Lichtenberg M, Stahlhoff W, Boese D
Department of Angiology and Vascular Center Arnsberg Clinic Arnsberg, Germany -
J Cardiovasc Surg (Torino). 2013 Aug;54(4):433-9.
Single center observational study analyzing the primary patency rate and freedom from target lesions revascularization rate of the Pulsar-18 nitinol stent after recanalization of long superficial femoral artery (SFA) occlusions (TASC D) in 22 patients with critical limb ischemia (CLI).
Between 1/2011 and 7/2011, 22 consecutive patients (9 male, 13 female) with chronic total occlusions (CTO) of the femoro-popliteal arteries presenting with CLI (17 patients with Rutherford 4 score, and 5 patients with Rutherford 5 score) were enrolled and successfully recanalized using the Pulsar-18 self-expanding (SE) nitinol stent (BIOTRONIK AG, Buelach, Switzerland). Primary patency at 12 months was defined as no binary restenosis (>50%) on Duplex ultrasound (PSVR<2.5) and respectively no target lesion revascularization performed within 12 months. The average lesion length of the treated femoro-popliteal segment was 315 mm. Performing spot stenting average stent length in all patients was 245 mm (minimal 215 mm, maximal 315 mm).
Technical success, with establishing an antegrade straight line flow to the foot through a reopened SFA, was achieved in all 22 patients. Subintimal and intraluminal recanalization techniques were used. Two patients with Rutherford 5 score had a minor amputation shortly after the recanalization procedure. All other patients had a complete wound healing of their lesions during a 6 month follow-up. After 12 month follow-up the primary patency rate of the Pulsar-18 SE nitinol stent was 77% with a per protocol restenosis in 5 of 22 patients. Seventeen patients showed a walking capacity on treadmill test >300 meters (Rutherford II). Two patients with a documented restenosis were Rutherford, these patients were treated conservatively. Three patients with restenosis and a Rutherford III score were scheduled for an endovascular target lesion revascularization leading to a freedom from target lesion revascularization rate of 86%.
Endovascular intervention of long SFA occlusions using subintimal or intraluminal recanalization technique with implantation of the Pulsar-18 SE nitinol stent in CLI patients is safe and clinically effective with a primary patency rate after 12 months of 77% and a freedom from target lesion revascularization rate of 86%.
单中心观察性研究，分析22例严重肢体缺血（CLI）患者长段股浅动脉（SFA）闭塞（TASC D型）再通后Pulsar-18镍钛合金支架的初始通畅率和无靶病变血运重建率。
2011年1月至2011年7月，连续纳入22例股腘动脉慢性完全闭塞（CTO）并伴有CLI的患者（9例男性，13例女性）（17例Rutherford 4级，5例Rutherford 5级），使用Pulsar-18自膨式（SE）镍钛合金支架（百多力公司，瑞士比拉赫）成功进行再通。12个月时的初始通畅定义为双功超声检查无二元性再狭窄（>50%）（PSVR<2.5），且12个月内未进行靶病变血运重建。治疗的股腘段平均病变长度为315 mm。所有患者均采用局部支架置入，平均支架长度为245 mm（最短215 mm，最长315 mm）。
所有22例患者均获得技术成功，即通过再通的SFA建立顺行直线血流至足部。采用了内膜下和管腔内再通技术。2例Rutherford 5级患者在再通术后不久进行了小截肢。所有其他患者在6个月随访期间病变完全愈合。12个月随访后，Pulsar-18 SE镍钛合金支架的初始通畅率为77%，22例患者中有5例按方案发生再狭窄。17例患者在跑步机试验中的行走能力>300米（Rutherford II级）。2例记录有再狭窄的患者为Rutherford分级，对这些患者进行了保守治疗。3例再狭窄且为Rutherford III级的患者计划进行血管内靶病变血运重建，无靶病变血运重建率为86%。
在CLI患者中，采用内膜下或管腔内再通技术并植入Pulsar-18 SE镍钛合金支架对长段SFA闭塞进行血管内干预是安全且临床有效的，12个月时的初始通畅率为77%，无靶病变血运重建率为86%。
