title: The Berlin Heart EXCOR Pediatric ventricular assist device: history, North American experience, and future directions.
abstract: Options for long-term mechanical circulatory support to sustain pediatric heart failure patients requiring cardiac transplantation while they wait for donor hearts have been unsatisfactory. The conventional approach has been to use extracorporeal membrane oxygenation (ECMO), but its lack of feasibility for long-term use and the major complications associated with the technology have limited its use, especially in light of lengthy waiting lists for donor hearts. With the advent of the Berlin Heart EXCOR® Pediatric ventricular assist device (VAD), pediatric heart failure specialists have gained an important tool for helping this patient population survive until a donor heart can be identified. The EXCOR Pediatric VAD is designed to support pediatric patients of all age groups, from newborns to teenagers, and can be used successfully for many months. This paper describes the early experience with the EXCOR Pediatric VAD and the challenging journey undertaken to gain U.S. FDA approval, including successful completion of the first worldwide prospective clinical study of VADs in a pediatric population.
authors.affiliation: Texas Children's Hospital, Houston, Texas 77030, USA. cdfraser@texaschildrens.org
authors.forename: Charles D
authors.initials: CD
authors.lastname: Fraser
authors.forename: Robert D B
authors.initials: RD
authors.lastname: Jaquiss
mesh_terms: D000818:Animals; D001604:Berlin / Q000453:epidemiology; D002648:Child; D002986:Clinical Trials as Topic / Q000639:trends; D018795:Device Approval; D005544:Forecasting; D006333:Heart Failure / Q000453:epidemiology* / Q000503:physiopathology / Q000601:surgery*; D016027:Heart Transplantation / Q000639:trends; D006353:Heart-Assist Devices / Q000639:trends*; D006801:Humans; D009656:North America / Q000453:epidemiology
keywords: Berlin Heart; EXCOR; VAD; pediatrics