Worldwide Experience of a Durable Centrifugal Flow Pump in Pediatric Patients

Pediatric VAD Investigators

doi:10.1053/j.semtcvs.2018.03.003

Worldwide Experience of a Durable Centrifugal Flow Pump in Pediatric Patients

Pediatric VAD Investigators

Research output: Contribution to journal › Article › peer-review

45 Scopus citations

Abstract

The primary objectives of this study were to describe the characteristics and survival outcomes for children supported with the HeartWare HVAD® system from the global community. This was a retrospective survey of patients <18 years of age with an HVAD® system. Questionnaires were sent to sites worldwide in April 2015 and collected between May 2015 and 2016. Information on 205 patients was collected. The median age at implantation was 13.1 years (interquartile range [IQR] 9.8-15.8 years) and the weight was 42 kg (IQR 28–60 kg). Over half of the implants occurred in males (61%), with the most common diagnosis being cardiomyopathy (n = 168, 82%). The majority of HVAD® systems implanted were left ventricular assist device (n = 189, 92.2%). Temporary right ventricular support was utilized in 24 patients (12%) with a median duration of 12 days (6-32 days). Fifty-five percent (n = 111) of the patients were discharged home after implantation after a median (IQR) duration of hospital stay of 40 days (28-71 days). By 12 months, the proportion of patients who underwent heart transplant was 65.4%, 10.7% had died, 3.2% were explanted for recovery, and 20.8% remained on the device. Death on the device on multivariable analysis was associated with the need for temporary RV support (hazard ratio [HR] 10.65 (95% CI 12.53-44.81), P = 0.001) and pump exchange (HR 7.9 (95% CI 1.8-34.2], P = 0.006). The use of the HeartWare HVAD system in the pediatric population is associated with mortality with the majority of patients supported to heart transplant by 1 year post implant. These positive results are independent of geographic location. The need for a temporary right heart support and pump exchange is associated with a higher risk of poor outcomes, and further work is required to predict these patients to allow for optimization. Although survival results are promising, further studies are needed to delineate the associated morbidities with this technology in the pediatric population.

Original language	English (US)
Pages (from-to)	327-335
Number of pages	9
Journal	Seminars in thoracic and cardiovascular surgery
Volume	30
Issue number	3
DOIs	https://doi.org/10.1053/j.semtcvs.2018.03.003
State	Published - Sep 1 2018

Keywords

children
continuous-flow pumps
outcomes
ventricular assist devices

ASJC Scopus subject areas

Surgery
Pulmonary and Respiratory Medicine
Cardiology and Cardiovascular Medicine

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10.1053/j.semtcvs.2018.03.003

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@article{4ec073d6eef0499bb9e3d977ddf5d290,

title = "Worldwide Experience of a Durable Centrifugal Flow Pump in Pediatric Patients",

abstract = "The primary objectives of this study were to describe the characteristics and survival outcomes for children supported with the HeartWare HVAD{\textregistered} system from the global community. This was a retrospective survey of patients <18 years of age with an HVAD{\textregistered} system. Questionnaires were sent to sites worldwide in April 2015 and collected between May 2015 and 2016. Information on 205 patients was collected. The median age at implantation was 13.1 years (interquartile range [IQR] 9.8-15.8 years) and the weight was 42 kg (IQR 28–60 kg). Over half of the implants occurred in males (61%), with the most common diagnosis being cardiomyopathy (n = 168, 82%). The majority of HVAD{\textregistered} systems implanted were left ventricular assist device (n = 189, 92.2%). Temporary right ventricular support was utilized in 24 patients (12%) with a median duration of 12 days (6-32 days). Fifty-five percent (n = 111) of the patients were discharged home after implantation after a median (IQR) duration of hospital stay of 40 days (28-71 days). By 12 months, the proportion of patients who underwent heart transplant was 65.4%, 10.7% had died, 3.2% were explanted for recovery, and 20.8% remained on the device. Death on the device on multivariable analysis was associated with the need for temporary RV support (hazard ratio [HR] 10.65 (95% CI 12.53-44.81), P = 0.001) and pump exchange (HR 7.9 (95% CI 1.8-34.2], P = 0.006). The use of the HeartWare HVAD system in the pediatric population is associated with mortality with the majority of patients supported to heart transplant by 1 year post implant. These positive results are independent of geographic location. The need for a temporary right heart support and pump exchange is associated with a higher risk of poor outcomes, and further work is required to predict these patients to allow for optimization. Although survival results are promising, further studies are needed to delineate the associated morbidities with this technology in the pediatric population.",

keywords = "children, continuous-flow pumps, outcomes, ventricular assist devices",

author = "{Pediatric VAD Investigators} and Jennifer Conway and Oliver Miera and Iki Adachi and Katsuhide Maeda and Pirooz Eghtesady and Henderson, {Heather T.} and Guleserian, {Kristine J} and Fan, {Chu Po S.} and Richard Kirk and Canter, {Charles E.} and Mustafa Pac and Christina VanderPluym and Lucas Eastaugh and Holger Buchholz and Daniel Zimpfer and Joseph Turek and Matthew Fenton and Neibler, {Robert A.} and Kirklin, {James K.} and Padalino, {Massimo A.} and Angela Lorts and Mohamed Hassan and Irene Lytrivi and Scott Auerbach and Slaughter, {Mark S.} and Martin Schweiger and Takayoshi Ueno and Davies, {Ryan R} and Jacqueline Lamour and Schmitto, {Jan D.} and Matthew Zinn and Derek Human and Scheel, {Janet N.} and Yijiang Li and Parrino, {Patrick E.} and {Borik Chiger}, Sharon and Brigitte Stiller and Julia Dumfarth and Morales, {David L.}",

note = "Funding Information: Mark Slaughter reports receiving training and an education grant from HeartWare Inc. Jan D. Schmitto reports being a consultant at Thoratec, Reliant Heart, and HeartWare Inc. David Morales reports being a consultant, a member of the advisory board, and a recipient of a grant from Cormatrix; an instructor and consultant at Berlin Heart; a proctor, consultant, and instructor at Syncardia Inc; a national principal investigator for 50/50 cc TAH Trial; and a consultant at HeartWare Inc. Daniel Zimpfer reports being a scientific advisor for HeartWare Inc and Thoratec and receiving scientific grants from HeartWare Inc and Thoratec. Katsuhide Maeda reports being a consultant at HeartWare. Iki Adachi reports being a consultant at Berlin Heart, HeartWare Inc, Sony-Olympus Med, and New England Research Institute. Jennifer Conway reports receiving a scientific grant from HeartWare Inc. Funding Information: This study was partially supported by an investigator-sponsored research grant from HeartWare, Inc. Publisher Copyright: {\textcopyright} 2018 Elsevier Inc.",

year = "2018",

month = sep,

day = "1",

doi = "10.1053/j.semtcvs.2018.03.003",

language = "English (US)",

volume = "30",

pages = "327--335",

journal = "Seminars in thoracic and cardiovascular surgery",

issn = "1043-0679",

publisher = "W.B. Saunders Ltd",

number = "3",

}

TY - JOUR

T1 - Worldwide Experience of a Durable Centrifugal Flow Pump in Pediatric Patients

AU - Pediatric VAD Investigators

AU - Conway, Jennifer

AU - Miera, Oliver

AU - Adachi, Iki

AU - Maeda, Katsuhide

AU - Eghtesady, Pirooz

AU - Henderson, Heather T.

AU - Guleserian, Kristine J

AU - Fan, Chu Po S.

AU - Kirk, Richard

AU - Canter, Charles E.

AU - Pac, Mustafa

AU - VanderPluym, Christina

AU - Eastaugh, Lucas

AU - Buchholz, Holger

AU - Zimpfer, Daniel

AU - Turek, Joseph

AU - Fenton, Matthew

AU - Neibler, Robert A.

AU - Kirklin, James K.

AU - Padalino, Massimo A.

AU - Lorts, Angela

AU - Hassan, Mohamed

AU - Lytrivi, Irene

AU - Auerbach, Scott

AU - Slaughter, Mark S.

AU - Schweiger, Martin

AU - Ueno, Takayoshi

AU - Davies, Ryan R

AU - Lamour, Jacqueline

AU - Schmitto, Jan D.

AU - Zinn, Matthew

AU - Human, Derek

AU - Scheel, Janet N.

AU - Li, Yijiang

AU - Parrino, Patrick E.

AU - Borik Chiger, Sharon

AU - Stiller, Brigitte

AU - Dumfarth, Julia

AU - Morales, David L.

N1 - Funding Information: Mark Slaughter reports receiving training and an education grant from HeartWare Inc. Jan D. Schmitto reports being a consultant at Thoratec, Reliant Heart, and HeartWare Inc. David Morales reports being a consultant, a member of the advisory board, and a recipient of a grant from Cormatrix; an instructor and consultant at Berlin Heart; a proctor, consultant, and instructor at Syncardia Inc; a national principal investigator for 50/50 cc TAH Trial; and a consultant at HeartWare Inc. Daniel Zimpfer reports being a scientific advisor for HeartWare Inc and Thoratec and receiving scientific grants from HeartWare Inc and Thoratec. Katsuhide Maeda reports being a consultant at HeartWare. Iki Adachi reports being a consultant at Berlin Heart, HeartWare Inc, Sony-Olympus Med, and New England Research Institute. Jennifer Conway reports receiving a scientific grant from HeartWare Inc. Funding Information: This study was partially supported by an investigator-sponsored research grant from HeartWare, Inc. Publisher Copyright: © 2018 Elsevier Inc.

PY - 2018/9/1

Y1 - 2018/9/1

N2 - The primary objectives of this study were to describe the characteristics and survival outcomes for children supported with the HeartWare HVAD® system from the global community. This was a retrospective survey of patients <18 years of age with an HVAD® system. Questionnaires were sent to sites worldwide in April 2015 and collected between May 2015 and 2016. Information on 205 patients was collected. The median age at implantation was 13.1 years (interquartile range [IQR] 9.8-15.8 years) and the weight was 42 kg (IQR 28–60 kg). Over half of the implants occurred in males (61%), with the most common diagnosis being cardiomyopathy (n = 168, 82%). The majority of HVAD® systems implanted were left ventricular assist device (n = 189, 92.2%). Temporary right ventricular support was utilized in 24 patients (12%) with a median duration of 12 days (6-32 days). Fifty-five percent (n = 111) of the patients were discharged home after implantation after a median (IQR) duration of hospital stay of 40 days (28-71 days). By 12 months, the proportion of patients who underwent heart transplant was 65.4%, 10.7% had died, 3.2% were explanted for recovery, and 20.8% remained on the device. Death on the device on multivariable analysis was associated with the need for temporary RV support (hazard ratio [HR] 10.65 (95% CI 12.53-44.81), P = 0.001) and pump exchange (HR 7.9 (95% CI 1.8-34.2], P = 0.006). The use of the HeartWare HVAD system in the pediatric population is associated with mortality with the majority of patients supported to heart transplant by 1 year post implant. These positive results are independent of geographic location. The need for a temporary right heart support and pump exchange is associated with a higher risk of poor outcomes, and further work is required to predict these patients to allow for optimization. Although survival results are promising, further studies are needed to delineate the associated morbidities with this technology in the pediatric population.

AB - The primary objectives of this study were to describe the characteristics and survival outcomes for children supported with the HeartWare HVAD® system from the global community. This was a retrospective survey of patients <18 years of age with an HVAD® system. Questionnaires were sent to sites worldwide in April 2015 and collected between May 2015 and 2016. Information on 205 patients was collected. The median age at implantation was 13.1 years (interquartile range [IQR] 9.8-15.8 years) and the weight was 42 kg (IQR 28–60 kg). Over half of the implants occurred in males (61%), with the most common diagnosis being cardiomyopathy (n = 168, 82%). The majority of HVAD® systems implanted were left ventricular assist device (n = 189, 92.2%). Temporary right ventricular support was utilized in 24 patients (12%) with a median duration of 12 days (6-32 days). Fifty-five percent (n = 111) of the patients were discharged home after implantation after a median (IQR) duration of hospital stay of 40 days (28-71 days). By 12 months, the proportion of patients who underwent heart transplant was 65.4%, 10.7% had died, 3.2% were explanted for recovery, and 20.8% remained on the device. Death on the device on multivariable analysis was associated with the need for temporary RV support (hazard ratio [HR] 10.65 (95% CI 12.53-44.81), P = 0.001) and pump exchange (HR 7.9 (95% CI 1.8-34.2], P = 0.006). The use of the HeartWare HVAD system in the pediatric population is associated with mortality with the majority of patients supported to heart transplant by 1 year post implant. These positive results are independent of geographic location. The need for a temporary right heart support and pump exchange is associated with a higher risk of poor outcomes, and further work is required to predict these patients to allow for optimization. Although survival results are promising, further studies are needed to delineate the associated morbidities with this technology in the pediatric population.

KW - children

KW - continuous-flow pumps

KW - outcomes

KW - ventricular assist devices

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Worldwide Experience of a Durable Centrifugal Flow Pump in Pediatric Patients

Abstract

Keywords

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