Efficacy and Safety of Ferric Carboxymaltose Therapy in Continuous Flow LVAD Patients

Abstract

Purpose Iron deficiency (ID) is common in heart failure patients and is associated with reduced exercise capacity, fatigue, worsening heart failure and increased rate of heart failure hospitalization. Intravenous iron therapy allows restoration of iron deficiency, increasing hemoglobin levels and ameliorates functional capacity. In this study, we aimed to determine the efficacy and safety of ferric carboxymaltose (FCM) treatment in continuous flow LVAD patients Methods In the study, we retrospectively analysed 29 patients treated with 1000 mg IV iron (FCM) due to ID between June 2018 and October 2018. We evaluated the effect of therapy on functional capacity, six-minute walking distance(6MWD), and laboratory findings. Results Mean age of the population was 51.6 ± 13.4 years, and 69% of the patients were male. Mean body mass index(BMI) was 26.8 ± 5.47kg/m2. The mean follow-up period after FCM infusion was 97.8 ± 21.2 days. NYHA functional class decreased from 1.83 ± 0.46 to 1.39 ± 0.49. 6MWD increased from 371 ± 75 meters to 395 ± 60 meters, mean change was 13.7 ± 35 meters. Hematological parameters (hemoglobin, hematocrit, blood iron level, ferritin, TSAT) improved. Mean NT pro-BNP value decreased from 1520 ± 1429 pg/ml to 1513 ± 1817 pg/ml, mean change was 6.7 pg/ml. The number of thrombocytes decreased (276 ± 97 to 220 ± 49.8, mean change 56.1 ± 87.7), mean platelet volume increased (10.25 ± 1.01 to 10.43 ± 0.92, mean change 0.188±0.55) and platecrit decreased (0.28 ± 0.071 to 0.23 ± 0.047, mean change -0.048 ± 0.074) In the follow up period four patients developed pump thrombosis (PT) and treated with iv thrombolytic therapy. When we compare the iron treated patients with the ones who were not treated there was an increase in the rate of pump thrombosis although it did not reach significance (PT rates were respetively, 13.7% - 6.3%, p=0.239). The variables associated with pump thrombosis were BMI (PT:50.7 ± 13.7 kg/m2- nonPT:57.25 ± 10.6 kg/m2 p=0.001), increase in mean platelet volume (PT: 10.3 ± 0.94 fl - nonPT: 11.15 ± 0.17 fl, p=0.001) and increase in platecrit (PT: 0.225 ± 0.039 % - nonPT:0.282 ± 0.063%, p= 0.023) after therapy. Conclusion FCM therapy increased functional class and 6MWD in LVAD patients with ID. Natriuretic peptid levels decreased after therapy. However there was a trend in pump thrombosis after therapy. Further studies are needed to establish the safety of FCM therapy in this population.