Adverse events in children implanted with ventricular assist devices in the United States

Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)

David N. Rosenthal, Christopher S. Almond, Robert D. Jaquiss, Christine E. Peyton, Scott R. Auerbach, David R. Morales, Deirdre J. Epstein, Ryan S. Cantor, Robert L. Kormos, David C. Naftel, Ryan J. Butts, Nancy S. Ghanayem, James K. Kirklin, Elizabeth D. Blume

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Background Ventricular assist devices (VADs) have been used in children on an increasing basis in recent years. One-year survival rates are now >80% in multiple reports. In this report we describe adverse events experienced by children with durable ventricular assist devices, using a national-level registry (PediMACS, a component of INTERMACS) Methods PediMACS is a national registry that contains clinical data on patients who are <19 years of age at the time of VAD implantation. Data collection concludes at the time of VAD explantation. All FDA-approved devices are included. PediMACS was launched on September 1, 2012, and this report includes all data from launch until August 2014. Adverse events were coded with a uniform, pre-specified set of definitions. Results This report comprises data from 200 patients with a median age of 11 years (range 11 days to 18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy (n = 146, 73%), myocarditis (n = 17, 9%), congenital heart disease (n = 35, 18%) and other (n = 2, 1%). Pulsatile-flow devices were used in 91 patients (45%) and continuous-flow devices in 109 patients (55%). Actuarial survival was 86% at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction (n = 79), infection (n = 78), neurologic dysfunction (n = 52) and bleeding (n = 68). Together, these accounted for 277 events, 66% of the total. Although 38% of patients had no reported adverse event and 16% of patients had ≥5 adverse events. Adverse events occurred at all time-points after implantation, but were most likely to occur in the first 30 days. For continuous-flow devices, there were broad similarities in adverse event rates between this cohort and historic rates from the INTERMACS population. Conclusions In this study cohort, the overall rate of early adverse events (within 90 days of implantation) was 86.3 events per 100 patient-months, and of late adverse events it was 20.4 events per 100 patient-months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurologic dysfunction, bleeding and infection. For continuous-flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurologic dysfunction and respiratory failure. Compared with an adult INTERMACS cohort, the overall rate and distribution of adverse events appears similar.

Original languageEnglish (US)
Pages (from-to)569-577
Number of pages9
JournalJournal of Heart and Lung Transplantation
Volume35
Issue number5
DOIs
StatePublished - May 1 2016

Fingerprint

Heart-Assist Devices
Registries
Pediatrics
Equipment and Supplies
Neurologic Manifestations
Hemorrhage
Infection
Pulsatile Flow
Myocarditis
Cardiomyopathies
Respiratory Insufficiency
Cardiac Arrhythmias
Heart Diseases
Cohort Studies
Survival Rate
Survival

Keywords

  • heart failure
  • mechanical circulatory support
  • pediatrics
  • pedimacs
  • registry
  • ventricular assist device

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

Cite this

Adverse events in children implanted with ventricular assist devices in the United States : Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS). / Rosenthal, David N.; Almond, Christopher S.; Jaquiss, Robert D.; Peyton, Christine E.; Auerbach, Scott R.; Morales, David R.; Epstein, Deirdre J.; Cantor, Ryan S.; Kormos, Robert L.; Naftel, David C.; Butts, Ryan J.; Ghanayem, Nancy S.; Kirklin, James K.; Blume, Elizabeth D.

In: Journal of Heart and Lung Transplantation, Vol. 35, No. 5, 01.05.2016, p. 569-577.

Research output: Contribution to journalArticle

Rosenthal, DN, Almond, CS, Jaquiss, RD, Peyton, CE, Auerbach, SR, Morales, DR, Epstein, DJ, Cantor, RS, Kormos, RL, Naftel, DC, Butts, RJ, Ghanayem, NS, Kirklin, JK & Blume, ED 2016, 'Adverse events in children implanted with ventricular assist devices in the United States: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)', Journal of Heart and Lung Transplantation, vol. 35, no. 5, pp. 569-577. https://doi.org/10.1016/j.healun.2016.03.005
Rosenthal, David N. ; Almond, Christopher S. ; Jaquiss, Robert D. ; Peyton, Christine E. ; Auerbach, Scott R. ; Morales, David R. ; Epstein, Deirdre J. ; Cantor, Ryan S. ; Kormos, Robert L. ; Naftel, David C. ; Butts, Ryan J. ; Ghanayem, Nancy S. ; Kirklin, James K. ; Blume, Elizabeth D. / Adverse events in children implanted with ventricular assist devices in the United States : Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS). In: Journal of Heart and Lung Transplantation. 2016 ; Vol. 35, No. 5. pp. 569-577.
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abstract = "Background Ventricular assist devices (VADs) have been used in children on an increasing basis in recent years. One-year survival rates are now >80{\%} in multiple reports. In this report we describe adverse events experienced by children with durable ventricular assist devices, using a national-level registry (PediMACS, a component of INTERMACS) Methods PediMACS is a national registry that contains clinical data on patients who are <19 years of age at the time of VAD implantation. Data collection concludes at the time of VAD explantation. All FDA-approved devices are included. PediMACS was launched on September 1, 2012, and this report includes all data from launch until August 2014. Adverse events were coded with a uniform, pre-specified set of definitions. Results This report comprises data from 200 patients with a median age of 11 years (range 11 days to 18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy (n = 146, 73{\%}), myocarditis (n = 17, 9{\%}), congenital heart disease (n = 35, 18{\%}) and other (n = 2, 1{\%}). Pulsatile-flow devices were used in 91 patients (45{\%}) and continuous-flow devices in 109 patients (55{\%}). Actuarial survival was 86{\%} at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction (n = 79), infection (n = 78), neurologic dysfunction (n = 52) and bleeding (n = 68). Together, these accounted for 277 events, 66{\%} of the total. Although 38{\%} of patients had no reported adverse event and 16{\%} of patients had ≥5 adverse events. Adverse events occurred at all time-points after implantation, but were most likely to occur in the first 30 days. For continuous-flow devices, there were broad similarities in adverse event rates between this cohort and historic rates from the INTERMACS population. Conclusions In this study cohort, the overall rate of early adverse events (within 90 days of implantation) was 86.3 events per 100 patient-months, and of late adverse events it was 20.4 events per 100 patient-months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurologic dysfunction, bleeding and infection. For continuous-flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurologic dysfunction and respiratory failure. Compared with an adult INTERMACS cohort, the overall rate and distribution of adverse events appears similar.",
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T1 - Adverse events in children implanted with ventricular assist devices in the United States

T2 - Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)

AU - Rosenthal, David N.

AU - Almond, Christopher S.

AU - Jaquiss, Robert D.

AU - Peyton, Christine E.

AU - Auerbach, Scott R.

AU - Morales, David R.

AU - Epstein, Deirdre J.

AU - Cantor, Ryan S.

AU - Kormos, Robert L.

AU - Naftel, David C.

AU - Butts, Ryan J.

AU - Ghanayem, Nancy S.

AU - Kirklin, James K.

AU - Blume, Elizabeth D.

PY - 2016/5/1

Y1 - 2016/5/1

N2 - Background Ventricular assist devices (VADs) have been used in children on an increasing basis in recent years. One-year survival rates are now >80% in multiple reports. In this report we describe adverse events experienced by children with durable ventricular assist devices, using a national-level registry (PediMACS, a component of INTERMACS) Methods PediMACS is a national registry that contains clinical data on patients who are <19 years of age at the time of VAD implantation. Data collection concludes at the time of VAD explantation. All FDA-approved devices are included. PediMACS was launched on September 1, 2012, and this report includes all data from launch until August 2014. Adverse events were coded with a uniform, pre-specified set of definitions. Results This report comprises data from 200 patients with a median age of 11 years (range 11 days to 18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy (n = 146, 73%), myocarditis (n = 17, 9%), congenital heart disease (n = 35, 18%) and other (n = 2, 1%). Pulsatile-flow devices were used in 91 patients (45%) and continuous-flow devices in 109 patients (55%). Actuarial survival was 86% at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction (n = 79), infection (n = 78), neurologic dysfunction (n = 52) and bleeding (n = 68). Together, these accounted for 277 events, 66% of the total. Although 38% of patients had no reported adverse event and 16% of patients had ≥5 adverse events. Adverse events occurred at all time-points after implantation, but were most likely to occur in the first 30 days. For continuous-flow devices, there were broad similarities in adverse event rates between this cohort and historic rates from the INTERMACS population. Conclusions In this study cohort, the overall rate of early adverse events (within 90 days of implantation) was 86.3 events per 100 patient-months, and of late adverse events it was 20.4 events per 100 patient-months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurologic dysfunction, bleeding and infection. For continuous-flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurologic dysfunction and respiratory failure. Compared with an adult INTERMACS cohort, the overall rate and distribution of adverse events appears similar.

AB - Background Ventricular assist devices (VADs) have been used in children on an increasing basis in recent years. One-year survival rates are now >80% in multiple reports. In this report we describe adverse events experienced by children with durable ventricular assist devices, using a national-level registry (PediMACS, a component of INTERMACS) Methods PediMACS is a national registry that contains clinical data on patients who are <19 years of age at the time of VAD implantation. Data collection concludes at the time of VAD explantation. All FDA-approved devices are included. PediMACS was launched on September 1, 2012, and this report includes all data from launch until August 2014. Adverse events were coded with a uniform, pre-specified set of definitions. Results This report comprises data from 200 patients with a median age of 11 years (range 11 days to 18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy (n = 146, 73%), myocarditis (n = 17, 9%), congenital heart disease (n = 35, 18%) and other (n = 2, 1%). Pulsatile-flow devices were used in 91 patients (45%) and continuous-flow devices in 109 patients (55%). Actuarial survival was 86% at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction (n = 79), infection (n = 78), neurologic dysfunction (n = 52) and bleeding (n = 68). Together, these accounted for 277 events, 66% of the total. Although 38% of patients had no reported adverse event and 16% of patients had ≥5 adverse events. Adverse events occurred at all time-points after implantation, but were most likely to occur in the first 30 days. For continuous-flow devices, there were broad similarities in adverse event rates between this cohort and historic rates from the INTERMACS population. Conclusions In this study cohort, the overall rate of early adverse events (within 90 days of implantation) was 86.3 events per 100 patient-months, and of late adverse events it was 20.4 events per 100 patient-months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurologic dysfunction, bleeding and infection. For continuous-flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurologic dysfunction and respiratory failure. Compared with an adult INTERMACS cohort, the overall rate and distribution of adverse events appears similar.

KW - heart failure

KW - mechanical circulatory support

KW - pediatrics

KW - pedimacs

KW - registry

KW - ventricular assist device

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