Vascular Surgery Unit, Sant'Eugenio Hospital, Rome, Italy -
Vascular Surgery Unit, Sant'Eugenio Hospital, Rome, Italy.
J Cardiovasc Surg (Torino). 2024 Jun;65(3):221-230. doi: 10.23736/S0021-9509.24.13067-4.
The study aims to evaluate the association of proximal flow-inversion cerebral protection and MicroNet-covered CGuard stents in reducing early and late embolic events in carotid artery stenting procedures.
From 2018 to 2023, we performed 204 procedures in 180 patients with flow inversion cerebral protection and CGuard stents at the Vascular Surgery Unit of Sant'Eugenio Hospital in Rome. Cerebral protection was achieved with a Flow-Gate2 catheter connected to a peripheral vein. The tip balloon is inflated in the CCA to obtain an effective endoclamping, the pressure difference between the carotid bifurcation and the venous compartment ensures a constant back flow with wash-out in the venous compartment. Inclusion criteria were: life expectancy of >12 months, target lesions indicating treatment according to ESVS Guidelines, increased surgical risk due to comorbidities or anatomic issues. ECD follow-up was performed immediately postoperatively, at 30 days, 6 and 12 months, and subsequently annually.
The treatment protocol was successfully implemented in 99% of cases. No major strokes occurred, while one minor stroke (0.5%) occurred within 8 hours of the procedure, regressing in the following months. One perioperative death (0.5%) due to cerebral hemorrhage occurred three hours after the procedure. All patients remained asymptomatic, with no short or medium-term neurological score deterioration. One hemodynamically significant restenosis (0.5%) was detected at the 6-month follow-up. All patients completed the 6 months follow-up, though 6 (3%) were lost at the 12-month appointment.
Our prospective monocentric study has demonstrated the effectiveness and safety of the FlowGate2 flow inversion cerebral protection system in association with MicroNet covered CGuard stent.
本研究旨在评估近端血流反转脑保护与 MicroNet 覆盖的 CGuard 支架在减少颈动脉支架置入术中早期和晚期栓塞事件中的作用。
2018 年至 2023 年，我们在罗马圣尤金尼奥医院血管外科进行了 204 例使用血流反转脑保护和 CGuard 支架的手术，共涉及 180 名患者。使用 Flow-Gate2 导管连接外周静脉实现脑保护。在 CCA 中充气尖端球囊以获得有效的内夹闭，颈动脉分叉处和静脉腔之间的压力差确保在静脉腔内持续反流和冲洗。纳入标准为：预期寿命>12 个月，根据 ESVS 指南提示需要治疗的靶病变，因合并症或解剖问题增加手术风险。术后立即、术后 30 天、6 个月和 12 个月进行 ECD 随访，随后每年进行一次。
治疗方案在 99%的病例中成功实施。无重大卒中发生，1 例（0.5%）小卒中在术后 8 小时内发生，随后几个月内恢复。1 例（0.5%）围手术期死亡发生在术后 3 小时，由于脑出血。所有患者均无症状，无短期或中期神经评分恶化。1 例（0.5%）在 6 个月随访时出现血流动力学显著再狭窄。所有患者均完成了 6 个月随访，但 12 个月随访时 6 例（3%）失访。
我们的前瞻性单中心研究表明，FlowGate2 血流反转脑保护系统与 MicroNet 覆盖的 CGuard 支架联合使用是有效且安全的。
