SW012. Installation software for the Right Ventricular Lead Integrity Alert feature. Reference Manual

Transcription

1 Installation software for the Right Ventricular Lead Integrity Alert feature Reference Manual Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

2 The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. CareAlert, CareLink, Concerto, EnTrust, InSync, InSync Maximo, InSync Sentry, Intrinsic, Marquis, Maximo, Medtronic, Medtronic CareAlert, Medtronic CareLink, Patient Alert, Quick Look, Sprint Fidelis, Virtuoso

3 1 RV Lead Integrity Alert feature overview 1.1 Introduction About this manual This manual describes the operation and intended use of the RV Lead Integrity Alert feature. This feature must be manually installed into a patient s device using the RV Lead Integrity Alert software Model on a Medtronic CareLink Model 2090 programmer Supporting clinical studies Information regarding clinical studies related to the RV Lead Integrity Alert feature is available at To view, download, print, or order clinical studies from the Medtronic website, perform the following steps: 1. Navigate your web browser to 2. Set the Your Location option to United States and click [OK]. 3. Select the Search for: field on the left side of the screen and type. 4. Click [Search]. The following clinical studies are relevant to the RV Lead Integrity Alert feature: The Enhanced Surveillance of Right Ventricle Lead Integrity Alert (RV LIA) This study, which prospectively assessed the performance of the Right Ventricle Lead Integrity Alert, provided an estimate of the probability of receiving a three-day warning for patients with a lead fracture. RV Lead Integrity Alert retrospective evaluation This retrospective evaluation assessed the ability of the RV Lead Integrity Alert feature to provide advance notice of a Sprint Fidelis lead fracture. The evaluation provides support for the RV Lead Integrity Alert feature Manual conventions The programmer screen image examples in this manual were produced using a Medtronic CareLink Model 2090 programmer. These screen images are provided for reference only and may not match the software for your patient s specific device. In procedures, the names of on-screen buttons are shown within brackets: [Button Name]. Reference Manual 3

4 1.2 Feature overview The RV Lead Integrity Alert feature is designed to extend the advance warning time of a lead related issue, improve opportunities for more patients to recognize the audible alert, and reduce inappropriate shocks. The RV Lead Integrity Alert feature is not intended to withhold therapy for true VT or VF. The RV Lead Integrity Alert software adds a new RV Lead Integrity Alert to improve the performance of the lead monitoring system, which includes the Lead Impedance Out of Range Alerts. The RV Lead Integrity Alert evaluates data from the ventricular Sensing Integrity Counter (SIC) and non-sustained VT episodes (VT-NS) to identify oversensing due to a potential lead issue. When the RV Lead Integrity Alert feature is installed, the device is configured to store EGM data with any rapid VT-NS episode that contributes to meeting the RV Lead Integrity Alert criteria. In the event of a suspected lead issue, the feature automatically turns on pre-arrhythmia EGM storage to capture onset EGM data for the VT-NS episodes. The feature also includes an automatic post-alert adjustment to the VF Initial Beats to Detect (VF NID) parameter, and an improvement in the audible alert behavior. Estimated performance Based on a retrospective analysis of Sprint Fidelis lead fracture data, Medtronic estimates that the RV Lead Integrity Alert feature will normally provide 76% of patients with at least 3 days of warning in advance of a shock due to oversensing from a Sprint Fidelis lead fracture. Actual experience may vary. 1.3 Indications and usage The RV Lead Integrity Alert feature is intended for patients who have a Medtronic ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930), based on performance data. Performance data for use of the RV Lead Integrity Alert feature in combination with other leads is not currently available. The RV Lead Integrity Alert feature is only compatible with the devices shown in Table 1. Table 1. Compatible devices Devices Models Concerto C154DWK, C164AWK Virtuoso DR a D154AWG Virtuoso VR a D154VWC EnTrust D154ATG, D153ATG, D154DRG, D153DRG, D154VRC, D153VRC InSync Sentry 7297, 7299 InSync Maximo 7303, 7304 Intrinsic 7288 Maximo DR Reference Manual

5 Table 1. Compatible devices (continued) Devices Models Maximo VR 7232 Marquis DR 7274 Marquis VR 7230 a Virtuoso DR and VR devices that were modified for the ST Segment Detection Study are not compatible with the RV Lead Integrity Alert feature. Due to the necessary changes to these devices for the study, these devices cannot accept the RV Lead Integrity Alert feature. The Medtronic CareLink Model 2090 programmer will display an error message if this installation is attempted. 1.4 Contraindications There are no known contraindications for the use of the RV Lead Integrity Alert. 1.5 Warnings and precautions Device Electrical Reset after installation In the event of a Device Electrical Reset after installation, the RV Lead Integrity Alert feature is cleared from the device. However, the Patient Information screen and printed reports still indicate that the feature is installed. To restore the operation of the RV Lead Integrity Alert feature, it must be reinstalled into the device. Notify a Medtronic representative if a Device Electrical Reset has occurred. RV Lead Integrity Alert feature and therapy delivery The RV Lead Integrity Alert feature improves advance warning of a potential lead issue, but it does not withhold therapy for episodes that extend beyond the programmed VF NID. When the alert criteria are met and the audible alert tone sounds, the patient should seek immediate medical attention to prevent the delivery of an inappropriate shock. Reference Manual 5

6 2 Installing the RV Lead Integrity Alert feature 2.1 Installation overview The RV Lead Integrity Alert feature adds new functionality, including the new RV Lead Integrity Alert, enhancements to EGM storage, an automatic post-alert adjustment of the VF NID, and enhancements to audible alerts related to the RV lead. For more information about these capabilities, see Chapter 3, Operation of the RV Lead Integrity Alert feature, page 10. When the RV Lead Integrity Alert feature is installed into a device, the data on the Patient Information screen is updated to provide an indication that the feature has been installed. A + sign is inserted at the beginning of the Patient ID field, and +LeadAlert is inserted at the beginning of the Notes field. Because the Patient ID appears on all printed reports, the + indicator also appears on all printed reports. Figure 1. Example of a Quick Look report after installation Jane Doe Device: EnTrust D154VRC Serial Numbe r: PNT726014S Date of Visit: 21-Jul :27: Soft ware Version 1. 5 Copyright Medtroni c, Inc Quick Look Report Page 1 1 The Patient ID is preceded by a + indicator. The RV Lead Integrity Alert feature also automatically configures the device parameters to be consistent with the current programming recommendations for patients who have a Sprint Fidelis lead. When you install the feature, the following changes are made to the parameter settings: The VF Initial Beats to Detect (VF NID) parameter is programmed to 18/24 (if it was less). The audible Lead Impedance Out of Range Alerts for RV Pacing, RV Defibrillation, and SVC Defibrillation are programmed to On. Note: The SVC Defibrillation Lead Impedance Out of Range Alert is only programmed to On if a valid SVC impedance is recorded. The Alert Urgency parameter for the Lead Impedance Out of Range Alerts is programmed to Low. The RV Pacing, RV Defibrillation, and SVC Defibrillation Lead Impedance Out of Range Alert thresholds are set to the recommended limits described in Table 2. 6 Reference Manual

7 Table 2. Lead Impedance Out of Range Alert thresholds for the RV Lead Integrity Alert feature Lead type Lead impedance a Alert threshold RV Pacing lead < 700 Ω (or unknown) 1000 Ω 700 Ω and < 1100 Ω 1500 Ω 1100 Ω 2000 Ω RV Defibrillation lead < 80 Ω (or unknown) 100 Ω 80 Ω and < 110 Ω 130 Ω 110 Ω 160 Ω SVC Defibrillation lead < 80 Ω (or unknown) 100 Ω 80 Ω and < 110 Ω 130 Ω 110 Ω 160 Ω a The lead impedance used for comparison is the average of the most recent weekly minimum and maximum measurements. If the most recent weekly minimum or maximum does not exist, then the alert threshold is set to the minimum value shown in the table. Note: After you install the feature, review the alert thresholds to make sure they are appropriate for the patient, and adjust them if necessary. 2.2 Preparing to install the feature System requirements Make sure you have a Medtronic CareLink Model 2090 programmer with a Model 2067 or 2067L programming head. Make sure the RV Lead Integrity Alert software is available on the Medtronic CareLink Model 2090 programmer. If the software is installed, it appears on the Other Software screen on the programmer. For information about viewing the Other Software screen, see Step 1 and Step 2 in Section 2.3. Make sure the patient s device is compatible with the software (see Table 1, page 4) Complete a patient follow-up session Before you install the RV Lead Integrity Alert feature into a patient s device, complete a standard follow-up session with the patient to evaluate the condition of the device and leads, and to verify that the device is configured appropriately for the patient. If you discover any clinical concerns, you should address those concerns before you proceed with installing the feature. Reference Manual 7

8 2.3 Installing the feature into a device 1. If you are in a patient session, select [End Session] to return to the Select Model screen. 2. Select the Programmer icon > Other Software. 3. Place the programming head over the device. Do not remove the programming head during the installation procedure. Note: All devices require the use of the programming head to install the RV Lead Integrity Alert feature, including wireless devices. 4. Select RV Lead Integrity Alert Software, and then select [Start]. The programmer interrogates the device and confirms that it is compatible with the software. If the device is not compatible with the software, a feature cannot be installed message appears. Follow the instructions displayed in the message window. 5. When the installation screen appears, select [Install]. A confirmation statement appears after the feature has been installed to the device. 6. The programmer automatically prints the RV Lead Integrity Alert Software Report to the programmer printer. The report includes the patient s name, Patient ID (preceded by a + sign), device model, serial number, date and time, and a summary of the changes made to the device parameters and functionality. Save the report for the patient s record. Note: The + sign before the Patient ID appears on all printed reports to indicate that the RV Lead Integrity Alert feature has been installed into the patient s device. If the feature is uninstalled from the device, the + sign no longer appears on reports. 7. Select [Exit Application]. When the confirmation window appears, select [Exit] to exit the installation application and return to the Other Software screen. 8 Reference Manual

9 8. To return to the Select Model screen, select the Select Model icon. 9. After the feature is installed, perform these follow-up checks: Ensure that the lead impedance thresholds that were set during the installation are appropriate for the patient. Ensure that one of the EGM sources selected for stored EGM during tachyarrhythmia episodes is set to RVtip to RVring (or Vtip to Vring). This EGM source corresponds to the signal used by the device for ventricular sensing. Demonstrate the audible alert tone for the patient. For Concerto and Virtuoso devices only: Patient Home Monitor alerts are not automatically turned on during the feature installation. If you want the RV Lead Integrity Alert feature to send a wireless transmission when an alert is triggered, you must program Patient Home Monitor to Yes and set the Enable parameter for the RV Pacing Lead Impedance Out of Range - Monitor field to On. Reference Manual 9

10 3 Operation of the RV Lead Integrity Alert feature 3.1 Feature description The RV Lead Integrity Alert feature includes new criteria to identify potential RV lead issues, several modifications to the audible alert tones associated with the RV lead, and post-alert modifications to device functionality that are designed to improve diagnostic data collection and to reduce the likelihood of an inappropriate shock due to lead noise oversensing RV Lead Integrity Alert feature criteria The RV Lead Integrity Alert feature uses both the existing RV Pacing Lead Impedance Out of Range Alert and the new RV Lead Integrity Alert to monitor lead integrity. The criteria for both of these alerts are described below. RV Pacing Lead Impedance Out of Range Alert This alert is triggered if the RV Pacing Lead Impedance measurement is out of range at the scheduled daily measurement time. RV Lead Integrity Alert The RV Lead Integrity Alert is triggered if both of the following criteria have been met within the past 60 days: The device senses 2 high rate non-sustained VT (VT-NS) episodes with a 4-beat average R-R interval of less than 220 ms. The ventricular Sensing Integrity Counter (SIC) is incremented by at least 30 within a period of 3 or fewer consecutive days. Note: The Sensing Integrity Counter total displayed on the Battery and Lead Measurement screen is calculated from the last time the device was interrogated. Therefore, the total could exceed 30 without satisfying the alert criteria if the total was reached during a period of more than 3 consecutive days. 10 Reference Manual

11 3.1.2 Alert tone audibility When the RV Lead Integrity Alert feature is installed, the following modifications are made to the audible device alert tones associated with the RV Lead Integrity Alert, the RV Pacing Lead Impedance Out of Range Alert, and the RV Defibrillation and SVC Defibrillation Lead Impedance Out of Range Alerts: An alert tone sounds immediately when one of these alert events occurs, and then every 4 hours beginning at the next scheduled 4-hour time interval (12:00 AM, 4:00 AM, 8:00 AM ). The alert tone also sounds at the programmed Alert Time. The alert tone continues to sound until the device is interrogated by a programmer. All of the Lead Impedance Out of Range Alerts use the same programmed value for Alert Urgency. When the feature is installed, this parameter is automatically programmed to Low. The duration of the tone is increased to 30 s. These modifications are designed to increase the likelihood that the patient will recognize the alert tone sooner, giving the patient more advance notice to seek medical attention and avoid a potential adverse event Post-alert changes to device functionality When the criteria for either the RV Lead Integrity Alert or the RV Pacing Lead Impedance Out of Range Alert are met, the device automatically adjusts tachyarrhythmia detection to reduce the chance of an inappropriate shock due to oversensing, and adjusts EGM storage to capture valuable diagnostic data about episodes Extend VF NID When the criteria are met for either of the alerts, the device automatically programs the VF NID to 30/40 (if it was less). If necessary, the device automatically adjusts the VT Monitor NID and the VT NID parameters, or sets AT/AF Detection to Monitor. These additional adjustments prevent the VF NID change from creating a parameter interlock condition Suspend detection during interrogation After either the RV Lead Integrity Alert or the RV Pacing Lead Impedance Out of Range Alert has been triggered, the device automatically suspends tachyarrhythmia detection when it is interrogated by a programmer or a CareLink monitor using nonwireless telemetry. This suspension prevents inappropriate detection during the interrogation process when a lead issue is suspected. Reference Manual 11

12 During a CareLink monitor session, tachyarrhythmia detection resumes automatically when the interrogation is complete. During a programmer session, tachyarrhythmia detection can be resumed by selecting [Resume] at the top of the programmer screen, by ending the session, or by removing the programming head. Note: This suspension behavior occurs for all nonwireless sessions until the alert has been cleared by an interrogation with a programmer and 3 consecutive days of RV Pacing Lead Impedance measurements are within the programmed alert thresholds Increase EGM storage The device turns on Pre-arrhythmia EGM Storage when either of the alerts is triggered. In EnTrust, Concerto, and Virtuoso devices, the Pre-arrhythmia EGM Storage automatically turns off after 30 days (unless it was previously programmed to remain active longer than 30 days). In Maximo, Marquis, Intrinsic, InSync Maximo, and InSync Sentry devices, Pre-arrhythmia EGM Storage is turned off when the device is interrogated by a programmer (unless it was previously programmed to On). If the RV Pacing Lead Impedance Out of Range Alert is triggered but the RV Lead Integrity Alert has not been triggered, the device changes the criteria for storing VT-NS episodes in order to provide more diagnostic data to help identify the cause of the alert. In this condition, a VT-NS episode with EGM data is recorded if a single ventricular interval less than 200 ms occurs. This condition persists until a rapid VT-NS episode occurs, or until the alert is cleared when the device is interrogated by a programmer. 3.2 Responding to an Alert If the patient s device is sounding an audible alert tone, or if the programmer indicates that an alert event has occurred, review the alert messages and evaluate the device s diagnostic data to determine the likelihood of a lead integrity issue Review the alert messages CareAlert pop-up window When the device is interrogated, a CareAlert pop-up window notifies you that an alert condition exists, including the new RV Lead Integrity Alert. 12 Reference Manual

13 Quick Look Observations Check the Quick Look Observations list to determine the type of alert condition. Alert: RV Pacing lead impedance This observation appears when the RV Pacing Lead Impedance is out of range. Sensing issue This observation may indicate that the RV Lead Integrity Alert (rapid oversensing) criteria have been met Medtronic CareAlert Events (Patient Alert Events) RV Pacing lead impedance This alert appears in the CareAlert Events list if the RV Pacing lead impedance measurement is out of range. The date and time of the event are also recorded in the list. Reference Manual 13

14 RV Lead Integrity Alert If the RV Lead Integrity Alert (rapid oversensing) criteria are met, the date and time of the event are recorded in the CareAlert Events list. The list also includes any lead-related events that exist. Note: If the RV Lead Integrity Alert has been triggered, but no other lead-related events exist, then the Event column does not include a text description Review the diagnostic data Review the VT/VF episode log and stored episodes to look for evidence of non-sustained ventricular tachyarrhythmias. Review the EGM from any stored episodes and the Sensing Integrity Counter for evidence of lead noise oversensing. Review the Lead Performance Trends for additional evidence of a potential lead problem. 14 Reference Manual

15 Sensing Integrity Counter (SIC) Check the Sensing Integrity Counter section of the Battery and Lead Measurements screen for a Short V-V Intervals total over 300, which may indicate an oversensing issue. If the RV Lead Integrity Alert (rapid oversensing) criteria are met, the device adds 301 to the Sensing Integrity Counter. This adjustment ensures that a Sensing issue observation appears in the Quick Look observations list. Arrhythmia Episodes (VT-NS) Check the Arrhythmia Episodes for VT-NS. If there are 2 or more episodes with an average R-R interval less than 220 ms (that is, if the average ventricular rate, as displayed in the episode log, is greater than 273 bpm), lead noise oversensing may have occurred. Review the stored EGM to determine the cause of the oversensing. Figure 2. VT-NS episode record 1 Average rate information in the episode log Lead Performance Trends If at least 1 RV Pacing Impedance measurement is greater than 2 times the baseline value, then the lead impedance should be considered abnormal, even if the value is within the programmed alert thresholds. Reference Manual 15

16 Figure 3. RV Lead Performance Trend data 1 Baseline value 2 Abnormal impedance measurements Review CareLink Network transmissions If available, the Medtronic CareLink Network provides another way to receive information about the condition of the RV lead. If a lead impedance alert occurs, the CareLink Network provides notification of the event on the Patient List screen, the Quick Look report, and the Alert Events List. For Concerto and Virtuoso devices, you can also receive notification through any enabled Clinic Notifications (by text message, voice message, pager, or ). If an RV Lead Integrity Alert occurs, the Event Summary column on the Patient List screen provides an indication of a sensing integrity issue. The Quick Look report lists a Sensing Integrity Counter observation. At the initial release of the RV Lead Integrity Alert software, RV Lead Integrity Alert Clinic Notifications for Concerto and Virtuoso devices are not supported by the CareLink Network. Note: If the RV LIA alert criteria are met, but no other lead-related alerts exist, then the Alert Events List does not display an alert event. CareLink network maintenance window If the patient sends a transmission to the CareLink Network during the nightly network maintenance window, the transmission is not visible on the network until the maintenance window is complete, including any information about the RV Lead Integrity Alert or the lead impedance alerts. Patients should contact their 16 Reference Manual

17 clinic and follow their instructions for responding to an alert that occurs outside of regular office hours Programming options for the RV Lead Integrity Alert feature You can adjust the lead impedance alert thresholds used by the RV Pacing Lead Impedance Out of Range Alert. You can also turn off the RV Lead Integrity Alert feature without removing the feature from the device by turning off the RV Pacing Lead Impedance Out of Range Alert. The procedure for adjusting parameters varies among devices. Follow the appropriate procedure for your patient s device. Note: If you program VF Detection or all of the VF therapies to Off, the RV Lead Integrity Alert does not operate. The RV Lead Integrity Alert operation resumes when you program VF Detection and the VF therapies to On, and only the data collected after that time are applied to the alert criteria. Maximo DR, Maximo VR, Marquis DR, Marquis VR, Intrinsic, InSync Maximo, or InSync Sentry How to configure parameters during a patient session: 1. Select the Data icon. 2. Select Patient Alert. 3. Select Lead Impedance Out of Range. 4. Set the RV Pacing Enable field to Off, or adjust the lead impedance thresholds. 5. Select [Program]. Concerto or Virtuoso How to configure parameters during a patient session: 1. Select the Params icon. 2. Select Alert. 3. Select Lead/Device Integrity Alerts. 4. In the Device Tone column, select Lead Impedance Out of Range. 5. Set the RV Pacing Lead Impedance Out of Range Alert to Off, or adjust the lead impedance thresholds. 6. Select [Program]. EnTrust How to configure parameters during a patient session: 1. Select the Params icon. 2. Select Patient Alert. 3. Select Lead Impedance Out of Range. Reference Manual 17

18 4. Set the RV Pacing Lead Impedance Out of Range Alert to Off, or adjust the lead impedance thresholds. 5. Select [Program] Removing the RV Lead Integrity Alert feature from a device If you do not want to use the RV Lead Integrity Alert feature after the feature has been installed, you can remove the feature from the device. To turn off the RV Lead Integrity Alert without removing the feature from the device, turn off the RV Pacing Lead Impedance Out of Range Alert. For more information, see Section If you are in a patient session, select [End Session] to return to the Select Model screen. 2. Select the Programmer icon > Other Software. 3. Place the programming head over the device. Do not remove the programming head during the process of uninstalling the feature. Note: All devices require the use of the programming head to remove the RV Lead Integrity Alert feature, including wireless devices. 4. Select RV Lead Integrity Alert Software. The programmer interrogates the device and confirms that the feature is installed. 5. Select [Uninstall]. 6. When the confirmation window appears, select [Uninstall]. When the feature has been removed from the device, a confirmation statement appears. 7. The programmer automatically prints the RV Lead Integrity Alert Software Report to the programmer printer. The report includes the patient s name, device model, serial number, date and time, and a statement that confirms that the feature has been uninstalled. Save the report for the patient s record. Note: After you uninstall the feature, the +LeadAlert is removed from the Notes field on the Patient Information screen. The + sign indicator is also removed from the Patient ID field, and is no longer be displayed on printed reports. 8. Select [Exit Application]. When the confirmation window appears, select [Exit] to exit the application and return to the Select Model screen. 18 Reference Manual

19

20 , Inc. 710 Medtronic Parkway Minneapolis, MN USA Tel Fax Medtronic USA, Inc. Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: Tachycardia: Europe/Africa/Middle East Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland Tel Fax Technical manuals: Medtronic, Inc M937300A001C *M937300A001*