Analysis of efficacy of radiofrequency obliteration with due regard for the target vein’s diameter

Shaidakov E.V.^1,2, Grigoryan A.G.^1,2,3, Ilyukhin E.A.², Bulatov V.L.^1,2,3, Galchenko M.I.³

1) Scientific Research Institute of Experimental Medicine, North-West Branch of the RAMS,
2) 1st Clinic of Surgery (advanced medical education), State Educational Facility of Higher Professional Education "Military Medical Academy named after S.M. Kirov" under the Ministry of Defence of the Russian Federation,
3) Clinic "Medalp", St. Petersburg, Russia

Introduction. Data concerning the effect of the target vein’s diameter on efficacy of radiofrequency obliteration (RFO) in the current literature are limited.

Objective of the study. To assess efficacy of RFO and stripping, peculiarities of the postoperative period course with due regard for the diameter of the target veins, to compare the outcomes of RFO and classical phlebectomy in treatment of varicose disease during 1-year follow up by a composite end point.

Materials and methods. A multicenter prospective non-randomized study based on analysing therapeutic outcomes in a total of 218 patients presenting with varicose disease (C2–C3 according to the CEAP). RFO was performed in 108 patients and phlebectomy in 110 subjects. The results were assessed by means of a composite end point including four components: technical outcome at 1-year follow-up, pain, subcutaneous haemorrhage, and paresthesias. The groups of patients who endured RFO and phlebectomy were subdivided into two subgroups according to the target vein’s diameter with a border of 14 mm. Statistical analysis. We used the methods of non-parametric statistics (contingency tables, chi squared test), calculating the odds ratio (OR) for a favourable outcome with a 95% confidential interval. Pain dynamics was assessed by means of intellectual data analysis (cluster analysis).

Results. "Phelbectomy ≥14 mm" and "RFO ≥14 mm". The incidence rate of a good outcome in the subgroups amounted to 20 (30.8%) and 61 (95.3%), respectively. The odds ratio for favourable outcome between the subgroups of RFA and phlebectomy amounted to 45.8; 95% CI (44.5–47.0). "RFA ≥14 mm" and "RFA <14 mm". Favourable outcome rate in the subgroups amounted to 25 (39.1%) and 17 (38.6%), respectively. The differences were not statistically significant, p=0.24. The odds ratio for a good outcome between the RFO subgroups amounted to: OR=0.98; 95% CI (0.18–1.77). Comparative analysis of RFO outcomes between the clinics. Favourable outcome rate in the first clinic was 50 (92.6%), in the second 34 (87.2%), and in the third 13 (86.6%), with the difference being statistically insignificant, p=0.7. The cluster analysis of the pain dynamics after the intervention. The clusters with moderate pain were composed of the patients after phlebectomy. These clusters showed association of pain intensity with increased BMI and greater vein diameter.

Conclusions

RFA of great-diameter veins by a favourable outcome by the composite end point (CED) turned out to be superior to the classic phlebectomy.
For RFA the incidence rate of a favourable outcome by the CED does not depend on the target vein’s diameter.
A pronounced pain syndrome after phlebectomy was associated with excessive body weight or obesity and greater diameter of the vein.

KEY WORDS: endovenous thermal obliteration, radiofrequency obliteration, stripping, phlebectomy, composite end point, great saphenous vein.

P. 94

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