Safety and efficacy of dual lumen balloon catheters for the Treatment of cerebral vascular malformations: A systematic review, pooled analysis, and meta-analysis

Abstract

Background 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. Registration-URL https://www.crd.york.ac.uk/prospero/ Unique Identifier: CRD42021269096