Introduction: Over the last 5 years there has been increased utilization of the HeartWare® HVAD in children despite limited safety and efficacy data in this patient population. We sought to describe the utilization and outcomes of children supported with the HVAD using the Pedimacs registry.
Methods: Between 9/12-9/16, all children aged <19 years supported with a HVAD were identified. Adverse events and outcomes were analyzed with subgroup analysis of children <20 kg.
Results: Of the 364 total patients enrolled in Pedimacs, HVADs were implanted in 149 patients at 28 centers. Ninety two percent (137) of the patients had a left ventricular HVAD only, 3% (4) received a right ventricular HVAD, and 5% (8) were on biventricular HVAD support. The mean age was 13.7 ± 3.8 yrs, with 75% (112) of patients aged 11-19 years, 21% (31) aged 6-10 yrs, and 4% (6) aged 1-6 yrs. The mean weight was 57.3 ± 27.9 (range 13.7-162.6 kg) with 9 patients less than 20 kg. Cardiomyopathy was the most common diagnosis in 71%, followed by congenital heart disease in 14% (21). At time of implant, 17% (25) of patients were in critical cardiogenic shock, with the majority of patients in progressive decline (66%, 98), and 13% (19) stable on inotropic support at time of implant. Median duration of support was 2.8 mos (2.7 days-25.2 mos). The most common adverse event was infection in 25% (event rate 7.8/100 patient months), followed by bleeding in 23% (8.4 /100 pt mos), neurological dysfunction in 19% (5.3/100 pts mos) and device malfunction in 12% (2.8/100 pt mos).Over half of patients (52.3%, 78) were discharged home. Of the patients who remained in hospital, 57 were transplanted during the implant admission. Overall, competing outcomes analysis at 6 months demonstrated 59.4% transplanted, 30.5% alive on support and 10.1% died. When examining the <20 kg cohort separately, the rate of neurologic dysfunction increased to 44%, with 1 patient mortality (11%).
Conclusion: HVAD support in the pediatric population is increasingly common, comprising 40% of patients enrolled in Pedimacs. Overall survival in children and adolescents is excellent, however adverse events are common, with a notably higher rate of neurologic dysfunction in patients <20kg as compared to larger pediatric patients.