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Escalation of Status for Time on Left Ventricular Assist Device

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Background

In 2018, heart allocation policy changed to better prioritize heart transplant candidates so those most in need receive donor heart offers first. Since the change, fewer heart candidates with a left ventricular assist device (LVAD) have been transplanted, resulting in decreased use of LVADs as bridge-to-transplant therapy, even if it would have been an appropriate therapy for the candidate. While evidence suggests LVADs provide a stable transplant alternative, the longer an LVAD is implanted, the greater the risk the patient has of developing a complication, like stroke, infection, or bleeding.

Supporting Media

Presentation

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Proposed changes

  • Adult heart candidates who have had an LVAD for at least the past six years will be eligible for Status 3
  • Adult heart candidates who have had an LVAD for at least the past eight years will be eligible for Status 2
  • 18 months after implementation of this proposed change, the timeframes for LVAD patients moving up in status will shorten:
    • Candidates with an LVAD for five years will be eligible for Status 3
    • Candidates with an LVAD for seven years will be eligible for Status 2

Anticipated impact

  • What it's expected to do
    • Provide more opportunity for LVAD patients to be transplanted before developing an LVAD-related complication, which could improve post-transplant outcomes
    • Encourage the use of LVADs as a bridge-to-transplant therapy
  • What it won't do
    • Will not impact existing Status 2 and 3 criteria for LVAD complications and the 30 day discretionary time

Terms to know

  • Dischargeable Device: A heart device that is approved by the US Food and Drug Administration for use outside of the hospital.
  • Left Ventricular Assist Device: A mechanical device implanted into a patient with left heart failure that assists the left ventricle in providing blood circulation.

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Read the full proposal (PDF)

Provide feedback

eye iconComments

Robert Goodman | 01/21/2025

As a 11+ year heart transplant recipient/survivor who was told that I was not eligible for LVAD (too fragile), I have been intrigued by the use of LVAD for a long time. I have come into contact with long-term LVAD dependent patients and have marveled at their ability to resume a somewhat normal life and their resiliency. I was dismayed to learn that the 2018 LVAD criteria has not achieved its desired effect and fully support the changes as recommended by the Heart Committee. Note: I was a visiting OPTN board member of the Heart Committee for two years a couple of years ago.

Anonymous | 01/21/2025

We fully support the UNOS decision to escalate the status for time on LVAD. LVAD patients are penalized for being implanted because they were too sick initially and now are considered too well for transplant. This paradoxical situation underscores the need for a more nuanced approach to prioritizing these patients, ensuring they receive the appropriate care and opportunities for transplantation.

Mohammed Quader | 01/21/2025

The time to recover with LVAD before uplisting should be shorter that what is proposed. Two years is a suitable time to recover then they should be uplisted to status 2.

Anonymous | 01/21/2025

I agree with the uplisting of patients with Left Ventricular assist device to status 2 or 3. However, I also think that type of device and whether the patient is hospitalized should be considered. Possibly have a scorecard of some sort to rank the patients within the status. Hospitalized, temporary device patients should have a higher status than patients who are at home with device. I also believe that patients who have had more complications such as stroke, infection, GI bleed etc should have a higher priority than a patient who has night despite similar time on device.

Anonymous | 01/21/2025

I am very encouraged to see the proposal for LVAD escalation of status time.
However, as LVAD complications tend to arise around year 4, I would recommend augmenting the timeline to allow status 3 starting at year 3 and status 2 starting at year 5. Additional LVAD complications should allow upgrade to higher status at any time post implant pending clinical urgency.

RV failure requiring inotropic support (status 2)
RV failure requiring RVAD (status 1)
MCS with bleeding > 3 transfusions in 6 months (status 2)
MCS with infection (as defined) (status 1 or 2 pending severity of infection)
MCS with pump malfunction (status 1)

David Silber | 01/21/2025

I do agree that there is some degree of disadvantage to LVAD patients we are awaiting transplant. I also agree that the longer you are on an LVAD more likely you are to develop either a complication from the device can be substantial or might need additional surgical interventions or a complication it makes you an adequate for transplant due to elevated risk.

I would concur that some adjustment needs to be made recognizing these stated problems in the present allocation system. While I do agree that there will be a switch to continuous distribution it is unclear when that might occur, and it is probably better to move forward with making the change as described.

Regarding the time on LVAD support the only additional comments I would make is that we have noticed with long-term LVAD support some degree of postoperative vasoplegia following transplant tends to be exacerbated with prolonged LVAD support and that 8 years or 7 years may turn out to be too long although I do understand the goal of phasing in the system and would agree with shortening this over time and following the data on the overall impact so that the amount of points in continuous distribution might be better statistically adjusted.