Background
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).
Methods
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.
Results
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∗10-44) and 80.8 ± 9 mm vs 117.6 ± 20.4 mm (P = 2.4∗10-38), 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.
Conclusion
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.
