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.