Restricted accessResearch articleFirst published online 2023-8
Safety and efficacy of dual lumen balloon catheters for the Treatment of cerebral vascular malformations: A systematic review,pooled analysis,and meta-analysis
There is little evidence in scientific literature assessing the safety and efficacy of dual-lumen balloon catheters (DLBCs) and their performance compared to single-lumen catheters (SLCs).
Methods
In this PROSPERO-registered, PRISMA-compliant systematic review, we identified all MEDLINE and EMBASE single-arm (DLBCs) and double-arm (DLBCs vs SLCs) cohorts where DLBCs were used for the treatment of cerebral arteriovenous malformations (AVMs) or dural arteriovenous fistulas (dAVFs). Immediate angiographic outcome, vascular complications, technical failures, reflux episodes and entrapment were the primary outcomes. A meta-analysis of the double-arm studies summarized the primary outcomes of total procedural time and immediate angiographic outcome.
Results
The authors identified 18 studies encompassing 209 treated lesions with reported outcomes. Complete occlusion was achieved in 108/132 treated dAVFs (81.8%, 95% CI: [74–87.8%]) and in 45/77 treated AVMs (58.4%, [46.7–69.4%]). The proportion of completely occluded dAVFs was statistically significantly higher than that of AVMs, p < .001. There were eight reported vascular complications (3.8%, [1.8–7.7%]), five technical failures (2.4%, [0.9–5.8%]), 14 reflux events (6.7%, [3.9–11.2%]), two entrapment events (1%, [0.2–3.8%]) and 0 deaths (mortality rate 0%, [0–2.3%]). In a meta-analysis for the treatment of dAVFs, the total procedural time was significantly less for DLBCs compared to SLCs (64.9 vs 125.7 min, p < .0001). The odds of complete immediate occlusion were significantly higher with DLBCs compared to SLCs (odds ratio (OR) 4.6, [1.5–14.3], p = .008).
Conclusion
Dual-lumen balloon catheters are safe and effective for the embolization of cerebral AVMs and dAVFs and can achieve faster and potentially superior results compared to SLCs.
ParamasivamSNiimiYFifiJ, et al.Onyx embolization using dual-lumen balloon catheter: initial experience and technical note. J Neuroradiol2013; 40: 294–302. DOI: 10.1016/j.neurad.2013.08.001
2.
SpiottaAMJamesRFLoweSR, et al.Balloon-augmented Onyx embolization of cerebral arteriovenous malformations using a dual-lumen balloon: a multicenter experience. J Neurointerv Surg2015; 7: 721–727. DOI: 10.1136/neurintsurg-2014-011285
3.
van BeijnumJvan der WorpHBBuisDR, et al.Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. Jama2011; 306: 2011–2019. DOI: 10.1001/jama.2011.1632
4.
ParamasivamSAltschulDOrtega-GutiarrezS, et al.N-butyl cyanoacrylate embolization using a detachable tip microcatheter: initial experience. J Neurointerv Surg2015; 7: 458–461. DOI: 10.1136/neurintsurg-2014-011165
5.
PierotLCognardCHerbreteauD, et al.Endovascular treatment of brain arteriovenous malformations using a liquid embolic agent: results of a prospective, multicentre study (BRAVO). Eur Radiol2013; 23: 2838–2845. DOI: 10.1007/s00330-013-2870-6
6.
TrianoMJLara-ReynaJSchupperAJ, et al.Embolic agents and microcatheters for endovascular treatment of cerebral arteriovenous malformations. World Neurosurg2020; 141: 383–388. DOI: 10.1016/j.wneu.2020.06.118
7.
HafazallaKBaldassariMPSweidA, et al.A comparison of dual-lumen balloon and simple microcatheters in the embolization of DAVFs and AVMs using onyx. J Clin Neurosci2020; 81: 295–301. DOI: 10.1016/j.jocn.2020.10.007
8.
KimJWKimBMParkKY, et al.Onyx embolization for isolated type dural arteriovenous fistula using a dual-lumen balloon catheter. Neurosurgery2016; 78: 627–636. DOI: 10.1227/neu.0000000000001069
9.
PageMJMcKenzieJEBossuytPM, et al.The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. J Clin Epidemiol2021; 134: 178–189. DOI: 10.1016/j.jclinepi.2021.03.001
10.
MatsoukasSBageacDSiddiquiN, et al.Systematic review of safety and efficacy of dual lumen balloon catheters for the treatment of cerebral AVMs and dural AVFs: a pooled analysis of single-arm studies and a meta-analysis of comparative studies. PROSPERO 2021 CRD42021269096 Available from:https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021269096
ClarençonFDi MariaFGabrieliJ, et al.Double-lumen balloon for Onyx® embolization via extracranial arteries in transverse sigmoid dural arteriovenous fistulas: initial experience. Acta Neurochir (Wien)2016; 158: 1917–1923. DOI: 10.1007/s00701-016-2906-1
13.
DabusGLinfanteIMartínez-GaldámezM. Endovascular treatment of dural arteriovenous fistulas using dual lumen balloon microcatheter: technical aspects and results. Clin Neurol Neurosurg2014; 117: 22–27. DOI: 10.1016/j.clineuro.2013.12.001
14.
JagadeesanBDGrandeAWTummalaRP. Safety and feasibility of balloon-assisted embolization with Onyx of brain arteriovenous malformations revisited: personal experience with the scepter XC balloon microcatheter. Interv Neurol2018; 7: 439–444. DOI: 10.1159/000490579
15.
JagadeesanBDGrigoryanMHassanAE, et al.Endovascular balloon-assisted embolization of intracranial and cervical arteriovenous malformations using dual-lumen coaxial balloon microcatheters and Onyx: initial experience. Neurosurgery2013; 73: ons238–243; discussion ons243. DOI: 10.1227/neu.0000000000000186
16.
JangCKKimBMParkKY, et al.Scepter dual-lumen balloon catheter for Onyx embolization for dural arteriovenous fistula. BMC Neurol2021; 21: 31. DOI: 10.1186/s12883-021-02046-6
17.
KimSHKimTGKongMH. Transarterial balloon-assisted Onyx embolization of intracranial arteriovenous malformations using a dual-lumen balloon microcatheter: two case reports. J Cerebrovasc Endovasc Neurosurg2017; 19: 223–230. DOI: 10.7461/jcen.2017.19.3.223
18.
LvXChenXGeH, et al.Adjunct to embolize the high-flow fistula part of arteriovenous malformation using a double-lumen balloon catheter. World Neurosurg2016; 96: 370–374. DOI: 10.1016/j.wneu.2016.09.006
19.
MehtaTHassanAMasoodK, et al.The next step in balloon assisted endovascular neurosurgical procedures: A case series of initial experience with the Scepter Mini balloon microcatheter. Interv Neuroradiol2021; 27: 298–306. DOI: 10.1177/1591019920972884
PiechowiakEZiboldFDobrockyT, et al.Endovascular treatment of dural arteriovenous fistulas of the transverse and sigmoid sinuses using transarterial balloon-assisted embolization combined with transvenous balloon protection of the venous sinus. AJNR Am J Neuroradiol2017; 38: 1984–1989. DOI: 10.3174/ajnr.A5333
22.
PulliBSussmanESMayercikV, et al.Initial experience with the Scepter Mini dual-lumen balloon for transophthalmic artery embolization of anterior cranial fossa dural arteriovenous fistulae. J Neurointerv Surg2020; 12: 1132–1136. DOI: 10.1136/neurintsurg-2020-016013
23.
ShotarEAl RaaisiALenckS, et al.Injection of N-butyl cyanoacrylate through a dual-lumen balloon for embolization of high-flow intranidal fistulas in brain arteriovenous malformations: technical note. Clin Neuroradiol2020; 30: 313–319. DOI: 10.1007/s00062-019-00780-6
24.
WhiteTGShahKATurpinJ, et al.Single institution early clinical experience with the Scepter Mini balloon catheter. Neuroradiol J2021: 34, 562–567. DOI: 10.1177/19714009211013495
25.
MatsoukasSBageacDYaegerK, et al.Initial experience with the Scepter Mini catheter for the embolization of vascular malformations in the pediatric population. Neuroradiol J2021. DOI: 10.1177/19714009211049084
26.
PanagiotopoulosVGizewskiEAsgariS, et al.Embolization of intracranial arteriovenous malformations with ethylene-vinyl alcohol copolymer (Onyx). AJNR Am J Neuroradiol2009; 30: 99–106. DOI: 10.3174/ajnr.A1314
27.
LanzaEGennaroNPorettiD, et al.Full recovery after non-target cerebral embolization of n-butyl-cyanoacrylate occurred during emergency treatment of a facial arteriovenous malformation. CVIR Endovasc2019; 2: 20. DOI: 10.1186/s42155-019-0063-3
28.
DerdeynCPZipfelGJAlbuquerqueFC, et al.Management of brain arteriovenous malformations: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke2017; 48: e200-e224. DOI: 10.1161/str.0000000000000134
29.
CrowleyRWDucruetAFMcDougallCG, et al.Endovascular advances for brain arteriovenous malformations. Neurosurgery2014; 74(Suppl 1): S74–S82DOI: 10.1227/neu.0000000000000176
30.
VollherbstDFChapotRWallochaM, et al.First clinical multicenter experience with the new Scepter Mini microballoon catheter. J Neurointerv Surg2021; 13: 261–266. DOI: 10.1136/neurintsurg-2020-016115
31.
MatsoukasSRossittoCPBerensteinA, et al.Infantile dural sinus malformation: curative embolization in two stages with the Scepter mini balloon microcatheter. J Neurointerv Surg2022. DOI: 10.1136/neurintsurg-2021-018608
32.
SaatciIGeyikSYavuzK, et al.Endovascular treatment of brain arteriovenous malformations with prolonged intranidal Onyx injection technique: long-term results in 350 consecutive patients with completed endovascular treatment course. J Neurosurg2011; 115: 78–88. DOI: 10.3171/2011.2.Jns09830
33.
MaimonSStraussIFrolovV, et al.Brain arteriovenous malformation treatment using a combination of Onyx and a new detachable tip microcatheter, SONIC: short-term results. AJNR Am J Neuroradiol2010; 31: 947–954. DOI: 10.3174/ajnr.A1959
34.
LohYDuckwilerGR. A prospective, multicenter, randomized trial of the Onyx liquid embolic system and N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations. Clinical article. J Neurosurg2010; 113: 733–741. DOI: 10.3171/2010.3.Jns09370
35.
ParkSHwangSMLimOK, et al.Compliant neurovascular balloon catheters may not be compatible with liquid embolic materials: intraprocedural rupture of the protecting balloon during tumor embolization using n-butyl cyanoacrylate and lipiodol mixture. J Neurointerv Surg2015; 7: 740–743. DOI: 10.1136/neurintsurg-2014-011331
36.
WhiteTGDehdashtiARWooHH. Scepter mini assisted angiographic cure of a vein of galen malformation with n-butyl cyanoacrylate. Interv Neuroradiol2021; 27: 663. DOI: 10.1177/1591019921993368
