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. 2016 May;35(5):569-77.
doi: 10.1016/j.healun.2016.03.005. Epub 2016 Mar 17.

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  1 , Christopher S Almond  2 , Robert D Jaquiss  3 , Christine E Peyton  4 , Scott R Auerbach  5 , David R Morales  6 , Deirdre J Epstein  7 , Ryan S Cantor  8 , Robert L Kormos  9 , David C Naftel  10 , Ryan J Butts  11 , Nancy S Ghanayem  12 , James K Kirklin  10 , Elizabeth D Blume  13
Affiliations

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 et al. J Heart Lung Transplant. 2016 May.

Erratum in

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 81% 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.

Keywords: heart failure; mechanical circulatory support; pediatrics; pedimacs; registry; ventricular assist device.

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Figures

Figure 1
Figure 1. Number of Adverse Events per Patient
Pedimacs patients receiving durable implants, Sept 2012 to Aug 2015 (patients=200)
Figure 2
Figure 2. Time to First Adverse Event for Patients on Pulsatile Flow Devices
Pedimacs patients receiving durable implants Sept 2012 to Aug 2015 (patients=91)
Figure 3
Figure 3. Time to First Adverse Event for Patients on Continuous Flow Devices
Pedimacs patients receiving durable implants Sept 2012 to Aug 2015 (patients=109)
See this image and copyright information in PMC

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