Research & Innovation
Publications
The Silk Vista Baby Study
PMU Author
Monika Killer-Oberpfalzer
All Authors
Ricardo A Hanel, Otavio F de Toledo, Natalia V De Oliveira Souza, Salvador F Gutierrez-Aguirre, Monika Killer-Oberpfalzer, Eytan Raz, Maksim Shapiro, Tareq Kass-Hout, Michael Hurley, Rami Z Morsi, Visish M Srinivasan, Brian T Jankowitz, Pierce Davis, Adnan Siddiqui, Vinay Jaikumar, Gustavo M Cortez, Omar Kass-Hout, Tibor Becske, Ramesh Grandhi, Craig Kilburg, Demetrius K Lopes, Andrew F Ducruet, Lucas Elijovich, Gavin Britz, Maria M Toledo, Joshua Seinfeld, Robert M Starke, Raul G Nogueira, Matthew T Bender, Peter T Kan, Tyler Lazaro, Victor H C Benalia, Fernanda R Erazu, Montserrat Lara-Velazquez, Amin Aghaebrahim, Eric Sauvageau, Vitor M Pereira
Journal association
NEUROSURGERY
Abstract
BACKGROUND AND OBJECTIVES: The Silk Vista Baby (SVB) flow diverter (FD) stent (Balt SAS) is the first device designed for treating distally located brain aneurysms. It can be delivered through a 0.017-inch ID microcatheter, enabling access to small, distal vessels. The aim of this study was to evaluate the effectiveness, safety, technical success, occlusion rate, and clinical outcomes of the SVB device.
METHODS: This retrospective, multicenter study included data from 18 centers from November 2023 to September 2024. Procedures were performed by experienced neurointerventionalists following institutional standards of care. Outcomes analyzed included effectiveness, safety, and aneurysm occlusion rates. Descriptive analyses and Pearson χ 2 or Independent t -Test were used for statistical evaluation.
RESULTS: A total of 95 patients, mean age 55.4 years, were included. A total of 31% of aneurysms were ruptured at admission. Most (58.3%) were located in the anterior circulation, and 45% had previous treatment, mainly coiling (69.4%). Complication rates were higher for ruptured aneurysms (24.1%) compared with unruptured ones (9.2%). Two deaths occurred, 1 (1.1%) related to the procedure. At discharge, 87% of patients had modified Rankin Scale ≤2. The latest follow-up showed overall complete/near-complete occlusion rates of 76.1%, with 81.14% for ruptured and 73.43% for unruptured aneurysms. Technical success was higher in unruptured cases (100% vs 93.1%).
CONCLUSION: Our case series demonstrated the efficacy of the SVB with a high rate of technical success. The occlusion rates for ruptured cases are comparable with those of other FDs. However, the rates are lower for unruptured cases. This discrepancy is likely due to the characteristics of the aneurysms, particularly in the presence of side branches in bifurcation lesions. The SVB safety profile is similar to other FDs in unruptured cases, while the ruptured group presented more complications.
Keywords
Humans, Male, Aged, Middle Aged, Female, Treatment Outcome, Intracranial Aneurysm/surgery, Endovascular Procedures/methods, Retrospective Studies, Stents, Embolization, Therapeutic/methods, ADULT, Aged, 80 and over, Europe/epidemiology, North America/epidemiology, Aneurysm, Ruptured/surgery