Laboratory testing of hydrocephalus shunts -- conclusion of the U.K. Shunt evaluation programme

Abstract

16 models of valves, currently in use in the U.K., have been tested long-term in the U.K. Shunt Evaluation Laboratory according to the protocol based on the new ISO 7197 standard. Valves tested were: Medtronic PS Medical: Delta Valve, Flow Control and Lumbo-Peritoneal Shunt, Heyer-Schulte Nero-Care: In-line, Low Profile and Pudenz Flushing Valve, Codman: Codman-Hakim Programmable, Hakim Precision, Accu-Flo, Holter, Uni-Shunt, and siphon-preventing device -- SiphonGuard, NMT: Orbis-Sigma Valve, Omni-Shunt and Hakim Valve, Sophysa: Sophy Programmable Valve, Radionics: Contour-Flex Valve. The majority of the valves had a non-physiologically low hydrodynamic resistance (with the exception of Orbis-Sigma, PS Lumbo-Peritoneal and Heyer-Schulte In-Line). This may result in overdrainage both related to posture and during nocturnal cerebral vasogenic waves. A long distal catheter increases the resistance of these valves by 100-200%. Drainage through valves without siphon-preventing mechanism is very sensitive to body posture. This may produce grossly negative intracranial pressure after implantation. A few shunts (Delta, Low Profile and Pudenz-Flushing with Anti-Siphon Devices) offer a reasonable resistance to negative outlet pressure, and hence potentially might prevent complications related to overdrainage. On the other hand, valves with siphon-preventing devices may be blocked by raised subcutaneous pressure (exception: SiphonGuard, but this device may block the drainage because of its faulty design). In most of the silicone-diaphragm valves, closing pressure varied and reached values lower than that specified by the manufacturer (exception: Heyer-Schulte Pudenz Flushing Valve). All programmable valves are susceptible to overdrainage in the upright body position. Programmed settings may be changed by external magnetic fields. Most shunts are very sensitive to the presence of small particles in the drained fluid. The behavior of a valve revealed during such testing is of immediate relevance to the surgeon and may not be adequately described in the manufacturer's product information. These results are also relevant to the assessment of shunt function in-vivo using an infusion test.