The SPEED study: initial clinical evaluation of the Penumbra novel 054 Reperfusion Catheter.

BACKGROUND AND PURPOSE: Revascularization of acute ischemic stroke from a large vessel occlusion continues to be a challenge with current thrombectomy devices. The purpose of the SPEED study was to report the safety and effectiveness of the Penumbra 054 Reperfusion Catheter System in revascularizing large vessel occlusions. METHODS: In this retrospective multicenter study, data were collected from patients with angiographic evidence of large vessel occlusion treated with the Penumbra 054 device as the intended primary therapy. Clinical outcome data were collected with 90-day follow-up and the results were compared with those from the Penumbra Pivotal trial. RESULTS: Eighty-seven target vessels in 86 consecutive patients treated with the Penumbra 054 device were included. The Thrombolysis In Myocardial Infarction (TIMI) 2 or 3 revascularization rate was 91% compared with a reported 82% in the Penumbra Pivotal trial. This was accomplished in a median time of 20 min compared with 45 min in the Penumbra Pivotal trial (p<0.0001). Eighteen (21%) patients experienced an intracranial hemorrhage of which 12 (14%) were symptomatic. Good neurologic outcome (modified Rankin scores ≤ 2) at 90-day follow-up was achieved in 34.9% of patients compared with 25% reported in the Penumbra Pivotal trial. All-cause mortality was 25.6%. CONCLUSIONS: These results suggest that the Penumbra 054 is a fast, safe and effective revascularization tool for patients experiencing ischemic stroke secondary to large vessel occlusive disease. Improvements in speed and effectiveness of revascularization probably contributed to improved outcomes.

Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial.

BACKGROUND AND PURPOSE: Endovascular mechanical thrombectomy may be used during acute ischemic stroke due to large vessel intracranial occlusion. First-generation MERCI devices achieved recanalization rates of 48% and, when coupled with intraarterial thrombolytic drugs, recanalization rates of 60% have been reported. Enhancements in embolectomy device design may improve recanalization rates. METHODS: Multi MERCI was an international, multicenter, prospective, single-arm trial of thrombectomy in patients with large vessel stroke treated within 8 hours of symptom onset. Patients with persistent large vessel occlusion after IV tissue plasminogen activator treatment were included. Once the newer generation (L5 Retriever) device became available, investigators were instructed to use the L5 Retriever to open vessels and could subsequently use older generation devices and/or intraarterial tissue plasminogen activator. Primary outcome was recanalization of the target vessel. RESULTS: One hundred sixty-four patients received thrombectomy and 131 were initially treated with the L5 Retriever. Mean age+/-SD was 68+/-16 years, and baseline median (interquartile range) National Institutes of Health Stroke Scale score was 19 (15 to 23). Treatment with the L5 Retriever resulted in successful recanalization in 75 of 131 (57.3%) treatable vessels and in 91 of 131 (69.5%) after adjunctive therapy (intraarterial tissue plasminogen activator, mechanical). Overall, favorable clinical outcomes (modified Rankin Scale 0 to 2) occurred in 36% and mortality was 34%; both outcomes were significantly related to vascular recanalization. Symptomatic intracerebral hemorrhage occurred in 16 patients (9.8%); 4 (2.4%) of these were parenchymal hematoma type II. Clinically significant procedural complications occurred in 9 (5.5%) patients. CONCLUSIONS: Higher rates of recanalization were associated with a newer generation thrombectomy device compared with first-generation devices, but these differences did not achieve statistical significance. Mortality trended lower and the proportion of good clinical outcomes trended higher, consistent with better recanalization.