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A new endovascular route for the treatment of brain AVMs may be possible in some cases: Trans-Venous Embolization (TVE). The technique uses microcatheters to navigate to the draining veins of AVM, to reach and then fill the AVM nidus retrogradely with liquid embolic agents until the lesion is occluded. This technique has the potential to improve on some of the problems with the arterial approach to AVM embolization, such as a low overall occlusion rate. However, by occluding the vein first, and filling the lesion with the embolic agent in a retrograde fashion, the method transgresses a widely held dogma in the surgical or endovascular treatment of AVMs: to preserve the draining vein until all afferent vessels have been occluded. Nevertheless, the initial case series have shown promising results, with high occlusion rates, and few technical complications.
The method is increasingly used in an increasing number of centers, but there is currently no research protocol to guide the use of this promising but still experimental treatment in a prudent fashion. Care trials can be designed to offer such an experimental treatment, taking into account the best medical interests of patients, in the presence of rapidly evolving indications and techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard Trans-Arterial Embolization (TAE) | Active Comparator | The standard TAE, without TVE, is used in patient allocated standard treatment. The arterial approach will consist of at least one attempted catheterization for trans-arterial injection of liquid embolic. Patients incompletely treated at the time of the final embolization procedure are adjudicated a failure to reach the primary outcome and can be treated using alternative standard options (including surgery, radiation therapy, conservative management). In addition, patients of the control group can also be offered TVE, if still feasible, once the TAE has been adjudicated to be a failure. If the operator deems, on the table, for a trans-arterial injection to be too dangerous, no arterial injection is necessary. Treatment, where indicated, can be completed through other means. |
|
| Trans-Venous Embolization (TVE) (+/- Arterial) strategy | Experimental | The experimental treatment is an attempt to completely occlude the AVM using venous catheterization and retrograde EVOH injection during the final session. TAE can be performed to prepare for final TVE during the same or one previous preparatory session, or TAE can be used to rescue an incomplete TVE. In some patients, balloon catheterization is used trans-arterially to assist TVE. It will be permissible to perform more than one treatment session when deemed necessary (occasionally to treat an AVM through the trans-venous route requires a two-stage approach, with a single trans-arterial attempt to decrease AVM filling prior to the definitive trans-venous approach, and this will be permitted). The trans-venous strategy will consist of at least one transvenous injection of ethyl vinyl alcohol (EVOH), with the choice of delivery microcatheters and other technical details left to the individual operator's discretion). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Trans-Arterial Embolization (TAE) | Procedure | The standard TAE, without TVE, is used in patient allocated standard treatment. The arterial approach will consist of at least one attempted catheterization for trans-arterial injection of liquid embolic. If the operator deems, on the table, for a trans-arterial injection to be too dangerous, no arterial injection is necessary. Treatment, where indicated, can be completed through other means. |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic evidence of residual AVM at time of confirmatory catheter angiography. | Angiographic evidence of residual AVM at time of confirmatory catheter angiography | 3 months +/- 1 month following embolization |
| Measure | Description | Time Frame |
|---|---|---|
| Failure to safely and effectively position the embolization microcatheter. | Failure to reach a safe and effective microcatheter position for embolization. | within day of procedure |
| Any procedural complication leading to transient new neurological deficit. |
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Inclusion Criteria:
Notes on potentially suitable cases:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | Canada | |||
| Centre Hospitalier de l'Université de Montréal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22068993 | Background | van Beijnum J, van der Worp HB, Buis DR, Al-Shahi Salman R, Kappelle LJ, Rinkel GJ, van der Sprenkel JW, Vandertop WP, Algra A, Klijn CJ. Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. JAMA. 2011 Nov 9;306(18):2011-9. doi: 10.1001/jama.2011.1632. | |
| 25794338 | Background |
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|
| Trans-Venous Embolization (TVE) | Procedure | The experimental treatment is an attempt to completely occlude the AVM using venous catheterization and retrograde EVOH injection during the final session. The trans-venous strategy will consist of at least one transvenous injection of ethyl vinyl alcohol (EVOH), with the choice of delivery microcatheters and other technical details left to the individual operator's discretion. |
|
Any procedural complication leading to transient new neurological deficit. |
| <5 days |
| Any procedural complication leading to new neurological deficit. | Any procedural complication leading to new neurological deficit. | ≥5 days |
| Any treatment-related complication that prolongs hospitalization by ≥5 days. | Any treatment-related complication that prolongs hospitalization by ≥5 days. | Within one week |
| Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences). | Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences). | within 5 days post procedure |
| Length of hospitalization (days). | Length of hospitalization (days). | ≥5 days |
| Patient discharge to a location that is not his/her home. | Discharge to location other than home. | through to 3 (+/- 1) months follow-up |
| mRS at discharge and 3(+/-1) months. | mRS at discharge and 3(+/-1) months. | through to 3 (+/- 1) months follow-up |
| Incidence of new admission to hospital during follow-up. | Incidence of new admission to hospital during follow-up. | Within 3 +/- months post final treatment |
| Incidence of intracranial hemorrhage during follow-up. | Incidence of intracranial hemorrhage during follow-up. | Within 3 +/- months post final treatment |
| Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment. | Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment. | at 3(+/-1) months post-treatment. |
| Montreal |
| Quebec |
| H2X 0C1 |
| Canada |
| Centre hospitalier universitaire de Bordeaux | Bordeaux | France |
| Centre hospitalier régional universitaire de Brest | Brest | France |
| Centre hospitalier universitaire de Grenoble | Grenoble | France |
| Centre hospitalier universitaire Limoges | Limoges | France |
| Hôpital Forndation Adolphe de Rothschild | Paris | France |
| Centre hospitalier universitaire de Rouen Normandie | Rouen | France |
| Centre hospitalier universitaire de la Réunion | Saint-Paul | France |
| Iosif C, Mendes GA, Saleme S, Ponomarjova S, Silveira EP, Caire F, Mounayer C. Endovascular transvenous cure for ruptured brain arteriovenous malformations in complex cases with high Spetzler-Martin grades. J Neurosurg. 2015 May;122(5):1229-38. doi: 10.3171/2014.9.JNS141714. Epub 2015 Mar 20. |
| 21346657 | Background | Kessler I, Riva R, Ruggiero M, Manisor M, Al-Khawaldeh M, Mounayer C. Successful transvenous embolization of brain arteriovenous malformations using Onyx in five consecutive patients. Neurosurgery. 2011 Jul;69(1):184-93; discussion 193. doi: 10.1227/NEU.0b013e318212bb34. |
| 29281075 | Background | Mendes GAC, Kalani MYS, Iosif C, Lucena AF, Carvalho R, Saleme S, Mounayer C. Transvenous Curative Embolization of Cerebral Arteriovenous Malformations: A Prospective Cohort Study. Neurosurgery. 2018 Nov 1;83(5):957-964. doi: 10.1093/neuros/nyx581. |
| 27913800 | Background | Zhang G, Zhu S, Wu P, Xu S, Shi H. The transvenous pressure cooker technique: A treatment for brain arteriovenous malformations. Interv Neuroradiol. 2017 Apr;23(2):194-199. doi: 10.1177/1591019916682357. Epub 2016 Dec 5. |
| 25042688 | Background | Raymond J, Darsaut TE, Altman DG. Pragmatic trials can be designed as optimal medical care: principles and methods of care trials. J Clin Epidemiol. 2014 Oct;67(10):1150-6. doi: 10.1016/j.jclinepi.2014.04.010. Epub 2014 Jul 16. |
| 28478113 | Background | Raymond J, Fahed R, Darsaut TE. Randomize the first patient. J Neuroradiol. 2017 Sep;44(5):291-294. doi: 10.1016/j.neurad.2017.03.004. Epub 2017 May 3. No abstract available. |
| 40143818 | Derived | Raymond J, Darsaut TE, Saleme S, Rouchaud A, Iancu D, Roy D, Weill A, Olijnyk L, Jabre R, Bojanowski MW, Chaalala C, Roberge D, Boubagra K, Heck O, Rempel JL, Papagiannaki C, Barreau X, Marnat G, Gentric JC, Ognard J, Nico L, Bintner M, Gauthier Lasalarie P, Veyrieres JB, Piotin M, Escalard S, Pereira VM, Abud DG, Zehr J, Chagnon M, Nguyen TN, Mathieu D, Gevry G, Klink R, Lorian E, Mounayer C; TATAM Collaborative Group. Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations: A Randomized Comparison With Transarterial Embolization. Stroke. 2025 Jun;56(6):1396-1403. doi: 10.1161/STROKEAHA.124.049109. Epub 2025 Mar 27. |
| 30843441 | Derived | Fahed R, Darsaut TE, Mounayer C, Chapot R, Piotin M, Blanc R, Mendes Pereira V, Abud DG, Iancu D, Weill A, Roy D, Nico L, Nolet S, Gevry G, Raymond J. Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial. Interv Neuroradiol. 2019 Jun;25(3):305-309. doi: 10.1177/1591019918821738. Epub 2019 Feb 4. |
| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| D001165 | Arteriovenous Malformations |
| D020521 | Stroke |
| D020300 | Intracranial Hemorrhages |
| D000013 | Congenital Abnormalities |
| D000783 | Aneurysm |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D020765 | Intracranial Arterial Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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