ORIGINAL CLINICAL SCIENCE
Berlin Heart EXCOR and ACTION post-approval surveillance study report

https://doi.org/10.1016/j.healun.2021.01.010Get rights and content

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.

Section snippets

Methods

ACTION is a learning collaborative of over 40 pediatric heart failure programs worldwide. ACTION collects data for all patients with VAD implants at its participating sites in a registry database. The data are collected under a protocol approved by the Institutional Review Board (IRB) at the Cincinnati Children's Hospital Medical Center (Cincinnati, OH), which houses the data coordinating center. Key data elements in the ACTION registry, including mortality and neurologic dysfunction, undergo

PSS group

There were a total of 72 patients in the PSS group, representing a total of 6,702 days of EXCOR support. The median age was 9.0 (IQR: 3.2‒36.6) months, body surface area (BSA) was 0.40 m2 (IQR: 0.28‒0.59 m2), and 44% of the patients (n = 32) were male (Table 1). Extracorporeal membrane oxygenation (ECMO) was used as previous support in 24% of the patients (n = 17), and 28% of the patients (n = 20) were in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1

Discussion

VAD therapy has continued to evolve in pediatrics, with an increasing number of patients being supported to transplantation on VADs. In addition, there have been changes in the spectrum of available devices (off label) for use in older children and adolescents, with expanding use of intracorporeal devices in recent years. This change in available devices has altered the demographics of the patient population supported by the EXCOR, which is highlighted in our results. The PSS patients from the

Conclusions

There have been substantial improvements in the outcomes of children on the Berlin Heart EXCOR as reported within the ACTION during the period of the post-approval study. These improvements in both survival and morbidity have occurred despite the changes in the baseline characteristics of the implant population, who would have traditionally been considered a high-risk group of patients. Ongoing collaboration is important for a continued improvement in pediatric VAD outcomes.

Disclosure statement

F.Z. is a consultant for SynCardia Systems and leads the Data Coordinating Center for the ACTION learning network. J.C. received an unrestricted educational grant from Abbott Laboratories and was a medical monitor for the PumpKIN trial. K.M. is a consultant for Berlin Heart, Heartare, Abbott Laboratories, and Abiomed. D.L.S.M. is a consultant for Abbott Laboratories, Berlin Heart, Comatrix/Azyio, Medtronic, and SynCardia Systems. A.L. reports receiving grants from Berlin Heart and grants and

Supplementary data

Supplementary data associated with this article can be found in the online version at www.jhltonline.org/.

References (20)

There are more references available in the full text version of this article.

Cited by (0)

1

These authors have contributed equally to this work.

View full text