Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial

Alexander Hoenning, Johannes Lemcke, Sergej Rot, Dirk Stengel, Berthold Hoppe, Kristina Zappel, Patrick Schuss, Sven Mutze, Leonie Goelz, Alexander Hoenning, Johannes Lemcke, Sergej Rot, Dirk Stengel, Berthold Hoppe, Kristina Zappel, Patrick Schuss, Sven Mutze, Leonie Goelz

Abstract

Background: Chronic subdural hematoma (cSDH) is the most common complication of mild traumatic brain injury demanding neurosurgery in high-income countries. If undetected and untreated, cSDH may increase intracranial pressure and cause neurological deficiencies. The first-line intervention of choice is burr hole trepanation and hematoma evacuation. However, any third patient may experience rebleeding, demanding craniotomy with excess morbidity. Adjunct endovascular embolization of the frontal and parietal branches of the middle meningeal artery (MMA) is a promising approach to avoid relapse and revision but was hitherto not studied in a randomized trial.

Methods: 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 cSDH will be assigned in a 1:1 fashion by block randomization to the intervention (surgery plus endovascular MMA embolization) or the control group (surgery alone). The primary trial endpoint is cSDH 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 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 onto this trial, employing an adaptive O'Brien-Fleming approach with a planned interim analysis halfway.

Discussion: The MEMBRANE trial will provide 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.

Clinicaltrials: gov NCT05327933 . Registered on 13 Apr 2022.

Keywords: Chronic subdural hematoma; Embolization; Endovascular; Mild traumatic brain injury; Randomized controlled trial; Surgery.

Conflict of interest statement

The authors declare they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Lateral angiograms of the MMA before embolization (A) and after injection of 0.5 ml PVA particles (100–300μm) obstructing the peripheral branches of the MMA (B)

References

    1. Stanisic M, Lund-Johansen M, Mahesparan R. Treatment of chronic subdural hematoma by burr-hole craniostomy in adults: influence of some factors on postoperative recurrence. Acta Neurochir (Wien) 2005;147(12):1249–1256. doi: 10.1007/s00701-005-0616-1.
    1. Yang W, Huang J. Chronic subdural hematoma: epidemiology and natural history. Neurosurg Clin N Am. 2017;28(2):205–210. doi: 10.1016/j.nec.2016.11.002.
    1. Juratli TA, Klein J, Schackert G. Das chronische Subduralhämatom im Alter. Der Chirurg. 2017;88(2):131–135. doi: 10.1007/s00104-016-0343-6.
    1. Schachenmayr W, Friede RL. The origin of subdural neomembranes. I. Fine structure of the dura-arachnoid interface in man. Am J Pathol. 1978;92(1):53–68.
    1. Adhiyaman V, Asghar M, Ganeshram KN, Bhowmick BK. Chronic subdural haematoma in the elderly. Postgrad Med J. 2002;78(916):71–75. doi: 10.1136/pmj.78.916.71.
    1. Karibe H, Kameyama M, Kawase M, Hirano T, Kawaguchi T, Tominaga T. Epidemiology of chronic subdural hematomas. No Shinkei Geka. 2011;39(12):1149–1153.
    1. Motiei-Langroudi R, Adeeb N, Foreman PM, Harrigan MR, Fisher WSR, Vyas NA, et al. Predictors of shunt insertion in aneurysmal subarachnoid hemorrhage. World Neurosurg. 2017;98:421–426. doi: 10.1016/j.wneu.2016.11.092.
    1. Hamou HA, Clusmann H, Schulz JB, Wiesmann M, Altiok E, Höllig A. Chronic subdural hematoma-antithrombotics and thrombotic complications. Dtsch Arztebl Int. 2022;119:208–213. doi: 10.3238/arztebl.m2022.0144.
    1. Ivaskevicius V, Biswas A, Thomas A, Lyonga S, Rott H, Halimeh S, et al. A common F13A1 intron 1 variant IVS1+12(A) is associated with mild FXIII deficiency in Caucasian population. Ann Hematol. 2013;92(7):975–979. doi: 10.1007/s00277-013-1724-2.
    1. Mezei ZA, Katona E, Kallai J, Bereczky Z, Molnar E, Kovacs B, et al. Regulation of plasma factor XIII levels in healthy individuals; a major impact by subunit B intron K c.1952+144 C>G polymorphism. Thromb Res. 2016;148:101–106. doi: 10.1016/j.thromres.2016.10.025.
    1. Gerlach R, Tolle F, Raabe A, Zimmermann M, Siegemund A, Seifert V. Increased risk for postoperative hemorrhage after intracranial surgery in patients with decreased factor XIII activity: implications of a prospective study. Stroke. 2002;33(6):1618–1623. doi: 10.1161/01.STR.0000017219.83330.FF.
    1. Imaizumi T, Horita Y, Honma T, Niwa J. Association between a black band on the inner membrane of a chronic subdural hematoma on T2*-weighted magnetic resonance images and enlargement of the hematoma. J Neurosurg. 2003;99(5):824–830. doi: 10.3171/jns.2003.99.5.0824.
    1. Almenawer SA, Farrokhyar F, Hong C, Alhazzani W, Manoranjan B, Yarascavitch B, et al. Chronic subdural hematoma management: a systematic review and meta-analysis of 34,829 patients. Ann Surg. 2014;259(3):449–457. doi: 10.1097/SLA.0000000000000255.
    1. Liu W, Bakker NA, Groen RJ. Chronic subdural hematoma: a systematic review and meta-analysis of surgical procedures. J Neurosurg. 2014;121(3):665–673. doi: 10.3171/2014.5.JNS132715.
    1. Weigel R, Krauss JK, Schmiedek P. Concepts of neurosurgical management of chronic subdural haematoma: historical perspectives. Br J Neurosurg. 2004;18(1):8–18. doi: 10.1080/02688690410001660418.
    1. Putnam RJ, Cushing H. Chronic subdural hematoma: its pathology, its relation to pachymengitis hemorrhagica and its surgical treatment. Arch Surg. 1925;11(3):329–393. doi: 10.1001/archsurg.1925.01120150002001.
    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;85(6):801–807. doi: 10.1093/neuros/nyy521.
    1. Mainka N, Borger V, Hadjiathanasiou A, Hamed M, Potthoff AL, Vatter H, Schuss P, Schneider M. Dehydration status at admission predicts recurrence in patients with traumatic chronic subdural hematoma. J Clin Med. 2022;11(5):1178. doi: 10.3390/jcm11051178.
    1. Schulz C, Kunz U, Mauer U. Die Bedeutung prädisponierender Faktoren bei chronischen Subduralhämatomen in der Altersgruppe unter 45 Jahren. Aktuelle Neurol. 2011;38(01):19–22. doi: 10.1055/s-0030-1266018.
    1. Ban SP, Hwang G, Byoun HS, Kim T, Lee SU, Bang JS, et al. Middle meningeal artery embolization for chronic subdural hematoma. Radiology. 2018;286(3):992–999. doi: 10.1148/radiol.2017170053.
    1. Majidi S, Matsoukas S, De Leacy RA, Morgenstern PF, Soni R, Shoirah H, et al. Middle meningeal artery embolization for chronic subdural hematoma using N-Butyl cyanoacrylate with D5W push technique. Neurosurgery. 2022. 10.1227/NEU.0000000000001882 Epub ahead of print. PMID: 35225245.
    1. Hashimoto T, Ohashi T, Watanabe D, Koyama S, Namatame H, Izawa H, et al. Usefulness of embolization of the middle meningeal artery for refractory chronic subdural hematomas. Surg Neurol Int. 2013;4:104. doi: 10.4103/2152-7806.116679.
    1. Iorio-Morin C, Touchette C, Levesque M, Effendi K, Fortin D, Mathieu D. Chronic subdural hematoma: toward a new management paradigm for an increasingly complex population. J Neurotrauma. 2018;35(16):1882–1885. doi: 10.1089/neu.2018.5872.
    1. Kim E. Embolization therapy for refractory hemorrhage in patients with chronic subdural hematomas. World Neurosurg. 2017;101:520–527. doi: 10.1016/j.wneu.2017.02.070.
    1. Link TW, Rapoport BI, Paine SM, Kamel H, Knopman J. Middle meningeal artery embolization for chronic subdural hematoma: Endovascular technique and radiographic findings. Interv Neuroradiol. 2018;24(4):455–462. doi: 10.1177/1591019918769336.
    1. Mewada T, Ohshima T, Yamamoto T, Goto S, Kato Y. Usefulness of embolization for iatrogenic dural arteriovenous fistula associated with recurrent chronic subdural hematoma: a case report and literature review. World Neurosurg. 2016;92(584):e7–e10.
    1. Tempaku A, Yamauchi S, Ikeda H, Tsubota N, Furukawa H, Maeda D, et al. Usefulness of interventional embolization of the middle meningeal artery for recurrent chronic subdural hematoma: five cases and a review of the literature. Interv Neuroradiol. 2015;21(3):366–371. doi: 10.1177/1591019915583224.
    1. Manelfe C, Guiraud B, David J, Eymeri JC, Tremoulet M, Espagno J, et al. Embolization by catheterization of intracranial meningiomas. Rev Neurol (Paris) 1973;128(5):339–351.
    1. Przybylowski CJ, Baranoski JF, See AP, Flores BC, Almefty RO, Ding D, et al. Preoperative embolization of skull base meningiomas: outcomes in the Onyx era. World Neurosurg. 2018;116:e371–e3e9. doi: 10.1016/j.wneu.2018.04.208.
    1. Tawfik KO, Harmon JJ, Walters Z, Samy R, de Alarcon A, Stevens SM, et al. Facial palsy following embolization of a juvenile nasopharyngeal angiofibroma. Ann Otol Rhinol Laryngol. 2018;127(5):344–348. doi: 10.1177/0003489418761456.
    1. Hayashi N, Kubo M, Tsuboi Y, Nishimura S, Nishijima M, Ahmed Abdel-Aal M, Endo S. Impact of anomalous origin of the ophthalmic artery from the middle meningeal artery on selection of surgical approach to skull base meningioma. Surg Neurol. 2007;68(5):568–571. doi: 10.1016/j.surneu.2006.11.033.
    1. Lasjaunias P, Moret J, Doyon D, Vignaud J. Exploration artériographique du nerf facial intra-pétreux: Embryologie et aspect radio-anatomiques normaux [Arteriographic exploration of the intrapetrous facial nerve: embryology and normal radiologic anatomy (author’s transl)] Neuroradiology. 1978;16:246–248. doi: 10.1007/BF00395262.
    1. Ebinger M, Siegerink B, Kunz A, Wendt M, Weber JE, Schwabauer E, et al. Association between dispatch of mobile stroke units and functional outcomes among patients with acute ischemic stroke in Berlin. JAMA. 2021;325(5):454–466. doi: 10.1001/jama.2020-26345.
    1. Goelz L, Arndt H, Hausmann J, Madeja C, Mutze S. Obstacles and solutions driving the development of a national teleradiology network. Healthcare (Basel) 2021;9(12):1684. doi: 10.3390/healthcare9121684.
    1. Forsting M, Von Kummer R, Sartor K. Interventionelle Neuroradiologie. In: Kauffmann GW, Rau WS, Roeren T, Sartor K, editors. Röntgenfibel: Praktische Anleitung für Eingriffe in der Röntgendiagnostik und interventionellen Radiologie. Berlin, Heidelberg: Springer Berlin Heidelberg; 2001. pp. 369–378.
    1. Wilson JL, Hareendran A, Hendry A, et al. Reliability of the modified Rankin Scale across multiple raters: benefits of a structured interview. Stroke. 36(4):777–81. 10.1161/01.STR.0000157596.13234.95 PMID 15718510.
    1. Janda V. On the concept of postural muscles and posture in man. Aust J Physiother. 1983;29(3):83–84. doi: 10.1016/S0004-9514(14)60665-6.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir