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Published on: June 12, 2021
HVAD Usage and Outcomes in the Current Pediatric Ventricular Assist Device Field: An Advanced Cardiac Therapies
Scott R Auerbach1, Kathleen E Simpson,
1From the Children's Hospital of Colorado, University of Colorado Denver, Anschutz Medical Campus, Aurora, CO.
Insights
The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) study found excellent outcomes for pediatric patients receiving the HeartWare HVAD device, with 96% survival at one year. Major bleeding and infection were the most common adverse events.
Area of Science:
- Pediatric Cardiology
- Mechanical Circulatory Support
- Quality Improvement Networks
Background:
- The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is the first pediatric ventricular assist device (VAD) quality improvement network, comprising 46 centers.
- Pediatric VAD implantation is complex, necessitating robust data collection and analysis to improve patient outcomes.
Purpose of the Study:
- To describe the outcomes of pediatric patients implanted with the HeartWare HVAD device within the ACTION network.
- To analyze baseline characteristics, adverse events, and survival rates associated with HVAD use in a pediatric population.
Main Methods:
- Analysis of patients implanted with a HeartWare HVAD in the ACTION registry between April 2018 and April 2020.
- Description of patient demographics, pre-implant support (mechanical ventilation, ECMO), adverse events, and survival data.
Main Results:
- Fifty pediatric patients received HVAD implants; 42% had prior sternotomy, and most (52%) were INTERMACS profile 2.
- One-year survival was 96%, with 3 deaths recorded, all in patients with congenital heart disease (CHD).
- The most frequent adverse events were bleeding (14%) and infection (14%); stroke occurred in 4% of patients.
Conclusions:
- The ACTION Network demonstrated excellent outcomes with the HeartWare HVAD in pediatric patients, achieving 96% one-year survival.
- Congenital heart disease was associated with increased mortality, highlighting a specific area for targeted intervention.
- Bleeding and infection represent key areas for adverse event mitigation strategies in pediatric VAD therapy.
Abstract:
Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is the first pediatric ventricular assist device (VAD) quality improvement network (46 centers). We aimed to describe outcomes with the HeartWare HVAD from ACTION centers. Patients with an HVAD implant in the ACTION registry (April 2018-April 2020) were analyzed. Baseline characteristics, adverse events, and survival were described. There were 50 patients implanted with a HVAD during the study period [36 cardiomyopathy, 8 congenital heart disease (CHD), and 6 other] and 21 (42%) had a prior sternotomy. Median age (range) was 12.9 years (3.4-19.1), body surface area was 1.3 m2 (0.56-2.62), and weight was 41.8 kg (12.8-135.3). Most were INTERMACS profile 2 (n = 26, 52%). Mechanical ventilation and ECMO were used pre-HVAD in 13 (26%) and 6 (12%), respectively. Median time on VAD was 71 (5-602) days. Survival was 96% at 1 year; 3 deaths were recorded, all of whom had CHD (p = 0.001). Neither ECMO nor mechanical ventilation were associated with death (p > 0.29). Most frequent AEs were bleeding (n = 7, 14%) and infection (n = 7, 14%). Stroke was rare (n = 2, 4%). ACTION Network HVAD outcomes were excellent, with 96% survival at 1 year and only 4% occurrence of stroke. Major bleeding and infection were the most common adverse events.
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