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Implantable Device Cardiac Observations (IDCO) Profile. Tim Becker, PhD Univ- Hospital Schleswig-Holstein, Campus Kiel. Implantable Cardiac Devices. Pacemakers – therapy for heart rate problems Defibrillators – therapy for life threatening heart rhythms

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implantable device cardiac observations idco profile

Implantable Device Cardiac Observations (IDCO) Profile

Tim Becker, PhD

Univ- Hospital Schleswig-Holstein, Campus Kiel

implantable cardiac devices
Implantable Cardiac Devices
  • Pacemakers – therapy for heart rate problems
  • Defibrillators – therapy for life threatening heart rhythms
  • Cardiac Resynchronization – therapy for congestive heart failure
idco programmer
IDCO - Programmer

Vendor specific ‚Programmers‘ used to communicate with implanted devices

impl cardiac device follow up
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
impl cardiac device follow up1
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
idco value proposition
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
idco profile approach
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
idco profile use cases
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
idco profile use cases1
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
idco actors
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.
idco actors1
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
transaction card 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
i1 in clinic followup
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
i2 in clinic followup with networked programmer that translates information
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
i3 remote followup
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
i4 third party value added systems
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
patient identification
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

potential extended actor groupings
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)

what s next
What’s Next?
  • Waveforms
  • Workflows (Scheduling / Orders)
stress testing workflow integration profile

Stress Testing Workflow Integration Profile

Tim Becker, PhD

Univ- Hospital Schleswig-Holstein, Campus Kiel

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 documentation
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
stress options
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
stress workflow diagram
Stress Workflow Diagram

Requires that Image Manager / Image Archive and Image Display support images, waveforms and structured reports

use cases
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
stress protocol and stage
Stress: Protocol and Stage

Procedure

Protocol

Stages

stress protocol and stage1
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!

slide32

Stress Echo: Stage and Views

  • Stress Echo Option
    • Stage Number & View Number
    • Stage Code Sequence & View Code Sequence
nuclear cardiology
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