Adverse events in children implanted with ventricular assist devices in the United States: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)

Abstract

Background Ventricular Assist Devices (VADs) have come into increasing use in recent years for children. One year survival rates are now above 80% in multiple reports. This report describes 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 less than 19 years of age at the time of implantation with a VAD. 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 median age of 11 years (range 11 days-18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy (n=146, 73%), myocarditis (17, 9%), congenital heart disease (35, 18%), and other (2, 1%). Pulsatile flow devices were used in 91 patients (45%), and continuous flow devices in 109 (55%). Actuarial survival was 86% at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction (n=79), infection (78), neurological dysfunction (52), and bleeding (68). Together, these accounted for 277 events, 66% of the total. Although 38% of patients had no reported adverse event, 16% of patients had 5 or more adverse events. Adverse events occurred at all times following 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 historical rates from the Intermacs population. Conclusions In this 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, 20.4 events per 100 patient months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurological dysfunction, bleeding and infection. For continuous flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurological dysfunction and respiratory failure. Compared to an adult Intermacs cohort, the overall rate and distribution of adverse events appears similar.

Antithrombotic Therapy in a Prospective Trial of a Pediatric Ventricular Assist Device

“…A larger, adequately powered prospective trial stratifying by patient size and initial diagnosis and using standardized PediMACS SAE definitions would be needed to properly perform VAD comparisons. 18 …”

“…Although the majority of the SAEs were not adjudicated to be related to the protocol, improvement of event-free survival may result from modifications of the protocol. It is critical that future guidelines are prospectively designed, have clearly defined objectives, use the same definitions of SAEs (PediMACS definitions 18 ), and collect comprehensive monitoring data with predetermined analysis plans to optimize future antithrombotic modifications.…”

Resource Utilization in Pediatric Patients Supported With Ventricular Assist Devices in the United States: A Multicenter Study From the Pediatric Interagency Registry for Mechanically Assisted Circulatory Support and the Pediatric Health Information System

“…We also counted the CCC subcategories (0, 1‐2, ≥3). Major adverse events were defined as any infection, bleeding, device malfunction, neurological dysfunction, or death, using PediMACS definitions as previously reported . We also counted the major adverse events (0, 1‐2, ≥3).…”

Mechanical circulation support of the treatment for children with end-stage chronic heart failure

“…За период до середины 2015 года был проведен анализ применения систем длительных МПК (более 3 месяцев) в 37 клиниках США (200 па-циентов <19 лет) [61]. Из них 91 пациент (45%) по-лучили насосы пульсирующего потока (в основном EXCOR) и 109 (55%) -насосы непульсирующего потока.…”