首次在人体中植入用于治疗股浅动脉疾病的 3D 打印全生物吸收药物洗脱支架

Annals of vascular surgery. Brief reports and innovations Pub Date : 2024-06-01 DOI:10.1016/j.avsurg.2024.100299

Hai Feng , Xuebin Wang , Mingyuan Liu , Bin Liu , Zhong Chen , Xueming Chen

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引用次数: 0

摘要

背景生物可吸收支架（BRS）是治疗股浅动脉（SFA）动脉硬化闭塞症的理想方法，可使靶血管恢复正常状态。方法一位57岁的女性患者患有间歇性跛行Rutherford-Becker 3级，踝肱指数（ABI）为0.70。结果用直径为5毫米的球囊扩张了病变部位，没有发现相关的残余狭窄，但在对照血管造影时发现了局部夹层，通过植入5毫米×76毫米的3D打印生物可降解药物洗脱外周支架（PERISORB® BRS）治疗了夹层。患者复诊后，分别在 6 个月和 16 个月的随访中进行了彩色双相超声检查（CDUS）和数字减影血管造影检查（DSA）。未发现围手术期并发症。16 个月随访时，超声波检查显示支架通畅，无狭窄。结论3D打印生物可降解药物洗脱外周支架（PERISORB® BRS）首次成功植入人体。

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First-in-human Implantation of a 3D-printing Fully Bioresorbable Drug Eluting Stent for Treatment of Superficial Femoral Artery Disease

Background

Bioresorbable stent (BRS) is ideal treatment for superficial femoral artery (SFA) arteriosclerosis obliterans, allowing the target vessel to return to its normal state. A 3D-printing Fully Bioresorbable Drug Eluting Stent (PERISORB® BRS) was implanted for a successful first-in-human treatment of a SFA obstruction.

Methods

A 57-year-old female patient suffered from intermittent claudication Rutherford-Becker category 3, the ankle-brachial index (ABI) was 0.70. Pre-procedure CTA showed a calcified 50 mm long severe stenosis in the distal segment of the left SFA.

Results

The lesion was dilated with a diameter of 5 mm balloon, no relevant residual stenosis but a local dissection was seen during control-angiograms, the dissection was treated by implantation of a 5 mm × 76 mm 3D-printing biodegradable drug-eluting peripheral stent (PERISORB® BRS). The patient returned for follow-up visits, color duplex ultrasonography (CDUS) and digital subtraction angiography (DSA) was performed at 6-month and 16-month follow-up. No perioperative complications were found. At 16-month follow-up, ultrasonography showed stent patency and no stenosis. The Rutherford-Becker category was 1 and the ABI improved to 0.85.