Midterm Results on Pipeline Vantage Embolization Device (MR-PVED): First Reported Experience in Asia.

Objectives: The purpose of this study is to evaluate the safety and efficacy in consecutive patients treated with Pipeline Vantage flow diverter in an Asian population before the partial recall, as well as their outcomes in both unruptured and ruptured cohorts. Materials and Methods: This was a retrospective study conducted at a single center. Consecutive patients treated with Pipeline Vantage for intracranial aneurysms between August 2022 and July 2024, regardless of their rupture status, were systematically reviewed. There was no aneurysm size or location exclusion criteria. New adverse neurological events noted during hospitalization or the follow-up period were recorded as clinical safety outcomes. Radiological performance, including the degree of aneurysm occlusion, in-stent stenosis (ISS) and their braid deformation patterns were analyzed. Statistical Analysis: Data were analyzed based on the intention-to-treat population. Categorical variables were presented as numbers with percentages, and continuous variables were summarized using mean and standard deviation (SD). Results: A total of 31 patients with 36 aneurysms were identified. The average maximum aneurysm dimension was 5.7 mm. Four cases (12.9%) were presented as acute aneurysm rupture. Adjunctive coiling of the aneurysm was performed in eight cases (26%). At a mean of 12.4 months, the morbidity rate was 6.5%, and no mortality was observed. All the new adverse neurological events belonged to ischemic complications. Adequate aneurysm occlusion was achieved at 77.8%. ISS was observed in four cases (12.9%) while the rate of braid changes was noted to be 6.5%. Conclusion: This is the first-ever study reporting the performance of Pipeline Vantage in Asia. The occlusion rate and safety outcomes were similar to those in recent studies. However, the relatively high incidence of ISS or braid deformation remains a concern.