Clancy W Mullan1, Fouad Chouairi2, Sounok Sen3, Makoto Mori4, Katherine A A Clark3, Samuel W Reinhardt3, P Elliott Miller3, Michael A Fuery2, Daniel Jacoby3, Christopher Maulion3, Muhammad Anwer4, Arnar Geirsson4, David Mulligan5, Richard Formica6, Joseph G Rogers7, Nihar R Desai3, Tariq Ahmad3. 1. Division of Cardiac Surgery, Yale School of Medicine, New Haven, Connecticut, USA. Electronic address: clancy.mullan@yale.edu. 2. Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA. 3. Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut, USA. 4. Division of Cardiac Surgery, Yale School of Medicine, New Haven, Connecticut, USA. 5. Division of Transplantation, Yale School of Medicine, New Haven, Connecticut, USA. 6. Division of Transplantation, Yale School of Medicine, New Haven, Connecticut, USA; Section of Nephrology, Yale School of Medicine, New Haven, Connecticut, USA. 7. Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
Abstract
OBJECTIVES: The goal of this study was to describe outcomes of patients with bridge to heart transplantation (BTT) after changes were made to the donor heart allocation system. BACKGROUND: Left ventricular assist devices (LVADs) have been used as a BTT. On October 18, 2018, the donor heart allocation system in the United States was updated. METHODS: This study identified adults in the United Network for Organ Sharing database with durable, continuous-flow LVAD at listing or implanted while listed between April 2017 and April 2020. Baseline recipient and donor characteristics, waitlist survival, and post-transplantation outcomes were compared pre- and post-allocation system change. RESULTS: A total of 1,794 patients met inclusion criteria: 983 in the pre-change period and 814 afterward. The number of patients listed with LVAD decreased nationally over time from 102 in April 2017 to 12 in April 2020 (p < 0.001). The proportion of patients with LVAD at time of transplant decreased from 47% to 14%. Before the change, the majority were Status 1A (75.8%) at transplantation; afterward, most were Status 2/3 (67.8%). Transplantation rates were not different (85.4% vs. 83.6%; p = 0.225), but waitlist time decreased in the post period (82 vs. 65 days; p = 0.004). Donors were more likely to be high risk (39.0% vs. 32.2%; p = 0.005), and both ischemic times and distance traveled increased (3.4 h vs. 3.1 h; p < 0.001; 199 miles vs. 82 miles; p < 0.001). Waitlist survival did not change, but post-transplantation survival was worse in patients with BTT post-change (p < 0.001). CONCLUSIONS: The number of patients with BTT on the transplant list decreased steadily and dramatically after the allocation system change. Although time to transplant decreased, there was an increase in post-transplant mortality. These data suggest that the risks and benefits of LVAD implantation as a BTT have changed under the new allocation system and that the appropriate indication for this treatment strategy warrants a re-evaluation.
OBJECTIVES: The goal of this study was to describe outcomes of patients with bridge to heart transplantation (BTT) after changes were made to the donor heart allocation system. BACKGROUND: Left ventricular assist devices (LVADs) have been used as a BTT. On October 18, 2018, the donor heart allocation system in the United States was updated. METHODS: This study identified adults in the United Network for Organ Sharing database with durable, continuous-flow LVAD at listing or implanted while listed between April 2017 and April 2020. Baseline recipient and donor characteristics, waitlist survival, and post-transplantation outcomes were compared pre- and post-allocation system change. RESULTS: A total of 1,794 patients met inclusion criteria: 983 in the pre-change period and 814 afterward. The number of patients listed with LVAD decreased nationally over time from 102 in April 2017 to 12 in April 2020 (p < 0.001). The proportion of patients with LVAD at time of transplant decreased from 47% to 14%. Before the change, the majority were Status 1A (75.8%) at transplantation; afterward, most were Status 2/3 (67.8%). Transplantation rates were not different (85.4% vs. 83.6%; p = 0.225), but waitlist time decreased in the post period (82 vs. 65 days; p = 0.004). Donors were more likely to be high risk (39.0% vs. 32.2%; p = 0.005), and both ischemic times and distance traveled increased (3.4 h vs. 3.1 h; p < 0.001; 199 miles vs. 82 miles; p < 0.001). Waitlist survival did not change, but post-transplantation survival was worse in patients with BTT post-change (p < 0.001). CONCLUSIONS: The number of patients with BTT on the transplant list decreased steadily and dramatically after the allocation system change. Although time to transplant decreased, there was an increase in post-transplant mortality. These data suggest that the risks and benefits of LVAD implantation as a BTT have changed under the new allocation system and that the appropriate indication for this treatment strategy warrants a re-evaluation.