Department of Vascular Surgery and Endovascular Therapy, Augusta Hospital, Düsseldorf, Germany.
J Vasc Surg. 2011 Nov;54(5):1317-23. doi: 10.1016/j.jvs.2011.04.040. Epub 2011 Jun 12.
Randomized controlled trials have shown that periprocedural rates of stroke and death are higher with carotid artery stenting (CAS) than with carotid endarterectomy (CEA) in the treatment of carotid artery stenosis. Diffusion-weighted magnetic resonance imaging (DW-MRI) has shown higher rates of clinically silent new ischemic brain lesions when CAS is performed as compared with CEA. The Silk Road Medical Embolic PROtectiOn System: First-In-Man (PROOF) Study is a single-arm first-in-man study using the MICHI Neuroprotection System (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcervical access and cerebral embolic protection system. This system enables stent implantation under controlled blood flow reversal of the carotid artery, also known as Flow Altered Short Transcervical Carotid Artery Stenting (FAST-CAS).
Between March 2009 and February 2010, a total of 44 subjects were enrolled into the study. The primary composite endpoint was major stroke, myocardial infarction, or death within 30 days. Forty-three patients (97.7%) completed the study through the 30-day endpoint. One patient was lost to follow-up. In a subgroup of consecutive subjects, DW-MRI examinations were performed preprocedure and within 24 to 48 hours after the stent implantation. Blinded independent neuroradiologists reviewed all DW-MRI studies and confirmed the absence or presence of new ischemic brain lesions.
All enrolled patients were successfully treated, and no major adverse events were seen through the follow-up period. Thirty-one subjects had DW-MRI examinations. Of these, five patients (16%) had evidence of new ischemic brain lesions but no clinical sequelae. Transient intolerance to reverse flow was reported in 9% of cases, but in all cases, a stent was successfully placed, and the intolerance was managed by minimizing the duration of reverse flow during the procedure.
In this first-in-man experience, FAST-CAS using the MICHI Neuroprotection System was shown to be a safe and feasible method for carotid revascularization. DW-MRI findings suggest controlled reverse flow provides cerebral embolic protection similar to that seen with CEA.
随机对照试验表明，在治疗颈动脉狭窄时，颈动脉支架置入术（CAS）的围手术期卒中率和死亡率高于颈动脉内膜切除术（CEA）。与 CEA 相比，CAS 时弥散加权磁共振成像（DW-MRI）显示出更高的临床无症状新缺血性脑病变发生率。丝绸之路医疗栓塞 PROtectiOn 系统：首例人体（PROOF）研究是一项使用 MICHI 神经保护系统（Silk Road Medical Inc，加利福尼亚州森尼韦尔）的单臂首例人体研究，这是一种新型经颈入路和脑栓塞保护系统。该系统允许在颈动脉血流逆转的控制下植入支架，也称为血流改变的短经颈颈动脉支架置入术（FAST-CAS）。
2009 年 3 月至 2010 年 2 月，共纳入 44 例患者。主要复合终点为 30 天内发生重大卒中、心肌梗死或死亡。43 例患者（97.7%）完成了 30 天的研究。1 例患者失访。在连续患者的亚组中，术前和支架置入后 24 至 48 小时进行 DW-MRI 检查。盲法独立神经放射学家审查了所有 DW-MRI 研究，并确认有无新的缺血性脑病变。
所有入组患者均成功治疗，随访期间无重大不良事件发生。31 例患者进行了 DW-MRI 检查。其中，5 例（16%）有新的缺血性脑病变证据，但无临床后遗症。9%的病例报告短暂不耐受逆行血流，但在所有病例中，支架均成功放置，并通过在手术过程中尽量减少逆行血流的持续时间来管理不耐受。
在这项首例人体经验中，使用 MICHI 神经保护系统的 FAST-CAS 被证明是一种安全可行的颈动脉血运重建方法。DW-MRI 结果表明，控制逆行血流可提供与 CEA 相似的脑栓塞保护。
