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Rome 2016, UIP chapter meeting Endovenous laser and radiofrequency ablation. Comparison with stripping and foam sclerotherapy George Geroulakos Professor and Chair of Vascular Surgery, National and Kapodestrian University of Athens
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Endovenous techniques have been developed as alternatives to open surgery for the management of saphenous reflux. It has been reported that they offer benefits over open surgery. What is the evidence?
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Endovenous laser therapy (EVLT) with 810nm wavelength has been compared to the ClosurePLUS radiofrequency ablation (RFA) in 118 patients. At one year there was no significant clinical difference in the reduction of symptoms and the quality of life between these 2 techniques. Gale SS et al, J.Vasc.Surg. 2010
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Comparison of EVLT and RFA in treating varicose veins in the same patient
60 patients with bilateral varicose veins had EVLT on one leg and RFA on the other leg. The level of patient satisfaction 51.7% with EVLT compared to 31% for RFA. Bozoglan et al; Vasc Endovasc Surg 2016
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Endovenous ablation versus open surgery. 2014 Cochrane Review
Endovenous ablation versus open surgery Cochrane Review. Nesbitt, Bedenis, Bhattacharya and Stansby 8 randomised controlled trials (n=1760) compared EVLT with surgery. 5 randomised controlled studies (n=642) compared RFA with surgery
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EVLT compared to surgery. 2014 Cochrane review
There were no differences between the treatment groups for either clinician noted recurrence (p=0.22) or symptomatic recurrence (p=0.67). Both early (p=0.97) and late recanalisation (p=0.1) were no different between the 2 groups
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EVLT compared to surgery. 2014 Cochrane review
Neovascularisation (p<0.0001) and technical failure (p=0.0009) were both reduced in the laser group. At 5 years EVLT and surgery maintained similar findings
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RFA compared to surgery. 2014 Cochrane collaboration.
There were no differences between the treatment groups in clinician noted recurrence (p=0.47) Symptomatic recurrence was only evaluated in one study.
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RFA compared to surgery. 2014 Cochrane collaboration.
There was no difference between the treatment groups for recanalisation (early or late) neovascularisation or technical failure.
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RFA compared to surgery. 2014 Cochrane collaboration
Quality of life scores, operative complications and pain were not amenable to meta-analysis, however quality of life improved similarly in all treatment groups and complications were generally low. In general pain was similar in all treatment groups.
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Patterns of clinical recurrence in open surgery and endothermal ablation
Neovascularisation and recurrence unrelated to the SF junction, including incompetent thigh perforators, have been reported to occur more often after stripping. Reflux into the GSV and incompetent GSV tributaries (anterior accessory GSV), have been reported more often after EVLA. Kakkos et al; Eur J Vasc Endovasc Surg 2015
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Predictors of recanalisation of the GSV in randomised controlled trials I year after EVTA
At one year 130/1226 GSV were recanalised (11%). Clinical class (odds ratio 2.1) and diameter (odds ratio 1.8) of the GSV were the strongest predictors of recanalisation. Van der Velden et al; Eur J Vasc Endovasc Surg 2016
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Complications at 6 months: comparisons of EVLA with foam sclerotherapy and surgery. The CLASS study; Health Technology Assessment
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Randomised to foam sclerotherapy
Complication Randomised to EVLA Randomised to foam sclerotherapy Randomised to surgery Clinic assessment at 6 months (N, n, %) 210 183 87.2 207 178 86.0 213 167 78.4 Numbness (N, n, %) 183 17 9.2 178 5 2.8 167 28 16.8 Persistent bruising (N, n, %) 25 13.6 26 14.6 34 20.4 Skin staining (N, n, %) 183 32 17.4 178 55 30.8 167 13 7.8
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EVLT & Phlebectomies vs UGFS Cost & Effectiveness RCT: Early Results
Lattimer C1 , Kalodiki E1, Azzam M1,Shawish E1, Trueman P2, Geroulakos G1 1 Josef Pflug Vascular Laboratory, Ealing Hospital & Imperial College, SW7 2AZ 2 Health Economics Research Group, Brunel University, Middlesex, UB8 3PH Eur J Vasc Endovasc Surg 2012; 43:
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CONSORT Flow Diagram (Lattimer CR et al, 2012 EJVES 43: 594-600 )
Enrollment Assessed for eligibility (n=191) Excluded (n=81) Randomized (n=110) Excluded (n=6) Excluded (n=4) Treatment EVLT (n=50) UGFS (n=50) Follow-Up 3 Weeks Analysed (n=50) Analysed (n=50) Lost to follow-up (n=4) Lost to follow-up (n=5) Follow-Up 3 Months Analysed (n=46) Analysed (n=45)
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Conclusions EVLT is over 7 times more expensive than standard UGFS in outpatients Cost differences remain after a sensitivity analysis UGFS is equivalent to EVLT (3/12) in terms of reflux obliteration, QoL, clinical improvements and VFI UGFS outperforms EVLT in terms of pain, analgesia requirements & return to normal
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Interim results on abolishing reflux alongside a randomised clinical trial EVLA with Phlebectomies versus UG Foam Sclerotherapy Lattimer CR, Azzam M, Kalodiki E, Makris GC, Somiayajulu S, Geroulakos G Int Angiol 2013; 32:
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Conclusions At 15 months follow up: GSV occlusion was better with EVLA
No difference in QoL, clinical severity, absence of saphenous/global reflux. To achieve this result a higher number of adjuvant treatments were required in the UGFS group (n=46) than the laser group (n=10)
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Is there still a role for traditional surgery?
Because of device related limitations with endothermal techniques (very superficial, torturous vein, large burden of varicose veins) and the poorer results of UGFS within the treatment of GSV reflux, there is still a role for open surgery that can be delivered with good short and long term outcomes in a cost effective manner . Coughlin and Berridge, Phlebology 2015;30:29-35
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