Balloon guide catheters: use, reject, or randomize?

Abstract

Thrombectomy devices played an important role in the success of endovascular treatment trials over the past five years. A balloon guide catheter (BGC) is an adjunctive device used to arrest and reverse flow by inflating the balloon at its tip, which allows for flow reversal in intracranial arteries during retrieval of thrombectomy devices by applying concomitant aspiration through its lumen. Thereby, it can decrease the risk of clot fragmentation and distal embolization. Despite the numerous benchtop and clinical observational studies showing the superiority of BGC to conventional guide catheters in improving reperfusion quality and clinical outcome, its use is still low in clinical practice. The reasons behind this reluctance might be related to technical and cost issues. Therefore, high level evidence data, i.e., a randomized clinical trial, are needed to increase its implementation in thrombectomy procedures. Nonetheless, several obstacles and challenges can prevent the completion of such a trial, and efforts are needed to overcome them. We provide an overview of the current opinions about BGCs in the neurointerventional community and discuss the feasibility and challenges of a possible randomized trial to answer the question "should a BGC be routinely used in endovascular treatment of acute ischemic stroke?" Keywords Balloon guide catheter • Endovascular treatment • Randomized controlled trial

A propensity score-matched comparative study of balloon guide catheters versus conventional guide catheters for concurrent mechanical thrombectomy with carotid stenting in tandem strokes: comparison of first pass effect, symptomatic intracranial hemorrhage, and 90-day functional outcomes

“…Several studies have demonstrated the beneficial role of BGCs in AIS treatment secondary to intracranial clot occlusion regardless of the first-line MT technique used (stent retriever alone vs aspiration alone vs combined approach) 7–11 16. Positive correlations between the use of BGCs and higher first pass effect rates, successful recanalization rates, and better clinical outcomes are reported, as well as shorter procedure durations and lower risk of mortality 7–11 16.…”

“…Several studies have shown the superiority of mechanical thrombectomy (MT) performed with balloon guide catheters (BGCs) over conventional guide catheters (GCs), regardless of the technique employed for clot retrieval 7–13. The initial BGCs were bulky and rigid and often could not be advanced to the desired location in the distal cervical or proximal intracranial anatomy, resulting in the use of the more navigable traditional non-balloon-tipped GCs 11. However, the newer generation is as navigable as non-balloon tipped catheters.…”

Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial

“…Compatibility and flexibility are common reasons for surgeon reluctant to use the BGC in previous investigations. 7 , 8 In our trial, device performance was set as the secondary outcome, and more than 90% of researchers scored 4–5 points for each performance, indicating the good performance of the SeparGate™ BGC for interventional diagnosis and treatment. Delayed therapy and increased procedural time are essential reasons for unfavorable outcomes and complications, especially in cases of acute cerebrovascular disease.…”

“…However, the use of BGC is controversial considering puncture site hematoma, iatrogenic dissections, other complications, and additional medical expenses. 7 , 8 The limited domestic BGC product options also impede its clinical use.…”

Effect of proximal blood flow arrest during endovascular thrombectomy (ProFATE): Study protocol for a multicentre randomised controlled trial

“…Despite recommendations in the current guidelines (2,3), there is a state of clinical equipoise globally, with approximately only one in four interventionists reporting routine use of BGCs during EVT (12). Reasons cited for not using BGCs include: potential device related complications (arterial dissection), handling properties such as lack of support, restricted compatibility with larger bore aspiration catheters, and higher costs (12).…”