David Fiorella, Keith Woodward, Charles Matouk, Elad I Levy, Ian Kaminsky, Kurt S Reuland, Christopher Nickele, Giuseppe Ammirati, Robert M Starke, William J Ares, Michael Nahhas, Ashutosh Mahapatra, Ali Sultan-Qurraie, Bradley Bohnstedt, Alexandra R Paul, Donald Frei
The Thunderbolt system was safe and effective for the treatment of ELVO, achieving high revascularization and clot ingestion 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.
INTRODUCTION: THUNDER (Acute Ischemic Stroke Study With the Penumbra System Including Thunderbolt Aspiration Tubing) was the first study to evaluate the safety and effectiveness of a proprietary computer assisted vacuum thrombectomy (CAVT) system including modulated aspiration (Penumbra System with Thunderbolt; Penumbra, California, USA) in patients with emergent large vessel occlusion (ELVO).
METHODS: THUNDER was a single arm, prospective, multicenter study with core laboratory adjudication and oversight by a Clinical Events Committee and Data Safety Monitoring Board. The primary endpoint was post-Thunderbolt successful revascularization (modified Treatment in Cerebral Infarction (mTICI) 2b-3). Secondary endpoints included first pass mTICI 2b-3, post-Thunderbolt mTICI 2c-3, time to revascularization, symptomatic intracranial hemorrhages (sICH), device/procedure related serious adverse events (SAEs) within 24 hours, 90- day modified Rankin Score (mRS) 0-2, and all cause mortality.
RESULTS: 216 patients were enrolled across 29 US centers (mean age 64.8 years, 45.4% women, median National Institutes of Health Stroke Scale score 15.0). The predefined performance goal was met, with post-Thunderbolt mTICI 2b-3 revascularization achieved in 87.5% (95% CI 82.3% to 91.6%; P<0.001). First pass mTICI 2b-3 was 64.8%. Post-Thunderbolt mTICI 2c-3 was 70.4%. Median time to revascularization was 20 min. Post-procedure, 83.0% of visualized clots were characterized as ingested. At 90 days, mRS 0-2 was 55.4%. Device/procedure related SAEs occurred in 2.8%, sICH in 0.9%, and the rate of all cause mortality at 90 days was 11.7%.
CONCLUSIONS: The Thunderbolt system was safe and effective for the treatment of ELVO, achieving high revascularization and clot ingestion 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.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05437055.