CMV Prophylaxis in the Optimization of Heart Transplant Recipients - A Single Center Open-Label Observational Study

Abstract

Purpose Cytomegalovirus (CMV) remains one of the most dangerous viruses emerging in patients (pts) after heart transplant (HTx). A number of prevention strategies are available. However, there is no single recommended strategy to prevent the infection. Pre-emptive strategies implicate regular follow-ups and costs connected with the diagnostic protocols. In turn, generalized prophylaxis is connected with drug-related adverse effects and the cost of antiviral drugs. The purpose is to compare the pre-emptive therapy model with generalized prophylaxis and to find the strategy best matching our pts. Methods Consecutive pts transplanted between May 2015 and May 2020 were enrolled in the study. To guide the pre-emptive strategy, the pp65 antigen was assessed in the 4th and 12th week after transplantation and additionally in the case of a suspected infection. As generalized prophylaxis, we used valganciclovir 900mg daily (dose adjusted to the renal function) for 110 days after transplant.130 pts were enrolled in the pre-emptive strategy (mean age at the time of transplant 54.6 ±12 years) 8 D+R-, 9 D-R-, 113 D±R+, according to CMV baseline serostatus. Generalized prophylaxis was implemented in 128 pts (mean age 55.2±11.6 years), 18 D+R-, 3 D-R-, 107 D±R+, respectively. Results In the pre-emptive strategy group, none of the pts with D-R- developed CMV infection. In the group of D±R+, 24 infections occurred, i.e. 5 symptomatic infections, 3 co-infections (> 3 months after HTx). None of the pts died due to CMV. In the D+R- group, 7 of 8 pts developed overt infection, and 4 of them died in the course of CMV infection. In the pre-emptive strategy group, prophylaxis was ceased in 7 patients due to drug-related adverse effects. CMV infection occurred in 2 pts (D+R-, after drug cessation). None of the pts developed CMV infection during the prophylaxis period. In 4 pts, CMV infection occurred after the prophylaxis period (D±R+: 3, D+R-: 1, respectively). None of the pts died due to CMV. Conclusion Pre-emptive therapy with the use of pp65 antigen may be safely applied in the D-R- group. In the D+R- group, this model of pre-emptive therapy is completely insufficient. In the D±R+ group, testing should be done more frequently or generalized prophylaxis should be applied. Infections other than CMV should prompt the workup for CMV, also in the late period after HTx. Cytomegalovirus (CMV) remains one of the most dangerous viruses emerging in patients (pts) after heart transplant (HTx). A number of prevention strategies are available. However, there is no single recommended strategy to prevent the infection. Pre-emptive strategies implicate regular follow-ups and costs connected with the diagnostic protocols. In turn, generalized prophylaxis is connected with drug-related adverse effects and the cost of antiviral drugs. The purpose is to compare the pre-emptive therapy model with generalized prophylaxis and to find the strategy best matching our pts. Consecutive pts transplanted between May 2015 and May 2020 were enrolled in the study. To guide the pre-emptive strategy, the pp65 antigen was assessed in the 4th and 12th week after transplantation and additionally in the case of a suspected infection. As generalized prophylaxis, we used valganciclovir 900mg daily (dose adjusted to the renal function) for 110 days after transplant.130 pts were enrolled in the pre-emptive strategy (mean age at the time of transplant 54.6 ±12 years) 8 D+R-, 9 D-R-, 113 D±R+, according to CMV baseline serostatus. Generalized prophylaxis was implemented in 128 pts (mean age 55.2±11.6 years), 18 D+R-, 3 D-R-, 107 D±R+, respectively. In the pre-emptive strategy group, none of the pts with D-R- developed CMV infection. In the group of D±R+, 24 infections occurred, i.e. 5 symptomatic infections, 3 co-infections (> 3 months after HTx). None of the pts died due to CMV. In the D+R- group, 7 of 8 pts developed overt infection, and 4 of them died in the course of CMV infection. In the pre-emptive strategy group, prophylaxis was ceased in 7 patients due to drug-related adverse effects. CMV infection occurred in 2 pts (D+R-, after drug cessation). None of the pts developed CMV infection during the prophylaxis period. In 4 pts, CMV infection occurred after the prophylaxis period (D±R+: 3, D+R-: 1, respectively). None of the pts died due to CMV. Pre-emptive therapy with the use of pp65 antigen may be safely applied in the D-R- group. In the D+R- group, this model of pre-emptive therapy is completely insufficient. In the D±R+ group, testing should be done more frequently or generalized prophylaxis should be applied. Infections other than CMV should prompt the workup for CMV, also in the late period after HTx.