Experience with concomitant ultrasound-guided foam sclerotherapy and endovenous laser treatment in chronic venous disorder and its influence on Health Related Quality of Life: interim analysis of more than 1000 consecutive procedures.

AIM: The aim of this paper was to evaluate the efficacy of the concomitant use of endovenous laser treatment (ELT) and ultrasound-guided foam sclerotherapy (USGFS) in the management of chronic venous disorder and to objectively analyze the influence of the combination therapy on the Health Related Quality of Life (HRQL) of the treated patients.

METHODS: In this prospective series, 1 114 varicose veins in 924 consecutive subjects were treated either with a 980 nm (7-15W) or a 1320 nm (3-10W) endovenous laser.

INCLUSION CRITERIA: informed consent, clinical, etiologic, anatomical, and pathophysiological (CEAP) clinical class >or=2, and an accessible vein.

EXCLUSION CRITERIA: coagulation disorder, pregnancy, lactation, current thrombosis, systemic disease, poor general health, or allergy to sodium tetradecyl sulfate (STS). ELT was performed on refluxing saphenous truncal and non-saphenous veins, including incompetent perforators. USGFS was utilized to treat selective refluxing, symptomatic varicose tributaries that were not amenable to ELT alone. The Venous Dysfunction Score (VDS) and Health Related Quality of Life (HRQL) were assessed. All of the patients were strictly monitored and had Duplex ultrasound scanning to evaluate for deep vein thrombosis (DVT) at 24-72 hours. Thorough Duplex scanning was done at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months.

RESULTS: At 1 month, there was continued reflux (> 0.5 seconds) in 26 SFJs (3.0%, N=824) and 4 SPJ s (2.5%, N=155) and at 3 months in 15 SFJs (1.8%), 5 SPJ s (3.7%). At 6 months, reflux was present in 10 SFJs (1.2%) and 4 SPJs (2.5%). At a mean of 12+/-10 months of post-treatment follow-up, 4 SFJ (1.9%, N=207) and 1 SPJ (1.9%, N=52) had reflux. Overall, there was elimination of reflux in 98% of junctions. The posterior accessory saphenous veins (PAV: N=117) had 100 % elimination of reflux at 1 month, a result that remained unchanged for more than a year (P<0.001). Similarly, anterior accessory saphenous veins (AAV: N=56), cranial, caudal, or thigh, extensions of the small saphenous vein (CESSV: N=31), and non-saphenous veins and incompetent perforators (NSV, IP: N=31) all had sustained and statistically significant response (P<0.001). Sequentially assessed VDS showed significant improvement (P<0.001). The Aberdeen Varicose Vein Questionnaire (AVVQ) revealed significant improvement in HRQL at 1-2 year (P<0.001). Failed ELT attempts occurred in six cases due to vein spasm (N=4, 0.36%) or fiber/laser machine malfunction (N=2, 0.18%). These veins were successfully treated with ultrasound-guided foam sclerotherapy. Thirty-two patients (2.9%) complained of a small area of numbness at one month. There was complete resolution in 6 (18.8%) of the patients by 6 months. There were four cases of a localized cellulitis at laser venous access sites. These resolved uneventfully with oral antibiotics. There were also two skin reactions, with localized urticaria, due to dressing tape. These required no additional treatment. There were two cases of superficial phlebitis that resolved with continued compression and NSAIDs. There was one asymptomatic popliteal DVT and one uncomplicated superficial skin burn that both resolved uneventfully with no treatment other than observation. No pulmonary embolism (PE), thrombophlebitis, or visual disturbance occurred.

CONCLUSIONS: Ultrasound-guided foam sclerotherapy given concomitantly with ELT is safe and highly efficacious in the management of GSV, SSV reflux and in their tributaries or in non-saphenous veins. CVD patients treated with combination therapy given in this manner demonstrated significant improvement in their HRQL.