Performance Notes
Clinical Management of VCM near Elective Replacement

Clinical Management of VCM near Elective Replacement

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Background

Medtronic Technical Services has received reports of devices going to ERI or end of life (EOL) sooner than expected after a normal follow-up in which the device longevity was projected to be approximately 18 months. It has been noted that these cases typically involve Kappa 700 devices where Ventricular Capture Management set the ventricular lead to high output (5 V, 1 ms), which occurs by device design when a high threshold is measured. It is important for physicians and allied professionals to understand VCM behavior as it relates to longevity so that they can, in turn, understand how this affects management of the device and follow-up visits as VCM equipped IPGs near the end of their expected longevity.

Device Longevity and VCM Behavior

Ventricular Capture Management is a feature that uses evoked response sensing to determine the stimulation threshold needed to capture the ventricular chamber. Proper detection of the evoked response is crucial to the VCM algorithm determining an accurate capture threshold. There are rare conditions, however, during which the VCM algorithm will not be able to measure the evoked response accurately.1 When this occurs, for safety reasons the VCM algorithm will reprogram the output to 5 V, 1 ms until the subsequent VCM measurement.

If the device has considerable remaining longevity, these occasional excursions to high output do not substantially affect remaining longevity. However, if the device has less than approximately 18 months remaining longevity, there is the possibility that the high output condition caused by the 5 V, 1 ms output will drain the battery and trigger ERI.

When ERI is declared by the device, VCM is disabled and the outputs are left at 5 V, 1 ms until the device is reprogrammed at an in-office follow-up. This increased current drain of a high output condition will speed depletion of the device, possibly resulting in the device getting to the EOL (battery voltage ≤ 2.15 V).

Please note that the following parameter changes occur when the device goes to ERI:

IPG Therapy Parameter Changes at ERI

Kappa 700 is Medtronic’s first-generation VCM algorithm, which has a relatively higher incidence of evoked response undersensing compared to subsequent algorithms, resulting in more frequent high output conditions. Therefore, Kappa 700 products are the primary focus of this note. It should be noted that IPGs equipped with the second-generation VCM algorithm (Kappa 900, EnPulse, Adapta/Versa/Sensia, and Relia) have not been observed with evoked response undersensing in the general population, though the items listed in “Follow-Up Considerations” may also be used on these devices.

Follow-Up Considerations

  • Estimated longevity in the event the device goes to high output can be determined by the following steps. This allows the clinician to determine follow-up frequency if he or she is concerned the device may go to ERI due to high output.
    • – Program the ventricular channel to 5 V, 1 ms
    • – Navigate to Data/Battery and Lead Measurements
    • – When the message stating “Warning – Old Data” is displayed, select “Yes” to measure battery voltage and lead impedance at the new ventricular outputs
    • – An updated remaining longevity estimate will be calculated on the elevated outputs. Note the “Minimum Remaining Longevity.” Clinical decisions can be based on this value.
    • – Program the Amplitude and Pulse Widths back to their original values before leaving the session
  • If the capture trends and lead impedance trends are stable, VCM can be programmed to “Monitor Only” for the remaining device life. This should be considered only if remaining longevity is 18 months or less.
  • Follow-up frequency can be increased for those patients who do not have stable capture or lead impedance trends. This can be done via a CareLink Home Monitor, or in-office.

1 Medtronic, Inc. (2001). Medtronic Kappa 700/600 Series Pacemaker Reference Guide (Chapter 4, p. 27). Can be retrieved from http://manuals.medtronic.com.

Specific Models This Applies To

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