Department of Radiology, Jena University Hospital, Jena, Germany.
Department of Radiology, Jena University Hospital, Jena, Germany -
J Cardiovasc Surg (Torino). 2021 Apr;62(2):153-161. doi: 10.23736/S0021-9509.21.11569-1. Epub 2021 Jan 22.
This study aimed to investigate performance, effectiveness, and safety of excimer laser atherectomy for the treatment of complex lower limb artery disease in a real-world setting.
In our prospective, multicenter registry, consecutive patients with complex lower limb lesions underwent excimer laser atherectomy with optional standard balloon angioplasty, paclitaxel-coated balloon angioplasty, and bailout stenting. Primary outcome was technical success. Secondary outcomes were device performance of the excimer laser system, freedom from target lesion revascularization (TLR), peri-procedural complications, and amputation-free survival in patients with critical limb ischemia (CLI).
A total of 294 patients were enrolled at 14 European centers (mean lesion length 109±103 mm, total occlusions 56.8% [167 of 294 lesions], CLI 47.3% [132 of 279 patients]. Adjuvant balloon angioplasty was conducted in 283 (96.3%), and complementary stent implantation in 98 patients (33.3%). Technical success was achieved in 95.3% of patients. Increasing lesion length was associated with decreased laser atherectomy performance (odds ratio [OR] per 10 mm: 0.94 [95% confidence interval [CI] 0.90 to 0.99], P=0.01). A total of 66 patients (22.4%) completed the 12-month follow-up. Freedom from TLR was 83.5% (95% CI: 74.9 to 92.1) at 12 months. Chronic total occlusions were associated with more TLR (OR 5.03 [95% CI: 1.01 to 25.1], P=0.049). Amputation -free survival in patients with CLI was 93.1% (95% CI: 83.9 to 100).
Excimer laser atherectomy substantially contributed to technical success of endovascular treatment of complex infra-inguinal lesions. Freedom from 12-month TLR was reasonable.
本研究旨在真实世界环境下，探讨准分子激光动脉切除术治疗复杂下肢动脉疾病的疗效、有效性和安全性。
在我们的前瞻性、多中心登记研究中，连续的下肢复杂病变患者接受准分子激光动脉切除术治疗，选择性地进行标准球囊血管成形术、紫杉醇涂层球囊血管成形术和紧急支架置入术。主要结局为技术成功。次要结局为准分子激光系统的设备性能、无靶病变血运重建（TLR）、围手术期并发症和有严重肢体缺血（CLI）患者的保肢生存率。
在欧洲的 14 个中心共纳入了 294 例患者（平均病变长度 109±103mm，完全闭塞 56.8%[294 个病变中的 167 个]，CLI 47.3%[279 例患者中的 132 例]）。283 例（96.3%）患者进行了辅助球囊血管成形术，98 例（33.3%）患者进行了补充支架植入术。95.3%的患者达到了技术成功。病变长度的增加与准分子激光动脉切除术性能的降低相关（每增加 10mm 的优势比[OR]：0.94[95%置信区间[CI]：0.90 至 0.99]，P=0.01）。共有 66 例患者（22.4%）完成了 12 个月的随访。12 个月时无 TLR 率为 83.5%（95%CI：74.9 至 92.1）。慢性完全闭塞与更多的 TLR 相关（OR 5.03[95%CI：1.01 至 25.1]，P=0.049）。CLI 患者的保肢生存率为 93.1%（95%CI：83.9 至 100）。
准分子激光动脉切除术在下肢复杂病变的血管内治疗中为技术成功做出了重大贡献。12 个月时无 TLR 率合理。
