1. IHE Workshop – Feb 2007 Tim Becker, PhD Univ- Hospital Schleswig-Holstein, Campus Kiel Implantable Device Cardiac Observations (IDCO) Profile

2. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 3 IDCO - Programmer Vendor specific Programmers used to communicate with implanted devices

4. IHE Workshop – Feb 2007 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 In-Clinic – Programmer Remote – Communicator / Data Collector Remote – Communicator / Data Collector Each interrogating device is vendor proprietary

5. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 13 I1: In-Clinic Followup Obvservation Creator Device Programmer Obvservation Processor Translator Proprietary Protocol Obvservation Repository Send Observation [CARD-12] No standardized communication between programmer and Observation Creator Device Proprietary Protocol

14. IHE Workshop – Feb 2007 14 I2: In-Clinic Followup with Networked Programmer that Translates Information Obvservation Creator Device Programmer Obvservation Processor Translator Obvservation Repository Send Observation [CARD-12] Programmer assumes role of the Observation Creator

15. IHE Workshop – Feb 2007 15 I3: Remote Followup Obvservation Creator Obvservation Processor Translator Obvservation Repository Send Observation [CARD-12] Use of ATNA to secure communication for remote followup Clinic A Clinic B ATNA: Secure Node untrusted network

16. IHE Workshop – Feb 2007 16 I4: Third Party Value-Added Systems Obvservation Creator Obvservation Processor Translator Obvservation Repository Send Observation [CARD-12] incl. rendered data as PDF 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 Value Added Systems Analysis

17. IHE Workshop – Feb 2007 17 Example Transaction Flow

18. IHE Workshop – Feb 2007 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 Patient Identifier Cross Reference Manager Patient Identifier Cross Reference Consumer Obvservation Processor Obvservation Repository HL/ Message Router PIX Query [ITI-9] PIX Update Notification [ITI-10] Patient Identity Feed [ITI-8] Asigning Authority: Device Manufacturer Patient Identifier: Model device model number + device serial number

19. IHE Workshop – Feb 2007 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. IHE Workshop – Feb 2007 20 Option for Standard OBX Segment

21. IHE Workshop – Feb 2007 21 Whats Next? Waveforms Workflows (Scheduling / Orders)

22. IHE Workshop – Feb 2007 22

23. IHE Workshop – Feb 2007 Tim Becker, PhD Univ- Hospital Schleswig-Holstein, Campus Kiel Stress Testing Workflow Integration Profile

24. IHE Workshop – Feb 2007 24 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

25. IHE Workshop – Feb 2007 25 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

26. IHE Workshop – Feb 2007 26 Stress Options Stress Echo Began in the early – mid 1990s 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

27. IHE Workshop – Feb 2007 27 Stress Workflow Diagram Requires that Image Manager / Image Archive and Image Display support images, waveforms and structured reports

28. IHE Workshop – Feb 2007 28 Stress Workflow – Actors and Options ActorOption NameOptionalityVol & Section Acquisition ModalityPatient Based Worklist QueryORAD-TF 2: 4.5 Broad Worklist QueryR (see note 1)RAD-TF 2: 4.5 PPS Exception ManagementORAD-TF 2: 4.7 Stress ECGR (see note 2)CARD-TF 2: 4.2 Stress EchoR (see note 2)CARD-TF 2: 4.2 Nuclear Medicine (see note 3)R (see note 2)RAD-TF 2: 4.8 Image Manager/ Image ArchivePPS Exception ManagementORAD-TF 2: 4.7 Intermittently Connected ModalityRCARD-TF 2: 4.3 Stress ECGRCARD-TF 2: 4.2 EchocardiographyRCARD-TF 2: 4.2 Nuclear Medicine (see note 3)RRAD-TF 2: 4.8 Availability of PPS-Referenced InstancesORAD-TF 3: 4.49 Image DisplayStress ECGRCARD-TF 2: 4.4 Stress EchoRCARD-TF 2: 4.2 Cardiac NM (see notes 3, 4)RRAD-TF 2: 4.16

29. IHE Workshop – Feb 2007 29 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

30. IHE Workshop – Feb 2007 30 Stress: Protocol and Stage Procedure Protocol Stages

31. IHE Workshop – Feb 2007 31 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!

32. IHE Workshop – Feb 2007 32 Attribute Summary ConceptModality WorklistEchoECGNM Requested Procedure Requested Procedure Code Sequence (0032,1064) Procedure Code Sequence (0008,1032) ProtocolScheduled Protocol Code Sequence (0040,0008) Performed Protocol Code Sequence (0040,0260) CID 12001* Performed Protocol Code Sequence (0040,0260) CID 3261 Performed Protocol Code Sequence (0040,0260) CID 3261** Protocol Stage Number Acquisition Context Sequence (0040,0555) >(109055, DCM, Protocol Stage) Patient StateStage Number (0008,2122) Stage Code Sequence (0040,000A) CID 12002* Acquisition Context Sequence (0040,0555) >(109054, DCM, Patient State) CID 3262 Acquisition Context Sequence (0040,0555) >(109054, DCM, Patient State) CID 3101

33. IHE Workshop – Feb 2007 33 Views Apical two chamber Apical four chamber Apical long axis Parasternal long axis Parasternal short axis Parasternal short axis at the aortic valve level Parasternal short axis at the level of the mitral chords Parasternal short axis at the Mitral Valve level Parasternal short axis at the Papillary Muscle level Right Ventricular Inflow Tract View Right Ventricular Outflow Tract View Subcostal long axis Subcostal short axis Suprasternal long axis Suprasternal short axis Stress Echo: Stage and Views Stress Echo Option Stage Number & View Number Stage Code Sequence & View Code Sequence Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) SRTP5-01201Image acquisition at baseline SRTP5-01202Pre-stress image acquisition SRTP5-01203Mid-stress image acquisition SRTP5-01204Peak-stress image acquisition SRTP5-01205Image acquisition during recovery

34. IHE Workshop – Feb 2007 34 Benefit: Stress Echo Viewing Consistency

35. IHE Workshop – Feb 2007 35 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 Nuclear Cardiology

36. IHE Workshop – Feb 2007 36