Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA)
Objectives To investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH). Background Patients with iNPH may benefit from VP shunting but are pr...
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| Veröffentlicht in: | Journal of neurology, neurosurgery and psychiatry neurosurgery and psychiatry, 2013-08, Vol.84 (8), p.850-857 |
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| creator | Lemcke, Johannes Meier, Ullrich Müller, Cornelia Fritsch, Michael J Kehler, Uwe Langer, Niels Kiefer, Michael Eymann, Regina Schuhmann, Martin U Speil, Andreas Weber, Friedrich Remenez, Victor Rohde, Veit Ludwig, Hans-Christoph Stengel, Dirk |
| description | Objectives To investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH). Background Patients with iNPH may benefit from VP shunting but are prone to overdrainage complications during posture changes. Gravitational valves with tantalum balls are considered to reduce the risk of overdrainage but their clinical effectiveness is unclear. Methods We conducted a pragmatic, randomised, multicentre trial comparing gravitational with non-gravitational programmable valves in patients with iNPH eligible for VP shunting. The primary endpoint was any clinical or radiological sign (headache, nausea, vomiting, subdural effusion or slit ventricle) of overdrainage 6 months after randomisation. We also assessed disease specific instruments (Black and Kiefer Scale) and Physical and Mental Component Scores of the Short Form 12 (SF-12) generic health questionnaire. Results We enrolled 145 patients (mean (SD) age 71.9 (6.9) years), 137 of whom were available for endpoint analysis. After 6 months, 29 patients in the standard and five patients in the gravitational shunt group developed overdrainage (risk difference −36%, 95% CI −49% to −23%; p |
| doi_str_mv | 10.1136/jnnp-2012-303936 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3717598</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1399506507</sourcerecordid><originalsourceid>FETCH-LOGICAL-b531t-96930620f8742d86970fc06765f2ce3b098a4d8cf56e4d7fe09fdd6de440ce2b3</originalsourceid><addsrcrecordid>eNqFkkuP0zAUhSMEYoaBPStkic0gGvAjsRMWSFXFSxp1xBRG7Cwnvm5ckjjYSaE_iv-IS4cK2Iw3lny-e-698kmSxwS_IITxl5u-H1KKCU0ZZiXjd5JTkvEiZQx_uZucYkz3So5PkgchbPD-FOX95ISyLBeU0tPk50oZGHdI9RqBMbZW9Q45g9Zebe2oRut61aLQTP2ItqrdQkC2R0MUoB8D-m7HBlltXXxpbI1657vIDx5CmDygZqe9q2FoVDuFV0hFRa27WF3PkI89XWcD6BlyA_SoVRW0M9RNbdSjfawfvY1256vr-epyOX_2MLlnVBvg0c19lnx---bT4n16cfnuw2J-kVY5I2Na8pJhTrEpREZ1wUuBTY254LmhNbAKl4XKdFGbnEOmhQFcGq25hizDNdCKnSWvD77DVHWgfw-jWjl42ym_k05Z-a_S20au3VYyQUReFtHg_MbAu28ThFHGRWtoW9WDm4IkeU44yWjBbkdZWeaY51hE9Ol_6MZNPn5QpERBaFZGNFL4QNXeheDBHOcmWO5jI_exkfvYyENsYsmTv_c9FvzJSQTSA2DDCD-OuvJfJRdM5HJ5vZDLJbsq8BWVHyP__MBX3eb29r8AlfvekA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1781249995</pqid></control><display><type>article</type><title>Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA)</title><source>MEDLINE</source><source>BMJ Journals - NESLi2</source><creator>Lemcke, Johannes ; Meier, Ullrich ; Müller, Cornelia ; Fritsch, Michael J ; Kehler, Uwe ; Langer, Niels ; Kiefer, Michael ; Eymann, Regina ; Schuhmann, Martin U ; Speil, Andreas ; Weber, Friedrich ; Remenez, Victor ; Rohde, Veit ; Ludwig, Hans-Christoph ; Stengel, Dirk</creator><creatorcontrib>Lemcke, Johannes ; Meier, Ullrich ; Müller, Cornelia ; Fritsch, Michael J ; Kehler, Uwe ; Langer, Niels ; Kiefer, Michael ; Eymann, Regina ; Schuhmann, Martin U ; Speil, Andreas ; Weber, Friedrich ; Remenez, Victor ; Rohde, Veit ; Ludwig, Hans-Christoph ; Stengel, Dirk</creatorcontrib><description>Objectives To investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH). Background Patients with iNPH may benefit from VP shunting but are prone to overdrainage complications during posture changes. Gravitational valves with tantalum balls are considered to reduce the risk of overdrainage but their clinical effectiveness is unclear. Methods We conducted a pragmatic, randomised, multicentre trial comparing gravitational with non-gravitational programmable valves in patients with iNPH eligible for VP shunting. The primary endpoint was any clinical or radiological sign (headache, nausea, vomiting, subdural effusion or slit ventricle) of overdrainage 6 months after randomisation. We also assessed disease specific instruments (Black and Kiefer Scale) and Physical and Mental Component Scores of the Short Form 12 (SF-12) generic health questionnaire. Results We enrolled 145 patients (mean (SD) age 71.9 (6.9) years), 137 of whom were available for endpoint analysis. After 6 months, 29 patients in the standard and five patients in the gravitational shunt group developed overdrainage (risk difference −36%, 95% CI −49% to −23%; p<0.001). This difference exceeded predetermined stopping rules and resulted in premature discontinuation of patient recruitment. Disease specific outcome scales did not differ between the groups although there was a significant advantage of the gravitational device in the SF-12 Mental Component Scores at the 6 and 12 month visits. Conclusions Implanting a gravitational rather than another type of valve will avoid one additional overdrainage complication in about every third patient undergoing VP shunting for iNPH.</description><identifier>ISSN: 0022-3050</identifier><identifier>EISSN: 1468-330X</identifier><identifier>DOI: 10.1136/jnnp-2012-303936</identifier><identifier>PMID: 23457222</identifier><identifier>CODEN: JNNPAU</identifier><language>eng</language><publisher>England: BMJ Publishing Group Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Ataxia ; Cerebrospinal Fluid Shunts - adverse effects ; Cerebrovascular Disease ; Csf Dynamics ; Dementia ; Endoscopy ; Endpoint Determination ; Equipment Design ; Female ; Follow-Up Studies ; Gait Disorders, Neurologic - etiology ; Gait Disorders, Neurologic - surgery ; Gravitation ; Humans ; Hydrocephalus ; Hydrocephalus - complications ; Hydrocephalus - surgery ; Hydrocephalus, Normal Pressure - psychology ; Hydrocephalus, Normal Pressure - surgery ; Magnetic Resonance Imaging ; Male ; Medical equipment ; Middle Aged ; Netherlands ; Neurosurgery ; Patients ; Quality of life ; Randomised Trials ; Surgery ; Tomography, X-Ray Computed ; Valves</subject><ispartof>Journal of neurology, neurosurgery and psychiatry, 2013-08, Vol.84 (8), p.850-857</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Copyright: 2013 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b531t-96930620f8742d86970fc06765f2ce3b098a4d8cf56e4d7fe09fdd6de440ce2b3</citedby><cites>FETCH-LOGICAL-b531t-96930620f8742d86970fc06765f2ce3b098a4d8cf56e4d7fe09fdd6de440ce2b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jnnp.bmj.com/content/84/8/850.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://jnnp.bmj.com/content/84/8/850.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,776,780,881,3182,23551,27903,27904,77346,77377</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23457222$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lemcke, Johannes</creatorcontrib><creatorcontrib>Meier, Ullrich</creatorcontrib><creatorcontrib>Müller, Cornelia</creatorcontrib><creatorcontrib>Fritsch, Michael J</creatorcontrib><creatorcontrib>Kehler, Uwe</creatorcontrib><creatorcontrib>Langer, Niels</creatorcontrib><creatorcontrib>Kiefer, Michael</creatorcontrib><creatorcontrib>Eymann, Regina</creatorcontrib><creatorcontrib>Schuhmann, Martin U</creatorcontrib><creatorcontrib>Speil, Andreas</creatorcontrib><creatorcontrib>Weber, Friedrich</creatorcontrib><creatorcontrib>Remenez, Victor</creatorcontrib><creatorcontrib>Rohde, Veit</creatorcontrib><creatorcontrib>Ludwig, Hans-Christoph</creatorcontrib><creatorcontrib>Stengel, Dirk</creatorcontrib><title>Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA)</title><title>Journal of neurology, neurosurgery and psychiatry</title><addtitle>J Neurol Neurosurg Psychiatry</addtitle><description>Objectives To investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH). Background Patients with iNPH may benefit from VP shunting but are prone to overdrainage complications during posture changes. Gravitational valves with tantalum balls are considered to reduce the risk of overdrainage but their clinical effectiveness is unclear. Methods We conducted a pragmatic, randomised, multicentre trial comparing gravitational with non-gravitational programmable valves in patients with iNPH eligible for VP shunting. The primary endpoint was any clinical or radiological sign (headache, nausea, vomiting, subdural effusion or slit ventricle) of overdrainage 6 months after randomisation. We also assessed disease specific instruments (Black and Kiefer Scale) and Physical and Mental Component Scores of the Short Form 12 (SF-12) generic health questionnaire. Results We enrolled 145 patients (mean (SD) age 71.9 (6.9) years), 137 of whom were available for endpoint analysis. After 6 months, 29 patients in the standard and five patients in the gravitational shunt group developed overdrainage (risk difference −36%, 95% CI −49% to −23%; p<0.001). This difference exceeded predetermined stopping rules and resulted in premature discontinuation of patient recruitment. Disease specific outcome scales did not differ between the groups although there was a significant advantage of the gravitational device in the SF-12 Mental Component Scores at the 6 and 12 month visits. Conclusions Implanting a gravitational rather than another type of valve will avoid one additional overdrainage complication in about every third patient undergoing VP shunting for iNPH.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Ataxia</subject><subject>Cerebrospinal Fluid Shunts - adverse effects</subject><subject>Cerebrovascular Disease</subject><subject>Csf Dynamics</subject><subject>Dementia</subject><subject>Endoscopy</subject><subject>Endpoint Determination</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gait Disorders, Neurologic - etiology</subject><subject>Gait Disorders, Neurologic - surgery</subject><subject>Gravitation</subject><subject>Humans</subject><subject>Hydrocephalus</subject><subject>Hydrocephalus - complications</subject><subject>Hydrocephalus - surgery</subject><subject>Hydrocephalus, Normal Pressure - psychology</subject><subject>Hydrocephalus, Normal Pressure - surgery</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Medical equipment</subject><subject>Middle Aged</subject><subject>Netherlands</subject><subject>Neurosurgery</subject><subject>Patients</subject><subject>Quality of life</subject><subject>Randomised Trials</subject><subject>Surgery</subject><subject>Tomography, X-Ray Computed</subject><subject>Valves</subject><issn>0022-3050</issn><issn>1468-330X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqFkkuP0zAUhSMEYoaBPStkic0gGvAjsRMWSFXFSxp1xBRG7Cwnvm5ckjjYSaE_iv-IS4cK2Iw3lny-e-698kmSxwS_IITxl5u-H1KKCU0ZZiXjd5JTkvEiZQx_uZucYkz3So5PkgchbPD-FOX95ISyLBeU0tPk50oZGHdI9RqBMbZW9Q45g9Zebe2oRut61aLQTP2ItqrdQkC2R0MUoB8D-m7HBlltXXxpbI1657vIDx5CmDygZqe9q2FoVDuFV0hFRa27WF3PkI89XWcD6BlyA_SoVRW0M9RNbdSjfawfvY1256vr-epyOX_2MLlnVBvg0c19lnx---bT4n16cfnuw2J-kVY5I2Na8pJhTrEpREZ1wUuBTY254LmhNbAKl4XKdFGbnEOmhQFcGq25hizDNdCKnSWvD77DVHWgfw-jWjl42ym_k05Z-a_S20au3VYyQUReFtHg_MbAu28ThFHGRWtoW9WDm4IkeU44yWjBbkdZWeaY51hE9Ol_6MZNPn5QpERBaFZGNFL4QNXeheDBHOcmWO5jI_exkfvYyENsYsmTv_c9FvzJSQTSA2DDCD-OuvJfJRdM5HJ5vZDLJbsq8BWVHyP__MBX3eb29r8AlfvekA</recordid><startdate>20130801</startdate><enddate>20130801</enddate><creator>Lemcke, Johannes</creator><creator>Meier, Ullrich</creator><creator>Müller, Cornelia</creator><creator>Fritsch, Michael J</creator><creator>Kehler, Uwe</creator><creator>Langer, Niels</creator><creator>Kiefer, Michael</creator><creator>Eymann, Regina</creator><creator>Schuhmann, Martin U</creator><creator>Speil, Andreas</creator><creator>Weber, Friedrich</creator><creator>Remenez, Victor</creator><creator>Rohde, Veit</creator><creator>Ludwig, Hans-Christoph</creator><creator>Stengel, Dirk</creator><general>BMJ Publishing Group Ltd</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>88I</scope><scope>8AF</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>M2P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>7TK</scope><scope>5PM</scope></search><sort><creationdate>20130801</creationdate><title>Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA)</title><author>Lemcke, Johannes ; Meier, Ullrich ; Müller, Cornelia ; Fritsch, Michael J ; Kehler, Uwe ; Langer, Niels ; Kiefer, Michael ; Eymann, Regina ; Schuhmann, Martin U ; Speil, Andreas ; Weber, Friedrich ; Remenez, Victor ; Rohde, Veit ; Ludwig, Hans-Christoph ; Stengel, Dirk</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b531t-96930620f8742d86970fc06765f2ce3b098a4d8cf56e4d7fe09fdd6de440ce2b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Ataxia</topic><topic>Cerebrospinal Fluid Shunts - adverse effects</topic><topic>Cerebrovascular Disease</topic><topic>Csf Dynamics</topic><topic>Dementia</topic><topic>Endoscopy</topic><topic>Endpoint Determination</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gait Disorders, Neurologic - etiology</topic><topic>Gait Disorders, Neurologic - surgery</topic><topic>Gravitation</topic><topic>Humans</topic><topic>Hydrocephalus</topic><topic>Hydrocephalus - complications</topic><topic>Hydrocephalus - surgery</topic><topic>Hydrocephalus, Normal Pressure - psychology</topic><topic>Hydrocephalus, Normal Pressure - surgery</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Medical equipment</topic><topic>Middle Aged</topic><topic>Netherlands</topic><topic>Neurosurgery</topic><topic>Patients</topic><topic>Quality of life</topic><topic>Randomised Trials</topic><topic>Surgery</topic><topic>Tomography, X-Ray Computed</topic><topic>Valves</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lemcke, Johannes</creatorcontrib><creatorcontrib>Meier, Ullrich</creatorcontrib><creatorcontrib>Müller, Cornelia</creatorcontrib><creatorcontrib>Fritsch, Michael J</creatorcontrib><creatorcontrib>Kehler, Uwe</creatorcontrib><creatorcontrib>Langer, Niels</creatorcontrib><creatorcontrib>Kiefer, Michael</creatorcontrib><creatorcontrib>Eymann, Regina</creatorcontrib><creatorcontrib>Schuhmann, Martin U</creatorcontrib><creatorcontrib>Speil, Andreas</creatorcontrib><creatorcontrib>Weber, Friedrich</creatorcontrib><creatorcontrib>Remenez, Victor</creatorcontrib><creatorcontrib>Rohde, Veit</creatorcontrib><creatorcontrib>Ludwig, Hans-Christoph</creatorcontrib><creatorcontrib>Stengel, Dirk</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Neurosciences Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of neurology, neurosurgery and psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lemcke, Johannes</au><au>Meier, Ullrich</au><au>Müller, Cornelia</au><au>Fritsch, Michael J</au><au>Kehler, Uwe</au><au>Langer, Niels</au><au>Kiefer, Michael</au><au>Eymann, Regina</au><au>Schuhmann, Martin U</au><au>Speil, Andreas</au><au>Weber, Friedrich</au><au>Remenez, Victor</au><au>Rohde, Veit</au><au>Ludwig, Hans-Christoph</au><au>Stengel, Dirk</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA)</atitle><jtitle>Journal of neurology, neurosurgery and psychiatry</jtitle><addtitle>J Neurol Neurosurg Psychiatry</addtitle><date>2013-08-01</date><risdate>2013</risdate><volume>84</volume><issue>8</issue><spage>850</spage><epage>857</epage><pages>850-857</pages><issn>0022-3050</issn><eissn>1468-330X</eissn><coden>JNNPAU</coden><abstract>Objectives To investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH). Background Patients with iNPH may benefit from VP shunting but are prone to overdrainage complications during posture changes. Gravitational valves with tantalum balls are considered to reduce the risk of overdrainage but their clinical effectiveness is unclear. Methods We conducted a pragmatic, randomised, multicentre trial comparing gravitational with non-gravitational programmable valves in patients with iNPH eligible for VP shunting. The primary endpoint was any clinical or radiological sign (headache, nausea, vomiting, subdural effusion or slit ventricle) of overdrainage 6 months after randomisation. We also assessed disease specific instruments (Black and Kiefer Scale) and Physical and Mental Component Scores of the Short Form 12 (SF-12) generic health questionnaire. Results We enrolled 145 patients (mean (SD) age 71.9 (6.9) years), 137 of whom were available for endpoint analysis. After 6 months, 29 patients in the standard and five patients in the gravitational shunt group developed overdrainage (risk difference −36%, 95% CI −49% to −23%; p<0.001). This difference exceeded predetermined stopping rules and resulted in premature discontinuation of patient recruitment. Disease specific outcome scales did not differ between the groups although there was a significant advantage of the gravitational device in the SF-12 Mental Component Scores at the 6 and 12 month visits. Conclusions Implanting a gravitational rather than another type of valve will avoid one additional overdrainage complication in about every third patient undergoing VP shunting for iNPH.</abstract><cop>England</cop><pub>BMJ Publishing Group Ltd</pub><pmid>23457222</pmid><doi>10.1136/jnnp-2012-303936</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0022-3050 |
| ispartof | Journal of neurology, neurosurgery and psychiatry, 2013-08, Vol.84 (8), p.850-857 |
| issn | 0022-3050 1468-330X |
| language | eng |
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| source | MEDLINE; BMJ Journals - NESLi2 |
| subjects | Adult Aged Aged, 80 and over Ataxia Cerebrospinal Fluid Shunts - adverse effects Cerebrovascular Disease Csf Dynamics Dementia Endoscopy Endpoint Determination Equipment Design Female Follow-Up Studies Gait Disorders, Neurologic - etiology Gait Disorders, Neurologic - surgery Gravitation Humans Hydrocephalus Hydrocephalus - complications Hydrocephalus - surgery Hydrocephalus, Normal Pressure - psychology Hydrocephalus, Normal Pressure - surgery Magnetic Resonance Imaging Male Medical equipment Middle Aged Netherlands Neurosurgery Patients Quality of life Randomised Trials Surgery Tomography, X-Ray Computed Valves |
| title | Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA) |
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