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71. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC)
9. Joint Meeting mit der Japanischen Gesellschaft für Neurochirurgie

Deutsche Gesellschaft für Neurochirurgie (DGNC) e. V.

21.06. - 24.06.2020

Codman Certas – collaps of accuracy, loss of pressure ranges, safety risks

Codman Certas – Verlust der Genauigkeit und Druckstufen, Sicherheitsrisiken

Meeting Abstract

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  • presenting/speaker Alfred Aschoff - Ruprecht-Karls-Universität Heidelberg, Neurochirurgische Klinik (ehemals), Heidelberg, Deutschland

Deutsche Gesellschaft für Neurochirurgie. 71. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), 9. Joint Meeting mit der Japanischen Gesellschaft für Neurochirurgie. sine loco [digital], 21.-24.06.2020. Düsseldorf: German Medical Science GMS Publishing House; 2020. DocP068

doi: 10.3205/20dgnc356, urn:nbn:de:0183-20dgnc3564

Published: June 26, 2020

© 2020 Aschoff.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

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Objective: In 2011 the Codman-Certas was launched, in 2013 recalled and in 2015 relaunched. We found in PubMed with Certas 8 und CertasPlus 3 papers only. The often combined SiphonGuard (SG) has 6 Journal titels.

Methods: Since 1988 we tested in vitro 195 adjustable valves, 34 new and 163 explanted. 118 were adjustable Codman-Medos, 10 Codman adjustable MicroValve, 2 MicroValve with SG, 41 Miethke ProGAV, 2 ProSA, 13 Sophysa SU 8+3, 3 Polaris, 3 Mini 8+3, and 2 Kuffer-Strub. Simultaneously we made clinical experiences with 1388 adjustable valves in 1127 patients. Due to closed lab of Certas and CertasPlus we could worked with demo-spezimen, but made an exhaustive analysis of 5 Certas-patents, company-data and related literature.

Results: In contrast to the excellent precision of the adjustable Medos (±10 mmH2O!) Certas showed tolerances of ±20 to ±50 mm, fivefold poorer. Eklund measured (2012) in range 400 mmH2O deviations of 51-156 mmH2O. The 18-stepped Medos allows a subtle fine regulation. Certas has only 7 steps, 3 of those in the seldom used high pressure (145-215 mm). Safety: During puncture the chamber needle tip can penetrate the valve mechanism. With strong magnets it is possible to elevate the rotor and to adjust every position. Using an iPhone 5S the mechanism can be switched-off (Ozturk 2017). According to own measurements SGs with 8-15 cmH20 pressure allow flow up to 150 ml/h, leading to a high quote of chronic subdural hematomas (cSAD) in iNPH-patients (19.3%, Sundström 2017); between 20-50 cmH2O the flow is critically low. The helictical bottleneck has a diameter of 0.4 mm, ergo is at risk for occlusion and underdrainage.

Conclusion: Certas/Plus has solved the Medos-problems of X-rays after adjustments and MRIs. The price is a massive deterioration of precision, loss of fine tuning options and safety deficits (missing needle guard; disturbance by electromagnetic apparatus). In iNPH-patients the risk of cSDHs counted with Certas 16.7% and with SG combined with the adjustable Medos 19.6% (Sundström 2017).