Sulakvelidze Levan, Lakhanpal Gaurav, Lakhanpal Sanjiv, Kennedy Richard, Lakhanpal Rohan, Pappas Peter J
From the Center for Vascular Medicine, Greenbelt, MD; Lakhanpal Vein Foundation, Greenbelt, MD.
From the Center for Vascular Medicine, Greenbelt, MD; Lakhanpal Vein Foundation, Greenbelt, MD.
J Vasc Surg Venous Lymphat Disord. 2023 Mar;11(2):357-364. doi: 10.1016/j.jvsv.2022.08.007. Epub 2022 Sep 29.
The Wallstent (WS; Boston Scientific, Malborough, MA) is currently the standard of care for comparisons of clinical efficacy for new stent devices in the treatment of iliac vein outflow disease. Many vein-specific Nitinol-based stents have been now approved by the Food and Drug Administration for use in the iliofemoral venous system. However, few comparisons of these devices to the current standard have been reported. The purpose of this investigation was to compare the complication and reintervention rates between the WS and Venovo stent (VS; BD, Franklin Lakes, NJ).
A random sample of 100 WS and 100 VS cases performed from April 2018 through December 2020 were selected for retrospective analysis. The demographics, presenting symptoms, and CEAP (Clinical, Etiology, Anatomy, Pathophysiology) class were assessed. The complication logs and 90-day follow-up data were reviewed for every case to assess the incidence of postoperative deep vein thrombosis, stent thrombosis, in-stent restenosis, bleeding, and transient back pain.
WSs had been placed more often in the left common iliac vein segment (52 vs 1), and VSs had been placed more often in the left common iliac vein and external iliac vein segments (36 vs 63; P = .0069). The average diameter and length of the WSs and VSs were 19.7 ± 2.2 mm vs 15 ± 1.4 mm (P = 2.4∗10) and 80.8 ± 9 mm vs 117.6 ± 20.4 mm (P = 2.4∗10), respectively. The average number of stents per patient was 1.05 for the WSs and 1.03 for the VSs (P = .47). The reintervention rates were similar between the two groups: WS, n = 5; and VS, n = 4 (P = .74). Four of the five WS reinterventions were stent extensions to treat in-stent restenosis and recurrence of symptoms, and one was secondary to occlusion requiring ipsilateral venoplasty and stenting. Two of the four VS reinterventions were venoplasty for in-stent restenosis and two were stent extensions for symptom recurrence. Transient back pain was the most common complication (WS, 37%; VS, 47%; P = 0.28). Insertion site deep vein thrombosis had developed in the three patients in the WS group and four patients in the VS group (P = .71). No patient had experienced bleeding requiring hospitalization, and no stent fractures, stent migration, or deaths had occurred.
The complication and reintervention rates between the WS and VS groups were similar. Both stents demonstrated evidence of in-stent stenosis requiring reintervention. Implanted VSs tended to be smaller in diameter and longer in length and covered the common and external iliac veins more often compared with the WSs. Therefore, one VS can be used to cover two territories compared with the WS for which two stents will be required to cover the same vein territory length.
Wallstent支架(WS;波士顿科学公司,马尔伯勒,马萨诸塞州)目前是用于比较新型支架装置治疗髂静脉流出道疾病临床疗效的护理标准。现在许多特定于静脉的镍钛合金支架已获美国食品药品监督管理局批准用于髂股静脉系统。然而,很少有关于这些装置与当前标准进行比较的报道。本研究的目的是比较WS和Venovo支架(VS;BD公司,富兰克林湖,新泽西州)之间的并发症和再次干预率。
选取2018年4月至2020年12月期间进行的100例WS和100例VS病例的随机样本进行回顾性分析。评估人口统计学、呈现症状和CEAP(临床、病因、解剖、病理生理学)分级。查阅每个病例的并发症记录和90天随访数据,以评估术后深静脉血栓形成、支架血栓形成、支架内再狭窄、出血和短暂性背痛的发生率。
WS更多地放置在左髂总静脉段(52例对1例),而VS更多地放置在左髂总静脉和髂外静脉段(36例对63例;P = 0.0069)。WS和VS的平均直径和长度分别为19.7 ± 2.2 mm对15 ± 1.4 mm(P = 2.4×10)和80.8 ± 9 mm对117.6 ± 20.4 mm(P = 2.4×10)。每组患者的平均支架数量,WS为每个患者1.05个,VS为每个患者1.03个(P = 0.47)。两组的再次干预率相似:WS组,n = 5;VS组,n = 4(P = 0.74)。WS的5次再次干预中有4次是支架延长以治疗支架内再狭窄和症状复发,1次是由于闭塞继发,需要同侧静脉成形术和支架置入。VS的4次再次干预中有2次是针对支架内再狭窄的静脉成形术,2次是针对症状复发的支架延长。短暂性背痛是最常见的并发症(WS组,37%;VS组,47%;P = 0.28)。WS组有3例患者和VS组有4例患者发生了穿刺部位深静脉血栓形成(P = 0.71)。没有患者发生需要住院治疗的出血,也没有发生支架断裂、支架移位或死亡。
WS组和VS组之间的并发症和再次干预率相似。两种支架均显示出需要再次干预的支架内狭窄证据。与WS相比,植入的VS直径往往更小、长度更长,并且更常覆盖髂总静脉和髂外静脉。因此,与WS相比,一个VS可用于覆盖两个区域,而覆盖相同静脉区域长度需要两个WS支架。