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Venovo venous open cell self-expanding stent implantation for chronic outflow obstruction

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    By Hratch L Karamanoukian MD FACS RVT RPVI RPHS DABVLM

    I am reviewing an article regarding endovascular venous stenting with dedicated venous stents for the treatment of chronic venous outflow obstruction.

    The article was published by Michael KW Lichtenberg and colleagues in the journal Vasa (see reference below).

    What was the premise of this study ?

    Endovenous stenting is developing as an efficacious alternative to conservative therapy or open surgery for chronic venous obstruction. The authors sought to determine mid and long-term evidence on effectiveness and safety for this technology. 

    What were the methods used for this study? 

    This was a prospective, single-center, observational study that enrolled consecutive patients with chronic non-thrombotic iliac vein lesions (NIVL) or post-thrombotic iliofemoral obstructions (PTO) from February 2016 to April 2017.

    The study was conducted at the Venous Center, Klinikum Arnsberg, Arnsberg, Germany; Herz-Jesu-Krankenhaus Dernbach, Dernbach, Germany; and Radiology Department, Klinikum Friedrichshafen, Friedrichshafen, Germany.

    What type of stent was used for this study? 

    The patients enrolled in this study underwent implantation of open-cell, self-expandable dedicated venous stents.

    What was measured in this study? 

    Short-term symptomatic improvement, patency, and complication rate were measured.

    Evaluation at 2  years included :

    1)  whether there was an improvement in revised venous clinical severity score (rVCSS)

    2) stent patency rates

    3 stent patency

    4) presence or absence of stent migration

    5) major target limb events

    6) clinically important pulmonary embolism

    7) major bleeding

    8) all-cause mortality. 

    What are the study results? 

    A total of 79 patients (57 ± 16 years) 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 in the revised VCSS score was not associated with thrombotic pathogenesis.

    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 was observed.

    No target limb deep vein thrombosis occured.

    No major amputation was observed.

    No pulmonary embolism was observed.

    No death occured in this series.

    What are the conclusions of this study? 

    The authors of this important study showed that the Venovo venous open-cell self-expanding stent implantation for chronic outflow obstruction was efficacious and provided a sufficient level of safety during the 2 years of follow-up. 

    Reference:  Lichtenberg MKW, Stahlhoff WF, Stahlhoff S, Ozkapi A, Breuckmann F and de Graaf R.  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. Vasa 2021; Jan;50(1):52-58.