Introduction: Iron deficiency (ID) is associated with worse outcomes in patients with heart failure (HF). In adults with HF and ID, intravenous (IV) iron replacement therapy (IRT) improves HF outcomes and is the first-line therapy for ID because oral IRT is ineffective. There are no data on the safety and efficacy of IV IRT in children with HF and ID.
Hypothesis: IV IRT with ferric carboxymaltose (FCM) is safe and replenishes iron levels in children with HF.
Methods: Single center retrospective review of patients age ≤18 years with systolic HF and ID who received IV IRT with FCM (15 mg/kg over 15 minutes; maximum dose 750 mg) from 3/2017 to 3/2019. The electronic medical record was reviewed for documentation of adverse events during and after each infusion. Efficacy of IV IRT was assessed after the initial FCM infusion in those patients in whom iron testing was available within 12 weeks.
Results: Fifty-five FCM infusions were administered in 42 patients (55% male, median age 8.1 years [IQR 2.3 – 13.7]). HF etiologies included cardiomyopathy (67%) and congenital heart disease (29%). Six patients (14%) were on a ventricular assist device, and the median BNP was 909 pg/mL (IQR 223 – 2636). Adverse events occurred after 4/55 infusions (7.3%; fever x2 and nausea x2). There were no documented episodes of hives, extravasation, hypophosphatemia, or anaphylaxis. One patient with a recent cardiac arrest died of recurrent arrest 24 hours after FCM. Iron testing was available after the first FCM infusion in 25 patients at a median of 38 days (IQR 15 – 67) post-IRT. All iron laboratory measures improved (Table), and 18 patients (72%) were iron replete after a single FCM infusion. Post-IRT phosphorus levels decreased but were not clinically significant. More than 1 FCM infusion was required in 7 patients for iron repletion.
Conclusions: In children with HF and ID, IV IRT with FCM was safe, was well-tolerated, and improved iron status. Future studies should determine the impact of FCM on pediatric HF outcomes.
Sources: Joseph A Spinner, Kriti Puri, Jacquelyn Powers, Tejasvi Dasari, Hari Tunuguntla, Swati Choudhry, Antonio G Cabrera, Mona Shah, William J Dreyer, Susan W Denfield and Jack F Price