OptiMed's Sinus-Venous Stent Evaluated in Treatment of Chronic Venous Obstructive Disease

October 6, 2015—Mark Antonius Friedrich de Wolf, MD, et al published initial results from an early experience with the sinus-Venous stent (OptiMed GmbH) in the European Journal of Vascular and Endovascular Surgery (EJVES, 2015;50:518–526). The investigators concluded that the short-term clinical results using the sinus-Venous stent are excellent, with significant symptom reduction, low morbidity rates, and no mortality. Loss of stent patency is seen less often compared with arterial stents described in the literature, noted the investigators.

The investigators stated that deep venous stenting has become the primary treatment option for chronic venous obstructive disease, both for iliac vein compression and postthrombotic venous lesions. Until recently, only stents aimed at arterial pathology were used, because no dedicated venous stents were available; however, three venous stents are now available. These venous stents are characterized by increased length, diameter, flexibility, and radial force. This study reports the investigators’ early experience with one of these devices, OptiMed’s sinus-Venous nitinol stent, at Maastricht University Medical Center in Maastricht, the Netherlands. 

As summarized in EJVES, between March 2012 and July 2014, 75 patients were treated with the sinus-Venous stent, including 35 cases of iliac vein compression syndrome and 40 cases of unilateral chronic obstruction in postthrombotic syndrome. Diagnosis of relevant obstruction was made using clinical evaluation, duplex ultrasound, and magnetic resonance venography. Patency during follow-up was assessed with duplex ultrasound. The investigators assessed clinical improvement using the Venous Clinical Severity Score, Villalta score, rate of ulcer healing, and improvement of venous claudication.

The investigators reported that the cumulative patency rates at 3, 6, and 12 months were 99%, 96%, and 92%, respectively. The cumulative assisted primary patency rates were 99% at 3, 6, and 12 months. The cumulative secondary patency rate at 12 months was 100%. Differences exist in patency rates between the nonthrombotic and postthrombotic subgroups, with the former group showing no reocclusions. 

All rethromboses in the postthrombotic syndrome group were treated by ancillary treatment modalities. Venous Clinical Severity Score and Villalta score decreased significantly after stenting, as did venous claudication. Morbidity was low without clinically relevant pulmonary embolism, and there was no mortality. Although two out of seven ulcers healed temporarily, no ulcer remained healed at 12-month follow-up, reported the investigators in EJVES.