Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial

Abstract

<jats:sec><jats:title>Background</jats:title><jats:p> Transvenous embolisation is a promising technique but the benefits remain uncertain. We hypothesised that transvenous embolisation leads to a higher rate of arteriovenous malformation angiographic occlusion than transarterial embolisation. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> The Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM) is an investigator initiated, multicentre, prospective, phase 2, randomised controlled clinical trial. To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm). The primary endpoint of the trial is complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography. Complete occlusions will be confirmed at 3 months, while incompletely occluded arteriovenous malformations, considered treatment failures, will then be eligible for complementary treatments by surgery, radiation therapy, or even transvenous embolisation. Standard procedural safety outcomes will also be assessed. Patient selection will be validated by a case selection committee, and participating centres with limited experience in transvenous embolisation will be proctored. </jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p> The TATAM trial is a transparent research framework designed to offer a promising but still unvalidated treatment to selected arteriovenous malformation patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03691870. </jats:p></jats:sec>

Transvenous retrograde embolization of ruptured brain arteriovenous malformations: A case report and review of the literature

“…Therefore, a randomized trial comparing the two transarterial and transvenous approaches is needed. There is currently a TATAM trial comparing transvenous embolization with standard trans-arterial embolization (NCT03691870) slated to end in 2023 [12] .…”

Experience of intracranial arteriovenous malformations endovascular treatment with advanced techniques and non-adhesive liquid embolic agents using

“…Эмболизация АВМ головного мозга сопряжена с риском. По данным разных авторов, частота инвалидизации составляет от 3 до 16 %, а смертность -от 0 до 4 % [3,8,11,12,16]. Эти показатели имеют очень высокий разброс, поскольку зависят от многих факторов, в том числе от характеристик мальформаций, наличия или отсутствия геморрагических осложнений, применяемых методик, эмболизирующих агентов, технических возможностей клиники, опыта и подготовленности оператора [8,16].…”

“…Цель работыоценить возможность применения эндоваскулярной эмболизации с использованием неадгезивных жидких [16] (рис. 1)), а также для формирования пробки в фидере в сочетании с Onyx-34 или акрилатной композицией (при использовании трансартериальной эмболизации по технике «pressure cooker» [11]).…”

Management of Unruptured Intracranial Aneurysms and Brain Arteriovenous Malformations

“…Transvenous embolization is a relatively recent technique that may achieve AVM obliteration, particularly in the setting of indirect feeder arteries, small nidi, a single draining vein, or deep location 70,71 . The TATAM (Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations) trial is an ongoing randomized trial testing the hypothesis that transvenous embolization is superior to transarterial embolization for AVM obliteration 72 …”