{"id":74917,"date":"2020-04-20T11:03:09","date_gmt":"2020-04-20T16:03:09","guid":{"rendered":"https:\/\/pulmonx.com\/transform-studio-clinico\/"},"modified":"2021-03-16T13:22:59","modified_gmt":"2021-03-16T18:22:59","slug":"transform-studio-clinico","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/it\/transform-studio-clinico\/","title":{"rendered":"TRANSFORM Studio clinico"},"content":{"rendered":"\n
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\n \"PMX-Corporate-Website-Assets_ForTranslation-Italian-TRANSFORM-Logo\" \n <\/div>\n \n \n <\/div>\n\n
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\u201cI benefici sono in linea con quelli osservati con la procedura LVRS (riduzione chirurgica di volume polmonare) e i risultati costanti nello studio, la potenziale riduzione della morbilit\u00e0 post-procedura e la reversibilit\u00e0 della procedura posizionano il trattamento con Zephyr come opzione di trattamento praticabile per i pazienti che rimangono sintomatici durante una terapia medica massimale.\u201d2<\/sup><\/a><\/p>\n

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

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

Uno studio controllato randomizzato, multicentrico, multinazionale relativo alle valvole endobronchiali Zephyr\u00ae<\/sup> in pazienti con enfisema eterogeneo e ventilazione collaterale scarsa o assente.<\/p>\n

Metodi ed endpoint<\/h3>\n
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    97 pazienti affetti da enfisema eterogeneo con assenza di ventilazione collaterale (CV) confermata con il sistema Chartis\u00ae<\/span><\/sup> e probabili responder al trattamento con valvola Zephyr, randomizzati 2:1 al trattamento con valvola Zephyr o alla gestione medica.<\/p>\n<\/li>\n

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    Per i pazienti trattati con valvola Zephyr, i lobi da trattare sono stati scelti in base ai punteggi di distruzione del tessuto causata dall\u2019enfisema e dalla riduzione della perfusione regionale, quindi sono stati occlusi completamente con le valvole.<\/p>\n<\/li>\n

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    Il posizionamento delle valvole \u00e8 stato valutato 45 giorni post-impianto mediante TAC e, se necessario, la valvola \u00e8 stata rimossa e sostituita.<\/p>\n<\/li>\n<\/ul> <\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n

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    Disegno dello studio<\/h2> <\/div>\n<\/div>\n\n
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    \n \"TRANSFORM-Study-Design-Italian\" \n <\/div>\n \n \n <\/div>\n\n
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    Motivi dei ritiri del consenso<\/h3>\n
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    • 5 soggetti con valvola Zephyr prima della visita a 3 mesi: 1 per anatomia con difficolt\u00e0 di posizionamento della valvola Zephyr; 1 ha sperimentato due pneumotoraci e un peggioramento della BPCO; 2 per assenza di benefici percepiti; 1 ritirato dallo sperimentatore per mancata compliance<\/li>\n
    • 1 soggetto con valvola Zephyr tra la visita a 3 mesi e a 6 mesi: Peggioramento della BPCO; rimozione di tutte le valvole e ritiro del consenso da parte del soggetto<\/li>\n
    • 1 soggetto trattato con standard di cura prima della visita a 3 mesi: Uscita dallo studio per ottenere il trattamento con valvola Zephyr al di fuori dello studio<\/li>\n<\/ul> <\/div>\n<\/div>\n\n
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      Risultati<\/h2> <\/div>\n<\/div>\n
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      Endpoint primario<\/h4>\n

      Percentuale di soggetti che hanno raggiunto un miglioramento del FEV1<\/sub> (L) pari o superiore al 12%<\/p> <\/div>\n<\/div>\n\n

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\"-.13\",\r\n\t\t\t\t\t\t\t\"Control open\": \"-.07\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-.13\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \".23\",\r\n\t\t\t\t\t\t\t\"Difference High\": \".28\",\r\n\t\t\t\t\t\t\t\"Difference Low\": \".17\",\r\n\t\t\t\t\t\t\t\"Difference Open\": \".28\",\r\n\t\t\t\t\t\t\t\"Difference Close\": \".17\"\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=\"transform-italian-fev-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 col3-1 tb_gqfc225\">\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: Miglioramento della 6MWD<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM Study Page - Italian: 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(\"transform-italian-6mwd-line\",\r\n\t\t\t\t{\r\n \"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": \"serial\",\r\n\t\t\t\t\t\"categoryField\": \"category\",\r\n\t\t\t\t\t\"autoMarginOffset\": 0,\r\n\t\t\t\t\t\"autoMargins\": false,\r\n\t\t\t\t\t\"marginBottom\": 60,\r\n\t\t\t\t\t\"marginLeft\": 76,\r\n\t\t\t\t\t\"sequencedAnimation\": false,\r\n\t\t\t\t\t\"startDuration\": 2,\r\n\t\t\t\t\t\"startEffect\": \"easeOutSine\",\r\n\t\t\t\t\t\"accessibleTitle\": \"miglioramentodella6mwd\",\r\n\t\t\t\t\t\"backgroundAlpha\": 0.8,\r\n\t\t\t\t\t\"decimalSeparator\": \",\",\r\n\t\t\t\t\t\"fontFamily\": \"Arial\",\r\n\t\t\t\t\t\"fontSize\": 14,\r\n\t\t\t\t\t\"pathToImages\": \"http:\/\/cdn.amcharts.com\/lib\/3\/images\/\",\r\n\t\t\t\t\t\"percentPrecision\": 1,\r\n\t\t\t\t\t\"precision\": 1,\r\n\t\t\t\t\t\"theme\": \"light\",\r\n\t\t\t\t\t\"categoryAxis\": {\r\n\t\t\t\t\t\t\"classNameField\": \"\",\r\n\t\t\t\t\t\t\"gridPosition\": \"start\",\r\n\t\t\t\t\t\t\"axisThickness\": 0,\r\n\t\t\t\t\t\t\"boldLabels\": true,\r\n\t\t\t\t\t\t\"centerLabels\": true,\r\n\t\t\t\t\t\t\"fontSize\": 14,\r\n\t\t\t\t\t\t\"gridColor\": \"#FFFFFF\",\r\n\t\t\t\t\t\t\"tickLength\": 0,\r\n\t\t\t\t\t\t\"title\": \"\"\r\n\t\t\t\t\t},\r\n\t\t\t\t\t\"trendLines\": [],\r\n\t\t\t\t\t\"graphs\": [\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"accessibleLabel\": \"TRANSFORM - Miglioramento della 6MWD\",\r\n\t\t\t\t\t\t\t\"balloonText\": \"\",\r\n\t\t\t\t\t\t\t\"closeField\": \"EBV close\",\r\n\t\t\t\t\t\t\t\"clustered\": false,\r\n\t\t\t\t\t\t\t\"columnWidth\": 0,\r\n\t\t\t\t\t\t\t\"dashLengthField\": \"column-2\",\r\n\t\t\t\t\t\t\t\"fillAlphas\": 1,\r\n\t\t\t\t\t\t\t\"fillColors\": \"#000000\",\r\n\t\t\t\t\t\t\t\"fixedColumnWidth\": 2,\r\n\t\t\t\t\t\t\t\"highField\": \"EBV Candle High\",\r\n\t\t\t\t\t\t\t\"id\": \"Candlestick - EBV\",\r\n\t\t\t\t\t\t\t\"labelText\": \"\",\r\n\t\t\t\t\t\t\t\"lineAlpha\": 0,\r\n\t\t\t\t\t\t\t\"lineColor\": \"#FF5C39\",\r\n\t\t\t\t\t\t\t\"lowField\": \"EBVCandle Low\",\r\n\t\t\t\t\t\t\t\"minBulletSize\": 0,\r\n\t\t\t\t\t\t\t\"minDistance\": 0,\r\n\t\t\t\t\t\t\t\"negativeBase\": -1,\r\n\t\t\t\t\t\t\t\"negativeFillAlphas\": 0,\r\n\t\t\t\t\t\t\t\"negativeLineAlpha\": 0,\r\n\t\t\t\t\t\t\t\"openField\": \"EBV 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-->\n<div class=\"module module-text tb_as6s700 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Figura 2c: Miglioramento RV<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM Study Page - Italian: 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\" 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(\"transform-italian-rv-line\",\r\n\t\t\t\t{\r\n \"hideCredits\": 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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_3 tb_cruh711\">\n <div data-lazy=\"1\" class=\"module_column sub_column col3-1 tb_aayz713 first\">\n <!-- module text -->\n<div class=\"module module-text tb_vc4f714 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Figura 2d: Miglioramento nel SGRQ<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM Study Page - Italian: 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 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\/>\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(\"transform-italian-bode-line\",\r\n\t\t\t\t{\r\n \"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": \"serial\",\r\n\t\t\t\t\t\"categoryField\": \"category\",\r\n\t\t\t\t\t\"autoMarginOffset\": 0,\r\n\t\t\t\t\t\"autoMargins\": false,\r\n\t\t\t\t\t\"marginBottom\": 60,\r\n\t\t\t\t\t\"marginLeft\": 76,\r\n\t\t\t\t\t\"sequencedAnimation\": false,\r\n\t\t\t\t\t\"startDuration\": 2,\r\n\t\t\t\t\t\"startEffect\": \"easeOutSine\",\r\n\t\t\t\t\t\"accessibleTitle\": 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class=\"p1\">Legenda per la Figura 2: I dati presentati sono espressi come media \u00b1 SEM (errore standard della media) per quanto riguarda le variazioni dal basale a 3 e 6 mesi post-broncoscopia per i gruppi valvola Zephyr e SdC e per la differenza tra gli stessi. Figura 2a: FEV<span class=\"s1\">1<\/span> = volume espiratorio massimo nel primo secondo (L); Figura 2b: 6MWD = distanza percorsa nel test del cammino in sei minuti (m); Figura 2c: RV = volume residuo (L); Figura 2d: SGRQ = St. George\u2019s Respiratory Questionnaire; Figura 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\">Conclusioni<\/h2>\n<p>Il trattamento con la valvola Zephyr<sup>\u00ae<\/sup> in pazienti affetti da iperinflazione ed enfisema eterogeneo con ventilazione collaterale assente nel lobo interessato garantisce benefici clinicamente significativi e statisticamente rilevanti nella funzione polmonare, nella dispnea, nella tolleranza all\u2019esercizio fisico e nella qualit\u00e0 della vita rispetto alla terapia medica standard di cura attuale.<\/p>\n<p>Le possibili complicazioni del trattamento con la valvola endobronchiale Zephyr includono, tra le altre, pneumotorace, peggioramento dei sintomi della BPCO, emottisi, polmonite, dispnea e, in rari casi, morte.<\/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>Uno studio controllato randomizzato, multicentrico, multinazionale relativo alle valvole endobronchiali Zephyr\u00ae in pazienti con enfisema eterogeneo e ventilazione collaterale scarsa o assente.<\/p>\n","protected":false},"author":2,"featured_media":75634,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[59],"tags":[],"class_list":["post-74917","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-studio-clinico","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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