Cardiovascular

Temporary flow arrest using EMBOGUARD™ balloon guide catheter may improve functional outcomes in acute stroke thrombectomy: a multicenter retrospective study.

TL;DR

The EMBOGUARD™ balloon guide catheter demonstrated comparable technical efficacy with reduced procedural times and improved clinical outcomes compared with non-BGC techniques in endovascular thrombectomy for acute ischemic stroke.

Key Findings

The EMBOGUARD™ BGC group achieved comparable first-pass effect rates to the non-BGC group.

  • FPE was 33.3% in the EMBOGUARD™ group versus 37.2% in the non-BGC group (p = 0.68).
  • The difference was not statistically significant.
  • Multivariate logistic regression showed an adjusted odds ratio of 2.01 (95% CI 0.65–6.41, p = 0.2) for FPE, which was not statistically significant.
  • Total sample: 178 patients (EMBOGUARD: n = 135, 75.8%; non-BGC: n = 43, 24.2%).

Successful recanalization rates (mTICI ≥2b) were similar between the EMBOGUARD™ and non-BGC groups.

  • Successful recanalization was achieved in 86.7% of the EMBOGUARD™ group versus 86.0% of the non-BGC group (p = 0.92).
  • The difference was not statistically significant.
  • The study included patients with anterior large vessel occlusions treated between January 2022 and December 2024.

Procedural time was significantly shorter in the EMBOGUARD™ group compared to the non-BGC group.

  • Median procedural time was 32 minutes in the EMBOGUARD™ group versus 49 minutes in the non-BGC group (p = 0.004).
  • This was a statistically significant difference.
  • This is one of the key differentiating findings between the two approaches in this study.

Distal embolization rates were similar between the EMBOGUARD™ and non-BGC groups.

  • Distal embolization occurred in 4.4% of the EMBOGUARD™ group versus 4.7% of the non-BGC group (p = 1.00).
  • No statistically significant difference was observed.
  • Reduced distal embolization is one of the theorized benefits of balloon guide catheters in mechanical thrombectomy.

The EMBOGUARD™ group showed significantly higher rates of favorable functional outcome at 90 days compared to the non-BGC group.

  • Favorable functional outcome (mRS 0–2) at 90 days was achieved in 48.6% of the EMBOGUARD™ group versus 28.1% of the non-BGC group (p = 0.04).
  • However, multivariate logistic regression did not confirm an independent association (aOR 1.36, 95% CI 0.35–5.34, p = 0.7).
  • The discrepancy between unadjusted and adjusted results suggests potential confounding by baseline characteristics.

Ninety-day mortality was lower in the EMBOGUARD™ group but the difference was not statistically significant.

  • Mortality at 90 days was 13.7% in the EMBOGUARD™ group versus 16.7% in the non-BGC group (p = 0.6).
  • Multivariate logistic regression showed an aOR of 0.32 (95% CI 0.05–1.85, p = 0.2) for mortality, which was not statistically significant.
  • The authors described this as a 'non-significantly lower' and 'favorably trending' result.

Multivariate logistic regression did not confirm independent associations between EMBOGUARD™ use and improved FPE, functional outcome, or reduced mortality.

  • Adjusted OR for FPE: 2.01 (95% CI 0.65–6.41, p = 0.2).
  • Adjusted OR for mRS 0–2 at 90 days: 1.36 (95% CI 0.35–5.34, p = 0.7).
  • Adjusted OR for 90-day mortality: 0.32 (95% CI 0.05–1.85, p = 0.2).
  • The authors noted results were 'although favorably trending' but did not reach statistical significance on adjusted analysis.

The study was a retrospective multicenter design enrolling patients with anterior large vessel occlusions treated with mechanical thrombectomy.

  • 178 total patients were included across multiple centers.
  • The study period was January 2022 to December 2024.
  • EMBOGUARD™ is described as a 'novel design with enhanced flexibility and compatibility with large-bore aspiration catheters' manufactured by Johnson & Johnson Neurovascular.
  • The non-BGC group comprised 43 patients (24.2%) and the EMBOGUARD™ group comprised 135 patients (75.8%).

What This Means

This research suggests that using a specific type of balloon guide catheter called the EMBOGUARD™ during stroke thrombectomy procedures — where doctors physically remove a blood clot from a blocked artery in the brain — may lead to faster procedures and better patient recovery compared to not using a balloon guide catheter. The study looked at 178 stroke patients treated at multiple hospitals between 2022 and 2024, and found that those treated with the EMBOGUARD™ device had their procedures completed in a median of 32 minutes versus 49 minutes for those without the device. Additionally, nearly half (48.6%) of EMBOGUARD™ patients had a good functional recovery at 90 days, compared to about 28% of those treated without the device. However, the study's more rigorous statistical analysis — which accounts for other differences between the patient groups — did not confirm that the EMBOGUARD™ device was independently responsible for these better outcomes. The rates of successfully clearing the blocked blood vessel, achieving clot removal on the first attempt, and preventing clot fragments from traveling to new locations were all similar between the two groups. Deaths at 90 days were slightly lower in the EMBOGUARD™ group (13.7% vs. 16.7%) but this difference was not statistically meaningful. This research suggests the EMBOGUARD™ balloon guide catheter is a safe and technically effective tool for stroke intervention that may offer advantages in procedure speed and potentially in patient recovery, though larger prospective studies are needed to confirm whether these clinical benefits are directly caused by the device itself or influenced by other factors.

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Citation

Morsi R, Falk S, Badillo Goicoechea E, Jaro T, Baskaran A, Thind S, et al.. (2026). Temporary flow arrest using EMBOGUARD™ balloon guide catheter may improve functional outcomes in acute stroke thrombectomy: a multicenter retrospective study.. Frontiers in neurology. https://doi.org/10.3389/fneur.2026.1875382