Neurocirugía Noviembre 2011 (Vol 17)

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Neurocirugía Noviembre 2011 (Vol 17)

  1. 1. 1Neurocirugía-Neurocirurgia / Vol 18/2011
  2. 2. NEUROCIRUGIA-NEUROCIRURGIA Órgano Oficial de la Federación Latinoamericana de Sociedades de Neurocirugía (F LANC) EDITOR GERMAN POSADAS NARRO 2 Oficina Editorial: Jr. Camilo Carrillo 225-602 Jesús María, Lima-PERU Correo e: gpn55@hotmail.com COMITE EDITORIALMADJID SAMII (Alemania) ERNESTO HERRERA (El Salvador)CARLOS GAGLIARDI (Argentina) JOSE MARTIN RODRIGUEZ (España)JACQUES BROTCHI (Bélgica) TETSUO KANO (Japón)MILTON SHIBATA (Brasil) ENRIQUE VEGA (Nicaragua)HILDO AZEVEDO (Brasil) FREDDY SIMON (Paraguay)LEONIDAS QUINTANA (Chile ) HUGO HEINICKE (Perú)REMBERTO BURGOS (Colombia) ALVARO CORDOVA (Uruguay)OSSAMA AL-MEFTY (EE.UU.) ALFONSO GUZMAN (Venezuela)EDWARD LAWS (EE.UU) JESUS VAQUERO (España)Neurocirugía-Neurocirurgia / Vol 18/2011
  3. 3. FEDERACION LATINOAMERICANA DE SOCIEDADES DE NEUROCIRUGIA (FLANC) 3 DIRECTORIO Presidente ROGELIO REVUELTA (México) Presidente Anterior MARCOS MASINI (Brasil) Vicepresidente ROBERTO SANTOS (Ecuador) Secretario General LUIS CARLOS DE ALENCASTRO (Brasil) Tesorero EDGARDO SPAGNUOLO (Uruguay) Editor de Publicaciones GERMAN POSADAS (Perú) Editor de Internet CLAUDIO YAMPOLSKY (Argentina) Historiador PATRICIO TAGLE (Chile) Parlamentario FERNANDO RUEDA (México) Secretario Ejecutivo BASILIO FERNANDEZ (México) Presidente CLANC JOSE LANDEIRO (Brasil) PRESIDENTES DE SOCIEDADES LATINOAMERICANAS DE NEUROCIRUGIAARGENTINA Platas Marcelo GUATEMALA Rafael de la RivaBOLIVIA Erwin Quintanilla HONDURAS Osly VasquezBRASIL-SOCIEDAD Marcus Rotta MEXICO Gerardo GuintoBRASIL-ACADEMIA José Luciano NICARAGUA Marvín F. SalgadoCHILE Melchor Lemp PANAMA Avelino GutiérrezCOLOMBIA Juan Oviedo PARAGUAY Ramón MigliosiriCOSTA RICA José Pérez PERU Alfonso BasurcoCUBA Enrique de Jongh R. DOMINICANA Giancarlo HernándezECUADOR Enrique Guzmán URUGUAY Edgardo SpagnuoloEL SALVADOR Manuel Guandique VENEZUELA Jorge MantillaE. UNIDOS-CANADÁ Fernando Díaz PRESIDENTES HONORARIOSR. POBLETE (Chile) L. DITZEL (Brasil SBN)H. HINOJOSA (Perú) T. PERILLA (Colombia)P. MANGABEIRA (Brasil) H. GIOCOLI (Argentina)A. KRIVOY (Venezuela) U. ROCCA (Perú)A. BASSO (Argentina) M. MOLINA (Honduras)M. LOYO (México) N. RENZI (Argentina)J. MENDOZA (Colombia) L. QUINTANA (Chile)J. MÉNDEZ (Chile) R. BURGOS (Colombia)F. RUEDA (México)Neurocirugía-Neurocirurgia / Vol 18/2011
  4. 4. FEDERACION LATINOAMERICANA DE SOCIEDADES DE NEUROCIRUGIA (FLANC) 4 DELEGADOS ANTE WFNS Marcos Masini DELEGADO SENIOR Rogelio Revuelta SEGUNDO DELEGADO Claudio Yampolsky DELEGADO ALTERNO PRESIDENTES SOCIEDADES FEDERADAS REGIONALES Rafael de la Riva ASOCAN Leonidas Quintana CONO SUR PRESIDENTES SOCIEDADES ADHERENTES EXTRACONTINENTALES José Eiras Ajuria ESPAÑA Antonio Cerejo PORTUGAL Massimo Collice ITALIA Marc Sindou LENGUA FRANCESA COMITÉSEDUCACION ESTATUTOS FINANZASL. Quintana (Chile) Molina (Honduras) E. Spagnulo (Uruguay)A. Pedroza (Colombia) F. Rueda Franco (México) R. Revuelta (México)L. Aguiar (Brasil) L. Quintana (Chile)N. Nazar (Honduras) N. Renzy (Argentina)R. Ramos (México)CANDIDATURAS:M. Molina (Honduras) MEDALLASM. Gonzales Portillo (Perú) M. Molina (Honduras)E. Herrera (El Salvador) M. Masini (Brasil)A. Antunes (Brasil)O. Aponte (Colombia)Neurocirugía-Neurocirurgia / Vol 18/2011
  5. 5. FEDERACION LATINOAMERICANA DE SOCIEDADES DE NEUROCIRUGIA (FLANC) 5____________________________________________________________________________________________ CAPITULOSNEUROCIRUGIA VASCULAR COLUMNA VERTEBRAL NEUROCIRUGIA PEDIATRICAE. Spagnulo (Uruguay) J. Soriano (México) T. Herreda (México)R. Ramos (México) J. Shilton (Argentina) G. Aranda (Panamá)F. Papalini (Argentina) G. BrocNEUROCIRUGIA ONCOLOGICA NEUROCIRUGIA FUNCIONAL NERVIOS PERIFERICOSA Rabadán (Argentina) J. Espinoza (Colombia) J. Guedes (Brasil)G. Guinto (México) M. Baabor H. Giocolli (Argentina)M. Rotta (Brasil) F. Jimenez S. SacchetoniNEUROCIRUGIA BASE CRANEO NEUROTRAUMATOLOGIA,R. Ramina (Brasil) NEUROINTENSIVISMOM. Melgar (Perú) E. GuzmanP. Aguiar (Brasil) E. De Jongh (Cuba) J. Da Rocha (Brasil)Neurocirugía-Neurocirurgia / Vol 18/2011
  6. 6. REVISTA LATINOAMERICANA DE NEUROCIRUGIA Noviembre, 2011. Volumen 18CONTENIDO.......................................................................................................................6EDITORIAL: Dr. Marcos MasiniPresidente Honorario FLANC.............................................................................................7PAGINA DEL PRESIDENTE: Dr. Mauro Loyo-VarelaPresidente Honorario FLANC y WFNS............................................................................11 6ARTICULOS ORIGINALES:IntraSPINE, an interlaminar, not interspinous, posterior motion preservation device inlumbar DDD: indications and clinical results (over 2 years follow-up)..............................13Ensayo clínico para evaluar la acción de la Simvastatina en la prevención de la isquemiacerebral en la hemorragia subaracnoidea aneurismática.Clinical trial to evaluate the action of Simvastatin in the prevention of cerebral ischemiain aneurysmal subarachnoid hemorrhageDrs. Quintana Leonidas, Bennett Carlos, Riveros Rodrigo, San Martín C. Loyola N………………………………… 21MISCELANEA NEUROCIENCIAS:Programa de Formación Subespecializada en Neurocirugía-Cuarto AñoTraining Program for Neurosurgery Subspecializes-Fourth YearDr. Germán Posadas …………………………………………………………………….28El Neurocirujano y la Gestión PúblicaThe Neurosurgeon and the Public ManagementDr. Mauro Loyo-Varela……………………………………………………………………44Reflexiones sobre Epigenética y NeurocirugíaReflections on Epigenetics and NeurosurgeryDr. Abraham Krivoy…………………………………………………..…………………..47SEMBLANZAS:Dr. Humberto Hinojosa del Arca…………………………………………………………55Dr. Sergio Gomez Llata-Andrade………………………………………………………...59Dr. Carlos Codas………………………………………………………………………….62REGLAMENTO DE PUBLICACIONES…………………………………………..……63Neurocirugía-Neurocirurgia / Vol 18/2011
  7. 7. Marcos Masini El CLAN & FLANC y WFNS Editorial 7 El CLAN & FLANC y WFNS Dr. Marcos Masini on los años el trabajo de los miembros de las juntas de la FLANC se centra en la integración C de todas las Sociedades de Neurocirugía existentes en América Latina. Esta política ha sido probada con éxito recientemente en el Intermeeting de la Federación Mundial de Sociedades de Neurocirugía (WFNS), celebrada en Recife, Brasil, en septiembre pasado, cuando las sociedades latinoamericanas han mostrado una notable presencia y sentido de unión regional, dando pleno apoyo a los proyectos de licitación para el Congreso Mundial del 2017 en favor de Argentina y Colombia. El próximo congreso se celebrará en Estambul, pero se ha demostrado que debemos estar siempre unidos en defensa de los proyectos de interés común para la Comunidad Latinoamericana de Neurocirugía. Debemos mantener y, al mismo tiempo, estimular el perfeccionamiento de la unión. En este sentido, quiero felicitar a todos los presidentes y delegados de las Sociedades Miembros de la FLANC por actuar siempre con el sentido común de la integración y la unidad. El episodio referido nos lleva a la cuestión de los principales congresos médicos, el contenido de estos eventos y sus implicaciones. En este sentido, limitaré mis comentarios a la escena geopolítica de América Latina, con la participación de la FLANC, sus sociedades nacionales afiliadas y su congreso oficial, el CLAN. La historia de la Federación Latinoamericana de Sociedades de Neurocirugía empezó en 1945 cuando el reconocido neurocirujano uruguayo, Alejandro Schroeder, organizó y presidió el Primer Congreso Sudamericano de Neurocirugía (CSN), en Montevideo. Los informes indican que fue el primer gran evento internacional de neurocirugía realizado en todo el mundo. En 1955, el evento amplió sus fronteras y el profesor y neurocirujano Roman Arana presidió el ahora llamado Congreso Latinoamericano de Neurocirugía - CLAN. Celebrado cada dos años alternativamente en los países del norte, centro y sur de América Latina, el evento tiene a lo largo del tiempo, convertido en una tradicional reunión de respetados neurocirujanos y ser la cuna de la idealización y la constitución legal de la FLANC, en 1981. Ahora en su 35 ª edición (Río de Janeiro, del 31 marzo - 5 abril 2012, www.clan2012.com), el CLAN es la memoria viva de la neurocirugía en América Latina, ha registrado más de 75 años de reuniones presenciales y contribuye en definitiva a la expansión cualitativa y cuantitativa de la práctica neuroquirúrgica profesional en nuestra región, hoy en manos de más de 7.500 neurocirujanos. Todas las sociedades miembros que han sido sede del CLAN, o de otro congreso importante, de alguna manera han incorporado técnicas y / o avances científicos al sector de neurocirugía de su país, especialmente en la educación de los neurocirujanos jóvenes. Eso es muy bueno, sin duda, pero no suficiente, porque parece que la mayor parte de la programación de congresos médicos sigue casi en su totalidad dedicado a temas científicos. Muchas otras cuestiones de vital importancia para el pleno éxito en la profesión rara vez se abordan o discuten en estos eventos. Neurocirugía-Neurocirurgia / Vol 18/2011
  8. 8. Marcos Masini El CLAN & FLANC y WFNS En base a esto, en el 2004, durante el XXVI Congreso de la Sociedad Brasileña de Neurocirugía (SBN) se celebró en la ciudad de Goiânia, Brasil, el primer Foro Político y Socioeconómico para el Desarrollo de la Neurocirugía en América Latina. El objetivo del encuentro es el amplio debate de las cuestiones no- clínicas que interfieren directamente en el ejercicio profesional de la neurocirugía en América Latina. Muchas de esas comunidades se enfrentan a problemas propios de su realidad local y debido a las similitudes políticas, económicas y sociales de los países cubiertos por FLANC, el Congreso Latinoamericano de Neurocirugía se presenta como un foro apropiado para el debate y la conducción de soluciones a estas cuestiones. Además de Brasil, el foro ya ha integrado el programa oficial del CLAN que se celebró en Argentina (2006), Colombia (2008) y El Salvador (2010), con una amplia variedad de temas presentados con éxito por profesionales reputados. El quinto foro está en el programa de la 35a CLAN que se celebrará en Río de Janeiro en 2012. Debido a su finalidad, el alcance y la justicia, espero que el formato original del Foro se pueda adaptar e incluir en la programación de otros eventos médicos nacionales. Los congresos de neurocirugía de la cobertura nacional o mundial realizada por las sociedades miembros de América Latina son en su mayoría auto-sostenidos, con un nivel de organización muy alto. Los 8 programas científicos suelen ser impecables y siempre acompañado de una logística eficiente y una agenda social emocionante, de buen gusto e integrado en todos los aspectos. Estos eventos atraen partícipes de muchos países, como también de ponentes de reconocido prestigio de todo el mundo. Identidad cultural y el lenguaje ayudan a integrar los miembros de las sociedades afiliadas a FLANC durante estos eventos. Incluso podríamos decir que un largo viaje a otros continentes, con la simple intención de actualización científica ya no es un requisito para el éxito profesional del neurocirujano en América Latina. El calendario de eventos médicos en nuestra región es muy extenso con excelencia de contenido y ponentes. La Neurocirugía de América Latina está madura, con fuerte identidad y respetada en todo el mundo. El padrón de los eventos médicos celebrada en nuestra región se ha incrementado significativamente en los últimos dos décadas y el alto nivel de nuestras instituciones de enseñanza han contribuido enormemente a la formación de excelencia de nuestros neurocirujanos. Debemos mantenernos enfocados en nuestra natural capacidad creativa y de versatilidad, y especialmente en nuestro fuerte sentido de unidad, integración e interacción. En adición a las actividades de las sociedades nacionales, la FLANC a través de las realizaciones del CLAN en los más diferentes países, busca disponer a toda comunidad neuroquirúrgica de nuestra región un importante foro y así cumplir con su propósito de promover la difusión del Conocimiento, Tecnología y Ética; y además de participar activamente junto con la WFNS su mayor desafío es el de la unificación global de la neurocirugía sin dejar de lado las realidades y las estrategias locales. Dr. Marcos Masini Presidente Honorario, Federación Latinoamericana de Sociedades de Neurocirugía , FLANC Profesor y Jefe del Departamento de Neurocirugía, FAMEPLAC, Brasil Vicepresidente, Comité de la Columna Vertebral WFNS Ex Presidente, Sociedad Brasileña de Neurocirujanos Ex Presidente , Academia Brasileña de Neurocirujanos Jefe y Director Técnico de la Clínica de Neurocirugía Queops, Brasil marcos.masini@uol.com.br Neurocirugía-Neurocirurgia / Vol 18/2011
  9. 9. Marcos Masini The CLAN & FLANC and WFNS The CLAN, FLANC and WFNS Dr. Marcos Masini O ver the years the work of the boards members of FLANC are focused on the integration of all existing neurosurgical societies in Latin America. This policy has been successfully tested recently during the Intermeeting of the World Federation of Neurosurgical Societies (WFNS), 9 held in Recife, Brazil, last September, when the Latin American societies have shown a remarkable presence and sense of the regional union by giving full support to the projects bidding for the 2017 World Congress in favor of Argentina and Colombia. The next congress will be held in Istanbul, but it has been proven that we ought to be always united in defense of projects of common interest to the Latin American Neurosurgery Community. We must maintain and, at the same time, stimulate the perfection of this union. In this regard, I want to congratulate all presidents and delegates of FLANC’s Member Societies by always acting with the common sense of integration and unity. The above episode brings us to the issue of major medical congresses, the content of these events and its implications. Here, we limit my comments to the geopolitical scene of Latin America, involving the FLANC, their affiliated national societies and its official congress, the CLAN. The history of Latin American Federation of Neurosurgical Societies began in 1945 when the renowned Uruguayan neurosurgeon, Alejandro Schroeder, organized and chaired the first South American Congress of Neurosurgery (CSN), in Montevideo. Reports indicate that it was the first major international event of neurosurgery performed around the world. In 1955, the event expanded its borders and the professor and neurosurgeon Roman Arana chairs the now called Latin American Congress of Neurosurgery – CLAN. Held every two years alternately in the countries of northern, central and southern of Latin America, the event has along the time, become a traditional meeting of respected neurosurgeons, being the birthplace of idealization and legal constitution of FLANC, in 1981. Now in its 35th edition In Rio de Janeiro, from 31 March to 5 April, 2012 (www.clan2012.com), the CLAN is the living memory of neurosurgery in Latin America, logging more than 75 years of presential meetings and contributing ultimately to qualitative and quantitative expansion of the professional neurosurgical practice in our region, now in the hands of more than 7,500 neurosurgeons. All member societies that have hosted the CLAN, or other major medical event, somehow incorporated technical and / or scientific advances to the neurosurgical sector of his country, especially in the education of the local young neurosurgeons. Thats good, no doubt, but not sufficient, because it appears that most of the programming of medical congresses is still almost entirely devoted to scientific topics. Numerous other issues of vital importance for the full success in the profession are rarely addressed or discussed at these events. Based on this, in 2004, during the XXVI Congress of the Brazilian Society of Neurosurgery (SBN) was held in the city of Goiania, Brazil, the first Forum for the Political and Socioeconomic Development of Neurosurgery in Latin America.The meetings objective was to enable the broad debate of non-clinical issues that directly interfere in the professional exercise of neurosurgery in Latin America. Many communities are faced with typical problems of their local realities and due to political, economic and social similarities of countries covered by FLANC, the Latin American Congress of Neurosurgery is presented as an appropriate forum for debate and rerouting solutions to these questions. Besides Brazil, the forum has already integrated the official program of the CLAN’s held in Argentina (2006), Colombia (2008) and El Salvador (2010), with a wide variety of topics presented successfully by reputed professionals.The fifth forum is in the program of the 35th CLAN to be held in Rio Janeiro in 2012. Due to its purpose, scope and fairness, I hope the original format of the Forum can be adapted and included in programming of other national medical events. Neurocirugía-Neurocirurgia / Vol 18/2011
  10. 10. Marcos Masini The CLAN & FLANC and WFNS The congresses of neurosurgery of national coverage performed by member societies in Latin America are mostly self-sustained with a very high organizational level. The scientific programs are usually impeccable and always accompanied by an efficient logistics and a social agenda exciting and tasteful integrated in all aspects. These events draw participants from throughout the region and are invariably attended by renowned speakers from around the world. Cultural identity and language help integrate members societies affiliated to FLANC during these events. We might even say that a long trip to other continents with the simple intention of scientific updating is no longer a requirement for the professional (training) success of the neurosurgeon in Latin America. The calendar of conferences in our region is extensive and with excellent content. The Latin America Neurosurgery is ripe with strong identity and respected worldwide. The pattern of medical events held in our region in the last two decades in association with the high standard of our teaching institutions has increased significantly and contributed enormously to the training of excellence of our neurosurgeons. We must remain focused on our natural creative ability and versatility, and 10 especially in our strong sense of unity, integration and interaction. In addition to the activities of national societies, the FLANC through the holding of CLANs in many different countries, seeks to offer an important forum at the service of the neurosurgical community in our region and thus fulfill its purpose of promoting the dissemination of Knowledge, Technology, Ethics and, furthermore, to support and actively participate with the WFNS in its major challenge: unifying the world of neurosurgery without ignoring, yet, the local realities and its strategies. Marcos Masini, MD., Ph.D. Honorary President, Latin American Federation of Neurosurgical Societies Professor and Head Department of Neurosurgery, FAMEPLAC, Brazil Vice Chairman , WFNS Spine Committee Former President, Brazilian Society of Neurosurgeons Former President, Brazilian Academy of Neurosurgeons Head and Technical Director, Queops Clinic of Neurosurgery, Brazil marcos.masini@uol.com.br Neurocirugía-Neurocirurgia / Vol 18/2011
  11. 11. Mauro Loyo-Varela La gestión clínica en los hospitales.. Página del Presidente La sabiduría comienza de nuevo con cada generación y no hay ninguna arrogancia en someter a prueba continuamente el pasado 11 H.G Wells La gestión clínica en los hospitales del mundo Dr. Mauro Loyo-Varela Presidente Honorario de la FLANC Presidente Honorario de la WFNS L os Bioéticos subrayan la necesidad de fijar en el presente siglo los fines de la medicina. Según Diego Gracia, en el nuevo milenio la función de la bioética será educar a los profesionales y a la población sobre los fines de la ciencia médica, y la gestión del cuerpo y la vida. La explosión tecnológica y la revolución genética nos pueden llevar a un uso irracional de los recursos, que siempre tendrán un límite. Si queremos sobrevivir al ya presente y nuevo milenio, debemos aprender cómo conservar y priorizar el uso creciente de nuestros recursos. Nuestro futuro va directamente hacia la prevención y los excelentes cuidados asistenciales, y esta acción es directamente proporcional a la participación y compromiso con los políticos en la distribución de los recursos. La toma de decisiones en la nueva asistencia médica se basará en la bioética, desarrollando los principios de autonomía, no maleficencia, justicia y beneficencia. En las próximas décadas se van a establecer alternativas a los modelos de gestión clínica que sustituirán el paradigma actual. Las fórmulas de autogestión por áreas sanitarias se apuntan como un modelo organizativo atrevido, moderno y eficaz. Estos modelos de áreas clínicas descentralizadas, ya viven sus primeras experiencias en algunos Hospitales Públicos; con la implicación de los profesionales sanitarios en la gestión de los recursos, del área en que se integran. Descentralización en la toma de decisiones y exigencia de responsabilidad, la implantación de una nueva forma de trabajo enfocada hacia la gestión de los procesos, a la autoevaluación y a la mejora continua de los mismos. Desarrollo de un nuevo modelo de organización, que en lugar de estructurarse en los servicios clásicos, contempla el proceso en su totalidad y gire en torno al paciente. Este tipo de modelo de gestión aplana el organigrama directivo hospitalario, conlleva mayor autonomía y precisa de un gran ejercicio de delegación por parte de los órganos directivos del Hospital. Según Carreras 16 y cols. , estos modelos de autogestión por áreas, pretenden acercar la organización al cliente, mejorando la gestión de los recursos. Probablemente la implantación de áreas clínicas de autogestión se desarrollarán los próximos años, del análisis de sus resultados dependerá la alternativa al modelo actual, la puesta en marcha de un proyecto de calidad total que lo autorice avalará su eficacia. Por último para concluir, hemos de aceptar que el cambio de milenio conlleva un concepto diferente de Hospital y más que nunca debemos hacer el esfuerzo de adaptación. No debemos olvidar que el Hospital Neurocirugía-Neurocirurgia / Vol 18/2011
  12. 12. Mauro Loyo-Varela La gestión clínica en los hospitales.. del futuro va a centrar sus esfuerzos, en la gestión del conocimiento con el único objetivo de satisfacer al usuario. Los Hospitales del siglo XXI deberán trabajar dentro del engranaje que supone la asistencia extra hospitalaria e intrahospitalaria. La implicación de los profesionales y los clientes en el diseño del modelo será imperativo. La calidad total, el desarrollo tecnológico, la revolución genética, el Hospital con mayores acciones ambulatorias y las áreas de autogestión clínica, parecen formar parte del nuevo paradigma hospitalario para el presente siglo. 1. El origen de todos los hospitales fue la caridad religiosa, alojándose generalmente a los pacientes en los anexos de los conventos. 2. A partir del siglo IV de nuestra era, los cristianos iniciaron la construcción de instituciones para “Enfermos Pobres”. 3. El Hospital Público, actualmente tiene la imagen en nuestra población, que es para atender a personas indigentes o de escasos y medianos recursos económicos. 12 4. El Hospital Privado se identifica para personas con gran capacidad de pago. 5. El Hospital Público vive de subsidios de presupuestos federales. estatales y en algunos casos municipales, así como de sus cuotas de recuperación, regidas y controladas por la Beneficencia Pública Nacional a la que hay que enviarle el 5% de las mismas. 6. El Hospital Privado, es una empresa que obtiene y administra sus recursos, por cobro directo al usuario o a través de seguros privados. 7. El recurso humano en los Hospitales Públicos, percibe salarios regidos por contratos colectivos o por condiciones generales de trabajo. 8. Los honorarios de los profesionales de Hospitales Privados, los marcan ellos mismos y los acuerdos con las aseguradoras. 9. Los Hospitales Públicos la mayoría de los casos son manejados por directores y administradores sin la preparación adecuada. 10. Los Hospitales Privados tienen especialistas médicos y administrativos que les permite mejorar sus ingresos. 11. Los Hospitales Públicos a finales de año habitualmente han agotado su presupuesto. 12. Los Hospitales Privados al final de su ciclo presupuestal habitualmente recuperan recursos para la renovación o ampliación de equipos e instalaciones y hay utilidad para socios capitalistas. 13. Los Hospitales Públicos tienen patronatos o comités que obtienen recursos para apoyar a los enfermos. 14. Los Hospitales de Beneficencia Privada, consiguen de grandes instituciones fundaciones o empresas donaciones de equipo o ampliación de instalaciones. 15. Es factible que con programas objetivos perfectamente definidos, muchos Hospitales Públicos en provincia, de ciudades medias o mayores, puedan transformarse en empresas de prestación de servicios médicos. 16. Es indispensable crear verdaderos sistemas de atención médica estatal y regional. 17. Los hospitales tienden a ser más importantes en sus instalaciones de auxiliares de diagnóstico y tratamiento, que como inversión de adquisición es muy cara, por lo que se debe mutar la compra a la renta o cooparticipación de empresas proveedoras. 18. Actualmente el único sincretismo que existe entre los Hospitales Públicos y Privados es que atienden enfermos o hacen estudios preventivos para detectar posibles problemas de salud y se les llama “clientes“ y en los hospitales públicos también atienden enfermos pero se les llama “pacientes”. Los actuales Hospitales Públicos deberán de transformarse gradualmente en su organización según los puntos anteriores. En ningún momento los Gobiernos Estatales Federales y Municipales, deberán disminuir sus aportaciones para que lo obtenido por autogestión sirva inicialmente para subsanar lo faltante de los raquíticos presupuestos, y en medida que se incrementen los ingresos financieros poder ir disminuyendo por hospital pero redistribuyendo a otros en los medios suburbanos y rurales, en los que será difícil obtener recursos extraordinarios a los subsidios oficiales Neurocirugía-Neurocirurgia / Vol 18/2011
  13. 13. G. Guizzardi IntraSPINE, an interlaminar, not interspinous, Artículos Originales IntraSPINE, an interlaminar, not interspinous, posterior motion preservation device in Lumbar DDD: indications and clinical results (over 2 year follow-up) 13 Drs. G. Guizzardi*, R. Morichi*, S. Pradella**, B. Piccardi**, E. Amoruso***, M. Ceccarelli****, C.M. Mattioli*****, M. Spezia******, and P. Petrini*******. * Neurosurgical Dpt, Careggi University and City Hospital, Florence, Italy. ** Neurological Dpt, Florence University, Florence, Italy. *** Neurosurgical Dpt, City Hospital, Nocera Inferiore, Italy. **** Orthopaedics Dpt, S. Zita Hospital, Lucca, Italy. ***** Orthopaedics and Traumatology Dpt, Vimercate City Hospital, Carate Brianza, Italy. ****** Orthopaedics and Traumatology Dpt, Omega City Hospital, Verbania, Italy. *******Orthopaedics and Traumatology Dpt, City Hospital, Città di Castello, Italy. ABSTRACT All interspinous systems presently available significantly reduce, albeit in different degrees, flexion- extension and, in minor measures, bending and axial rotation. Thus we examine the efficacy of an ® interlaminar (IntraSPINE ) device in motion preservation in the treatment of lumbar DDD. 6 Italian centres enrolled a total of 120 consenting candidates over a period of 4 months. Patients were considered eligible for surgery based on the presence of degenerated disc with facet syndrome (group A), large extruded disc herniations (group B) or stenosis due to soft tissue “soft stenosis” (Group C); all pathologies were confirmed by radiographic analysis, and affected 1 or maximum 2 levels. All patients underwent 6 months conservative treatment prior to surgery. Only patients that had completed 2 year follow-up are included in these results. At present 84 patients have completed a 2 year follow-up. Group A: 31 patients. The mean VAS score improved from 8,1 to 1,3*, and the ODI from 33,8 to 12,8*. 2 patients required second surgery at 6 and 10 months; 1 patient with poor results refused further surgical treatment. Group B: 38 patients. The mean VAS score improved from 8,4 to 0,5*, and the ODI improved from 40,1 to 11,6*. No patient required further surgical treatment. No recurrences appeared. Group C: 15 patients. The mean VAS score improved from 8,0 to 1,1*, and the ODI improved from 36,5 to 11,5*. 1 patient required second surgery at 9 months for decompression. All poor results from each group are included in their respective score evaluation. The strict observation of the right indications is recommended to obtain good results. At present no device failures and/or anterior migrations have been reported. However, use of the device is recommended after failure of conservative treatment and as a first choice over more invasive surgical procedures. * final scores ® Key Words: Interlaminar, Implant, IntraSPINE Lumbar Spine, Motion Preservation Abbreviations: ROM: Range of Motion, ASD: Adjacent Segment Disease, PMP: Posterior Motion Preservation, VAS: Visual Analogue Scale, ODI: Oswestry Disability Index,DDD: Degenerative Disc Disease, AIR : Axis of Instantaneous Rotation Neurocirugía-Neurocirurgia / Vol 18/2011
  14. 14. G. Guizzardi IntraSPINE, an interlaminar, not interspinous, INTRODUCTION Current surgical management of lumbar DDD (Degenerative Disc Disease) is not standardized. Similarly, the currently known sources of pain are multiple and their origin is not always easy to determine. Improvements are necessary in the clinical success rates of pain reduction, morbidity and function. In low-back pain disorders, a literature analysis of lumbar fusion with different techniques reveals a trend that pedicle screw fixation enhances the fusion rate but not the clinical outcome (1). Fusion suggests to us that a damaged or partially immobilized interspace puts additional strain on the space above or below it, resulting in an Adjacent Segment Disease (ASD) (2). The percentage of ASD ranges from 5 to 18% in various published papers in the last year (3,4). 14 To prevent this problem, over the past two decades a new philosophy based on “Posterior Motion Preservation” (PMP) (5,6,7) has developed. Moreover, in recent years, many dynamic interspinous devices for PMP in the treatment of a lumbar spine degenerative diseases (8,9,10,11,12) have been introduced on the market. At the same time many papers have been published on the biomechanical effect (13, 14), results (15, 16) and complications (17, 18) of these devices. Assessed for Eligiblity = 190 Excluded = 70  Refused to participate = 9  Non meeting inclusive criteria = 16  Negative response to facet joint block test = 30  Unavailable for repeated follow-up = 15 Enrolled = 120 For Prospective Non Randomized Clinical Study Lost in Follow Up = 36  20 lost after one year because one center refused to give more results (personal reasons)  3 patients died (car 2 acute heart failure, 1 ANALYZED = 84 car accident)  10 refused to talk to interviewer  3 changed address At 2 years of Follow Up The aim of this study is to evaluate the efficacy of a new device not for interspinous, but for ® interlaminar assistance (IntraSPINE ) in the lumbar DDD. Neurocirugía-Neurocirurgia / Vol 18/2011
  15. 15. G. Guizzardi IntraSPINE, an interlaminar, not interspinous, METHODS After obtaining consensus and approval on the protocol from all the surgeons participating to the trial, the eligible subjects were decided. The multicenter prospective trial was conducted in 6 Italian centres and a total of 120 patients were enrolled in a period of 4 months. Patients were divided into 3 groups according to pathology prior to study initiation; Group A patients (total 43) all presented with degenerated spinal disc with facet syndrome; Figure 2a: As shown in this figure, and intelaminar Group B patients (total 56) all presented with device can be placed much closer to the AIR than an large extruded disc herniations; Group C interspinous device. patients (total 21) all presented with soft stenosis. Follow up with medical examination was carried out at 3 months, 6 months, 1 year the fundamental features of IntraSPINE® is the and 2 years post-op. difference in compression ratio between the anterior and posterior parts of the device: The Device The IntraSPINE® device (Cousin Biotech, France) The function of the anterior part, “the nose”, which is rigid and designed exactly to reproduce is a dynamic stabilization system manufactured the inferior border of the superior laminae and in medical silicon 65 shore coated by an the superior border of the inferior laminae, is adherent pure polyester terephthalate sleeve able to distract and to re-open the which accelerates formation of fibroblastic neuroforamen, which in turn re-lifts and re- tissue around the device; after three weeks aligns the facet joints, as well as re-strain the post-op, the device is completely surrounded by thickened yellow ligament due to the reduction strong tissue thus will prevent any of the disc height. The posterior part which is completely tunnelized and thus compressible, displacement. Contrarily, the anterior part, does note refrain the spinous process which must be placed between the laminae, has movement and therefore does not reduce the a frontal extremity covered by a silicone film ROM (Range of Motion). that prevents adhesion to the neural structures in cases where the yellow ligament needs to be IntraSPINE®, with respect to other posterior devices the advantage that it may be implanted removed (Fig. 1). more anteriorly (interlaminar) and thus placed even closer to the center of instantaneous rotation of the segment, which in turn allows for better decompression and correction of the physiological lordosis (Fig. 2). Figure 1: The rigid anterior part, “the nose”, duplicates the borders of the adjacent laminae it distract. The soft Figure 2 b: The 3D CT Scan reconstruction shows the exact “tunnelized” posterior does not limit movement of the positioning of the device with respect to the laminae. implanted segment. Neurocirugía-Neurocirurgia / Vol 18/2011
  16. 16. G. Guizzardi IntraSPINE, an interlaminar, not interspinous, A semirigid ligament can be used in cases of Patient Groups insufficiency of the supraspinous ligament so to as so perform a sort of ligamentoplasty. The measurement scales used to evaluate the The biomechanical tests that confirm this low back pain and function scores in the aspect were performed in the institution patients were VAS (0-10) and ODI (0-50) ENSAM (École Nationale Supérieure d’Arts et respectively. Métiers) in Paris and the results will be argument of a different paper that we are Group A (patients affected by degenerated disc preparing with the engineers of the same with facet syndrome) institution. The Facet Joint Block Test was performed on all Patient Selection and Pathologies the patients of this group so as to correctly diagnose facet syndrome. The test was carried The inclusion criteria comprised patients: out by administering 2 separate injections under fluoroscopy (19,20) of maximum 1cc per 16 1. of both sexes, with chronic low back pain facet (left /right) of the painful segment, of thought to be secondary to degenerative anaesthetics and corticosteroids. Results were disease, aged between 18 and 70 years considered positive where at least 70% of pain (inclusive) who had all already undergone reduction was achieved. conservative treatment for at least 6 months. Group A was made up of 31 patients (16 2. who were eligible for surgical procedure for females and 15 males) between the ages of 30 a. Degenerated disc with facet syndrome to 70 years (inclusive) and with a mean age of b. Large extruded disc hernias 42 years. Out of the 31 total, 27 patients c. Stenosis due to soft tissue “soft underwent single level placement, and 4 stenosis” double. d. The pathology must involve 1 or Group B (patients with large extruded disc maximum 2 levels, from L3 to S1 hernias) The candidates were evaluated prior to surgery This group was comprised of patients with large through radiographic analysis with MRI, CT Scan extruded disc hernias. Hernias were considered with sagittal, coronal and 3D reconstructions, as to be “large” in those cases where the extruded well as dynamic lumbar X-rays, so as to fragment occupied 1 to 2 thirds of the canal correctly determine the trial pathologies. area. Key Exclusion Criteria Use of the device in these patients was chosen after the removal of the extruded fragment, Despite the simple device and its relatively easy and without performing discectomy, so as to surgical technique, which is discussed further prevent the rapid collapse of the disc height on in this paper, it is of utmost importance to and the consequent discomforting chronic low keep in mind that the right indication is always back pain (21), due to facet joint syndrome. the key point to obtaining good results. For this reason, patients with pathologies such as Group B was made up of 38 patients (17 osteoporosis, spine bone tumours, allergies to females and 21 males) between the ages of 24 one or several components, infections, previous to 65 years (inclusive) and with a mean age of surgery of the lumbar spine, and instability, 39 years. All patients from Group B underwent were excluded from the trial. Other single level surgical procedure. contraindications included discogenic pain, spondylolisthesis due to isthmic lysis, Group C (patients affected by “soft stenosis” spondylolisthesis due to instability and lamina without decompression) or spinous process congenital malformation. According to the literature (22), soft stenosis is Moreover, the late stages of the degenerative a reduction of the canal area caused by disc pathologies like a disc height less than thickening of the yellow ligament with/without 7mm (measured in the central part of the discal bulging, with consequent protrusion of intervertebral space, with the use of the 2D CT these 2 soft structures into the canal. In all of scan “bone windows” sagittal reconstruction), the patients of this group, the prevalent were also considered exclusion criteria. Finally symptomatology was low back pain and not leg pregnancy, growth period in children, previous pain. lumbar surgery and compensation problems. Neurocirugía-Neurocirurgia / Vol 18/2011
  17. 17. G. Guizzardi IntraSPINE, an interlaminar, not interspinous, Thanks to the function of the anterior part of STATISTICAL METHODS ® the device, IntraSPINE was used so as to re- strain the thickened yellow ligament, thus The same statistical method was used for the reducing its width, which in turn increased the three patient groups, and the collected data area of the canal. For this reason, no was analysed with an ANOVA (Analysis of decompression was carried out on these Variants), on the VAS and ODI scores. patients. The descriptive statistics used were mean with Group C was made up of 15 patients (9 females standard deviation and median with maximum and 6 males) between the ages of 35 to 64 and minimum. The t-Test was carried out to years and with a mean age of 56 years. Of the compare the VAS and ODI results between pre- total 15, 12 underwent single level placement, op and final follow-up at 2 years. Data was and 3 double. considered significant at p < 0,05. Surgical Technique RESULTS 17 The patient was placed on the operating table The clinical results were conducted by in prone-knee position or prone with lumbar collecting and evaluating the scores of the low spine in kyphosis. The segment to be treated back pain (VAS) and function (ODI) was identified by fluoroscopy. After general or measurement scales. Only the last collection local anaesthesia a skin incision from 3,5 (single was carried out by telephone interview and level) to 6 cm (two levels) was performed in line overseen by two independent observers (S.P. with the lateral border of the spinous and B.P.). processes. With monolateral approach this is carried down to the fascia. A lot of respect was At present 84 patients were eligible for the given to keeping the supraspinous ligament follow up with an average time of 29 months intact. Removal of the interspinous ligament is (range 28 to 40). For all three groups, the VAS performed. A special distractor is inserted into and ODI pair t-Tests at pre-operative and 2 the middle of the interspinous space to enlarge years were less than 0,001. the area and to restore the right tension of the supraspinous ligament (tension band function) Group A (patients affected by degenerated disc (23). The correct implant size is indicated with and facet syndrome) the use of a sizing instrument (8, 10, 12, 14 In this group, 3 patients had poor results, 2 of mm) positioned in the interlaminar space close which required a second surgery “fusion” after to the yellow ligament. After compression of 6 and 10 months and the third refused to the device with the appropriate holder forceps ® receive further surgical treatment. The three the IntraSPINE is inserted with a clockwise poorer results are included in the score movement. The distraction and compression evaluation (Fig. 3 and Fig. 4). instruments are removed with a circular anti- clockwise movement. The immediate stability of the device is controlled by forcefully pushing and pulling the same. The skin is closed in the usual fashion and any drain is utilized. The use of a postoperative brace is not necessary but the patient is invited to avoid flexion movement for 3 weeks. The mean time of the surgical procedure is generally between 30 minutes and 1 hour and the patients can be discharged from the hospital within 24 hours. Figure 3 : The mean percent change of the symptoms severity score collected at pre-op, 3 months, 6 months, 1 year and 2 years. Neurocirugía-Neurocirurgia / Vol 18/2011
  18. 18. G. Guizzardi IntraSPINE, an interlaminar, not interspinous, No device-related intraoperative complication occurred and the surgeons were able to ® complete implantation of the IntraSPINE in all patients. Minor complications like minor fluid collection with wound swelling were reported in 7 patients from all 3 groups (5,39%). No spinous process fracture and increased pain at implanted level was described by the surgeon in any patient. Moreover, no major complications like nerve root motor deficit, dural tear, or bleeding occurred in the perioperative period. However, posterior displacement or inaccurate Group 4 : The result ofwith large placement. disc Figure B (patients double level extruded positioning (2 to 4mm posterior to the laminae) hernias) was found in 7,1% of cases, but this positioning At present no further surgical procedures have 18 did not influence the outcome of results. been necessary in this group and especially no Finally, at present no device failures and/or recurrences have appeared (Fig. 5). anterior migrations have been reported. The overall re-operation rate was 3,5% (3/84). DISCUSSION The aim of our study was to evaluate the ® efficacy of the IntraSPINE device on lumbar DDD in young and old patients. The notable results obtained at a 2 year follow-up demonstrate how an interlaminar device can alleviate the patient from chronic low back pain, and we believe that this is thanks to its Figure 5 : The mean percent change of the symptoms placement closer to the AIR compared to other severity score collected at pre-op, 3 months, 6 months, devices (interspinous). This allows us to better assist the posterior part of the disc and in turn 1 year and 2 years reduce the load in this area and in the facet joints. The material used for this device is not as rigid or incompressible as the titanium/peek/carbon material generally used for interspinous devices and this prevents further unnecessary load or possible breakage of the spinous processes, as already mentioned in the safety/complication paragraph. It must be said that devices that are manufactured in rigid materials, may only be considered as “spacers”, and “spacers” generally induce segmental kyphosis (13). To prevent all these problems, we developed Figure 6: The mean percent change of the symptoms ® this interlaminar device (IntraSPINE ) that at severity score collected at pre-op, 3 months, 6 months, 1 present is used in Europe, central and southern year and 2 years America and in some countries of Asia and the Group C (patients affected by “soft stenosis” Middle East. without decompression) With our results we clearly demonstrate that, even if the number of patients is low, with a In this group, only 1 patient required a second mini-invasive surgical procedure, that can be surgery after 9 months (decompression) and performed via a mono-lateral approach and in this poor result is included in the score local anesthesia, you can achieve good results evaluation (Fig. 6). relatively to the improvement of chronic low Safety/Complications back pain: it is of utmost importance that the invasivity of this procedure, that is completely Neurocirugía-Neurocirurgia / Vol 18/2011
  19. 19. G. Guizzardi IntraSPINE, an interlaminar, not interspinous, reversible, cannot at all be compared to a described in the late follow-up control, that this transpedicular fixation and fusion arthrodesis, type of pathology creates, especially in young even if performed by percutaneous approach. patients, very discomfortable low back pain The learning surgeon curve is very low and the (21). To be noted that in our study this result patient hospital stay, blood loss and costs are remained constant between the first post- significantly reduced. operative control at 3 months and final control at 2 years. To be noted that close observation of the right indications and an accurate selection of However, in spite of the good results we have patients is strictly recommended, even if the obtained, we should recommend the use of this minimally invasive and relatively easy surgical device only after failure of conservative procedure encourages the surgeons to an treatment, or as first choice over more invasive incorrect use of the device, as this could lead to surgical procedures. a vast amount of unsatisfactory results. The only one tip that we would like to 19 In observation of these important points, we recommend from our experience, is that if the believe we can obtain further commendable surgeon is not sure on the implant size after results even with a greater number of case distraction, because one size is too small and studies, a longer follow-up, and/or a that next size is too large, we prefer to use the randomized multicentre study that we are larger. This preference is due to the rigid “nose” scheduled to start in the next few months. In (anterior part) of the device that can be this future randomised international study we “captured” by the laminae to obtain the correct will compare the conservative treatment with distraction, achieve immediate stability of the ® the surgical insertion of IntraSPINE for patients device and also to avoid any posterior affected by chronic low back pain due to facet displacement. joint syndrome. ACKNOWLEDGEMENTS To be underlined are the important results obtained from use of the device in group C The Lead author would like to thank Chiara treated for “soft stenosis” without any type of Sodini for translation and review of the text, decompression (for this reason we believe that and Amélie Coulombel for providing the these good results are thanks only to the device images. itself – by re-stretching and reducing the size of the yellow ligament we can reduce the compression of the dural sac). To be emphasized is the fact that, at present, we have no recurrences in group B treated for large extruded disk hernias and low development of low back pain. It is well Neurocirugía-Neurocirurgia / Vol 18/2011
  20. 20. G. Guizzardi IntraSPINE, an interlaminar, not interspinous, REFERENCES 1. Boos N, Webb JK. Pedicle screw fixation in 14. Labaro BC, Brasiliense LB, Sawa AG, Reyes spinal disorders: a European view. Euro Spine PM, Theodore N, Sonntag VK, Crawford NR. Journal; 1997; 6: 2-12. Biomechanics of a novel minimally invasive 2. Cloward RB. Article and discussion appeared lumbar interspinous spacer: effects on in Journal of Neurosurgery. 15 602-617, 1958. kinematics, facet loads and foramen height. 3. Hillibrand S, Robbins M. Adjacent segment Spine; 2010; 66: 126-133. 20 degeneration and adjacent segment disease: 15. Kondrashov DG, Hannibal M, Hsu KY, the consequence of spinal fusion? The Spine Zucherman JF. Interspinous process Journal. 4, S1; 2004; S190-S194. decompression with the X-STOP device for 4. Park P, Garton HJ, Gala VC, Hoff JT, lumbar spinal stenosis; a 4-year follow-up McGillicuddy J. Adjacent Segment Disease study. Journal Spinal Disord Technology; after Lumbar or Lumbosacral Fusion: Review 2006; 19, 5: 323-327. of the Literature. Spine. Vol 29; 2004; 17: 16. Adelt D, Samani J, Kim WK, Eif M, Lowery GL, 1938-1944. Chomiak RJ. Coflex interspinous stabilization: 5. Caserta S, La Maida GA, Misaggi B. Elastic clinical and radiographic results of an stabilization alone or combined with rigid international multicenter retrospective study. fusion in spinal surgery: a biomechanical Paradigm Spine Journal; 2007; 1: 1-4. study and clinical experience based on 82 17. Chung JC, Hwang YS, Koh SH. Stress Fracture case. Euro Spine Journal.; 2002; 11 (suppl2): of bilateral posterior facet after insertion of 192-197. interspinous implant. Spine; 2009; 34, 10: 6. Markwalder TM, Wenger M. Dynamic E380-E383. Stabilization of lumbar motion segments by 18. Barbagallo GM, Olindo G, Corbino L, Albanese use of Graf’s ligaments: results with an V. Analysis of com plications in patients average follow-up of 7,4 years in 39 highly treated with the X-Stop interspinous process selected, consecutive patients. Acta decompression system: proposal for a novel Neurochirugia; 2003; 145: 209-214. anatomic scoring system for patient selection 7. Stoll TM, Dubois G, Schwarzenbach O. The and review of the literayure. Neurosurgery; dynamic neutralization system for the spine: 2009; 65, 1: 111-120. a multicenter study of a novel non-fusion 19. Carette S, Marcoux S, Truchon R, et al. A system. Euro Spine Journal; 2002; 11 (suppl controlled trial of corticosteroid injections 2): 170-178. into facet joints for chronic low back pain. N 8. Christie SD, Song JK, Fessler RG. Dynamic Engl J Med; Oct 3 1991;325(14):1002-7. Interspinous Process Technology. Spine; 2005; 20. Boswell MV, Colson JD, Sehgal N, Dunbar EE, 30, 16S, S73-S78. Epter R. A systematic review of therapeutic 9. Nockels RP. Dynamic stabilization in the facet joint interventions in chronic spinal surgical management of painful lumbar spinal pain. Pain Physician; Jan 2007;10(1):229-53. disorders. Spine; 2005; 30, 16S, S68-S72. 21. Guizzardi G, Petrini P., Morichi R, Paoli L. The 10. Sengupta DK. Dynamic stabilization devices in use of DIAM in the prevention of chronic low the treatment of low back pain. Orthop Clin back pain in yung patients operated on for Morth Am; 2004; 35: 43-56 large dimension disc herniations. Proceedings 11. Guizzardi G, Petrini P. DIAM Spinal XII° European Congress of Neurosurgery, Stabilization System Chapter 68 in Motion Monduzzi ed.; 2003; 835-839. Preservation Surgery of the Spine: Advanced 22. 2nd INTERNATIONAL MEETING. Lumbar canal techniques and controversies. Sounders stenosi between imaging and disease: Elsivier; 2007; 519-522 proposal of a new nosographic classification. 12. Dhruve J, Kaushik D. Interspinous process Spine Section of the Italian neurosurgical devices for the treatment of lumbar Society; November 27/28 2009; Naples, Italy. degenerative disease. Spine; 2009; 20, 3: 232- 23. Bono CM, Vaccaro RV. Interspinous process 237. devices in the lumbar spine. Journal Spinal 13. Wilke HJ, Drumm J, Haussler K, Mack C, Disord Technology vol 20; May 2007; 255-261. Strudel WI, Kettler A. Biomechanical effect of different lumbar interspious implants on flexibility and intradiscal pressare. Euro Spine Journal; 2008; 17: 1049-1056 Neurocirugía-Neurocirurgia / Vol 18/2011
  21. 21. Quintana Leonidas Ensayo clínico… Ensayo clínico para evaluar la acción de la Simvastatina en la prevención de la isquemia cerebral en la hemorragia subaracnoidea aneurismática Clinical trial to evaluate the action of Simvastatin in the prevention of cerebral 21 ischemia in aneurysmal subarachnoid hemorrhage *** *** Drs. Quintana Leonidas*, Bennett Carlos**, Riveros Rodrigo**, San Martín C., Loyola N (*) Profesor Adjunto, (**) Residente Cátedra de Neurocirugía, Escuela de Medicina, Universidad de Valparaíso, Chile. (***) Alumna de Medicina, Escuela de Medicina, Universidad de Valparaíso, Chile RESUMEN El vasoespasmo cerebral es una complicación temida y aun no resuelta en los pacientes que cursan con hemorragia subaracnoidea aneurismática (HSA), y que significa una importante morbi-mortalidad en dichos pacientes. Se revisaron los registros de 161 pacientes ingresados en el Hospital Carlos Van Buren de Valparaíso por HSA entre Mayo de 2007 y Agosto de 2009, comparando la aparición de complicaciones isquémicas y resultados funcionales, según fuesen o no tratados con Simvastatina (40 mg/dia). El grupo de pacientes tratados con Simvastatina presentó significativamente menos infartos cerebrales (9,30% vs. 24,58%, p=0,02) y menos mortalidad intrahospitalaria (1,24% vs. 11,80%, p=0,04). Si bien el diseño del estudio impide atribuir las diferencias encontradas al uso de Simvastatina, dado el contexto del mismo, es muy probable que así sea. El uso de estatinas en la hemorragia subaracnoidea aneurismática, como profilaxis del vasoespasmo es aún un tema controversial y promisorio, que se encuentra en plena etapa de estudio y desarrollo. Palabras Clave: Hemorragia subaracnoídea, Aneurisma Cerebral roto, Vasoespasmo Cerebral,Inhibidores de la Hidroxi-metilglutaril-CoA reductasa , Estatinas. SUMMARY Background: Vasospasm is a feared complication in patients who present with aneurysmal subarachnoid hemorrhage(SAH) and that means significant morbidity and mortality in these patients. Material and methods: We reviewed the records of 161 patients admitted to the Hospital Carlos Van Buren with SAH between May 2007 and August 2009, comparing the occurrence of ischemic complications and functional results as they were or not treated with simvastatin(40mg/day). Results: The patient group treated with simvastatin had significantly fewer strokes (p = 0.02) and fewer hospital mortality (p = 0.04) compared with the untreated group. Neurocirugía-Neurocirurgia / Vol 18/2011
  22. 22. Quintana Leonidas Ensayo clínico… Conclusions: Although the study design precludes attributing the differences found when using simvastatin, given the context, it is likely to be so. The use of statins in aneurismal subarachnoid hemorrhage for vasospasm prophylaxis is still a controversial and promising topic, which is under full development and study. Keywords: Subarachnoid Hemorrhage, Cerebral Vasospasm, Ruptured Intracranial Aneurysm, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Statins. INTRODUCCIÓN La hemorragia subaracnoidea (HSA) es una actualmente el término Manejo emergencia neurológica devastadora con una Hemodinámico, a base de agentes vasoactivos 1, 2 mortalidad en torno al 50% . Una parte y expansores del volumen circulante efectivo, importante de las muertes y secuelas ya que la hemodilución prácticamente no se 22 atribuibles a la HSA es consecuencia del utiliza. vasoespasmo cerebral. Si bien el vasoespasmo cerebral es detectable hasta en El uso de estatinas ha sido esgrimido como un 70% de los pacientes mediante angiografía, parte de la prevención del vasoespasmo post solo se hace clínicamente significativo ( HSA, sustentada fundamentalmente por 13-20 vasoespasmo angiográfico sintomático o abundante evidencia fisiopatológica y 20-23 déficit isquémico retrasado) en sólo un 20 a clínica . Sin embargo, dos metanálisis 3 consecutivos han mostrado conclusiones 30% de éstos , progresando un 50% de los 24, 25 4 contradictorias , por lo que el uso de enfermos sintomáticos a infarto cerebral . El único factor claramente identificado es la estatinas en pacientes portadores de HSA, magnitud del sangrado en el espacio como prevención y tratamiento del 5, 6 vasoespasmo aún no constituye un subaracnoídeo . La forma de tratamiento del aneurisma roto pareciera no incidir tratamiento con un buen sustento de acuerdo radicalmente en la presentación del a las evidencias clínicas. 6-8 vasoespasmo . El presente trabajo tiene por objeto revisar el En su fisiopatología intervienen distintos efecto del tratamiento con Simvastatina en la elementos, pero el rol de los intermediarios aparición de complicaciones isquémicas en la derivados de la degradación de la evolución de pacientes portadores de oxihemoglobina por auto-oxidación a meta- hemorragia subaracnoídea. hemoglobina, parece fundamentales en generar una respuesta inflamatoria, con daño MATERIALES y MÉTODO directo de membrana por radicales libres Se diseñó un estudio de corte transversal en asociada a disfunción endotelial la que que se revisaron los pacientes ingresados con mediante cambios funcionales y estructurales el diagnóstico de HSA aneurismática al en la pared arterial llevará a la disminución del 9, Servicio de Neurocirugía de HCVB en un calibre de las arterias del polígono de Willis 10 período de tiempo comprendido entre Mayo por una parte, y a isquemia cerebral distal, a de 2007 y Junio de 2009. Se compararon los nivel de la microcirculación cerebral, con un 26,27 resultados de los enfermos agrupados según real vasoespasmo a ese nivel. recibiesen o no el tratamiento con 40 mg/día En la prevención y tratamiento de la isquemia de Simvastatina diarios, aparte del por vasoespasmo cerebral, se han planteado tratamiento médico habitual (nimodipino y diversas intervenciones; a la fecha las medidas manejo hemodinámico), aprovechando el con mayor evidencia son el uso del hecho de que a partir de Septiembre de 2008 calcioantagonistas, como el nimodipino y la todos los pacientes recibieron dicho terapia hemodinámica (conocida también tratamiento por protocolo. como triple H, acrónimo de hipertensión, 11, 12 Los pacientes ingresados al estudio, debían hipervolemia y hemodilución) ; en realidad ser mayores de 15 años y tener el diagnóstico , en la práctica solo se puede plantear de HSA (con scanner y/o punción lumbar) y contar con angiografía diagnóstica de Para el análisis descriptivo se utilizaron aneurisma cerebral roto. frecuencias, media, desviación estándar (DS) e intervalos de confianza (IC95%). Se utilizaron Neurocirugía-Neurocirurgia / Vol 18/2011
  23. 23. Quintana Leonidas Ensayo clínico …... 2 además las pruebas de Chi , T Test y Mann controlado aleatorizado o un metanálisis de Whitney; para evaluar la homogeneidad de los éstos. Nuestro estudio pese a ser un estudio datos se utilizó el test de Levene. La totalidad retrospectivo, y por tanto, no randomizado, de los datos fueron analizados en el software generó dos grupos balanceados y por tanto STATA 10.0, considerándose como sin otra diferencia que el tratamiento con significativo un p-value<0.05. Simvastatina, que pudieran influir en los parámetros estudiados (tabla 1). RESULTADOS El hallazgo fundamental del presente estudio, Ciento sesenta y un enfermos cumplieron los fue el menor número de infartos cerebrales y criterios de inclusión planteados, siendo la menor mortalidad intrahospitalaria en el incluidos en el presente análisis. grupo tratado con Simvastatina. Es muy posible que dichos infartos detectados y 23 No se encontraron diferencias significativas en dichas muertes sean provocados por el las características demográficas, co- vasoespasmo esperable en la evolución de la morbilidades, modo de presentación, HSA. Sin embargo, la subutilización de localización del aneurisma y vía de exclusión, técnicas diagnósticas (angiografía de control y entre los pacientes tratados con Simvastatina doppler transcranial), que certifiquen el (43 enfermos) y los no tratados (118 vasoespasmo sospechado clínicamente impide pacientes) (tabla 1 ). un diagnóstico diferencial certero entre el vasoespasmo y otras causas de isquemia Los pacientes tratados con Simvastatina cerebral posibles en estos pacientes, como el tuvieron significativamente menor número de clipaje accidental de perforantes o la embolía infartos cerebrales durante el curso de su posterior a la instalación de coils. evolución, comparados con los no tratados (9,30% vs. 24,58%, p=0,02). Asimismo, los Por otra parte, la dosis de Simvastatina pacientes tratados con simvastatina tuvieron empleada, es menor a la publicada en la menos mortalidad intrahospitalaria (1,24% vs. literatura (40 mg/día y 80 mg/día 11,80%, p=0,04). respectivamente). Dicha diferencia pudiera subestimar los efectos del tratamiento No se encontró asociación estadísticamente indicado. significativa entre el uso de Simvastatina y vasoespasmo angiográfico, déficit neurológico En nuestra experiencia, esta es la primera al alta y mortalidad a los 6 meses (tabla 2). publicación originada en nuestro medio respecto al uso de estatinas en el manejo de DISCUSIÓN la HSA. Sin lugar a dudas, son necesarios De acuerdo a los estándares de la Medicina nuevos estudios con la metodología Basada en Evidencias, el diseño adecuado adecuada, que corroboren los hallazgos acá para responder preguntas de investigación planteados. referidas a tratamiento es el estudio clínico Declaración de conflictos de interés Ninguno de los autores declara conflictos de interés. Neurocirugía-Neurocirurgia / Vol 18/2011
  24. 24. Quintana Leonidas Ensayo clínico ….. REFERENCIAS 1. Hop JW, Rinkel GJ, Algra A, van Gijn J. Case- 9. Kolias AG, Sen J, Belli A. Pathogenesis of fatality rates and functional outcome after cerebral vasospasm following aneurysmal subarachnoid hemorrhage: a systematic subarachnoid hemorrhage: putative review. Stroke 1997;28:660-4. mechanisms and novel approaches. J Neurosci 2. Stegmayr B, Eriksson M, Asplund K. Declining Res 2009;87:1-11. mortality from subarachnoid hemorrhage: 10. Quintana L. Vasoespasmo cerebral en la changes in incidence and case fatality from hemorragia subaracnoídea aneurismática: 1985 through 2000. Stroke 2004;35:2059-63. Bases fisiopatológicas y tratamiento. Rev 3. Kassell NF, Sasaki T, Colohan AR, Nazar G. Neurocir 2002;5:1-23. Cerebral vasospasm following aneurysmal 11. Rinkel GJ, Feigin VL, Algra A, van den Bergh subarachnoid hemorrhage. Stroke WM, Vermeulen M, van Gijn J. Calcium 1985;16:562-72. antagonists for aneurysmal subarachnoid 24 4. Bederson JB, Connolly ES, Jr., Batjer HH, et al. haemorrhage. Cochrane Database Syst Rev Guidelines for the management of aneurysmal 2005:CD000277. subarachnoid hemorrhage: a statement for 12. Treggiari MM, Walder B, Suter PM, Romand healthcare professionals from a special writing JA. Systematic review of the prevention of group of the Stroke Council, American Heart delayed ischemic neurological deficits with Association. Stroke 2009;40:994-1025. hypertension, hypervolemia, and 5. Harrod CG, Bendok BR, Batjer HH. Prediction hemodilution therapy following subarachnoid of cerebral vasospasm in patients presenting hemorrhage. J Neurosurg 2003;98:978-84. with aneurysmal subarachnoid hemorrhage: a 13. Sugawara T, Jadhav V, Ayer R, Zhang J. review. Neurosurgery 2005;56:633-54; Simvastatin attenuates cerebral vasospasm discussion -54. and improves outcomes by upregulation of 6. Claassen J, Bernardini GL, Kreiter K, et al. PI3K/Akt pathway in a rat model of Effect of cisternal and ventricular blood on risk subarachnoid hemorrhage. Acta Neurochir of delayed cerebral ischemia after Suppl 2008;102:391-4. subarachnoid hemorrhage: the Fisher scale 14. Cheng G, Wei L, Zhi-Dan S, Shi-Guang Z, Xiang- revisited. Stroke 2001;32:2012-20. Zhen L. Atorvastatin ameliorates cerebral 7. Dehdashti AR, Mermillod B, Rufenacht DA, vasospasm and early brain injury after Reverdin A, de Tribolet N. Does treatment subarachnoid hemorrhage and inhibits modality of intracranial ruptured aneurysms caspase-dependent apoptosis pathway. BMC influence the incidence of cerebral vasospasm Neurosci 2009;10:7. and clinical outcome? Cerebrovasc Dis 15. Tseng MY, Hutchinson PJ, Czosnyka M, 2004;17:53-60. Richards H, Pickard JD, Kirkpatrick PJ. Effects 8. Rabinstein AA, Pichelmann MA, Friedman JA, of acute pravastatin treatment on intensity of et al. Symptomatic vasospasm and outcomes rescue therapy, length of inpatient stay, and 6- following aneurysmal subarachnoid month outcome in patients after aneurysmal hemorrhage: a comparison between surgical subarachnoid hemorrhage. Stroke repair and endovascular coil occlusion. J 2007;38:1545-50. Neurosurg 2003;98:319-25. 16. Tseng MY, Czosnyka M, Richards H, Pickard JD, 20. Sugawara T, Ayer R, Zhang JH. Role of statins Kirkpatrick PJ. Effects of acute treatment with in cerebral vasospasm. Acta Neurochir Suppl statins on cerebral autoregulation in patients 2008;104:287-90. after aneurysmal subarachnoid hemorrhage. 21. Lynch JR, Wang H, McGirt MJ, et al. Neurosurg Focus 2006;21:E10. Simvastatin reduces vasospasm after 17. McGirt MJ, Lynch JR, Parra A, et al. Simvastatin aneurysmal subarachnoid hemorrhage: results increases endothelial nitric oxide synthase and of a pilot randomized clinical trial. Stroke ameliorates cerebral vasospasm resulting from 2005;36:2024-6. subarachnoid hemorrhage. Stroke 22. Tseng MY, Czosnyka M, Richards H, Pickard JD, 2002;33:2950-6. Kirkpatrick PJ. Effects of acute treatment with 18. Sugawara T, Ayer R, Jadhav V, Zhang JH. A new pravastatin on cerebral vasospasm, grading system evaluating bleeding scale in autoregulation, and delayed ischemic deficits filament perforation subarachnoid after aneurysmal subarachnoid hemorrhage: a hemorrhage rat model. J Neurosci Methods phase II randomized placebo-controlled trial. 2008;167:327-34. Stroke 2005;36:1627-32. 19. Tseng MY, Hutchinson PJ, Turner CL, et al. 23. Parra A, Kreiter KT, Williams S, et al. Effect of Biological effects of acute pravastatin prior statin use on functional outcome and treatment in patients after aneurysmal delayed vasospasm after acute aneurysmal subarachnoid hemorrhage: a double-blind, subarachnoid hemorrhage: a matched placebo-controlled trial. J Neurosurg controlled cohort study. Neurosurgery 2007;107:1092-100. 2005;56:476-84; discussion -84. Neurocirugía-Neurocirurgia / Vol 18/2011
  25. 25. Quintana Leonidas Ensayo clínico …. 24. Sillberg VA, Wells GA, Perry JJ. Do statins 26. Quintana L. . Fisiopatología de la Hemorragia improve outcomes and reduce the incidence Subaracnoídea. En: Tratado de Neurocirugía of vasospasm after aneurysmal subarachnoid Vascular Latinoamericana. ( Pedroza A., hemorrhage: a meta-analysis. Stroke Quintana L., Perilla T. Eds.), Legis S.A., Bogotá 2008;39:2622-6. ,Colombia, 2008,pp 29-41). 25. Vergouwen MD, de Haan RJ, Vermeulen M, 27. Quintana L.: Physiopathological bases for Roos YB. Effect of statin treatment on the treament of cerebral vasospasm, In: vasospasm, delayed cerebral ischemia, and Proceedings of the 13th World Congress functional outcome in patients with of Neurological Surgery, Marrakesh, aneurysmal subarachnoid hemorrhage: a Morocco,June 19-24,2005, (A.El Khamlichi systematic review and meta-analysis update. Ed.),Medimond International Stroke;41:e47-52. Proceedings,Bologna (Italy),2005, pp 307- 31. 25 Neurocirugía-Neurocirurgia / Vol 18/2011
  26. 26. Quintana Leonidas Ensayo clínico …. ANEXOS Tabla 1. Características de los grupos estudiados Tratados con No tratados con p - value Simvastatina Simvastatina (n=43) (n=118) Sexo NS* Femenino 30 (69,8%) 83 (70,3%) Masculino 13 (30,2%) 35 (29,7%) Edad (promedio ± DE) 51,7 ± 14,4 52,6 ± 14,9 NS† Escala de Fisher modificada 1 (2,38%) 1 (0,88%) NS* 0‡ 7 (16,67%) 6 (5,31%) NS* I 4 (9,52%) 10 (8,85%) NS* II 8 (19,05%) 32 (28,32%) NS* III 22 (52,38%) 64 (56,64%) NS* IV Escala de WFNS 18 (42,86%) 36 (31,86%) NS* 1 13 (30,95%) 35 (30,97%) NS* 2 5 (11,90%) 16 (14,16%) NS* 3 6 (14,29%) 22 (19,47%) NS* 4 - 4 (3,54%) NS* 5 Modalidad terapéutica 24 (55,81%) 80 (67,80%) NS* Cirugía 19 (44,19%) 31 (26,27%) NS* Endovascular - 7 (5,93%) NS* Abstención terapéutica DE= Desviación Estándar NS= No significativo * Chi cuadrado † Mann Whitney ‡ Diagnóstico realizado por punción lumbar Neurocirugía-Neurocirurgia / Vol 18/2011

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