title: Comparative pathology of an implantable left atrial pressure sensor.
abstract: A left atrial pressure (LAP) monitoring system was developed for guiding the management of patients with heart failure. The LAP sensor is implanted into the left atrium via transseptal catheterization and affixed to the interatrial septum by nitinol anchors. The long-term safety of permanent implantation of the LAP sensor in patients was evaluated based on the comparative pathology in animals. Tissue specimens of the LAP sensor from 7 patients, 49 canines, and 14 ovine were examined for thrombosis and tissue overgrowth. Implant duration ranged from 22 to 1,686 days. Gross examination showed minimal-to-moderate tissue overgrowth with no evidence of migration, erosion, or perforation. There was no excessive host-to-device reaction or active thrombogenesis in any of the subjects that followed the antithrombotic therapy protocol. Micro-computed tomography scanning confirmed the structural integrity of the device. Low vacuum scanning electron microscopy and histology showed neoendocardial tissue overgrowth with no inflammation or fibrin. The pathology of both animal models was found to closely approximate the pathology in humans and favorably supports the long-term safety of the device.
authors.affiliation: Department of Veterinary Pathobiology, Texas A&M University, College Station, Texas 77843, USA.
authors.forename: Karen E
authors.initials: KE
authors.lastname: Trainor
authors.forename: Aaron
authors.initials: A
authors.lastname: Roberts
authors.forename: Brad
authors.initials: B
authors.lastname: Weeks
authors.forename: Nicolette
authors.initials: N
authors.lastname: Jackson
authors.forename: Richard W
authors.initials: RW
authors.lastname: Troughton
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Charles
authors.forename: Miriam T
authors.initials: MT
authors.lastname: Rademaker
authors.forename: Iain C
authors.initials: IC
authors.lastname: Melton
authors.forename: Ian G
authors.initials: IG
authors.lastname: Crozier
authors.forename: Werner
authors.initials: W
authors.lastname: Hafelfinger
authors.forename: Dan E
authors.initials: DE
authors.lastname: Gutfinger
authors.forename: Neal L
authors.initials: NL
authors.lastname: Eigler
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.forename: Fred J
authors.initials: FJ
authors.lastname: Clubb
mesh_terms: D000818:Animals; D016477:Artifacts; D062185:Atrial Pressure; D004285:Dogs; D004868:Equipment Failure; D006325:Heart Atria / Q000473:pathology*; D006333:Heart Failure / Q000175:diagnosis* / Q000503:physiopathology* / Q000628:therapy; D006801:Humans; D008855:Microscopy, Electron, Scanning; D023421:Models, Animal; D061214:Patient Safety; D011312:Pressure; D012756:Sheep; D013927:Thrombosis / Q000503:physiopathology; D013997:Time Factors; D014160:Transducers, Pressure; D055114:X-Ray Microtomography