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Analyzing the Safety and Efficacy of Flow-Diverting Stents in Pediatric Aneurysms: A Systematic Review
Jonathan Scoville1, Evan Joyce1, Cordell Baker1
1Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, Utah, USA.
Insights
Flow-diverting stents show promise for treating pediatric aneurysms, with a low complication rate in a systematic review. Further evaluation for FDA approval in children is recommended.
Area of Science:
- Neurology
- Interventional Neuroradiology
- Pediatric Neurosurgery
Background:
- Ruptured intracranial aneurysms are a significant cause of mortality in children.
- Flow-diverting stents are effective for complex aneurysms common in pediatric cases.
- Current US FDA approval restricts flow-diverting stent use to patients aged 22 and older.
Purpose of the Study:
- To systematically review the safety and efficacy of flow-diverting stents in treating pediatric intracranial aneurysms.
- To assess the incidence of complications associated with flow-diverting stent use in children.
- To inform potential future FDA approval for pediatric use.
Main Methods:
- Systematic literature review adhering to PRISMA criteria.
- Searched PubMed, Embase, and Web of Science for pediatric aneurysm cases treated with flow-diverting stents (2007-2019).
- Extracted patient data to calculate complication rates.
Main Results:
- 24 articles with data on 37 pediatric patients met inclusion criteria.
- 8 out of 37 patients (21.6%) experienced complications, including death, residual aneurysm, and parent artery occlusion.
- Calculated incidence rate of 0.018 complications per patient-at-risk month (95% CI 0.008-0.035).
Conclusions:
- Flow-diverting stent treatment for pediatric aneurysms appears to have an acceptable safety profile.
- The findings support re-evaluation of FDA approval for flow-diverting stent use in pediatric populations.
- This systematic review, despite limitations of case reports/series, provides crucial risk quantification for pediatric aneurysm treatment.
Abstract:
Ruptured intracranial aneurysms cause 50% of spontaneous subarachnoid hemorrhages in children, resulting in up to 65% mortality when left untreated. Although flow-diverting stents are especially suited to treat the fusiform and giant aneurysms more commonly found in children, the US Food and Drug Administration (FDA) has only approved their use in patients ≥22 years of age. Our objective was to assess the safety of flow-diverting stents in the treatment of pediatric patients with aneurysms through a systematic literature review using the PRISMA criteria. We used PubMed, Embase, and Web of Science to identify all published cases of pediatric aneurysms treated or retreated using flow-diverting stents from 2007 through 2019. Two independent researchers developed a consensus regarding the inclusion of all articles. Patient data were extracted from the identified articles and used to calculate the incidence rate of complications. From 1396 journal articles identified, 24 articles contained data on 37 pediatric patients that met the inclusion criteria. Of these 37 patients, 8 (21.6%) had a complication by last follow-up (death: 2; residual aneurysm: 2; parent artery occlusion: 4). This resulted in an incidence rate of 0.018 complications per patient at-risk month (95% CI 0.008-0.035). These data suggest that the use of flow-diverting stents for treatment of aneurysms in children may be safe and that FDA approval for this use should be evaluated. Although this analysis is comprised of case reports and case series, it represents the best attempt thus far to quantify the risk of using flow-diverting stents in children.
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