Efficacy and safety of surpass evolve flow diverters: A systematic review and meta-analysis

To provide cumulative evidence on the safety and efficacy of the Surpass Evolve Flow Diverters (SE-FDs) in treating intracranial aneurysms.

PubMed, Scopus, Embase, and Web of Science were searched until May, 2024. The primary efficacy endpoint was complete occlusion rate, and the safety endpoints included rate of different complications and mortality. Data is pooled and reported with 95 % confidence intervals (CIs) using random-effect models. A meta-regression analysis was performed to assess the potential effects of confounding factors on study endpoints.

Eleven studies with 690 patients and 757 aneurysms were included. There was moderate risk of bias in all studies. With a median follow-up of 243 days, the complete occlusion rate was 67.1 % (95 %CI: 57.3-75.5 %, I²=72 %), with no difference between ruptured and unruptured aneurysms (p = 0.97). Stent stenosis was the most frequent complication which occurred in 18.2 % (95 %CI: 10.3-30.1 %, I²=71 %) of aneurysms at a median follow-up of 306 days. The rate of thromboembolic complications was 6.6 % (95 %CI: 3.8-11 %, I²=50 %), including ischemic stroke in 1.9 % (95 %CI: 1.1-3.4 %, I²=0 %) of patients. Device-related mortality rate was 0.5 % (95 %CI: 0.2-1.5 %, I²=0 %). Meta-regression showed that diameter of aneurysm was significantly associated with complete occlusion rate (coefficient: - 0.11, p < 0.001).

SE-FD is effective for treating intracranial aneurysms, with moderate efficacy compared to other devices and an acceptable rate of complications. Larger aneurysm size predicts lower occlusion rates. The lack of controlled trials warrants further research to explore the efficacy and safety of SE-FDs in clinical practice.