BACKGROUND
The Berlin Heart EXCOR Pediatric (EXCOR) ventricular assist device (VAD) was introduced
in North America nearly 2 decades ago. The EXCOR was approved under Humanitarian Device
Exemption status in 2011 and received post-market approval (PMA) in 2017 from Food
and Drug Administration. Since the initial approval, the field of pediatric mechanical
circulatory support has changed, specifically with regard to available devices, anticoagulation
strategies, and the types of patients supported. This report summarizes the outcomes
of patients supported with EXCOR from the Advanced Cardiac Therapies Improving Outcomes
Network (ACTION) registry. These data were part of the PMA surveillance study (PSS)
required by the Food and Drug Administration.
METHODS
ACTION is a learning collaborative of over 40 pediatric heart failure programs worldwide,
which collects data for all VAD implantations as one of its initiatives. All patients
in North America with EXCOR implants reported to ACTION from 2018 to 2020 (n = 72) who had met an outcome were included in the EXCOR PSS group. This was compared
with a historical, previously reported Berlin Heart EXCOR study group (Berlin Heart
study [BHS] group, n = 320, 2007‒2014).
RESULTS
Patients in the PSS group were younger, were smaller in weight/body surface area,
were more likely to have congenital heart disease, and were less likely to receive
a bi-VAD than those in the BHS group. Patients in the PSS group were less likely to
be in Interagency Registry for Mechanically Assisted Circulatory Support Profile 1
and were supported for a longer duration. The primary anticoagulation therapy for
92% of patients in the PSS group was bivalirudin. Success, defined as being transplanted,
being weaned for recovery, or being alive on a device at 180 days after implantation,
was 86% in the PSS group compared with 76% in the BHS group. Incidence of stroke was
reduced by 44% and the frequency of pump exchange by 40% in the PSS group compared
with those in the BHS group. Similarly, all other adverse events, including major
bleeding, were reduced in the PSS group.
CONCLUSIONS
The PSS data, collected through ACTION, highlight the improvement in outcomes for
patients supported with EXCOR compared with the outcomes in a historical cohort. These
findings may be the result of changes in patient care practices over time and collaborative
learning.
KEYWORDS
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Article info
Publication history
Published online: January 19, 2021
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© 2021 International Society for Heart and Lung Transplantation. All rights reserved.
