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Pediatric ventricular assist device (VAD) therapy is a rapidly changing field where devices and applications are rapidly evolving. We sought to describe some of the most recent trends in pediatric VAD use and contemporary outcomes since UNOS began collecting VAD data on all listed patients regardless of whether they survived. All children ≤21 years of age listed for isolated HT between Jan 2004 and 2019 and underwent VAD placement were identified using OPTN data. Descriptive statistics were used to characterize recent trends in VAD utilization. Waitlist survival in children with cardiomyopathy, CHD and single-ventricle heart disease were estimated using the Kaplan-Meier method. Overall, 2059 children met the study inclusion criteria of whom the median age was 11 (IQR 1, 17), median weight 38 (11,66) kg, 26% were black; 18.3 had congenital heart disease (CHD) including 5.1% with single-ventricle (SV) HD. Forty-nine percent were supported with a VAD at listing, 72% at transplant and 13% received a VAD but was not supported at listing or transplant. Overall, 64% received LVADs, 31% BIVADs, 2.5% RVADs 1.7% total artificial hearts (TAH). Implants of the Berlin Heart fell dipped sharply to 34 in 2015 after a peak of 63 but have rebounded since in the era of bivalirudin. As of 2018, the Heartware HVAD was the most commonly implanted VAD in children (N=61) followed by the Berlin Heart (N=48), CentriMag/PediMag (N=18) and Heartmate III (N=11). The fastest growing segment of VAD patients are single-ventricle patients (Figure). The total number of pediatric VADs continues to grow at a brisk pace. The most recent era has seen growth of the Heartmate III and resurgence of the Berlin Heart EXCOR, after a brief decline in 2015. Single-ventricle and Heartmate III patients represent the fastest growing segment of the VAD population. [ABSTRACT FROM AUTHOR]

In June 2018, the US Food and Drug Administration approved Prograf granules for pediatric solid-organ heart transplant without a US trial. This was due to concerns over compounding errors associated with pharmacy preparation of Prograf suspension for children who cannot swallow capsules. We reviewed our early experience converting children from Prograf suspension to granules to ensure safe transition practices. All children transitioned from Prograf suspension to Prograf granules at a single center in 2019 were identified using pharmacy records. The starting dose for the transition from compounded liquid to granules was determined by using a one to one dosing conversion. The steady dose of Prograf pre and post conversion were compared, as was the time to reach a therapeutic level. Patients with modified target goals (e.g. secondary to infection) before or after conversion were excluded. Between January and September 2019, a total of 12 children were converted from Prograf suspension to Prograf granules of whom 9 met the inclusion criteria. Of these, the median age was 6.25 (IQR 4, 8) years, the median weight was 17 (15, 21) kg; 56% were female and 67% had prior congenital heart disease. Prior to conversion, the mean daily dose was 0.106 (SD 0.07) mg/kg. Following conversion, the mean daily dose was 0.112 (SD 0.08) mg/kg, a 15% increase on average. On average, 3 levels were obtained before a goal target level was achieved at a mean of 34 days after conversion. Children transitioned from Prograf suspension to granules often required a dosing change to achieve the same target level on Prograf granules. The number of dose increases outnumbered dose decreases. Increasing the frequency of monitoring tacrolimus levels after conversion may help to foreshorten the period of time outside the goal range. [ABSTRACT FROM AUTHOR]

In June 2018, the US Food and Drug Administration approved Prograf granules for pediatric solid-organ heart transplant without a US trial. This was due to concerns over compounding errors associated with pharmacy preparation of Prograf suspension for children who cannot swallow capsules. We reviewed our early experience converting children from Prograf suspension to granules to ensure safe transition practices. All children transitioned from Prograf suspension to Prograf granules at a single center in 2019 were identified using pharmacy records. The starting dose for the transition from compounded liquid to granules was determined by using a one to one dosing conversion. The steady dose of Prograf pre and post conversion were compared, as was the time to reach a therapeutic level. Patients with modified target goals (e.g. secondary to infection) before or after conversion were excluded. Between January and September 2019, a total of 12 children were converted from Prograf suspension to Prograf granules of whom 9 met the inclusion criteria. Of these, the median age was 6.25 (IQR 4, 8) years, the median weight was 17 (15, 21) kg; 56% were female and 67% had prior congenital heart disease. Prior to conversion, the mean daily dose was 0.106 (SD 0.07) mg/kg. Following conversion, the mean daily dose was 0.112 (SD 0.08) mg/kg, a 15% increase on average. On average, 3 levels were obtained before a goal target level was achieved at a mean of 34 days after conversion. Children transitioned from Prograf suspension to granules often required a dosing change to achieve the same target level on Prograf granules. The number of dose increases outnumbered dose decreases. Increasing the frequency of monitoring tacrolimus levels after conversion may help to foreshorten the period of time outside the goal range. [ABSTRACT FROM AUTHOR]