Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
Department of Vascular Surgery, Jessa Hospital, Hasselt, Belgium.
Phlebology. 2023 Dec;38(10):641-648. doi: 10.1177/02683555231193883. Epub 2023 Aug 6.
To prove that the ELVeS® Radial® 2ring slim fiber (Biolitec AG, Wien, Austria) is safe and effective, with a reliable fiber durability.
This prospective, non-randomized, registry recruited patients with venous incompetence of the great saphenous vein, with or without concomitant incompetence of the small, anterior accessory and posterior accessory saphenous veins. Anatomic success, clinical success and pain were assessed.
150 patients (410 veins) underwent endovenous laser ablation (EVLA). Mean number of veins treated was 2.7 (1-7) with a mean total length of 80.7 cm. 98.3% occlusions were observed after 12 months. Clinical improvement was significant with reduced venous clinical severity scores at 1 month (1.7 ±1.9; < .0001) and 12 months (0.7 ±1.3; < .0001) versus pre-operation (4.4 ± 2.2). Mean pain level after 1-week was 5.8/100. No major surgery- or device-related complications occurred.
1470-nm EVLA with the 2ring slim fiber is a highly effective treatment option well tolerated by patients. Despite intensive use, fiber integrity was preserved.
The study protocol was registered in clinicaltrials.gov (NCT03810677).
证明 ELVeS® Radial® 2 环光纤（Biolitec AG，维也纳，奥地利）安全有效，纤维耐用性可靠。
本前瞻性、非随机、登记研究招募了大隐静脉静脉功能不全伴或不伴小隐静脉、前辅助和后辅助隐静脉功能不全的患者。评估解剖学成功、临床成功和疼痛。
150 例患者（410 条静脉）接受了静脉内激光消融术（EVLA）。治疗的平均静脉数为 2.7（1-7）条，总长度平均为 80.7cm。12 个月后观察到 98.3%的闭塞。临床改善显著，1 个月时静脉临床严重程度评分（1.7±1.9；<0.0001）和 12 个月时（0.7±1.3；<0.0001）较术前（4.4±2.2）降低。术后 1 周时平均疼痛水平为 5.8/100。无重大手术或器械相关并发症。
1470nm EVLA 联合 2 环光纤是一种高度有效的治疗选择，患者耐受性良好。尽管使用频繁，但纤维完整性得以保持。
研究方案在 clinicaltrials.gov 注册（NCT03810677）。
