Telemetric ICP measurement with the first CE-approved device: data from animal experiments and initial clinical experiences.
The objective was to evaluate the qualification of the new telemetric intracranial pressure (ICP) measurement (t-ICP) device Raumedic(®) NEUROVENT P-Tel and S-Tel. The proof of concept was examined in a pilot animal study measuring intraperitoneal pressure with a telemetric and a conventional ICP measurement probe at five rates for 1 h each. Moderate external pressure load allowed measuring values between 0 and 40 mmHg. To estimate long-term performance 18 t-ICP devices were implanted subdurally or intraparenchymally into minipigs. Reference measurements were performed regularly using conventional ICP probes. From the short-term as well as from the long-term perspective t-ICP proved to have excellent dynamic ICP signal components perception (e.g. pulse amplitude). Some zero drift of static ICP was found, ranging between 5 and 8 mmHg. While all telemetric, intraparenchymal probes kept their functionality throughout the follow-up, 33% of the subdurals failed for reasons detailed in another paper. Raumedic's NEUROVENT(®) P-Tel/S-Tel proved to provide reliable data over periods of up to 18 months. Minor zero drift can be well tolerated as the dynamic ICP signal is measured with excellent stability. Clinicians should focus more on such ICP dynamic signal information than on static ICP when using the device over longer follow-up periods.
Department of Neurosurgery, Saarland University, Homburg-Saar, Germany. michael.kiefer@uks.eu
Michael
M
Kiefer
Sebastian
S
Antes
Steffen
S
Leonhardt
Melanie
M
Schmitt
Berk
B
Orakcioglu
Oliver W
OW
Sakowitz
Regina
R
Eymann
D000704:Analysis of Variance; D000818:Animals; D004867:Equipment Design; D005260:Female; D007427:Intracranial Pressure / Q000502:physiology*; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D023421:Models, Animal; D008991:Monitoring, Physiologic / Q000295:instrumentation* / Q000379:methods*; D019736:Prostheses and Implants; D051381:Rats; D017208:Rats, Wistar; D013686:Telemetry; D014160:Transducers, Pressure