title: Long-term performance of a CE-approved telemetric intracranial pressure monitoring.
abstract: Telemetric intracranial pressure (ICP) monitoring has been a challenge throughout several decades. Major obstruction was to minimize zero drift of absolute pressure sensors. A new promising product demonstrating in-vitro excellent long-term stability has been tested for its reliability in an animal model with a follow-up of up to 2 years. In "minipigs" sub-dural (Raumedic-STel®, Helmbrechts Germany) and intraparenchymal (Raumedic-PTel®) telemetric ICP probes have been inserted. Standard ICP probes (Raumedic Neurovent P®) served as controls. In regular intervals of 3 months the telemetrically and conventionally measured ICP have been compared. For each control a new conventional ICP probe has been inserted frontally to the telemetric device in the generalized anesthetized minipigs, resulting in overall 38 comparisons. Bland-Altman-plots, Chi2-tests and matched pair T-tests (significance level < 0.05) were used for data-analysis. The zero-shift was -1.7 ± 7.6 mm Hg (limits of agreement: 4.4 ± 1.9 mm Hg) and -3.0 ± 6.0 mm Hg (limits of agreement: 3.6 ± 2.6 mm Hg) in STel and PTel respectively meeting well the devices specification of ± 2 mm Hg drift per year. The reliability of both telemetric probes has been proved as quite comparable (p=0.2). These new telemetric ICP probes demonstrate reliable data during at least the first 6 months after implantation.
authors.affiliation: Department of Neurosurgery, Saarland University, Medical School, Homburg-Saar 66421,Germany. Michael.Kiefer@uks.eu
authors.forename: Michael
authors.initials: M
authors.lastname: Kiefer
authors.forename: Sebastian
authors.initials: S
authors.lastname: Antes
authors.forename: Melanie
authors.initials: M
authors.lastname: Schmitt
authors.forename: Inga
authors.initials: I
authors.lastname: Krause
authors.forename: Regina
authors.initials: R
authors.lastname: Eymann
mesh_terms: D000818:Animals; D004867:Equipment Design; D019544:Equipment Failure Analysis; D007427:Intracranial Pressure / Q000502:physiology*; D008365:Manometry / Q000295:instrumentation*; D018670:Monitoring, Ambulatory / Q000295:instrumentation*; D019736:Prostheses and Implants; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013552:Swine; D013556:Swine, Miniature; D013686:Telemetry / Q000295:instrumentation*