Impact of cytomegalovirus hyperimmune globulin on outcome after cardiothoracic transplantation - A comparative study of combined prophylaxis with CMVhyperimmune globulin plus ganciclovir versus ganciclovir alone

Background. Cytomegalovirus (CMV) disease was previously shown to be unalte red by a 28-day course of ganciclovir compared with placebo in seronegative recipients of hearts from seropositive donors (D+/R-). This study tests th e hypothesis that a combination of ganciclovir plus CMV hyperimmune globuli n (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 tran splant recipients (D+/R-) and 53 heart-lung and lung transplant recipients (R+ and/or D+). Each group was matched with historical controls who underwe nt transplantation within the preceding 2-3 years. Outcome measures compare d were as follows: 3-year incidence of CMV disease; fungal infection; acute rejection; survival; rates and severity of transplant coronary artery dise ase (in heart patients) defined by intimal thickness (ultrasound) and coron ary artery stenosis (angiographic); and incidence and death from obliterati ve bronchiolitis defined by pathological criteria on endobronchial biopsy s pecimens (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 thick ness and the prevalence of intimal thickening were lower in the patients re ceiving CMVIG. Heart-lung and lung transplant patients treated with CMVIG h ad lower incidences of obliterative bronchiolitis and death from obliterati ve bronchiolitis and longer survival compared with the patients treated wit h ganciclovir alone. Conclusions. CMVIG plus ganciclovir seems to be more effective that gancicl ovir alone for preventing the sequelae of CMV infection. A prospective rand omized study is required to confirm these observations.