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.

• Delay or Failure to Restart (Especially Subgroups 1, 2, and 3)
  • Bridge to Transplant, Candidacy, or Recovery
  • Destination Therapy
  • Bridge to Transplant, Candidacy, or Recovery, When Modified Controller Not Available
  • Destination Therapy, When Modified Controller Not Available
  • Revisiting the Medium Priority [Controller Fault] Alarms
  • Patient Planning Worksheet
• Controller Port Bent Pins
• Hardened Driveline Cover Hindering Driveline Disconnection
• Driveline Strain Relief Repair
• Pump Weld Non-Conformance

More information

For complete information regarding patient management recommendations, please reference the urgent medical device communication letters via the Medtronic website: https://www.medtronic.com/en-us/healthcare-professionals/products/cardiac-rhythm/ventricular-assist-devices/heartware-hvad-system/mcs-product-advisory.html.

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

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 urgent medical device communication letters via the Medtronic website: https://www.medtronic.com/en-us/healthcare-professionals/products/cardiac-rhythm/ventricular-assist-devices/heartware-hvad-system/mcs-product-advisory.html.

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

Mechanical circulatory support HVAD product advisories: https://www.medtronic.com/en-us/healthcare-professionals/products/product-performance/mcs-product-advisory.html

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

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

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 plan 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.

Hardened driveline cover hindering driveline disconnection

Evaluating the driveline (DL) cover
All HVAD™ — supported patients

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

Pump Weld Non-Conformance

All HVAD™ — supported Patients