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.
Subject(s)
Heart Failure/surgery , Heart-Assist Devices/adverse effects , Adolescent , Child , Child, Preschool , Female , Heart Failure/mortality , Humans , Male , Middle Aged , Quality Improvement , Young AdultABSTRACT
BACKGROUND: Cardiomyopathies are a rare cause of pediatric heart disease, but they are one of the leading causes of heart failure admissions, sudden death, and need for heart transplant in childhood. Reports from the Pediatric Cardiomyopathy Registry (PCMR) have shown that almost 40% of children presenting with symptomatic cardiomyopathy either die or undergo heart transplant within 2 years of presentation. Little is known regarding circulating biomarkers as predictors of outcome in pediatric cardiomyopathy. STUDY DESIGN: The Cardiac Biomarkers in Pediatric Cardiomyopathy (PCM Biomarkers) study is a multi-center prospective study conducted by the PCMR investigators to identify serum biomarkers for predicting outcome in children with dilated cardiomyopathy (DCM) and hypertrophic cardiomyopathy (HCM). Patients less than 21 years of age with either DCM or HCM were eligible. Those with DCM were enrolled into cohorts based on time from cardiomyopathy diagnosis: categorized as new onset or chronic. Clinical endpoints included sudden death and progressive heart failure. RESULTS: There were 288 children diagnosed at a mean age of 7.2±6.3 years who enrolled in the PCM Biomarkers Study at a median time from diagnosis to enrollment of 1.9 years. There were 80 children enrolled in the new onset DCM cohort, defined as diagnosis at or 12 months prior to enrollment. The median age at diagnosis for the new onset DCM was 1.7 years and median time from diagnosis to enrollment was 0.1 years. There were 141 children enrolled with either chronic DCM or chronic HCM, defined as children ≥2 years from diagnosis to enrollment. Among children with chronic cardiomyopathy, median age at diagnosis was 3.4 years and median time from diagnosis to enrollment was 4.8 years. CONCLUSION: The PCM Biomarkers study is evaluating the predictive value of serum biomarkers to aid in the prognosis and management of children with DCM and HCM. The results will provide valuable information where data are lacking in children. CLINICAL TRIAL REGISTRATION NCT01873976: https://clinicaltrials.gov/ct2/show/NCT01873976?term=PCM+Biomarker&rank=1.