Abstract

Introduction After the 2018 allocation policy change, the rate of listings and transplants with durable LVADs has decreased significantly in favor of bridging patients from temporary mechanical circulatory support to heart transplant. The Organ Procurement and Transplantation Network (OPTN) recently approved a policy, to be implemented in September 2026, stipulating that patients supported by durable LVADs for 6 and 8 years will obtain statuses 3 and 2, respectively.

Methods Using OPTN data, we identified all adult heart transplant candidates with a durable LVAD implanted between October 18, 2018 and May 31, 2025. We estimated the cumulative incidence of status upgrades and durable LVAD-related complications, treating transplantation and waitlist removal before experiencing complications as competing events. We also assessed how the composition of the adult heart transplant waitlist on June 1, 2025 would have changed based on the upcoming policy change.

Results During the study period, 3,881 adult patients were listed for heart transplant with a durable LVAD. 3,182 (82.0%) of the durable LVADs were Abbott HeartMate 3, 568 (14.6%) were Medtronic Heartware HVAD, and 91 (2.3%) were Abbott HeartMate II. Transplant centers submitted a total of 6,924 justifications for status upgrades due to LVAD-related complications (6.3% status 1, 34.3% status 2, and 59.4% status 3) for 1,500 (38.6%) of these patients, with a median of 3 per patient. The cumulative incidence of complications or status upgrades was 38.6% [95% CI (37.1%, 40.2%)]. Nearly all of the 2,381 patients who did not experience any complication or status upgrade during listing were removed from the waitlist by 6 years. Had the upcoming OPTN policy change been implemented on June 1, 2025, the proportion of the waitlist that would have achieved higher priority status instantaneously was 0.06%.

Conclusions The cumulative incidence of status upgrades and complications among heart transplant candidates with durable LVADs was nearly 40% within 6 years of device implantation. The upcoming OPTN policy to escalate patients to statuses 3 and 2 after 6 and 8 years of durable LVAD support, respectively, is unlikely to make a meaningful impact on waitlist priority status.

Competing Interest Statement

Nikhil Narang was a speaker for Boehringer Ingelheim and AstraZeneca and provided consulting services for BridgeBio. All other authors do not report any financial disclosures or other conflicts of interest.

Funding Statement

One of the co-authors, William F Parker, is supported by R01 LM014263.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was exempted by the Stanford University Institutional Review Board. The source data is Organ Procurement and Transplantation Network (OPTN) Standard Transplant Analysis and Research (STAR) files, which can be requested at this website: https://optn.transplant.hrsa.gov/data/view-data-reports/request-data/

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data utilized for analysis in the present study are available upon reasonable request to the Organ Procurement and Transplantation Network. The code written to perform all analyses in this manuscript are available here at this GitHub repository: https://github.com/danieljaechulahn/determining-timing-of-lvad-priority

https://github.com/danieljaechulahn/determining-timing-of-lvad-priority

AbbreviationstMCSTemporary mechanical circulatory supportIABPIntra-aortic balloon pumpPEVADPercutaneous endovascular ventricular assist deviceLVADLeft ventricular assist deviceHRSAHealth Resources and Services AdministrationOPTNOrgan Procurement and Transplantation Network