Middle meningeal artery embolization for chronic subdural hematoma trials

Middle meningeal artery embolization for chronic subdural hematoma trials

Several randomized controlled trials are planned or ongoing. In most of these trials, conventional neurosurgical treatment with or without adjunctive endovascular embolization is compared.


Given the encouraging results with a 91% long-term success rate in the series of Link et al., a large scale clinical trial is warranted 1).

https://clinicaltrials.gov/ct2/show/NCT03307395


A proposed trial aimed to conduct a head-to-head comparison between neurosurgical and endovascular treatment as stand-alone treatments.

The trial is academically driven and funded within existing public healthcare systems and infrastructure. Patients with uni- or bilateral cSDH, presenting with mild-to moderate symptoms, and admitted to neurosurgery on clinical grounds will be offered participation. Subjects are randomized 1:1 between conventional neurosurgical treatment (control) and endovascular embolization of the middle meningeal artery (intervention). Primary endpoint is reoperation due to clinically and/or radiologically significant recurrence within 3 months. Secondary endpoints include safety, technical success rate, neurological disability, and quality of life.

There are mounting retrospective data suggesting eMMA, as sole treatment or as an adjunctive to neurosurgery for cSDH, is safe and effective with a reoperation rate lower than neurosurgical hematoma evacuation alone. If randomized controlled trials confirm these findings, there is a potential for a paradigm shift in the treatment of cSDH where a minimally invasive procedure can replace open surgery in a large and oftentimes old and fragile patient cohort.

Trial registration: ClinicalTrials.gov, ClinicalTrials.gov Identifier NCT05267184 . Registered March 4, 2022 2).


MEMBRANE is an investigator-initiated, single-center, randomized controlled trial. Male, female, and diverse patients older than 18 years scheduled for surgical evacuation of a first chronic subdural hematoma will be assigned in a 1:1 fashion by block randomization to the chronic subdural hematoma treatment (surgery plus endovascular MMA embolization) or the control group (surgery alone). The primary trial endpoint is chronic subdural hematoma recurrence within 3 months of follow-up after surgery. Secondary endpoints comprise neurological deficits assessed by the modified Rankin Scale (mRS) and recurrence- or intervention-associated complications (see Chronic subdural hematoma surgery complications) see Middle meningeal artery embolization for chronic subdural hematoma complications during 3 months of follow-up. Assuming a risk difference of 20% of rebleeding and surgical revision, a power of 80%, and a drop-out rate of 10%, 154 patients will be enrolled in this trial, employing an adaptive O’Brien-Fleming approach with a planned interim analysis halfway.

The MEMBRANE trial will provide the first clinical experimental evidence on the effectiveness of endovascular embolization of the MMA as an adjunct to surgery to reduce the risk of recurrence after the evacuation of cSDH.

Trial registration: German Clinical Trials Registry (Deutsches Register Klinischer Studien [DRKS]) DRKS00020465. Registered on 18 Nov 2021 3).


1)

Link TW, Boddu S, Paine SM, Kamel H, Knopman J. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma: A Series of 60 Cases. Neurosurgery. 2019 Dec 1;85(6):801-807. doi: 10.1093/neuros/nyy521. PMID: 30418606.
2)

Drake M, Ullberg T, Nittby H, Marklund N, Wassélius J. Swedish trial on embolization of middle meningeal artery versus surgical evacuation in chronic subdural hematoma (SWEMMA)-a national 12-month multi-center randomized controlled superiority trial with parallel group assignment, open treatment allocation and blinded clinical outcome assessment. Trials. 2022 Nov 8;23(1):926. doi: 10.1186/s13063-022-06842-4. PMID: 36348417.
3)

Hoenning A, Lemcke J, Rot S, Stengel D, Hoppe B, Zappel K, Schuss P, Mutze S, Goelz L. Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial. Trials. 2022 Aug 22;23(1):703. doi: 10.1186/s13063-022-06506-3. PMID: 35996195.

Anterior communicating artery aneurysm endovascular treatment complications

Anterior communicating artery aneurysm endovascular treatment complications

Intraprocedural aneurysm rupture and thrombus formation are serious complications during coiling of ruptured intracranial aneurysms, and they more often occur in patients with anterior communicating artery aneurysms.

It is associated with a high rate of complete angiographic occlusion. However, the procedure-related permanent morbidity and mortality are not negligible for aneurysms in this location 1).


Delgado Acosta et al. from Hospital Universitario Reina Sofía aimed to report the characteristics of patients suffering intra- or peri-procedural ruptures during embolization of cerebral aneurysms.

Between March 1994 and October 2021, 648 consecutive cerebral aneurysms were treated by the endovascular procedureMedical records were reviewed retrospectively with emphasis on procedure description, potential risk factors, and clinical outcomes related to intra- or peri-procedural rupture.

Of the 648 patients, 17 (2.6%) suffered an intra- or peri-procedural hemorrhagic event. The most common location was the anterior communicating artery. There was no significant difference between previously ruptured and unruptured aneurysms in the incidence of bleeding. In four patients, bleeding was evident within 24 h after the procedure. The clinical evolution at three months was poor and only four patients presented a positive evolution. There were 11 deaths (64.71%). Balloon remodeling was associated with an increased frequency of ruptures, while stenting was a safer treatment.

Aneurysm rupture during endovascular therapy is unpredictable, and its occurrence can be devastating. The incidence is quite low although the outcome is frequently poor. Early detection and proper management, including prompt occlusion of the aneurysm, are important to achieve a positive outcome. Anterior communicating artery aneurysms and those treated with balloon catheters have a higher incidence of rupture. A small number of ruptures of uncertain origin occur that go unnoticed in digital subtraction angiograms 2).


The immediate and long-term outcomes, complications, recurrences and the need for retreatment were analyzed in a series of 280 consecutive patients with anterior communicating artery aneurysms treated with the endovascular technique. From October 1992 to October 2001 280 patients with 282 anterior communicating artery aneurysms were addressed to our center. For the analysis, the population was divided into two major groups: group 1, comprising 239 (85%) patients with ruptured aneurysms and group 2 comprising of 42 (15%) patients with unruptured aneurysms. In group 1, 185 (77.4%) patients had a good initial pre-treatment Hunt and Hess grade of I-III. Aneurysm size was divided into three categories according to the larger diameter: less than 4 mm, between 4 and 10 mm and larger than 10 mm. The sizes of aneurysms in groups 1 and 2 were identical but a less favorable neck to depth ratio of 0.5 was more frequent in group 2. Endovascular treatment was finally performed in 234 patients in group 1 and 34 patients in group 2. Complete obliteration was more frequently obtained in group 2 unlike a residual neck or opacification of the sac that were more frequently seen in group 1. No peri-treatment complications were recorded in group 2. In group 1 the peri-treatment mortality and overall peri-treatment morbidity were 5.1% and 8.1% respectively. Eight patients (3.4%) in group 1 presented early post treatment rebleeding with a mortality of 88%. The mean time to follow-up was 3.09 years. In group 1, 51 (21.7%) recurrences occurred of which 14 were minor and 37 major. In group 2, eight (23.5%) recurrences occurred, five minor and three major. Two patients (0.8%) presented late rebleeding in group 1. Twenty-seven second endovascular retreatments were performed, 24 (10.2%) in group 1 and three (8.8%) in group 2, seven third endovascular retreatments and two surgical clippings in group 1 only. There was no additional morbidity related to retreatments. Endovascular treatment is an effective method for the treatment of anterior communicating artery aneurysms allowing late rebleeding prevention. Peri-treatment rebleeding warrants caution in anticoagulation management. This is a single center experience and the follow-up period is limited. Patients should be followed-up in the long-term as recurrences may occur and warrant additional treatment 3).


Prolonged anterograde amnesia and disorientation after anterior communicating artery aneurysm coil embolization 4)


LVIS stent-assisted coiling for ruptured wide-necked ACoA aneurysms was safe and effective, with a relatively low rate of perioperative complications and a high rate of complete occlusion at follow-up 5)


1)

Fang S, Brinjikji W, Murad MH, Kallmes DF, Cloft HJ, Lanzino G. Endovascular treatment of anterior communicating artery aneurysms: a systematic review and meta-analysis. AJNR Am J Neuroradiol. 2014 May;35(5):943-7. doi: 10.3174/ajnr.A3802. Epub 2013 Nov 28. PMID: 24287090; PMCID: PMC7964525.
2)

Delgado Acosta F, Bravo Rey I, Jiménez Gómez E, Saucedo VR, Toledano A, Oteros Fernández R. Intra- or peri-procedural rupture in the endovascular treatment of intracranial aneurysms. Acta Neurol Scand. 2022 Aug 17. doi: 10.1111/ane.13686. Epub ahead of print. PMID: 35975464.
3)

Finitsis S, Anxionnat R, Lebedinsky A, Albuquerque PC, Clayton MF, Picard L, Bracard S. Endovascular treatment of ACom intracranial aneurysms. Report on series of 280 patients. Interv Neuroradiol. 2010 Mar;16(1):7-16. doi: 10.1177/159101991001600101. Epub 2010 Mar 25. PMID: 20377974; PMCID: PMC3277962.
4)

Al-Atrache Z, Friedler B, Shaikh HA, Kavi T. Prolonged anterograde amnesia and disorientation after anterior communicating artery aneurysm coil embolisation. BMJ Case Rep. 2019 Jul 30;12(7). pii: e230543. doi: 10.1136/bcr-2019-230543. PubMed PMID: 31366616.
5)

Xue G, Liu P, Xu F, Fang Y, Li Q, Hong B, Xu Y, Liu J, Huang Q. Endovascular Treatment of Ruptured Wide-Necked Anterior Communicating Artery Aneurysms Using a Low-Profile Visualized Intraluminal Support (LVIS) Device. Front Neurol. 2021 Jan 28;11:611875. doi: 10.3389/fneur.2020.611875. PMID: 33584512; PMCID: PMC7876256.

terior communicating artery aneurysm endovascular treatment complications

Middle cerebral artery M4 segment aneurysm

Middle cerebral artery M4 segment aneurysm

Middle cerebral artery aneurysms, are mainly found in the proximal and bifurcation tracts and only in the 1.1-1.7% of cases they are located in the M4 segment of the middle cerebral artery 1) 2) 3).

Generally, these aneurysms are secondary to traumatic brain injury and inflammatory or infectious diseases and only rarely they have idiopathic origin 4).

At present, only nine cases of ruptured cortical middle cerebral artery aneurysms have been described in literature 5) 6) 7) 8) 9) 10).

The patients are all males, except the case of Ricci et al. 11). The average age of the reported patients is 40 years. The size of the aneurysms is between 1 mm and 10 mm and, in most cases, they are saccular intracranial aneurysms or fusiform morphology. In five patients, the aneurysms present infectious etiology. Usually, they occur with ICH, sometimes associated with subarachnoid hemorrhage (SAH).

The endovascular treatment (EVT) has been performed in four cases, while the surgical treatment has been performed in three cases (two of trapping and one of clipping). In one patient, the infectious aneurysm has resolved spontaneously after antibiotic therapy. In all treatments performed, the patients have improved the neurologic symptoms and no residual aneurysms have been observed in the subsequent neuroradiology follow-up 12). Although surgery remains the main choice in the M4 aneurysms, because of the extremely distal location of them over the motor/somatosensory cortices, 13) Lv et al. 14) propose the use of the EVT in all types of the M4 aneurysms, especially after the surgery, when it is impossible to locate the small ruptured aneurysm.

The main difficulty of the surgery is the precise surgical localization of the small M4 aneurysms 15). An inaccurate localization of these vascular lesions may result in larger craniotomies and unnecessary arachnoid and pial dissections with possible resultant permanent neurological injuries 16).

In cases of aneurysms or arteriovenous malformations located at the sylvian point or at the posterior superior aspect of the insula, especially in dominant hemisphere, to reduce the dissection and open easily sylvian fissure, a logical path would follow the angular artery in the sylvian fissure cutting the arachnoid fibers and retracting only the tissues which are necessary to gain more exposure of the lesion 17).

A case of a ruptured dissecting pseudoaneurysm in the distal Middle cerebral artery (distal M3/proximal M4) prefrontal division in an healthy young patient (<60 years) successfully treated with a Pipeline Embolization Device. The PED was chosen both as the only vessel sparing option in the young patient as well as for its potential as a vessel sacrifice tool if the pseudoaneurysm was felt to be incompletely treated, which in this case was not necessary-though would have leveraged the thrombogenicity of the device as a therapeutic advantage 18).

2017

A 53-year-old female was admitted with a sudden severe headache, nausea, vomiting, and a slight left hemiparesis. The computed tomography (CT) scan showed subarachnoid hemorrhage (SAH) in the left sylvian fissure and intracerebral hemorrhage (ICH) in the left posterior parietal area. The CT angiography (CTA) reconstructed with 3D imaging showed a small saccular aneurysm in the M4 segment in proximity of the angular area. A left parieto-temporal craniotomy was performed, the aneurysm was clipped and the ICH evacuated. The motor deficit was progressively recovered. At 3-month follow-up examination, the patient was asymptomatic and feeling well.

Surgery is the best choice for the treatment of ruptured M4 aneurysms with ICH in the opinion of Ricci et al., because it allows to evacuate the hematoma and to exclude the aneurysm from the intracranial circulation. In addition, we suggest both the use of the neuronavigation technique and of the indocyanine green videoangiography (ICGV) for the aneurismal surgery 19).

2007

A 41-year-old man presented with an infarction manifesting as left-sided weakness and dysarthria. Magnetic resonance angiography revealed a subacute stage infarction in the right MCA territory and complete occlusion of the right ICA. Angiography demonstrated aneurysmal dilatation of the M4 segment of the right MCA. Surgery was performed to prevent hemorrhage from the aneurysm. The aneurysm was proximally clipped guided by Navigation-CT angiography and flow to the distal MCA was restored by superficial temporal artery-middle cerebral artery (STA-MCA) anastomosis 20).

2005

A 20-year-old man with an intracerebral haemorrhage due to a ruptured aneurysm, which arose from a penetrating artery of the distal middle cerebral artery (MCA; M4 segment). Excision of the aneurysm was successfully achieved via a right pterional approach. The follow-up angiogram demonstrated filling of the parent vessel and no residual aneurysm. This report illustrates the angiographical finding of a penetrating artery aneurysm of the distal MCA and summarizes the previous reports to discuss their pathological and clinical characteristics 21).


1) , 4) , 5) , 21)

Ahn JY, Han IB, Joo JY. Aneurysm in the penetrating artery of the distal middle cerebral artery presenting as intracerebral haemorrhage. Acta Neurochir (Wien). 2005 Dec;147(12):1287-90; discussion 1290. Epub 2005 Aug 29. PubMed PMID: 16133768.
2) , 8) , 14)

Lv N, Zhou Y, Yang P, Li Q, Zhao R, Fang Y, Xu Y, Hong B, Zhao W, Liu J, Huang Q. Endovascular treatment of distal middle cerebral artery aneurysms: Report of eight cases and literature review. Interv Neuroradiol. 2016 Feb;22(1):12-7. doi: 10.1177/1591019915617317. Epub 2015 Dec 3. Review. PubMed PMID: 26637241; PubMed Central PMCID: PMC4757379.
3)

Elsharkawy A, Lehečka M, Niemelä M, Billon-Grand R, Lehto H, Kivisaari R, Hernesniemi J. A new, more accurate classification of middle cerebral artery aneurysms: computed tomography angiographic study of 1,009 consecutive cases with 1,309 middle cerebral artery aneurysms. Neurosurgery. 2013 Jul;73(1):94-102; discussion 102. doi: 10.1227/01.neu.0000429842.61213.d5. PubMed PMID: 23615110.
6)

Horiuchi T, Tanaka Y, Takasawa H, Murata T, Yako T, Hongo K. Ruptured distal middle cerebral artery aneurysm. J Neurosurg. 2004;100:384–8.
7)

Lee SM, Park HS, Choi JH, Huh JT. Ruptured mycotic aneurysm of the distal middle cerebral artery manifesting as subacute subduralhematoma. J Cerebrovasc Endovasc Neurosurg. 2013;15:235–40.
9) , 13) , 15) , 16)

Raza SM, Papadimitriou K, Gandhi D, Radvany M, Olivi A, Huang J. Intra-arterial intraoperative computed tomography angiography guided navigation: a new technique for localization of vascular pathology. Neurosurgery. 2012 Dec;71(2 Suppl Operative):ons240-52; discussion ons252. doi: 10.1227/NEU.0b013e3182647a73. PubMed PMID: 22858682.
10) , 11) , 12) , 19)

Ricci A, Di Vitantonio H, De Paulis D, Del Maestro M, Raysi SD, Murrone D, Luzzi S, Galzio RJ. Cortical aneurysms of the middle cerebral artery: A review of the literature. Surg Neurol Int. 2017 Jun 13;8:117. doi: 10.4103/sni.sni_50_17. eCollection 2017. PubMed PMID: 28680736; PubMed Central PMCID: PMC5482160.
17)

Ausman JI, Diaz FG, Malik GM, Tomecek F. A new microsurgical approach to cerebrovascular lesions of the sylvian point: report of two cases. Surg Neurol. 1990 Jul;34(1):48-51. PubMed PMID: 2360163.
18)

Berwanger RP, Hoover MC, Scott JA, DeNardo AJ, Amuluru K, Payner TD, Kulwin CG, Sahlein DH. The Use of a Pipeline Embolization Device for Treatment of a Ruptured Dissecting Middle Cerebral Artery M3/M4 Aneurysm: Challenges and Technical Considerations. Neurointervention. 2022 Apr 7. doi: 10.5469/neuroint.2022.00045. Epub ahead of print. PMID: 35385900.
20)

Lee SH, Bang JS. Distal Middle Cerebral Artery M4 Aneurysm Surgery Using Navigation-CT Angiography. J Korean Neurosurg Soc. 2007 Dec;42(6):478-80. doi: 10.3340/jkns.2007.42.6.478. Epub 2007 Dec 20. PubMed PMID: 19096593; PubMed Central PMCID: PMC2588183.
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