Browsing by Author "Niebler, Robert A."

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    Impact of HeartWare ventricular assist device discontinuation on the pediatric population: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry analysis
    (Elsevier, 2024-02-05) Niebler, Robert A.; Shezad, Muhammad; Absi, Mohammed; Aljohani, Othman A.; Amdani, Shahnawaz; Auerbach, Scott; Bearl, David W.; Boucek, Katerina; Buchholz, Holger; Castleberry, Chesney; Dykes, John; Engelhardt, Kevin; Friedland-Little, Joshua; Hope, Kyle; Iqbal, Mehreen; Jeewa, Aamir; Joong, Anna; Lorts, Angela; May, Lindsay; Mokshagundam, Deepa; Nandi, Deipanjan; O'Connor, Matthew; Parent, John J.; Peng, David M.; Shwaish, Natalie; Shugh, Svetlana B.; VanderPluym, Christina; Vaughn, Gabrielle; Zinn, Mattew; Pediatrics, School of Medicine
    Background: The HeartWare ventricular assist device (HVAD) was discontinued in July 2021. The study aims to describe the impact the discontinuation the HVAD had on pediatric ventricular assist device (VAD) utilization and outcomes. Methods: The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry was queried for type of VAD utilization and outcomes/adverse event rates in patients with a body surface area of 0.7 to 1.4 m2. Results were compared from before and after July 2021. All patients in the registry implanted with an HVAD were reported to determine overall outcomes of these patients and define who remains on the device. Results: The HeartMate 3 (HM3) primarily replaced the HVAD in pediatric patients increasing from 29 of 258 (11%) of implants before July 2021 to 31 of 109 (29%) of implants after. A small increase in the use of the Berlin Heart EXCOR (40 of 258, 16% before to 20 of 109, 18% after) and paracorporeal continuous flow devices (116 of 258, 45% before to 58 of 109, 53% after) was also observed. The rate of ischemic stroke increased in the overall population and a decrease in bleeding complications in the EXCOR group was observed. Of the 187 pediatric patients implanted with an HVAD in the registry, 7 patients remain supported, 1 patient transitioned from the HVAD to an HM3, and 6 patients were lost to follow-up. Conclusions: The HM3 has been the primary replacement for the HVAD in the medium-sized pediatric population. The rate of ischemic stroke was higher after July 2021.
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    Infectious Complications of Ventricular Assist Device Use in Children in the US: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs)
    (Elsevier, 2017) Auerbach, Scott R.; Richmond, Marc E.; Schumacher, Kurt R.; Lopez-Colon, Dalia; Mitchell, Max B.; Turrentine, M. W.; Cantor, Ryan S.; Niebler, Robert A.; Eghtesady, Pirooz; Surgery, School of Medicine
    Background Infections are frequent in pediatric ventricular assist device (VAD) patients. In this study we aimed to describe infections in durable VAD patients reported to Pedimacs. Methods Durable VAD data from the Pedimacs registry (September 19, 2012 to December 31, 2015) were analyzed. Infections were described with standard descriptive statistics, Kaplan–Meier analysis and competing outcomes analysis. Results There were 248 implants in 222 patients, with a mean age and a median follow-up of 11 ± 6.4 years and 2.4 patient-months (<1 day to 2.6 years), respectively. Device types were pulsatile flow (PF) in 91 (41%) patients and continuous flow (CF) in 131 (59%) patients. PF patients were younger (4 ± 4 vs 14 ± 4 years; p < 0.0001) and were more likely to have congenital heart disease (25% vs 12%; p = 0.03), prior surgery (53% vs 26%; p < 0.0001) and prior extracorporeal membrane oxygenation (24% vs 7%; p = 0.0003). Infection accounted for 17% (96 of 564) of the reported adverse events (AEs). A non-device infection was most common (51%), followed by sepsis (24%), external pump component infection (20%) and internal pump component infection (5%). Most infections were bacterial (73%) and required intravenous therapy only (77%). The risk of infection in the constant phase was higher in patients with a history of prior infection and in patients with a history of a non-infectious major AEs. Survival was lower after infection only in CF patients (p = 0.008). Conclusions Infection was the most common AE after pediatric VAD implantation. Non-device infections were most common. The best predictor of a future infection was a past infection. CF patients have higher risk of death after an infection.