The Use of Micronized Purified Flavonoid Fraction for Postoperative Symptoms Regression After Endovenous Thermal Ablation. A Randomized Controlled Study

Abstract

Introduction: Micronized purified flavonoid fraction (MPFF) is a venoactive agent with proven positive effects in the treatment of chronic venous disease. The aim of our study was to assess the use of MPFF for the post-operative symptoms relief after endovenous thermal ablation (EVTA) with phlebectomies. Methods: 120 patients undergoing EVTA (Laser 1470nm or Radiofrequency) of the greater saphenous vein with phlebectomies were randomized in two groups: group 1 (60 patients) receiving MPFF 500mg Bid 7 days before and 30 days after the procedure; and group 2 (60 patients) not receiving MPFF (Control group). Demographics (age, gender), intra-operative details such as (type of ablation, linear endovenous energy density, vein diameter and length of ablated vein), Clinical -Etiology- Anatomy- Pathophysiology (CEAP) clinical classification, 10-cm Visual Analog Scale (VAS) for pain, Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Quality-of-Life Questionnaire (CΙVIQ) were recorded. Follow up visits were performed at 7 days prior to ablation and 7 and 30 days post-ablation. Primary outcome was postoperative pain assessement using the VAS scale and CIVIQ pain score. Secondary outcomes included assessemnt of VCSS and CΙVIQ scores. Results: Patients' demographics, CEAP clinical classification and intra-operative details were not different between the two groups. Mean preoperative VAS and CIVIQ pain score were similar in both groups (5±1.9 and 8.7±3 in the group 1 vs. 5.4±1.7 and 9.4±3.4 in the group 2, respectively; p=0.7). At 30-day follow up an improvent of VAS and CIVIQ pain score was recorded in both groups (0.2±0.5 VAS pain score and 4.5±1.1 CIVIQ pain score in the group 1 vs 1.1±1.3 and 5±1 in the group 2, respectively), (p=0.03). The improvement of VAS and CIVIQ pain scores was higher in the group 1 in comparison to group 2 at 7 day and 30 day postoperatively in realtion to pre-operative status [at 7 days: VAS; group 1 from 5±1.9 to 1.5±1.5 vs. group 2 from 5.4±1.7 to 2.6±1.8 (p=00.4); CIVIQ; group 1 from 8.7±3 to 5±1.2 vs. group 2 from 9.4±3.4 to 5.8±1.8 (p=0.04); at 30 days: VAS; group 1 from 5±1.9 to 0.2±0.5 vs. group 2 from 5.4±1.7 to 1.1±1.3 (p=0.04); CIVIQ; group 1 from 8.7±3 to 4.5±1.1 vs. group 2 from9.4±3.4 to 5±1 (p=0.03)]. Both groups showed a significant improvement in all domains of CIVIQ and VCSS compared to preoperative assessment (p=0.02) at 30-days post-operatively, but there was no difference between the two groups in terms of improvement. Conclusion: Administration of MPFF agent in patients undergoing EVTA may improve postoperative pain. Larger studies are needed to confirm these findings. Disclosure: Nothing to disclose