LVAD Use Under the New Heart Allocation Policy
Quick Takes
- The proportion of heart transplant candidates on the waitlist with LVAD decreased 33% following the implementation of the new heart allocation policy.
- Post-policy change, donors for candidates with LVAD were more likely to have high-risk features, such as hepatitis C positivity and longer ischemic times, while transplant rates remained stable and wait times declined.
- In recipients with LVAD, post-transplant survival was significantly worse following implementation of the new heart allocation policy.
Study Questions:
What is the impact of the 2018 US heart allocation policy on outcomes in patients with left ventricular assist devices (LVADs)?
Methods:
Using data from the United Network for Organ Sharing, waitlist and post-transplant outcomes were evaluated in adult heart transplant candidates on the waitlist who had durable, continuous-flow LVAD at the time of listing or were implanted while listed between April 2017 and April 2020. The new heart allocation policy went into effect October 2018. The cohort was divided into a pre-policy cohort (prior to October 18, 2018) and post-policy cohort (after October 18, 2018). Kaplan-Meier was used for survival analysis, log-rank to compare patients before and after the policy change, and competing-risk analyses for waitlist outcomes.
Results:
A total of 1,797 patients had LVAD at the time of transplant; 983 candidates were listed prior to the policy change and 814 listed after the policy change. The number of LVADs present at the time of listing declined from 102 in April 2017 to 12 in April 2020. The number of LVADs implanted after listing also decreased, from 21 to 0. Aside from a slight increase in body mass index (BMI), baseline characteristics were similar between both cohorts. Prior to the policy change, most candidates (61.7%) were status 1B at the time of listing and status 1A (75.8%) at the time of transplant; under the new policy, most candidates were status 4 (55.9%) at the time of listing and status 3 (47.4%) at the time of transplant. Ischemic time (3.1 hours vs. 3.4 hours) and distance traveled (82 miles vs. 199 miles) were significantly higher post-policy change. There was no significant difference in waitlist survival between the two cohorts; however, donors were more likely to be high risk or be hepatitis C positive following the policy change. One-year post-transplant survival was significantly worse in the post-policy cohort (83.4% vs. 91.7%, p < 0.001). On multivariate Cox analysis, transplantation in the post-policy period was independently associated with worse post-transplant survival (hazard ratio, 2.0; 95% confidence interval, 1.4-2.9; p < 0.001).
Conclusions:
Following implementation of the new heart allocation policy, there was a substantial decline in candidates with LVAD and an increase in post-transplant mortality. The cause of the increased mortality is unclear and bears further study.
Perspective:
The new heart allocation policy, implemented in 2018, was designed to prioritize the most critically ill heart transplant candidates, resulting in lower prioritization for stable LVAD patients. Following the policy change, there has been a decrease in the number of candidates with LVAD. In this analysis, waitlist outcomes were not impacted after the policy change; however, donors in the post-policy period were more likely to have high-risk features. Furthermore, candidates were not likely to achieve the highest status listing by the time of transplant under the new policy as they did under the former policy. Whether the lower post-transplant survival found in this study is an impact of the policy change versus center-behavior is unclear and cannot be determined from this study; however additional analyses are warranted to better understand the impact of the new policy on outcomes.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant, Mechanical Circulatory Support
Keywords: Body Mass Index, Critical Illness, Graft Survival, Health Policy, Heart Failure, Heart Transplantation, Heart-Assist Devices, Hepatitis C, Myocardial Ischemia, Risk Assessment, Secondary Prevention, Tissue Donors, Waiting Lists
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