Article
First results of the prospective multicenter PROSAIKA-registry regarding the programmable shunt assistant for hydrocephalus shunting
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Authors
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U. Kehler
- Neurochirurgische Klinik, Asklepios Klinik Hamburg Altona, Germany
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M. Kiefer
- Neurochirurgische Klinik, Universitätskliniken des Saarlandes, Homburg/Saar
| Published: | June 4, 2012 |
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Outline
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Objective: Since December 2008, the programmable Shunt-assistant (proSA), the first adjustable gravitational device for hydrocephalus shunting is available. With proSA overdrainge in upright position can be counterbalanced for the first time without interfering with the drainage in a horizontal position. To learn about the potentials, pitfalls and complications of this new device, a multicenter prospective data registry was started: PROSAIKA (proSA – initial clinical application). The first results are now available.
Methods: 120 patients entered the PROSAIKA registry between March 2009 and July 2010. The follow-up data acquisition ended in October 2011. ProSA-indication was heterogeneous, being mainly shunt malfunctions but also including first shunt implantations. 91 patients finished the 12 months follow-up with a clinical reexamination. 13 patients needed a shunt revision in between 12 months, 2 patients died unrelated to the proSA or shunt, and 14 were lost of follow-up. Clinical results, pitfalls and complications were documented.
Results: In 81 cases, a reprogramming of the proSA was intended to treat suspected suboptimal shunt function, in 79 cases it was possible, in 2 cases readjustment failed. In 65 cases, the short time effect of reprogramming after 4 weeks was recorded with clinical improvement in 55% (n=35), no change in 24% (n=16) and deterioration in 20% (n=13). After 12 months, 78 of 91 patients were clinically improved (86%), 8 were unchanged (n=9%) and 3% (n=3) had deteriorated. The revision rate of the shunt with proSA (besides shunt dislocation and disconnections) was 12% in 12 months. Complications possibly related to proSA were seen in 8 cases (5%) with under- and overdrainage.
Conclusions: This is the first paper with a substantial number of proSA with a follow-up of 12 months. Despite the heterogeneous indications, the overall results after 12 months are very acceptable. The high incidence of readjustments (n=81) underlines the fact that preoperative valve choice with the right pressure setting is difficult. The low number of revisions and complications in comparison to other valves proves that the proSA has no additional risk. Further studies are necessary to show the effectiveness of proSA in more homogeneous indications like normal pressure hydrocephalus, pseudotumor cerebri etc. and whether the theoretical advantages of the new device can be demonstrated on clinical application.
