Five-year Follow-Up of a Randomized, Controlled Trial Comparing Saphenofemoral Ligation and Stripping of the Great Saphenous Vein With Endovenous Laser Ablation (980 Nm) Using Local Tumescent Anesthesia

J Vasc Surg. 2016 Feb;63(2):420-8. doi: 10.1016/j.jvs.2015.08.084. Epub 2015 Oct 23.

Abstract

Objective: The objective of this study was to compare the long-term results (groin-related recurrence, great saphenous vein [GSV] occlusion rate, Clinical class, Etiology, Anatomy, and Pathophysiology [CEAP] staging, and quality of life [QoL]) after the treatment of a GSV incompetence by saphenofemoral ligation and stripping (SFL/S) with endovenous laser ablation bare fiber, 980 nm (EVLA).

Methods: Patients with GSV insufficiency and varicose veins were randomized to either undergo SFL/S or EVLA, both of which were performed under tumescent anesthesia. The long-term results, which included the anatomic occlusion rate, varicose vein recurrence at the saphenofemoral junction (SFJ), relief of venous symptoms and QoL, were compared up to 5 years after treatment.

Results: A total of 130 legs of 121 patients were treated with either SFL/S (n = 68) or EVLA (n = 62). In the first 12 months, three recanalizations of the GSV were observed after EVLA. Up to 5 years later, more recurrent varicose veins caused by neoreflux in incompetent tributaries of the SFJ were observed in after EVLA (31%; 19/61) compared with SFL/S (7%; 4/60; P < .01). Neovascularization in the groin with clinically visible recurrence identified at 3 and 5 years post-treatment follow-up was only observed in the SFL/S group (n = 6). After 5 years, clinically visible recurrences originating from the SFJ region after EVLA were observed 33% (20/61) compared with 17% of patients (10/60) after SFL/S (P < .04). In both treatment groups, venous symptoms improved significantly. Patients in both groups reported a continuing significant cosmetic improvement measured on a visual analog scale of 1 to 10 (mean, 7.49; P < .01). There was no difference in the CEAP staging and a standardized, non-disease-specific instrument for describing and valuing health states (EuroQol-5D), between the groups up to 5 years after follow-up.

Conclusions: At the 5-year follow-up, a significantly higher varicose vein recurrence rate originated at the SFJ region after EVLA compared with SFL/S. There were no differences in the relief of venous symptoms, CEAP staging, or general QoL between the groups.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anesthesia, Local*
  • Female
  • Follow-Up Studies
  • Humans
  • Kaplan-Meier Estimate
  • Laser Therapy* / adverse effects
  • Laser Therapy* / instrumentation
  • Ligation
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Prospective Studies
  • Quality of Life
  • Recurrence
  • Saphenous Vein / diagnostic imaging
  • Saphenous Vein / surgery*
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Duplex
  • Varicose Veins / diagnosis
  • Varicose Veins / physiopathology
  • Varicose Veins / surgery*
  • Vascular Surgical Procedures / adverse effects
  • Vascular Surgical Procedures / instrumentation
  • Vascular Surgical Procedures / methods*
  • Venous Insufficiency / diagnosis
  • Venous Insufficiency / physiopathology
  • Venous Insufficiency / surgery*