5.1.1. Transmission Report

5.1.1.1. Overview

The transmission report has been designed to provide a synthesized view of the main technical and diagnostic data in order to evaluate the functioning status of the implanted cardiac device and the patient's health condition.

When MicroPort servers receive a transmission, the report is automatically generated by following the system's analysis of data sent. If you want to view all of the data, download the source file from the Transmission Details page and import into a programmer.

The transmission report is provided as a PDF on the website on the NEW TRANSMISSIONS, NEW EVENTS, and/or NEW FOLLOW UPS pages and can be printed. You can download the patient reports to PDF onto your computer, using the Save icon available in Acrobat Reader or select Save a Copy from the File drop-down menu. Browse the possible locations on your PC or the network where you can save a copy of a document. Click on the Save button.

The structure of the report remains the same across all report types.

5.1.1.2. Header

The header provides patient and device information:

• patient's name and birth date
• current device implant date
• device family, model and serial number

5.1.1.3. Footer

The footer provides the following information:

• transmission date and time
• the confidential patient information statement
• page number over total number of pages
• report version number
• device software version

5.1.1.4. Title of Report

The title provides the following information:

Report type

• Alert report: for alert conditions that are enabled the report may include the following:
  • an active alert condition occurred and triggered a transmission
  • alert condition occurred and is included in a PIT (Patient Initiated Transmission) or scheduled transmission
• Follow up: scheduled transmission
• Patient initiated transmission (PIT): transmitted manually by the patient

• Sent date: date of transmission from the device to the monitoring device
• Sent time: time of transmission from the device to the monitoring device

If the report generation is delayed more than 24 hours following the communication between the implanted device and the monitoring device, the title will include the following indicators:

• Sent: the date-time of transmission from the device to the monitoring device
• Received: date-time referring to the report's availability

5.1.1.5. Alert Conditions

The device is programmed to automatically detect conditions outside of alert parameter settings. When an event occurs that meets the alert conditions, an alert report is transmitted, usually during the following evening.

If the implanted device detects more than one event, the title will display the message "Several alerts raised" and all the events will be reported in the Warnings section.

5.1.1.6. Synthesis Overview

The top panel is a snapshot of the device activity since the previous report, presented in 4 different categories: Therapies (Disease Management), Device Management, Warnings and Observations.

5.1.1.6.1. Therapies (Disease Management)

Provides the following significant indicators:

• Tachy Therapies
• Arrhythmia history
• Cumulative percentage of BiV pacing: if programmed to pace both ventricular chambers
• Cumulative percentage of Vs: if programmed to pace a single ventricular chamber

Messages may appear as follows:

Tachy Therapies:

• Abnormal:
  • High or Low Shock Impedance measured
  • Excessive Charge time
  • Inefficient Max Shock
  • Deleterious ATP delivered
• Delivered: tachy therapies delivered since last report (ATP or shock)
• Not delivered or None: no therapy delivered and no abnormal conditions detected

Arrhythmia History

Displays ventricular and atrial events:

• Events: some episodes have been detected
• No events: no events have been detected

Significant statistics

• Cumulative % BiV pacing will be reported if the device is programmed to pace both ventricular chambers
• Cumulative % Vs will be reported if the device is programmed to pace a single ventricular chamber.

Device Management

Device management provides 3 significant indicators regarding battery status, leads impedance status and coils impedance status. See color codes for status below.

Battery

• OK: normal
• Red: indicates RRT (Recommended Replacement Time)* condition has been reached

*: corresponds to the previously used Elective Replacement Indicator (ERI). The indicator will display a message “<3 months” or “<12 months” for Platinium products when the remaining longevity can be calculated and is close to the Recommended Replacement Time.

Leads

For each patient, a normal impedance range is programmed with a high level and a low level threshold for each lead. Programming must be done by the programmer during the in-office follow up and is only possible if alert transmissions are enabled. Otherwise, values will be compared with the default normal range (values between 200 ohms and 3000 ohms).

Lead status is evaluated comparing the impedance measurement performed with the normal impedance range programmed. Lead status is displayed according to the color codes described below. The warning section will display a specific message when more information is available.

• OK:
  • Normal lead impedance conditions
• Red:
  • An alert condition related to lead measurement was detected since the previous remote monitoring transmission.
  • The last impedance measurement for a specific lead was out of the normal range. Last measurement is displayed in the Device Management Summary and in Device Management section.
  • Warning on current low P wave measurement
• Yellow:
  • An alert condition related to lead measurement was detected before the previous transmission and therefore already displayed in an older patient report.
  • No impedance measurements have been performed for at least one lead after the previous transmission and no data are available to evaluate the lead condition.
  • No P wave amplitude measurement since the previous transmission
  • No R wave amplitude measurement since the previous transmission

Coils

Coils status is evaluated comparing the impedance measurement performed with the defined thresholds and will display according to the color codes described below. The coil continuity thresholds are not programmable. The warning section will display a specific message when more information is available.

• OK:
  • Normal coil continuity conditions
• Red:
  • An alert condition related to coil measurement was detected since the previous remote monitoring transmission.
  • The last impedance measurement for a specific coil was out of the normal range. Last impedance measurement is displayed in the Device Management Summary and in Device Management section.
• Yellow:
  • An alert condition related to coil measurement was detected before the previous transmission. The warning section will display a specific message.
  • No impedance measurements have been performed for at least one coil after the previous remote monitoring transmission and are therefore already displayed in an older patient report.

5.1.1.6.2. Warnings

The warning section highlights specific conditions detected by the device that are considered critical for the proper functioning of the device and for the patient.

It contains the conditions that triggered a critical alert as well as other important technical or clinical events which need to be highlighted.

In this section, all critical alert conditions are reported even if they are disabled for triggering a transmission within the remote monitoring system.

5.1.1.6.2. Messages Priority Display

The list of messages is sorted in the following way:

• Escalation of recurring alert condition
• New occurrences of alert conditions programmed to trigger transmissions
• New occurrences of alert conditions not programmed to trigger transmissions
• Occurrences of alert conditions already transmitted and still present.
• All others met warnings conditions

Messages referring to new occurrences will be highlighted in Bold.

If no warning conditions are detected, the section will display the message: "No warning detected."

If the list of messages is too long, the list is truncated and the user informed.

5.1.1.6.3. Observations

The observations section is a collection of clinical information regarding any significant alert conditions detected by the device and other specific events analyzed by AIDA.

The significant conditions are reported in this section even if they are disabled for triggering a transmission within the remote monitoring system.

If no special information is to be provided, the section will display the message: "No observation detected."

If the list of messages is too long, the list is truncated and the user informed.

Observation messages include:

• Significant alert conditions:
  • Shock delivered (except inefficient max shock delivered which is considered critical)
  • V oversensing
  • Limited percentage of V pacing in CRT
  • High AT/AF burden
  • Fast V rate during AT/AF
• Other specific events analyzed by AIDA:
  • High ventricular sensing percentage in CRT (>3%)
  • Atrial arrhythmia and fall-back episodes detected
  • SafeR mode related recorded data present
• Automatic programming that has occurred:
  • Device in mode switch
  • SonR sensor deactivated
  • AVD reprogrammed
  • Pacing configuration reprogrammed by CRT optimization
• General observations:
  • Number of treated arrhythmia episodes
  • Number of untreated arrhythmia episodes

5.1.1.7. Therapies (Disease Management) Summary

Therapies summary offers a synthesized view of tachy and brady therapy along with the arrhythmic episodes detected. It provides a snapshot of the patient's condition.

The information provided in this section refers to the time between the last and the current transmission.

Tachy Therapy and Episodes

Tachy therapy and episodes table presents the arrhythmic episodes detected and the therapies delivered by the device.

• Columns: automatically detected rhythms:
  • Slow VT
  • VT
  • FVT+VF
  • SVT->VT
  • Total: cumulative number for each row
  • SVT/ST: no treatments are possible for this kind of episode
• Rows: total number of episodes detected, applied therapies
  • Episodes: total number of episodes detected (in bracket for episodes treated)
  • ATP: events treated by ATP (in brackets for episodes treated successfully)
  • Shocks: events treated by shock (in brackets for episodes treated successfully)
  • Shocks 42J: events treated by max energy shock (in brackets for episodes treated successfully)
• Cell: number of events recorded for the corresponding detected rhythm (column) and the corresponding therapy (row)

If one or more shocks (or Max energy shocks) applied for a specific detected rhythm was not effective, the associated cell will be highlighted.

Brady Therapies

Brady therapy snapshot displays statistics since the last transmission:

• Percentage of atrial sensing (As)
• Percentage of atrial pacing (Ap)
• Percentage of ventricular sensing (Vs)
• Percentage of ventricular pacing (Vp)
• Number of detected PMT episodes
• Number of Mode Switches
• Total Time in Mode Switch

5.1.1.8. Device Management Summary

This summary provides a global view on the device working conditions, with special attention to battery, lead and coil status.

Battery

The battery condition is evaluated by the voltage measurement. The value provided is highlighted if the RRT condition is reached.

Time to RRT:

estimated time to reach the Recommended Replacement Time.

Leads

For each display:

• grey values may indicate the measurement was captured during in clinic visits
• if the impedance measurement is out of the programmed normal range, the value is highlighted
• values outside the range 200 – 3000 ohms are indicated “≤200” or “>3000 ohms”
• the measurement date is added when available

The table provides the main information related to each lead:

• Impedance (ohms): the last impedance measurements (performed every six hours) for each lead
  • A
  • RV
  • LV
• Detection (mV): the last endocardial wave amplitude measurements performed beat-to-beat in millivolts:
  • P wave amplitude for atrial channel
  • R wave amplitude for right ventricular channel
• Threshold (V and ms): the last saved pacing threshold value in Volts and milliseconds
  • Displayed in grey if the last saved value during a clinic visit
• OutPut (V and ms): the programmed output in Volts and milliseconds
  • Displayed in grey if the last saved value during a clinic visit

Coils

Provides the last saved value for the RV coil continuity and for the SVC coil continuity. Measurements are automatically made once a week for PARADYM RF/INTENSIA devices and once a day for PLATINIUM devices.

If the impedance measurement is out of the normal range, the value will be highlighted. Values between 200 ohm and 3000 ohm are considered normal.

5.1.1.9. Real Time EGM

Provides a 7 second EGM strip automatically recorded during the data transmission from the implanted device to the monitoring device.

The strip shows Atrial and RV channel EGM records and the associated marker chain.