Toward a high-quality evidence base for pediatric stroke intervention

A recent editorial in JNIS, “No Child Left Behind,” raises important concerns regarding the lack of clinical evidence for neurointerventional procedures in pediatric patients. ¹ However, his comparison of his own findings with available case series and subsequent conclusion that the literature is inherently biased requires further scrutiny. A more balanced and evidence-based assessment emerges when considering the findings of the Save ChildS Pro registry, a prospective study demonstrating the superiority of mechanical thrombectomy over best medical therapy in pediatric acute ischemic stroke (AIS) cases. ²

The publication asserts that the literature surrounding pediatric neurointervention lacks reliability due to limited data and potential publication bias. While it is true that pediatric AIS studies are limited compared to adult populations, the Save ChildS Pro registry, published in The Lancet Child & Adolescent Health, represents a significant advancement in this area. This prospective study included a cohort of pediatric patients treated with mechanical thrombectomy and rigorously compared outcomes to best medical therapy. The results clearly demonstrated that mechanical thrombectomy led to superior functional outcomes and lower rates of disability, challenging the notion that case series are inherently unreliable for guiding pediatric care decisions.

The Save ChildS Pro data not only provides a stronger basis for evaluating the efficacy of mechanical thrombectomy in children but also counters the suggestion that current literature lacks generalizability. While Dr Kansagra critiques retrospective case series as biased, the prospective nature of Save ChildS Pro minimizes many of the limitations he highlights, such as selection bias and non-standardized reporting. By dismissing the findings of more rigorous studies like Save ChildS Pro, his argument risks downplaying a critical body of evidence that supports mechanical thrombectomy as a viable and effective treatment for pediatric AIS.

Moreover, the assertion that randomized controlled trials (RCTs) are necessary to establish definitive evidence in pediatric stroke care overlooks the significant challenges associated with conducting such trials in this population. Pediatric AIS is rare, with an incidence rate of approximately 1-2 per 100,000 children per year. This low prevalence makes the recruitment of sufficient participants for an adequately powered RCT exceedingly difficult. Additionally, the ethical considerations surrounding equipoise in denying mechanical thrombectomy, which has shown significant benefit in adult stroke care and in Save ChildS Pro, further complicate the feasibility of such trials.

The Save ChildS Pro registry effectively bridges this gap by providing a well-designed prospective dataset, which, while not a randomized trial, offers robust comparative evidence. The findings affirm that mechanical thrombectomy can be both safe and effective in pediatric populations, reinforcing the need for guideline adaptations to reflect these outcomes rather than dismissing the entire body of literature as insufficient.

In conclusion, while the recent editorial correctly identifies the need for more research in pediatric neurointervention, his critique of existing literature as biased does not fully consider the high-quality evidence presented in the Save ChildS Pro registry. This prospective study provides compelling data supporting mechanical thrombectomy in pediatric AIS cases and highlights the practical limitations of pursuing RCTs in this rare condition. Rather than dismissing the current literature as unreliable, the neurointerventional community should embrace the evidence we do have while advocating for continued registry-based studies and collaborative data pooling to further strengthen pediatric stroke care. A nuanced, evidence-driven approach will ensure that no child is indeed left behind.

ORCID iD

Adam A Dmytriw https://orcid.org/0000-0003-0131-5699