Eficacia y seguridad del stent Pipeline Vantage Shield versus el stent Pipeline Flex Shield en pacientes con aneurismas intracraneales no rotos, estudio multicéntrico

dc.contributor.advisorSerrano Gómez, Sergio Eduardo
dc.contributor.advisorMantilla García, Daniel Eduardospa
dc.contributor.apolounabMantilla García, Daniel Eduardo [daniel-eduardo-mantilla-garcía]spa
dc.contributor.apolounabSerrano Gómez, Sergio Eduardo [sergio-eduardo-serrano-gomez-2]spa
dc.contributor.authorCatalá, Andrés José
dc.contributor.cvlacMantilla García, Daniel Eduardo [0001437130]spa
dc.contributor.cvlacSerrano Gómez, Sergio Eduardo [0001521095]spa
dc.contributor.googlescholarCatalá, Andrés José [4p-5O-YAAAAJ]spa
dc.contributor.googlescholarMantilla García, Daniel Eduardo [es&oi=ao]spa
dc.contributor.orcidCatalá, Andrés José [0000-0003-3339-6630]spa
dc.contributor.orcidMantilla García, Daniel Eduardo [0000-0003-1532-2101]spa
dc.contributor.orcidSerrano Gómez, Sergio Eduardo [0000-0002-3119-0439]spa
dc.contributor.scopusCatalá, Andrés José [7811136500]spa
dc.coverage.campusUNAB Campus Bucaramangaspa
dc.coverage.spatialFloridablanca (Santander, Colombia)spa
dc.coverage.temporalEnero del 2017 y Mayo del 2023spa
dc.date.accessioned2024-11-21T19:27:04Z
dc.date.available2024-11-21T19:27:04Z
dc.date.issued2024-10-01
dc.degree.nameEspecialista en Radiología Intervencionistaspa
dc.description.abstractIntroducción y objetivos: Los aneurismas intracraneales no rotos son abultamientos patológicos de las paredes arteriales que pueden romperse y causar una hemorragia subaracnoidea. Recientemente se han utilizado endoprótesis con superficies modificadas como tratamiento de los aneurismas intracraneales. Así pues, la comparación de la eficacia y la seguridad de la endoprótesis Pipeline Flex Shield y la endoprótesis Pipeline Vantage Shield contribuye a la literatura científica. Con el objetivo de determinar la eficacia de estas endoprótesis, creemos que la endoprótesis pipeline vantage shield es tan eficaz y segura como la endoprótesis pipeline flex shield en el tratamiento de pacientes con aneurismas no rotos. Materiales y métodos: Analizamos datos a través de una cohorte multicéntrica anonimizada de múltiples servicios de radiología intervencionista en Colombia desde enero de 2017 hasta junio de 2023. Resultados: 574 aneurismas intracraneales no rotos en 546 pacientes. A los 12 meses, los resultados angiográficos globales adecuados de la escala de clasificación O'Kelly-Marotta (OKM C-D) fueron del 83,13%. Para la endoprótesis Pipeline Embolization Device con tecnología Vantage (PEDV) fue del 97,47% y para la endoprótesis Pipeline Flex Embolization Device con tecnología Shield (PED-Shield) del 80,39% (p< 0,001). Mortalidad (0,93%, p=0,342) y morbilidad global 0,53% (PEDV 0,35% y PED-Shield 0,17%). Eventos de complicaciones globales 3,1%, eventos tromboembólicos 2,11% en el stent PED-Shield y 6,7% en el stent PEDV (p=0,008). (p=0,342) Las complicaciones hemorrágicas globales fueron del 1,74%, en el stent PED-Shield (0,92%) y dos en el stent PEDV (1,45%). Conclusiones: El stent PEDV mejoró la eficacia en comparación con el stent PED-Shield a los 12 meses, mientras que el stent PED-Shield mostró un perfil de seguridad ligeramente mejor.spa
dc.description.abstractenglishBackground and Purpose: Unruptured intracranial aneurysms are pathological bulging of the arterial walls that could rupture and cause subarachnoid hemorrhage. Recently, stents with modified surfaces have been used as treatment for intracranial aneurysms. Thus, comparing efficacy and security of the pipeline flex shield stent and the pipeline vantage shield stent contributes to the scientific literature. Aiming to determine the efficacy of these stents, we believe the pipeline vantage shield stent is as effective and safe as the pipeline flex shield stent in management of patients with unruptured aneurysms. Materials and Methods: We analyzed data through an anonymized, multicentered-cohort from multiple interventional radiology services in Colombia from January 2017 until June 2023. Results: 574 unruptured intracranial aneurysms in 546 patients. At 12 months, overall adequate O’Kelly-Marotta grading scale (OKM C-D) angiographic results was 83.13%. For the Pipeline Embolization Device with Vantage Technology (PEDV) stent was 97.47% and for the Pipeline Flex Embolization Device with Shield Technology (PED-Shield) stent 80.39 % (p< 0.001). Mortality (0.93%, p=0.342) and overall morbidity 0.53% (PEDV 0.35% and 0.17% PED-Shield). Overall complications events 3.1%, thromboembolic events 2.11% in the PED-Shield stent and 6.7% in the PEDV stent (p=0.008). (p=0.342) Overall bleeding complications were 1.74%, in the PED-Shield stent (0.92%) and two in PEDV stent (1.45%). Conclusion: The PEDV stent improved efficacy in comparison with PED-Shield stent at 12-months while the PED-Shield stent showed a slightly better safety profile.spa
dc.description.degreelevelEspecializaciónspa
dc.description.learningmodalityModalidad Presencialspa
dc.description.tableofcontentsIntroducción ........................................................................................................................................6 Justificación ........................................................................................................................................7 Planteamiento del problema ...............................................................................................................8 Marco teórico .................................................................................................................................... 11 Definición ...................................................................................................................................... 11 Epidemiología ............................................................................................................................... 11 Factores de riesgo ......................................................................................................................... 12 Manifestaciones clínicas ................................................................................................................ 12 Diagnóstico ................................................................................................................................... 13 Tratamiento ................................................................................................................................... 13 Estado del arte.................................................................................................................................. 15 Pregunta de investigación ................................................................................................................. 18 Objetivos ........................................................................................................................................... 18 Objetivo general ............................................................................................................................ 18 Objetivos específicos .................................................................................................................... 18 Hipótesis ........................................................................................................................................... 19 Metodología ...................................................................................................................................... 19 Tipo de estudio .............................................................................................................................. 19 Población ...................................................................................................................................... 19 Tamaño de muestra .......................................................................................................................... 20 Criterios de inclusión ..................................................................................................................... 21 Criterios de exclusión .................................................................................................................... 21 Variables ....................................................................................................................................... 21 Recolección de la información .......................................................................................................... 24 Control de sesgos ......................................................................................................................... 25 Plan de análisis ................................................................................................................................. 25 Análisis univariado ........................................................................................................................ 25 Análisis bivariado .......................................................................................................................... 25 Consideraciones éticas ..................................................................................................................... 26 Cronograma de actividades .............................................................................................................. 28 Resultados ........................................................................................................................................ 28 Resultados de eficacia .................................................................................................................. 31 Complicaciones ............................................................................................................................. 33 Eventos tromboembólicos ............................................................................................................. 33 Eventos hemorrágicos neurológicos y no neurológicos ................................................................. 34 Mortalidad ..................................................................................................................................... 35 Morbilidad ..................................................................................................................................... 36 Antiagregantes y anticoagulación .................................................................................................. 37 Independencia funcional ............................................................................................................... 38 Discusión .......................................................................................................................................... 39 Características de los pacientes y aneurismas .............................................................................. 39 Resultados de eficacia .................................................................................................................. 39 Seguridad y complicaciones .......................................................................................................... 40 Inadecuada aposición de la pared del stent ............................................................................... 41 Hiperplasia intimal ..................................................................................................................... 41 Limitaciones ............................................................................................................................... 41 Conclusión ........................................................................................................................................ 42 Referencias ...................................................................................................................................... 42spa
dc.format.mimetypeapplication/pdfspa
dc.identifier.instnameinstname:Universidad Autónoma de Bucaramanga - UNABspa
dc.identifier.reponamereponame:Repositorio Institucional UNABspa
dc.identifier.repourlrepourl:https://repository.unab.edu.cospa
dc.identifier.urihttp://hdl.handle.net/20.500.12749/27513
dc.language.isospaspa
dc.publisher.facultyFacultad Ciencias de la Saludspa
dc.publisher.grantorUniversidad Autónoma de Bucaramanga UNABspa
dc.publisher.programEspecialización en Radiología Intervencionistaspa
dc.publisher.programidERI-2152
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dc.relation.references25. Starke RM, Thompson J, Pagani A, Choubey A, Wainwright JM, Wolf MF, et al. Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology. Journal of NeuroInterventional Surgery [Internet]. 2020 Oct 1 [cited 2023 Mar 4];12(10):981–6. Available from: https://jnis.bmj.com/content/12/10/981spa
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dc.rights.accessrightsinfo:eu-repo/semantics/openAccessspa
dc.rights.creativecommonsAtribución-NoComercial-SinDerivadas 2.5 Colombiaspa
dc.rights.localAbierto (Texto Completo)spa
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/2.5/co/*
dc.subject.keywordsMedical sciencesspa
dc.subject.keywordsHealth sciencesspa
dc.subject.keywordsUnruptured intracranial aneurysmspa
dc.subject.keywordsIntracranial aneurysmspa
dc.subject.keywordsCerebrovascular diseasespa
dc.subject.keywordsPublic healthspa
dc.subject.keywordsEpidemiologyspa
dc.subject.keywordsRadiodiagnosisspa
dc.subject.keywordsMedical X-rayspa
dc.subject.keywordsDiagnostic imagingspa
dc.subject.lembCiencias médicasspa
dc.subject.lembEnfermedad cerebrovascularspa
dc.subject.lembSalud públicaspa
dc.subject.lembEpidemiologíaspa
dc.subject.lembRadiodiagnósticospa
dc.subject.lembRadiografía médicaspa
dc.subject.lembDiagnóstico por imagenspa
dc.subject.proposalCiencias de la saludspa
dc.subject.proposalAneurisma intracranealspa
dc.subject.proposalAneurisma intracraneal no rotospa
dc.subject.proposalPEDspa
dc.titleEficacia y seguridad del stent Pipeline Vantage Shield versus el stent Pipeline Flex Shield en pacientes con aneurismas intracraneales no rotos, estudio multicéntricospa
dc.title.translatedEfficacy and safety in the use of Pipeline Vantage Shield stent versus Pipeline Flex Shield stent in the treatment of patients with unruptured intracranial aneurysms: a multicenter studyspa
dc.typeThesiseng
dc.type.coarhttp://purl.org/coar/resource_type/c_bdcc
dc.type.coarversionhttp://purl.org/coar/version/c_ab4af688f83e57aaspa
dc.type.driverinfo:eu-repo/semantics/masterThesisspa
dc.type.hasversioninfo:eu-repo/semantics/acceptedVersionspa
dc.type.localTesisspa
dc.type.redcolhttp://purl.org/redcol/resource_type/TMspa

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