Download Implantable Device Cardiac Observations (IDCO) Profile

Implantable Device Cardiac
Observations (IDCO) Profile
Tim Becker, PhD
Univ- Hospital Schleswig-Holstein, Campus Kiel
IHE Workshop – Feb 2007
Implantable Cardiac Devices
Pacemakers – therapy for heart rate problems
Defibrillators – therapy for life threatening heart rhythms
Cardiac Resynchronization – therapy for congestive heart
failure
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IDCO - Programmer
Vendor specific ‚Programmers‘ used to communicate with implanted devices
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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
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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
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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
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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
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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
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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
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IDCO Actors
Send Observation
[CARD - 12]
PIX Consumer
Observation
Processor
Observation
Creator
Send Observation
[CARD - 12]
Observation
Repository
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.
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IDCO Actors
Send Observation
[CARD - 12]
Observation
Processor
Send Observation
[CARD - 12]
Observation
Creator
HL7 Router
Send Observation
[CARD - 12]
Observation
Repository
PIX Consumer
Patient
Demographics
Consumer
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
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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
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I1: In-Clinic Followup
Device
Proprietary Protocol
Device
Programmer
Translator
Proprietary Protocol
Obvservation
Creator
Send Observation [CARD-12]
Obvservation
Processor
•
Obvservation
Repository
No standardized communication between programmer and Observation
Creator
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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
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I3: Remote Followup
Translator
Obvservation
Creator
Clinic A
ATNA: Secure
Node
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
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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
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Example Transaction Flow
Device
Interrogator
Observation Creator
Observation Processor
Observation Repository
PIX Manager
Query Device (1)
Send Interrogation
Send Interrogation (2)
Validate and Review (3)
Translate Information (4)
Send Observation [CARD-12] (5)
PIX Query [ITI-9] (6)
Process Observation (7)
Send Observation [CARD-12] (8)
PIX Query [ITI-9] (9)
Store Observation (10)
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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]
Obvservation
Processor
Obvservation
Repository
Patient Identity Feed [ITI-8]
PIX Update Notification [ITI-10]
Patient Identifier
Cross Reference
Consumer
Patient Identifier
Cross Reference
Manager
HL/ Message
Router
Asigning Authority:
Device Manufacturer
Patient Identifier:
Model device model number + device serial number
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Potential Extended Actor Groupings
Basic IDCO Report Display using Retrieve Information for Display Profile (RID)
Retrieve Specific Info for Display [ITI - 11]
Retrieve Document for Display [ITI - 12]
Observation
Repository
Information
Source
Display
IDCO Data Incorporation into a Report using Displayable Reports Profile (DRPT)
Encapsulated Report Submission [CARD - 7]
Observation
Processor
Report
Creator
Report Manager
IDCO Discrete Data Storage using Evidence Documents Profile (ED)
Modality Images/Evidence Stored [CARD - 2]
Storage Committment [CARD - 3]
Observation
Processor
Evidence
Creator
Image Manager
Store Evidence Documents [RAD - 43]
Storage Committment [CARD - 7]
IDCO Submission to an EHR using Cross Domain Document Sharing Profile (XDS)
Provide and Register Document Set [ITI - 15]
Observation
Processor
Document
Source
IHE Workshop – Feb 2007
Document
Repository
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What’s Next?
Waveforms
Workflows (Scheduling / Orders)
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Stress Testing Workflow
Integration Profile
Tim Becker, PhD
Univ- Hospital Schleswig-Holstein, Campus Kiel
IHE Workshop – Feb 2007
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
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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
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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
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Stress Workflow Diagram
ADT
Pt. Registration [RAD-1] 
Patient Update [RAD-12] 
DSS/ Order Filler
 Pt. Registration [RAD-1]
 Patient Update [RAD-12]
 Placer Order Management [RAD-2]
 Filler Order Management [RAD-3]
 Modality PS in Progress [CARD-1]
 Modality PS Completed [RAD-7]
Order Placer
 Procedure Scheduled [RAD-4]
 Patient Update [RAD-12]
 Procedure Updated [RAD-13]
 Instance Availability Notification [RAD-49]
Requires that Image Manager / Image Archive
and Image Display support images,
waveforms and structured reports
Evidence
Creator
 Modality PS in Progress [CARD-1]
 Modality PS Completed [RAD-7]
Performed
Procedure
Step Manager
Storage 
Commitment
[CARD-3]
Image Display
 Modality Image/Evidence
Stored [CARD-2]
Image
Manager
Report Creator
 Query Images [RAD-14]
 Retrieve Images/Evidence [CARD-4]
Image
Archive
 Modality PS in Progress [CARD-1]
 Modality PS Completed [RAD-7]
Storage
Commitment 
[CARD-3]
Modality Image/Evidence
Stored [CARD-2]
 Modality PS in Progress [CARD-1]
 Modality PS Completed [RAD-7]
 Query Modality Worklist [RAD-5]
IHE Workshop – Feb 2007
Acquisition
Modality
Report Creator
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Stress Workflow – Actors and Options
Actor
Acquisition Modality
Option Name
Patient Based Worklist Query
Broad Worklist Query
PPS Exception Management
Image Manager/ Image Archive
Image Display
IHE Workshop – Feb 2007
Optionality
Vol & Section
O
RAD-TF 2: 4.5
R (see note 1)
RAD-TF 2: 4.5
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
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
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
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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
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Stress: Protocol and Stage
Procedure
Protocol
Stages
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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!
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Attribute 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
Patient State
IHE Workshop – Feb 2007
Acquisition Context
Sequence
(0040,0555)
>(109055, DCM,
“Protocol Stage”)
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
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Stress Echo: Stage and Views
Views
 Stress Echo Option
•
•
Stage Number & View Number
Stage Code Sequence & View
Code Sequence
Apical two chamber
Apical four chamber
Apical long axis
Parasternal long axis
Parasternal short axis
Parasternal short axis at the aortic valve level
Code Meaning (0008,0104)
Parasternal short axis at the level of the mitral
chords
Coding
Scheme
Designator
(0008,0102)
Code Value
(0008,0100)
SRT
P5-01201
Image acquisition at baseline
Right Ventricular Inflow Tract View
SRT
P5-01202
Pre-stress image acquisition
Right Ventricular Outflow Tract View
SRT
P5-01203
Mid-stress image acquisition
Subcostal long axis
SRT
P5-01204
Peak-stress image acquisition
Subcostal short axis
SRT
P5-01205
Image acquisition during
recovery
Suprasternal long axis
Parasternal short axis at the Mitral Valve level
Parasternal short axis at the Papillary Muscle
level
IHE Workshop – Feb 2007
Suprasternal short axis
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Benefit: Stress Echo
Viewing Consistency
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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
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