{"id":451,"date":"2021-05-19T17:15:38","date_gmt":"2021-05-19T15:15:38","guid":{"rendered":"https:\/\/hjerteforeningen.dk\/fagnet\/?p=6229"},"modified":"2025-12-18T14:12:44","modified_gmt":"2025-12-18T14:12:44","slug":"flere-med-forkammerflimren-kan-maaske-faa-glaede-af-aurikellukning","status":"publish","type":"artikel","link":"https:\/\/hjerteforeningen.dk\/fagnet\/artikler\/alle-artikler\/flere-med-forkammerflimren-kan-maaske-faa-glaede-af-aurikellukning\/","title":{"rendered":"Flere med forkammerflimren kan m\u00e5ske f\u00e5 gl\u00e6de af aurikellukning"},"content":{"rendered":"\t\t
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Studie\u00a0<\/span>peger p\u00e5<\/span>, at lukning af venstre hjerte\u00f8re\u00a0<\/span>kan v\u00e6re\u00a0<\/span>en bedre behandling\u00a0<\/span>end blodfortyndende medicin<\/span>.\u00a0<\/span>Behandlingen kan\u00a0<\/span>med fordel\u00a0<\/span>tilbydes en bredere gruppe af patienter<\/span>, hvis resultaterne bekr\u00e6ftes i\u00a0<\/span>randomisere<\/span>de<\/span>\u00a0unders\u00f8gelse<\/span>r<\/span>.<\/span>\u00a0<\/span>\u00a0<\/span><\/h2>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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For at mindske risikoen for\u00a0<\/span>blodpropper i hjernen\u00a0<\/span>hos patienter med forkammerflimren<\/span>,<\/span>\u00a0har\u00a0<\/span>man gennem de sidste ti \u00e5r<\/span>\u00a0i Danmark<\/span>\u00a0<\/span>tilbudt\u00a0<\/span>aurikellukning<\/span>\u00a0(lukning af\u00a0<\/span>venstre\u00a0<\/span>hjerte\u00f8re<\/span>)<\/span>\u00a0<\/span>til de patienter,\u00a0<\/span>der ikke kan t\u00e5le blodfortyndende behandling<\/span>.\u00a0<\/span>Aurikellukning er et lille hjerteindgreb<\/span>,<\/span>\u00a0som udf\u00f8res i lokalbed\u00f8velse med kateterteknik fra lysken og varer ca. 40 min.<\/span>\u00a0<\/span><\/p>

Men d<\/span>o<\/span>kumentation<\/span>en bag\u00a0<\/span>behandlingen<\/span>\u00a0er baseret p\u00e5\u00a0<\/span>et\u00a0<\/span>ti \u00e5r gammelt\u00a0<\/span>randomiseret fors\u00f8g<\/span>, hvor<\/span>\u00a0<\/span>behandling med\u00a0<\/span>aurikellukning<\/span>\u00a0<\/span>sammenlignes med\u00a0<\/span>det\u00a0<\/span>\u00e6ldre\u00a0<\/span>blodfortyndende middel\u00a0<\/span>w<\/span>arfarin<\/span>.\u00a0<\/span>\u00a0<\/span><\/p>

Derfor har e<\/span>n forskergruppe i et<\/span>\u00a0nyt\u00a0<\/span>observations<\/span>studie<\/span>\u00a0<\/span>unders\u00f8g<\/span>t<\/span>\u00a0<\/span>aurikellukning<\/span>\u00a0hos 1<\/span>.<\/span>071 patienter<\/span>\u00a0<\/span>med forkammerflimren\u00a0<\/span>overfor\u00a0<\/span>en kontrolgruppe\u00a0<\/span>p\u00e5<\/span>\u00a01<\/span>.<\/span>184\u00a0<\/span>matchede patienter fra danske registre<\/span>,<\/span>\u00a0der f\u00e5r behandling med<\/span>\u00a0<\/span>de\u00a0<\/span>nyere blodfortyndende\u00a0<\/span>DOAC<\/span>–<\/span>midler<\/span>\u00a0(<\/span>Direct Oral\u00a0<\/span>Anticoagulant<\/span>s<\/span>)<\/span>.\u00a0<\/span>\u00a0<\/span><\/p>

– Vi ved fra tidligere, at behandlingen <\/span>med aurikellukning\u00a0<\/span>er lige s\u00e5 god som\u00a0<\/span>behandling med\u00a0<\/span>warfarin<\/span>.\u00a0<\/span>Resultaterne af det nye studie\u00a0<\/span>peger<\/span>\u00a0nu<\/span>\u00a0<\/span>p\u00e5, at\u00a0<\/span>aurikellukning\u00a0<\/span>er\u00a0<\/span>en\u00a0<\/span>lige s\u00e5 god eller bedre\u00a0<\/span>behandling\u00a0<\/span>sammenlignet med\u00a0<\/span>de nye blodfortyndende midler<\/span>, <\/span>siger\u00a0<\/span>klinisk professor og overl\u00e6ge Jens Erik Nielsen-Kudsk fra Aarhus Universitet og Afdeling for Hjertesygdomme p\u00e5 Aarhus Universitetshospital Skejby.<\/span>\u00a0<\/span>\u00a0<\/span><\/p>

Han er en af forskerne bag det nye studie.<\/span>\u00a0<\/span><\/p>

\u00a0<\/span><\/p>

Alvorlige bl\u00f8dninger og d\u00f8d reduceret<\/span><\/h3>

I unders\u00f8gelsen\u00a0<\/span>s\u00e5 man p\u00e5, om patienterne fik\u00a0<\/span>slagtilf\u00e6lde<\/span>\u00a0(stroke<\/span>)<\/span>, st\u00f8rre bl\u00f8dninger<\/span>\u00a0<\/span>eller<\/span>\u00a0om de<\/span>\u00a0<\/span>d\u00f8d<\/span>e<\/span>.<\/span>\u00a0<\/span>Det prim\u00e6re endepunkt i studiet var en kombination af de tre endepunkter<\/span>,<\/span>\u00a0og\u00a0<\/span>det viste<\/span>,<\/span>\u00a0at den samlede risiko var mindre med aurikellukning.\u00a0<\/span>\u00a0<\/span><\/p>

– <\/span>V<\/span>i<\/span>\u00a0s\u00e5<\/span>\u00a0<\/span>samlet set<\/span>\u00a0<\/span>43 procent\u00a0<\/span>mindre risiko<\/span>\u00a0for<\/span>\u00a0<\/span>enten\u00a0<\/span>at f\u00e5 et slagtilf\u00e6lde<\/span>, f\u00e5\u00a0<\/span>st\u00f8rre bl\u00f8dninger eller<\/span>\u00a0for<\/span>\u00a0at d\u00f8\u00a0<\/span>efter aurikellukning <\/span>sammenlignet\u00a0<\/span>med\u00a0<\/span>blodfortyndende\u00a0<\/span>behandling i form af DOAC<\/span>,<\/span>\u00a0forklarer Jens Erik Nielsen-Kudsk.<\/span>\u00a0<\/span><\/p>

N\u00e5r man s\u00e5<\/span>\u00a0enkeltvis<\/span>\u00a0p\u00e5\u00a0<\/span>de tre typer\u00a0<\/span>af\u00a0<\/span>h\u00e6ndelser, var r<\/span>isikoen for<\/span>\u00a0at f\u00e5 et<\/span> slagtilf\u00e6lde med aurikellukning den samme som ved blodfortyndende behandling<\/span>\u00a0<\/span>med DOAC\u00a0<\/span>(39 versus 37 tilf\u00e6lde)<\/span>.\u00a0<\/span>Derimod\u00a0<\/span>var\u00a0<\/span>risikoen for st\u00f8rre bl\u00f8dninger\u00a0<\/span>s\u00e6nket\u00a0<\/span>med 38 procent\u00a0<\/span>(<\/span>108 versus 183 tilf\u00e6lde<\/span>)\u00a0<\/span>og risikoen for d\u00f8d\u00a0<\/span>var s\u00e6nket\u00a0<\/span>med 47 procent<\/span>\u00a0<\/span>(155 versus 308 tilf\u00e6lde)\u00a0<\/span>ved aurikellukning<\/span>\u00a0sammenlignet med\u00a0<\/span>DOAC<\/span>–<\/span>behandling<\/span>.<\/span>\u00a0<\/span><\/p>

– Ikke alene tyder de her data p\u00e5, at aurikellukning er lige s\u00e5 god som blodfortyndende behandling. De tyder ogs\u00e5 p\u00e5, at det er en bedre behandling, fordi vi ser f\u00e6rre bl\u00f8dninger og f\u00e6rre d\u00f8dsfald med aurikellukningen, siger Jens Erik Nielsen-Kudsk og uddyber: <\/span>\u00a0<\/span><\/p>

– N\u00e5r du har indsat lukkeren<\/span>\u00a0<\/span>i<\/span>\u00a0venstre hjerte\u00f8re<\/span>, kan du p\u00e5 sigt helt undv\u00e6re den blodfortyndende behandling, og det vil alt andet lige forventeligt give f\u00e6rre bl\u00f8dninger, som vi ogs\u00e5 ser i den her unders\u00f8gelse. S\u00e5 resultaterne er en bekr\u00e6ftelse af<\/span>,<\/span> hvad vi kan forvente.<\/span>\u00a0<\/span><\/p>

Eftersom aurikellukningen<\/span>\u00a0i dag<\/span>\u00a0bliver givet til de patienter, der ikke kan t\u00e5le blodfortyndende behandling,\u00a0<\/span>inkluderede man\u00a0<\/span>i den\u00a0<\/span>nye unders\u00f8gelse\u00a0<\/span>kun\u00a0<\/span>patienter, der ikke kunne t\u00e5le blodfortyndende behandling<\/span> i gruppe<\/span>n<\/span>\u00a0med\u00a0<\/span>aurikellukning<\/span>.\u00a0<\/span>Patienterne i\u00a0<\/span>det \u00e6ldre\u00a0<\/span>studie<\/span>\u00a0med\u00a0<\/span>warfarin<\/span>\u00a0<\/span>kunne\u00a0<\/span>derimod alle\u00a0<\/span>t\u00e5le\u00a0<\/span>blodfortyndende behandling.\u00a0<\/span>\u00a0<\/span><\/p>

\u00a0<\/span><\/p>

Ikke overraskende<\/span><\/h3>

If\u00f8lge\u00a0<\/span>Jens Erik Nielsen-Kudsk er\u00a0<\/span>resultaterne\u00a0<\/span>ikke\u00a0<\/span>s\u00e5\u00a0<\/span>overraske<\/span>nde<\/span>.<\/span>\u00a0<\/span><\/p>

– I det oprindelige <\/span>randomiserede\u00a0<\/span>studie med <\/span>w<\/span>arfarin<\/span>,<\/span>\u00a0s\u00e5 man de samme signaler med f\u00e6rre bl\u00f8dninger og f\u00e6rre d\u00f8dsfald, selvom resultater<\/span>ne her<\/span>\u00a0ikke var statistisk signifikante<\/span>, siger han og tilf\u00f8jer:<\/span>\u00a0<\/span>\u00a0<\/span><\/p>

– <\/span>E<\/span>n\u00a0<\/span>mulig<\/span>\u00a0forklaring p\u00e5\u00a0<\/span>de f\u00e6rre tilf\u00e6lde af d\u00f8d\u00a0<\/span>med\u00a0<\/span>aurikellukningen\u00a0<\/span>kunne v\u00e6re en f\u00f8lge af\u00a0<\/span>de\u00a0<\/span>f\u00e6rre\u00a0<\/span>bl\u00f8dninger<\/span>,\u00a0<\/span>som<\/span>\u00a0vi ser i studiet for\u00a0<\/span>denne gruppe<\/span>. M<\/span>en det\u00a0<\/span>er\u00a0<\/span>registrering af d\u00f8d og d\u00f8ds\u00e5rsager ikke detaljerede nok i vores registre<\/span>\u00a0til at sige noget konkret om ud fra unders\u00f8gelsen<\/span>.<\/span><\/p>

\u00a0<\/span><\/p>

Tilbydes til flere<\/span><\/h3>

I<\/span>\u00a0fremtiden\u00a0<\/span>vil aurikellukning m\u00e5ske blive tilbudt flere patienter som\u00a0<\/span>en alternativ\u00a0<\/span>behandling<\/span>\u00a0til blodfortyndende medicin<\/span>.<\/span>\u00a0<\/span><\/p>

– Et fremtidigt perspektiv vil v\u00e6re at tilbyde behandlingen som standardbehandling til en bredere population \u2013 det kunne v\u00e6re til alle de patienter, som ellers ville blive sat i blodfortyndende behandling. En mange\u00e5rig langvarig blodfortyndende behandling er nemlig forbundet med en v\u00e6sentlig risiko for at f\u00e5 alvorlige bl\u00f8dninger, siger Jens Erik Nielsen-Kudsk. <\/span>\u00a0<\/span><\/p>

– Studiet her har v\u00e6ret et skridt p\u00e5 vejen til at afklare effekterne af behandlingen med aurikellukning, men vi har stadig brug for flere solide studier i form af randomiserede unders\u00f8gelser, siger han. <\/span>\u00a0<\/span><\/p>

\u00a0– Studiet har kunne<\/span>t<\/span>\u00a0lade sig g\u00f8re med de danske data, fordi vi i Danmark er gode til at registrere og f\u00f8lge op p\u00e5 vores patienter. Vores registre har gjort det muligt at skabe en kontrolgruppe af patienter med atrieflimren, der n\u00f8jagtigt ligner patienterne\u00a0<\/span>i gruppen, der fik aurikellukning<\/span>, siger <\/span>han<\/span>.\u00a0<\/span>\u00a0<\/span><\/p>

\u00a0<\/span><\/p>

N<\/span>\u00e6ste skridt<\/span>\u00a0er randomiseret unders\u00f8gelse<\/span><\/h3>

Det nye studie ligger if\u00f8lge Jens Erik Nielsen-Kudsk evidensm\u00e6ssigt midt imellem en registerunders\u00f8gelse og en randomiseret unders\u00f8gelse. <\/span>N\u00e6ste skridt er<\/span>\u00a0derfor<\/span>\u00a0en\u00a0<\/span>stor randomiseret unders\u00f8gelse. <\/span>\u00a0<\/span><\/p>

– <\/span>Vi k\u00f8rer en stor nordisk\u00a0<\/span>randomiseret\u00a0<\/span>unders\u00f8gelse,\u00a0<\/span>kaldet \u2019<\/span>Occlusion<\/span>\u00a0AF<\/span>\u2019<\/span><\/a>, hvor vi\u00a0<\/span>unders\u00f8ger\u00a0<\/span>750\u00a0<\/span>patienter med forkammerflimren, der\u00a0<\/span>tidligere har\u00a0<\/span>haft en blodprop\u00a0<\/span>i<\/span>\u00a0hjernen.<\/span>\u00a0<\/span>I unders\u00f8gelsen f\u00e5r p<\/span>atienterne\u00a0<\/span>DOAC<\/span>-midler<\/span>\u00a0eller aurikellukning<\/span>, siger Jens Erik Nielsen-Kudsk<\/span>\u00a0og tilf\u00f8jer, at der\u00a0<\/span>er flere andre\u00a0<\/span>internationale randomiserede unders\u00f8gelser\u00a0<\/span>p\u00e5 vej<\/span>.<\/span>\u00a0<\/span><\/p>

Han forklarer hvorfor\u00a0<\/span>det er n\u00f8dvendigt med en randomiseret unders\u00f8gelse:<\/span>\u00a0<\/span><\/p>

– <\/span>Hvis<\/span>\u00a0vi vil \u00e6ndre e<\/span>n behandling<\/span>, der\u00a0<\/span>i forvejen\u00a0<\/span>er dokumenteret med randomiserede kliniske unders\u00f8gelser,\u00a0<\/span>til f.eks. at omfatte en bredere patientgruppe,\u00a0<\/span>skal\u00a0<\/span>vi\u00a0<\/span>komme med\u00a0<\/span>studier<\/span>\u00a0p\u00e5<\/span>\u00a0samme evidensniveau<\/span>.<\/span>\u00a0<\/span><\/p>

N\u00e5r det er sagt<\/span>,<\/span>\u00a0har man i det<\/span>\u00a0nuv\u00e6rende studie gjort et stort nummer ud af at\u00a0<\/span>tage h\u00f8jde for de\u00a0<\/span>faktorer, der\u00a0<\/span>potentielt set\u00a0<\/span>kan\u00a0<\/span>sk\u00e6vvride unders\u00f8gelsens\u00a0<\/span>resultat<\/span>er<\/span>.<\/span>\u00a0<\/span><\/p>

– N\u00e5r man laver en unders\u00f8gelse som den <\/span>aktuelle her<\/span>, der ikke er et lodtr\u00e6kningsstudie, er der risiko for bias. De<\/span>t\u00a0<\/span>har vi fors\u00f8gt at tage h\u00f8jde for ved at matche en relevant kontrolgruppe, der minder meget om den gruppe, vi unders\u00f8ger, siger <\/span>Jens Erik Nielsen-Kudsk<\/span>.\u00a0<\/span>\u00a0<\/span><\/p>

Og det kan lade sig g\u00f8re, fordi\u00a0<\/span>patienternes risikoprofil er\u00a0<\/span>forholdsvis\u00a0<\/span>let at forudsige.<\/span>\u00a0<\/span><\/p>

– Ved forkammerflimren, kan man ud fra patienternes sygdomsprofil forudsige risikoen for slagtilf\u00e6lde og bl\u00f8dning. Vi har ud fra de danske registre skabt en kontrolgruppe med samme risikoscore i forhold til stroke og bl\u00f8dning som gruppen, der fik aurikellukning. Med andre ord har vi selekteret de patienter, der ligner aurikelgruppen bedst muligt<\/span>, <\/span>forklarer han.<\/span>\u00a0<\/span><\/p>

Den m\u00e5de at g\u00f8re det p\u00e5 hedder en \u2019<\/span>propensity<\/span>\u00a0score match\u2019 unders\u00f8gelse.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n Forkammerflimren og blodpropper i hjernen <\/div>\n\n
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