{"id":74896,"date":"2020-04-15T10:30:50","date_gmt":"2020-04-15T15:30:50","guid":{"rendered":"https:\/\/pulmonx.com\/transform-estudio-clinico\/"},"modified":"2021-05-03T14:44:17","modified_gmt":"2021-05-03T19:44:17","slug":"transform-estudio-clinico","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/es\/transform-estudio-clinico\/","title":{"rendered":"TRANSFORM Estudio cl\u00ednico"},"content":{"rendered":"\n
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\n \"TRANSFORM-Estudio-Clinico\" \n <\/div>\n \n \n <\/div>\n\n
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Los beneficios son acordes con los observados con la CRVP (cirug\u00eda de reducci\u00f3n del volumen pulmonar) y los resultados coherentes con los ensayos, es decir, posible disminuci\u00f3n de la morbilidad despu\u00e9s del procedimiento y reversibilidad del procedimiento de colocaci\u00f3n de v\u00e1lvulas Zephyr como opci\u00f3n de tratamiento viable en aquellos pacientes que siguen sintom\u00e1ticos en tratamiento m\u00e9dico m\u00e1ximo.2<\/sup><\/a><\/p>\n<\/blockquote> <\/div>\n<\/div>\n <\/div>\n

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Publicado en The American Journal of Respiratory and Critical Care Medicine2<\/a><\/sup><\/h1>\n

Ensayo controlado aleatorizado, multinacional y multic\u00e9ntrico de v\u00e1lvulas endobronquiales Zephyr\u00ae<\/sup> en pacientes con enfisema heterog\u00e9neo y poca o ninguna ventilaci\u00f3n colateral.<\/p>\n

M\u00e9todos y criterios de valoraci\u00f3n<\/h3>\n
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    97 pacientes con enfisema heterog\u00e9neo confirmados como negativos a la ventilaci\u00f3n colateral con el sistema Chartis\u00ae<\/span><\/sup> y que probablemente responder\u00edan al tratamiento con v\u00e1lvulas Zephyr, que se aleatorizaron en una proporci\u00f3n 2:1 para el tratamiento con v\u00e1lvulas Zephyr o el tratamiento est\u00e1ndar.<\/p>\n<\/li>\n

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    Para los pacientes tratados con v\u00e1lvulas Zephyr, se seleccionaron los l\u00f3bulos afectados a partir de las puntuaciones de destrucci\u00f3n del enfisema y el deterioro de la perfusi\u00f3n regional, y se ocluyeron por completo con v\u00e1lvulas.<\/p>\n<\/li>\n

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    La posici\u00f3n de las v\u00e1lvulas se evalu\u00f3 a los 45 d\u00edas despu\u00e9s del implante mediante TC, y se retiraron y sustituyeron en los casos necesarios.<\/p>\n<\/li>\n<\/ul> <\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n

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    Dise\u00f1o del ensayo<\/h2> <\/div>\n<\/div>\n\n
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    \n \"TRANSFORM-Study-Design-Spanish-1\" \n <\/div>\n \n \n <\/div>\n\n
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    Motivos de retirada de consentimiento<\/h3>\n
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    • 5 pacientes tratados con v\u00e1lvulas Zephyr antes de la consulta de los 3 meses: 1 anatom\u00eda dif\u00edcil para la colocaci\u00f3n de v\u00e1lvulas Zephyr; 1 experiment\u00f3 2 neumot\u00f3rax y empeoramiento de la EPOC; 2 no percibieron ning\u00fan beneficio; 1 no cumpl\u00eda los requisitos, retirado por el investigador<\/li>\n
    • 1 paciente tratado con v\u00e1lvulas Zephyr entre las consultas de los 3 y los 6 meses: Empeoramiento de la EPOC, se retiraron todas las v\u00e1lvulas, el paciente retir\u00f3 su consentimiento<\/li>\n
    • 1 paciente con tratamiento de referencia antes de la consulta de los 3 meses: Sali\u00f3 del ensayo para someterse al tratamiento con v\u00e1lvulas Zephyr fuera del ensayo<\/li>\n<\/ul> <\/div>\n<\/div>\n\n
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      Resultados<\/h2> <\/div>\n<\/div>\n
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      Criterio de valoraci\u00f3n principal<\/h4>\n

      Porcentaje de pacientes que logran una mejora del 12% o mayor en VEF1<\/sub> (l)<\/p> <\/div>\n<\/div>\n\n

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background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html><\/h5> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_gqfc225 last\">\n <!-- module text -->\n<div class=\"module module-text tb_uj4n492 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Figura 2b: Mejora de DR6<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM Study Page - Spanish: TRANSFORM - 6MWD - Line | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" 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\"-1.3\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t]\r\n\t\t\t\t}\r\n\t\t\t);\r\n\t\t<\/script>\r\n\t<\/head>\r\n\t<body>\r\n\t\t<div id=\"spanish-transform-bode-line\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html><\/h5> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_n16j714 last\">\n <!-- module text -->\n<div class=\"module module-text tb_ev1z715 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5><strong>3 Meses<\/strong><br \/>V\u00e1lvula Zephyr n=65, TR n=32<\/h5>\n<h5><strong>6 Meses<\/strong><br \/>V\u00e1lvula Zephyr n=65, TR n=32<\/h5>\n<h6 class=\"p1\">Leyenda de la Figura 2: Los datos que se muestran son medias de \u00b1 SEM de cambios con respecto al valor inicial de referencia transcurridos 3 y 6 meses despu\u00e9s de broncoscopia para la v\u00e1lvula Zephyr, TR y la diferencia entre la v\u00e1lvula Zephyr y TR Figura 2a: VEF1\u00a0(l); Figura 2b: prueba de marcha de 6 minutos (m); Figura 2c: VR(L) Figura 2d: Cuestionario respiratorio St.George; y Figura 2e: \u00cdndice BODE<\/h6> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_kgi885\">\n <div data-lazy=\"1\" class=\"module_column sub_column col-full tb_gf5k87 first\">\n <!-- module divider -->\n<div class=\"module tf_mw module-divider tb_gb3g584 solid \" style=\"border-width: 1px;border-color: #3095b4;margin-top: 10px;margin-bottom: 40px;\" data-lazy=\"1\">\n <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div class=\"module module-text tb_u6r8619 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h2 class=\"p1\">Conclusi\u00f3n<\/h2>\n<p>El tratamiento con v\u00e1lvulas Zephyr<sup>\u00ae<\/sup> produce beneficios cl\u00ednica y estad\u00edsticamente significativos en la funci\u00f3n pulmonar, la disnea, la tolerancia al ejercicio y la calidad de vida en comparaci\u00f3n con el tratamiento de referencia cuando se utiliza en pacientes con hiperinsuflaci\u00f3n y enfisema heterog\u00e9neo sin ventilaci\u00f3n colateral en el l\u00f3bulo afectado.<\/p>\n<p>Entre las complicaciones del tratamiento con la v\u00e1lvula endobronquial Zephyr, se pueden incluir, entre otras, neumot\u00f3rax, empeoramiento de la sintomatolog\u00eda de EPOC, hemoptisis, neumon\u00eda, disnea y, con escasa incidencia, fallecimiento.<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<!--\/themify_builder_content-->","protected":false},"excerpt":{"rendered":"<p>Ensayo controlado aleatorizado, multinacional y multic\u00e9ntrico de v\u00e1lvulas endobronquiales Zephyr\u00ae en pacientes con enfisema heterog\u00e9neo y poca o ninguna ventilaci\u00f3n colateral.<\/p>\n","protected":false},"author":2,"featured_media":75355,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[51],"tags":[],"class_list":["post-74896","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-evidencia-clinica","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>TRANSFORM Estudio cl\u00ednico - Pulmonx<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pulmonx.com\/es\/transform-estudio-clinico\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" 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