Comparing First- and Second-Year Palivizumab Prophylaxis in Patients with Hemodynamically Significant Congenital Heart Disease in the CARESS Database (2005-2015).

BACKGROUND: Respiratory syncytial virus hospitalization (RSVH) rates in children less than <2 years of age with hemodynamically significant congenital heart disease (HSCHD) are 2-4 fold higher compared with healthy term infants. Pediatric recommendations differ as to whether palivizumab is beneficial beyond 1 year of age. The objective was to determine whether differences exist in respiratory-related illness hospitalization (RIH) and RSVH in HSCHD infants receiving palivizumab during the first year versus second year of life in the Canadian Registry of Palivizumab (CARESS).

METHODS: CARESS is a prospective database of infants who received ≥1 dose of palivizumab in 32 hospitals from 2005-2015. Demographic data were collected at enrollment and RIH events recorded monthly. Infants <24 months with HSCHD were recruited.

RESULTS: Of 1909 HSCHD infants, 1380 (72.3%) in the first year (mean age 4.2 months) and 529 (27.7%) in the second year of life (mean age 17.8 months) received prophylaxis. Baseline demographics for daycare attendance, multiple births, enrollment age and weight differed between the groups (all p<0.05). Additionally, second year infants had a more complicated neonatal course, with significantly longer length of stay (51.2 versus 24.9 days) compared with those in the first year. The RIH and RSVH rates in the first year and second year were 11.2%; 10.6% and 2.3%; 1.7% respectively. Cox regression analysis showed similar hazard for RIH (Hazard ratio: 1.9, 95%CI 0.7-4.6, p=0.18) and RSVH (Hazard ratio: 2.0, 95%CI 0.2-16.5, p=0.52).

CONCLUSIONS: Infants in the first and second year of life had a similar RSVH hazard. These findings suggest that infants in the second year with HSCHD, who remain unstable, are equally at risk for RSVH and merit prophylaxis.