Faculty Collaboration Database

Berlin Heart EXCOR and ACTION post-approval surveillance study report. J Heart Lung Transplant 2021 Apr;40(4):251-259

Date

02/14/2021

Pubmed ID

33579597

DOI

10.1016/j.healun.2021.01.010

Scopus ID

2-s2.0-85100719896 (requires institutional sign-in at Scopus site)   38 Citations

Abstract

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.

Author List

Zafar F, Conway J, Bleiweis MS, Al-Aklabi M, Ameduri R, Barnes A, Bearl DW, Buchholz H, Church S, Do NL, Duffy V, Dykes JC, Eghtesady P, Fisher L, Friedland-Little J, Fuller S, Fynn-Thompson F, George K, Gossett JG, Griffiths ER, Griselli M, Hawkins B, Honjo O, Jeewa A, Joong A, Kindel S, Kouretas P, Lorts A, Machado D, Maeda K, Maurich A, May LJ, McConnell P, Mehegan M, Mongé M, Morales DLS, Murray J, Niebler RA, O'Connor M, Peng DM, Phelps C, Philip J, Ploutz M, Profsky M, Reichhold A, Rosenthal DN, Said AS, Schumacher KR, Si MS, Simpson KE, Sparks J, Louis JS, Steiner ME, VanderPluym C, Villa C, ACTION Learning Network Investigators

Authors

Steven J. Kindel MD Associate Professor in the Pediatrics department at Medical College of Wisconsin
Robert Niebler MD Professor in the Pediatrics department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Child, Preschool
Device Approval
Female
Heart Defects, Congenital
Heart Failure
Heart Transplantation
Heart-Assist Devices
Humans
Incidence
Infant
Male
North America
Population Surveillance
Registries
Retrospective Studies
Survival Rate