Broadway 8 system: a multicenter early evaluation of safety, performance, and clinical outcomes in mechanical thrombectomy.

Abstract

Background: Large-bore aspiration catheters are integral to mechanical thrombectomy (MT) for large vessel occlusions (LVOs), offering potential for improved first pass success and faster recanalization.

Objective: To assess the clinical performance, efficacy, and safety profile of the Broadway 8 system as a primary aspiration device in MT of LVOs.

Methods: This is a multicenter observational study conducted across 8 US comprehensive stroke centers. Efficacy outcomes included first pass effect (FPE), defined as a single-pass modified Treatment In Cerebral Infarction (mTICI) score ≥2c, and successful reperfusion (final mTICI ≥2b). Safety outcomes included device-related complications, symptomatic intracranial hemorrhage (sICH), and inpatient mortality. Functional outcomes included modified Rankin Scale (mRS) at discharge and delta National Institutes of Health Stroke Scale (NIHSS) score. Logistic regression was used to assess predictors of thrombus access and intermediate catheter use.

Results: 49 patients were included. The Broadway 8 system reached the thrombus in 44 (89.8%). Median puncture-to-thrombus and puncture-to-reperfusion times were 11 min (IQR 9-18) and 20 min (14-31), respectively. FPE was achieved in 20 (40.8%). Successful reperfusion was achieved in 46/49 (93.8%), with 35 (71.4%) using Broadway 8. sICH occurred in 2 patients (4.1%). Median mRS at discharge was 3.0 (IQR 1.0-4.0); delta NIHSS was 8 (IQR 5-12). Regression analysis showed faster reperfusion when Broadway 8 was used without an intermediate catheter.

Conclusion: The Broadway 8 system appears to be a safe and effective frontline aspiration device, demonstrating a safety and efficacy profile comparable to other large-bore aspiration systems that incorporate delivery-assist technology.