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 Urgent Medical Device Communication letters via the Medtronic website:
For additional HVAD patient management resources, please consult the Instructions for Use and Patient Manual, and contact your local Medtronic Field Representative.
Delay or Failure to Restart Discussion Guide and Worksheet for Case-by-Case Assessment Plan
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, etc.);
- 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, and
- Patient and caregiver understanding/compliance to alarm response protocols and power source management to prevent unnecessary pump stops.
Mechanical circulatory support HVAD product advisories:
For additional HVAD patient management resources, please consult the Instructions for Use and Patient Manual, 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) [APR 2024] | ||
|---|---|---|
| High Risk Subgroups | 1 | 2.7% |
| 2 | 31.0% | |
| 3 | 4.8% | |
| General HVAD population | 0.5% | |
Bridge to Transplant, Candidacy, or Recovery, Especially Subgroups 1, 2, and 3
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.
Bent Pin in the Controller Port
If a bent pin is identified in a controller port, considerations for a controller exchange should include the invididual 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.
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.
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.
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.