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Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart
Published on: May 11, 2018
Outcomes of children supported with an intracorporeal continuous-flow left ventricular assist system
Christina J VanderPluym1, Iki Adachi2, Robert Niebler3
1Department of Cardiology, Boston Children's Hospital, Harvard School of Medicine, Boston, Massachusetts.
Insights
Pediatric use of the HeartWare continuous flow ventricular assist device (VAD) shows encouraging survival rates comparable to young adults. However, adverse events like infection and device malfunction are common in children, necessitating further evaluation.
Area of Science:
- Pediatric cardiology
- Mechanical circulatory support
- Cardiac surgery
Background:
- The HeartWare continuous flow (CF) ventricular assist device (VAD) has seen increased use in pediatric patients since 2012, despite lacking pediatric indication.
- This study addresses the need to understand the outcomes of this off-label use in children.
Purpose of the Study:
- To describe the utilization and outcomes of the HeartWare VAD in pediatric patients.
- To compare adverse events and survival rates between children and young adults receiving HeartWare VAD support.
Main Methods:
- Analysis of patients under 30 years old implanted with HeartWare VAD, registered in the Pediatric Mechanical Circulatory Support (Pedimacs) and Intermacs registries from September 2012 to June 2017.
- Comparison of baseline characteristics, adverse events (infection, bleeding, device malfunction, stroke), and survival between pediatric and young adult cohorts.
Main Results:
- 192 children and 247 young adults received HeartWare VADs; children had significantly lower weight and body surface area.
- Median support duration was shorter in children (2.8 months) than young adults (9.7 months).
- While overall survival was comparable, children experienced higher rates of infection (27% vs 44%) and device malfunction (11% vs 19%), with lower discharge rates (33-48% vs 80%).
Conclusions:
- HeartWare VAD support in children demonstrates survival rates comparable to young adults.
- Adverse events, particularly infections and device issues, remain a concern in pediatric patients.
- Further research is needed to optimize HeartWare VAD use in children and improve discharge outcomes.
Background:
Since 2012, there has been growing use of the HeartWare (Medtronic, Mounds View, MN) intracorporeal continuous flow (CF) ventricular assist device (VAD) in children, despite it not being labeled for use in pediatric patients. We sought to describe the use and outcomes of children with HeartWare VADs.
Methods:
We identified all patients aged < 19 years and young adults aged 19 to 30 years supported with HeartWare who were entered into the pediatric portion (Pedimacs) of the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) and the Intermacs registries, respectively, between September 2012 and June 2017. Adverse events and outcomes were analyzed and compared.
Results:
We identified 192 children and 247 young adult HeartWare patients. Baseline characteristics of children differed from young adults, with lower median weight of 51.5 kg (range, 13.1-162) vs 75.8 kg (range, 29.8-191; p ≤ 0.0001) and body surface area of 1.5 m2 (range, 0.6-2.9 m2) vs 1.9 m2 (range, 1.1-3.2 m2; p ≤ 0.0001) . At the time of implant, 12 children weighed < 20 kg, and 58.3% of these children had congenital heart disease compared with 11.7% in children who weighed ≥ 20 kg and 6.1% in young adults (p ≤ 0.0001). Median duration of support was 2.8 months (IQR, 1.3-6.0 months) in children and 9.7 months (IQR 4.0-19.2 months) in young adults (p ≤ 0.0001). Serious adverse events in children and young adults included infection in 27% and 44% of patients, respectively (p=0.0002), major bleeding in 23% and 23%, respectively (p = 0.9), device malfunction/pump thrombosis in 11% and 19.0%, respectively (p = 0.04), and stroke in 10% and 12%, respectively (p = 0.5). Of the children who weighed < 20 kg at time of implant, 0% had major bleeding, 16.7% had infections, and 8.3% had stroke. Overall survival was not statistically different between children and young adults, and there was no increased mortality in children who weighed < 20 kg. Rate of discharge on HeartWare was 80% in young adults vs 48% in children who weighed ≥ 20 kg and only 33% in children who weighed < 20 kg.
Conclusions:
Survival in children supported with HeartWare is encouraging and comparable to young adults; however, adverse events are not uncommon in children. Ongoing evaluation of the HeartWare use in children is necessary to further decrease the rate of adverse events and understand obstacles to discharge.
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