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

Abstract

BackgroundThe 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 ResultsThe 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.ConclusionsOf 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 RegistrationURL: www.clinicaltrials.gov. Unique Identifier: NCT00583661.

Trends in Congenital Heart Disease

“…94 Continuing improvements in ventricular assist device technologies and management should reduce associated morbidities, such as stroke, and will increasingly allow for treatment of smaller patients and for patients awaiting heart transplant to be cared for and monitored at home. 95,96 Other novel approaches for myocardial failure are available, but their cost-effectiveness and specific roles have yet to be determined. 97 An example is the use of resynchronization therapy, which has been extensively used in adults with left ventricular dysfunction but not yet systematically and prospectively studied in complex heart disease, and, as a result, it does not yet have a clearly defined role in management.…”

Favorable Waitlist and Posttransplant Outcomes in Children and Adolescent Patients Supported With Durable Continuous-Flow Ventricular Assist Devices

“…Multivariable analysis was not performed in light of the low event numbers. For the same reason, caution must be applied in interpreting these predictors, although the requirement for biventricular support has been consistently observed as a risk factor in the pediatric pulsatile-flow VAD literature (2,3,23,24).…”

“…In addition, it is likely that these patients were listed for transplantation after a period of stability was observed, an assumption supported by the observation that only 13% were mechanically ventilated and 37% were on inotropic support at the time of listing ( Table 2). This may mean that the early risk associated with device implantation is not fully captured in these data, a period that coincides with greatest hazard in many VAD outcome studies (3,24). Finally, many important comorbidities are not captured in this data set, and the large proportions of missing data precluded detailed analysis of neurological outcomes in these patients-a point that would be of great interest, given the prevalence of these comorbidities in pediatric patients implanted with a pulsatile VAD (2,24).…”

“…This may mean that the early risk associated with device implantation is not fully captured in these data, a period that coincides with greatest hazard in many VAD outcome studies (3,24). Finally, many important comorbidities are not captured in this data set, and the large proportions of missing data precluded detailed analysis of neurological outcomes in these patients-a point that would be of great interest, given the prevalence of these comorbidities in pediatric patients implanted with a pulsatile VAD (2,24). Many of these comorbidity concerns will be addressed specifically through analysis of the Pedimacs registry.…”

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

“…Несмотря на это, в межцентровом исследовании в США при использовании EXCOR отмечаются значительные неврологические осложнения (29%) из-за тромбоза в насосе, которые послужили основ-ной причиной смерти от тромбоэмболии [54].…”