Waveforms • Workflows (Scheduling / Orders)

22. Stress Testing Workflow Integration Profile Tim Becker, PhD Univ- Hospital Schleswig-Holstein, Campus Kiel

23. So what is Stress Testing? • Uses exercise or medication to increase the work of the heart. • Continuous 12 lead ECG monitoring during study • Looking for changes in ST segments • Used as a screening tool • Or to test effectiveness of therapy • Done in Hospital and Cardiologist Office • Optional: Image acquisition

24. Stress Documentation • Multiple samples of 12 lead ECG during the protocol • Ultrasound or Nuclear images • Summary report usually one page in length • Physician will do comparisons to previous studies

25. Stress Options • Stress Echo • Began in the early – mid 1990’s • Observation of wall motion and ejection fractions with the heart under stress • High specificity for correlating ischemia to functional abnormalities • Can be done with exercise but mainly chemical • Nuclear Stress • Most often combined with exercise or chemical stress testing • Use of radioisotope to detect presence and resolution of ischemic regions of the heart • Scan immediately post • Scan 4 hours to 1 day later • Resolution of ischemic area determines viability of muscle

26. Stress Workflow Diagram Requires that Image Manager / Image Archive and Image Display support images, waveforms and structured reports

27. Stress Workflow – Actors and Options

28. Use Cases • Case S1: Cardiac Stress Test, ECG Only • Limited use with lower sensitivities and specificities • Screening tool only • Case S2: Cardiac Stress Test with Imaging • More common use case • Echocardiography – requires Consistent Time to combine clinical data from Stress Monitor and Echo Modality

29. Stress: Protocol and Stage Procedure Protocol Stages

30. Stress: Protocol and Stage • Procedure : Exercise Stress • Protocol: Bruce • Stages: • Standard Bruce has 7 stages • Stage 1: 1.7 mph @ 10 % grade • Stage 7: 6.0 mph @ 22 % grade Important Note: A procedure can be considered complete irrespective of the protocol being complete!

31. Attribute Summary

32. Stress Echo: Stage and Views • Stress Echo Option • Stage Number & View Number • Stage Code Sequence & View Code Sequence

33. Benefit: Stress EchoViewing Consistency

34. Nuclear Cardiology • Image formats • Stress and Rest raw data review • Stress and Rest processed data • Gated SPECT data • Quantitative data • Screen captures, “snap shots” • Color maps • Gray scale is default • Color overlays can be applied