Stroke in pediatric ventricular assist device patients—a pedimacs registry analysis

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Background

Cerebralvascular accidents (CVA) are common complications of pediatric ventricular assist devices (VADs). We employed the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) to investigate rates, risk factors, and outcomes of CVA in pediatric patients supported on VAD.

Methods

Analysis of Pedimacs (September 2012-June 2019) data to determine rates of all neurologic events and specifically CVA. Risk factors were determined by a multiphase parametric hazard model. Outcomes of patients with CVA were compared with patients without CVA.

Results

We included 662 patients in our analysis. In total, 87 CVA events occurred in 71 patients (10.7%). The proportion of patients with CVA was highest in the paracorporeal pulsatile group (16.9%) followed by the paracorporeal continuous group (10.4%). However, the rate of CVA was lower in the paracorporeal pulsatile group compared to the paracorporeal continuous group (6.4 vs 11.1 events/100 patient months), which reflects differences in support duration. Ascites, higher patient profile groups, and implants within small volume centers were associated with the occurrence of CVA. Our analysis found that the recent era (i.e., June 2017), and intracorporeal continuous implants were protective. Mortality was higher in patients following a CVA diagnosis compared to those without a CVA diagnosis.

Conclusions

CVA continues to be a problem in pediatric VAD support, though the overall percent is now <11%. Data from the most recent era are encouraging, but CVA is still significantly associated with mortality. Future efforts should focus on pre-implant and early support periods.

Section snippets

Methods

Pedimacs is a North American registry of mechanical circulatory support in the pediatric population supported initially by the National Heart, Lung, and Blood Institute (NHLBI), and later assumed by the Society of Thoracic Surgeons. Supplementary Appendix 1 displays the enrollment of devices, patients, and hospitals over time. Pedimacs includes data on patients younger than 19 years age at the time of initiation of circulatory support. As the Berlin Heart EXCOR is the only FDA approved

Discussion

The use of VAD to support end-stage heart failure in pediatric patients has continued to expand, resulting in a reduction in transplant waitlist mortality by 50%.17 The risks of neurologic injury (specifically, CVA) have tempered enthusiasm for these devices, though. As a result, many practitioners postpone placement of a VAD until risk of death is imminent, or only when they feel a VAD's potential benefits outweigh the significant risk of CVA. This has led to delayed implant in patients

Disclosure statement

Dr. R.A.N. reports personal fees from Abbott and Berlin Heart for travel funds to attend learning network and educational conferences; not related to the submitted work. Dr. J.K.K. reports salary support from the Society of Thoracic Surgeons as the database coordinator. Dr. A.L. reports grants and personal fees from Abbott, personal fees from Abiomed, grants from Syncardia, grants from Berlin Heart, and grants and personal fees from Medtronic; not related to the submitted work. Dr. D.L.M.

Acknowledgement

The authors thank the tireless effort of multiple investigators who contributed to the data within the Pedimacs registry. The data for this research were provided by the Society of Thoracic Surgeons’ National Database Access and Publications Research Program. This analysis would not be possible without the collaboration from all institutions and individuals.

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