Long-term outcomes after transplantation after support with a pulsatile pediatric ventricular assist device

Aamir Jeewa, Michiaki Imamura, Charles Canter, Robert A. Niebler, Christina VanderPluym, David N. Rosenthal, James K. Kirklin, Ryan S. Cantor, Margaret Tresler, David Michael McMullan, Victor O. Morell, Mark Turrentine, Rebecca K Ameduri, Khanh Nguyen, Kirk Kanter, Jennifer Conway, Robert Gajarski, Charles D. Fraser

Research output: Contribution to journalArticle

Abstract

BACKGROUND: There has been increasing use of durable ventricular assist devices (VAD) in children as a bridge to transplantation (BTT). The Berlin Heart investigational device exemption (IDE) trial was the first pediatric VAD trial to demonstrate excellent survival outcomes as a BTT. OBJECTIVES: Our aim was to compare the expanded post-transplant outcomes for children enrolled in the Berlin Heart IDE trial to a matched Pediatric Heart Transplant Study (PHTS) cohort not requiring mechanical circulatory support (MCS). SETTING: University Hospitals. METHODS: This was a retrospective review of linked PHTS and Berlin Heart IDE databases for pediatric (≤18 years) recipients transplanted from 2007-2011. Subjects with <5 years of follow up were excluded. VAD supported patients were matched 1:2 to non-VAD supported controls from the PHTS database. RESULTS: Among 109 Berlin Heart IDE study enrollees, 83 were merged with the PHTS database and matched to 166 non-MCS supported patients. There was no difference in diagnosis, status at listing, and age between groups with the expected difference in inotrope use in the non-MCS supported patients. Compared to their matched cohort, there was no statistical difference in 5-year patient survival between VAD and non-VAD patients (81% vs 88%; p = 0.09) nor was there a difference in freedom from rejection or infection. CONCLUSIONS: This data suggests that children supported with a Berlin Heart VAD had similar survival, infection and rejection rates compared to those not requiring MCS support. Continued surveillance of the Berlin Heart IDE trial population post heart transplantation is warranted.

Original languageEnglish (US)
Pages (from-to)449-455
Number of pages7
JournalJournal of Heart and Lung Transplantation
Volume38
Issue number4
DOIs
StatePublished - Apr 1 2019
Externally publishedYes

Fingerprint

Heart-Assist Devices
Transplantation
Berlin
Pediatrics
Equipment and Supplies
Transplants
Databases
Survival
Heart Transplantation
Infection
Cohort Studies
Age Groups

Keywords

  • pediatric end-stage heart failure
  • pediatric heart transplant
  • pediatric mechanical circulatory support
  • post transplant survival
  • ventricular assist device

PubMed: MeSH publication types

  • Journal Article

Cite this

Jeewa, A., Imamura, M., Canter, C., Niebler, R. A., VanderPluym, C., Rosenthal, D. N., ... Fraser, C. D. (2019). Long-term outcomes after transplantation after support with a pulsatile pediatric ventricular assist device. Journal of Heart and Lung Transplantation, 38(4), 449-455. https://doi.org/10.1016/j.healun.2018.10.005

Long-term outcomes after transplantation after support with a pulsatile pediatric ventricular assist device. / Jeewa, Aamir; Imamura, Michiaki; Canter, Charles; Niebler, Robert A.; VanderPluym, Christina; Rosenthal, David N.; Kirklin, James K.; Cantor, Ryan S.; Tresler, Margaret; McMullan, David Michael; Morell, Victor O.; Turrentine, Mark; Ameduri, Rebecca K; Nguyen, Khanh; Kanter, Kirk; Conway, Jennifer; Gajarski, Robert; Fraser, Charles D.

In: Journal of Heart and Lung Transplantation, Vol. 38, No. 4, 01.04.2019, p. 449-455.

Research output: Contribution to journalArticle

Jeewa, A, Imamura, M, Canter, C, Niebler, RA, VanderPluym, C, Rosenthal, DN, Kirklin, JK, Cantor, RS, Tresler, M, McMullan, DM, Morell, VO, Turrentine, M, Ameduri, RK, Nguyen, K, Kanter, K, Conway, J, Gajarski, R & Fraser, CD 2019, 'Long-term outcomes after transplantation after support with a pulsatile pediatric ventricular assist device', Journal of Heart and Lung Transplantation, vol. 38, no. 4, pp. 449-455. https://doi.org/10.1016/j.healun.2018.10.005
Jeewa, Aamir ; Imamura, Michiaki ; Canter, Charles ; Niebler, Robert A. ; VanderPluym, Christina ; Rosenthal, David N. ; Kirklin, James K. ; Cantor, Ryan S. ; Tresler, Margaret ; McMullan, David Michael ; Morell, Victor O. ; Turrentine, Mark ; Ameduri, Rebecca K ; Nguyen, Khanh ; Kanter, Kirk ; Conway, Jennifer ; Gajarski, Robert ; Fraser, Charles D. / Long-term outcomes after transplantation after support with a pulsatile pediatric ventricular assist device. In: Journal of Heart and Lung Transplantation. 2019 ; Vol. 38, No. 4. pp. 449-455.
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abstract = "BACKGROUND: There has been increasing use of durable ventricular assist devices (VAD) in children as a bridge to transplantation (BTT). The Berlin Heart investigational device exemption (IDE) trial was the first pediatric VAD trial to demonstrate excellent survival outcomes as a BTT. OBJECTIVES: Our aim was to compare the expanded post-transplant outcomes for children enrolled in the Berlin Heart IDE trial to a matched Pediatric Heart Transplant Study (PHTS) cohort not requiring mechanical circulatory support (MCS). SETTING: University Hospitals. METHODS: This was a retrospective review of linked PHTS and Berlin Heart IDE databases for pediatric (≤18 years) recipients transplanted from 2007-2011. Subjects with <5 years of follow up were excluded. VAD supported patients were matched 1:2 to non-VAD supported controls from the PHTS database. RESULTS: Among 109 Berlin Heart IDE study enrollees, 83 were merged with the PHTS database and matched to 166 non-MCS supported patients. There was no difference in diagnosis, status at listing, and age between groups with the expected difference in inotrope use in the non-MCS supported patients. Compared to their matched cohort, there was no statistical difference in 5-year patient survival between VAD and non-VAD patients (81{\%} vs 88{\%}; p = 0.09) nor was there a difference in freedom from rejection or infection. CONCLUSIONS: This data suggests that children supported with a Berlin Heart VAD had similar survival, infection and rejection rates compared to those not requiring MCS support. Continued surveillance of the Berlin Heart IDE trial population post heart transplantation is warranted.",
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T1 - Long-term outcomes after transplantation after support with a pulsatile pediatric ventricular assist device

AU - Jeewa, Aamir

AU - Imamura, Michiaki

AU - Canter, Charles

AU - Niebler, Robert A.

AU - VanderPluym, Christina

AU - Rosenthal, David N.

AU - Kirklin, James K.

AU - Cantor, Ryan S.

AU - Tresler, Margaret

AU - McMullan, David Michael

AU - Morell, Victor O.

AU - Turrentine, Mark

AU - Ameduri, Rebecca K

AU - Nguyen, Khanh

AU - Kanter, Kirk

AU - Conway, Jennifer

AU - Gajarski, Robert

AU - Fraser, Charles D.

PY - 2019/4/1

Y1 - 2019/4/1

N2 - BACKGROUND: There has been increasing use of durable ventricular assist devices (VAD) in children as a bridge to transplantation (BTT). The Berlin Heart investigational device exemption (IDE) trial was the first pediatric VAD trial to demonstrate excellent survival outcomes as a BTT. OBJECTIVES: Our aim was to compare the expanded post-transplant outcomes for children enrolled in the Berlin Heart IDE trial to a matched Pediatric Heart Transplant Study (PHTS) cohort not requiring mechanical circulatory support (MCS). SETTING: University Hospitals. METHODS: This was a retrospective review of linked PHTS and Berlin Heart IDE databases for pediatric (≤18 years) recipients transplanted from 2007-2011. Subjects with <5 years of follow up were excluded. VAD supported patients were matched 1:2 to non-VAD supported controls from the PHTS database. RESULTS: Among 109 Berlin Heart IDE study enrollees, 83 were merged with the PHTS database and matched to 166 non-MCS supported patients. There was no difference in diagnosis, status at listing, and age between groups with the expected difference in inotrope use in the non-MCS supported patients. Compared to their matched cohort, there was no statistical difference in 5-year patient survival between VAD and non-VAD patients (81% vs 88%; p = 0.09) nor was there a difference in freedom from rejection or infection. CONCLUSIONS: This data suggests that children supported with a Berlin Heart VAD had similar survival, infection and rejection rates compared to those not requiring MCS support. Continued surveillance of the Berlin Heart IDE trial population post heart transplantation is warranted.

AB - BACKGROUND: There has been increasing use of durable ventricular assist devices (VAD) in children as a bridge to transplantation (BTT). The Berlin Heart investigational device exemption (IDE) trial was the first pediatric VAD trial to demonstrate excellent survival outcomes as a BTT. OBJECTIVES: Our aim was to compare the expanded post-transplant outcomes for children enrolled in the Berlin Heart IDE trial to a matched Pediatric Heart Transplant Study (PHTS) cohort not requiring mechanical circulatory support (MCS). SETTING: University Hospitals. METHODS: This was a retrospective review of linked PHTS and Berlin Heart IDE databases for pediatric (≤18 years) recipients transplanted from 2007-2011. Subjects with <5 years of follow up were excluded. VAD supported patients were matched 1:2 to non-VAD supported controls from the PHTS database. RESULTS: Among 109 Berlin Heart IDE study enrollees, 83 were merged with the PHTS database and matched to 166 non-MCS supported patients. There was no difference in diagnosis, status at listing, and age between groups with the expected difference in inotrope use in the non-MCS supported patients. Compared to their matched cohort, there was no statistical difference in 5-year patient survival between VAD and non-VAD patients (81% vs 88%; p = 0.09) nor was there a difference in freedom from rejection or infection. CONCLUSIONS: This data suggests that children supported with a Berlin Heart VAD had similar survival, infection and rejection rates compared to those not requiring MCS support. Continued surveillance of the Berlin Heart IDE trial population post heart transplantation is warranted.

KW - pediatric end-stage heart failure

KW - pediatric heart transplant

KW - pediatric mechanical circulatory support

KW - post transplant survival

KW - ventricular assist device

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