THE ASSOCIATION BETWEEN CYTOMEGALOVIRUS IMMUNE GLOBULIN (CMVIG) USE AND LONG-TERM RECIPIENT AND GRAFT SURVIVAL IN PEDIATRIC HEART TRANSPLANTATION RECIPIENTS

A NEW CENTURY OF PEDIATRIC TRANSPLANTATION?

D.R. Snydman¹, K. Kistler², J. Morris², P. Ulsh^3
1Division Of Geographic Medicine And Infectious Diseases And Hospital Epidemiologist, Tufts Medical Center, Tufts University School of Medicine, Boston/UNITED STATES OF AMERICA, ², ProSanos Corporation, Harrisburg/PA/UNITED STATES OF AMERICA, ³, CSL Behring, King of Prussia/UNITED STATES OF AMERICA

Body: Rates & Adjusted Risk For AR, Graft Loss and Death

Total Pediatric Cohort
Kaplan-Meier Survival Analysis				Cox Proportional Hazards Regression
	CMVIG (+/- other anti-virals) % without event	No Anti-Virals % without event	p	HR	95% CI	P
AR	64%	51%	<.001	1.0	0.82,1.22	0.98
Graft Loss	66%	63%	0.02	0.79	0.63,0.98	0.03
Death	69%	67%	0.05	0.82	0.65,1.03	0.09
	CMVIG alone % without event	Ganciclovir alone % without	p	HR	95% CI	p
AR	55%	68%	0.03	0.61	0.38,0.98	0.04
Graft Loss	67%	64%	0.50	1.11	0.73,1.70	0.61
Death	68%	69%	0.99	1.18	0.75,1.86	0.46
D+/R- Cohort
	CMVIG (+/- other anti-virals) % without event	No Anti-Virals % without event	p	HR	95% CI	p
AR	74%	58%	0.03	0.61	0.38,0.98	0.04
Graft Loss	79%	60%	0.005	0.44	0.26,0.75	0.003
Death	82%	64%	0.01	0.44	0.24,0.80	0.01

Introduction: Cytomegalovirus (CMV) isresponsible for considerable morbidity post heart transplantation including both direct (e.g., pneumonitis, hepatitis, enteritis, CMV syndrome) and indirect effects (e.g., rejection, cardiacvasculopathy). The majority of data related to CMV and heart transplantation are derived from adult studies. The available pediatric data have largely focused on CMV-related outcomes associatedwith ganciclovir use. The association between CMVIG and clinical outcomes in pediatric heart transplantation has notbeen evaluated using data derived from large national data bases. We examined the association between CMVIG and acute rejection (AR), and CMVIG and long-term recipient and graft survival in pediatricheart transplantation including examination of outcomes within the subset of D+/R- patients.
Methods: Data from the Scientific Registry of Transplant Recipients included patients with a transplant date between January 1995 and October 2008; follow-up data were through March 2009. Allpediatric (<18 years) recipients of primary, single-organ heart transplants were included. Kaplan-Meier analysis was used to examine rates of AR, recipient death and graft loss at 7 yearspost-transplantation. Cox proportional hazards regression models were used to estimate risk for AR, graft loss and death after adjusting for recipient, donor, and transplantation characteristics.Comparisons were made between recipients on CMVIG (+/- other anti-virals; n=455) vs. no anti-virals (n=1884); the D+/R- population on CMVIG (+/- other anti-virals; n=139) vs. noanti-virals (n=129); and between recipients of CMVIG alone (n=124) vs. ganciclovir alone (n=534).
Results: CMVIG was associated with significantly (p ≤ 0.05) lower rates of AR, graft loss and death. After adjustment for baseline characteristics CMVIG was associated with asignificantly decreased risk for graft loss (Table). In the D+/R- cohort, CMVIG was associated with decreased AR and increased recipient and graft survival. From the Cox multivariablemodel, CMVIG was independently associated with decreased risk for AR, graft loss, and death (Table). Compared to ganciclovir alone, CMVIG alone was associated with similar rates and adjustedrisk for graft loss and death; AR was more frequent for CMVIG vs. ganciclovir but after taking baseline characteristics into account the risk for AR was significantly decreased in the CMVIG group(Table).
Conclusions: CMVIG use at discharge is associated with decreased AR and increased long-term recipient and graft survival in CMV high-risk pediatric heart transplant recipients. Theseobservational data suggest that CMVIG may offer an advantage over ganciclovir in terms of AR risk.

Disclosure: All authors have declared no conflicts of interest.