{"id":75446,"date":"2020-04-27T12:55:15","date_gmt":"2020-04-27T17:55:15","guid":{"rendered":"https:\/\/pulmonx.com\/transform-etude-clinique\/"},"modified":"2021-05-03T14:47:06","modified_gmt":"2021-05-03T19:47:06","slug":"transform-etude-clinique","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/fr\/transform-etude-clinique\/","title":{"rendered":"TRANSFORM \u00c9tude clinique"},"content":{"rendered":"\n
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\n \"PMX-Corporate-Website-Assets_ForTranslation-French-TRANSFORM-Logo\" \n <\/div>\n \n \n <\/div>\n\n
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\u00ab Les b\u00e9n\u00e9fices sont conformes \u00e0 ceux observ\u00e9s avec la chirurgie de r\u00e9duction du volume pulmonaire (CRVP), et les r\u00e9sultats coh\u00e9rents des essais, la r\u00e9duction potentielle de la morbidit\u00e9 post-proc\u00e9dure et la r\u00e9versibilit\u00e9 de la proc\u00e9dure positionnent le traitement Zephyr comme une option de traitement viable chez ceux qui restent symptomatiques sous traitement m\u00e9dical maximal. \u00bb2<\/sup><\/a><\/p>\n

\u00a0<\/p>\n<\/blockquote> <\/div>\n<\/div>\n <\/div>\n

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Publi\u00e9 dans la revue American Journal of Respiratory and Critical Care Medicine2<\/sup><\/a><\/h1>\n

Une \u00e9tude multicentrique, multinationale, randomis\u00e9e et contr\u00f4l\u00e9e \u00e9valuant les valves endobronchiques Zephyr\u00ae<\/sup> chez des patients atteints d\u2019emphys\u00e8me h\u00e9t\u00e9rog\u00e8ne et pr\u00e9sentant une ventilation collat\u00e9rale faible ou inexistante.<\/p>\n

M\u00e9thodes et crit\u00e8res d\u2019\u00e9valuation<\/h3>\n
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    97 patients pr\u00e9sentant un emphys\u00e8me h\u00e9t\u00e9rog\u00e8ne avec une ventilation collat\u00e9rale (VC) inexistante et une probabilit\u00e9 de r\u00e9pondre au traitement par la valve Zephyr (s\u00e9lection \u00e0 l\u2019aide du syst\u00e8me Chartis\u00ae<\/sup><\/span>) ont \u00e9t\u00e9 randomis\u00e9s selon un rapport 2:1 soit dans le groupe trait\u00e9 par la valve Zephyr, soit dans le groupe recevant une prise en charge m\u00e9dicale standard.<\/p>\n<\/li>\n

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    Pour les patients trait\u00e9s par la valve Zephyr, les lobes cibles ont \u00e9t\u00e9 s\u00e9lectionn\u00e9s en fonction des scores obtenus lors de l\u2019\u00e9valuation du degr\u00e9 de destruction caus\u00e9e par l\u2019emphys\u00e8me et en fonction des troubles r\u00e9gionaux de la perfusion. Ensuite ils ont \u00e9t\u00e9 compl\u00e8tement obtur\u00e9s \u00e0 l\u2019aide de valves.<\/p>\n<\/li>\n

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    Le positionnement de la valve a \u00e9t\u00e9 \u00e9valu\u00e9 45 jours apr\u00e8s la pose de l’implant gr\u00e2ce \u00e0 une tomodensitom\u00e9trie et la valve a \u00e9t\u00e9 retir\u00e9e et remplac\u00e9e si n\u00e9cessaire.<\/p>\n<\/li>\n<\/ul> <\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n

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    Conception de l\u2019\u00e9tude<\/h2> <\/div>\n<\/div>\n\n
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    \n \"TRANSFORM-Study-Design-French\" \n <\/div>\n \n \n <\/div>\n\n
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    Raisons des retraits de consentement<\/h3>\n
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    • 5 sujets trait\u00e9s par valve Zephyr avant la visite du 3e mois : 1 anatomie difficile pour le placement de la valve Zephyr; 1 a subi deux pneumothorax et une aggravation de la BPCO; 2 pour manque de b\u00e9n\u00e9fice per\u00e7u; 1 sujet non conforme retir\u00e9 par l\u2019investigateur<\/li>\n
    • 1 sujet trait\u00e9 par valve Zephyr entre la visite du 3e mois et celle du 6e mois: aggravation de la BPCO, retrait de toutes les valves, le sujet a retir\u00e9 son consentement<\/li>\n
    • 1 sujet en traitement m\u00e9dical standard avant la visite du 3e mois: a quitt\u00e9 l’\u00e9tude pour poursuivre le traitement par valve Zephyr en dehors de l’\u00e9tude<\/li>\n<\/ul> <\/div>\n<\/div>\n\n
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      R\u00e9sultats<\/h2> <\/div>\n<\/div>\n
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      Crit\u00e8re primaire d\u2019\u00e9valuation<\/h4>\n

      Pourcentage de sujets obtenant une am\u00e9lioration de 12% ou plus du VEMS1<\/sub> (l)<\/p> <\/div>\n<\/div>\n\n

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class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Figure 2b : Am\u00e9lioration du TM6<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM Study Page - French: 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\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script type=\"text\/javascript\">\r\n\t\t\tAmCharts.makeChart(\"french-transform-page-6mwd-line\",\r\n\t\t\t\t{\r\n \t\t\"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": 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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>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_2 tb_cruh711\">\n <div data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_aayz713 first\">\n <!-- module text -->\n<div class=\"module module-text tb_as6s700 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Figure 2c : Am\u00e9lioration du VR<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM Study Page - French: TRANSFORM - RV - 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\" 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class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Figure 2d : Am\u00e9lioration du QRSG<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM Study Page - French: TRANSFORM - SGRQ - 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\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script type=\"text\/javascript\">\r\n\t\t\tAmCharts.makeChart(\"french-transform-page-sgrq-line\",\r\n\t\t\t\t{\r\n \t\t\"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": 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id=\"french-transform-page-sgrq-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>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_2 tb_9tn2447\">\n <div data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_clt3448 first\">\n <!-- module text -->\n<div class=\"module module-text tb_4jk2449 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Figure 2e : Am\u00e9lioration de l\u2019indice BODE<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM Study Page - French: TRANSFORM - BODE - 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\" 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module-text tb_k2sn450 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5><strong>3 mois<\/strong><br \/>Valve Zephyr n=65, TS n=32<\/h5>\n<h5><strong>6 mois<\/strong><br \/>Valve Zephyr n=65, TS n=32<\/h5>\n<h6 class=\"p1\">L\u00e9gende de la Figure 2: Les donn\u00e9es pr\u00e9sent\u00e9es sont des moyennes \u00b1 ET pour les variations par rapport au d\u00e9but de l’\u00e9tude \u00e0 3 et 6 mois apr\u00e8s la bronchoscopie pour la valve Zephyr, le TS et la diff\u00e9rence entre la valve Zephyr et le TS. Figure 2a: VEMS<span class=\"s1\">1<\/span> (l); Figure 2b: Test de marche de 6 minutes (m); Figure 2c: VR (l); Figure 2d: Questionnaire respiratoire St. George; et Figure 2e: Indice 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\">Conclusion<\/h2>\n<p>Par rapport au traitement standard actuel, le traitement par valve Zephyr<sup>\u00ae<\/sup> pr\u00e9sente des b\u00e9n\u00e9fices consid\u00e9rables sur les plans clinique et statistique au niveau de la fonction pulmonaire, de la dyspn\u00e9e, de la tol\u00e9rance \u00e0 l\u2019activit\u00e9 physique et de la qualit\u00e9 de vie lorsqu’il est utilis\u00e9 chez des sujets pr\u00e9sentant une hyperinflation avec un emphys\u00e8me h\u00e9t\u00e9rog\u00e8ne sans ventilation collat\u00e9rale dans le lobe cible.<\/p>\n<p>Les complications du traitement par valve endobronchique Zephyr peuvent notamment comprendre un pneumothorax, une aggravation des sympt\u00f4mes de BPCO, une h\u00e9moptysie, une pneumonie, une dyspn\u00e9e et, dans de rares cas, la mort.<\/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>Une \u00e9tude multicentrique, multinationale, randomis\u00e9e et contr\u00f4l\u00e9e \u00e9valuant les valves endobronchiques Zephyr\u00ae chez des patients atteints d\u2019emphys\u00e8me h\u00e9t\u00e9rog\u00e8ne et pr\u00e9sentant une ventilation collat\u00e9rale faible ou inexistante.<\/p>\n","protected":false},"author":2,"featured_media":75922,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[54],"tags":[],"class_list":["post-75446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-preuves-cliniques","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 - 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