Jobst Vascular Institute, Toledo, Ohio 43606, USA.
J Vasc Surg. 2012 Dec;56(6):1615-21. doi: 10.1016/j.jvs.2012.06.071. Epub 2012 Sep 11.
Percutaneous techniques for crossing femoropopliteal chronic total occlusions (CTOs) offer an alternative to bypass surgery in patients deemed to be at increased risk due to advanced age or comorbidities. Recent reports document good success rates in catheters designed to reconstitute peripherally occluded arteries following failed guidewire passage. The Wildcat catheter (Avinger, Redwood City, Calif) is a novel device with a rotating distal tip and deployable wedges fashioned for channeling a passage through arterial occlusions. This report describes the results of a prospective, multicenter, nonrandomized trial evaluating the safety and efficacy of the Wildcat device when crossing de novo or restenotic femoropopliteal CTOs.
Between August 2010 and April 2011, patients with peripheral arterial disease due to a femoropopliteal CTO>1 cm and ≤35 cm were evaluated for study enrollment at 15 U.S. sites. During treatment, the physician initially attempted to cross the CTO using conventional guidewires per protocol; if the guidewire successfully crossed, the patient was considered a screen failure and the Wildcat was not deployed. At 30 days, patients were reevaluated. The primary efficacy end point was successful crossing of the Wildcat into the distal true lumen as confirmed by angiography. Primary safety end points included no in-hospital or 30-day major adverse events, no clinically significant perforation or embolization, and no grade C or greater dissection. Additional data collected included lesion length, degree of calcification, and location.
Eighty-eight patients were enrolled in the trial. Of these, the Wildcat device was used in 84 patients (95%) per protocol. Successful CTO crossing was reported and confirmed by independent review in 89% (75/84) of cases with 5% (4/84) major adverse events as defined in the protocol (predominantly perforations sealed with balloon inflation). There were no clinically relevant events associated with any of the perforations. The mean CTO length was 174±96 mm (range, 15-350 mm). Approximately 57% (n=48) of all lesions were categorized as containing at least moderate calcification. Eighty-nine percent (n=75) of vessels recanalized were superficial femoral arteries.
In this multicenter study, the Wildcat catheter demonstrated an 89% crossing success rate with little associated morbidity. The Wildcat catheter is a viable device for crossing moderately calcified femoropopliteal CTOs.
经皮技术可用于治疗股腘慢性完全闭塞（CTO），为因高龄或合并症而被认为处于高风险的患者提供了一种替代旁路手术的方法。最近的报告显示，在导丝通过失败后，设计用于重建外周闭塞动脉的导管有很好的成功率。Wildcat 导管（Avinger，加利福尼亚州雷德伍德市）是一种新型设备，其远端尖端可旋转，可部署楔形物，用于在动脉闭塞处形成通道。本报告描述了一项前瞻性、多中心、非随机试验的结果，该试验评估了 Wildcat 导管在治疗新形成或再狭窄的股腘 CTO 时的安全性和疗效。
2010 年 8 月至 2011 年 4 月，在美国 15 个地点评估了因股腘 CTO>1 cm 且≤35 cm 导致外周动脉疾病的患者是否符合入组条件。在治疗过程中，医生最初根据方案尝试使用传统导丝穿过 CTO；如果导丝成功穿过，则患者被认为是筛检失败，不会使用 Wildcat 导管。在 30 天时，对患者进行重新评估。主要疗效终点是血管造影证实 Wildcat 导管成功进入远端真腔。主要安全性终点包括无院内或 30 天内重大不良事件、无临床意义的穿孔或栓塞、无 C 级或更高级别的夹层。收集的其他数据包括病变长度、钙化程度和位置。
88 例患者参与了试验。其中，根据方案，84 例（95%）患者使用了 Wildcat 导管。89%（75/84）的病例报告和独立审查证实 CTO 成功穿过，符合方案定义的 5%（4/84）主要不良事件（主要是穿孔，用球囊扩张封闭）。任何穿孔均与任何临床相关事件无关。CTO 长度平均为 174±96 mm（范围，15-350 mm）。所有病变中约 57%（n=48）被归类为至少含有中度钙化。89%（n=75）再通的血管为股浅动脉。
在这项多中心研究中，Wildcat 导管的穿过成功率为 89%，相关发病率较低。Wildcat 导管是一种治疗中度钙化股腘 CTO 的可行器械。
