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A new study sounds a cautionary note about using donor hearts with active COVID-19 infection for heart transplant procedures.
Heart transplant recipients from donors with active COVID-19 had a higher risk of dying at 6 months and 1 year compared with heart transplant recipients from recently resolved COVID-19 donors and non-COVID-19 donors, researchers found.
“These early trends should be concerning enough such that heart transplantation centers need to thoroughly evaluate and continue to weigh the risks/benefits of using hearts from active COVID-19 donors,” lead investigator Shivank Madan, MD, cardiologist, Center for Advanced Cardiac Therapy, Montefiore Medical Center/Albert Einstein College of Medicine, New York City, said in a statement.
The study was published online May 17 in the Journal of the American College of Cardiology.
Evolving Issue, No Clear Consensus
COVID-19 can cause subclinical endothelial dysfunction and myocardial injury in potential donors. Currently, there is no clear consensus regarding evaluation and use of COVID-19 donors for heart transplants.
Prior data from two small studies suggested that patients who receive hearts from COVID-19-positive donors will likely have short-term outcomes similar to those who receive hearts from COVID-19-negative donors, as reported by theheart.org | Medscape Cardiology.
For this analysis, Madan and colleagues identified 27,862 donors in the United Network for Organ Sharing database between May 2020 and June 2022, with 60,699 COVID-19 nucleic acid amplification tests prior to organ procurement.
Donors were considered COVID-19 donors if they tested positive at any time during their terminal hospital stay. Active COVID-19 status was given to those who tested positive within 2 days of organ procurement and recently resolved COVID-19 status was given to those who tested positive initially but became negative prior to procurement.
Of the 1445 COVID-19 donors, 1017 were classified as active cases and 428 as recently resolved. Overall, 309 heart transplants used COVID-19 donors, with 239 adult heart transplants included in the analysis (150 with active and 89 with recently resolved infection).
Heart transplantation from an active COVID-19 donor was associated with increased risk for death at 6 months (hazard ratio [HR], 1.74; 95% confidence interval [CI], 1.02 to 2.96; P = .043) and 1 year (HR, 1.98; 95% CI, 1.22 to 3.22; P =.006) compared with heart transplantation from a non-COVID donor.
Mortality rates at 6 months and 1 year were 13.8% and 23.2%, respectively, for recipients of active COVID-19 donor hearts, versus 7% and 9.2%, respectively, for recipients of non-COVID-19 donor hearts.
Mortality rates at 6 months and 1 year were similar for heart transplants from recently recovered and non-COVID donors. The results were similar in propensity-matched cohorts.
Caveats and Cautionary Notes
“The current study highlights importance of continued evaluation and probably the need for a more nuanced approach towards utilizing this new donor pool,” Madan and colleagues write.
“Further studies of larger numbers of patients, longer follow-up, and more detailed clinical data are needed to assess the outcomes of [heart transplantation] from COVID-19 infected donors,” they add.
Reached for comment, Sean Pinney, MD, chief of cardiology, Mount Sinai Morningside, New York City, said that this “carefully performed analysis raises a note of caution about accepting hearts from donors with active or recent COVID-19.”
“Contrary to two previous reports that found no increased risk of adverse outcomes, the present study noted an increased risk of death associated with the use of hearts from COVID-19-infected patients,” Pinney told theheart.org | Medscape Cardiology.
“While there appears to be a signal of harm, I think it unwise to draw too many conclusions from the data as they are presented. This analysis is unable to provide details about the mechanisms which might explain the observed increase in mortality,” Pinney said.
“It is curious that a signal for harm does not appear until more than 3 months after transplant. Furthermore, we do not know the immunization status of these recipients and how vaccination may impact outcomes,” Pinney noted.
Heart transplant programs should continue to carefully weigh the pros and cons of using these donor organs, “keeping in mind that transplant candidates who remain on the list face a very high chance of dying. Using a carefully selected organ from a COVID-19 patient may still be in their best interest,” Pinney told theheart.org | Medscape Cardiology.
Also providing outside perspective, Alex Reyentovich, MD, medical director, heart transplant program, NYU Langone Transplant Institute, New York City, cautioned that the study lacks “granular” data on viral burden in the COVID donors.
A donor could have a “very high” cycle threshold, which means COVID is clearing, or a “very low” cycle threshold, which signals a high viral burden. “This study does not get into that level of granularity,” Reyentovich told theheart.org | Medscape Cardiology.
“A donor with an active COVID infection is someone that none of us would probably take. But someone with a positive COVID test and a very low virus burden, that is someone that I think most centers would take,” Reyentovich said.
“Hopefully, in the future, this will become less and less of an issue and we can stop making these types of decisions,” he added.
J Am Coll Cardiol. Published online May 17, 2023. Abstract
The study had no funding. Madan, Pinney, and Reyentovich have disclosed no relevant financial relationships.
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