RESUMEN
BACKGROUND: New trials are planned regularly to provide the highest quality of evidence and invade new occlusion territories, which requires a pre-defined reporting strategy with consistent, common data elements for more straightforward collective evidence synthesis. We sought to review all active endovascular thrombectomy trials to investigate their patient selection criteria, intervention description, and reported outcomes. METHODS: A literature search was systematically conducted on clinicaltrials.gov for active trials and all intervention, inclusion criteria, and outcomes reported were extracted. A qualitative synthesis of the frequency of study design types and data elements are graphically and narratively presented. RESULTS: A total of 32 studies were tagged and included in the final qualitative analysis. The inclusion criteria were highly variable, including different cut-offs for the last well-known baseline National Institutes of Health Stroke Scale, Alberta Stroke Program Early CT Score, and modified Rankin scale (mRS). Half of the studies (16/32) mentioned "thrombectomy" without defining which technique or device was used, and the final thrombolysis in cerebral infarction scale was provided in 19 (59.4%) studies. Heterogeneity was also present among the studies reporting a first-pass effect, both in how studies defined the outcome and in used ranges for mRS. Mortality and intracerebral hemorrhage (ICH) were more homogenous in their presentation and follow-up. CONCLUSIONS: There is a great degree of heterogeneity in the active thrombectomy trials concerning inclusion criteria, interventions used, and how outcomes are being reported.
RESUMEN
BACKGROUND: The Silk Vista Baby (SVB, BALT) is a first-in-class flow-diverter device delivered using a 0.017" microcatheter, designed for the treatment of intracranial aneurysms, including those in small diameter vessels. This study reports a systematic literature review (SLR) to evaluate the safety and efficacy of using SVB to treat intracranial aneurysms in vessels less than 3.5 mm in diameter. METHODS: We performed a PRISMA-compliant SLR to evaluate the outcomes of SVB in the treatment of aneurysms in small intracranial vessels. Primary outcomes were occlusion status and major stroke, and secondary outcomes included all-cause mortality, procedure-related neurologic death, and post-operative aneurysm rupture. Data were expressed as descriptive statistics only. RESULTS: A total of four studies, including 163 patients with 173 intracranial aneurysms, were included. The most common aneurysm locations were the anterior cerebral artery (24.9% [43/173]), the middle cerebral artery (24.3% [42/173]), and the anterior communicating artery (23.1% [40/173]). Parent artery diameter ranged from 0.9 mm to 3.6 mm, and 29% were acutely or previously ruptured aneurysms. Overall, complete or near-complete occlusion was 72.1% on early-term follow-up. Mortality rate among the studies was 2.5%, with 3 instances adjudicated as neurologic deaths (1.8%). Major stroke was noted in 1.2% of cases, and branch occlusion or stent thrombus formation in 5.5%. CONCLUSION: Our review suggests that SVB is a safe and effective treatment for intracranial aneurysms in small vessels. Further prospective and comparative studies with patient outcome data specific to aneurysm location are needed to confirm the safety and efficacy of SVB.