DISCUSSION:
Heart transplantation remains the definitive therapy for patients with end stage heart disease. The number of heart transplants performed in the United States has gradually increased to approximately 3000/year over the past 20 years7. The recent past has seen the introduction of a variety of means by which the donor pool may increase including ex vivo support platforms, older donors and extended criteria donors.
However, much of the potential benefit of these advances have not been recognized in the past year due to a world-wide pandemic secondary to COVID-19. In the United States, more than nine-million individuals have been infected and nearly 250,000 individuals have died as a result of infection8. The impact of this pandemic on the healthcare landscape has yet to be fully realized but it is likely to be substantial. The late spring and early summer saw widespread mitigation attempts including the shuttering of schools, places of work and businesses. Initial uncertainty regarding the scale of infection, the need for healthcare resources and the availability of personal protective equipment prompted many centers to institute moratoriums on all non-emergent care9. Anecdotal evidence suggests that many individuals did not seek medical care for non-COVID related chronic illness and more still did not present for urgent/emergent care.
The impact of COVID-19 on solid organ transplant, particularly orthotopic heart transplant, remains unclear. Scientific Registry of Transplant Recipients (SRTR) data suggests that many programs in geographically hard-hit areas significantly reduced or stopped all solid organ transplants10. The driver behind these observations has yet to be fully elucidated. As one of the largest heart transplant programs in the country, we were able to navigate the pandemic while keeping our program open.
At the height of the COVID lockdown between March and June 2020, we were able to increase our transplant volume by nearly 40%. Our ability to do this is attributable to both nation-wide trends regarding transplant during this time as well as institutional initiatives which prioritized the maintenance of programs which offered life-saving therapies. An examination of our program’s performance during this time highlights many of the tensions that predated COVID-19 for transplant programs nationwide and perhaps provides a model for how to expand orthotopic heart transplant availability in the post-COIVD era.
As we look at demographic information for donors and recipients, a few interesting observations were made. There was no significant difference in age of donor or recipient, no significant difference in status at the time of transplant and no significant difference in travel time of the allograft to our center. There was, however, a statistically significant difference in race of recipients between the two time periods, with the COVID era having a greater number of recipients of color. The specific reason for this remains unclear. Many studies demonstrate that people of color have a reduced incidence of transplant and have more complications compared to Caucasian recipients11. Access to care, comorbidities and financial limitations have all been identified as potential reasons. Our program has made a concerted effort to identify potentially reversable barriers to transplant and address them in a multidisciplinary fashion such that certain socio-economic limitations do not prevent patients from transplant. It is a testament to the success of these endeavors that during a pandemic which disproportionately affected people of color, these patients’ access to life-saving heart transplant was not impacted.
Outcomes including 30-day survival, length of stay, primary graft dysfunction and rejection were unchanged. There was a significant decrease in the incidence of post-operative renal replacement therapy in those patients who underwent transplant during the COVID era. This, most likely, had less to do with COVID and more to do with some changes to our intra- and post-operative management of these patients. We have seen an overall trend towards less utilization of renal replacement therapy in our post-transplant patients.
More significant, perhaps, is the focus our institution placed on maintaining and even expanding access to transplant during this time. We speculate that while many programs curtailed transplant activity due to capacity constraints secondary to COVID hospitalization and personal protective equipment conservation efforts, our institution elected to prioritize the maintenance of our transplant programs. The end result, potentially, was that we had access to organs that, under normal circumstances, would have been utilized by surrounding programs.
From an institutional perspective, we implemented a rigorous program of testing, monitoring and isolating pre- and post-transplant patients from the remainder of patients in the hospital. This included testing on admission and immediately prior to transplant, co-localizing transplant patients in a single intensive care unit and a single step-down unit and the most rigorous utilization of personal protective equipment in all interactions with transplant patients. The end result was that at no point during this study period was a patient or staff member taking care of these patients noted to develop COVID-19. In addition, travel restrictions and limited access to donor hospitals forced us to rethink procurement strategies. We relied much more heavily on local surgeons to recover organs for us, a shift from traditional practice. These initiatives could very well represent a paradigm shift in the manner in which organs are procured, eliminating certain personnel constraints that are common in a program of our size.
As an institution, we were not immune to the impact of COVID-19. Like many institutions across the country, we scaled back “elective” procedures to ensure enough resources for urgent/emergent care. This naturally raised a number of questions surrounding which services would be offered and what would be considered urgent/emergent. The same ethical principles inherent to transplant practices continue to apply during the COVID-19 era, but the balance between autonomy, beneficence, nonmaleficence, and justice will be inherently fluid. Transplantation is inherently a resource intensive service. Recipients demand close monitoring by staff, long stays in an intensive care unit, utilization of ventilators and blood products, and use of personal protective equipment. Additionally, immunosuppressed individuals are at higher risk of being susceptible to a highly infectious, aerosolized virus. Moreover, staff safety concerns regarding travel on planes and prolonged periods of time in the operating room or ward must be considered. Perhaps most importantly is the acknowledgement that transplantation is never an elective procedure. Patients awaiting heart transplant often have no alternative therapy that can provide long-lasting results. While inotropic therapy and ventricular assist device support are options for some, they do not provide the durable results found with transplant. Without knowing when this pandemic will end, is it fair to deprive patients of potentially more life-extending therapy? Another consideration is the fact that donor organs are not widely available. For some patients who have waited months or years on a waitlist, should they be deprived of transplant when a suitable donor is identified? While there are no clear answers to these ethical considerations, we sought to find a delicate balance between access to care for the many as a result of the pandemic and specialized care for the few in need of a life-saving transplant.
In the final analysis, COVID-19 has dramatically affected all aspects of our lives. Perhaps nowhere has this been more readily apparent than in the healthcare space. In spite of that impact, we demonstrate that orthotopic heart transplants can continue to be performed safely. While we cannot deny that we potentially benefited from other programs’ reduction in volume, what we have truly demonstrated is that a rigorous testing and surveillance program allows one to continue providing this life-saving therapy, while ensuring the health and safety of both patients and providers.
TABLE 1: Heart transplant recipient demographics for 2019 and 2020. There was a statistically significant difference in race of recipients between the two groups (p= 0.029).Gender: M = male; F = female. Race: C = Caucasian; AA = African American; A = Asian American.