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Third Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report: Preimplant
David L S Morales1, Joseph W Rossano2, Christina VanderPluym3
1The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Insights
Pediatric ventricular assist device (VAD) use is growing, with implantable continuous-flow (IC) VADs showing over 90% positive outcomes in children. This highlights advancements in patient selection and timing for VAD implantation.
Area of Science:
- Pediatric cardiology
- Mechanical circulatory support
- Congenital heart disease
Background:
- Ventricular assist device (VAD) use in pediatric end-stage heart failure is rapidly increasing.
- The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) database tracks this growing population.
- This report analyzes data from 423 patients implanted between 2012 and 2017.
Purpose of the Study:
- To analyze the outcomes of VAD support in children with end-stage heart failure.
- To compare the effectiveness of different VAD types in pediatric patients.
- To identify factors associated with early mortality in pediatric VAD recipients.
Main Methods:
- Data collected from 30 hospitals in the Pedimacs registry between September 2012 and December 2017.
- Analysis of 508 VAD implantations in 423 patients younger than 19 years.
- Comparison of outcomes between implantable continuous-flow (IC), paracorporeal continuous-flow (PC), and paracorporeal pulsatile (PP) VADs.
Main Results:
- Cardiomyopathy (62%) and congenital heart disease (20%) were the most common diagnoses.
- Left VAD was the most common support strategy (81%).
- Overall positive outcome at 6 months was 80%. IC VADs had the highest positive outcome rate (92%) compared to PP (77%) and PC (63%).
- Early mortality was associated with specific patient profiles (e.g., Intermacs profile 1, biventricular support, low weight) and device types (PC).
Conclusions:
- Implantable continuous-flow (IC) VADs are the most common and demonstrate superior outcomes in pediatric patients.
- Paracorporeal devices (PP/PC) are reserved for the most complex cases, including those weighing less than 20 kg and with congenital heart disease.
- Continued advancements in device technology, patient selection, and shared learning are crucial for improving survival and quality of life in pediatric VAD recipients.
Background:
The influence of ventricular assist device (VAD) use in the care of children with end-stage heart failure is growing rapidly through increasing numbers, new devices, expanding indications, and improving outcomes. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Institutes of Health-sponsored United States database, provides a platform to understand this emerging population.
Methods:
Between September 19, 2012, and December 31, 2017, 30 hospitals implanted 508 devices in 423 patients aged younger than 19 years. This past year was one of evolution for the database as its management was transitioned to The Society of Thoracic Surgery; therefore, this report does not include data from institutions not under contract by August 1, 2018.
Results:
Of the 423 patients, the diagnosis was cardiomyopathy in 261 (62%), myocarditis in 48 (11%), other in 28 (7%), and congenital heart disease (CHD) in 86 (20%), with 52 of these patients having single-ventricle physiology. The two most common support strategies included left VAD in 342 (81%) and biventricular assist device in 64 (15%). Positive outcome (alive on device or bridge to transplantation/recovery) was 80% at 6 months (overall mortality of 20%). The patient cohort for implantable continuous-flow (IC) pumps (n = 197; age at implant, 13.4 ± 3.8 years; 19% Interagency Registry for Mechanically Assisted Circulatory Support [Intermacs] profile 1, 21% intubated at implant, and 12% with CHD) was significantly different from the paracorporeal continuous-flow (PC) pump cohort (n = 79; age, 3.9 ± 5.2 years; 49% Intermacs profile 1, 86% intubated at implant, and 38% with CHD) and the paracorporeal pulsatile (PP) pump cohort (n = 121; age, 3.3 ± 3.9 years; 41% Intermacs profile 1, 77% intubated at implant, and 21% with CHD). Consistent with their cohort composition, device type positive outcomes at 6 months were PC, 63%; PP, 77%; and IC, 92%. Parametric hazard modeling showed an early hazard for death was associated with Intermacs profile 1, biventricular assist device, percutaneous devices, PC devices, small-volume institutions, low age, and low weight, whereas a constant hazard was associated with intubation and liver dysfunction at time of implant.
Conclusions:
IC VADs are the most common VAD type placed in children. The positive outcomes for the IC VADs exceed 90% at 6 months, which may represent our field's maturation in both patient selection and timing of implantation. The PP/PC devices are currently limited to supporting our most challenging patients, those weighing less than 20 kg and those with CHD. The introduction of new devices and our communities' commitment to shared learning and improvement will lead to more pediatric lives saved by VAD support and will also focus on improving the quality of life of children supported with VADs.
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