Background: Cytomegalovirus (CMV) infection remains a common complication after heart transplantation (HTx). The association between CMV infection and allograft rejection is debated in the era of efficient prophylactic antiviral therapies.Methods: This single-center cohort study utilized a highly phenotyped database of HTx recipients (2012)(2013)(2014)(2015)(2016). The primary endpoint was the analysis of the association between CMV infection (CMV load ≥ 500 IU/mL whole blood) and the risk of allograft rejection (cellular rejection ≥ 1R1B, antibody-mediated rejection ≥ pAMR1).Secondary endpoints included the analysis of a higher CMV load threshold (≥10 000 IU/mL) and different risk periods after PCR positivity. A mixed-effect logistic regression model with a random intercept was applied. Results were adjusted for important risk factors of rejection.Results: Overall, 384 patients were included and 6388 CMV loads and 3,494 endomyocardial biopsies were analyzed. CMV infections ≥ 500 IU/mL were diagnosed on 1223 (19.2%) blood samples from 284 (72.1%) patients and allograft rejections on 246 biopsies (7%) from 149 patients (38.8%). We did not find any association between CMV infection ≥ 500 IU/mL and rejection (univariable: OR 0.94, 95% CI [0.61, 1.45], P = .78, multivariable: OR 0.86, 95% CI [0.55, 1.33], P = .85). These results were consistent when analyzing a higher CMV load threshold and different periods of risk, reinforced by internal validation procedures and a posteriori calculation of the power (primary endpoint: power = 0.82, 95% CI [0.79-0.84]) and reproducible across different clinical scenarios.Conclusions: CMV infection was not associated with an increased risk of rejection in a contemporary cohort of HTx recipients.
Summary
Available data on clinical presentation and mortality of coronavirus disease‐2019 (COVID‐19) in heart transplant (HT) recipients remain limited. We report a case series of laboratory‐confirmed COVID‐19 in 39 HT recipients from 3 French heart transplant centres (mean age 54.4 ± 14.8 years; 66.7% males). Hospital admission was required for 35 (89.7%) cases including 14/39 (35.9%) cases being admitted in intensive care unit. Immunosuppressive medications were reduced or discontinued in 74.4% of the patients. After a median follow‐up of 54 (19–80) days, death and death or need for mechanical ventilation occurred in 25.6% and 33.3% of patients, respectively. Elevated C‐reactive protein and lung involvement ≥50% on chest computed tomography (CT) at admission were associated with an increased risk of death or need for mechanical ventilation. Mortality rate from March to June in the entire 3‐centre HT recipient cohort was 56% higher in 2020 compared to the time‐matched 2019 cohort (2% vs. 1.28%,
P
= 0.15). In a meta‐analysis including 4 studies, pre‐existing diabetes mellitus (OR 3.60, 95% CI 1.43–9.06,
I
2
= 0%,
P
= 0.006) and chronic kidney disease stage III or higher (OR 3.79, 95% CI 1.39–10.31,
I
2
= 0%,
P
= 0.009) were associated with increased mortality. These findings highlight the aggressive clinical course of COVID‐19 in HT recipients.
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