ORIGINAL CLINICAL SCIENCEBerlin Heart EXCOR and ACTION post-approval surveillance study report
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/.
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These authors have contributed equally to this work.