title: Long-term results of CMV hyperimmune globulin prophylaxis in 377 heart transplant recipients.
abstract: BACKGROUND
  Cytomegalovirus (CMV) has emerged as the most important pathogen to affect the post-operative course after heart transplantation. We performed a retrospective analysis to evaluate the efficiency of CMV hyperimmune globulin (CMVIG) prophylaxis in preventing CMV disease in aggressively immunosuppressed patients after heart transplantation.
  
  
  METHODS
  We studied 377 heart transplant recipients who received quadruple-immunosuppressive therapy and CMVIG as sole CMV prophylaxis. The study population was categorized into 4 groups according to donor and recipient CMV serology at the time of transplantation (D+/R+, D+/R-, D-/R+, D-/R-) and was monitored for CMV immediate early antigen in peripheral blood cells, in urine sediments, and in throat washings; for the presence of serum CMV immunoglobulin M and CMV immunoglobulin G; and for clinical evidence of CMV-related symptoms. In addition, we compared the incidence of cardiac allograft vasculopathy and infection among the groups.
  
  
  RESULTS
  During the first 5 years after transplantation, CMV disease developed in 79 patients (20.96%). Comparison among the groups showed significantly increased risk for CMV disease in allograft recipients of organs from seropositive donors (D+, 27.31%; D-, 11.33%; p = 0.0003). We observed 6 CMV-associated deaths, all in CMV-antibody-negative recipients. Additionally CMV-positive recipients had a greater incidence of cardiac allograft vasculopathy (p = 0.048), and a greater overall infection rate (p = 0.0034).
  
  
  CONCLUSIONS
  Cytomegalovirus hyperimmune globulin administration prevents CMV disease and infection in aggressively immunosuppressed heart transplant recipients. Because fatal CMV disease in CMV-negative recipients of organs from seropositive donors could not be prevented with CMVIG alone, we recommend the additional use of prophylactic ganciclovir in this CMV-mismatched population.
authors.affiliation: Cardiothoracic Surgery, University of Vienna, Vienna, Austria. Alfred.Kocher@univie.ac.at
authors.forename: Alfred A
authors.initials: AA
authors.lastname: Kocher
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Bonaros
authors.forename: Daniela
authors.initials: D
authors.lastname: Dunkler
authors.forename: Marek
authors.initials: M
authors.lastname: Ehrlich
authors.forename: Bernhard
authors.initials: B
authors.lastname: Schlechta
authors.forename: Barbara
authors.initials: B
authors.lastname: Zweytick
authors.forename: Michael
authors.initials: M
authors.lastname: Grimm
authors.forename: Andreas
authors.initials: A
authors.lastname: Zuckermann
authors.forename: Ernst
authors.initials: E
authors.lastname: Wolner
authors.forename: Guenther
authors.initials: G
authors.lastname: Laufer
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D003586:Cytomegalovirus Infections / Q000188:drug therapy / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000627:therapeutic use; D016027:Heart Transplantation; D006801:Humans; D007116:Immunization, Passive; D007136:Immunoglobulins / Q000008:administration & dosage*; D016756:Immunoglobulins, Intravenous; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D014184:Transplantation, Homologous
chemical_list: D000998:Antiviral Agents; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; D007166:Immunosuppressive Agents; C045781:cytomegalovirus-specific hyperimmune globulin; D015774:Ganciclovir