title: Impact of cytomegalovirus hyperimmune globulin on outcome after cardiothoracic transplantation: a comparative study of combined prophylaxis with CMV hyperimmune globulin plus ganciclovir versus ganciclovir alone.
abstract: BACKGROUND
  Cytomegalovirus (CMV) disease was previously shown to be unaltered by a 28-day course of ganciclovir compared with placebo in seronegative recipients of hearts from seropositive donors (D+/R-). This study tests the hypothesis that a combination of ganciclovir plus CMV hyperimmune globulin (CMVIG) is more effective than ganciclovir alone for preventing acute CMV illness and its long-term sequelae.
  
  
  METHODS
  The study population receiving CMVIG (n=80) included 27 heart transplant recipients (D+/R-) and 53 heart-lung and lung transplant recipients (R+ and/or D+). Each group was matched with historical controls who underwent transplantation within the preceding 2-3 years. Outcome measures compared were as follows: 3-year incidence of CMV disease; fungal infection; acute rejection; survival; rates and severity of transplant coronary artery disease (in heart patients) defined by intimal thickness (ultrasound) and coronary artery stenosis (angiographic); and incidence and death from obliterative bronchiolitis defined by pathological criteria on endobronchial biopsy specimens (in heart-lung/lung patients).
  
  
  RESULTS
  Patients treated with CMVIG had a higher disease-free incidence of CMV, lower rejection incidence, and higher survival rate compared with the patients treated with ganciclovir alone. The coronary artery intimal thickness and the prevalence of intimal thickening were lower in the patients receiving CMVIG. Heart-lung and lung transplant patients treated with CMVIG had lower incidences of obliterative bronchiolitis and death from obliterative bronchiolitis and longer survival compared with the patients treated with ganciclovir alone.
  
  
  CONCLUSIONS
  CMVIG plus ganciclovir seems to be more effective that ganciclovir alone for preventing the sequelae of CMV infection. A prospective randomized study is required to confirm these observations.
authors.affiliation: Falk Cardiovascular Research Center, Stanford University, 300 Pasteur Drive, Stanford, CA 94305, USA.
authors.forename: H A
authors.initials: HA
authors.lastname: Valantine
authors.forename: H
authors.initials: H
authors.lastname: Luikart
authors.forename: R
authors.initials: R
authors.lastname: Doyle
authors.forename: J
authors.initials: J
authors.lastname: Theodore
authors.forename: S
authors.initials: S
authors.lastname: Hunt
authors.forename: P
authors.initials: P
authors.lastname: Oyer
authors.forename: R
authors.initials: R
authors.lastname: Robbins
authors.forename: G
authors.initials: G
authors.lastname: Berry
authors.forename: B
authors.initials: B
authors.lastname: Reitz
mesh_terms: D000328:Adult; D000368:Aged; D002423:Cause of Death; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage*; D016027:Heart Transplantation / Q000009:adverse effects*; D016041:Heart-Lung Transplantation / Q000009:adverse effects*; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage*; D016756:Immunoglobulins, Intravenous; D016040:Lung Transplantation / Q000009:adverse effects*; D008232:Lymphoproliferative Disorders / Q000517:prevention & control; D008297:Male; D008875:Middle Aged
chemical_list: D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C045781:cytomegalovirus-specific hyperimmune globulin; D015774:Ganciclovir