title: Minimally invasive implantable fetal micropacemaker: mechanical testing and technical refinements.
abstract: This paper discusses the technical and safety requirements for cardiac pacing of a human fetus with heart failure and hydrops fetalis secondary to complete heart block. Engineering strategies to meet specific technical requirements were integrated into a systematic design and implementation consisting of a novel fetal micropacemaker, a percutaneous implantation system, and a sterile package that enables device storage and recharging maintenance in a clinical setting. We further analyzed observed problems on myocardial fixation and pacing lead fatigue previously reported in earlier preclinical trials. This paper describes the technical refinements of the implantable fetal micropacemaker to overcome these challenges. The mechanical performance has been extensively tested to verify the improvement of reliability and safety margins of the implantation system.
authors.affiliation: Medical Device Development Facility, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, 1042 Downey Way, Los Angeles, CA, 90089, USA. zhou15@usc.edu.
authors.forename: Li
authors.initials: L
authors.lastname: Zhou
authors.affiliation: Medical Device Development Facility, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, 1042 Downey Way, Los Angeles, CA, 90089, USA.
authors.forename: Adriana Nicholson
authors.initials: AN
authors.lastname: Vest
authors.affiliation: Medical Device Development Facility, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, 1042 Downey Way, Los Angeles, CA, 90089, USA.
authors.forename: Raymond A
authors.initials: RA
authors.lastname: Peck
authors.affiliation: Medical Device Development Facility, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, 1042 Downey Way, Los Angeles, CA, 90089, USA.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Sredl
authors.affiliation: Medical Device Development Facility, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, 1042 Downey Way, Los Angeles, CA, 90089, USA.
authors.forename: Xuechen
authors.initials: X
authors.lastname: Huang
authors.affiliation: Division of Cardiology, Department of Pediatrics, Children's Hospital of Los Angeles, 4650 Sunset, Los Angeles, CA, 90027, USA.|Keck School of Medicine, University of Southern California, 1975 Zonal Ave, Los Angeles, CA, 90033, USA.
authors.forename: Yaniv
authors.initials: Y
authors.lastname: Bar-Cohen
authors.affiliation: Division of Cardiology, Department of Pediatrics, Children's Hospital of Los Angeles, 4650 Sunset, Los Angeles, CA, 90027, USA.|Keck School of Medicine, University of Southern California, 1975 Zonal Ave, Los Angeles, CA, 90033, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Silka
authors.affiliation: Division of Cardiology, Department of Pediatrics, Children's Hospital of Los Angeles, 4650 Sunset, Los Angeles, CA, 90027, USA.|Keck School of Medicine, University of Southern California, 1975 Zonal Ave, Los Angeles, CA, 90033, USA.|Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, 1300 North Vermont Avenue, Suite 710, Los Angeles, CA, 90027, USA.
authors.forename: Jay D
authors.initials: JD
authors.lastname: Pruetz
authors.affiliation: Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, 1300 North Vermont Avenue, Suite 710, Los Angeles, CA, 90027, USA.
authors.forename: Ramen H
authors.initials: RH
authors.lastname: Chmait
authors.affiliation: Medical Device Development Facility, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, 1042 Downey Way, Los Angeles, CA, 90089, USA.
authors.forename: Gerald E
authors.initials: GE
authors.lastname: Loeb
mesh_terms: D000818:Animals; D004566:Electrodes; D005333:Fetus / Q000502:physiology; D055595:Mechanical Phenomena; D010138:Pacemaker, Artificial; D019736:Prostheses and Implants; D012756:Sheep; D019415:Torque; D014965:X-Rays
keywords: Epicardial; Fetal; Heart block; Hydrops fetalis; Pacemaker