A retrospective multicenter cohort study evaluated the Pipeline Embolization Device (PED) in 71 patients with intracranial aneurysms located in parent vessels measuring less than 2 mm. The median follow-up was 9 months (IQR 7-15). The primary outcomes were complete aneurysm occlusion on follow-up DSA and safety events including procedure-related death, stroke, hemorrhage, and asymptomatic in-stent stenosis.
The 1-year complete occlusion rate was 52%. For patients with follow-up exceeding 12 months, the long-term complete occlusion rate was 80%. Longer PED length was negatively associated with delayed aneurysm occlusion (OR 0.91, 95% CI 0.83-1.00, p=0.040) and positively associated with ischemic complications in multivariable analysis (OR 1.31, 95% CI 1.06-1.63, p=0.013). Pre-existing parent vessel stenosis was strongly associated with subsequent asymptomatic in-stent stenosis (OR 13.50, 95% CI 2.80-65.04, p=0.001).
Safety data showed ischemic events in 16.9% of patients, hemorrhagic events in 4.2%, and asymptomatic in-stent stenosis in 12.7%. Serious adverse events and discontinuation rates were not reported. Key limitations include the retrospective design, absence of a comparator group, and a limited sample size of 71 patients. The study was observational, reporting associations rather than establishing causation.
For clinical practice, these findings provide preliminary, hypothesis-generating data on PED use in a challenging anatomical subset of very small parent vessels. The occlusion rates and safety profile observed in this small cohort should be interpreted with restraint, and decisions should be based on broader evidence and individual patient anatomy.
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BackgroundFlow diversion stents (FDS), particularly the Pipeline Embolization Device (PED), have been widely used for intracranial aneurysm (IA) treatment. However, data on PED deployment in small-caliber parent vessels (< 2 mm) remain limited. This study aimed to evaluate the technical feasibility, safety, and efficacy of PED for IAs arising from small-caliber vessels.MethodsThis was a multicenter retrospective study enrolling 71 eligible patients with IA located in parent vessels < 2 mm who underwent PED implantation. The primary safety endpoint included procedure-related death, symptomatic stroke, intracranial hemorrhage and asymptomatic in-stent stenosis; the primary efficacy endpoint was complete aneurysm occlusion [O’Kelly-Marotta (OKM) grade D] on follow-up digital subtraction angiography (DSA). Binary logistic regression analyses were used to identify factors associated with complications and delayed IA occlusion.ResultsThe patient age was 55 (47, 59) years, with 37 (52.1%) males. The follow-up duration was 9 (7, 15) months. Postoperative complications included ischemic events (16.9%), hemorrhagic events (4.2%), and asymptomatic in-stent stenosis (12.7%). The 1-year complete occlusion rate was 52%, whereas the long-term occlusion rate gradually increased to 80% with follow-up beyond 12 months. Univariable analysis showed PED length was associated with both delayed IA occlusion [odds ratio (OR) = 0.91, 95% confidence interval (CI) = 0.83–1.00; p = 0.040] and ischemic complications (OR = 1.36, 95% CI = 1.11–1.66; p = 0.003) and also revealed that pre-existing parent vessel stenosis was strongly associated with asymptomatic in-stent stenosis (OR = 13.50, 95% CI = 2.80–65.04; p = 0.001); multivariable analysis confirmed PED length as an independent predictor of ischemic complications (OR = 1.31, 95% CI = 1.06–1.63; p = 0.013).ConclusionPED deployment in small-caliber parent vessels (