Troisi Nicola, De Blasis Giovanni, Salvini Mauro, Michelagnoli Stefano
Unit of Vascular and Endovascular Surgery, Department of Surgery, San Giovanni di Dio Hospital, Florence, Italy -
Unit of Vascular Surgery, Santi Filippo e Nicola Hospital, Avezzano, L'Aquila, Italy.
Int Angiol. 2019 Aug;38(4):299-304. doi: 10.23736/S0392-9590.19.04199-3. Epub 2019 Jul 24.
In the endovascular era peripheral bypass surgery still plays a key role. In situ saphenous vein bypass is a standardized technique. The main limitation of this procedure is the vein diameter. A new hydrophylic valvulotome (HYDRO LeMaitre® Valvulotome; LeMaitre Vascular, Burlington, MA, USA) allows even to disrupt the valves in smaller veins. The aim of this study was to analyze the intraprocedural and technical successes of this new valvulotome.
In January 2018 in Italy a national, multicenter, observational, prospective registry based on the examination of treatment of critical limb ischemia with infragenicular bypass adopting in situ saphenous vein technique (LIMBSAVE registry) started the enrollment. Until December 2018 216 patients have been enrolled in the registry. All data concerning the procedures were prospectively collected in a dedicated database. The information included demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative features, and discharge outcomes, including the safety and effectiveness of the valvulotome during the surgical procedure.
Patients were predominantly male (160, 74.1%) with a mean age of 74.1 years (range 49-95). The mean diameter of the great saphenous vein was 3.7 mm (range 1.7-10) in the proximal part of the thigh, 3.4 mm (range 1.6-7) in the distal part of the thigh, and 3.1 mm in the proximal part of the leg (range 1.6-5). The technical success was obtained in all cases (the bypass pulsed after the utilization of the valvulotome). The valvulotome was able to reach the proximal anastomosis in all cases. The mean number of utilizations was 2.6 (range 1-5). No vein perforation has been detected. In 6 cases (2.8%) a vein adventitial damage occurred. In one case with uncontrolled bleeding (0.5%) the substitution of the deleted vein segment was necessary.
Preliminary intraprocedural outcomes of LIMBSAVE registry showed that HYDRO LeMaitre® Valvulotome was safe and effective in disrupting the valves and obtaining the pulsatility of the saphenous vein. The rate of complications related to the utilization of the valvulotome was low. Further examinations are needed to evaluate the long-term outcomes of the bypass in terms of patency, reinterventions, and limb salvage.
在血管内治疗时代，外周旁路手术仍发挥着关键作用。原位大隐静脉旁路术是一种标准化技术。该手术的主要局限性在于静脉直径。一种新型亲水瓣膜刀（HYDRO LeMaitre®瓣膜刀；美国马萨诸塞州伯灵顿市的LeMaitre Vascular公司生产）甚至能够破坏较细静脉中的瓣膜。本研究的目的是分析这种新型瓣膜刀在手术过程中的成功率及技术成功率。
2018年1月，在意大利启动了一项基于采用原位大隐静脉技术治疗下肢严重缺血的全国性、多中心、观察性、前瞻性注册研究（LIMBSAVE注册研究）。截至2018年12月，已有216例患者纳入该注册研究。所有与手术相关的数据均前瞻性地收集于一个专用数据库中。信息包括人口统计学资料、术前危险因素、临床及诊断性术前评估、术中特征以及出院结局，包括手术过程中瓣膜刀的安全性和有效性。
患者以男性为主（160例，占74.1%），平均年龄74.1岁（范围49 - 95岁）。大隐静脉在大腿近端的平均直径为3.7mm（范围1.7 - 10mm），在大腿远端为3.4mm（范围1.6 - 7mm），在小腿近端为3.1mm（范围1.6 - 5mm）。所有病例均取得技术成功（使用瓣膜刀后旁路有搏动）。在所有病例中瓣膜刀均能到达近端吻合口。平均使用次数为2.6次（范围1 - 5次）。未检测到静脉穿孔。6例（2.8%）发生静脉外膜损伤。1例出现难以控制的出血（0.5%），需要替换被破坏的静脉段。
LIMBSAVE注册研究的初步术中结果显示，HYDRO LeMaitre®瓣膜刀在破坏瓣膜及使大隐静脉产生搏动方面安全有效。与使用瓣膜刀相关的并发症发生率较低。需要进一步研究以评估旁路在通畅率、再次干预及肢体挽救方面的长期结局。
