Neurological complications and outcomes in the Berlin Heart EXCOR® pediatric investigational device exemption trial

Lori C Jordan, Rebecca N Ichord, Olaf Reinhartz, Tilman Humpl, Sumit Pruthi, Christine Tjossem, David N Rosenthal, Lori C Jordan, Rebecca N Ichord, Olaf Reinhartz, Tilman Humpl, Sumit Pruthi, Christine Tjossem, David N Rosenthal

Abstract

Background: The Berlin Heart EXCOR(®) ventricular assist device has been approved for use in the United States as a bridge to heart transplantation in children. We sought to characterize neurological events in children supported with the Berlin Heart EXCOR(®) device.

Methods and results: The multicenter prospective cohort consisted of all 204 children implanted with the Berlin Heart EXCOR(®) device at 47 centers in North America between May 2007 and December 2010. There were 73 neurological events in 59 patients, with 29% of the cohort experiencing ≥1 neurological event. Events included 52 strokes in 43 patients (21% of the cohort). The neurological event rate was 0.51 events per 100 patient-days. Many of the neurological events occurred early in the course of support, with 30 events recorded during the first 14 days of support. The mortality rate in participants with at least 1 neurological event was 42% (25 of 59), significantly higher than the 18% mortality rate (26 of 145) for those who did not have a neurological event (P=0.0006). Risk-factor analysis did not identify significant preimplantation predictors of neurological injury.

Conclusions: Of children treated with the Berlin Heart EXCOR(®) device as a bridge to transplant, 29% experienced at least 1 neurological event. The majority of neurological events were ischemic strokes, and many of those occurred early in the course of support. Neurological injury was the leading cause of death after implantation of the Berlin Heart EXCOR(®) device. Risk stratification for stroke or neurological injury is not possible based on baseline preimplantation characteristics.

Clinical trial registration url: www.clinicaltrials.gov. Unique Identifier: NCT00583661.

Keywords: cardiomyopathy; heart failure; pediatrics; stroke.

© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Figures

Figure 1.
Figure 1.
Temporal distribution of neurological events after implantation with the Berlin Heart EXCOR® ventricular assist device.
Figure 2.
Figure 2.
Hazard rate of first neurological event compared with the number of days of EXCOR® support. EXCOR® indicates Berlin Heart EXCOR® ventricular assist device.
Figure 3.
Figure 3.
Freedom from first neurological event. The Kaplan–Meier curve shows the survival function for the probability of children implanted with EXCOR® to remain free from neurological events. EXCOR® indicates Berlin Heart EXCOR® ventricular assist device.
Figure 4.
Figure 4.
Pediatric Stroke Outcome Measure (PSOM) severity following neurological event. The bar graph shows neurological outcome severity as measured by the PSOM, when available, for children within 7 days of a neurological event and long term, at a median of 136 days (interquartile range 79 to 171) after a neurological event.

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