Neurological Complications and Outcomes in the Berlin Heart EXCOR ® Pediatric Investigational Device Exemption Trial

Author:

Jordan Lori C.1,Ichord Rebecca N.2,Reinhartz Olaf3,Humpl Tilman4,Pruthi Sumit5,Tjossem Christine6,Rosenthal David N.7

Affiliation:

1. Division of Pediatric Neurology, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN

2. Department of Neurology, The Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA

3. Department of Cardiac Surgery, Stanford University, Palo Alto, CA

4. Department of Critical Care Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada

5. Department of Radiology, Vanderbilt University School of Medicine, Nashville, TN

6. Berlin Heart, Inc, The Woodlands, TX

7. Department of Pediatrics, Stanford University, Palo Alto, CA

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: NCT 00583661.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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