Berlin Heart EXCOR and ACTION post-approval surveillance study report.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Zafar Farhan, Conway Jennifer, Bleiweis Mark S, Al-Aklabi Mohammed, Ameduri Rebecca, Barnes Aliessa, Bearl David W, Buchholz Holger, Church Stephanie, Do Nhue L, Duffy Vicky, Dykes John C, Eghtesady Pirooz, Fisher Lauren, Friedland-Little Joshua, Fuller Stephanie, Fynn-Thompson Francis, George Kristen, Gossett Jeffrey G, Griffiths Eric R, Griselli Massimo, Hawkins Beth, Honjo Osami, Jeewa Aamir, Joong Anna, Kindel Steven, Kouretas Peter, Lorts Angela, Machado Desiree, Maeda Katsuhide, Maurich Andrea, May Lindsay J, McConnell Patrick, Mehegan Mary, Mongé Michael, Morales David L S, Murray Jenna, Niebler Robert A, O'Connor Matthew, Peng David M, Phelps Christina, Philip Joseph, Ploutz Michelle, Profsky Michael, Reichhold Allison, Rosenthal David N, Said Ahmed S, Schumacher Kurt R, Si Ming-Sing, Simpson Kathleen E, Sparks Joshua, Louis Jim St, Steiner Marie E, VanderPluym Christina, Villa Chet, ACTION Learning Network Investigators
Аннотация
METHODS: ACTION is a learning collaborative of over 40 pediatric heart failure programs worldwide, which collects data for all VAD implantations as one of its initiatives. All patients in North America with EXCOR implants reported to ACTION from 2018 to 2020 (n = 72) who had met an outcome were included in the EXCOR PSS group. This was compared with a historical, previously reported Berlin Heart EXCOR study group (Berlin Heart study [BHS] group, n = 320, 2007‒2014).
RESULTS: Patients in the PSS group were younger, were smaller in weight/body surface area, were more likely to have congenital heart disease, and were less likely to receive a bi-VAD than those in the BHS group. Patients in the PSS group were less likely to be in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 and were supported for a longer duration. The primary anticoagulation therapy for 92% of patients in the PSS group was bivalirudin. Success, defined as being transplanted, being weaned for recovery, or being alive on a device at 180 days after implantation, was 86% in the PSS group compared with 76% in the BHS group. Incidence of stroke was reduced by 44% and the frequency of pump exchange by 40% in the PSS group compared with those in the BHS group. Similarly, all other adverse events, including major bleeding, were reduced in the PSS group.
CONCLUSIONS: The PSS data, collected through ACTION, highlight the improvement in outcomes for patients supported with EXCOR compared with the outcomes in a historical cohort. These findings may be the result of changes in patient care practices over time and collaborative learning.