The Heart Hospital Baylor Plano, Plano, Texas, USA.
Midwest Cardiovascular Research Foundation, Davenport, Iowa, USA.
Catheter Cardiovasc Interv. 2024 May;103(6):949-962. doi: 10.1002/ccd.31023. Epub 2024 Apr 2.
Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow.
The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD).
The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge.
One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge.
The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.
动脉切除术是一种重要的方法，可以从患有下肢动脉疾病的患者的病变动脉中切除粥样硬化斑块。激光动脉切除术使用高能激光从动脉中切除斑块，以恢复血液流动。
Pathfinder 多中心注册研究旨在评估 355nm 激光动脉切除术系统在真实世界环境中用于治疗下肢动脉疾病患者新发病变、再狭窄和支架内再狭窄（ISR）病变的安全性和有效性。
该研究是一项前瞻性、单臂、多中心、开放性标签的注册研究，共纳入 102 例接受 355nm 激光系统治疗的患者。收集临床和病变特征、手术安全性和疗效数据，以及基线、6 个月和 12 个月的结局数据，包括踝肱指数（ABI）、Rutherford 分级和步行障碍问卷（WIQ）。主要疗效终点是血管造影核心实验室评估的指数病变经动脉切除术后残余狭窄率≤30%和辅助治疗。主要安全性终点是在出院前未发生围手术期主要不良事件（PPMAE）的患者比例。
在 10 个中心共纳入 102 例患者的 121 处病变进行了 355nm 激光设备治疗。平均年龄为 68.4±10.21 岁，61.8%的患者为男性，44.6%为严重肢体缺血（CLI），47.3%为胫骨病变。手术结束时的平均残余狭窄率为 24.4±15.5，其中 69 处病变（69.0%）达到技术手术成功（狭窄率<30%）；ISR（25.5±14.9）、慢性完全闭塞（CTO）（28.1±17.0）和严重钙化（36.5±21.6）病变的结果相似。ABI、Rutherford 和 WIQ 评分在 6 个月和 12 个月时均有所改善。102 例患者中有 97 例（95.1%）达到了在出院前不发生围手术期主要不良事件的主要安全性终点。
Pathfinder 注册研究的初步数据表明，在真实世界环境中，355nm 激光系统在下肢动脉疾病患者中进行动脉切除术是安全有效的。
