Auryon 激光治疗症状性下肢动脉疾病：1 年结果。
Auryon Laser in Treating Symptomatic Infrainguinal Arterial Disease: 1-Year Outcome.
机构信息
Midwest Cardiovascular Research Foundation, 630 East 4th Street, Davenport, IA 52803 USA.
出版信息
J Invasive Cardiol. 2022 Jul;34(7):E496-E498. doi: 10.25270/jic/22.00155. Epub 2022 Jun 17.
BACKGROUND
The Auryon 355-nm laser atherectomy system (AngioDynamics, Inc) showed a low rate of target-lesion revascularization (TLR) at 6-month follow-up in the EX-PAD-03 investigational device exemption study and the Auryon single-center experience (SCE) in treating infrainguinal arteries. In this study, we present the 1-year outcomes of the Auryon SCE study on TLR in all comers at a single center.
METHODS
The Auryon SCE was a retrospective study that evaluated the outcomes of all comers treated with the Auryon laser for infrainguinal arterial disease. There was no TLR seen at 6-month follow-up. We present the TLR rate at 1 year in the same cohort of patients. TLR rates were obtained from medical record review of patients enrolled in the study who had completed office visit follow-up at 1 year. Secondary endpoints included unplanned major amputation and total mortality. Kaplan-Meier survival analysis was performed to estimate the freedom from TLR rate following index procedure. Statistical differences were analyzed for ankle-brachial index (ABI) between baseline and 1 year.
RESULTS
A total of 56 patients (65 procedures, 70 lesions) were enrolled. The mean age was 70.9 ± 10 years, with 66.1% males, 48.2% diabetics, and 25% demonstrating limb ischemia. Of the 70 lesions, 31.4% had severe calcification, 38.6% were chronic total occlusions, and 48.6% were de novo disease (in-stent restenosis, 29.6%). Stenting was performed in 24/70 lesions (34.3%), with 11/70 (15.7%) bailout procedures. Embolic filters were used in 26/65 procedures (40%). The majority of treated lesions were femoropopliteal (90.0%); of all procedures, 29.2% had 2 or more prior interventions. Drug-coated balloon usage was 47.1% Lutonix (BD/Bard), 27.1% In.Pact (Boston Scientific), and 1.4% both in all lesions treated. Distal embolization occurred in 1/65 procedures (1.5%). At 1 year, mortality occurred in 3/56 patients (5.4%). Of 65 limbs treated, 2 (3.1%) had major amputation at 1 year. The probability of freedom from TLR was 83.7%.
CONCLUSION
In a realworld cohort of patient with complex disease, the Auryon laser had excellent freedom from TLR at 1 year.
背景
在 EX-PAD-03 研究和 Auryon 单中心经验（SCE）中，Auryon 355nm 激光动脉切除术系统（AngioDynamics，Inc.）在 6 个月的随访中显示出较低的靶病变血运重建（TLR）率，用于治疗下肢动脉疾病。在这项研究中，我们报告了 Auryon SCE 研究中在单一中心所有患者的 1 年 TLR 结果。
方法
Auryon SCE 是一项回顾性研究，评估了所有接受 Auryon 激光治疗下肢动脉疾病的患者的结局。在 6 个月的随访中未发现 TLR。我们报告了同一队列患者在 1 年时的 TLR 率。通过对完成 1 年门诊随访的研究患者的病历进行回顾性分析，获得 TLR 率。次要终点包括非计划性主要截肢和总死亡率。采用 Kaplan-Meier 生存分析估计指数手术后 TLR 无复发率。分析了基线和 1 年时踝肱指数（ABI）的差异。
结果
共纳入 56 例患者（65 例手术，70 处病变）。平均年龄为 70.9±10 岁，66.1%为男性，48.2%为糖尿病患者，25%有肢体缺血。70 处病变中，31.4%有严重钙化，38.6%为慢性完全闭塞，48.6%为新发病变（支架内再狭窄，29.6%）。24/70 处病变（34.3%）进行了支架置入，11/70 处病变（15.7%）进行了挽救性治疗。26/65 例手术（40%）使用了栓塞滤器。大多数治疗病变为股腘段（90.0%）；所有手术中，29.2%有 2 次或以上既往介入治疗。药物涂层球囊的使用率为 47.1% Lutonix（BD/Bard）、27.1% In.Pact（波士顿科学公司）和 1.4%两种均用于所有治疗的病变。65 例手术中有 1 例（1.5%）发生远端栓塞。1 年后，56 例患者中有 3 例（5.4%）死亡。65 条肢体中，2 条（3.1%）在 1 年后行大截肢术。无 TLR 发生率为 83.7%。
结论
在复杂疾病的真实世界患者队列中，Auryon 激光在 1 年内有极好的 TLR 无复发率。
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