Comments

Anonymous | 02/21/2025

I agree with the escalation of status for LVAD patients. Thanks

Chris Whiffen | 02/21/2025

I am a 4 year LVAD patient that is in favor of escalation of status of LVAD patients. It gives a hope that one day we can live a more normal life. Sometimes transplant seems like a dream. And not having the complications of living with a LVAD.

Anonymous | 02/21/2025

I agree with the escalation of status for the L-Vad patient’s.

AdventHealth Transplant Institute | 02/21/2025

Our program supports the escalation of status based on time spent while supported with an LVAD. We believe that using the shortened timeline of 7 years for status 2 and 5 years for status 3 is appropriate even now. The chances of transplantation at status 3 are still not very high. Of course, the old policy of escalation based on complications would still apply. The risk of complications rises with time as noted in the presentation. Thanks.

Richard Stenseth | 02/20/2025

I have been on an LVAD for 5 years. I am in favor of reviewing the status guidelines for transplant to include time on an LVAD.

Anonymous | 02/20/2025

OPTN Response to Escalation of Status for Time on LVAD

I agree with status escalation for patients on LVAD support for extended periods of time, though I do believe the proposed timeframes are too long for various reasons.
Surgical risk - Extended time on LVAD support can lead to increased adhesion formation and surgical difficulty during device explant and subsequent Htx, complicating HTx surgeries in various ways.
Continuous Flow - Currently available LVADs are exclusively continuous flow devices which are not fully understood at the chronic level of 6-10 years post implant. We do have strong evidence that, though hemocompatibility with current devices is quite strong, continuous flow LVADs do come with complications like GI bleed, acquired Von Willebrand Disease, and other bleeding risks associated with required anticoagulation. The longer a patient spends on support, the greater their risk of experiencing at least one adverse event which, if sustained, could preclude them from HTx candidacy indefinitely.
Infection risk - the REMATCH trial showed that infection risk is not insignificant in LVAD patients. Despite the risk for sepsis being highest in the first 3 weeks post implant, the overall freedom-from-infection rates decrease as time goes on according to multiple studies. Of course, infection at the time of transplant further complicates the care of these patients who then receive necessary immunosuppression post HTx. Finding a reasonable window of time on support without a significantly increased risk of infection is critical to good outcomes post HTx.
Age - Though this varies from center to center, it is well evidenced that age is an important consideration in HTx candidates. Many advanced heart failure patients receive LVADs just a few years before some center's age cutoff for Htx. Though this will always be the case for some patients, the current proposal limits the field of potential candidates significantly.
Right sided heart failure - Though I do feel strongly in my own center's approach to proactively preventing and treating late RHF, it is unfortunately a high risk in LVAD patients on support for long periods of time. Medical management does seem to be improving this, but RHF cannot be neglected as an important factor in long term outcomes for people on LVAD support.
Survival - Though the Momentum 3 trial showed us that 5 year survival on mag lev support far outperformed that on axial flow support, it still only resulted in a 54% overall survival rate. This is not insignificant in and of itself, but as it relates to the proposed timeline of status escalation we would see a significant number of LVAD patients potentially miss out on the opportunity for HTx, especially when considering other factors like blood type and body surface area affecting overall wait time while listed for HTx.
Other factors to be considered in this proposal should include but are not limited to quality of life, caregiver burnout, economic burden, device recall incidence, and many others.
Based on my own center's experience with this patient population as well as published data within this field, I strongly recommend status escalation for patients on LVAD support be shortened to three years on support for status 3 and five years on support for status 2.
Thank you to everyone who is participating in this review for your careful consideration.

Anonymous | 02/20/2025

I support the escalation of status for LVADs. We know that the longer you have an LVAD the more at risk you are for complication. There is no exit strategy for these patients, other than transplant. We often see LVAD patients who are having complications wait many years to receive a transplant, especially if they are blood type O.

Anonymous | 02/20/2025

Agree with these proposed allocation changes. This should help facilitate the concept of "the right therapy for the right patient at the right time" and help alleviate external factors from risk-benefit assessments.

Portland State University | 02/19/2025

I agree that this could be a beneficial solution. I also wonder about patients who are already experiencing negative effects despite a shorter period of mechanical support. Overall, this seems like it could make the most difference.

University of Chicago | 02/19/2025

University of Chicago’s response to the OPTN proposal

We would like to commend OPTN for trying to address this critical issue, in a phased fashion. Outcomes of recipients of the contemporary LVAD (HM3) are continuing to improve both in terms of morbidity and mortality, yet it is being primarily used as a destination/ long-term therapy for lack of a positive path forward to transplant. These patients have ‘paid their dues’ once by not having a transplant in ‘round 1’ (for any number of reasons), but that should put them at an advantage (having access to a timely transplant in the absence of a complication) and not disadvantage (which is what ends up happening). In the meantime, patients are being supported on temporary MCS devices for exceedingly long times with the concern that ‘once they get an LVAD, we won’t be able to transplant them unless they have a complication’.

The proposed timeframe makes inherent sense, especially for younger patients ( 65 years) who may lose their eligibility to benefit from transplant due to age cut-offs.

The goal of advanced therapies (whether LVAD or transplant or LVAD followed by transplant) is to offer a patient net prolongation of life. For those awaiting transplantation, it should also give them an opportunity to get transplanted in a timely fashion. Our current allocation system is often not of reflective of that intent and ends up putting BTT LVAD patients/ strategy at a disadvantage -so we support this as a step in the right direction.

Andrew Shaffer | 02/19/2025

I strongly support this proposal of escalation of status for time on LVAD.
I think the timeframe to escalation should be shortened to 2 years for status 3 and 3 years for status 2.
Agree that patients should not have to be hospitalized to qualify for this.
We have seen in our program that current allocation system has dramatically influenced decision making for patients with declining heart failure.
There has been a dramatic increase in the use of temporary mechanical support, and with this we are implanting LVADs on only the sickest patients.
The use of temporary support requires prolonged ICU stays prior to transplant which in turn leads to device related complications.
Additionally, increasing tMCS limits the beds available for other patients presenting with heart failure, and other critical cardiac issues as these patients have prolonged pre-transplant stays.
We know that VAD patients in general do well with median event free survival continuing to improve with the current generation of pumps.

Melana yuzefpolskaya | 02/19/2025

I support upgrading LVAD patients based on the time spent on the LVAD. These patients should not be penalized for getting an LVAD, i.e. never being able to be transplanted once stable on the VAD, if this is what their preference is. The timeframe when to upgrade seems very arbitrary, not sure how that was chosen? Also, important to note once upgraded to status 2 or 3 patients should be allowed to stay home and not be in the hospital. overall, i think is way overdue to implement. I would also advocate for escalation of status in patients with driveline infection of less severity of what the guidelines are allowing now.

Anonymous | 02/19/2025

Adult heart candidates who have had an LVAD for at least the past 2 years will be eligible for Status 3.
Adult heart candidates who have had an LVAD for at least the past 4 years will be eligible for Status 2.
18 months after implementation of this proposed change, the time frames for LVAD patients moving up in status will shorten:
Candidates with an LVAD for 2 years will be eligible for Status 3.
Candidates with an LVAD for 4 years will be eligible for Status 2.

Anonymous | 02/19/2025

Agree that escalation. HOWEVER, I would like to see more options for escalation of patients with LVADs with complications.

We have a patient that has had an occlusive and hemorrhagic stroke post-LVAD implant; however, we can't escalate his case because he does not have an indication for hospitalization. He should be prioritized over a stable LVAD patient.

Remove requirement for hospitalization for LVADs if we want to submit an exemption.

Anonymous | 02/19/2025

I am in favor of escalation of status for time on LVAD. Decreased use of LVADs is a waste of resources and patients need some benefit to choosing LVAD support. We know sicker patients do not do as well after transplant. We should give the opportunity to those who are most viable and have been optimized on support. With that, we can study long-term outcomes when transplanting fewer sicker patients versus transplanting before adverse events such as strokes or infection choose our patient's fate.

Anonymous | 02/19/2025

At present BTT VADs are at extreme disadvantage and remain endlessly on the waitlist increasing morbidity and mortality. Hence, I support the proposition that LVADs need more fair evaluation and heart allocation in the appropriate candidates

Anonymous | 02/19/2025

I believe that LVAD patients that now meet transplantation criteria and be escalated to receive available donor organs. Many times, they have already proven their ability to manage he device and made lifestyle changes that would make the best use of donor organs.

Anonymous | 02/19/2025

While this is a much needed change in policy, there is perceived discrimination of the LVAD patient for transplant given their status. The timeframe may still be a bit longer especially in a patient who is in their 60's waiting for transplant on LVAD therapy. I would like to see the time frame change from 5 years to 4 years as I think all agree that the longer the time on LVAD the greater the risk of complications and prolonged inpatient time on temporary support may not always be the best strategy to decrease transplant wait times.

Sylvie Baudart | 02/19/2025

I support the current proposal although it remains timid in its escalation. It will certainly be an improvement on the current state. Ideally VAD patients>5years should be status 3 with the possibility of a 30 day status 2 upgrade.
Additionally VAD patients with device infection should be escalated to status 2 instead of 3 to improve their transplant outcomes.

Summa Health | 02/19/2025

As a growing LVAD center implanting a variety of potential transplant eligible patients due to the current allocation system most of our patients will wait years for a heart. As our patients age with their LVAD and for assorted reasons desire transplant as an option, we want to be able to offer the appropriate care at the appropriate time without LVAD being the limitation.

joshua hermsen | 02/15/2025

i agree with this type of change. clearly the pendulum has swung too far. the explanation given for the specified timeframes is reasonably based upon durable VAD natural history and i am in favor of a phased approach to avoid a glut of status changes all at once.

however i think some consideration should be given to VAD pt/txp candidate age in such a scheme. These proposed timeframes seem quite reasonable for young patients (< 50-55) at the time of VAD implant. in thinking about a patients entire life/overall survival its not unreasonable in many circumstances to 'relegate' a patient to VAD for an extended (5+ years) amount of time before considering transplant. so in younger patients i can imagine this scheme may very well change behavior of clinicians (more likely to use durable VAD vs tMCS)

However if a patient is implanted with a VAD at, say, 63 or older they are going to be at the cusp of transplantability (in most centers) by the time their status in this system would facilitate transplant. in older patients i doubt this scheme will change clinician behaviour. i would guess these patients will continue to be funneled through tMCS pathway to facilitate transplant. Given the generally older age distribution of heart transplant recipients the 'bang for the buck' of this change will be less if clinician behavior is not changed for the older patients.

Would need some statistical modeling to estimate the 'most appropriate' age cutpoint (s). alternatively could be modeled continuously/in 3 or 5 year increments etc. A system where someone in their 60's is upgraded after 1 or two years while someone in their 40's waits 5+ seems reasonable/fair, workable and may provide for overall maximization of aggregate patient survival.

Anonymous | 02/14/2025

I agree . I’m a lvad patient 7 yrs now at status 4 . I’m getting worried that I wouldn’t survive a complication . The clinic I’m at only has offers for status 2 .

Anonymous | 02/13/2025

I support escalating LVAD pt’s status on the transplant list. It’s basically impossible to get a heart with an LVAD unless you are so sick you have to live in the hospital.

Anonymous | 02/13/2025

While I feel that this is a step in the right direction, the time on the LVAD needs to be reduced for increasing the status. We have the data to support these changes. The Momentum 3 Trial showed a significant increase in mortality at 5 years (54%). The 1-month mortality rate while on Impella support is 48%. If the mortality rate is higher for an LVAD patient at 5 years, than a patient on Impella support it seems logical that they should be at the same status on the heart transplant waitlist. For this reason, I feel that someone on an LVAD device for 5 years should be equivalent to a status 2. Those on the device at 3 years should be a status 3. If any LVAD patient has a major complication with their device after 3 years, they should have 30 days status 2 time. The current restricted guidelines make it virtually impossible to upgrade any LVAD patient unless they have a major complication, which in most times needs to be so significant that they are no longer eligible for transplant. If the goal is to reduce the need for temporary support which is clogging up our health care system, then make the change that will actually have an impact. If you keep the timeline as proposed, you are essentially not changing the system at all. Physicians will continue to choose the temporary support pathway. There is absolutely no reason a patient that requires a heart transplant should be waiting for 7-8 years to be transplanted. While the LVAD is a great device it still has major complications the longer it is in. The infection rate in the HM3 is substantially higher and the restrictions on transplanting a patient with a device infection does not match the data. A bacteremic LVAD patient has a mortality rate of 37% at 2 years. There is no treatment option other than transplant. Why should this patient not have immediate upgrade in status? Instead, they need to go through washouts and IV antibiotics and secondary infections just to qualify as a status 3. If the goal is to transplant the sickest patients with the highest risk of mortality, then the status system should be reflective of that.

Anonymous | 02/13/2025

I agree that stable LVAD patients should be given an opportunity to receive a transplant before they experience a complication. Some of the complications that patients experience can be catastrophic, resulting in the need to remove them from the heart transplant waitlist.

When patients and their caregivers are committed to the LVAD process and take fantastic care of their device, they will also take care of the limited resource which is heart transplant. At some point, stable non-hospitalized candidates should be given the same priority as candidates who experienced device related complications. These complications will happen eventually and some of them have long term impacts on the patient's life.

I would wait until after the allocation changes associated with the Amend Adult Heart Status 2 Mechanical Device Requirements have been implemented and monitoring results are available before making the proposed changes. I believe the key to implanting more dischargeable LVADs will be making it harder for centers to keep temporary devices in for weeks and months at a time. The dischargeable LVADs available have good outcomes, and I feel like centers don't implant them as often despite their good outcomes because they won't be performing as many heart transplants.

I think the timeframes granting eligibility following device implant should be shorter in an ideal world. I feel like patients will get a complication before 5-7 years, so if we want to give stable patients a chance at transplant before complications, it should be shorter. The number of higher status patients would have to go down before the ability to shorten the timeframe would be a realistic policy to implement.

University Hospitals of Cleveland | 02/13/2025

Fully support this proposal

Anonymous | 02/13/2025

I support the proposal to escalate status for time on LVAD. There should also be consideration for patients still supported on HeartMate II's. Their status should be allowed to be upgraded as was HVAD patients, Status 2 that could remain at home, considering these devices are no longer in production. In patients who have already received an exchange, time on LVAD should be from time on initial device rather than most recent. In certain regions, patients do not experience decreased wait times for Status 3. Rather than changing in 18 months, the standard should immediately be candidates with an LVAD for five years will be eligible for Status 3 and candidates with an LVAD for seven years will be eligible for Status 2.

Anonymous | 02/12/2025

I fully support the proposal of this as a caregiver of a family member with an LVAD.

Anonymous | 02/12/2025

I support the proposed changes. An LVAD has many purposes for patients. BTT LVAD support provides time for critically ill patients to stabilize and get strong at home, giving them the potential for optimal survival outcomes going into transplantation. An LVAD explant and heart transplant is a very complicated surgery and places them at high risk. The longer the LVAD is in... the longer the patient waits, they accumulate risk and the potential for life-threatening complications (more so than what they live with daily). The current allocation system hinders the purpose of a BTT LVAD and is mentally and physically taxing for those on BTT support.

While acute devices are excellent. But they come with a high risk of complications creating long hospital admissions, and a longer road to recovery post-transplant. It is taxing the healthcare system and placing the most important person at risk- the patient and their donor heart.

I appreciate this is being reviewed and potentially revised and I believe these changes could help our LVAD population and our patients who are trying their very best to wake up every day and put their best foot forward with their LVAD in hopes of being cordless one day.

Thank you,
JL

Anonymous | 02/11/2025

Received my LVAD nine years ago as part of the "Momentum Study". I support the changes that are proposed.

Cindy Hildebran | 02/11/2025

As a LVAD patient coming up on 5 years in June I agree with this change. I would be status 4 with or without LVAD at the time of evaluation so we chose VAd for quality of Life. Thankful for the life it has given me to enjoy travel, time with family and grandchildren. I do have a bucket list of things I want to do when I get my gift♥️

Anonymous | 02/11/2025

I agree with status escalation for patients on LVAD support for extended periods of time, though I do believe the proposed timeframes are too long for various reasons.

Surgical risk - With extended time on LVAD support comes increased adhesion formation and surgical difficulty during explant and subsequent Htx, complicating HTx surgeries in various ways.

Continuous Flow - Currently available LVADs are exclusively continuous flow devices which are not fully understood at the chronic level of 6-10 years post implant. We do have strong evidence that, though blood handling with current devices is quite strong, continuous flow LVADs do come with complications like GI bleed, acquired Von Willebrand Disease, and other bleeding risks associated with required anticoagulation. The longer a patient spends on support, the greater their risk of experiencing at least one adverse event which, if sustained, may necessarily exclude them from HTx candidacy indefinitely.

Infection risk - the REMATCH trial showed that infection risk is not insignificant in LVAD patients. Despite the risk for sepsis being highest in the first 3 weeks post implant, the overall freedom-from-infection rates decrease as time goes on according to multiple studies. Of course, infection at the time of transplant further complicates the care of these patients who receive necessary immunotherapy post HTx. Finding a reasonable window of time on support without a significantly increased risk of infection is critical to good outcomes post HTx.

Age - Though this varies from center to center, it is well evidenced that age is an important consideration in HTx candidates. Many advanced heart failure patients receive LVADs just a few years before their center's age cutoff for Htx. Though this will always be the case for some patients, the current proposal limits the field of potential candidates significantly.

Right sided heart failure - Though I do feel strongly in my own center's approach to preventing RHF, it is unfortunately an inevitability in LVAD patients on support for long periods of time. Medical management does seem to be improving this, but RHF cannot be neglected as an important factor in long term outcomes for people on LVAD support.

Survival - Though the Momentum 3 trial showed us that 5 year survival on mag lev support far outperformed that on axial flow support, it still only resulted in a 54% overall survival rate. This is not insignificant in and of itself, but as it relates to the proposed timeline of status escalation we would see a significant number of LVAD patients potentially miss out on the opportunity for HTx, especially when considering other factors like blood type and body surface area affecting overall wait time while listed for HTx.

Other factors to be considered in this proposal should include but are not limited to quality of life, caregiver burnout, economic burden, device recall incidence, and many others.

Based on my own center's experience with this patient population as well as published data within this field, I strongly recommend status escalation for patients on LVAD support be shortened to three years on support for status 3 and five years on support for status 2.

Thank you to everyone who is participating in this review for your careful consideration.

Anonymous | 02/10/2025

I support the proposed policy changes.

Anonymous | 02/06/2025

I agree with the escalation of status for time on lvad . I’ve had my lvad since 04/2018 . Almost 7 yrs now . This would help a lot . The clinic I’m in only transplants status 2 patients due to the rules we have now . So a stable lvad patient is never considered. I’m grateful for my lvad , but it was meant just to get me strong enough to handle heart transplant.

Anonymous | 02/06/2025

I am very much in favor of this proposal. Like many others I am a larger man with O+ blood type and have been told that it would probably be a long time before I see a transplant. I am one of the lucky ones who have lived with my LVAD for 7 years now with absolutely no issues. However, until I read this proposal I was not aware that, for my age group of 59 years, the % of survival would drop to as much as 70%. Also as I tip the year 60 there is concern on recovery time if get a transplant. Therefore, I think it would be great to have this proposal align with years on LVAD to not making the decision on getting the LVAD a reason why would not see transplant.

Thank You

Anonymous | 02/06/2025

I believe this change to OPTN policy would increase the chances of our LVAD patients receiving heart transplantation. We have numerous LVAD patients who have waited years as status 4 for transplant, and this will allow them to increase their status and hopefully be transplanted sooner. Our end goal is increased quality of life, and this will directly impact our bridge-to-transplant LVAD patients. I am in support of this change.

Susan Bernardo | 02/06/2025

Happy to hear this is up for public comment. Overall, I'm in favor. I agree LVAD pts should receive higher status once listed. If we believe survival on HM3 will continue to rise then 6 and 8 years is appropriate timeframes. What I would like to see change is the criteria for listing for LVAD complications. They are too strict and at times pts need to meet ALL of the criteria. If they only meet 3 of the 4 they don't qualify. This would help those pts less than 6 years post implant get transplanted. When they start having LVAD complications risk of mortality increases. Without changing the stringency of the VAD complication criteria it is unlikely they will get transplanted any sooner. Especially those who are blood group O.

Rainer Moosdorf | 02/06/2025

I very much support this proposal, as it reflects the real world situation for LVAD patients on the waiting list, with a special focus on the increasing complication rate over time. On the other hand, patients on temporary percutaneous devices cannot automatically be ranked higher on the waiting list, which simply means a special incentive for the implantation of these devices, particularly, as some indications are - best - borderline.

Lakeisha Brown | 02/05/2025

I was implanted with the LVAD January 2022 and was transplanted just shy of three years (December 2024). I will forever be grateful for my LVAD for being the life-saving bridge I desperately needed and for the TIME it allowed me that I would not have had. I had been listed for one year before receiving my heart. If this will be a means of shortening the amount of time that one would have to wait, I wholeheartedly support this.

Anonymous | 02/05/2025

I’m writing on behalf of myself. I’m currently an lvad patient for 2+ years now! Been on the transplant list for almost two years now as a status 4 due to having an lvad. I’ve done my part in getting fit and complying with the requirements to be listed but I fear as an lvad recipient I’m not a priority. I’ve had my control changed out and clips already due to them being faulty. I’m grateful for my lvad because my health was deteriorating way too fast and I wouldn’t have made it these past years. I believe us lvad patients that have done their work to be listed should be moved up after a certain time frame. We’re risking our health if we get an infection or our equipment can fail as well. Our batteries are bulky and hard to manage at times. I myself am comfortable with them but my father in law who’s also an lvad patient is having a hard time. He struggles with the weight and after a lengthy hospital stay has yet to recover. Being diagnosed and living with heart failure is difficult as it is, we deserve a bump in our status. Thank you for your time and concern over us lvad patients.

Anonymous | 02/04/2025

I wholeheartedly agree on this proposed change. My husband will have his LVAD 8 years in September and has already had to have a pump replacement 5 years ago due to a recall. In my opinion this should have elevated him in status already which it did not. Years of being on the list at a status 4 without one call, not even for backup.

Anonymous | 02/04/2025

While, this is a tremendous step in the right direction. The time frames are still too long. Especially given recent recalls with the heart mate 3 and the risks and sacrifices that come along with having an LVAD. I feel the most appropriate timeframe would be status three after three years and status two after six years. The ability to have an LVAD is incredible and life saving, however, it is not fair or appropriate that these individuals still have to wait such an extended period of time, especially when a transplant can be a much better option for many patients. Additionally, these shorter time frames should be on implementation. I don’t think that an 18 month trial should be needed to have the right time frames in place. I truly hope the committee will reevaluate these time frames and speak with more patients to see how reduced years would make a significant positive impact.

Anonymous | 02/04/2025

Thousands of patients were affected by the MEDTRONIC LVAD recall. Whether in recovery to the point where a transplant is no longer immediately required or not, many still have the devices attached to their hearts. Those who just hairnet to be in recovery, even with low ejection fractions, are no longer listed. HOWEVER, we cannot get a replacement device should our health deteriorate, meaning our only option is to get a transplant. We cannot get another LVAD. Therefore, those who were taken off the list who met this criteron should be immediately relisted in a new category - maybe with an asterisk. That way, if there is an emergency requiring a transplant, and their current team still has all the information showing they would still be eligible for transplant, they can go immediately to the top of the list.

Anonymous | 02/04/2025

I am giving feedback as a heart transplant recipient who had an LVAD for two plus years before transplant.

Having an LVAD saved my life but it also drastically reduced my quality of life and my mental health deteriorated while I had it. My activities were very limited and I was listed as a status 4. Personally, I was extremely fortunate to receive my transplant ten months after being listed the second time, but the majority of LVAD patients, at least at my transplant hospital, wait much longer. I don’t know if I could have mentally handled having an LVAD for six years, nor could my immediate family. Those two years with it were the most difficult and trying years of my life.

If there is consideration being presented to allow LVAD patients be listed as a status 3 after a specific amount of time, it is my opinion that six years is too long. A requirement of three years after placement seems more reasonable, especially when you consider the implications of risk of infections, driveline deterioration, and mechanical problems.

Thank you for taking the time to read my feedback and giving everyone the opportunity to provide input before making changes to current policies.

Samantha Thomas | 02/04/2025

I would love yall to change the guidelines about the status update when they hit so many years with the LVAD. My husband has has an LVAD for 5 years now, still a status 4, but has been having CHF related problems, and pain from the pump now. It's time for a transplant, but he doesn't fit in the certain "categories" for status 2 or 3. He's not sick enough. But he is! He has been for a long time now. Not able to live his life to the fullest..he got the LVAD when he was 23 years old. He's had it for long enough, I believe he should fit in the status 2 category by now.

Anonymous | 02/04/2025

I’m commenting for myself since I’m an lvad recipient waiting on transplant list for two years now. Without my lvad I wouldn’t have made it these two years but I feel we are at a disadvantage since our status is mostly always gonna be a status 4. I’ve done my work to be able to be listed but now I’m not sure when I’ll even get the call since lvad patients are not a priority. Hope something can be done to bump up lvad patients that have some time already with it successfully to avoid complications down the line. I’ve had to have my control replaced already and my clips. Thank you for your help in making sure us lvad patients get the help we need.

Anonymous | 02/03/2025

I kind of agree but being o+ and 6’4 I was told it was going to be a while before I get a heart, I also take a antibiotic and I had a drive line to administer the medication, I have been on an lvad heart mate 3 for almost 5yrs and I had a “ infection that made me in pain and couldn’t walk without hurting, but I still believe that lvad patients should be taken with a little bit more care and caution, I understand that there are people with worse conditions and can’t leave the hospital, but a patient with an lvad can fail and I know there are 3 hospital who are not lvad ready if me or anyone needed care, so like I say I kind of agree but it needs to be a lil different for people who have had it 2 plus years and who have had complications and infections

Sharp Memorial Hospital | 02/03/2025

Our team appreciates the work done to evaluate wait time for LVAD patients. We agree with the upgrade to status 3 if they have been waiting longer than 6 years. We do not agree with upgrade to status 2 for an LVAD patient without significant complications. If complications exist that place the LVAD patient at risk then there is a current process in place to upgrade the patient to a higher status.

Anonymous | 02/03/2025

I agree with the consensus that patients waiting for transplant with an LVAD are at a disadvantage with our current allocation system. These proposed changes, I believe, are a step in the right direction. Patients on LVAD support will develop complications at some point and it would benefit these patients to be status 2 or 3 before these complications prevent the patient from being a transplant candidate. The current allocation system has several common complications associated with LVAD to upgrade to status 1, 2, or 3, but very strict criteria that many patients do not meet despite having complications. I believe these proposed changes would significantly help the LVAD patients who are waiting for heart transplant.

Anonymous | 01/29/2025

Hello, I’m a little confused on this proposal. As an LVAD patient for almost 4 years now. Last year when I started the process for Transplant I was told that LVAD patients automatically get listed as status 3. LVAD great source of keeping you alive. I believe that patients who have had an LVAD should only wait a minimum of maybe two years just to see how they do on the LVAD even though, it takes the place of controlling your symptoms and you still live a healthy life. There can be several complications as mentioned in other posts. Well, I am pretty much healthy. I still suffer sometimes from severe palpitations and my VAD alarming “ Low Flows” the fear and the anxiety of something happening especially because I have a HeartWare LVAD that is no longer approved by the FDA. I live in fear that something could happen to my VAD and then would that leave me? I pray to get on the Transplant list soon, as we are working on that now. Therefore, I feel that people should automatically be bumped up especially if they have Heart Ware.

Anonymous | 01/29/2025

I agree that evidence supports the policy change to address time spent waiting for those on LVADs. I do not think the committee should wait on this proposal. In my current practice I see many LVAD patients supported on device therapy for the years discussed that would benefit from transplantation. I do believe the time frame proposed could be further decreased to ~4 and 5 years instead of 5 and 7 years. By 4 years out (and usually earlier) from implantation patients will have recovered from their long-standing HF and be more robust physically and mentally to undergo another major operation.

I thank the proposed changes to continue advocating for LVAD therapy especially considering the ongoing excellent survival benefit.

Anonymous | 01/29/2025

Time on LVAD support is extremely complex as many have pointed out. Patients on VAD support have increased risk for complications the longer they are on support between pump damage from wear and tear, infections, RV failure, stroke, bleeding and many more.

These patients do have increased follow up and increased needs due to trying to maintain their active listing status, requiring more follow ups and routine testing to make sure that all of their needs for transplant are met while also having to do the follow ups for LVAD maintenance as well, doing double the work. These patients come from far away to their nearest transplant center for these testing and transplant and some completely uprooting their lives for an opportunity, spending countless financial resources to be able to do this and many end up running their resources dry which also causes psychosocial issues long term.

The wait times of 5-7 or 6-8 years is also extremely high risk for these patients still, many of these patients struggle to even make it that long out without complications AND still be eligible for transplant. Many who do are living with driveline infections, stroke, or pump damage of some kind. Many of these complications also disqualify the opportunity for transplant as well. A more realistic time frame would be upgrade status 3 after 2 years and status 2 after 4 years.

Older patients in their 60s also miss an opportunity for transplant by aging out because they are "stable" on an LVAD. Patients are stable on an LVAD until they are not, and when they become unstable, they decompensate quick and lose the opportunity for transplant all together. Without the LVAD in place, these patients are not stable and should not be panelized for doing the extra hard work to get the same opportunity that other people have who do not have to work as hard to get the same thing.

The psychological impact is also significant and many of the patients we work with have lost hope and feel like they were tricked into a life that is more miserable that if they were to have just passed. Many of the patients have extreme depression because of life with an LVAD and then cannot take half the medications that could help due to VAD specific medication interactions. Many patients feel like BTT is not a bridge and build resentment towards something that can bring hope which also leads to the difficulty many VAD programs face of less referrals and implants because patients then promote this negativity towards

Anonymous | 01/27/2025

Appreciate the efforts however 5-6/7-8 year timeframe is still too long. The chance for complications, likely repeated complications such as infections and GI bleeds remain high. In addition, increasing length of time on LVAD makes the transplant surgery more difficult, resulting in longer recovery.

LVAD support provides time to patients to overcome their heart failure symptoms and enter the transplant phase well recovered leading to better outcomes. But that advantage diminishes after a certain point.

In addition, it is difficult to convince patients that LVAD is an advantage when they are looking at waiting an additional 5-6 years + time needed to find an appropriate donor. It is psychologically impactful for those patients.

Also, depending on age, 5-6 years may put them outside the inclusion criteria for transplant age. We have had LVAD patients age out while waiting for a donor.

I believe that centers will not all be on board with that length of waiting which will continue to drive discrepancies in bridging strategies, leading to continued use of temporary MCS vs. Durable MCS. This ultimately will not change the transplant center behaviors.

Lastly, it would be beneficial to know what this looks like embedded in the continuous distribution plan. How will it impact the patients listed in that environment?

Anonymous | 01/26/2025

Although I am in favor for such a policy change, the proposed cutoff times (ie 6 years for status 3 and 8 years for status 2) of LVAD support seem to be too long with likely little impact on currently supported LVAD patients as BTT. Most LVAD patients who have been supported for such an along time are DT patients. With current data showing higher complications after year 3-4 of support ( ie stroke, RV failure and outflow graft twist/obstruction), selecting the optimal time for upgrade is crucial. Current data shows that LVAD patients listed as status 1-2 for LVAD complications have poorer post-Tx outcomes and with few exceptions, most of these complications in my experience happen between year 3 to 5 and then increase drastically after year 5. A policy that would allow lVAD patients with no complications to be upgraded as status 3 at year 3 and status 2 at year 4 will have more impact and may reduce long term LVAD complications including post TX mortality.

Anonymous | 01/25/2025

I have been an NP for 18 years caring for VAD patients. The mental toll of waiting more than five years for transplant is real , and then device complications happen ….
I believe that after two years on support they should be escalated to status three.this would hopefully prevent them from hitting device complications like infection , etc while giving them time to get stronger . Most likely they would wait at status three a while but it would give them a better shot before mental breakdowns or complications occur.
My BTT patients have basically lost hope with this current system .

Anonymous | 01/24/2025

I am generally in favor of this rule and believe it is entirely in the right direction. I would also favor starting eligibility for status 3 listing at 4 years post LVAD given what we know about real-world annualized mortality and morbidity in the BTT LVAD population.

Anonymous | 01/24/2025

LVAD patients go through incredibly complex surgery and require more follow up, support and management than a transplant patient. They should NOT be penalized for doing the hard work and getting passed over because “they are living with an LVAD”. Not to mention the cost on healthcare caring for these patients. Economic burden is undeniably greater with LVAD. Hospitalizations for stroke- GI bleeds- Infections- longterm impact is incredibly costly and CRUEL TO THESE PATIENTS.
LVAD is a BRIDGE- NOT an end all to transplant. They should not be passed over.

Anonymous | 01/24/2025

The current allocation system has been a disservice to both patients with LVADs and patients with advanced heart failure. Patients with LVADs should have the opportunity for transplant in a more timely fashion. Compliance to medication regimens and follow up is objective data to consider when considering transplant. Also, providers delay advanced heart failure therapies hoping the patient receives a transplant. This results in longer time on acute devices/LOS with potential negative sequalae. Intermacs 1-2 patients are the result and are being implanted with HM3 with a more challenging postop course vs having been referred earlier in disease progression

Roxanne Siemeck | 01/23/2025

I have cared for LVAD patients for 17 years and have witnessed the impact of a long wait time for transplant while on LVAD therapy. Aside from the mental anguish of waiting an extended time for the transplant, these patients are at high risk to suffer right heart failure, driveline infection, GI bleeding or arrhythmias. All of these comorbid conditions lessen the opportunity for optimal outcomes post transplant, not to mention the fact that they could lead to mortality before a transplant can even be done.

David Rosenthal | 01/23/2025

This proposal stems from the well-recognized paradox of LVAD patients being strongly disadvantaged in the current allocation system. In that regard, I support addressing this issue through allocation policy updates. However, I think this proposal should be deferred until the newer allocation updates have been understood better and until there is modeling performed to estimate the number of LVAD patients this would add to the list. The impetus for the current status ultimately was that so many patients were eligible for the highest listing status, that seniority rather than urgency became the primary means of gaining access to a transplantation. Albeit for good reasons, this policy proposal is a step towards seniority again ascending in importance for allocation, and knowing as we do how many problems this can create, it would be important to understand how many patients would be favorably and unfavorably impacted by this change.

Anonymous | 01/23/2025

A step in the right direction for correcting the avoidance of LVAD, but it should be even shorter than purposed the burden of LVAD becomes the complications as time passes on the therapy. Complication rates associated with LVAD would be mitigated by beginning the escalation of status at 2-3 years where percentage of survival on LVAD begins to drop from the 80% range to 50% range. Please consider shortening the purposed time further, if possible, to limit adverse events in the LVAD population.

Anonymous | 01/23/2025

The proposal is a good step forward. Once stabilized VAD patients >5 years should be status 3.
On another note, VAD patients with infections requiring IV Abx should be status 2.

Emily Mathews | 01/22/2025

I am in support of this proposal. I understand that there is a delicate balance of potentially transplanting fewer of the sicker patients if this proposal is implemented, however, I do believe the overall benefit will be evident. Transplanting patients before complications arise on their LVAD device is the ideal circumstance. I have heard many stories from my surgical colleagues about how challenging the transplant surgery can be, the longer the device is in place, leading to a higher risk of peri or post operative complications. I would support lessening the time frames (6 years-status 3, 8 years-status 2 as the starting point) because as you mentioned in your presentation, the risk of mortality even at 3 years post VAD implant is relatively high. I would also want to consider less than 18 months before implementing "phase 2" if feasible. Thank you!

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.