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IHE Workshop – Feb 2007
Tim Becker, PhDTim Becker, PhDUniv- Hospital Schleswig-Holstein, Campus KielUniv- Hospital Schleswig-Holstein, Campus Kiel
Implantable Device Cardiac Implantable Device Cardiac Observations (IDCO) ProfileObservations (IDCO) Profile
2IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Implantable Cardiac DevicesImplantable Cardiac Devices
Pacemakers – therapy for heart rate problems
Defibrillators – therapy for life threatening heart rhythms
Cardiac Resynchronization – therapy for congestive heart failure
3IHE Workshop – Feb 2007IHE Workshop – Feb 2007
IDCO - ProgrammerIDCO - Programmer
Vendor specific ‚Programmers‘ used to communicate with implanted devices
4IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Impl. Cardiac Device Follow-upImpl. Cardiac Device Follow-up
Electrophysiologists follow patients with implantable cardiac Electrophysiologists follow patients with implantable cardiac devices from multiple vendorsdevices from multiple vendors
For each patient follow-up information that is stored in the For each patient follow-up information that is stored in the implantable device is electronically collected by an implantable device is electronically collected by an “interrogating” device“interrogating” device
In-Clinic – ProgrammerIn-Clinic – Programmer Remote – Communicator / Data CollectorRemote – Communicator / Data Collector
Each “interrogating” device is vendor proprietaryEach “interrogating” device is vendor proprietary
5IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Impl. Cardiac Device Follow-upImpl. Cardiac Device Follow-up
The follow-ups can occur in-clinic or remotely in the home The follow-ups can occur in-clinic or remotely in the home healthcare environmenthealthcare environment
Access to follow-up information often requires clinicians to use Access to follow-up information often requires clinicians to use multiple vendor specific systems and interfaces, complicating multiple vendor specific systems and interfaces, complicating efficiency and quality of workflowsefficiency and quality of workflows
Most of the interrogation devices are (portable) stand-alone Most of the interrogation devices are (portable) stand-alone systems without network interfacesystems without network interface
Aggregation of data into a central EMR or device clinic Aggregation of data into a central EMR or device clinic management systems requires manual and paper processesmanagement systems requires manual and paper processes
6IHE Workshop – Feb 2007IHE Workshop – Feb 2007
IDCO Value PropositionIDCO 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
7IHE Workshop – Feb 2007IHE Workshop – Feb 2007
IDCO Profile ApproachIDCO 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
8IHE Workshop – Feb 2007IHE Workshop – Feb 2007
IDCO Profile Use CasesIDCO 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
9IHE Workshop – Feb 2007IHE Workshop – Feb 2007
IDCO Profile Use CasesIDCO 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
10IHE Workshop – Feb 2007IHE Workshop – Feb 2007
IDCO ActorsIDCO Actors
Observation Processor
Observation Repository
Send Observation[CARD - 12]
Send Observation[CARD - 12]
PIX Consumer
ObservationCreator
PIX Consumer
Patient Demographics
Consumer
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.
11IHE Workshop – Feb 2007IHE Workshop – Feb 2007
IDCO ActorsIDCO 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
Observation Processor
Observation Repository
Send Observation[CARD - 12]
ObservationCreator
Patient Demographics
Consumer
HL7 RouterSend Observation
[CARD - 12]
Send Observation[CARD - 12]
PIX Consumer
12IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Transaction CARD 12Transaction 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
13IHE Workshop – Feb 2007IHE Workshop – Feb 2007
I1: In-Clinic FollowupI1: 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
14IHE Workshop – Feb 2007IHE Workshop – Feb 2007
I2: In-Clinic Followup with Networked I2: In-Clinic Followup with Networked Programmer that Translates InformationProgrammer that Translates Information
Obvservation Creator
Device Programmer
Obvservation Processor
Translator
Obvservation Repository
Send Observation [CARD-12]
• Programmer assumes role of the Observation Creator
15IHE Workshop – Feb 2007IHE Workshop – Feb 2007
I3: Remote FollowupI3: 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
ATNA: Secure Node
ATNA: Secure Node
untrusted network
16IHE Workshop – Feb 2007IHE Workshop – Feb 2007
I4: Third Party Value-Added SystemsI4: 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
17IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Example Transaction FlowExample Transaction FlowDevice Interrogator Observation Creator Observation Processor Observation Repository
Query Device (1)
Send Interrogation
Send Interrogation (2)
Validate and Review (3)
Translate Information (4)
Send Observation [CARD-12] (5)
Process Observation (7)
Send Observation [CARD-12] (8)
Store Observation (10)
PIX Manager
PIX Query [ITI-9] (6)
PIX Query [ITI-9] (9)
18IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Patient IdentificationPatient 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
19IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Potential Extended Actor GroupingsPotential Extended Actor Groupings
ObservationRepository
Information Source
Display
Retrieve Document for Display [ITI - 12]
Retrieve Specific Info for Display [ITI - 11]
ObservationProcessor
ReportCreator
Report Manager
Encapsulated Report Submission [CARD - 7]
ObservationProcessor
EvidenceCreator
Image Manager
Storage Committment [CARD - 3]
Modality Images/Evidence Stored [CARD - 2]
Store Evidence Documents [RAD - 43]
Storage Committment [CARD - 7]
ObservationProcessor
Document Source
Document Repository
Provide and Register Document Set [ITI - 15]
Basic IDCO Report Display using Retrieve Information for Display Profile (RID)Basic IDCO Report Display using Retrieve Information for Display Profile (RID)
IDCO Data Incorporation into a Report using Displayable Reports Profile (DRPT)IDCO Data Incorporation into a Report using Displayable Reports Profile (DRPT)
IDCO Discrete Data Storage using Evidence Documents Profile (ED)IDCO Discrete Data Storage using Evidence Documents Profile (ED)
IDCO Submission to an EHR using Cross Domain Document Sharing Profile (XDS)IDCO Submission to an EHR using Cross Domain Document Sharing Profile (XDS)
21IHE Workshop – Feb 2007IHE Workshop – Feb 2007
What’s Next?What’s Next?
Waveforms
Workflows (Scheduling / Orders)
22IHE Workshop – Feb 2007IHE Workshop – Feb 2007
IHE Workshop – Feb 2007
Tim Becker, PhDTim Becker, PhDUniv- Hospital Schleswig-Holstein, Campus KielUniv- Hospital Schleswig-Holstein, Campus Kiel
Stress Testing Workflow Stress Testing Workflow Integration ProfileIntegration Profile
24IHE Workshop – Feb 2007IHE Workshop – Feb 2007
So what is Stress Testing?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
25IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Stress DocumentationStress 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
26IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Stress OptionsStress 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
27IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Stress Workflow DiagramStress Workflow Diagram
Pt. Registration [RAD-1] Patient Update [RAD-12]
Pt. Registration [RAD-1] Patient Update [RAD-12]
Placer Order Management [RAD-2] Filler Order Management [RAD-3]
ADT
Query Images [RAD-14] Retrieve Images/Evidence [CARD-4]
Image Display
Modality Image/Evidence Stored [CARD-2]
Storage Commitment
[CARD-3]
Procedure Scheduled [RAD-4]
Procedure Updated [RAD-13]
Query Modality Worklist [RAD-5]
Performed Procedure
Step Manager
Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]
Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]
Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]
Order Placer
Acquisition Modality
ImageManager
ImageArchive
DSS/ Order Filler
Patient Update [RAD-12]
Modality Image/Evidence Stored [CARD-2]
Storage Commitment
[CARD-3]
Evidence Creator Modality PS in Progress [CARD-1]
Modality PS Completed [RAD-7]
Instance Availability Notification [RAD-49]
Report Creator
Report Creator
Requires that Image Manager / Image Archive Requires that Image Manager / Image Archive and Image Display support images, and Image Display support images, waveforms and structured reportswaveforms and structured reports
28IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Stress Workflow – Actors and OptionsStress Workflow – Actors and OptionsActor Option Name Optionality Vol & Section
Acquisition Modality Patient Based Worklist Query O RAD-TF 2: 4.5
Broad Worklist Query R (see note 1) RAD-TF 2: 4.5
PPS Exception Management O RAD-TF 2: 4.7
Stress ECG R (see note 2) CARD-TF 2: 4.2
Stress Echo R (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 Archive PPS Exception Management O RAD-TF 2: 4.7
Intermittently Connected Modality R CARD-TF 2: 4.3
Stress ECG R CARD-TF 2: 4.2
Echocardiography R CARD-TF 2: 4.2
Nuclear Medicine (see note 3) R RAD-TF 2: 4.8
Availability of PPS-Referenced Instances O RAD-TF 3: 4.49
Image Display Stress ECG R CARD-TF 2: 4.4
Stress Echo R CARD-TF 2: 4.2
Cardiac NM (see notes 3, 4) R RAD-TF 2: 4.16
29IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Use CasesUse CasesCase 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
30IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Stress: Protocol and Stage Stress: Protocol and Stage
Procedure
Protocol
Stages
31IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Stress: Protocol and Stage 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 Important Note: A procedure can be considered complete irrespective of the considered complete irrespective of the
protocol being complete!protocol being complete!
32IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Attribute SummaryAttribute Summary
Concept Modality Worklist Echo ECG NM
Requested Procedure
Requested Procedure Code Sequence (0032,1064)
Procedure Code Sequence (0008,1032)
Procedure Code Sequence (0008,1032)
Procedure Code Sequence (0008,1032)
Protocol Scheduled 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 State Stage 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
33IHE Workshop – Feb 2007IHE Workshop – Feb 2007
ViewsApical 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 ViewsStress Echo: Stage and ViewsStress Echo: Stage and ViewsStress 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)
SRT P5-01201 Image acquisition at baseline
SRT P5-01202 Pre-stress image acquisition
SRT P5-01203 Mid-stress image acquisition
SRT P5-01204 Peak-stress image acquisition
SRT P5-01205 Image acquisition during recovery
34IHE Workshop – Feb 2007IHE Workshop – Feb 2007
Benefit: Stress EchoBenefit: Stress EchoViewing ConsistencyViewing ConsistencyBenefit: Stress EchoBenefit: Stress EchoViewing ConsistencyViewing Consistency
35IHE Workshop – Feb 2007IHE Workshop – Feb 2007
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 CardiologyNuclear Cardiology
36IHE Workshop – Feb 2007IHE Workshop – Feb 2007