Silk Device for the Treatment of Intracranial Aneurysms. Part 1: Peri-Procedural Results, Technical Aspects and Learning Curve.

Abstract

We evaluated the procedural outcomes of intracranial aneurysm treatment with the Silk device and its relation with operator experience. We also detailed some technical points we learned throughout our experience. One hundred and six consecutive patients with intracranial aneurysms treated using Silk (BaltExtrusion, Montmorency, France) stent between October 2010 and November 2013 were included. Patients were evaluated in terms of age, sex, aneurysm size, location, technical success, and adverse events. There were 106 patients (71 female) undergoing 116 procedures with a mean age of 49.8 (range: 3-78 years). Mean aneurysm size was 10.7±8.0 (range, 2-40 mm). Technical success of the procedures was 96.5%. Adverse event rate was 11.2%. Among adverse events, there were 4 adverse events without complications, 2 mild complications, 7 severe complications, 4 of which resulted with death. The adverse event rate was significantly higher during the first half of the operator's experience. The rate of adverse events seemed to stabilize after around 50 patients. Adverse events, regardless of the presence or absence of a clinical complication, were more frequent in aneurysms larger than 18.5 mm. Safety of flow-diverter (FD) placement for intracranial aneurysms increases with operator experience. Training programs in endovascular management of cerebrovascular diseases and relevant fellowship curricula must be adapted to include sufficient flow diverter experience. The learning curve needs to be kept in mind when studies comparing different FD devices or those comparing other treatments to FDS are planned.