Obtura: A novel liquid embolic agent with post-embolization radiopacity loss, in endovascular treatment of brain arteriovenous malformations, dural arteriovenous fistulas, and tumors: CLARIDAD trial

Before this is used you'll have to ask your doctor what is the difference between this liquid embolic agent and Onyx glue.

FDA issues warning about Covidien brain device that has killed nine - Onyx glue

Embolization - A procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel. Embolization may be used to stop bleeding or to block the flow of blood to a tumor or abnormal area of tissue.

The latest here:

 

 Obtura: A novel liquid embolic agent with post-embolization radiopacity loss, in endovascular treatment of brain arteriovenous malformations, dural arteriovenous fistulas, and tumors: CLARIDAD trial

1. http://orcid.org/0000-0002-5521-2524Juan Carlos Llibre-Guerra1,2,
2. Leopoldo Guimaraens3,4,
3. Krzysztof Bartosz Kadziolka5,6,
4. http://orcid.org/0000-0002-9519-0059Adnan H Siddiqui7,8,
5. http://orcid.org/0000-0002-2584-8361René Chapot9,
6. Alberto Gil3,10

1. Correspondence to Dr Juan Carlos Llibre-Guerra; juancarlos.llibre@gmail.com

Abstract

Background Endovascular embolization is frequently used for vascular lesions of the head and neck. Newer agents may help to enhance visualization and improve treatment outcomes.

Methods The CLARIDAD clinical trial was a prospective, single center, first-in-man investigation of neurovascular embolization using the novel embolic agent _ihtObtura for a broad indication, covering the need for a liquid embolic agent in head and neck procedures. The primary outcomes assessed were therapeutic efficacy to deliver _ihtObtura to embolize the catheterized pedicle and associated angiographic vascularity, and subsequent loss of radiopacity. Safety endpoints included procedural adverse events, modified Rankin Scale (mRS) score, morbidity, and mortality. Radiologic and clinical follow-up evaluations were conducted at 30, 90, 180 days, and 1 year post-treatment.

Results 65 consecutive patients (mean age 37.8 years, 50.8% women) were treated over 129 sessions. A total of 42 brain arteriovenous malformations (AVMs; 90% grades III and IV), 8 dural arteriovenous fistulas (DAVFs), and 15 hypervascular tumors were treated with _ihtObtura using an average of 3.9 mL per session and 7.7 mL per patient. We achieved therapeutic effectiveness in 99% of catheterizations. Radiopacity loss was complete after 74.3% of the sessions at 30 days, 95.6% at 90 days, and 100% at the 1 year follow-up. Serious adverse events (mRS score >2) occurred in two patients (3.1%) with previously ruptured high grade AVMs leading to one death and one permanent disabling morbidity.

Conclusions The study showed that _ihtObtura was a novel, safe, and effective liquid embolic agent for the treatment of AVMs, DAVFs, and hypervascular tumors. Its key property of significant radiopacity loss contributes to improve anatomical understanding, particularly in staged procedures, as well as reduction in post-procedural imaging artifact. There may be additional benefits of eliminating tantalum from the embolic mixture in terms of lesion penetration.

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/jnis-2023-021442

Single institution early clinical experience with the Scepter Mini balloon catheter

Before this is used you'll have to ask your doctor what is the difference between this liquid embolic agent and Onyx glue.

FDA issues warning about Covidien brain device that has killed nine - Onyx glue

The latest here:

Single institution early clinical experience with the Scepter Mini balloon catheter

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Timothy G White, Kevin A Shah, Justin Turpin, ...

First Published May 20, 2021 Research Article 

https://doi.org/10.1177/19714009211013495

Article information

Abstract

Background

The use of liquid embolic agents in the endovascular treatment of dural arteriovenous (dAVFs) fistulas and brain arteriovenous malformations (AVMs) has become common practice. The use of dual lumen balloon microcatheters has greatly improved the efficacy of liquid embolization. The purpose of this series is to discuss our early experience with the Scepter Mini dual lumen balloon microcatheter.

Methods

A retrospective chart review was performed of all patients who underwent embolization with the Scepter Mini dual lumen balloon at a single institution. Technical details and procedural complications were recorded for each case.

Results

In total, 10 Scepter Mini dual lumen balloon microcatheters were used in nine patients. All patients except two were treated for AVMs. Technical success was achieved in all but one case where one balloon had to be discarded due to precipitation of the tantalum powder. Average vessel diameter where the balloon was inflated was 1.1 mm (0.8–2.4 mm). It provided flow arrest in 100% of cases with no cases of reflux of embolic material. Balloon “jump back” was found to occur in 44.4% (4/9) of cases. Seven out of nine cases used Onyx, and two cases used n-butyl cyanoacrylate.

Conclusions

The Scepter Mini is a new dual lumen balloon ideal for distal access and can be used for embolization with liquid embolic agents with a high degree of technical success. Its great benefit is the immediate and safe flow arrest of distal vasculature upon balloon inflation. One important consideration for effective embolization is early identification of balloon jump back.

Keywords Arteriovenous fistulas, arteriovenous malformations, dual lumen balloon, liquid embolic

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Onyx embolization for dural arteriovenous fistulas: a multi-institutional study

I thought gluing was not done for brain work. Ask your doctor for guarantees on its use.
FDA issues warning about Covidien brain device that has killed nine - Onyx glue

 

Onyx embolization for dural arteriovenous fistulas: a multi-institutional study

1. http://orcid.org/0000-0002-3634-883XYangchun Li1,
2. Stephanie H Chen2,
3. Ridhima Guniganti3,
4. Akash P Kansagra4,
5. Jay F Piccirillo4,
6. Ching-Jen Chen5,
7. Thomas Buell6,
8. Jason P Sheehan7,
9. http://orcid.org/0000-0002-2627-446XDale Ding8,
10. Giuseppe Lanzino9,
11. http://orcid.org/0000-0001-5271-5524Waleed Brinjikji10,
12. Louis J Kim11,
13. http://orcid.org/0000-0003-3612-3347Michael R Levitt12,
14. Isaac Josh Abecassis13,
15. Diederik O Bulters14,
16. Andrew Durnford15,
17. http://orcid.org/0000-0002-7762-9902W Christopher Fox16,
18. Adam J Polifka17,
19. Bradley A. Gross18,
20. Samir Sur1,
21. David J McCarthy18,
22. Dileep R Yavagal19,
23. http://orcid.org/0000-0002-0625-8438Eric C Peterson20,
24. Minako Hayakawa21,
25. http://orcid.org/0000-0002-5932-2683Colin Derdeyn22,
26. Edgar A Samaniego23,
27. Sepideh Amin-Hanjani24,
28. http://orcid.org/0000-0002-1491-4634Ali Alaraj25,
29. Amanda Kwasnicki26,
30. Fady T Charbel25,
31. http://orcid.org/0000-0002-0814-5680J Marc C van Dijk27,
32. Adriaan RE Potgieser28,
33. Junichiro Satomi29,
34. Yoshiteru Tada30,
35. Adib Abla31,
36. Ryan Phelps32,
37. Rose Du33,
38. Pui Man Rosalind Lai33,
39. Gregory J Zipfel34,34,
40. Robert M Starke1,35
41. On behalf of the Consortium for Dural Arteriovenous Fistula Outcomes Research

Author affiliations

Abstract

Background Although the liquid embolic agent, Onyx, is often the preferred embolic treatment for cerebral dural arteriovenous fistulas (DAVFs), there have only been a limited number of single-center studies to evaluate its performance.

Objective To carry out a multicenter study to determine the predictors of complications, obliteration, and functional outcomes associated with primary Onyx embolization of DAVFs.

Methods From the Consortium for Dural Arteriovenous Fistula Outcomes Research (CONDOR) database, we identified patients who were treated for DAVF with Onyx-only embolization as the primary treatment between 2000 and 2013. Obliteration rate after initial embolization was determined based on the final angiographic run. Factors predictive of complete obliteration, complications, and functional independence were evaluated with multivariate logistic regression models.

Results A total 146 patients with DAVFs were primarily embolized with Onyx. Mean follow-up was 29 months (range 0–129 months). Complete obliteration was achieved in 80 (55%) patients after initial embolization. Major cerebral complications occurred in six patients (4.1%). At last follow-up, 84% patients were functionally independent. Presence of flow symptoms, age over 65, presence of an occipital artery feeder, and preprocedural home anticoagulation use were predictive of non-obliteration. The transverse-sigmoid sinus junction location was associated with fewer complications, whereas the tentorial location was predictive of poor functional outcomes.

Conclusions In this multicenter study, we report satisfactory performance of Onyx as a primary DAVF embolic agent. The tentorium remains a more challenging location for DAVF embolization, whereas DAVFs located at the transverse-sigmoid sinus junction are associated with fewer complications.

http://dx.doi.org/10.1136/neurintsurg-2020-017109

 

 

Severe Neovascular Glaucoma Exacerbation as a Complication of Carotid Artery Stenting: A Case Report

I can see almost zero use for stenting a carotid artery if the Circle of Willis is complete, you would have three arteries still feeding the brain.  If fact I would have the artery closed in that case to prevent the chance of plaque breaking loose and causing  a stroke. 

Don't listen to what I have to say, I'm not medically trained.

I guess this is why gluing is not done for brain work:
FDA issues warning about Covidien brain device that has killed nine - Onyx glue

Talk to your doctor about the dangers of stroke due to the endarterectomy procedure and why you would want to put inflexible metal stents in flexible arteries. Don't listen to me, but ask your doctor plenty of questions.   Ask for a guarantee of no stroke due to any procedure.  

Instead of doing a carotid endarterectomy with its attendant risks, why not glue it up or close it some other way?

1. Verify that the Circle of Willis is complete. Mine obviously is since one carotid artery is completely blocked and I am having no cognitive issues(arrogance is not one of my issues).

2. Glue the offending artery shut, No risky surgery.

You need to know where the blockage is, above or below the split to the face.

The latest here:

Severe Neovascular Glaucoma Exacerbation as a Complication of Carotid Artery Stenting: A Case Report

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Sishir Mannava, MD, Luis F. Torres, MD, Keith G. DeSousa, MD, ...

First Published May 22, 2020 Case Report

https://doi.org/10.1177/1941874420923914

Article information

Abstract

Introduction:

Neovascular glaucoma (NVG) has been rarely reported as an acute complication of carotid endarterectomy, but there is scant literature available regarding this potential condition following carotid artery stenting (CAS). We present a case of severe worsening of NVG occurring after bilateral CAS with progressive deterioration of vision ultimately leading to blindness.

Case Description:

A 66-year-old male with multiple stroke risk factors, bilateral cataract extraction, proliferative diabetic retinopathy of left eye, and nonproliferative diabetic retinopathy of right eye, and prior left eye pars plana vitrectomy presented with episodes of transient right eye vision loss in context of bilateral high-grade internal carotid artery stenoses. He underwent right CAS with subsequent elevation of bilateral intraocular pressures (IOPs) concerning for acute NVG. Over time, the patient had some interval improvement in IOPs and underwent planned left CAS. After the procedure, he again developed elevated IOPs, concerning for acute NVG which eventually led to right eye pars plana vitrectomy for vitreous hemorrhage and refractory IOP elevation. At 6-month follow-up from initial stenting, the patient was blind in both eyes.

Discussion:

We present a case of recurrent IOP elevations following CAS eventually resulting in bilateral eye blindness. This case is important not only as an illustration of an underrecognized postprocedural CAS complication but also as a demonstration of likely elevated risk of NVG following CAS for patients with other predisposing risk factors for ocular hypertension such as glaucoma, proliferative diabetic retinopathy, prior cataract extraction, and prior pars plana vitrectomy.

Keywords carotid artery stenting, endovascular therapy, neovascular glaucoma

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Unruptured Brain Arteriovenous Malformations: Primary ONYX Embolization in ARUBA (A Randomized Trial of Unruptured Brain Arteriovenous Malformations)-Eligible Patients

I don't understand, did gluing the AVM really work? Secondary outcomes of death or stroke really are quite significant.
https://www.ncbi.nlm.nih.gov/pubmed/29114088

Singfer U¹, Hemelsoet D¹, Vanlangenhove P¹, Martens F¹, Verbeke L¹, Van Roost D¹, Defreyne L².

Author information

Abstract

BACKGROUND AND PURPOSE:

In light of evidence from ARUBA (A Randomized Trial of Unruptured Brain Arteriovenous Malformations), neurovascular specialists had to reconsider deliberate treatment of unruptured brain arteriovenous malformations (uBAVMs). Our objective was to determine the outcomes of uBAVM treated with primary embolization using ethylene vinyl alcohol (ONYX).

METHODS:

Patients with uBAVM who met the inclusion criteria of ARUBA and were treated with primary Onyx embolization were assigned to this retrospective study. The primary outcome was the modified Rankin Scale score. Secondary outcomes were stroke or death because of uBAVM or intervention and uBAVM obliteration.

RESULTS:

Sixty-one patients (mean age, 38 years) were included. The median observation period was 60 months. Patients were treated by embolization alone (41.0%), embolization and radiosurgery (57.4%), or embolization and excision (1.6%). Occlusion was achieved in 44 of 57 patients with completed treatment (77.2%). Forty-seven patients (77.1%) had no clinical impairment at the end of observation (modified Rankin Scale score of <2). Twelve patients (19.7%) reached the outcome of stroke or death because of uBAVM or intervention. Treatment-related mortality was 6.6% (4 patients).

CONCLUSIONS:

In uBAVM, Onyx embolization alone or combined with stereotactic radiosurgery achieves a high occlusion rate. Morbidity remains a challenge, even if it seems lower than in the ARUBA trial.

© 2017 American Heart Association, Inc.