A314 Aspiration thrombectomy for acute ischemic stroke secondary to large vessel occlusion: primary results of the THUNDER study

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Background/Introduction Modulated aspiration, a form of computer-assisted vacuum thrombectomy (CAVT), improves clot removal efficiency and minimizes periprocedural complications in the periphery. However, this technology has not been previously studied for use in acute ischemic stroke. Objective/Purpose To evaluate safety and effectiveness of a proprietary CAVT system including modulated aspiration (Penumbra System with Thunderbolt; Penumbra, Inc., CA) in patients with emergent large vessel occlusion (ELVO). Methods/Case Description THUNDER was a single-arm, prospective, multicentre study with independent core-lab adjudication and oversight by a Clinical Events Committee and Data Safety Monitoring Board. Adults with ELVO, pre-stroke modified Rankin Scale (mRS) 0-2, Alberta Stroke Program Early CT Score >6 or core infarct volume ≤50 mL on MRI/CT imaging and planned first-line treatment using the Thunderbolt System within 8 hours of symptom onset were eligible. The primary endpoint was post-Thunderbolt successful revascularization (modified treatment in cerebral infraction [mTICI] 2b-3). Secondary endpoints included first-pass mTICI 2b-3, post-Thunderbolt mTICI 2c-3, time-to-revascularization, symptomatic intracranial haemorrhages (sICH), device/procedure-related serious adverse events (SAEs) within 24 hours, 90-day mRS 0-2, and all-cause mortality. Results/Findings 216 patients were enrolled across 29 US centres (mean age 64.8 years, 45.4% female, median National Institutes of Health Stroke Scale 15.0). The predefined performance goal was met, with post-Thunderbolt mTICI 2b-3 achieved in 87.5% (95%CI: 82.3%–91.6%; P<.001). First-pass mTICI 2b-3 was 64.8%. Post-Thunderbolt mTICI 2c-3 was 70.4%. Median time-to-revascularization was 20 min. At 90 days, mRS 0-2 was 55.4%. Device/procedure-related SAEs occurred in 2.8%, sICH in 0.9%, and all-cause mortality at 90 days was 11.7%. Discussion/Conclusions/Learning Points The Thunderbolt System was safe and effective for the treatment of ELVO, achieving high revascularization rates, short procedure times, and low complication rates. The first-pass effect rate was numerically higher than those previously reported for large-bore catheters and approximated those of ultra bore/super large-bore devices.

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