Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report: Pre-implant characteristics and outcomes

Elizabeth D. Blume, Christina VanderPluym, Angela Lorts, J. Timothy Baldwin, Joseph W. Rossano, David L.S. Morales, Ryan S. Cantor, Marissa A. Miller, James D. St. Louis, Devin Koehl, David L. Sutcliffe, Pirooz Eghtesady, James K. Kirklin, David N. Rosenthal

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

Background: Expanded use of pediatric ventricular assist devices (VADs) has decreased mortality in children awaiting heart transplantation. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Heart, Lung, and Blood Institute-sponsored North American database, provides a platform to understand this emerging population. Methods: Between September 2012 and September 2016, patients aged younger than 19 years who underwent VAD implantation were enrolled in Pedimacs. FDA approved durable devices as well as temporary support devices were included. The second annual report updates the current Pedimacs data. Patients implanted with temporary devices are included in Pedimacs and this analysis includes this group of paracorporeal continuous flow VADs. Results: Over the 4 years, 42 hospitals implanted 432 devices in 364 patients less than 19 yrs of age. Diagnoses included cardiomyopathy in 223 (61%), myocarditis in 41 (11%), and congenital heart disease in 77 (21%), of which 48 had single-ventricle physiology. At implant, 87% were at Intermacs patient profile 1 or 2. The age distribution of children (59% male) supported on VAD included 69 (19%) aged younger than 1 year, 66 (18%) aged 1 to 6 years, 56 (15%) aged 6 to 10 years, and 173 (48%) aged 11 to 19 years. Median follow-up was 2.2 months (range, 1 day to 41.5 months). Median (interquartile) age at implant was 1.7 (0.3-10.0) years for paracorporeal continuous-flow pumps (n = 60), 1.7 (0.4-5.3) years for paracorporeal pulsatile pumps (n = 105), and 15.0 (11.3-16.9) years for implantable continuous-flow pumps (n = 174). Support strategies included LVAD in 293 (80%), biventricular device in 55 (15%), and total artificial heart in 8 (2%). Nearly 50% of patients underwent transplantation within 6 months, with overall mortality of 19%. Adverse event burden continues to be high. Conclusions: Pedimacs constitutes the largest longitudinal pediatric VAD registry. Preimplant data across centers will be helpful at creating shared protocols with which to improve outcomes. Adverse events continue to be the major challenge, especially among the young critically ill children with complex congenital disease.

Original languageEnglish (US)
JournalJournal of Heart and Lung Transplantation
DOIs
StateAccepted/In press - Jan 1 2017

Fingerprint

Heart-Assist Devices
Registries
Pediatrics
Equipment and Supplies
National Heart, Lung, and Blood Institute (U.S.)
Artificial Heart
Annual Reports
Child Mortality
Age Distribution
Myocarditis
Heart Transplantation
Cardiomyopathies
Critical Illness
Heart Diseases
Transplantation
Databases
Mortality
Population

Keywords

  • Advanced heart failure
  • Bridge to transplant
  • Children
  • Mechanical support
  • Pediatrics
  • Pedimacs
  • Ventricular assist device

ASJC Scopus subject areas

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

Cite this

Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report : Pre-implant characteristics and outcomes. / Blume, Elizabeth D.; VanderPluym, Christina; Lorts, Angela; Baldwin, J. Timothy; Rossano, Joseph W.; Morales, David L.S.; Cantor, Ryan S.; Miller, Marissa A.; St. Louis, James D.; Koehl, Devin; Sutcliffe, David L.; Eghtesady, Pirooz; Kirklin, James K.; Rosenthal, David N.

In: Journal of Heart and Lung Transplantation, 01.01.2017.

Research output: Contribution to journalArticle

Blume, ED, VanderPluym, C, Lorts, A, Baldwin, JT, Rossano, JW, Morales, DLS, Cantor, RS, Miller, MA, St. Louis, JD, Koehl, D, Sutcliffe, DL, Eghtesady, P, Kirklin, JK & Rosenthal, DN 2017, 'Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report: Pre-implant characteristics and outcomes', Journal of Heart and Lung Transplantation. https://doi.org/10.1016/j.healun.2017.06.017
Blume, Elizabeth D. ; VanderPluym, Christina ; Lorts, Angela ; Baldwin, J. Timothy ; Rossano, Joseph W. ; Morales, David L.S. ; Cantor, Ryan S. ; Miller, Marissa A. ; St. Louis, James D. ; Koehl, Devin ; Sutcliffe, David L. ; Eghtesady, Pirooz ; Kirklin, James K. ; Rosenthal, David N. / Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report : Pre-implant characteristics and outcomes. In: Journal of Heart and Lung Transplantation. 2017.
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abstract = "Background: Expanded use of pediatric ventricular assist devices (VADs) has decreased mortality in children awaiting heart transplantation. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Heart, Lung, and Blood Institute-sponsored North American database, provides a platform to understand this emerging population. Methods: Between September 2012 and September 2016, patients aged younger than 19 years who underwent VAD implantation were enrolled in Pedimacs. FDA approved durable devices as well as temporary support devices were included. The second annual report updates the current Pedimacs data. Patients implanted with temporary devices are included in Pedimacs and this analysis includes this group of paracorporeal continuous flow VADs. Results: Over the 4 years, 42 hospitals implanted 432 devices in 364 patients less than 19 yrs of age. Diagnoses included cardiomyopathy in 223 (61{\%}), myocarditis in 41 (11{\%}), and congenital heart disease in 77 (21{\%}), of which 48 had single-ventricle physiology. At implant, 87{\%} were at Intermacs patient profile 1 or 2. The age distribution of children (59{\%} male) supported on VAD included 69 (19{\%}) aged younger than 1 year, 66 (18{\%}) aged 1 to 6 years, 56 (15{\%}) aged 6 to 10 years, and 173 (48{\%}) aged 11 to 19 years. Median follow-up was 2.2 months (range, 1 day to 41.5 months). Median (interquartile) age at implant was 1.7 (0.3-10.0) years for paracorporeal continuous-flow pumps (n = 60), 1.7 (0.4-5.3) years for paracorporeal pulsatile pumps (n = 105), and 15.0 (11.3-16.9) years for implantable continuous-flow pumps (n = 174). Support strategies included LVAD in 293 (80{\%}), biventricular device in 55 (15{\%}), and total artificial heart in 8 (2{\%}). Nearly 50{\%} of patients underwent transplantation within 6 months, with overall mortality of 19{\%}. Adverse event burden continues to be high. Conclusions: Pedimacs constitutes the largest longitudinal pediatric VAD registry. Preimplant data across centers will be helpful at creating shared protocols with which to improve outcomes. Adverse events continue to be the major challenge, especially among the young critically ill children with complex congenital disease.",
keywords = "Advanced heart failure, Bridge to transplant, Children, Mechanical support, Pediatrics, Pedimacs, Ventricular assist device",
author = "Blume, {Elizabeth D.} and Christina VanderPluym and Angela Lorts and Baldwin, {J. Timothy} and Rossano, {Joseph W.} and Morales, {David L.S.} and Cantor, {Ryan S.} and Miller, {Marissa A.} and {St. Louis}, {James D.} and Devin Koehl and Sutcliffe, {David L.} and Pirooz Eghtesady and Kirklin, {James K.} and Rosenthal, {David N.}",
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T1 - Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report

T2 - Pre-implant characteristics and outcomes

AU - Blume, Elizabeth D.

AU - VanderPluym, Christina

AU - Lorts, Angela

AU - Baldwin, J. Timothy

AU - Rossano, Joseph W.

AU - Morales, David L.S.

AU - Cantor, Ryan S.

AU - Miller, Marissa A.

AU - St. Louis, James D.

AU - Koehl, Devin

AU - Sutcliffe, David L.

AU - Eghtesady, Pirooz

AU - Kirklin, James K.

AU - Rosenthal, David N.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Background: Expanded use of pediatric ventricular assist devices (VADs) has decreased mortality in children awaiting heart transplantation. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Heart, Lung, and Blood Institute-sponsored North American database, provides a platform to understand this emerging population. Methods: Between September 2012 and September 2016, patients aged younger than 19 years who underwent VAD implantation were enrolled in Pedimacs. FDA approved durable devices as well as temporary support devices were included. The second annual report updates the current Pedimacs data. Patients implanted with temporary devices are included in Pedimacs and this analysis includes this group of paracorporeal continuous flow VADs. Results: Over the 4 years, 42 hospitals implanted 432 devices in 364 patients less than 19 yrs of age. Diagnoses included cardiomyopathy in 223 (61%), myocarditis in 41 (11%), and congenital heart disease in 77 (21%), of which 48 had single-ventricle physiology. At implant, 87% were at Intermacs patient profile 1 or 2. The age distribution of children (59% male) supported on VAD included 69 (19%) aged younger than 1 year, 66 (18%) aged 1 to 6 years, 56 (15%) aged 6 to 10 years, and 173 (48%) aged 11 to 19 years. Median follow-up was 2.2 months (range, 1 day to 41.5 months). Median (interquartile) age at implant was 1.7 (0.3-10.0) years for paracorporeal continuous-flow pumps (n = 60), 1.7 (0.4-5.3) years for paracorporeal pulsatile pumps (n = 105), and 15.0 (11.3-16.9) years for implantable continuous-flow pumps (n = 174). Support strategies included LVAD in 293 (80%), biventricular device in 55 (15%), and total artificial heart in 8 (2%). Nearly 50% of patients underwent transplantation within 6 months, with overall mortality of 19%. Adverse event burden continues to be high. Conclusions: Pedimacs constitutes the largest longitudinal pediatric VAD registry. Preimplant data across centers will be helpful at creating shared protocols with which to improve outcomes. Adverse events continue to be the major challenge, especially among the young critically ill children with complex congenital disease.

AB - Background: Expanded use of pediatric ventricular assist devices (VADs) has decreased mortality in children awaiting heart transplantation. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Heart, Lung, and Blood Institute-sponsored North American database, provides a platform to understand this emerging population. Methods: Between September 2012 and September 2016, patients aged younger than 19 years who underwent VAD implantation were enrolled in Pedimacs. FDA approved durable devices as well as temporary support devices were included. The second annual report updates the current Pedimacs data. Patients implanted with temporary devices are included in Pedimacs and this analysis includes this group of paracorporeal continuous flow VADs. Results: Over the 4 years, 42 hospitals implanted 432 devices in 364 patients less than 19 yrs of age. Diagnoses included cardiomyopathy in 223 (61%), myocarditis in 41 (11%), and congenital heart disease in 77 (21%), of which 48 had single-ventricle physiology. At implant, 87% were at Intermacs patient profile 1 or 2. The age distribution of children (59% male) supported on VAD included 69 (19%) aged younger than 1 year, 66 (18%) aged 1 to 6 years, 56 (15%) aged 6 to 10 years, and 173 (48%) aged 11 to 19 years. Median follow-up was 2.2 months (range, 1 day to 41.5 months). Median (interquartile) age at implant was 1.7 (0.3-10.0) years for paracorporeal continuous-flow pumps (n = 60), 1.7 (0.4-5.3) years for paracorporeal pulsatile pumps (n = 105), and 15.0 (11.3-16.9) years for implantable continuous-flow pumps (n = 174). Support strategies included LVAD in 293 (80%), biventricular device in 55 (15%), and total artificial heart in 8 (2%). Nearly 50% of patients underwent transplantation within 6 months, with overall mortality of 19%. Adverse event burden continues to be high. Conclusions: Pedimacs constitutes the largest longitudinal pediatric VAD registry. Preimplant data across centers will be helpful at creating shared protocols with which to improve outcomes. Adverse events continue to be the major challenge, especially among the young critically ill children with complex congenital disease.

KW - Advanced heart failure

KW - Bridge to transplant

KW - Children

KW - Mechanical support

KW - Pediatrics

KW - Pedimacs

KW - Ventricular assist device

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