HVAD™ field actions: patient planning tool

Considerations for developing a case-by-case patient management plan

This tool is intended to help clinicians develop personalized management plans for HVAD™ patients. Content in this tool is based on recommendations in previously published Field Corrective Actions (FCAs) and is not intended to be prescriptive. As always, patient care decisions should be made by practitioners on a case-by-case basis, based on their clinical judgment.

This tool will be updated as needed; please bookmark and refer back to this page regularly.

Use this Planning Worksheet to develop a case-by-case assessment for your patients.


More information

For complete information regarding patient management recommendations, please reference the mechanical circulatory support HVAD product advisories via the Medtronic website.

For additional HVAD™ patient management resources, please consult the Medtronic manual library, and contact your local Medtronic field representative.


Use this Planning Worksheet to develop a case-by-case assessment for your patients.


Delay or failure to restart discussion guide and worksheet for case-by-case assessment plan

For complete information regarding patient management recommendations, please reference the mechanical circulatory support HVAD product advisories via the Medtronic website.
 

Recommendations for patient management:

In consultation with the MCS Independent Practitioner Quality Panel, Medtronic recommends:

  • That treatment decisions for all patients should be determined on an individual case-by-case basis 
  • That healthcare providers have prepared an individualized patient management plan for each subgroup patient, especially patients in subgroup 2
  • That healthcare providers upload controller logfiles to Autologs and/or HVADlogs with each patient visit and review reports (e.g., the reports include pump parameters, motor start events, alarms, power disconnects)
  • That healthcare providers routinely speak with their patients to emphasize avoidance of unnecessary pump stops and reinforce education regarding device management and alarm troubleshooting
  • That patients do not exchange their controller unless explicitly directed by a high priority alarm condition or a VAD team member
  • That controller exchanges are performed in a clinical setting, and with immediate hemodynamic support available especially for subgroups 1, 2, and 3

 

Factors to consider for a controller exchange include but are not limited to:

  • Whether the patient is a candidate for a pump exchange if the pump does not restart
  • The existence of a do not resuscitate (DNR) order and co-morbidities
  • Length of time the patient is expected to remain on therapy; examples include but are not limited to bridge to transplant care and/or therapeutic recovery potential
  • Distance/time it will take for the patient to reach the hospital/clinic for support
  • Patient and caregiver understanding/compliance to alarm response protocols and power source management to prevent unnecessary pump stops

 

View the mechanical circulatory support HVAD product advisories.

For additional HVAD™ patient management resources, please consult the Medtronic manual library and contact your local Medtronic field representative.


Discussion guide for elective controller exchange planning

Cumulative probability of experiencing a pump stop resulting in failure or delay to restart (by 3 years) [JAN 2026]

High risk subgroups 3.1%
2 31.3%
3.8%
General HVAD population 0.4%

Bridge to transplant, candidacy, or recovery, especially subgroups 1, 2, and 3


Destination therapy, especially subgroups 1, 2, and 3


Bridge to transplant, candidacy, or recovery, especially in subgroups 1, 2, and 3

When modified controller not available

Destination therapy, especially subgroups 1, 2, and 3

When modified controller not available

Revisiting the  medium priority (controller fault) alarms

During medium priority alarms, the pump is still working. 
 

[Controller Fault] alarms have several potential causes (e.g., internal battery end-of-life, component malfunctions) which may be identified using logfile analysis.
 

The decision to change the controller or what other action is needed will be based on logfile analysis and patient‘s clinical condition.


Alarm type: medium priority

Controller alarm display line 1

Action
line 2

Potential causes

[Controller Fault]

[Call]

Controller component malfunction but pump is still working

[Controller Fault]

[Call: ALARMS OFF]

  • Controller component malfunction
  • Suction detection disabled
  • [Low Flow] alarm disabled
  • [VAD stopped] alarm may be disabled
  • [High power] alarm may be disabled

Permanently silencing the [Controller Fault] alarm due to a low internal battery


One purpose of the [Controller Fault] alarm is to alert the user that the internal battery is nearing end-of-life.
 

When the internal battery completely depletes, the [No Power] alarm will not sound during a loss of power (e.g., double power disconnect).
 

Using the HeartWare monitor, the low internal battery [Controller Fault] alarm may be permanently silenced once the alarm is activated.
 

All other alarms will remain active as long as the controller has external power.
 

Re-silencing a [Controller Fault] alarm due to internal battery end-of-life may be required:

• Following a double power disconnect;
• If the internal battery charge rebounds and then later depletes to the low internal battery threshold.


This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
 

This tool will be updated as needed; please bookmark and refer back to this page regularly.


Planning worksheet

Use this Planning Worksheet to develop a case-by-case assessment for your patients.


This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing any of these referenced actions, including a controller exchange, should be made on a case-by-case basis considering the patient’s individual risk and depending on a number of clinical factors assessed by practitioners. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.

*Currently the Modified Controller with unapproved software is not available in all geographies. Use of the Modified Controller with unapproved software is with risk. Refer to the Physician Acknowledgement Form for potential risks associated with using the Modified Controller with the unapproved software.
 

This tool will be updated as needed; please bookmark and refer back to this page regularly.


HVAD controller programming and use of the disable “VAD Stop“ alarm button

Use of the Disable “VAD Stop“ Alarm Button

All HVAD-supported patients

A [VAD Stopped] Alarm will occur when a controller has been powered on, but a driveline has not yet been connected.
 

Disable “VAD Stop” Alarm Feature:

• Designed to silence the high priority [VAD Stopped] alarm during the programming of an HVAD controller.
• Disables the HVAD pump from starting automatically when a driveline is connected to the controller.


Considerations for the individual risk of pump delay or failure to restart

This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
 

This tool will be updated as needed; please bookmark and refer back to this page regularly.


Controller port bent pins — replacement of power source and data monitor cables

Bent pins: identifying and replacing damaged or worn connectors

Bent Pin in the Controller Port

If a bent pin is identified in a controller port, considerations for a controller exchange should include the individual risk for delay or failure to restart following pump stop for the exchange.


This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
 

This tool will be updated as needed; please bookmark and refer back to this page regularly.


Hardened driveline cover hindering driveline disconnection

Evaluating the driveline (DL) cover

All HVAD™-supported patients

Instructions for evaluating the driveline cover

While immobilizing the controller, push the DL toward the controller and pull the DL cover back from the flange with a side-to-side wiggle motion.
 

DO NOT pull the driveline cover with excessive force or use a twisting motion as this may damage the DL connector or dislodge the DL connection.


Considerations for the individual risk of pump delay or failure to restart

This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.

This tool will be updated as needed; please bookmark and refer back to this page regularly.


Driveline cover management following strain relief repair

Driveline (DL) strain relief repair considerations

For HVAD patients with DL strain relief repair who are in need of controller exchange

Advise patients that, whenever possible, controller exchanges should be performed under clinical supervision, as it will likely be difficult to pull back the driveline cover to access the driveline connector. 


Leave DL cover in place. Medtronic does not recommend clinicians tamper with or cut off the cover or remove it.


Considerations for the individual risk of pump delay or failure to restart.

This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
 

This tool will be updated as needed; please bookmark and refer back to this page regularly.


Pump weld non-conformance

All HVAD™-supported patients

Explant of the HVAD pump

Routine prophylactic explant of the HVAD pump is not recommended as risks associated with explanation may outweigh potential benefits of continued HVAD therapy.1

Physicians should make the decision regarding explant/exchange of the HVAD pump on a case-by-case basis, considering the patient‘s clinical condition and surgical risk. 

1 Salerno CT, Jorde UP, Molina E, Cantor RS, Pagani FD, Kirklin J. Elective HeartWare HVAD to HeartMate 3 Pump Exchange: Risk Mitigation or Increasing Risk? Ann Thorac Surg. 2023;116:438-440.


Upload and submit logfiles here

This clinician tool is provided as a general reference only and should not be considered the exclusive source for this type of information. Consideration for performing these actions, including a controller exchange, should be made on a case-by-case basis taking into account the patient’s individual risk. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
 

This tool will be updated as needed; please bookmark and refer back to this page regularly.