The Initial Analysis of Infectious Adverse Events in Pediatric Ventricular Assist Devices Reported to the ACTION Registry

Abstract

<h3>Purpose</h3> Infection adverse events (IAE) are frequent in pediatric ventricular assist device (VAD) patients. In this study we aim to describe IAE in pediatric VAD patients from the Advanced Cardiac Therapy Improving Outcome Network (ACTION) multi-center registry. <h3>Methods</h3> VAD data from the ACTION registry (9/2018 to 8/2021) were analyzed. Cohort was divided by device type as paracorporeal (PC) (Berlin EXCOR, Pedimag, Centrimag, Rotaflow) and intracorporeal (IC) (Heartware (HVAD), Heartmate3 (HM3), Heartmate2, Syncardia). IAE rates and incidence per 100 patient months were described with descriptive statistics and compared between groups by chi-square test. <h3>Results</h3> Of the 506 patients, 139 patients (27.5%) experienced at least one IAE. Majority were sepsis (77, 34.5%) or localized non device related (77, 34.5%), 51 (22.9%) being IAE of percutaneous site and only 4 (1.8%) were pump related. Median time to first device related IAE was 40 days [6 - 1648]. Infections were bacterial in 121 (46.5%), fungal in 10 (3.86%) and unknown in 119 (46%). Upon comparison, patients on PC devices were significantly younger (0.81 vs 15.2 years), smaller (0.39 vs 1.46 m²), and sicker (INTERMACS profile1 and 2, ECMO at implant and ventilator support; all <i>p</i> values <0.05) than patients on IC. There was no difference in gender, diagnosis, and dialysis frequency between devices. PC devices had a significantly higher IAE rate and had significantly more sepsis IAE (Table). Device related IAE were significantly higher in HM3 than HVAD [17 (47.2%) vs 7 (17.9%); <i>p</i>= 0.019; IAE/100 patient months=2.58 vs 1.02; <i>p</i>= 0.007], which seem to be driven by driveline infections (IAE/100 patient months=2.28 vs 1.02; <i>p</i> =0.028) <h3>Conclusion</h3> A significant proportion of children on VAD experienced IAE, the majority of which are not device related. PC VAD had a higher risk of IAE than IC VAD. Within IC devices, there was a significantly higher rate of driveline site infections in HM3 patients.