Implantable Device Cardiac Observations (IDCO) Profile

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


IDCO - ProgrammerIDCO - Programmer

Vendor specific ‚Programmers‘ used to communicate with implanted devices


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


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


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


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


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


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


IDCO ActorsIDCO Actors

Observation Processor

Observation Repository

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.


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


ObservationCreator

Patient Demographics

Consumer

HL7 RouterSend Observation

[CARD - 12]


PIX Consumer


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


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


I2: In-Clinic Followup with Networked I2: In-Clinic Followup with Networked Programmer that Translates InformationProgrammer that Translates Information


Device Programmer


Translator



• Programmer assumes role of the Observation Creator


I3: Remote FollowupI3: Remote Followup



Translator



• Use of ATNA to secure communication for remote followup

Clinic A

Clinic B

ATNA: Secure Node

ATNA: Secure Node

ATNA: Secure Node

untrusted network


I4: Third Party Value-Added SystemsI4: Third Party Value-Added Systems



Translator


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


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)


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



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


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]


EvidenceCreator

Image Manager

Storage Committment [CARD - 3]

Modality Images/Evidence Stored [CARD - 2]

Store Evidence Documents [RAD - 43]

Storage Committment [CARD - 7]


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)


What’s Next?What’s Next?

Waveforms

Workflows (Scheduling / Orders)


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


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


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


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


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]



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


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


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


Stress: Protocol and Stage Stress: Protocol and Stage

Procedure

Protocol

Stages


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!


Attribute SummaryAttribute Summary

Concept Modality Worklist Echo ECG NM

Requested Procedure

Requested Procedure Code Sequence (0032,1064)

Procedure Code Sequence (0008,1032)



Protocol Scheduled Protocol Code Sequence (0040,0008)

Performed Protocol Code Sequence (0040,0260)

CID 12001*


CID 3261


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


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


Benefit: Stress EchoBenefit: Stress EchoViewing ConsistencyViewing ConsistencyBenefit: Stress EchoBenefit: Stress EchoViewing ConsistencyViewing Consistency


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


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