Gorenchtein Mike, Rajper Naveed, Green Philip, Khullar Pankaj, Amoruso Daniel, Bulacan Christian Franz, Kwan Tak, Puma Joseph, Ratcliffe Justin
Department of Cardiovascular Medicine, Mount Sinai Morningside Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Cardiology, Mount Sinai Beth Israel Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
CVIR Endovasc. 2021 Jan 6;4(1):9. doi: 10.1186/s42155-020-00203-5.
Transpedal access is increasingly utilized for the treatment of peripheral artery disease (PAD). Femoral-popliteal artery chronic total occlusions (CTOs) are some of the most difficult lesion subsets that sometimes require the use of re-entry support devices during percutaneous intervention. Limited data is available on the use of re-entry devices when treating femoral-popliteal CTOs via transpedal access. The aim of this study was to demonstrate the feasibility of using the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via the transpedal approach in an outpatient based lab setting.
Seventeen patients presented with femoral-popliteal CTOs in which treatment required the use of the Outback® Elite re-entry device. All procedures were performed in a single outpatient based lab. Patients were followed at 1 week and 1 month post-procedure, with lower extremity arterial duplex ultrasound assessment during the 1 month follow-up.
The average patient age was 78 years-old, with 71% being males. Most patients presented with Rutherford class IV symptoms. Procedural success was achieved in all patients with no requirement to convert to femoral artery access in any of the cases. No immediate post-procedural complications nor at any time during follow-up were observed. Ultrasonography at 1 month follow-up showed patent intervention sites and access site vessels in all patients.
The use of the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via transpedal access is a feasible option and may have potential benefits by avoiding risks associated with traditional femoral artery access.
经足入路越来越多地用于治疗外周动脉疾病（PAD）。股腘动脉慢性完全闭塞（CTO）是一些最难处理的病变亚组，有时在经皮介入治疗期间需要使用再入路支持装置。关于经足入路治疗股腘CTO时使用再入路装置的数据有限。本研究的目的是在门诊实验室环境中证明使用Outback® Elite再入路装置经足入路治疗股腘CTO的可行性。
17例患有股腘CTO的患者，其治疗需要使用Outback® Elite再入路装置。所有手术均在单一门诊实验室进行。术后1周和1个月对患者进行随访，在1个月随访期间进行下肢动脉双功超声评估。
患者平均年龄为78岁，71%为男性。大多数患者表现为卢瑟福IV级症状。所有患者手术均成功，无一例需要转为股动脉入路。术后未观察到即刻并发症，随访期间任何时候也未观察到并发症。1个月随访时的超声检查显示所有患者的介入部位和入路部位血管通畅。
使用Outback® Elite再入路装置经足入路治疗股腘CTO是一种可行的选择，通过避免与传统股动脉入路相关的风险可能具有潜在益处。
