IHE ITI IDCO 2006 Dec V2

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					  Implantable Device Cardiac
  Observations (IDCO) Profile

                     Nicholas Steblay

IHE ITI – Dec 2006             1        What IHE Delivers
  Implantable Cardiac Devices

   Pacemakers – therapy for heart rate problems
   Defibrillators – therapy for life threatening heart rhythms
   Cardiac Resynchronization – therapy for congestive heart

IHE ITI – Dec 2006                                               2
                Device Interrogations
The act of retrieving data from
implanted cardiac devices.
Done at implant or during          Implant
patient follow-ups.


Information includes Patient and
Device Observations, and
Therapy Settings

   IHE ITI – Dec 2006                        3
                        Market Statistics
   Sudden Cardiac Death (SCD) is the leading single cause
   of death in the U.S. - estimates are 19% of all deaths.-
   460,000 in 2005. 1
   3 to 5% of Americans have atrial fibrillation. 2
   About 5 million people in the United States have heart
   failure, and the number is growing. Each year, another
   550,000 people are diagnosed for the first time. It
   contributes to or causes about 300,000 deaths
   each year. 3
   From 1990 to 2002, 2.25 million pacemakers were
   implanted and 417,780 ICDs were implanted in the U.S. 4
   Estimated total implantable cardiac device market for
   2006 is 9.4 – 9.6 billion dollars. Project growth in the
   market through 2009 is 4 – 8%. 5
   Numerous published clinical studies (COMPANION,
   MADIT, MADIT II, SCDHeft) have shown the efficacy of
   implanted cardiac rhythm management devices.
    1 SCDHeft | 2 ACC | 3 NHLBI | 4 Jama | BSC

IHE ITI – Dec 2006                                            4
 Cardiology and EP Workload
   According to Heart Rhythm Society
   studies 1
     Electrophysiology is the fastest growing of all
      cardiovascular disciplines.
     Demands for cardiologist and electrophysiologist
      time is projected to increase through 2020.
   To manage workload EPs and device
   clinics are looking for more efficient ways
   of following patients with implantable

    1 HRS http://www.hrsonline.com

IHE ITI – Dec 2006                                       5
            Clinical Process – Device Follow-up
Level 0                   1.0                   2.0                3.0                   4.0
                                                                                                         Acute Events
                       Diagnosis              Implant       Device Follow-up     Patient Follow-up

                                                                                                            3.5 Update Medical
Level 1   3.1 Schedule Follow-      3.2 Exam Patient &        3.3 Analyze          3.4 Adjust Therapy
                  ups               Interrogate Device        Information         and Configure Device

           3.1.1 Schedule In       3.2.1 Exam Patient    3.3.1 Review Exam     3.3.1 Pharmalogical      3.5.1 Record and
            Clinic Follow-ups        (Physical & Lab        and Interrogation     3.3.2 Configure and       Follow-up Process
           3.1.2 Schedule           Tests If Needed)       Information            Test Pulse                and Outcomes
            Remote Follow-ups       3.2.2 Interrogate     Determine New or       Generator                3.5.2 Record
                                     Device In Clinic       Adjusted Therapies                               Pertinent Data
                                    3.2.3 Interrogate                                                       Concerning Device
                                     Device Remote                                                           and Pharmalogical
Level 2                                                                                                     3.5.4 Sign-Off
                                                                                                            3.5.5 Create Follow-
                                                                                                             up Summary
                                                                                                             (Referral Letter) for
                                                                                                             Following Physician

          IHE ITI – Dec 2006                                                                                                   6
      Implantable Cardiac Device Follow-up
           Problems and Opportunities

   Device follow-up load is significant. ICD patients are
   typically followed 4 times a year, and Pacemaker patients 2
   times a year.
   The follow-ups can occur in-clinic or remotely in the home
   healthcare environment.
   EPs follow patients with implantable cardiac devices from
   multiple vendors.
   Each “interrogating” device is vendor proprietary.
   Access to follow-up information often requires
   cardiologists and EPs to use multiple vendor specific
   systems and interfaces, complicating efficiency and quality
   of workflows.
   Aggregation of data into a central EMR or device clinic
   management systems requires manual and paper

IHE ITI – Dec 2006                                               7
               IDCO Value Proposition

   Enable management of follow-up
   information in a central system such as an
   EMR, Cardiology Information System or
   Device Clinic Management System
   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

IHE ITI – Dec 2006                                      8
                IDCO Profile Approach

   Rallied domain vendors around a profile that defines a
   standard approach to integrating implantable cardiac
   device follow-up information into a receiving clinic system
   Enabled the needed systems integration by profiling the
   use of standard, domain applicable messaging protocols,
   structures and data semantics
     HL7 Therapeutic Device Domain – Implantable Device
      Cardiac messaging standards
     ISO/IEEE 11073 Point of Care Medical Device
      Communication Standards nomenclature
   Defined actors, transactions and constraints consistent
   with existing and evolving IHE profiles and contexts
     Aligning with future EP Workflow and other related profiles

IHE ITI – Dec 2006                                                  9
IDCO Profile    Home Healthcare Environment
Systems Model                                Inductive or RF


                                                                        a   ns
                Device Vendor Environment                  D
                  Device Data Information     Ve
                   Management System

                                                                                             IHE TRANSACTION
                                                                                                                                               Another Clinic
                                                       A   NS
                In-Clinic Healthcare Environment                                                                                        TIO
                                                                                                                     IH   ET

                                          EHR or Device
                                        Management System

                                                                                                   IHE TRANSACTION

                                            Inductive or RF
               EMR Interest in IDCO Profile

   Do any EMR vendors have plans in place to
   support the IDCO profile in future product?
   What will it take to get EMR vendors interested in
   IDCO profile participation for 2008?
   What factors drive potential participation?
   How did EMR vendors decide to participate in
   their current portfolio of supported IHE profiles?
   Who should be contacted within the EMR vendor
   companies to discuss this further?

IHE ITI – Dec 2006                                      11
         EMR Interest continued
   Do EMR vendors need help from IMD device
   vendors to understand the domain and data
   mapping. Would that be useful and positive factor
   in decision making to support the profile?

   If the IDCO message would be extended with
   nontrivial EGM waveforms and annotations data,
   histograms and trends data – what would EMR
   vendors like to parse
     XML document
     Discrete OBX segments
     DICOM objects?

IHE ITI – Dec 2006                                  12
                     HL7 v2 and v3
   Current IDCO profile requires the use of
   an embedded HL7 v3 message structure
   within a HL7 v2 ORU message.
   Current profile has specified an option for
   a standard HL7 v2 ORU message.
   Would EMR vendors be more likely to
   participate if the IDCO profile specified
   compliance using a standard v2 ORU

IHE ITI – Dec 2006                               13

 IDCO Profile - Details

IHE ITI – Dec 2006        14     What IHE Delivers
               IDCO Profile Use Cases

   In-Clinic Implants or Follow-ups
     Patients present themselves in-clinic for implantation or
     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
     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

IHE ITI – Dec 2006                                                   15
IDCO Actors and Transaction

                     Send Observation   PIX Consumer
                       [CARD - 12]

        Creator      Send Observation
                       [CARD - 12]

                                        PIX Consumer


IHE ITI – Dec 2006                                     16
                        IDCO Actors
                                   Send Observation   PIX Consumer
                                     [CARD - 12]

                       Creator     Send Observation
                                     [CARD - 12]

                                                      PIX 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 (not required first year).

IHE ITI – Dec 2006                                                    17
                            IDCO Actors
                                                                     Send Observation
                                                                       [CARD - 12]

                                   Send Observation
                                     [CARD - 12]
                                                       HL7 Router
                       Creator                                       Send Observation
                                                                       [CARD - 12]
                                                      PIX Consumer                      Demographics

   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

IHE ITI – Dec 2006                                                                                     18
             Potential Participants
   Observation Creator
     Implantable Cardiac Device Vendors
   Observation Processor and Repository
     EMR or Device Clinic Management System
   HL7 Router
     Integration Engine Vendors
   Others (?)

IHE ITI – Dec 2006                             19
                 IDCO Transaction
                                   Send Observation   PIX Consumer
                                     [CARD - 12]

                       Creator     Send Observation
                                     [CARD - 12]

                                                      PIX Consumer


     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

IHE ITI – Dec 2006                                                     20
                       Embedded XML Data Payload in OBX
                            Based on v3 IDC RMIM
                                                                                                                                                                                                                                                      classCode*: <= OBS
                                                  Note:                                                                                                  0..1 roleName                   1..1 patient *
                                                                                                                                                               CMET: (PAT)                                                                            moodCode*: <= EVN
component                                         E.g.: Brady Settings                                                                                             R_Patient              recordTarget                                                id*: SET<II> [1..*]
                                                  Pacing Output Settings                                                                                  [identified/confirmable]        typeCode*: <= RCT                                           code*: CD CWE [1..1] <=
typeCode*: <= COMP
                                                  Atrial Tachy Settings                                                                                       (COCT_MT050002)             contextControlCode: CS CNE [0..1] <= "OP"                   DeviceInterrogation
contextControlCode: CS CNE [0..1]
                                                  Ventricular Tachy Settings
 <= ContextControlPropagating "AP"                                                                                                                                                                                                                     (The capturing or reading out of data                   Implantable Cardiac Device Summary
contextConductionInd: BL [0..1]                                                                                                                                                                1..1 patient                                           stored in the                                           (POTD_RM000001)
                                                                                                                                                        subject                                                                                        medical device)
sequenceNumber: INT [0..1]                                                                                                                                                                                                                                                                                     Description: Implantable Cardiac Device Summary report.
                                                                                                                                                        typeCode*: <= SBJ                                                                             statusCode: CS CNE [0..1] <=                             This report contains a subset of current programmed settings
priorityNumber: INT [0..1]
                                                                                                                                                        contextControlCode: CS CNE [0..1]                                                             ActStatus                                                and device observations
                                DeviceTherapySetting                                                                                                     <= OP "ContextControlOverriding"                                                             effectiveTime*: TS [1..1]
                                classCode*: <= OBS                                                  0..* deviceTherapySetting                         MedicalDeviceAct
                                moodCode*: <= EVN                                                   controlVariable
  0..* deviceTherapySetting                                                                                                                   classCode*: <= ACT
                                code*: CE CWE [1..1] <= ImplantedCardiacDeviceControlVariable       typeCode*: <= CTRLV
                                 (Externally defined subset of IEEE 1073 vocabulary)                                                          moodCode*: <= EVN
                                                                                                    contextControlCode: CS CNE [0..1] <= "AN"
                                text: ED [0..1]                                                                                               id: SET<II> [0..*]                                                                                                                                                               1..* assignedEntity
                                                                                                    contextConductionInd: BL [0..1] "false"
                                value: ANY [0..1]                                                                                             code*: CD CWE [1..1] <= MedicalDeviceAct                                                                                                         author                                                0..1 roleName
                                                                                                                                              text: ED [0..1]                                                                                                                                  typeCode*: <= AUT                                        CMET: (ASSIGNED)
                                                                                                                                              effectiveTime: TS [0..1]                                                                                                                         time*: TS [1..1]                                           R_AssignedEntity
                                                                                                                                                                                                                                                                                               signatureCode: CE CNE [0..1] <= X                      [identified/confirmable]
                                                                                                                                                                                                      0..* medicalDeviceAct                                                                    signatureText: ED [0..1]
                        DeviceTherapy                                                                                                                                                                     subject
                        classCode*: <= PROC                                                         0..* deviceTherapy
                                                                                                                                                                                                          typeCode*: <= SUBJ
                        moodCode*: <= EVN                                                           component3                                                                                            contextControlCode: CS CNE [1..1] <= "ON"                                                                            0..* assignedEntity
                        id: II [0..1]                                                               typeCode*: <= COMP
                                                                                                                                                                                                          contextConductionInd: BL [0..1] "true"                                               performer
                        code*: CE CWE [1..1] <= ImplantedCardiacDeviceTherapy (IEEE 1073)           contextControlCode: CS CNE [0..1] <= "AN"
                        text: ED [0..1]                                                             contextConductionInd: BL [0..1] "true"                                                                                                                                                     typeCode*: <= PRF
                        activityTime: TS [0..1]

                                 PatientObservation                                                                                                                                                                                                                                                 Participant who assists in
                                 classCode*: <= OBS                                                                                                                                                                                                                                                 performing the interrogation
                                 moodCode*: <= EVN                                                  0..* patientObservation                                                                                                                                                                         of the implanted device
                                 id: II [0..1]                                                      component2
                                 code*: CD CWE [1..1] <= CardiacDevicePatientObservationType        typeCode*: <= COMP
                                 text: ED [0..1]                                                    contextControlCode: CS CNE [0..1] <= "AN"                                                                                                                                                    componentOf                                                CMET: (ENC)
                                 effectiveTime: IVL<TS> [0..1]                                      contextConductionInd: BL [0..1] "true"                                                                                                                                                                                                                  A_Encounter
                                 value: ANY [0..1]                                                                                                                                                                                                                                               typeCode*: <= COMP
                                                                                                                                                                                                                                                                                                 contextControlCode: CS CNE [1..1] <= "OP"                   [universal]
     0..* patientObservation     interpretationCode: CE CNE [0..1]                                                                                                                                                                                                                                                                                        (COCT_MT010000)
                                  <= ObservationInterpretationNormality                                                                                                                                                                                                                          contextConductionInd: BL [1..1] "false"
                                                                                                                                                                                                                                                                                                                                         0..1 encounter *
                                                       Organizer                                    0..* organizer
typeCode*: <= COMP
                                                       classCode*: <= ORGANIZER                     component1
contextControlCode: CS CNE [0..1]
                                                       moodCode*: <= EVN                            typeCode*: <= COMP
 <= ContextControlPropagating "AP"
                                                                                                    contextControlCode: CS CNE [0..1] <= "AN"
contextConductionInd: BL [0..1]
                                                                                                    contextConductionInd: BL [0..1] "true"
sequenceNumber: INT [0..1]
priorityNumber: INT [0..1]
                                                                                                                                                          typeCode*: <= PPRF
                                                                                                                                                                                                                                                                                                0..1 externalCardiacInterrogationDevice
                                                                                                                                                          contextControlCode: CS CNE
                                                                                                                                                           [0..1] <= "OP"                                                                                                                      reusableDevice                               ExternalCardiacInterrogationDevice
                                                                                                                                                                                                                                                                                               typeCode*: <= RDV                            classCode*: <= ASSIGNED
                                                                                                                                                                                           1..1 assignedDevice                                                                                                                              id: II [0..1]
                        This ACT changes the
                        subject from patient to                                                                               1..1 assignedDevice *                                                                                                                                                                                         code: CE CWE [0..1] <= DedicatedServiceDeliveryLocationRoleType
                                                                                                                                                       0..1 roleName
                        the device.                                                                                                                          CMET: (ASSIGNED)
                                                                                                   typeCode*: <= SBJ                                             [universal]
                                                                                                   contextControlCode: CS CNE [0..1] <= "OP"                   (COCT_MT090300)
                                                       component                                                                                                                                                                                                                                              Organization
                                                       typeCode*: <= COMP                                                                                                                                                                                                                                     classCode*: <= ORG
                                                       contextControlCode: CS CNE [0..1] <= "ON"                                                                                                                                                                                                              determinerCode*: <= INSTANCE
                                                       contextConductionInd: BL [0..1] "true"                                                                                                                                                                                                                 id: SET<II> [0..*]
                                                                                                   0..* deviceObservation                                                                                                                                                                                     name: BAG<EN> [0..*]
                                                                                                                                                                   Implantable Cardiac                                                                                                                                                                                      0..1 assignedInterrogationDevice
                                                       DeviceObservation                                                                                           Device or identified lead
                                                       classCode*: <= OBS                                                                                                                                                                                                                                                                 InterrogationDevice
                                                       moodCode*: <= EVN                                                                                                                                                                                                                                                                  classCode*: <= DEV
                                                       code*: CD CWE [1..1]                                                                                                                                                                                                                                                               determinerCode*: <= INSTANCE
                                                        <= CardiacDeviceSelfObservationType                                                                                                                                                                                                                                               id: II [0..1] (e.g. Serial Number)
                                                        (IEEE1073)                                                                                                                                                                                                                                                                        desc: ED [0..1]
                                                       text: ED [0..1]                                                                                                                                                                                                                                                                    manufacturerModelName: SC CWE [0..1] <= ManufacturerModelName
                                                       effectiveTime: IVL<TS> [0..1]                                                                                                                                                                                                                                                      softwareName: SC CWE [0..1] <= SoftwareName
                                                       value: ANY [0..1]
                                                       interpretationCode: CE CNE [0..1]
                                                        <= ObservationInterpretationNormality
                              0..* deviceObservation   methodCode: CE CWE [0..1]
                                                        <= ObservationMethod (IEEE 1073)
                               typeCode*: <= COMP
                               contextControlCode: CS CNE [1..1]
                                <= ContextControlPropagating "AP"
                               contextConductionInd: BL [0..1]
                               sequenceNumber: INT [0..1]
                               priorityNumber: INT [0..1]

         IHE ITI – Dec 2006                                                                                                                                                                                                                                                                                                                                                            21
              Option for Standard OBX Segment
     ELEMENT NAME          SEQ   COMP    DT    LEN   USAGE    CARD    TBL#   ITEM #   Fixed          Ex. Values

 Set ID - OBX             1             SI     4     R       [1..1]          00569             1
 Value Type               2             ID     2     R       [1..1]   0125   00570             DTM
 Observation Identifier   3             CE     250   R       [1..1]          00571
 Identifier                      1      ST     80    R       [1..1]                           PLANT_DATE
                                                                                              The implant date of the
 Text                            2      ST     256   R       [1..1]                           device
 Name of Coding System           3      ST     20    R       [1..1]                            IEEE P10731.1.3
 Observation Sub-ID       4             ST     20    C       [1..1]          00572            3.1
 Observation Value        5             varies *     RE      [0..1]          00573             20060317
 Units                    6             CE     250   RE      [0..1]
 Observation Result Status 11           ID     1     R       [1..1]   0085 00579      Y       F
 Date/Time of the
Observation               14            TS     26    RE      [0..1]          00582            20060317170000+0006
Observation Method        17            CE     250                           00936
 Identifier                      1      ST     80    R       [1..1]                           TYPE
 Text                            2      ST     256   R       [1..1]                            In Clinic
 Name of Coding System           3      ST     20    R       [1..1]                            IEEE P10731.1.3
 Equipment Instance
Identifier                18            EI    256    O       [0..*]          01479             Programmer XXXX
                                          Observations Coded Using
                                      ISO/IEEE 11073 IDC Nomenclature
IEEE 1073.1.1.3 IDC terms - nomenclature
    Device Observations
    Patient Observations
    Device Therapy Settings
    Device Therapies
    Data Types
    Enumerated Value Tables

Device Observations - [top]

#                              Display Name                                      Reference ID                               Parent ID                         SeqNr       Discriminator                            Manual      Description
                              1 Device Type                                      MDC_IDC_DEVICE_TYPE                                                                                                                           The type of device
                              2 Device Manufacturer                              MDC_IDC_DEVICE_MANUFACTURER                MDC_IDC_DEVICE_TYPE                                                                                The manufacturer of the device
                              3 Device Name                                      MDC_IDC_DEVICE_NAME                        MDC_IDC_DEVICE_TYPE                                                                                The marketing name given to a device by the
                              4 Device Model                                     MDC_IDC_DEVICE_MODEL                       MDC_IDC_DEVICE_TYPE                                                                                The model of a device
                              6 Device Serial Number                             MDC_IDC_DEVICE_SERIAL_NUMBER               MDC_IDC_DEVICE_TYPE                                                                                The serial number for a device
                              7 Device Implant Date                              MDC_IDC_DEVICE_IMPLANT_DATE                MDC_IDC_DEVICE_TYPE                                                                                The implant date of the device
                              8 Device Explant Date                              MDC_IDC_DEVICE_EXPLANT_DATE                MDC_IDC_DEVICE_TYPE                                                                                The explant date of the device
                              9 Device Abandon Date                              MDC_IDC_DEVICE_ABANDON_DATE                MDC_IDC_DEVICE_TYPE                                                                                The date the device was abandoned (still implanted but
                                                                                                                                                                                                                               not functioning)
                          10 System Status                                       MDC_IDC_SYSTEM_STATUS                                                                                                                         Overall status of the system
                          17 Lead State                                          MDC_IDC_LEAD_STATE                                                                                                                            The state of lead
                          18 Lead Polarity Type                                  MDC_IDC_LEAD_POLARITY_TYPE                                                                                                                    The type of lead polarity
                          19 Lead Heart Anatomy Location                         MDC_IDC_LEAD_ANOTOMICAL_LOCATION                                                         MDC_IDC_discriminator_LeadLocationType               The heart anatomy where the lead is located

                          20 Lead Heart Anatomy Location Modifier                MDC_IDC_LEAD_ANOTOMICAL_LOCATION_MODIFI MDC_IDC_LEAD_ANOTOMICAL_LOCATION                                                                      The site within the heart anatomy where the lead is
                                                                                 ER                                                                                                                                            fixated
                          21 Lead Intrinsic Amplitude at Implant                 MDC_IDC_LEAD_INTRINSIC_AMPLITUDE_IMPLANT                                                 MDC_IDC_discriminator_HowMeasured                    Intrinsic Amplitude (P-Wave) measured during an
                                                                                                                                                                                                                               Intrinsic Amplitude Test at implant
                          22 Lead Intrinsic Amplitude Configuration at Implant   MDC_IDC_LEAD_INTRINSIC_AMPLITUDE_CONFIGU                                                 MDC_IDC_discriminator_ElectrodeType                  For each low voltage lead, the sensing configuration
                                                                                 RATION_IMPLANT                                                                                                                                used during implant to measure the intrinsic amplitude

                          23 Lead Pace Impedance at Implant                      MDC_IDC_LEAD_PACE_IMPEDANCE_IMPLANT                                                      MDC_IDC_discriminator_HowMeasured                    Lead Impedance measured during a Lead Impedance
                                                                                                                                                                                                                               Test at implant
                          24 Lead Pace Impedance Configuration at Implant        MDC_IDC_LEAD_PACE_IMPEDANCE_CONFIGURAT                                                   MDC_IDC_discriminator_ElectrodeType                  For each low voltage lead, the pacing configuration
                                                                                 ION_IMPLANT                                                                                                                                   used during implant to measure the lead impedance
                          25 Lead Pace Threshold at Implant Amplitude @ Pulse    MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT                                                      MDC_IDC_discriminator_HowMeasured                    The minimum electrical stimulation (pacemaker output
                             Width                                                                                                                                                                                             pulse) required to consistently initiate chamber
                                                                                                                                                                                                                               depolarization and cardiac contraction, as determined
                                                                                                                                                                                                                               by a clinician-interpreted threshold test at implant.

                          26 Lead Pace Threshold at Implant Amplitude            MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT_AM MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT           1                                                        The minimum Chamber Pulse Amplitude needed for
                                                                                 PLITUDE                                                                                                                                       capture
                          27 Lead Pace Threshold at Implant Pulse Width          MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT_PU MDC_IDC_LEAD_PACE_THRESHOLD_IMPLANT           2                                                        The minimum Pulse Width needed for capture
                          28 Lead Pace Threshold Configuration at Implant        MDC_IDC_LEAD_PACE_THRESHOLD_CONFIGURA                                                    MDC_IDC_discriminator_ElectrodeType                  For each low voltage lead, the pacing configuration
                                                                                 TION_IMPLANT                                                                                                                                  used during implant to measure the capture threshold

                          29 Lead DFT at Implant                                 MDC_IDC_LEAD_DFT_IMPLANT                                                                                                                      For each high voltage lead, the measured defibrillation
                                                                                                                                                                                                                               threshold (DFT) at implant.
                          30 Lead DFT Configuration at Implant                   MDC_IDC_LEAD_DFT_CONFIGURATION_IMPLANT                                                   MDC_IDC_discriminator_ElectrodeType                  For each high voltage lead, the shock configuration
                                                                                                                                                                                                                               used during defibrillation threshold (DFT) measurement
                                                                                                                                                                                                                               at implant.
                          31 Date/Time of Communication Session                  MDC_IDC_SESSION_DATE_TIME                                                                                                                     Date of the current in-clinic or remote interrogation.

                          32 Previous Session Date                               MDC_IDC_PREVIOUS_SESSION_DATE_TIME                                                                                                            Date of most recent in-clinic or remote interrogation.

                          33 Session Type                                        MDC_IDC_SESSION_TYPE                                                                                                                          The type of device interaction that generated the
                                                                                                                                                                                                                               current data set. If the specific cause of a remote data
                                                                                                                                                                                                                               transmission is unknown, use the "Remote" value. If the
                                                                                                                                                                                                                               specific cause is known, use the values of Remote-
                                                                                                                                                                                                                               Scheduled, Remote-Patient Initiatied or Remote-Device

                IHE ITI – Dec 2006                                                                                                                                                                                                                                       23
                 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)

          IHE ITI – Dec 2006                                                                                                             24
 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    Information
 Repository       Source

   IDCO Data Incorporation into a Report using Displayable Reports Profile (DRPT)
                                    Encapsulated Report Submission [CARD - 7]

 Observation     Report
                                                                                       Report Manager
  Processor      Creator

  IDCO Discrete Data Storage using Evidence Documents Profile (ED)
                                    Modality Images/Evidence Stored [CARD - 2]

                                              Storage Committment [CARD - 3]

 Observation     Evidence
                                                                                       Image Manager
  Processor       Creator
                                          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     Document                                                                Document
  Processor       Source                                                                 Repository

IHE ITI – Dec 2006                                                                                      25
IHE ITI – Dec 2006   26

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