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.

Patency rates, safety and clinical results of the sinus-Obliquus venous stent in the treatment of chronic ilio-femoral venous outflow obstruction - data from the Arnsberg venous registry.

Background: We sought to determine the patency and clinical symptom relief following the usage of the sinus-Obliquus venous stent in the endovascular treatment of venous obstruction of the ilio-femoral track in short-term. Patients and methods: 48 patients (62 % female, mean age 57 years) with chronic unilateral post-thrombotic obstruction (PTO) and non-thrombotic iliac vein obstructive lesions (NIVL) without involvement of inferior vena cava receiving a sinus-Obliquus venous stent was included in the analysis. Clinical improvement determined by the revised venous clinical severity score (rVCSS) as well as the clinical, etiologic, anatomic and pathophysiologic score (CEAP), safety, and stent patency rates were determined at baseline and at 1, 6 and 12 months after stent placement. Ten of the 48 included patients had a venous ulceration. Results: Primary patency rates were 98 % at FU1, 94 % at FU2 and 94 % at FU3, respectively. Secondary patency was 100 % at FU1, 96 % at FU2 and remained 96 % at FU3. At 12 months, the mean rVCSS dropped from 9.0 to 4.8 points (p < 0.001) whereas the mean CEAP improved from 3.45 to 2.96 (p < 0.001). A substantial healing of ulcerations was observed in 8 of 10 patients with initial venous ulceration. There were no relevant safety concerns noticed. Conclusions: Even though long-term studies are missing, the sinus-Obliquus venous stent already showed very promising patency rates at short term, associated with substantial clinical improvement and low device-related complications in both NIVL and PTS.

Venovo venous stent in the treatment of non-thrombotic or post-thrombotic iliac vein lesions - short-term results from the Arnsberg venous registry.

BACKGROUND: We sought to determine the patency and clinical symptom relief of the Venovo venous stent in the endovascular treatment of non-thrombotic (NIVL) or post-thrombotic venous obstruction (PTO) of the iliofemoral track over a period of 6 months. PATIENTS AND METHODS: A total of 80 patients (45 female, mean age 57 years) treated in 2016 and 2017 were included in the Arnsberg venous registry. Clinical improvement was determined by the revised venous clinical severity score (rVCSS) as well as the clinical, etiologic, anatomic and pathophysiologic (CEAP) score. Primary and secondary stent patency was evaluated using duplex ultrasound. RESULTS: Overall 6-months patency rates were 98 % for primary and 100 % for secondary patency. For NIVL primary patency was 97 %, whereas for PTO primary patency was 96 %. Early stent re-occlusion occurred in 3 patients within 34, 59 and 156 days after intervention. Two of these patients were successfully treated by endovascular mechanical thrombectomy and stent in stent implantation. Clinical improvement with a gain of ≥ 2 rVCSS levels was observed in 51 %. CEAP scores decreased from 4.3 to 2.7. CONCLUSIONS: In this first time report the novel Venovo venous stent showed adequate patency rates associated with reasonable clinical improvement and low device-related complications throughout a 6-months-follow-up in both NIVL and PTO.