Uwe Kehler1, Michael Kiefer2, Regina Eymann3, Wolfgang Wagner4, Christoph A Tschan5, Niels Langer6, Veit Rohde7, Hans C Ludwig8, Jan Gliemroth9, Ullrich Meier10, Johannes Lemcke11, Ulrich-W Thomale12, Michael Fritsch13, Joachim K Krauss14, M Javad Mirzayan15, Martin Schuhmann16, Alexandra Huthmann17. 1. Neurosurgical Department, Asklepios Klinik Hamburg Altona, Paul-Ehrlich-Straße 1, 22763 Hamburg, Germany. Electronic address: u.kehler@asklepios.com. 2. Neurosurgical Department, University of the Saarland, Kirrberger Straße, 66421 Homburg-Saar, Germany. Electronic address: Michael.Kiefer@uks.eu. 3. Neurosurgical Department, University of the Saarland, Kirrberger Straße, 66421 Homburg-Saar, Germany. Electronic address: Regina.Eymann@uks.eu. 4. Neurosurgical Department, Section of Pediatric Neurosurgery, Johannes Gutenberg University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany. Electronic address: wolfgang.wagner2@unimedizin-mainz.de. 5. Neurosurgical Department, Section of Pediatric Neurosurgery, Johannes Gutenberg University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany. Electronic address: tschan@ludmillenstift.de. 6. Neurosurgical Department, Asklepios Klinik Hamburg Altona, Paul-Ehrlich-Straße 1, 22763 Hamburg, Germany. Electronic address: n.langer@aesklepios.com. 7. Neurosurgical Department, Georg-August-University Göttingen, Robert-Koch-Straße 40, 37075 Göttingen, Germany. Electronic address: veit.rohde@med.uni-goettingen.de. 8. Neurosurgical Department, Georg-August-University Göttingen, Robert-Koch-Straße 40, 37075 Göttingen, Germany. Electronic address: hludwig@med.uni-goettingen.de. 9. Neurosurgical Department, Medical University Clinic Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany. Electronic address: Jan.Gliemroth@t-online.de. 10. Neurosurgical Department, Unfallkrankenhaus Berlin, Warener Straße 7, 12683 Berlin, Germany. Electronic address: Ullrich.Meier@ukb.de. 11. Neurosurgical Department, Unfallkrankenhaus Berlin, Warener Straße 7, 12683 Berlin, Germany. Electronic address: Johannes.Lemcke@ukb.de. 12. Pediatric Neurosurgery, Neurosurgical Department, Charité: Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: ulrich-wilhelm.thomale@charite.de. 13. Neurosurgical Department, Ernst-Moritz-Arndt University Greifswald, Sauerbruchstraße, 17475 Greifswald, Germany. Electronic address: FritschM@dbknb.de. 14. Neurosurgical Department, Medizinische Hochschule Hannover, Carl-Neuberg-Straße 1, 30625 Hannover, Germany. Electronic address: Krauss.Joachim@mh-hannover.de. 15. Neurosurgical Department, Medizinische Hochschule Hannover, Carl-Neuberg-Straße 1, 30625 Hannover, Germany. Electronic address: mirzayan@hotmail.com. 16. Neurosurgical Department, Eberhard Karls University Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany. Electronic address: martin.schuhmann@med-uni.tuebingen.de. 17. Neurosurgical Department, Section of Pediatric Neurosurgery, Johannes Gutenberg University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany. Electronic address: huthmann@ludmillenstift.de.
Abstract
OBJECTIVE: Cerebrospinal fluid (CSF) overdrainage is a major problem in shunt therapy for hydrocephalus. The adjustable gravitational valve proSA allows for the first time a targeted compensation for overdrainage in the upright position without interfering with the differential pressure valve. To evaluate benefit, safety and reliability, the multicenter prospective registry PROSAIKA was conducted in 10 German neurosurgical centers. METHODS: Between March 2009 and July 2010, 120 hydrocephalic patients undergoing first time shunt implantation or shunt revision using proSA entered the study. 93 patients completed the 12 months follow-up. RESULTS: Hydrocephalus symptoms were improved in 86%, unchanged in 9% and deteriorated in 3%. In 51%, the proSA opening pressure was readjusted one or several times to treat suspected suboptimal shunt function, this resulted in clinical improvement in 55%, no change in 25%, and deterioration in 20% of these patients. The 1 year censored proSA shunt survival rate was 89%. Device related shunt failure was seen in two cases. CONCLUSIONS: This is the first clinical report on the implantation of the adjustable gravitational valve proSA with a follow-up of 12 months in a substantial number of patients. Irrespective of different hydrocephalus etiologies and indications for shunt surgery, the overall results after 12 months were very satisfying. The high frequency of valve readjustments underlines the fact that preoperative selection of the appropriate valve opening pressure is difficult. The low number of revisions and complications compared to other valves proves that proSA implantation adds no further risk; this valve is reliable, helpful and safe.
OBJECTIVE: Cerebrospinal fluid (CSF) overdrainage is a major problem in shunt therapy for hydrocephalus. The adjustable gravitational valve proSA allows for the first time a targeted compensation for overdrainage in the upright position without interfering with the differential pressure valve. To evaluate benefit, safety and reliability, the multicenter prospective registry PROSAIKA was conducted in 10 German neurosurgical centers. METHODS: Between March 2009 and July 2010, 120 hydrocephalic patients undergoing first time shunt implantation or shunt revision using proSA entered the study. 93 patients completed the 12 months follow-up. RESULTS:Hydrocephalus symptoms were improved in 86%, unchanged in 9% and deteriorated in 3%. In 51%, the proSA opening pressure was readjusted one or several times to treat suspected suboptimal shunt function, this resulted in clinical improvement in 55%, no change in 25%, and deterioration in 20% of these patients. The 1 year censored proSA shunt survival rate was 89%. Device related shunt failure was seen in two cases. CONCLUSIONS: This is the first clinical report on the implantation of the adjustable gravitational valve proSA with a follow-up of 12 months in a substantial number of patients. Irrespective of different hydrocephalus etiologies and indications for shunt surgery, the overall results after 12 months were very satisfying. The high frequency of valve readjustments underlines the fact that preoperative selection of the appropriate valve opening pressure is difficult. The low number of revisions and complications compared to other valves proves that proSA implantation adds no further risk; this valve is reliable, helpful and safe.