Effectivness and tolerability of bipolar radiofrequency-induced thermotherapy for the treatment of incompetent saphenous veins

Abstract

SummaryEndoluminal techniques such as laser therapy, radiofrequency therapy and sclerotherapy are increasingly replacing classic stripping for the treatment of incompetent saphenous veins. Interim results of the ongoing international, multicentre BRITTIV study to investigate the effectiveness and tolerability of the minimally invasive bipolar radiofrequency-induced thermal therapy (RFITT) are presented. Patients, methods: A flexible bipolar RFITT applicator is passed under ultrasound control into the affected vein of patients with varicosis of the great saphenous vein (GSV) or small saphenous vein (SSV). The vein is occluded by impedance-controlled release of radiofrequency energy as the RFITT applicator is slowly and smoothly withdrawn. The effectivness and tolerability of RFITT is checked over a one-year period by regular follow-ups. Results: To date a total of 345 saphenous veins (90% GSV, 10% SSV) in 271 patients (average age 50 years, 63% women, mean CEAP score 2.8) have been treated with RFITT in eight European hospitals. 72% of patients underwent general anaesthesia (18% spinal, 11% local) and tumescent anaesthesia was also used in 83% of the veins (mean length 45 cm). The average application time was 1.4 s/cm with a mean power output of 24 Watt. At the interim analysis after an average follow-up of 103 days, 90% of 335 treated veins were occluded. Differential analysis showed that partial (P) and complete (C) recurrences occurred significantly less often when longer application times had been used, whereby complete recurrences showed a greater reduction in frequency than partial. The total recurrence rate with an application time < 1 s/cm was 22% (P = 10%, C = 12%); with an application time between 1.0 and 1.4 s/cm it had already fallen to 9% (P = 6%, C = 3%) and with a time greater than 1.4 s/cm it was only 4% (P = 3%, C = 1%). According to subjective pain assessment on a visual analogue scale (VAS) of 0 to 10 (corresponding to no pain up to the strongest conceivable pain), by the first day after treatment already 74% of those questioned had only slight remaining pain or none at all (VAS 0–2). This generally low subjective pain sensation continued to fall at subsequent followups and at the 6-month follow-up, 99% of patients reported a VAS score of 0. Nearly all patients (99%) were satisfied with the treatment and would recommend it to others. Conclusions: With the same power output, even a minor increase in the application time to more than 1.4 s/cm can markedly reduce recurrence rate. In summary, the ongoing BRITTIV study illustrates the potential of RFITT for use in phlebology as it combines a spatially-defined obliteration of incompetent saphenous veins with overall moderate side effects and impressive results.