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Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report: Pre-implant
Elizabeth D Blume1, Christina VanderPluym1, Angela Lorts2
1Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.
Insights
Pediatric ventricular assist device (VAD) use has improved outcomes for children awaiting heart transplants. The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) database tracks these young patients, highlighting ongoing challenges with adverse events.
Area of Science:
- Pediatric Cardiology
- Mechanical Circulatory Support
- Cardiac Surgery
Background:
- Expanded use of pediatric ventricular assist devices (VADs) has significantly decreased mortality in children awaiting heart transplantation.
- The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) is a key National Heart, Lung, and Blood Institute-sponsored North American database for studying this patient population.
Purpose of the Study:
- To analyze data from the Pedimacs registry to understand the characteristics and outcomes of pediatric patients receiving VADs.
- To provide an update on the current Pedimacs data, including temporary support devices.
Main Methods:
- Data were collected from the Pedimacs registry between September 2012 and September 2016 for patients younger than 19 years who underwent VAD implantation.
- Analysis included both FDA-approved durable devices and temporary support devices, specifically paracorporeal continuous flow VADs.
- Patient demographics, diagnoses, implant characteristics, support strategies, and outcomes including transplantation and mortality were analyzed.
Main Results:
- Over 4 years, 432 devices were implanted in 364 pediatric patients across 42 hospitals.
- Common diagnoses included cardiomyopathy (61%), congenital heart disease (21%), and myocarditis (11%).
- Nearly 50% of patients received a heart transplant within 6 months, with an overall mortality rate of 19%. Adverse event burden remains high, particularly in younger children with complex conditions.
Conclusions:
- Pedimacs is the largest longitudinal registry for pediatric VADs, offering valuable insights into this patient group.
- Standardizing pre-implant data collection across centers can facilitate the development of shared protocols to improve patient outcomes.
- Managing adverse events remains a critical challenge, especially for critically ill neonates and children with complex congenital heart disease.
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.
