Adami Carlo A, Scuro Alberto, Spinamano Luca, Galvagni Elisabetta, Antoniucci Davide, Farello Gian A, Maglione Franco, Manfrini Stefano, Mangialardi Nicola, Mansueto Gian C, Mascoli Francesco, Nardelli Ettore, Tealdi Domenico
Department of Vascular Surgery, University of Verona, Italy.
J Endovasc Ther. 2002 Apr;9(2):147-54. doi: 10.1177/152660280200900202.
To investigate the safety and efficacy of the Parodi anti-embolism system (PAES) in establishing flow reversal in the internal carotid artery (ICA) as a means of protecting against embolic phenomena during carotid stenting.
Seven centers participated in a nonrandomized, prospective trial of carotid angioplasty and stenting under PAES protection in 30 patients (22 men; mean age 72 years, range 49-88) with 15 symptomatic (>70%) and 15 asymptomatic (>80%) stenotic ICAs. Safety was defined as achieving sufficient brain oxygenation during flow reversal as determined by level of awareness and motor control. The presence of new or enhanced neurological deficits and death were endpoints. Performance was based on angiographic evidence of successful retrograde flow.
The PAES was positioned in all 30 patients, but technical error and access-related difficulties prevented establishment of reversed flow in 2. Among the 28 (93%) patients treated under PAES protection, 1 patient developed aphasia after flow reversal, necessitating balloon deflation between subsequent stages of the procedure. Three other adverse events included 1 case of bradycardia and 2 cases of hypotension, with dysarthria and facial paresis in one and temporary loss of consciousness in the other. All events resolved with appropriate therapy, and there was no change from baseline in the neurological status or brain scans at 24 hours. There were no strokes or neurological deficits at 30 days.
The PAES appears to be a safe and effective means of providing protection from embolic complications during carotid stenting.
研究帕罗迪抗栓系统（PAES）在颈内动脉（ICA）建立血流逆转以预防颈动脉支架置入过程中栓塞现象的安全性和有效性。
7个中心参与了一项非随机、前瞻性试验，对30例患者（22例男性；平均年龄72岁，范围49 - 88岁）进行PAES保护下的颈动脉血管成形术和支架置入术，其中15例有症状（>70%）和15例无症状（>80%）的ICA狭窄。安全性定义为根据意识水平和运动控制确定的血流逆转过程中实现足够的脑氧合。新的或加重的神经功能缺损和死亡的出现为终点指标。性能基于逆行血流成功的血管造影证据。
所有30例患者均放置了PAES，但技术失误和与通路相关的困难导致2例未能建立血流逆转。在PAES保护下治疗的28例（93%）患者中，1例在血流逆转后出现失语，需要在后续手术阶段之间放气球囊。其他3例不良事件包括1例心动过缓和2例低血压，其中1例伴有构音障碍和面瘫，另1例伴有短暂意识丧失。所有事件经适当治疗后均得到缓解，24小时时神经状态或脑部扫描与基线相比无变化。30天时无卒中或神经功能缺损。
PAES似乎是在颈动脉支架置入过程中预防栓塞并发症的一种安全有效的方法。
