Abstract
This open multicentre prospective cohort study carried out in four French centers report the obliteration rate of the great saphenous vein (GSV) in 75 patients treated using the steam vein sclerosis (SVS) system with high energy levels. Inclusion criteria were reflux at the sapheno-femoral junction (SFJ) and/or from the sub-terminal valve of the GSV of more than 0.5 s, vein diameter of between 4 and 13 mm (measured 3 cm distal to the SFJ) and a CEAP from C2 to C5. After pre-operative duplex ultrasound scan tumescent anesthesia was administered around the previously marked vein, in between the fascias, using a 21 gauge needle to inject a solution of 1.4% bicarbonate 500 mL, plus 20 mL 1% lidocaine with adrenaline. This was also performed in patients undergoing general anesthesia or loco-regional spinal anesthesia to provide a heat sink and protect the saphenous nerve. Access to the GSV under the knee was made through surgical incision or echo-guided percutaneous puncture placing a 16 G infusion catheter. Then, a flexible stainless steel SVS catheter covered with Teflon and with a diameter of 1.2 mm was inserted through the infusion catheter to a level of 2 and 3 cm below the SFJ. The SVS generator was calibrated to emit one pulse of steam with 60 J of energy every 1.8 s. The steam temperature delivered at the tip was 120°C. Two (for up to 7 mm) or three (for over 7 mm) or four (for large trunks over 12 mm) pulses were emitted for every cm of vein treated with the catheter stationary. Post-operative treatment consisted of 2 weeks of compression by class II stockings worn during the day and pain-killers (ibuprofen) at the patient’s discretion. Patients were then followed up at 1, 6 and 12 months with clinical examination, duplex ultrasound scanning, quality of life and safety assessments. A total of 75 patients (88 limbs-13 bilateral) underwent surgery with a median treatment time of 35 min (range 12-85) including patient preparation time; the median length of vein treated was 42 cm (range 15-57 cm). At 6-month visit the obliteration rate was 96% [95% CI: 89-99] at 12 months was 92% [95% CI: 83-97]. Vein diameter improved at 6 months from a median of 8 mm (range: 4-12 mm) to 1 mm (range: 0-9 mm) at mid-thigh. There were no adverse events either during or after the surgical procedure. The majority of adverse events occurred by day 8, the most common being ecchymosis at the entry site and pain in seven patients. At 1 month, inflammation of the venous pathway occurred in two patients and hypoesthesia in one patient. One protrusion of thrombus in the femoral vein (less than 1 cm) occurred fully resolved in 8 days under treatment by low molecular weight heparin. An ongoing study is focused on the treatment of tributaries. This could be a significant improvement as it allows an all-in-one endovenous procedure.
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