RESUMEN
BACKGROUND AND PURPOSE: The Neuroform Atlas is a new microstent to assist coil embolization of intracranial aneurysms that recently gained FDA approval. We present a postmarket multicenter analysis of the Neuroform Atlas stent. MATERIALS AND METHODS: On the basis of retrospective chart review from 11 academic centers, we analyzed patients treated with the Neuroform Atlas after FDA exemption from January 2018 to June 2019. Clinical and radiologic parameters included patient demographics, aneurysm characteristics, stent parameters, complications, and outcomes at discharge and last follow-up. RESULTS: Overall, 128 aneurysms in 128 patients (median age, 62 years) were treated with 138 stents. Risk factors included smoking (59.4%), multiple aneurysms (27.3%), and family history of aneurysms (16.4%). Most patients were treated electively (93.7%), and 8 (6.3%) underwent treatment within 2 weeks of subarachnoid hemorrhage. Previous aneurysm treatment failure was present in 21% of cases. Wide-neck aneurysms (80.5%), small aneurysm size (<7 mm, 76.6%), and bifurcation aneurysm location (basilar apex, 28.9%; anterior communicating artery, 27.3%; and middle cerebral artery bifurcation, 12.5%) were common. A single stent was used in 92.2% of cases, and a single catheter for both stent placement and coiling was used in 59.4% of cases. Technical complications during stent deployment occurred in 4.7% of cases; symptomatic thromboembolic stroke, in 2.3%; and symptomatic hemorrhage, in 0.8%. Favorable Raymond grades (Raymond-Roy occlusion classification) I and II were achieved in 82.9% at discharge and 89.5% at last follow-up. mRS ≤2 was determined in 96.9% of patients at last follow-up. The immediate Raymond-Roy occlusion classification grade correlated with aneurysm location (P < .0001) and rupture status during treatment (P = .03). CONCLUSIONS: This multicenter analysis provides a real-world safety and efficacy profile for the treatment of intracranial aneurysms with the Neuroform Atlas stent.
Asunto(s)
Prótesis Vascular , Embolización Terapéutica/instrumentación , Aneurisma Intracraneal/terapia , Vigilancia de Productos Comercializados , Stents , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Thrombectomy trials are often specifically interpreted as evidence for the effectiveness of stent retrievers. The effectiveness of other thrombectomy techniques such as aspiration thrombectomy should be validated through further investigation and review. PURPOSE: To evaluate published treatment times and clinical outcomes in patients treated with aspiration thrombectomy or ADAPT (A Direct Aspiration, First Pass Technique) for acute ischemic stroke. DATA SOURCES: A systematic literature review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE, Scopus, and the Cochrane trial register were searched on November 8, 2016. STUDY SELECTION: Twenty studies (n = 1523 patients) were included in this review and meta-analysis. One of these studies was prospective, and the rest were retrospective. DATA ANALYSIS: Meta-analysis was performed by using a random effects model. Data and publication bias were visualized with forest plots and funnel plots. DATA SYNTHESIS: Five studies investigated aspiration thrombectomy only, and 16 studies investigated ADAPT. Of the 16 studies on ADAPT, the rate of successful recanalization (TICI 2b/3) was 89.3% (95% CI, 85.4%-92.3%). The proportion of patients with good clinical outcome (90-day mRS ≤2) was 52.7% (95% CI, 48.0%-57.4%). LIMITATIONS: Studies on ADAPT were retrospective, and there was heterogeneity between studies for successful recanalization (P < .001) and good clinical outcome (P < .001). There was evidence of publication bias for recanalization rates (P = .01), but not for clinical outcomes (P = .42). CONCLUSIONS: ADAPT and aspiration thrombectomy are effective approaches to thrombectomy, with high recanalization rates and excellent clinical outcomes reported in the literature. Aspiration thrombectomy is a promising neurointervention, but large prospective randomized studies are needed to validate its utility.