A Multi-Center Study of CMV Prophylaxis Strategies in Intermediate Risk (R+) Heart Transplant Recipients

Abstract

<h3>Purpose</h3> Heart transplant recipients with prior exposure to cytomegalovirus (CMV R+) are considered intermediate risk for CMV-related complications. Current guidelines allow for a pre-emptive approach to CMV prophylaxis (i.e. "watch and wait" strategy) in these patients; however, it remains unclear if this is a safe and effective strategy to mitigate the risks of CMV reactivation. In the present study, we assessed the utility of a pre-emptive approach to CMV prophylaxis compared to a universal prophylaxis strategy in an intermediate risk population. <h3>Methods</h3> Multi-center, retrospective analysis of 564 intermediate risk (CMV R+) HTx recipients from 6 U.S. centers between 2010-2018 with 18 months of follow-up. The primary endpoint was the development of CMV viremia or end-organ disease resulting in the initiation/escalation of anti-CMV therapy. The secondary endpoint was hospitalization for CMV-related infection. <h3>Results</h3> Of 564 intermediate risk (CMV R+) patients in the analysis, 123 (21.8%) were treated with a pre-emptive CMV prophylaxis strategy. Patient's treated with a pre-emptive approach had a significantly higher risk of both the primary (p < 0.001, Figure 1a) and secondary endpoints (p = 0.003, Figure 1b). Multivariable Cox regression analysis revealed a significant association between a pre-emptive strategy and the risk of the primary (HR 2.44, 95% CI 1.51 - 3.94, p < 0.001) and secondary (HR 2.66, 95% CI 1.13 - 6.28, p = 0.025) endpoints. <h3>Conclusion</h3> The use of a pre-emptive prophylaxis approach in intermediate risk CMV HTx recipients (CMV R+) is associated with a significantly higher risk of both the need for therapy escalation and hospitalization for CMV-related complications.