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
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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.</p><p><strong>Methods: </strong>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 χ2 or Independent t-Test were used for statistical evaluation.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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. 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引用次数: 0
摘要
背景和目的：Silk Vista Baby （SVB）血流分流器（FD）支架（Balt SAS）是第一个用于治疗远端脑动脉瘤的设备。它可以通过一个0.017英寸ID的微导管输送，可以进入小的，远端血管。本研究的目的是评估SVB装置的有效性、安全性、技术成功率、闭塞率和临床结果。方法：这项回顾性的多中心研究纳入了2018年11月至2024年9月18个中心的数据。手术由经验丰富的神经介入医师按照机构护理标准进行。结果分析包括有效性、安全性和动脉瘤闭塞率。统计学评价采用描述性分析、Pearson χ2或独立t检验。结果：共纳入95例患者，平均年龄55.4岁。31%的动脉瘤在入院时破裂。大多数（58.3%）位于前循环，45%以前治疗过，主要是盘绕（69.4%）。破裂动脉瘤的并发症发生率（24.1%）高于未破裂动脉瘤（9.2%）。2例死亡，1例（1.1%）与手术有关。出院时，87%的患者改良Rankin量表≤2。最新随访显示，整体完全/接近完全闭塞率为76.1%，其中破裂动脉瘤为81.14%，未破裂动脉瘤为73.43%。未破裂病例的技术成功率更高（100% vs 93.1%）。结论：我们的病例系列证明了SVB的有效性和高技术成功率。破裂病例的闭塞率与其他fd相当。然而，未破裂病例的发生率较低。这种差异可能是由于动脉瘤的特征，特别是在分叉病变中存在侧分支。在未破裂病例中，SVB的安全性与其他fd相似，而破裂组出现了更多的并发症。
The Silk Vista Baby Study: A Multicenter Aneurysm Report From North America and Europe.
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 χ2 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.
期刊介绍：
Neurosurgery, the official journal of the Congress of Neurological Surgeons, publishes research on clinical and experimental neurosurgery covering the very latest developments in science, technology, and medicine. For professionals aware of the rapid pace of developments in the field, this journal is nothing short of indispensable as the most complete window on the contemporary field of neurosurgery.
Neurosurgery is the fastest-growing journal in the field, with a worldwide reputation for reliable coverage delivered with a fresh and dynamic outlook.
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