Background: Stenting of chronic nonmalignant obstruction in the venous outflow tract started in earnest in 1997. Data sets are now available to perform long-term analysis of stent-related outcome and clinical and hemodynamic results of this intervention.
Materials: From 1997 to 2005, 982 chronic nonmalignant obstructive lesions of the femoroiliocaval vein were stented under intravascular ultrasound guidance. Median patient age was 54 years (range, 14 to 90 years), the female/male was 2.6:1, and left/right limb symptoms, 2.4:1. Clinical score of CEAP was 2 in 7%, 3 in 47%, 4 in 24%, 5 in 5%, and 6 in 17%; primary/secondary etiology was 518:464. Stent-related outcome (morbidity, thrombotic events, patency, in-stent recurrent stenosis), clinical outcome, quality of life (QOL) as assessed by the Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ), and hemodynamics were evaluated before and after intervention.
Result: Monitoring for 94% of patients lasted a mean 22 months (range, 1 to 107 months). Stenting was performed with no mortality (<30 days) and low morbidity. Thrombotic events were rare (1.5%) during the postoperative period (<30 days) and during later follow-up (3%). At 72 months, primary, assisted-primary, and secondary cumulative patency rates were 79%, 100%, and 100% in nonthrombotic disease and 57%, 80%, and 86% in thrombotic disease, respectively. Cumulative rate of severe in-stent restenosis (>50%) occurred in 5% of limbs at 72 months (10% in thrombotic limbs, 1% in nonthrombotic limbs). The main risk factors associated with stent occlusion were the presence and severity of thrombotic disease; thrombophilia by itself was not a risk factor. The median pain score and degree of swelling decreased significantly poststent. Severe leg pain (visual analogue scale >5) and leg swelling (grade 3) decreased from 54% and 44% prestent to 11% and 18% poststent, respectively. At 5 years, cumulative rates of complete relief of pain and swelling were 62% and 32%, respectively, and ulcer healing was 58%. The mean CIVIQ scores of QOL improved significantly in all categories. Mean hand-foot pressure differential decreased and mean ambulatory venous pressure improved in stented limbs with no concomitant reflux. The hemodynamic response was modified, depending on the presence of deep and superficial reflux in subsets of patients with adjunct saphenous procedures. No increase in venous reflux was observed.
Conclusions: Venous stenting can be performed with low morbidity and mortality, long-term high patency rate, and a low rate of in-stent restenosis. It resulted in major symptom relief in patients with chronic venous disease, which was not consistently reflected in any substantial hemodynamic improvement by conventional measurements. The beneficial clinical outcome occurred regardless of presence of remaining reflux, adjunct saphenous procedures, or etiology of obstruction.