Objectives To compare the effectiveness of two foam sclerotherapy techniques of the great saphenous vein. Methods Fifty subjects with varicose veins, edema, and great saphenous vein incompetence (diameter 6–10 mm) were randomly categorized into two equal groups and were treated with different foam sclerotherapy techniques: A (usual ultrasound-guided) and B (catheter-directed with tumescence). Concomitant phlebectomy was performed in all patients. Patients were seen on days 7 and 28, and at six and 12 months. The primary outcomes were the full success rate of the treated great saphenous vein and the number of patients who required retreatment sessions performed at 28-day follow-up. The secondary-assisted outcomes were the full success rates of the treated great saphenous vein after the retreatment sessions at six- and 12-month follow-up. Secondary outcomes were changes in quality of life and side effects and complications of the intervention. In case of reflux, retreatment sessions were performed at 28 days and six months in both groups. Results Full success rate of the treated great saphenous vein was 36% in group A vs. 80% in group B ( p = 0.012) and the number of patients who required retreatment sessions were n = 14 in group A vs. n = 3 in group B at 28-day follow-up ( p = 0.002). Both were statistically significant. At six and 12 months, the success rates were not statistically significant between the groups. Complication rates were similar between the groups. Quality of life improved in both groups with statistical difference ( p < 0.001). Conclusions Catheter-directed foam sclerotherapy with tumescence was better than usual ultrasound-guided foam sclerotherapy as it reached higher full success rate of the treated great saphenous vein and as a lower number of patients required retreatment sessions in the short-term. Both methods proved to be safe and improved the quality of life.
Objectives To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence. Method This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS). Results Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT). Conclusions RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome. Registration: Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.
Objective To analyze prevalence of venous thromboembolism (VTE) after ultrasound guided foam sclerotherapy. Method Clinical retrospective study with patients treated from 2004 to 2014. Charts with incomplete data and follow-up less than 60 days were excluded. Polidocanol foam (Tessari method) was used. The primary outcome was the prevalence of VTE and the secondary were possible risk factors. Chi-square test and Marascuillo prodecure were applied at a significance level of 5%. Results 2,616 patients were included with 4,712 lower limbs treated. The mean age was 50.7±0.86, in majority female, 83.7%. VTE occurred in 0.49% (pulmonary embolism 0,3%) in a mean time of 44.0±42.2 days. Male gender, personal or family history of phlebitis or DVT and high caliber varicose veins were significantly associated to VTE. Conclusion incidence of VTE is low, male gender, personal or family history of VTE and caliber of varicose veins greater than 7 mm increased the risk.
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