The Source for Neurovascular News and Education

March 29, 2024

 

Clinical trials directly comparing outcomes with and without balloon guide catheters are needed to determine whether their use should become

 


A new analysis of nonrandomized trials—the only data available to date on the benefits of using balloon guide catheters during mechanical thrombectomy for large vessel occlusion—suggests their use does indeed improve outcomes. Its authors acknowledge, however, that randomized trials are needed to confirm their findings, which were published online last month in the Journal of NeuroInterventional Surgery.

“Over the past several years there has been growing interest in the use of flow arrest with a balloon guide catheter (BGC) as a technique to improve both angiographic and clinical outcomes” of mechanical thrombectomy for large vessel occlusions, write researchers led by Waleed Brinjikji, MD (Mayo Clinic, Rochester MN). They point out that while benchtop and clinical studies have demonstrated improved results, such as reduced distal embolization, higher revascularization rates, and better neurological outcomes, registry data indicate that only about half of stroke interventions employ balloon guide catheters

The authors conducted a meta-analysis of 5 nonrandomized studies that included 1,083 patients treated with balloon guide catheters and 939 treated without them. All of the studies used modern techniques, such as stent retrievers.

Outcomes were better with balloon guide catheters across the board, including increased odds of achieving first-pass recanalization, full recanalization, and a good outcome. Mortality rates were also lower with balloon guide catheters, and procedure times and number of passes were lower.

Outcomes With vs Without Balloon Guide Catheters

 

Odds Ratio/Weighted Mean Difference (95% CI)

First-Pass Recanalization

2.05 (1.65-2.55)

TICI 3

2.13 (1.43-3.17)

TICI 2b/3

1.54 (1.21-1.97)

Mean Number of Passes

−0.34 (−0.47 to −0.22)

Mean Procedure Time, mins

−7.7 (−9.0 to −6.4)

mRS 0-2

1.84 (1.52-2.22)

Mortality

0.52 (0.37-0.73)

 

Clear Benefits Noted

“Data from our meta-analysis suggest that BGC use is associated with significant improvement in procedural, angiographic, and clinical outcomes,” write the authors. They point out that preclinical benchtop studies suggest the balloons may improve outcomes via several mechanisms, including the reduction of large clot fragments and improved recanalization.

On the other hand, use of balloon guide catheters requires concomitant use of “an 8-Fr or 9-Fr groin sheath, which is larger than the typical 6-Fr access needed for performing direct aspiration,” the authors note. “It is important to point out that recently published studies have very low groin complication rates with 8-Fr and 9-Fr sheaths, however.” In addition, use of a balloon guide catheter can produce problems with stability, particularly in difficult arches.

Brinjikji et al recognize the limitations of their study, such as the fact that all the included trials were post hoc analyses of registries or clinical trials or small retrospective experiences of a few centers. They were also unable to compare use of balloon guide catheters with distal access catheters, aspiration techniques, or pinning techniques.

As a result, they call for “further rigorously conducted studies . . .  to confirm these results. Ultimately, a randomized controlled trial comparing the efficacy of BGC versus no-BGC may be needed to determine if BGC use should be standard of care.”

 


Source:

Brinjikji W, Starke RM, Murad MH, et al. Impact of balloon guide catheter on technical and clinical outcomes: a systematic review and meta-analysis. J NeuroInterv Surg. 2017;Epub ahead of print.

 

Disclosures:

Brinjikji reports being CEO of Marblehead Medical LLC and having patents pending in balloon catheter technologies.