title: The impact of CytoGam on cardiac transplant recipients with moderate hypogammaglobulinemia: a randomized single-center study.
abstract: BACKGROUND
  We have previously shown that the preemptive use of cytomegalovirus (CMV) immunoglobulin (Ig) replacement (CytoGam) decreases the incidence of opportunistic infections in cardiac transplant recipients with severe hypogammaglobulinemia. However, the impact of Ig replacement in moderately hypogammaglobulinemic patients is unknown.
  
  
  METHODS
  Periodic monitoring of the IgG levels was done in 300 heart transplant recipients. Moderate hypogammaglobulinemia (IgG, 350-500 mg/dl) developed in 56 patients (18.6%). Thirty-three patients declined randomization but agreed to have their IgG levels monitored. Twenty-three patients were randomized to placebo (n = 10) or CytoGam (n = 13) at 105 +/- 63 days after transplantation.
  
  
  RESULTS
  The baseline characteristics were similar. A significant reduction in CMV infection was noted in the CytoGam Group compared with the Placebo Group (15.4% [2/13] vs 60% [6/10], p = .039). Among patients who declined randomization, CMV infection developed in 13 (39.4%) of 33, and 6 (46.1%) of the 13 progressed to severe hypogammaglobulinemia. A trend for reduction in the average episodes of > or =grade 2 rejection during the 6-month period after randomization was noted in the CytoGam group (0.4 +/- 0.6 vs 1.4 +/- 1.3, p = 0.065).
  
  
  CONCLUSIONS
  The preemptive use of CytoGam decreases the incidence of CMV infection in patients with moderate hypogammaglobulinemia. A larger randomized study is needed to substantiate these results.
authors.affiliation: Department of Cardiovascular Medicine, Kaufman Center for Heart Failure, Cleveland Clinic Foundation, Cleveland, OH, USA. yamanim@ccf.org
authors.forename: Mohamad H
authors.initials: MH
authors.lastname: Yamani
authors.forename: Robin
authors.initials: R
authors.lastname: Avery
authors.forename: Steven D
authors.initials: SD
authors.lastname: Mawhorter
authors.forename: Ann
authors.initials: A
authors.lastname: McNeill
authors.forename: Daniel
authors.initials: D
authors.lastname: Cook
authors.forename: Norman B
authors.initials: NB
authors.lastname: Ratliff
authors.forename: David
authors.initials: D
authors.lastname: Pelegrin
authors.forename: Phyllis
authors.initials: P
authors.lastname: Colosimo
authors.forename: Karen
authors.initials: K
authors.lastname: Kiefer
authors.forename: Kristin
authors.initials: K
authors.lastname: Ludrosky
authors.forename: Robert
authors.initials: R
authors.lastname: Hobbs
authors.forename: David
authors.initials: D
authors.lastname: Taylor
authors.forename: Tiffany
authors.initials: T
authors.lastname: Buda
authors.forename: Michael
authors.initials: M
authors.lastname: Yeager
authors.forename: James B
authors.initials: JB
authors.lastname: Young
authors.forename: Nicholas
authors.initials: N
authors.lastname: Smedira
authors.forename: Randall C
authors.initials: RC
authors.lastname: Starling
mesh_terms: D000328:Adult; D000361:Agammaglobulinemia / Q000188:drug therapy*; D002311:Cardiomyopathy, Dilated / Q000601:surgery; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology; D016027:Heart Transplantation / Q000009:adverse effects*; D006801:Humans; D007116:Immunization, Passive; D016867:Immunocompromised Host; D007136:Immunoglobulins / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous; D008297:Male
chemical_list: D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C045781:cytomegalovirus-specific hyperimmune globulin