Impact of Drug Elution on Infectious Outcomes after Ductal Stenting in Newborns

Ductal stenting (DS) is an interesting palliation for neonates with duct-dependent pulmonary circulation. With the introduction of drug-eluting stents (DES), which have a lower rate of restenosis and longer patency, these stents have replaced bare metal stents (BMS) in the global market. DES release Rapamycin group drugs, which have anti-proliferative and immunosuppressive effects. While the released drug amount is negligible in adult patients, it can lead to high blood levels in neonates, potentially increasing their risk of infections. We conducted a retrospective observational study on infants (under 2 months of age) with duct-dependent pulmonary circulation who underwent successful DS procedures between September 2013 and September 2023. Infants who received at least one DES were categorized into the DES group, while those receiving only BMS were categorized into the BMS group. We compared the prevalence of sepsis (both clinical and proven) and mortality between the two groups. We identified 53 infants (58.4% males), comprising 30 (56.6%) in the DES group and 23 (43.4%) in the BMS group. In the DES group, there were 11 cases (36.7%) of sepsis, including 8 clinical and 3 culture-positive cases. In contrast, the BMS group had 4 cases (13%) of sepsis, all of which were clinical (p = 0.053). Three patients (5.6%) died due to sepsis: two from the DES group and one from the BMS group. Six patients were suspected of having immunodeficiency (22q11.2 deletion or asplenia), with three in each group. Among these, only one patient in the DES group developed clinical sepsis. Our findings indicate that drug elution did not significantly increase the risk of infection following DS in newborns.