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Potential Impact of the OPTN Status Escalation Policy for Adult Heart Transplant Candidates With Durable LVADs
Daniel J Ahn1,2,3, Antony Attia1,2, Toshihiro Nakayama1,2
1Department of Surgery (D.J.A., A.A., T.N., K.S.), Stanford University, CA.
Insights
Most durable left ventricular assist device (LVAD) patients either experience complications or receive a transplant within six years. The new Organ Procurement and Transplantation Network (OPTN) policy may not prevent complications before status upgrades and will affect few patients.
Area of Science:
- Cardiology
- Transplantation Medicine
- Biomedical Engineering
Background:
- The 2018 heart allocation policy change reduced priority for durable left ventricular assist device (LVAD) patients.
- New Organ Procurement and Transplantation Network (OPTN) policy aims to expedite transplantation for stable LVAD patients.
Purpose of the Study:
- To evaluate the impact of the 2018 policy change on heart transplant candidates with durable LVADs.
- To assess the incidence of LVAD-related complications and transplantation rates.
- To determine the potential effect of the upcoming OPTN policy on waitlist status distribution.
Main Methods:
- Analysis of Organ Procurement and Transplantation Network (OPTN) data for adult heart transplant candidates with durable LVADs (October 2018 - May 2025).
- Estimation of cumulative incidence of LVAD complications, with transplantation and waitlist removal as competing events.
- Assessment of the impact of the proposed OPTN policy change on waitlist status.
Main Results:
- 4967 adult patients received a durable LVAD.
- At 6 years post-implantation, cumulative incidence of complications was 42.1%, and transplantation was 36.0%.
- Only 1.2% remained on the waitlist by 6 years; the new policy would have instantaneously changed statuses for only 4.7% of the waitlist.
Conclusions:
- Nearly all durable LVAD candidates either experience complications, status upgrades, or are removed from the waitlist within 6 years.
- The upcoming OPTN policy is unlikely to prevent device complications before status upgrades.
- The policy is expected to impact a small percentage of durable LVAD candidates.
Background:
The 2018 heart allocation policy change substantially lowered the priority of candidates supported with durable left ventricular assist devices (LVADs) for heart transplantation. To provide stable candidates supported by durable LVADs with a quicker path to transplantation before they suffer complications, the Organ Procurement and Transplantation Network (OPTN) approved a policy stipulating that stable 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 LVAD-related complications, treating transplantation and waitlist removal before experiencing complications as competing events. Furthermore, we assessed how the OPTN policy change would impact the status distribution of the waitlist.
Results:
In our study cohort, 4967 adult patients who were listed for heart transplant received a durable LVAD. Transplant centers submitted 2879 justifications for status upgrades due to LVAD-related complications for 1812 (36.5%) patients. At 6 years after durable LVAD implantation, the cumulative incidence of complications and status upgrades was 42.1% (95% CI, 40.5%-43.8%), and that of transplantation was 36.0% (95% CI, 34.6%-37.6%). Of the 3779 patients who were not censored administratively, only 47 (1.2%) remained on the waitlist by 6 years after durable LVAD implantation. Had the 6- to 8-year OPTN policy change been implemented on June 1, 2025, only 4.7% of the waitlist would have changed statuses instantaneously.
Conclusions:
Almost all listed candidates with durable LVADs either experience a complication, status upgrade or are removed from the waitlist within 6 years of obtaining a durable LVAD. The upcoming OPTN policy is unlikely to prevent device complications before granting status upgrades and will likely impact a small percentage of candidates with durable LVADs.
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