Venovo venous stent for treatment of non-thrombotic or post-thrombotic iliac vein lesions - long-term efficacy and safety results from the Arnsberg venous registry.

Background: Endovascular venous stenting with dedicated venous stents for the treatment of chronic venous outflow obstruction is developing as efficacious alternative to conservative therapy or open surgery. However, so far, mid- and long-term evidence on effectiveness and safety is poor. Patients and methods: The prospective, single-center, observational study enrolled consecutive patients with chronic non-thrombotic iliac vein lesions (NIVL) or post-thrombotic iliofemoral obstructions (PTO). From February 2016 to April 2017, patients underwent implantation of open cell, self-expandable dedicated venous stents. Short-term symptomatic improvement, patency, and complication rate were favorable. Evaluation at 2-years included improvement in the revised venous clinical severity score (rVCSS), patency, stent migration, major target limb events, clinically important pulmonary embolism, major bleeding, and all-cause mortality. Results: A total of 79 patients (57 ± 16 years, 44 female) were evaluated. At 2 years, rVCCS improved by 4.3 ± 2.7 (p < 0.001). Substantial clinical improvement of ≥ 2 score points was achieved in 86.4% (38 of 44) of patients. Improvement was not associated with thrombotic pathogenesis (regression coefficient [B] with PTO = 0.6 [95%CI: -1.1 to 2.3], p = 0.48). At 2 years, all ulcers (in 8 of 79 patients) were healed and none recurred. Two-year primary patency was 95.5% (95%CI: 86.5 to 98.5) with no difference between NIVL- and PTO-patients (log-rank p = 0.83). Target vessel revascularization was conducted in two PTO- and one NIVL-patients in the period of 34 days to 156 days from index procedure, resulting in a secondary patency of 100%. No stent migration, target limb deep vein thrombosis, major amputation, pulmonary embolism, or death occurred. Conclusions: Venovo venous open cell self-expanding stent implantation for chronic outflow obstruction was efficacious and provided a sufficient level of safety throughout 2 years.

[Endovascular Recanalization of Chronic Venous Outflow Obstructions]. / Endovenöse Rekanalisationen von chronischen Beckenvenenverschlüssen.

Approximately 60 % of patients with acute iliofemoral deep vein thrombosis recover without further symptoms. However, 40 % will have some degree of post-thrombotic syndrome (PTS) and 4 % will develop severe PTS. PTS is the most common complication; it reduces quality of life and increases DVT-related costs. The clinical symptoms and severity of PTS may vary; the most common symptoms include edema, pain, hyperpigmentation, lipodermatosclerosis, and ulceration. PTS is based on the principle of outflow obstruction, may be caused by venous hypertension, and may lead to valvular damage and venous reflux or insufficiency. A significant lumen reduction within the iliac vein system is defined by an aspect ratio ≥ 2. Recent technical developments and new dedicated venous stent techniques now give the opportunity to recanalize even complex venous outflow obstructions. First in man safety and efficacy data are very promising for the new dedicated venous stents, but long-term data are still missing.