Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children

Christopher S. Almond, David L. Morales, Eugene H. Blackstone, Mark W. Turrentine, Michiaki Imamura, M. Patricia Massicotte, Lori C. Jordan, Eric J. Devaney, Chitra Ravishankar, Kirk R. Kanter, William Holman, Robert Kroslowitz, Christine Tjossem, Lucy Thuita, Gordon A. Cohen, Holger Buchholz, James D. St. Louis, Khanh Nguyen, Robert A. Niebler, Henry L. WaltersBrian Reemtsen, Peter D. Wearden, Olaf Reinhartz, Kristine J. Guleserian, Max B. Mitchell, Mark S. Bleiweis, Charles E. Canter, Tilman Humpl

Research output: Contribution to journalArticle

249 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1702-1711
Number of pages10
JournalCirculation
Volume127
Issue number16
DOIs
StatePublished - Apr 23 2013

Fingerprint

Heart-Assist Devices
Berlin
Heart Transplantation
Pediatrics
Equipment and Supplies
Mortality
Extracorporeal Membrane Oxygenation
Transplantation
Bilirubin
Kidney
Patient Selection
Cause of Death
Heart Diseases
Cohort Studies
Clinical Trials
Prospective Studies
Weights and Measures
Survival
Liver

Keywords

  • cardiac surgical procedures
  • heart failure
  • heart-assist devices
  • pediatrics
  • transplantation
  • waiting lists

ASJC Scopus subject areas

  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Cite this

Almond, C. S., Morales, D. L., Blackstone, E. H., Turrentine, M. W., Imamura, M., Massicotte, M. P., ... Humpl, T. (2013). Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation, 127(16), 1702-1711. https://doi.org/10.1161/CIRCULATIONAHA.112.000685

Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. / Almond, Christopher S.; Morales, David L.; Blackstone, Eugene H.; Turrentine, Mark W.; Imamura, Michiaki; Massicotte, M. Patricia; Jordan, Lori C.; Devaney, Eric J.; Ravishankar, Chitra; Kanter, Kirk R.; Holman, William; Kroslowitz, Robert; Tjossem, Christine; Thuita, Lucy; Cohen, Gordon A.; Buchholz, Holger; St. Louis, James D.; Nguyen, Khanh; Niebler, Robert A.; Walters, Henry L.; Reemtsen, Brian; Wearden, Peter D.; Reinhartz, Olaf; Guleserian, Kristine J.; Mitchell, Max B.; Bleiweis, Mark S.; Canter, Charles E.; Humpl, Tilman.

In: Circulation, Vol. 127, No. 16, 23.04.2013, p. 1702-1711.

Research output: Contribution to journalArticle

Almond, CS, Morales, DL, Blackstone, EH, Turrentine, MW, Imamura, M, Massicotte, MP, Jordan, LC, Devaney, EJ, Ravishankar, C, Kanter, KR, Holman, W, Kroslowitz, R, Tjossem, C, Thuita, L, Cohen, GA, Buchholz, H, St. Louis, JD, Nguyen, K, Niebler, RA, Walters, HL, Reemtsen, B, Wearden, PD, Reinhartz, O, Guleserian, KJ, Mitchell, MB, Bleiweis, MS, Canter, CE & Humpl, T 2013, 'Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children', Circulation, vol. 127, no. 16, pp. 1702-1711. https://doi.org/10.1161/CIRCULATIONAHA.112.000685
Almond CS, Morales DL, Blackstone EH, Turrentine MW, Imamura M, Massicotte MP et al. Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation. 2013 Apr 23;127(16):1702-1711. https://doi.org/10.1161/CIRCULATIONAHA.112.000685
Almond, Christopher S. ; Morales, David L. ; Blackstone, Eugene H. ; Turrentine, Mark W. ; Imamura, Michiaki ; Massicotte, M. Patricia ; Jordan, Lori C. ; Devaney, Eric J. ; Ravishankar, Chitra ; Kanter, Kirk R. ; Holman, William ; Kroslowitz, Robert ; Tjossem, Christine ; Thuita, Lucy ; Cohen, Gordon A. ; Buchholz, Holger ; St. Louis, James D. ; Nguyen, Khanh ; Niebler, Robert A. ; Walters, Henry L. ; Reemtsen, Brian ; Wearden, Peter D. ; Reinhartz, Olaf ; Guleserian, Kristine J. ; Mitchell, Max B. ; Bleiweis, Mark S. ; Canter, Charles E. ; Humpl, Tilman. / Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. In: Circulation. 2013 ; Vol. 127, No. 16. pp. 1702-1711.
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abstract = "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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T1 - Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children

AU - Almond, Christopher S.

AU - Morales, David L.

AU - Blackstone, Eugene H.

AU - Turrentine, Mark W.

AU - Imamura, Michiaki

AU - Massicotte, M. Patricia

AU - Jordan, Lori C.

AU - Devaney, Eric J.

AU - Ravishankar, Chitra

AU - Kanter, Kirk R.

AU - Holman, William

AU - Kroslowitz, Robert

AU - Tjossem, Christine

AU - Thuita, Lucy

AU - Cohen, Gordon A.

AU - Buchholz, Holger

AU - St. Louis, James D.

AU - Nguyen, Khanh

AU - Niebler, Robert A.

AU - Walters, Henry L.

AU - Reemtsen, Brian

AU - Wearden, Peter D.

AU - Reinhartz, Olaf

AU - Guleserian, Kristine J.

AU - Mitchell, Max B.

AU - Bleiweis, Mark S.

AU - Canter, Charles E.

AU - Humpl, Tilman

PY - 2013/4/23

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N2 - 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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