Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children

Ovid Technologies (Wolters Kluwer Health) - Tập 127 Số 16 - Trang 1702-1711 - 2013
Christopher S. Almond1, David L.S. Morales1, Eugene H. Blackstone1, Mark W. Turrentine1, Michiaki Imamura1, M. Patricia Massicotte1, Lori C. Jordan1, Eric J. Devaney1, Chitra Ravishankar1, Kirk R. Kanter1, William L. Holman1, Robert Kroslowitz1, Christine Tjossem1, Lucy Thuita1, Gordon Cohen1, Holger Buchholz1, James D. St. Louis1, Khanh Nguyen1,2, Robert A. Niebler1, Henry L. Walters1, Brian Reemtsen1, Peter D. Wearden1, Olaf Reinhartz1, Kristine J. Guleserian1, Max B. Mitchell1, Mark S. Bleiweis1, Charles E. Canter1, Tilman Humpl1
1From Boston Children’s Hospital, Boston, MA (C.S.A.); Cincinnati Children’s Hospital, Cincinnati, OH (D.L.M.); Heart and Vascular Institute and Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH (E.H.B., L.T.); Riley Hospital for Children, Indianapolis, IN (M.W.T.); Arkansas Children’s Hospital, Little Rock (M.I.); Stollery Children’s Hospital, Edmonton, AB, Canada (M.P.M., H.B.); Vanderbilt University Medical Center, Nashville, TN (L.C.J.); C.S. Mott Children’s Hospital,...
2Mount Sinai School

Tóm tắt

Background— Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Published data are limited to 1 in 4 children who received the device as part of the US clinical trial. We analyzed outcomes for all US children who received the EXCOR to characterize device outcomes in an unselected cohort and to identify risk factors for mortality to facilitate patient selection. Methods and Results— This multicenter, prospective cohort study involved all children implanted with the Berlin Heart EXCOR Pediatric ventricular assist device at 47 centers from May 2007 through December 2010. Multiphase nonproportional hazards modeling was used to identify risk factors for early (<2 months) and late mortality. Of 204 children supported with the EXCOR, the median duration of support was 40 days (range, 1–435 days). Survival at 12 months was 75%, including 64% who reached transplantation, 6% who recovered, and 5% who were alive on the device. Multivariable analysis identified lower weight, biventricular assist device support, and elevated bilirubin as risk factors for early mortality and bilirubin extremes and renal dysfunction as risk factors for late mortality. Neurological dysfunction occurred in 29% and was the leading cause of death. Conclusions— Use of the Berlin Heart EXCOR has risen dramatically over the past decade. The EXCOR has emerged as a new treatment standard in the United States for pediatric bridge to transplantation. Three-quarters of children survived to transplantation or recovery; an important fraction experienced neurological dysfunction. Smaller patient size, renal dysfunction, hepatic dysfunction, and biventricular assist device use were associated with mortality, whereas extracorporeal membrane oxygenation before implantation and congenital heart disease were not.

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Ovid Technologies (Wolters Kluwer Health)

Tập 127 Số 16

1702-1711

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