aree scientifiche
ABSTRACT
OBJECTIVE:
The quality of available evidence regarding new minimally invasive techniques to abolish great saphenous vein reflux is moderate. This study aimed to assess whether radiofrequency ablation (RFA) was noninferior to each of the stripping (HL/S) and CHIVA methods on clinical and ultrasound recurrence at 2 years in patients with primary varicose veins (VV) due to great saphenous vein (GSV) insufficiency.
METHODS:
A randomized, single-centre, open-label, controlled, noninferiority trial comparing RFA with two surgical techniques for the treatment of primary VV due to GSV insufficiency. The noninferiority margin was set at 15% for absolute differences. Patients aged over 18 years with primary VV and GSV incompetence, with or without clinical symptoms, C2 – C6 clinical class of CEAP and GSV diameter >4 mm were randomized with a 1:1:1 ratio to RFA, HL/S or CHIVA. Rate of clinical recurrence at 24 months was the primary endpoint and was analyzed using a delta noninferiority margin of 15%. Ultrasound recurrence, safety and quality of life were considered as secondary endpoints for descriptive purposes.
RESULTS:
From December 2012 to June 2015, 225 limbs were randomized to RFA, HL/S or CHIVA (74/75/76). Clinical follow-up and Doppler Ultrasound (DUS) were performed after surgery at 1 week, 1, 6, 12 and 24 months. No differences in postoperative complications or pain were observed between groups. RFA was found to be noninferior to HL/S on clinical recurrence at 24 months, with an estimated difference in recurrence (95% CI) of 3% (-4.8%, 10.7%), noninferiority P= 0.002, and noninferior to CHIVA (95% CI) of -7% ( -17%, 3%) P<0.001. For ultrasound recurrence, RFA was found to be noninferior to CHIVA with an estimated difference (95% CI) of -34% (-47, -20) noninferiority P<0.001 at 24 months, but noninferiority could not be demonstrated compared to HL/S (5.9% 95% CI -4.1, 15.9) P=0.073. There were no differences in quality of life between groups.
CONCLUSIONS:
RFA is noninferior in terms of clinical recurrence to HL/S and CHIVA in the treatment of VV due to the insufficiency of GSV.
REVISIONI COCHRANE e METANALISI
1) BELLMUNT–MONTOYA S., ESCRIBANO J.M., DILME J., MARTINEZ–ZAPATA M.J., CHIVA method for the treatment of chronic venous insufficiency, Cochrane Database Syst. Rev., 2013 Jul 3, (7): CD009648.
2) BELLMUNT–MONTOYA S., ESCRIBANO J.M., DILME J., MARTINEZ–ZAPATA M.J., CHIVA method for the treatment of chronic venous insufficiency, Cochrane Database Syst. Rev., 2015 Jun 29, (6): CD009648.
The first review was published in 2013 and aimed to compare the effectiveness and safety of the CHIVA method with alternative therapeutic techniques for the treatment of chronic superficial venous insufficiency. Randomized controlled trials (RCTs) have been included to compare the CHIVA method compared to any other treatment. The primary endpoint was clinical recurrence, the studies included in the review had a follow-up of 3 to 10 years, and showed more favorable results for the CHIVA method compared to stripping (721 people, RR 0.63, 95% CI 0.51 to 0.78).
Only one of the studies included in the review reported data related to
quality of life (presented graphically) and these results also significantly favored the CHIVA method.
The stripping group had a higher risk of side effects than the CHIVA group; in particular, for the presence of hematomas (RR 0.63 95% CI from 0.53 to 0.76;) for nerve damage (RR 0.05 95% CI from 0.01 to 0.38).
No statistically significant differences were reported between the groups regarding the incidence of infection and superficial venous thrombosis. (Comment by Paolo Zamboni)
3) Guo L. et Al.: Long-term efficacy of different procedures for treatment of varicose veins A network meta-analysis
Medicine (2019) 98:7
Abstract
Background: Various procedures for the treatment of varicose veins have been shown to have long-term effectiveness, but research has yet to identify the most effective procedure. The aim of this study was to investigate the long-term efficacy of different procedures based on Bayesian network meta-analysis and to rank therapeutic options for clinical decision-making.
Methods: Globally recognized databases, namely, MEDLINE, Embase, and Cochrane Central, were searched for randomized controlled trials (RCTs). Quantitative pooled estimation of successful treatment rate (STR) and recurrence rate (RR) was performed to
assess the long-term efficacy of each procedure with more than a 1-year follow-up. The surface under the cumulative ranking (SUCRA) probabilities of the P values regarding STR and RR were calculated to rank various procedures. Grades of Recommendations Assessment, Development and Evaluation (GRADE) criteria were utilized for the recommendation of evidence from pairwise direct comparisons.
Results: A total of 39 RCTs encompassing a total of 6917 limbs were eligible and provided relative raw data. After quantitative
analysis, the CHIVA procedure was determined to have the best long-term efficacy, as it had the highest STR (SUCRA, 0.37).
Additionally, the results revealed that CHIVA possessed the highest probability of achieving the lowest long-term RR (SUCRA, 0.61).
Moreover, the sensitivity analysis with inconsistency approach clarified the reliability of the main results, and the evidence of most
direct comparisons was ranked as high or moderate.
Conclusion: CHIVA seemed to have superior clinical benefits on long-term efficacy for treating varicose veins. However, the
conclusion still needs additional trials for supporting evidence.
Abbreviations: CHIVA = Ambulatory Conservative Hemodynamic Management of Varicose Veins, Development and Evaluation,
GRADE = Grades of Recommendations Assessment, PRISMA = Preferred Reporting Items for Systematic Reviews and Metaanalyses,
RCT = randomized controlled trial, RR = recurrence rate, STR = successful treatment rate, SUCRA = surface under the
cumulative ranking.
ARTICLES OF GENERAL REVIEW
1) Mendoza, E.: CHIVA 1988-2008: Review of studies on the CHIVA method and its development in different countries
(2008) Gefasschirurgie, 13 (4), pp. 249-256. Cited 1 time.
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