Comments

Anonymous | 03/20/2025

I fully support the proposed changes

Jeff | 03/20/2025

As an LVAD patient, I am 1000% in favor of this proposal. I continue to strive towards BTR, with diet, exercise and a heavy dose of faith. But I also know the reality of this happening is very slim. With statistics about the long term complications surrounding remaining on an LVAD, a change to the process for obtaining a heart needs to change with the science behind it. To this point, I agree with many others about shortening the waiting period to allow the best chance at a successful BTT.

We as LVAD patients, along with our families, friends, caregivers and our medical teams deserve a revamping that would not hold stable LVAD patients back for years, if not decades.

Anonymous | 03/20/2025

As a caregiver, I am 100% for escalation of status for LVAD patients. I also agree with shortening the years, and moving up to status 3 at 2 years and status 2 at 3 years with the LVAD.

The daily tasks are what needs to be done, some people can do it alone but most people can’t. We don’t have a choice. As someone who is trained in dressing changes, wound care, and everything LVAD, if something were to happen to me, my patient would be left in a bad position.

Although the LVAD was life saving, it has limited our ability to truly live life to the fullest. Always looking back for a bag, medical supplies, batteries, equipment during travel, running into security that doesn’t understand, getting physically pat searched because we are different than the norm. None of this is ideal but it is what we have to do. Endless amount of complications, doctor visits, hospital visits, and medications.

The financial burden of long term LVAD will cost more to both insurance/hospitals and the patient. A patient should not have to get sick in order to have a chance at a normal life. Often times complications arise that can change the outcome come of a healthy LVAD patient that is transplanted.

Escalation would be great so we have a better chance of living a long life with a generous gift from our donor.

Anonymous | 03/19/2025

I would like to thank the committee for providing an opportunity to comment on this important proposal. Since the 2018 UNOS changes, people receiving LVADs as a bridge to transplant have been effectively prevented from receiving a heart transplant unless they have serious complications, effectively requiring them to be extremely sick not once, but twice. While the proposed new criteria would achieve the goals of reducing (perhaps not removing entirely) the disincentive to LVAD placement and likely will improve outcomes, the proposal should consider shortening the number of years of support required, combined with other clinical and age-related factors, to create a pathway for people on LVADs to get a new heart.
Reading the comments, it is clear that the LVAD community supports the concept of the proposal, but recognizes that time should not be the only factor, and that the number of years before a status improvement should be shorter.

International Society for Heart and Lung Transplantation | 03/19/2025

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Joan Roskaft | 03/19/2025

I support the proposed changes for escalation status of LVAD patients.

Anonymous | 03/19/2025

Completely support the proposed changes for escalation of status of ventricular assist device patients awaiting transplant.

Todd Roskaft | 03/19/2025

I agree with the proposed changes. I've had my LVAD for 7 years and I am currently stable. I feel the longer I have my LVAD the greater my chances are for medical complications. Why wait for someones health to deteriorate before moving forward with a heart transplant? I think a stable LVAD patient in good condition is better suited for a heart transplant then someone who is very ill and might have a harder time accepting the transplant because they are in poor condition.

BRIOHEALTH SOLUTIONS | 03/19/2025

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Region 10 | 03/19/2025

Sentiment: 1 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: The region is supportive of this proposal. An attendee noted that the proposal seems evidence-based and should improve access for LVAD patients. The impact on access to transplant for other Status 2 and 3 candidates should be monitored.

Timothy lomnes | 03/19/2025

I think that being on the list with an LVAD for 7.5 years has taken away my ability to function with a normal life. Because I have this pump, I was held back from getting a transplant at the time that I got the pump when I was so sick. If I would not have gotten the pump, I would have gotten a heart sooner. Here I sit as a status 4 for years and years.

Anonymous | 03/19/2025

I have been working with VAD patients for 9 years and whole heartedly agree with this overdue proposed change to the allocation system.

Stavros Drakos | 03/19/2025

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Jordan Shouey | 03/19/2025

I have concerns about the proposed time on LVAD support which will be taken into consideration for escalation of waitlist status. While the 2018 changes to the allocation system recategorized dMCS patients to align with a healthier (less prioritized for transplant urgency) patient population, this created a system in which these patients have prolonged wait times and the opportunity to develop known LVAD complications while on support. dMCS patient suitability for heart transplant certainly changes over time due to age and comorbidities such as driveline infection, GI bleed (potential sensitization d/t blood transfusion), worsening aortic insufficiency, and right heart failure while on support. The risk profile for these potential recipients changes as each year on support passes. While there are existing qualifiers for escalating dMCS patient status when some of these complications arise, the criteria remain strict and do not account for patients who have moderate versions of each complication (i.e. concomitant moderate AI, intermittent GIB with infrequent transfusion, and moderate RV failure). Patients in this situation potentially reach their transplant event in moderate heart failure despite chronic durable support, and likely with underlying infection or allosensitization.

I am also concerned about the proposed timeframe-to-escalation of status based on the known impact of long-term continuous flow device support and how that translates to profound post-transplant vasoplegia and PGD. Please consider shorter times to status escalation that will allow centers to successfully transplant patients who receive their durable MCS device after the age of 60, while not raising their risk profile by excessive years on support while accumulating device-related adverse events.

https://onlinejcf.com/article/S1071-9164(21)00486-3/abstract#:~:text=Lay%20Summary,intensive%20care%20and%20in%20hospital

https://www.ahajournals.org/doi/10.1161/JAHA.119.013108

https://pmc.ncbi.nlm.nih.gov/articles/PMC11198707/

Thank you for your consideration of the risk profiles that evolve over time for dMCS patients who require durable VAD bridging in light of year-by-year lengthening status 2 wait times for those who are unable to be successfully bridged to transplant in a reasonable time on temporary MCS.

Anonymous | 03/19/2025

I support this proposal!

The Society of Thoracic Surgeons | 03/19/2025

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Preventive Cardiovascular Nurses Association | 03/19/2025

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Region 6 | 03/19/2025

Sentiment: 1 strongly support, 8 support, 6 neutral/abstain, 2 oppose, 0 strongly oppose

Comments: During the discussion some attendees raised concern that giving patients preference based on their treatment can unintentionally influence clinical practice toward certain interventions. They added that predicting individual outcomes is inherently challenging, making it difficult to assign values and priorities to different patients. They added that a more granular status scoring system could provide better guidance. Another attendee commented that LVAD patients receive a 30-day status 3 period to improve their transplant eligibility, which in some cases is sufficient. However, they expressed concerns about the shifting priorities in this field, suggesting that a more nuanced approach beyond LVAD prioritization is needed. An attendee commented that while there are understandable concerns about changing policies, this change is expected to have a longer feedback loop and has been thoughtfully implemented to minimize drastic swings in policy. The goal remains to reduce waitlist mortality while also improving post-transplant outcomes. Another attendee recommended that the committee consider reducing the wait time before qualifying for revised statuses and incorporating additional criteria to ensure that patients with well-functioning LVADs are not prioritized over more critical cases. One attendee commented that establishing LVAD priority should be based on mortality and morbidity outcomes rather than simply the presence of a device.

Andrew Kao | 03/19/2025

I want to thank the committee for tackling this difficult issue. Prior to the allocation change, LVAD patients had an advantage over other patients and were often transplanted quite soon after LVAD placement due to prioritization to status 1A. With the allocation change, LVAD patients are invariably waiting for protracted periods of time and patients who would have otherwise been stabilized on a VAD are now supported by temporary mechanical devices and transplanted as status 1 or 2. While LVAD is a stable support platform, there are innumerable complications which can affect the outcome of the patient. I believe giving some priority after a period of waiting is warranted. The questions I have are below and the committee addressed these issues nicely - what waiting period is ideal? I believe 6 and 8 years are probably too long and would ask the committee to consider 5 and 7 years. The INTERMACS survival curves clearly show a linear decline in survival after the first 3 years and there is not a "cutpoint" past which patients stabilize and survive. I think waiting 6 and 8 years will lead to LVAD patients developing complications and possibly not surviving (even as a status 3). The flip side of the issue is what happens to the patients who are currently status 2 and 3 - they would be competing with stable outpatients just because they achieved an artificial time on LVAD - initially, this would disadvantage those patients (not sure how we can get around that issue) but I believe this will allow programs to feel comfortable supporting some of these patients with a durable MCS device, thus decreasing the number of people who are status 2 or 3. The analysis of the effect of "bolus" addition of patients at the time of implementation is informative, but this obviously does not factor in program decisions on whether to support someone with temporary or mechanical devices. I believe the explosion of patients on temporary devices is due to the allocation system and programs are choosing temporary support followed by transplant vs waiting with a durable device. I do appreciate all the effort the committee has put in and there is no clear answer but I would support changing to 5 years for status 3 and 7 years for status 2 and then reviewing every 6 months before changing it to 4 and 6 years. Thank you.

UVA Health | 03/19/2025

We appreciate the OPTN Heart Transplant Committee’s efforts to improve allocation policy by providing additional priority for patients supported on a LVAD for an extended duration. We see this proposal as a reasonable first step in acknowledging the needs of LVAD recipients who have achieved clinical stability over time.

However, we remain concerned that the current proposal does not adequately address LVAD patients who experience serious complications—particularly infections—within the first three years post-implant. These complications can significantly elevate mortality risk yet fall outside the proposed criteria. We urge the Committee to give additional consideration to these high-risk scenarios to ensure that vulnerable patients receive the priority they need.

Furthermore, we are also concerned that the proposed policy changes do not account for differences in transplant center size or population density within a given region. Without further analysis, there is a risk that certain programs—and their patients—could inadvertently be advantaged or disadvantaged based on factors unrelated to clinical need.

While we support the intent of the proposal, we respectfully request that the final policy language incorporate mechanisms to address early, life-threatening LVAD complications and ensure equitable application across centers of varying sizes and demographics. We believe this more comprehensive approach will best serve all LVAD patients and promote equitable access to heart transplantation.

Shawn Pelletier, MD

UVA Health Transplant Service Line Director

Abbott | 03/19/2025

Abbott commends the OPTN Heart Transplantation Committee (the Committee) for its thoughtful approach to heart distribution policy changes. We support the proposed escalation of status for time on LVAD as a positive step towards more equitable distribution of available hearts for all patients in need for a heart transplantation. However, the proposed duration on LVAD support of 8 years for Status 2 upgrade (from Status 4) and 7 years for Status 3 upgrade (from Status 4) is too long and may not change current clinical practice. We suggest that the Committee consider shorter wait times for certain LVAD patients based on their risk, which would allow for a more equitable administration of all advanced heart failure therapeutic options such that the valuable resource of a heart transplant be a consideration for all patients in need.

Since the 2018 changes in heart distribution policy, clinical teams have been reticent to use LVAD therapy as a bridge to heart transplantation (BTT) because waiting time in this population has increased significantly for patients in Status 4. This is despite recently published 2022 Joint AHA/ACC/HFSA guidelines for the management of heart failure. These guidelines resulted in a Class 1A indication for the use of durable MCS in patients on Inotropic or tMCS support based upon the 5-yr survival outcome data from the MOMENTUM 3 trial which showed that use of a magnetically levitated centrifugal LVAD (HeartMate 3™) achieving a 5-year survival of 58.8%. 1 Contemporary evaluation from registry-based studies have demonstrated a 5-year survival of 64% in the real-world. 2

Ideally, the proposed time on LVAD policy would be further refined by an assessment of patient risk both at the time of therapeutic consideration (LVAD or Heart Transplantation) and the risk of an adverse clinical outcome for a patient on an LVAD. We recognize that this is difficult to achieve prior to implementation. For the initial roll-out of time on LVAD policy, we believe that the length of time should be shortened to 5 and 7 years to qualify for escalation to Status 3 and 2, respectively. Following an 18-month transition period, that timeline should be 4 and 6 years. To further help with prioritization of organs, we recommend the committee consider the following policy changes, which will allow for a more equitable distribution of available hearts:
1. Recent studies 3, 4, 5, have shown that younger LVAD recipients (e.g. < 40 years) have a reasonable chance of myocardial recovery when their left ventricle is adequately unloaded for about 12 months. Despite the potential of myocardial recovery in young patients, the number of patients receiving an LVAD as a bridge to candidacy (BTC, which includes patients who are being considered for recovery) has significantly diminished since the implementation of 2018 UNOS allocation policy (from 26.2% prior to 2018 to 7.5% for implants from 2018-2023). One possible reason is that many young patients are getting transplanted before being given the option of recovery with a chronic LVAD over concerns of patients ever receiving a heart transplantation. To address this disparity and allow for more patients being given the chance of myocardial recovery, we recommend an escalation of Status 2 for young patients who receive an LVAD as a bridge to recovery (BTR), and: a) don’t have myocardial recovery within 2 years and have a serious adverse event on an LVAD; or b) have their LVADs explanted due to recovery but have recurrence of advanced heart failure. Furthermore, LVAD outcomes in younger patients have also improved with the HeartMate 3 with 5-year survival rates approaching 74%, which supports the use of an LVAD in younger patients as either BTT or BTC. 6
2. Patients who are on an LVAD support for less than 5 years but experience a serious adverse event (such as a serious driveline infection) should get their status escalated to Status 2 (instead of 3). This will also allow more clinicians to offer LVADs based on the patient’s imminent risk of an adverse clinical outcome while waiting for a heart transplantation.
3. Patients who are stable on temporary mechanical circulatory support for > 30 days, should automatically have Status 4; particularly if they are not at imminent risk of mortality and have been stabilized.

If such policy changes are implemented, more LVADs may be offered as BTT or BTR or BTC and more hearts will be available for patients who need them, including LVAD patients who meet criteria (1) or (2). Additionally, we encourage the Committee to start analyzing SRTR and INTERMACS data jointly to more accurately determine when an LVAD patient’s time is optimized for transplant. As the Committee noted, it may be several more years before the Continuous Distribution Model (CDM) is finalized. Now is the time to begin analyzing the data so that risk-adjustment can be considered for inclusion in the CDM’s medical urgency criteria and length of time on LVAD.

With regards to specific questions asked by the Committee, we believe that the Committee should not wait to make these changes until after the allocation changes associated with the Amend Adult Heart Status 2 Mechanical Device Requirements have been implemented and monitoring results are available. The two policies are complementary and should be implemented as soon as possible to ensure equitable patient access to transplant.

Again, we appreciate the difficult work of the Committee to develop this proposal. Ultimately, the proposal for Escalation in Status for Time on LVAD, along with the 2024 Amend Adult Heart Status 2 policy changes, will enable more equitable distribution of hearts. We do think that a few adjustments to the timeline will make an even greater impact on equity.

1. Mehra MR, Goldstein DJ, Cleveland JC, Cowger JA, Hall S, Salerno CT, Naka Y, Horstmanshof D, Chuang J, Wang A, Uriel N. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 2022 Sep 27;328(12):1233-1242.
2. Jorde UP, Saeed O, Koehl D, Morris AA, Wood KL, Meyer DM, Cantor R, Jacobs JP, Kirklin JK, Pagani FD, Vega JD. The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices. Ann Thorac Surg. 2024 Jan;117(1):33-44.
3. Birks EJ, Drakos SG, Patel SR, Lowes BD, Selzman CH, Starling RC, Trivedi J, Slaughter MS, Alturi P, Goldstein D, Maybaum S, Um JY, Margulies KB, Stehlik J, Cunningham C, Farrar DJ, Rame JE. Prospective Multicenter Study of Myocardial Recovery Using Left Ventricular Assist Devices (RESTAGE-HF [Remission from Stage D Heart Failure]): Medium-Term and Primary End Point Results. Circulation. 2020 Nov 24;142(21):2016-2028.
4. Goldstein DJ, Maybaum S, MacGillivray TE, Moore SA, Bogaev R, Farrar DJ, et al. Young patients with nonischemic cardiomyopathy have higher likelihood of left ventricular recovery during left ventricular assist device support. J Card Fail 2012;18(5):392–5.
5 Pan S, Aksut B, Wever-Pinzon OE, Rao SD, Levin AP, Garan AR, et al. Incidence and predictors of myocardial recovery on long-term left ventricular assist device support: Results from the United Network for Organ Sharing database. J Heart Lung Transplant 2015;34(12):1624–9.
6. Meyer DM, Nayak A, Wood KL, Blumer V, Schettle S, Salerno C, Koehl D, Cantor R, Kirklin JK, Jacobs JP, Cascino T, Pagani FD, Kanwar MK. The Society of Thoracic Surgeons Intermacs 2024 Annual Report: Focus on Outcomes in Younger Patients. Ann Thorac Surg. 2025 Jan;119(1):34-58. doi: 10.1016/j.athoracsur.2024.10.003. Epub 2024 Oct 21. PMID: 39442906.

Abbott
March 19, 2025

Anonymous | 03/18/2025

I applaud the OPTN for creating a policy to offer higher status based on time served for patients who are without device related AE's on a LVAD. I would suggest a slightly shorter time of 6 years until Status 2 without an AE, given the median survival on HM3 devices is about this time frame. Furthermore, the OPTN should offer consideration for older candidates above 60-65 years old who have an LVAD or were not candidates for transplant and can hope to be upgraded prior to 70 years of age. This age cutoff is considered by many centers for transplant.

Pam Eckhart | 03/18/2025

My daughter, as an L-VAD recipient since 2020, has such gratitude for the L-vad as it has undoubtedly given her the opportunity for living a mostly normal life for nearly five years. Though we are all eternally grateful for this borrowed time if a shorter time frame could be given for the possibility of receiving a heart I am sure that not just my daughter, but all who have lived with the L-vad would be eternally grateful. I pray that you can make this proposal a reality so that my precious child can live a long and fulfilling life.

Robert Dowling | 03/18/2025

Agree that patients on durable LVAD should have higher status and think the wait time to listing as Status 3 should be measured in months not years.
Our results with impella 5.5 as bridge to transplant have been excellent with no mortality or delisting and no Neuro events. Survival to discharge has been 100%.

Region 9 | 03/18/2025

Sentiment:  1 strongly support, 6 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose 

An attendee recommended that the committee should consider creating a prioritization within status to address both stabilized non-hospitalized patients and medically urgent patients. A member expressed support for the proposal, commenting that Status 3 and Status 2 might become less congested with this change. Another attendee also stated support for the proposal, underscoring their experience as a patient who declined an LVAD because of the perception that it does not lead to transplant. Additionally, the attendee added their support for continued progress on continuous distribution for heart allocation, as it will ultimately help all patients with advanced heart failure. One member stated this proposal is a long overdue correction to the 2018 allocation changes, and while they agreed with the phase in approach, suggested shortening the timeframes to 3 years for Status 3 and 5 years for Status 2.  

Nebraska Medicine | 03/18/2025

Q1: Does clinical evidence support the need to give greater prioritization to candidates who have waited an extended period of time for a transplant?

A1: Yes, NEUN agrees there has been a perceived disincentive across the nation to utilize durable LVADs despite improvements in the technology, management, and overall survival of LVADs.

Q2: Should stable, non-hospitalized candidates be given the same priority as candidates who experienced stroke, infection, or device malfunction?

A2: NEUN recommends that there should be consideration age of listing candidate as well as time of support on VAD and if they are experiencing complications.

Q3: From the perspective of patients, donors, and their families and caregivers, is the tradeoff between potentially transplanting fewer sicker patients versus transplanting more patients before they get sicker appropriate?

A3: NEUN believes action should be taken to transplant LVADs before they experience severe complications leading them to cardiogenic or septic shock. We agree with the OPTN Heart Transplant Committee that it is imperative to reduce the number of patients being brought to transplant in shock and/ or that are hospitalized for extended periods before transplant. We believe this will improve the transplant outcomes for this patient population.

Q4: Should the committee include the proposed ‘step-down’ provision granting status 2 and 3 eligibility after seven- and five-year following device implant, respectively, or wait for monitoring results to determine effectiveness before shortening the timeframes?

A4: NEUN would implore the OPTN Heart Transplant Committee to consider shortening the length of support timeframes. Specifically in the 18-month post-implementation stage with VADs being eligible for status 3 at five years and eligible for status 2 at seven years. Could the committee consider shortening the years of support? Potentially having VAD patients be eligible for status 3 at three years and status 2 at five years? The rationale for decreasing these timeframes comes directly from the data the OPTN Heart Transplant Committee cited that illustrates the ongoing risk of continued LVAD support in the long-term – even in patient population who have done well initially. If average survival of only 60-70% the year following 3-year survival is noted from the Kaplan Meyer curve from Hariri, Imad M., et al. – then NEUN believes the phased approach timeline should fall in line with the data evidence from Source: Hariri, Imad M., et al., “Long-Term Survival on LVAD Support: Device Complications and End-Organ Dysfunction Limit Long-Term Success,” The Journal of Heart and Lung Transplantation 41, no2 (2022) p. 165.

Thank you!

Geetha Bhat | 03/18/2025

I feel that all LVADs should be status 3 from time of listing. Pts on support for eight years are often the most stable patients.
Also, we have had the vast majority of our status 2 pts bridged to Tx with no mortality or stroke or need for delisting. Wait times have not been prolonged with exception of large O blood type. Operative survival has been 100% to discharge without any neuro events and 1 yr survival of 94%.

Region 11 | 03/18/2025

Sentiment: 4 strongly support, 11 support, 8 neutral/abstain, 1 oppose, 0 strongly oppose

Comments: Region 11 supports this proposal. An attendee inquired about patients doing well on LVAD support, questioning if they would have the same status as status 2 or 3 patients with post-VAD complications, if modifiers would apply, and if status 3 patients could remain at home given long waiting times. Another attendee raised questions about patients never added to the waiting list, regional disparities in LVAD patient listings, potential regional imbalances, waiting times for hospitalized status 2 patients with devices, and policy granularity for patients with complications being downgraded after treatment. An attendee asked how blood type factors into LVAD status, with clarification that current escalation status is temporary until Continuous Distribution implementation, where blood type will become a composite score factor. Questions were raised by attendees about prioritizing time for multiple LVAD patients upgraded to status 2 from the same center, with confirmation that status and waitlist time are current determining factors. One attendee suggested running a model to estimate wait time changes across regions, while another sought clarification on whether waitlist time or implant time determines status upgrades. Attendees expressed support for the proposal as LVAD patients were severely impacted by previous allocation changes. An attendee requested the Committee provide more clarity in the proposal and another suggested shortening the timeframe to 3-4 years with less than 18 months for the next reduction.

OPTN Transplant Administrators Committee | 03/18/2025

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Heart Committee’s proposal on Escalation of Status for Time on Left Ventricular Assist Device.

The Committee offers the following feedback for consideration:

•The Transplant Administrators Committee feels that it is a well-balanced, non-burdensome proposal that allows program flexibility.

Overall, the Committee is supportive of the Heart Committee’s work on this proposal.

Jacob Abraham | 03/18/2025

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Anonymous | 03/18/2025

As a VAD Coordinator for almost a decade, I am encouraged to see this proposal for change for our VAD patient population. I imagine the change to the current system will offer more hope and a positive change for those patients who have been listed for >5 years and for those people who are receiving a VAD for the first time. Knowing the system will attempt to work for you and not against you feels like a breath of fresh air in a system that is challenging at times.

Miriam Freundt | 03/18/2025

Our2-year experience with Impella 5.5 as bridge to transplant has been an incredible success. Our program has used Impella 5.5 successfully for patients presenting with cardiogenic shock who have then undergone heart transplant with no complications while waiting and excellent clinical outcomes post transplant with one year survival approaching 95%. With this strategy, our program has zero % mortality during wait time.

Region 8 | 03/18/2025

Sentiment: 0 strongly support, 8 support, 5 neutral/abstain, 1 oppose, 0 strongly oppose 

Comments: Regarding implementation time frame, an attendee though it would be reasonable to have it roll out automatically but also monitor data in the interim; in favor of this because the LVADs really are stuck. A member suggested simulated status 2 and 3 numbers – specifically, if there’s an escape pathway there might be fewer status 2’s done. There was discussion of whether to move these candidates to status 3. And explained it’s a balance of not disadvantaging higher risk patients at higher statuses with this policy change, but this has been part of the discussion, and the goal of the monitoring period will be to make sure we don’t disadvantage those at higher risk. An attendee pointed out that another aspect of this situation is the candidate’s quality of life on an LVAD. They encouraged other to think about whether the device is helping the candidate live the lifestyle the candidate had prior. They explained there are several activities the candidate can't do with a device that they could do with a transplant. Another attendee supported this comment. Another agreed that LVAD patients are likely the most likely to benefit from the transplant, and less time on LVAD is likely best. Several attendees recommended a shorter timeframe for prioritization to status 2/3 for LVAD patients. For status 3, 3-5 years seems reasonable and status 2 closer to 5 years. A member said they are in favor of any changes that will get more people transplanted. The devices were never intended to be a destination for any and all patients.

University of Washington | 03/18/2025

The Mechanical Circulatory Support Program at the University of Washington supports escalation of status for time on LVAD therapy. We agree that a new proposal would advantage BTT LVAD patients eligible for Status 3 at six years and Status 2 at 8 years of mechanical circulatory support in comparison to contemporary standards. We would even encourage consideration for a further decrement of time even up to 3 years on LVAD support as the temporal threshold for Status 2 and Status 3 considerations. Recent analyses of post-LVAD outcomes have demonstrated 3 and 5 year survival on current fully magnetically levitated centrifugal flow LVADs to be 64.6% and 54.0%, respectively1,2. Registry data also informs us that the rates of device-related infection, GI bleeding and stroke have a higher incidence within the 3-year post-LVAD implant time period3. For those LVAD patients in whom an initial transplant strategy may have been challenged, the available data does suggest that a shorter path to transplant while on device support should be strongly considered.

1. Jorde, UP, et al. The Society of Thoracic Surgeons INTERMACS 2023 Annual Report: Focus On Magnetically Levitated Devices. Ann. Thorac. Surg. 117, 33-44 (2024)
2. Mehra, MR, et al. Five Year Outcomes In Patients With Fully Magnetically Levitated vs Axial Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 328, 1233-1242 (2022)
3. Molina, EJ, et al. The Society of Thoracic Surgeons INTERMACS 2020 Annual Report. Ann. Thorac. Surg. 111, 778-792 (2021)

NATCO | 03/17/2025

NATCO appreciates the efforts of the OPTN Heart Transplantation Committee for their work on escalation of status for time on a left ventricular assist device (LVAD). Our membership feels the proposed changes would offer LVAD patients to the opportunity to progress to transplantation and avoid complications such as infections, stroke, right heart failure and surgical challenges during explant with long-term use. While the membership appreciates the committee pensiveness of transitioning LVAD patients to a higher status earlier due to the concern of the patients already listed as status 2 or 3 not receiving an organ, we still question if the proposed 8 year and 6 year time frames may be too long and lead to increased morbidity.

Matthew Ruddy | 03/17/2025

I am 63 and currently on an LVAD since October 16 2023..now with a line drive infection I was just added to the heart transplant list after meeting all criteria I have an O+ blood type which as I’m told makes it more difficult for me to receive a heart. At the time of my LVAD surgery I was given the option of a heart transplant but my survival odds were not good due to kidney liver and thyroid issues although those issues have been remedied with the help of the LVAD a good diet and cardio rehab I still have hopes of receiving a new heart and I am hopeful that the new policies you are enacting will help me to achieve that goal and live a more productive life for my son and family. Thanks for your consideration.. Matthew Ruddy VIII

Lovelace Medical Center | 03/17/2025

As a Destination Therapy LVAD implanting center, we have a unique perspective on patients pursuing advanced heart failure therapies. We agree with the proposed changes to escalate listing for current LVAD patients and would be supportive of more aggressive timeframes in the future. As New Mexico does not have a heart transplant program, our patients have to commit to traveling states away to pursue OHT and this already-complex decision is made more difficult by the insufficient promise of a Status 4 listing. LVAD patients should be afforded the opportunity for expedited transplant prior to developing significant complications and their medical adherence and success on therapy should be part of this consideration.

-New Mexico Heart Institute/Heart Hospital of New Mexico LVAD Program

American Society of Transplant Surgeons | 03/17/2025

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Vanderbilt Transplant Center | 03/17/2025

On behalf of Vanderbilt Transplant Center, we appreciate the opportunity to provide feedback on this proposal. We support these potential policy changes in so much as they offer greater opportunity for LVAD patients to be transplanted prior to developing an LVAD-related complication. We feel it is reasonable to implement the proposed changes – making adult heart candidates eligible for Status 3 at six years and Status 2 at eight years of LVAD support. However, we suggest that further changes, including the “step-down” provision, should only be implemented after monitoring results of the initial phase for effectiveness.

Pamela Brennan | 03/17/2025

From a VAD program perspective, these updates promote the use of LVADs as a bridge-to-transplant therapy, providing patients with a more defined and reliable route to heart transplantation. By addressing transplant eligibility proactively before LVAD-related complications arise, this change has the potential to enhance post-transplant outcomes and overall patient care. Crucially, it preserves the integrity of existing Status 2 and 3 criteria for LVAD complications, ensuring that urgent cases continue to receive appropriate prioritization.

I support this proposal as a vital advancement in heart transplantation policy that aligns with both clinical progress and patient-centered care.

Heart Failure Society of America | 03/17/2025

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OPTN Transplant Coordinators Committee | 03/17/2025

The OPTN Transplant Coordinators Committee thanks the OPTN Heart Committee for their work on this project. They agree that the project is well-timed and are supportive of the initiative. They offer that perhaps a shorter time period than 18-months for reconsideration of the review period could be better.

Region 1 | 03/17/2025

Sentiment:  2 strongly support, 5 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: No Comments 

Anonymous | 03/17/2025

This proposed change is a significant step forward for the VAD community, ensuring that long-term LVAD patients receive equitable access to transplantation before complications arise. By adjusting the status criteria, the policy better reflects the evolving needs of LVAD patients, acknowledging the increasing durability of these devices while also prioritizing timely transplant opportunities.

From a VAD program perspective, these updates encourage the use of LVADs as a bridge-to-transplant therapy, offering patients a clearer and more predictable path toward heart transplantation. Additionally, by proactively addressing transplant eligibility before LVAD-related complications occur, this change has the potential to improve post-transplant outcomes and overall patient care. Importantly, it maintains the integrity of existing Status 2 and 3 criteria for LVAD complications, ensuring that urgent cases continue to receive appropriate prioritization.

I support this proposal as a necessary evolution in heart transplantation policy that aligns with both clinical advancements and patient-centered care.

Anonymous | 03/16/2025

The recent OPTN proposal to escalate transplant priority for patients on durable left ventricular assist devices (LVADs) based solely on duration of support raises serious concerns about fairness, clinical rationale, and the broader impact on transplant allocation. While the intent to improve access for patients with prolonged LVAD dependence is understandable, this approach prioritizes time on the device rather than actual medical urgency, introducing an unnecessary and inequitable change to an already functional system.

Current transplant allocation policies already recognize when LVAD patients experience complications such as stroke, infection, pump thrombosis, or right ventricular failure. When these events occur, patients are appropriately escalated to higher priority status because their condition has worsened. The proposed policy does not address a gap in care but instead introduces an arbitrary mechanism that benefits LVAD patients who have remained stable without complications while ignoring the true clinical needs of others awaiting transplant.

A patient who has been stable on an LVAD for five years with no major complications is fundamentally different from one who has experienced worsening heart failure or recurrent device-related problems. The current system already provides a pathway for escalation when an LVAD patient deteriorates.

Rather than implementing a time-based escalation for LVAD patients, a more effective and equitable approach would be to continue prioritizing patients based on actual clinical deterioration, not arbitrary time thresholds. Transplant allocation should focus on demonstrated worsening heart failure, declining end-organ function, and hemodynamic instability—factors that truly reflect medical urgency. There should also be a stronger emphasis on early use of tMCS to allow for proper decision-making, whether that be durable LVAD implantation, transplantation, or even native heart recovery. Additionally, stable LVAD patients should be regularly assessed for explantation before automatically being given higher transplant priority, ensuring that every effort is made to optimize native heart function rather than defaulting to transplant listing.

OPTN is responsible for ensuring that transplant allocation remains fair, evidence-based, and focused on patients with the greatest medical need. A time-based escalation system for LVAD patients does not accomplish this goal. Instead, it rewards patients based on how long they have had a device, rather than how sick they are. The current system already prioritizes LVAD patients when they develop complications. This proposal introduces unnecessary complexity and disadvantages patients on tMCS, who may be in more urgent need but do not qualify for an upgrade simply because their treatment strategy avoids the very complications that trigger status escalation in LVAD patients.

Transplantation must remain a patient-centered and clinically driven decision, not one based on arbitrary timelines that reflect institutional variability rather than true medical urgency. I urge OPTN to reconsider this proposal and ensure that transplant prioritization reflects the best possible outcomes for all patients, regardless of their support strategy.

Anonymous | 03/14/2025

It is with passion for the field that I present this public comment on Escalation of Status for Time Spent on LVAD. For many people with end stage HF, LVAD is the only option at that moment. There are MANY reasons why a person is not able to get a heart. Sometimes there are things that are modifiable over time (BMI, compliance, smoking) that prevent immediate transplant listing. Sometimes a heart is not found, and the patient is too sick to wait. Sometimes programs feel other conditions elevate the patient’s risk for transplant beyond an acceptable level (due to social or medical concerns). The vast major of the time, these decisions are likely in line with those of 99% of programs in the US. However, there are some decisions made by one program that may be 180 degrees different from a program in a neighboring state (ie the patient deemed not a candidate at center A would be a candidate at center B). Sometimes, the decision of one doctor to decline transplant candidacy may even be 180 degrees different from their colleague sitting right next to them. This should not be viewed as surprising or wrong- Risk stratification and candidacy assessment for heart transplant is NOT a perfect science. Each center has their own threshold for acceptable risk. Doctors and teams are not perfect and we don't have a crystal ball.

Thus, we must not forget that WE-through this allocation process and through our decisions to list or not list- are determining the patient’s fate. The patient is fully relying on us to make the best decision possible for them, even when our ability as doctors to make that decision with any level of precision and accuracy is often (but not always) poor. As a field, we must have a way to offer LVAD patients an opportunity for transplant because our ability to predict the patient’s future is terrible (Teuteberg et al paper).

Until 2018, we used to offer LVAD candidates a fair chance at transplant. However, in 2018, that fair chance was removed and we did a sudden disservice to hundreds of patients and their families. Suddenly tMCS is used by everyone. People literally walk into the cath lab and exit with a balloon pump as a UNOS 2. Centers submit exception requests and transplant patients, EVEN IF the exception is declined. No penalty. Studies show that patients transplanted using exception are less ill than those within the status requested. Yet, people argue that it “is not fair that the LVAD patient should get priority when my Impella patient is so ill.” Are they all that ill? Look from within- are ALL your UNOS 2 patients that ill???

We forget that the LVAD patient who is now active for transplant was equally ill prior to entering the OR- we don’t VAD INTERMACS profile 4-7 in large numbers in the US. This same LVAD patient survived LVAD surgery, modified whatever kept them from transplant initially, and has lived on a device with a driveline and surrendered their ability to swim and soak in a bathtub, to travel without dragging batteries around, and to go to church without batteries beeping with the choir. They did this to live, they listened to our advice, and we changed the rules and we made those rule favor the industry of tMCS.

To right the wrong, we need to give LVAD patients a reasonable chance at transplant. This means we need to transplant LVAD patients when the LVAD patient is safest- not when they have seeded their spine and CNS from a driveline infection, only to come out of the OR post transplant vasoplegic from SIRS. We need to transplant them before they have gotten 18 units of blood in the past 12 months from a GI bleed and now that female who had a PRA of 25% has a PRA of 75%. We need to give LVAD patients a fair chance... THe present system is a start. It is hopeful that 5 years will become an eventual threshold for prioritization given average survival metrics.

Region 2 | 03/14/2025

Sentiment: 6 strongly support, 5 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: Overall, members of the region are supportive of the proposal.  There was strong support for updating status criteria to allow LVAD patients to qualify for higher statuses. Some attendees believe the proposed policy does not go far enough to expedite transplants for these patients and suggest reducing the time requirements, proposing eligibility for Status 3 at three years and Status 2 at five years post-implantation. These changes could impact initial listing decisions, potentially leading to more LVAD implantations and fewer urgent cases requiring Impella or balloon pumps. Another attendee noted concerns about the length of time an LVAD remains implanted, as longer durations can lead to complications and make extraction more difficult. Clarifications were provided that time is counted from the primary device implantation, and receiving a secondary device does not reset the timeline. Patients must be healthy enough to remain on the transplant list, as determined by their transplant center. LVAD patients do not require hospitalization for status 2 or 3 and the 30-day VAD time for status 3 remains unchanged. 

Ellis Freed | 03/14/2025

I support the escalation of status for LVAD patients. I'm a former LVAD patient and presently a heart transplant survivor and patient, although there is a lot of gratitude receiving an LVAD as a bridge to transplant,but there is a trade off and that is you have life because of the LVAD,but at the same time it's a life that has limits as you are bound to batteries and electricity. The other issues you face living with the LVAD is that it can be cumbersome while trying to participate in daily activities,and also mentally it can be taxing worrying about battery life, or misplacement of back up batteries especially in the early stages in this new way of living it comparable to being locked into a state of psychological turmoil. I did suffer an infection that kept me in a constant state of worry because the possibility of this infection taking over and therefore could prevent my transplant. In closing although the road was rough and despair would occasionally creep in it was all worth it when I returned home and put my feet on the floor unattached from cords moving freely it's 1a memory I will always be thankful for,so this is why I support LVAD patients to remain a priority on the transplant list. Thank you for letting me share it's very emotional having a second chance at life and I owe it all to Dr. Cowgher and the whole transplant team at Henry Ford hospital.

American Society of Transplantation | 03/13/2025

The American Society of Transplantation (AST) generally supports the proposal, “Escalation of Status for Time on Left Ventricular Assist Device.”

The AST agrees there is sufficient clinical evidence to indicate that candidates with a left ventricular assist device (LVAD) who have waited an extended period of time should receive greater priority. Time on LVAD is a risk factor for worse outcomes for patients who develop a codified device complication, but there is residual risk associated with time on LVAD that is true clinically and reported in specific scenarios (such as risk for primary graft dysfunction).

The AST supports heart candidates who acquire complications from durable LVAD therapy, have LVAD specific infections, or experience a cerebrovascular accident receiving higher priority than patients who are stable on the LVAD platform. Advanced age should also be considered since some LVAD patients can “age-out” of their transplant window. Patients with LVAD complications may not exactly meet the Status 3 criteria, and writing an exception narrative requires that the patient remain hospitalized until the time of transplant. Further, the AST is also supportive of allowing heart candidates with LVADs with an approved device exception status to live at home, if medically appropriate.

The AST suggests the OPTN consider implementing these proposed policy changes independent of future analysis of the recently implemented Status 2 mechanical circulatory support policy. These policies have differing focuses, and the Escalation of Status for Time on Left Ventricular Assist Device proposal may inform patients in their considerations of LVAD over temporary mechanical circulatory support, especially patients with de novo heart failure (or potentially reversible heart failure with LVAD support) who should not likely be offered heart transplantation upfront but who may insist upon this therapy (and otherwise show no contraindication). Heart candidates may be more amenable to LVAD therapy with this proposal as the length of time with an implanted LVAD will now factor into heart allocation.

As for the proposed “step-down” provision, did the OPTN evaluate other measures to address and avoid overcrowding statuses? The burden to balance appropriate stratification of heart candidates in each status should not be placed solely on heart candidates with LVADs. The AST also has questions about the proposed step-down time frames- how were these determined and why wasn’t a shorter period, e.g., three or four years, proposed?

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/13/2025

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on the proposal to allow dischargeable LVAD candidates to qualify for increase in status on the waitlist based on defined time on LVAD. Use of LVADs has been associated with increased sensitization against HLA antigens, although recent literature shows a decline in such correlation. ASHI and NCAC suggest evaluating the risk of sensitization as part of the clinical outcomes listed for patients with long term LVAD.

Anonymous | 03/13/2025

As an LVAD coordinator at a transplant facility, I think this would be a great idea and beneficial to our BTT patients. We've had patients who have been waiting years that are taller with a bigger body habitus and O blood type, knowing they'll be waiting much longer for an organ. I'd even recommend shortening the timeframe to 5 years as a status 2 and 3 years as a status 3 due to the rate of complications as time goes on with a VAD. My program always says, "our patients are thriving on their VAD, until they're not", since we know they are likely to eventually have some sort of complication, even if minor. Each time a patient has a complication, it can cause further comorbidities and health problems, potentially causing more issues with the VAD.

I think these patients should be rewarded for managing life with a VAD for years and remaining compliant with both VAD and transplant standards. This could also decrease waitlist mortalities, as well, if these patients are transplanted sooner before they get a chance to develop a major complication.

Robert Kormos MD, FRCS(C), FAHA, FACS | 03/12/2025

I appreciate the important opportunity that has been presented to the community involved in cardiac transplantation to comment on the latest iteration of the criteria developed to adjust for the waiting time on an LVAD in a way that promotes a more rationale hierarchy of urgency for those who have chosen a path of support with a durable LVAD. We are all aware of the delicate balance between the benefit of time on LVAD vs the potential late complications that can occur and effect post-transplant uncomplicated survival. Time on LVAD allows for proper assessment of the chances of recovery with support. This recovery includes both the chances of overall patient rehabilitation and in some cases myocardial healing that has been shown to allow for retention of the native heart as well as resolution of end organ function that has deteriorated due to the complications of shock associated with terminal heart failure. However, we are also aware that complications of infection and chronic heart failure, although significantly reduced with modern technology and management strategies, continue to create challenges in some LVAD patients beyond five years of support.

I am supportive of the proposed changes below but with reservations:

•Adult heart candidates with an LVAD for at least the past six years will be eligible for Status 3

•Adult heart candidates with 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

Having watched the evolution of donor-recipient allocation policies over the past 25 years, there is one principle that stands out above all: heart failure physicians and surgeons are true advocates for their heart transplant candidates. They are all driven to maximize the chances for their candidates to receive a donor organ. This has forced clinicians to rank candidates using algorithms that identify the most hemodynamically compromised but still transplantable patients as those that get the highest priority. However, we are all aware of the dilemma that faces clinicians having a conversation with a transplant candidate. When speaking with a patient about the potential waiting time as a stable LVAD recipient within the framework of 6 to 8 years, this is a lifetime to a candidate. When faced with those decisions they are hard pressed not to accept the logic of waiting on a temporary support device in hospital when told that the waiting time for a heart using that approach can be measured potentially in weeks. The real challenge comes to those on a temporary device where if the waiting time extends beyond 3 weeks and this delay results in death or creation of complications that produce a less suitable candidate for a heart transplant or subsequent durable LVAD. Recent publications demonstrate that the hazard of a perioperative stroke within 7 days of a durable LVAD implant is over 3 times higher if that patient had a combination of percutaneous trans-aortic temporary LVAD and ECMO before the durable LVAD.

We must understand that in the backdrop of ever increasingly successful adverse event free 5-year survival in the fully Maglev rotary LVAD’s, younger candidates below the age of 50 derive benefit from additional life years of survival on an LVAD prior to the heart transplant. This action frees up donor hearts for the sicker candidates. But I also acknowledge that there are populations of patients in whom an LVAD implant is not practical, such as those with documented severe right heart failure, life threatening arrythmias, or those after a myocardial infarction in whom the Left Ventricle is less than 5 CM in diameter and any new allocation algorithm cannot disadvantage this group

1) My first suggestion is that the waiting times on an LVAD for which a status upgrade be awarded be reduced to a more patient relevant time frame from 6 and 8 years to 4 and 6 years to qualify for escalation to Status 2 and 3, respectively. This should be accomplished as soon as the relevant backlog of status 2 and 3 candidates can accommodate such a move.

2) The most advantageous time to transplant such patients is after they have recovered and physiologically rehabilitated but before the development of a life-threatening complication This leads to my second suggestion. There is an urgent need for the SRTR to work collaboratively with the Interagency Registry of Mechanical Circulatory Assistance (Intermacs). The goal is to develop a representative risk score while on an LVAD that can better determine the time frame for a Status upgrade that is longitudinally calculated which includes the concomitant risk of early adverse events that have the potential for becoming life threatening. This could be proposed, in the 18 months after implementation of the newly adopted waiting time score to prepare for the Continuous Distribution Model.

True risk while waiting for a transplant on an LVAD is a complex interrelationship between the pre-implant and perioperative risks, and accumulation of further risk while on the LVAD. Although, Intermacs is beginning to show us data that not only reveals the risks of stroke, heart failure and infection on an LVAD in a reliable time dependent and risk adjusted fashion but also how the risk evolves with compounded complications.

Presently, the benefit of documenting an adverse event on an LVAD only has it’s impact on a status upgrade while on the waiting list once the patient has a complication that mandates being admitted to hospital. The complication in this scenario is likely to either to create a high-risk transplant candidate or even nullify candidacy. This has most relevance to those with an infection. The ideal time for a heart transplant in those patients is before the infection becomes deep seated requiring additional surgery or treatment for sepsis. But this risk is often added while the patent is at home. Other risk models for non-life threating adverse events can similarly be modeled.

Again, a proper risk adjusted system would consider the true risk of time on the waiting list with an LVAD before the occurrence of fatal complications. This would have a secondary beneficial effect of reducing the number of exceptions for Status upgrades.

Finally, how risk relates to age is also critical. Just arbitrarily adding a Status benefit to a 65-year-old candidate at 6 or 8 years is to be of little practical benefit given that this candidate may not see the transplant until age over 70.

Also, the Committee should not wait to make these changes until after the allocation changes associated with the Amend Adult Heart Status 2 Mechanical Device Requirements have been implemented and monitoring results are available. The two policies are complementary and should be implemented as soon as possible to ensure equitable patient access to transplant.

It is imperative that we move away from arbitrarily designed risk models driven by opinion to those driven by hard data. I urge the committee to consider the benefit of collaborating with medical and surgical societies and registries that can help to establish stronger algorithms for determining individualized time on LVAD adjustments.

The Mended Hearts, Inc. | 03/12/2025

As the largest peer-to-peer cardiovascular patient support network with over 124,000 members, The Mended Hearts, Inc. champions optimal care for all through offering support and education, while raising awareness about heart disease. Recognizing the complexities of heart transplants and the critical needs of patients in advanced heart failure, MHI strongly endorses the OPTN’s proposed Escalation of Status for Time on LVAD.

This critical change addresses existing inequities in the allocation system and provides much-needed hope to LVAD patients who face growing risks and diminished quality of life while waiting for transplants. LVADs are often a necessary bridge to transplant, but patients on durable support for extended periods face increasing complications, such as infections, strokes, right heart failure, and surgical challenges during explantation. Current policies unfairly require patients to experience severe health declines before becoming eligible for higher statuses, penalizing those who are stable and compliant. The proposed escalation ensures that these patients—who have already endured years of physical, emotional, and financial burdens—are not left in limbo.

While we endorse this proposal, we urge the committee to consider shortening the timeframes for escalation if there are data that will support it. Addressing the needs and improving outcomes for all patients should be considered. We believe this policy represents a step toward equity and fairness in transplant allocation. We commend the committee's efforts and urge expedited adoption of this change to improve the lives of LVAD patients nationwide.

Anonymous | 03/12/2025

I’ve been implanted with an LVAD for a little over two years now with little to no hope of going up in status anytime soon ! As I’ve been doing well on the LVAD , it would be very nice to have a time frame to look forward too where I can go up in status , I fully support this

Sara E. | 03/12/2025

As a long-time VAD coordinator since 2010, first at a transplant center and now at a destination therapy center, I've watched how opportunities for LVAD patients has changed. While it is considered a non-inferior therapy and has gotten safer, transplant remains the gold-standard for end stage HF patients and these patients who prove to be longtime, reliable LVAD patients deserve the opportunity to have more of a fighting chance to realistically be transplanted before they "age out" of candidacy.

Anonymous | 03/12/2025

I agree with this change

Anonymous | 03/11/2025

I agree with this change

Amir H | 03/11/2025

I have family I agree with this change

Anonymous | 03/11/2025

I agree with this change

Doris Ervin | 03/11/2025

I am the mother of a LVAD patient and I agree with this change so I can see my daughter more happy and active. Instead I see her unhappy that she can't participate in different family activities. So yes I agree with this change so I can see her smile again that has been missing not just due to the LVAD more and ongoing issues that have been linked to it. Please provide this change not just for her but for all patients that have an LVAD.

Armentha Hooker | 03/11/2025

I have an LVAD I've had it for 7 years now. It has impacted my life in many was. It has kept me alive to continue to enjoy my family. But it has also taken things from me like being able to do things with my family (outings, swimming, doingthings with my grandson) that's just a few things. Lastly I have had and still have more and longer hospital stays along with more complications. I agree with this change because to me it would give me a better chance of having a better quality of life.

Anonymous | 03/11/2025

I agree with this change.

Region 4 | 03/11/2025

Sentiment: 6 strongly support, 6 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: Region 4 supported the proposal. Several attendees commented that they agreed with using the time since implantation of the LVAD so there is a specific point in time, and it will not create a necessity for listing too early.  There was also support for staggering the waiting times by 18 months.

University of North Carolina | 03/10/2025

Our HF physician group and transplant program wholeheartedly support the proposal for escalating stable LVAD patients to at least Status 3, for all of the reasons detailed in the proposal. More specifically, we support granting Status 3 to all LVAD patients who have been on durable support for over 5 years and Status 2 for all LVAD patients on support for more than 5 years who develop an LVAD-related complication. Furthermore, we believe that all LVAD patients on support for more than 7 years should automatically be granted Status 2.

Rita Heidelberger | 03/10/2025

I am 82 years old. I would like to stay with this LVAD device. I feel to old and more adjustments to a heart transplant would be more trouble I don't need. The transplants should go to the young first.
Thank you for understanding.
Rita Heidelberger

Anonymous | 03/10/2025

As a patient living with an LVAD for the last 8+ years, this is welcome news. I am on my second implant. I have had a long struggle to meet the UNOS requirements (BMI) for transplant and am nearly there. Once I meet the requirements and am finally (hopefully) on the wait list, it still may take forever, if at all, to receive a heart transplant. At least this status escalation would move me up the list a little quicker without any further, more drastic negative change to my overall health status. Almost 9 years on an LVAD has had its challenges and ongoing trials. After this amount of time, you tend to keep a smile on your face and push through, but it's surely tiring.

Northwestern Memorial Hospital | 03/06/2025

The advanced heart failure team at Northwestern Memorial Hospital, Chicago, IL (ILNM) is in support of updating the status criteria to allow patients implanted with LVADs to become eligible for higher statuses as stated in the OPTN’s Escalation of Status for Time on Left Ventricular Assist Device proposal. However, the proposed timeframe for status escalation after device implantation would likely still result in prolonged time on the waitlist putting this patient population at risk for developing LVAD related complications. We strongly suggest reducing the length of time requirements to the following:
• Three years prior will be eligible for status 3
• Five years prior will be eligible for status 2

Additionally, while this proposed update may allow more opportunities for patients with LVADs to be transplanted, we are ultimately in greater support of the transition to a continuous distribution system for heart transplantation allocation.

Anonymous | 03/06/2025

I strongly support the proposed escalation of status for time on LVADs as a necessary step toward improving transplant allocation and patient outcomes.

As someone deeply involved in cardiac care and quality improvement, I have seen firsthand the challenges LVAD patients face while waiting for a transplant. The longer a patient remains on an LVAD, the higher their risk of device-related complications, infections, right heart failure, and reduced quality of life. Despite these increasing risks, current allocation policies do not always prioritize these patients appropriately compared to those with acute decompensations.

This proposed change is critical because it:

Better reflects the clinical progression of LVAD patients, recognizing that time on device correlates with worsening morbidity.

Improves equity in organ allocation, ensuring that patients who have been stabilized on LVADs but are experiencing increasing complications are not left at a disadvantage.

Supports patient safety and outcomes, allowing for earlier transplant opportunities before irreversible complications arise.

Aligning allocation policy with real-world patient risk will enhance fairness and improve survival rates for those who rely on LVADs. I urge the committee to adopt this change and continue refining the system to ensure the best possible outcomes for heart transplant candidates.

Philip Maniaci | 03/05/2025

Dear UNOS,

I cannot express how much it means to my family and me that you are reconsidering your policy towards LVAD patients. In January 2016, my son J***** Maniaci, a patient at H**** **** ********, became critically ill with an ejection fraction of five. He was placed on ECMO until the Heart team deemed it possible to implant an LVAD. J*** spent 30 days in a drug-induced coma, followed by another 30 days in the ICU before being transferred to a step-down unit.

After three months at H**** ****, J*** was moved to D** ******* ******, where he had to relearn basic functions such as walking and feeding himself. He was discharged at the end of April and by September, he returned to complete his undergraduate studies at the University of Michigan, relying on a cane, walker, and scooter to navigate the campus. Despite numerous falls and challenges, J***** persevered, determined to achieve his dream of graduating from U of M. He went on to earn a master’s degree in science from the University of Michigan and is now in his third year of medical school at Michigan State University.

J***'s journey has equipped him with a level of compassion and dedication that cannot be taught in a classroom. His resilience and determination to give back to his patients are truly inspiring. However, UNOS has determined that because he has an LVAD, he does not need a transplant—or, at best, has been placed so low on the transplant list that he may never receive a new heart.

The fact that you are considering changing your policy on LVAD patients gives us hope. Allowing my son to receive a heart transplant would enable him to fulfill his dream of becoming an excellent doctor, one who can make a significant difference in the lives of others, drawing from his own life experiences. J***'s story has already inspired many, including professional football player Damar Hamlin, who personally thanked J*** for sharing his journey and being an inspiration to him.

Thank you in advance for doing the right thing and making these necessary changes, so that J*** can continue with his life and I can have peace of mind.

Sincerely,

Philip J. Maniaci

“J***'s Dad”

Anonymous | 03/05/2025

I agree with this proposal. Patients with LVAD who are complaint with treatment are great transplant candidates. With the current listing criteria, patients with LVAD are at a disadvantage which is unfair to them. They wait for something to go wrong before their status can be increase.

Steven Hsu | 03/04/2025

I support this proposal. The current criteria heavily skew behavior towards transplant. As a result, fewer patients try LVAD therapy. This reduces the chances that patients may recover heart function with a VAD and GDMT. If we could even save some patients from transplant it would afford more transplants for those who have convincingly proven their need for it.

Given that median HM3 survival is only 6-8 years I think younger patients or more sensitized patients should have the chance to move up to status 3 or 2 sooner than others.

Region 7 | 03/04/2025

Sentiment:  2 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

The region is supportive of this proposal. Discussion centered on the potential impact of the proposed changes, with particular concern regarding the timeframe for escalation. Several attendees felt that the proposed 5-7 year period was too long, emphasizing that post-LVAD mortality is around 50% after five years and that most patients develop complications qualifying them for Status 3 within that timeframe. Some suggested that the escalation should occur earlier to better serve patients who have been dependent on LVAD for extended periods. A patient representative stressed the importance of early transplantation. The presenter acknowledged these concerns and committed to ongoing monitoring, with reports every six months to assess the impact and identify necessary adjustments. Attendees also asked about the statistical modeling used to predict the impact of the proposal, the implications for pediatric patients, and whether continuous distribution policies would eventually incorporate extra points for LVAD duration. The presenter reiterated the Heart Committee’s intent to work closely with pediatric representatives and maintain an attribute in continuous distribution to reflect time on LVAD. Concerns about balancing LVAD patient needs with those of other transplant candidates were also noted, with some attendees advocating for shorter timeframes and further evaluation of clinical outcomes related to the proposed escalation periods. 

Ryan Snelling | 03/03/2025

I extremely support escalation of transplant status for LVAD patients, as I have had my LVAD for 4 years in Aug 2025. I’m 48 and have a son and daughter to be here for and need to see the bridge to transplant happen to be here for them. Let’s help this happen

Anonymous | 03/03/2025

I am a heart transplant recipient who was not on an LVAD prior to transplant. However, I know patients who were on LVADs, and I know that they have many challenges while on LVADs. I support the current proposal, and hope that there will be additional status escalations for these brave and determined patients. 

I saw the comment from the wife of the patient who is on milrinone. I was on milrinone prior to the transplant, and I fully agree with her comments, especially the comment that the health of LVAD and milrinone patients should not have to decline in order to move up in status. LVAD and milrinone patients are subject to long-term risks of infection and other life-threatening challenges for extended periods pre-transplant. I understand these are "bridges" to transplant. But the bridge has failed if you die before arrival at destination heart transplant.

Thank you for the opportunity to comment.

Anonymous | 03/03/2025

Many patients get a VAD because the AHF team thinks the wait for a transplant will be too long. Once the patient gets the VAD, the wait should not be forever as it currently is for patients who are blood type O and not having complications. What message does it send to VAD patients to say they will never get a transplant unless they get a horrible driveline infection, much worsening heart failure, going on ECMO, or pump malfunction? We want our VAD patients to avoid infections, avoid worsening HF, take care of their equipment, avoid getting worse and going on ECMO. We also think they have served their time with a VAD and should be elevated on the list. A VAD "bridge to transplant" should mean a bridge to transplant and not a literal dead end.

Region 3 | 03/03/2025

Sentiment: 1 strongly support, 8 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: None

Anonymous | 03/02/2025

Sooooo many have been awaiting transplant for years. Yes to the proposed changes for escalation of status. Let’s make this a reality now.

Anonymous | 03/02/2025

I would like patients on 24/7 infused medication for heart failure (Milrinone) to also be considered for uplifting their status. My husband has been on infused medication for 20 months as a status 4. Technology has provided the opportunity for infused and LVAD patients to stay alive, remain at home with some since of normality, and increase their strength and endurance, but they shouldn't be penalized by staying on the wait list for many years. Due to the continuous infusion, a home health nurse comes to the house to change the PICC line dressing every week. Every night, I flush the PICC line. Every 48 hours, we change to a new Milrinone bag and infusion pump. Having a PICC line itself runs the risk of infection. His (and LVAD patients) health should not have to decline in order to move up in Status. We are extremely grateful that he has gained strength and endurance during the past 20 months on the Infusion as he was really frail prior. But, at this point, it makes you wonder if you'll ever get transplanted as "he isn't bad enough". Infused and LVAD patients should move up to a Status 2 or 3 after they've had infusion or the LVAD for two years. They shouldn't be penalized due to technology advances. I appreciate the opportunity to comment. Thank you.

Anonymous | 02/28/2025

I am a member of the congential heart defect community. LVADs were always meant to be temporary, a bridge to transplant. I support escalation of status for LVAD patients.

Region 5 | 02/28/2025

Sentiment: 9 strongly support, 14 support, 5 neutral/abstain, 1 oppose, 0 strongly oppose 

Comments: The region broadly supports the proposal but suggests that the time frames for LVAD patients are too long. Several comments highlight that complications often arise sooner, which can negatively impact post-transplant outcomes and patient morbidity. There is a consensus that even a small reduction in time frames could be beneficial. Overall, the region supports the proposal as a step forward but recommends reevaluating and shortening the time frames to improve patient outcomes. 

Specific suggestions include: 

• Shortening the time frames to 4-6 years. 
• Considering adjustments to LVAD complication listing criteria, especially for outflow graft issues, infections, and right ventricular (RV) problems. 
• Acknowledging that improved VAD outcomes might reduce the need for longer wait times but also recognizing that extended LVAD use increases transplant risks. 
• Ensuring that patients do not have to wait longer than necessary.

American Association of Heart Failure Nurses | 02/28/2025

The change in heart allocation policy in 2018, which impacted patients on left ventricular assist devices (LVADs), ignited concerns about these patients’ access to heart transplants.  The American Association of Heart Failure Nurses (AAHFN) advocates for this policy change to better support our heart failure population by allowing a higher listing status for those on LVAD therapy. The central argument is that while LVADs help patients live longer, they don’t cure heart failure, and the risk of complications remains significant. Furthermore, LVAD therapy enables patients to live more independently and to become viable candidates for heart transplantation, which supports the ultimate goal of improving their quality of life. By adjusting the allocation policy to reflect the unique needs of LVAD patients, we can offer better support for the heart failure community.

Evelyn Horn | 02/28/2025

This is long overdue and current policy is a root cause for clogging up ICU’s, and prolonged use for temporary devices. We have resorted to what existed decades ago re patients waiting in house for transplants and now adding infectious and vascular complications. Nevertheless, the current proposed time frame is off and an LVAD device for 5 years should be equivalent to a status 2 and device @ 3 years should be a status 3 and expedite patients with complications with 30 days status 2 time and prolonged status 2 for more serious complications. Current transplant protocols have discouraged further development of alternative durable LVADs, inappropriately have led to must transplant patients who present acutely without giving them adequate chance of time for recovery (beyond remaining in house), and sometimes necessitating OHTx in the absence of knowing patients as well as we would like to. It also discourages the possibility of extending cumulative years of life on cardiac replacement therapy where some young patients may do well with sequential LVAD and OHTx assuming there is a true pathway for BTT. In the previous era we also had an opportunity to bond and support patients who have less than ideal support, may have some degree of dependence on smoking, alcohol and/or recreational drugs and were skeptical of the medical profession and allow them to become good OHTx candidates and not be a “prisoner” to life with LVAD only. Last, it seems half baked to suggest 7-8 years for transplantation. Act proactively in light of the near 50% 5 yr LVAD survival.

Anonymous | 02/26/2025

I agree with the escalation of status for the L-Vad patients.

Anonymous | 02/25/2025

I feel patient's with LVADs should be escalated because we have seen firsthand how "Bridge to Transplant" is not really a bridge to a transplant. Unless patients suffer a major complication, they wait at home until they have one. It has been YEARS since a LVAD patient at our center get a call at home to come in for transplant. Patients are even taught not to expect an organ offer without a complication requiring hospitalization. In addition, the team favors transplant over LVAD because we know "BTT's don't get transplanted." Instead, they favor impella and temporary MCS even when patients are approved for LVAD because "it's the only way to get him transplanted". I would also think even 6 and 8 years is a long time to live with a LVAD. Even though patients are "stable", living with an LVAD comes with a unique set of challenges our patients must deal with daily. Waiting for transplant with a LVAD is not the same as waiting for a transplant without one.

Anonymous | 02/24/2025

Ive been living with an implanted LVAD for over 2 years now with little no hope of going up in status unless something major happened to my health. I fully support this policy change !

Anonymous | 02/22/2025

I agree with this proposed process! It would greatly help patients.

Kristi Philbrook | 02/22/2025

I totally agree with the escalation of status .
All people that have been waiting and living with this device cannot be overlooked because of it.

Anonymous | 02/22/2025

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

Alva Philbrook | 02/22/2025

I agree 100% with the escalation of status for those with lvad

Anonymous | 02/22/2025

I agree with the escalation of status for LVAD patients.

Anonymous | 02/22/2025

I support the proposed changes for escalation status of LVAD patients, it would be very helpful for ppl who are awaiting transplants and are several years in!!!

Anonymous | 02/22/2025

I support the proposed policy changes. LVADs should not be getting punished for everything they are going through! They deserve a shot.

Anonymous | 02/21/2025

I support the proposed changes for escalation status of LVAD patients and am very glad to have this opportunity to express my support. I hope that the changes will be implemented soon.

Anonymous | 02/21/2025

I fully support this escalation of status for LVAD patients and I feel that is underscores a commitment to proactive and responsive healthcare.

Anonymous | 02/21/2025

I support the proposed changes for escalation status of LVAD patients.

Zach Gust | 02/21/2025

I support the proposed policy changes

Anonymous | 02/21/2025

I support the proposed changes for escalation status of LVAD patients.

Vonda Payne | 02/21/2025

I fully support the escalation status for LVAD patient as proposed.

Anonymous | 02/21/2025

I support the proposed changes for escalation status of LVAD patients. The LVAD is a great device but it does not come without complications or worry. The change in status can save lives and restore and increase hope for so many.

Matthew Klobe | 02/21/2025

I support the proposed policy changes

K Norris | 02/21/2025

I support escalation of the status for those with LVADs but I think that that after 3 years, they should be able to move up to a status 3 and after 5 years a status 2 for those with at least 2 hospitalizations within a year. Otherwise the 5 and 7 year escalations stand.

Anonymous | 02/21/2025

I support the proposed policy changes for LVAD recipients. They should be able to move up the transplant list just like everyone else!

Anonymous | 02/21/2025

I’ve been implanted with an LVAD for over 2 years now with little to no hope of getting a call for a transplant , this would change that and at least put a light at the end of the tunnel I fully support this !

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.