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The difference in efficacy of endovenous laser ablation and conventional surgery of the greater saphenous vein

Full article by Aamna Malik

SummaryFull ArticleReferences

Background-Varicose veins are long, tortuous, dilated veins caused by valvular incompetence and/or venous wall insufficiencies. Varicosities are most common in the lower limbs, anal canal and the esophagus and when advanced, they may cause great morbidity. The objective of this SSM is therefore to determine the best treatment option for varicose veins, comparing intraoperative comfort and postoperative clinical and quality of life outcomes as well as the cost-effectiveness of both treatments, focussing on the lower limbs

Objectives-In 1890, Friedrich Trendelenburg described GSV ligation, after which, patients were hospitalized for 5 weeks7. However, such a major operation difficult to sustain for a condition affecting 25% of the western adult population2. It is therefore crucial to find an effective alternative which not only has comparable clinical outcomes but also faster recovery times and decreased complication rates to allow patients to quickly return to work and normal activities8. The aim of this structured review, therefore, is to compare EVLA and conventional surgery in the treatment of VV, focusing on the GSV.

Method- The database Science Direct was accessed through OVID, Scopus and CINAHL Plus for randomized controlled trials (RCTs) pertinent to the topic. Inclusion and exclusion criteria were used to limit the number of hits. Each abstract was read to determine the most relevant articles.

Results-Five RCTs were found and examined by the Critical Appraisal Skills Programme tool. Each RCT compared clinical outcomes in high ligation and stripping (HL/S) of the great saphenous vein (GSV) vs. endovenous laser ablation (EVLA).

Conclusion- Although the sample size of each study is small, together the five studies provide sufficient evidence to conclude that EVLA is an acceptable alternative to surgery, albeit more expensive. Two studies showed post-EVLA bruising and pain and determined that this can be minimized by increasing the wavelength of the laser, improving recovery time.

Abstract
Background: Varicose veins are long, tortuous, dilated veins caused by valvular incompetence and/or venous wall insufficiencies. Varicosities are most common in the lower limbs, anal canal and the esophagus and when advanced, they may cause great morbidity. The objective of this SSM is therefore to determine the best treatment option for varicose veins, comparing intraoperative comfort and postoperative clinical and quality of life outcomes as well as the cost-effectiveness of both treatments, focussing on the lower limbs.
Method: The database Science Direct was accessed through OVID, Scopus and CINAHL Plus for randomized controlled trials (RCTs) pertinent to the topic. Inclusion and exclusion criteria were used to limit the number of hits. Each abstract was read to determine the most relevant articles.
Results: Five RCTs were found and examined by the Critical Appraisal Skills Programme tool. Each RCT compared clinical outcomes in high ligation and stripping (HL/S) of the great saphenous vein (GSV) vs. endovenous laser ablation (EVLA).
Conclusion: Although the sample size of each study is small, together the five studies provide sufficient evidence to conclude that EVLA is an acceptable alternative to surgery, albeit more expensive. Two studies showed post-EVLA bruising and pain and determined that this can be minimized by increasing the wavelength of the laser, improving recovery time.

Background: Disease Framework of Varicose Veins (VV)
Definition:
 Long, tortuous, dilated superficial veins.1
Aetiology:

  •  Risk Factors: old age (↓venous elasticity), female, prolonged standing (↓venous return), obesity (↑venous pressure), family history, contraceptives, deep vein thrombosis (DVT) and arteriovenous fistula.2,3
  •  Primary varicosities: caused by genetic or developmental weakness of the vein wall resulting in decreased elasticity, causing dilatation and valvular incompetence over time.3
  •  Secondary varicosities: caused by venous outflow obstruction due to pregnancy, pelvic malignancy, ovarian cysts, ascites, lymphadenopathy or retroperitoneal fibrosis.3

Pathophysiology:

  •  Incompetent valves allow reflux from the SFJ, SPJ, or perforator veins in the mid-thigh into the superficial venous system causing venous hypertension and dilatation.
  • Excess fluid may escape into the interstitium, causing inflammation and tenderness. The most common sites of varices are the esophagus, anal canal (hemorrhoids) and the lower limbs.2

Symptoms:

  •  Pain, cramps, swelling, itchiness, heaviness, restless legs.
  •  The majority are asymptomatic.1-3

Signs:
 Oedema, eczema, ulcers, hemorrhagic, phlebitis, haemosiderin skin staining, atrophie blanche, lipodermatosclerosis, positive cough impulse and positive tap test.1-3
Investigations:
Level I: history, examination and hand-held Doppler scan.
Level II: noninvasive vascular laboratory testing and duplex ultrasound scan (DUSS) used to localise sites of valvular incompetence or reflux.4
Level III: ascending and descending venography, venous pressure measurements, computed tomography (CT), venous helical scanning, or magnetic resonance imaging (MRI). Used only for complex cases.4
Management:

  • Conservative: Increase exercise, elevate legs at rest and use compression stockings covering the thigh.2
  • Surgical/conventional: The gold standard of VVs treatment, performed under general anesthetic (GA). In stripping, a groin incision is made and a flexible wire is threaded through the vein to pull it out of the body. In ligation, the vein is tied off. Both ligation and stripping may be performed together. High ligation and stripping (HL/S) refers to ligation of the SFJ (‘crossectomy’) and stripping of the GSV.1,3 Phlebectomy of small VVs through small incisions may also be performed. Post-operatively, legs are elevated for 24h and bandaged tightly to prevent bruising, tenderness and blood clot formation. Complete recovery requires 1-4wks.3
  • Catheter-directed Minimally Invasive Endovenous Procedures (MIEPs): Performed under local anesthetic (LA) to shut down large superficial veins. Avoids groin incision.
    o Endovenous laser ablation (EVLA): under ultrasound guidance (USG), laser energy is delivered through a fine optic fibre, cauterizing the vein shut.1,3
    o Radiofrequency ablation (RFA)
    o Ultrasound guided foam sclerotherapy (UGFS):

After non-conservative treatment, the diseased veins are closed off and blood is automatically redirected to healthier deep veins. As the deep venous system’s role in primary collection increases, venous return improves causing signs and symptoms to disappear, decreasing morbidity. If collateral veins develop after an incision, VVs may recur. After occlusion, the vein may reflux and/or reopen. Post-operatively, anti-inflammatory and/or analgesic prescriptions may be required to prevent side effects.5
Complications:

  • of vv: dermatitis causing bleeding or ulceration, and superficial thrombophlebitis.6
  • of endovenous treatment: reflux, recanalization, recurrence, skin burns, nerve injury, bruising, thrombophlebitis.1-3
  • of surgery: recurrence, hemorrhage, infection, paraesthesia, nerve injury, DVT.1-3
    Prognosis:

Up to 40% recurrence rates.3

Objectives
In 1890, Friedrich Trendelenburg described GSV ligation, after which, patients were hospitalized for 5 weeks.7 However, such a major operation difficult to sustain for a condition affecting 25% of the western adult population.2 It is therefore crucial to find an effective alternative which not only has comparable clinical outcomes but also faster recovery times and decreased complication rates to allow patients to quickly return to work and normal activities.8
The aim of this structured review, therefore, is to compare EVLA and conventional surgery in the treatment of VV, focusing on the GSV.
Methods
The databases OVID, Pubmed and CINAHL Plus were searched and inclusion/exclusion criteria were applied to limit hits to relevant articles (table 1).

Results
After reading each abstract, all duplicate and irrelevant articles were removed and five studies remained. The Critical Appraisal Skills Programme9 (CASP) tool was then used, deeming each study highly relevant (table 2).

 

Discussion
Study one (Rasmussen et al11)
118 patients were analysed. 80 patients were lost to follow-up (LTFU) over 5 years. The primary endpoint (PEP) was recanalization; reflux >0.5s.
Respectively, 9 (Kaplan-Meier (KM), 17.9%) and 4 (KM, 10.1%) of the EVLA and HL/S (High Ligation/Stripping) groups had refluxing segments of >5cm, 24 (KM, 46.6%) and 25 (KM, 37.7%) cases of recurrence, 17 (KM, 38.6%) and 15 (37.7%) reoperations (UGFS), 3 and 2 technical failures. EVLA may have done worse due to type II error.
Venous Clinical Severity Score (VCSS) and Quality of Life (QoL) scores improved significantly for both groups and were comparable, except at 4 years in which mean VCSS was higher for EVLA.
Study two (Christenson et al12)
Pre-operative DUSS and CEAP classifications were used to screen for eligible patients. Patients were computer randomized to HL/S (100 limbs) and EVLA (104 limbs). 4 limbs were excluded from EVLA because severe spasm prohibited laser insertion. The PEP was GSV reflux.
At 1 year, EVLA and HL/S respectively, had 1 and 0 LTFU, 2 and 0 recurrences, 3 and 0 refluxes. At 2 years, 4 and 1 LTFU, and 2 EVLA GSVs partially reopened however the statistical difference (EVLA 7/98, HL/S 0/99) in failure was not significant (P=0.051). Including asymptomatic GSVs, the recanalization rate increases to 7.4%, nearly a significant difference.
There was a significant improvement in QoL in both groups at 1 year but no difference at 2 years.
Study three (Pronk et al13)
Eligible patients were recruited by screening and were computer randomized to HL/S (68) or EVLA (62).
EVLA using hemoglobin-specific wavelengths (810nm, 940nm and 980nm) can cause perforation allowing blood to escape into surrounding tissue, causing bruising and pain.13 This finding led to an early stop in the trial; all patients that had undergone treatment were followed-up.
All treatments were technically successful with high patient satisfaction (79% HL/S, 77% EVLA) and recommendation rates (88% HL/S, 84% EVLA).
After 1 year, symptoms were significantly improved; there was no significant difference in the rate of recurrence, defined as visible or palpable varicosities in the area of the treated GSV with CEAP ≥ C2. 8.9% HL/S and 10.2% EVLA patients had reflux. 4.1% EVLA patients had complete recanalization.
The study found that HL/S under LA is well tolerated and decreases post-operative pain and hematomas compared to GA. Post-treatment complication rates for both treatments are low.
Study four (De Medeiros et al14)
20 patients with bilateral insufficiency of the entire GSV with equal diameters on both limbs (seen on DUSS) were treated by EVLA and HL/S on opposite legs.
After 60 days, all patients, still blinded, said they were satisfied with outcomes of both limbs and 70% said the post-EVLA limb benefitted more.
There was no significant difference in pain intensity after 7 days. Swellings were present in 15% post-EVLA and 40% post-HL/S limbs. Bruising was present in 20% of limbs post-EVLA and 60% post-HL/S. This is because, in the process of stripping, tributaries are broken off, causing bleeding and bruising.14 Oedema was also much more common after HL/S due to damage to lymphatic vessels in the surrounding tissue. One limb had reflux after EVLA.

The only adverse event was paraesthesia in one limb post-HL/S which resolved within a month.
This is an interesting RCT as it allows individual patients to compare both treatment effects however there is a tremendous opportunity for error due to the very small sample size and lack of standardization of baseline variables and procedures other than the intervention, confounding the results and decreasing the internal validity of the conclusion. That the data obtained from this study is correlational also makes it difficult to compare to the other RCTs.
Study five (Kalteis et al15)
The aim of this study was to determine the effects of EVLA on postoperative comfort, clinical outcome and complication rates. Patients completed a Chronic Venous Insufficiency Questionnaire (CIVIQ) and scored their pain on a visual analogue pre-operatively. The VCSS of both groups was comparable at baseline.
100 patients were randomized to HL/S (50) and EVLA (50), with a type II error of 2%. One patient was excluded from EVLA due to inaccessibility of the vein and instead underwent HL/S. There was a statistically significant difference in size of hematoma: 125cm2 (EVLA) vs. 200cm2 (HL/S). After 16 weeks, more patients with HL/S (12%) had residual hematomas than EVLA (10%). There was no significant difference in CIVIQ score. Patient satisfaction and willingness to repeat the procedure was higher after EVLA.
2 weeks post-treatment, one EVLA patient was rehospitalized for inflammation due to a higher than normal level of energy usage (low laser wavelength) causing thermal damage to the skin.

Comparisons/contrasts between studies
All five RCTs had minimum performance bias as both groups were treated equally other than the treatment intervention.
Clinicians were blinded in FU procedures, except in study four which was patient-blinded. Study five was also patient-blinded until post-treatment.
All, except trial 2, had a high possibility of type II error due to the small sample sizes used, creating low power and decreasing the external validity of the results and conclusion.
Selection bias was minimized by randomization, the methods of which are described clearly for the first four studies but not study five, questioning its internal validity.
All studies used inclusion/exclusion criteria; however the patients in study four did not have similar baseline demographic characteristics, confounding the results and questioning its internal validity.
Endpoints included reflux diagnosed by DUSS, pain scores, size of hematoma and QoL outcomes. Reflux was higher after EVLA but this was not statistically significant. Size of hematoma after HL/S was significantly higher than EVLA and pain scores were significantly higher after EVLA. There were no significant differences in QoL although EVLA was expected to take a shorter time to return to work.
This led to the conclusion that although successful, EVLA should use longer wavelengths that do not target haemoglobin to prevent venous perforation and bruising. This will decrease pain scores and recovery time.
Studies one, three and five found the use of tumescence effective. Laser energy may cause burns when the vein is too near the germ layer of the epidermis. To prevent this complication, a tumescent solution may be added to the anaesthetic which will pull the vein away from the skin, allowing heat to dissipate.10
Conclusion
This review concludes that EVLA is a good alternative to surgery as it has comparable clinical and QoL outcomes. EVLA does not require a groin incision or GA, decreasing the risk of complication or recurrence. However, the disposable laser equipment required for EVLA is costly compared to surgery, possibly explaining why 54% of cases are treated by EVLA rather than 90%. Another problem with EVLA is that cannulation is not possible in excessively tortuous veins. Therefore, treatment is dependent on individual circumstances and DUSS is required to make this decision.
A new study with a large sample size should be performed in order to test the external validity of the conclusion. This study should use low energy lasers, proven to be more effective16 in an RCT, and tumescent anesthesia to decrease adverse events. A further study should be performed to determine the effectiveness of EVLA on high risk patients, such as pregnant women, which were excluded from the analysed studies.

1. Longmore JM. Varicose Veins. Oxford handbook of clinical medicine. 8th ed. Oxford University Press; 2010.
2. Mayfield-Blake R. Varicose veins. Bupa Health Information Team [Internet]. 2012; Available from: http://www.bupa.co.uk/individuals/health-information/directory/v/varicose-veins.
3. Obi EE. Varicose Veins. Rapid surgery. 1st ed. Oxford, UK: Blackwell; 2005. pp.203–4.
4. Eklof B. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004 Dec;40(6):1248–52.
5. X-Plain: Varicose Veins reference summary. The Patient Education Institute, Inc [Internet]. 2008; Available from: https://www.nlm.nih.gov/medlineplus/tutorials/varicoseveins/vs059103.pdf.
6. What are the signs and symptoms of varicose veins? National Institute of Health [Internet]. 2011; Available from: https://www.nhlbi.nih.gov/health/health-topics/topics/vv/signs.
7. Bremer J van den B. Historical overview of varicose vein surgery. Ann Vasc Surg 2010;24(3):426–32.
8. B. Siribumrungwong B, Noorit C, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg 2012 Aug;44(2):214–23.
9. http://www.radiologyinfo.org/en/info.cfm?pg=varicoseabl.
10. Varicose vein treatment (endovenous ablation of varicose veins). Radiology Society of North America [Internet]. 2013; Available from: Critical Appraisal Skills Programme (CASP) [Internet]. Minervation; Available from: http://www.casp-uk.net/wp-content/uploads/2011/11/CASP-Randomised-Controlled-Trial-Checklist-31.05.131.pdf.
11. Rasmussen L, Lawaetz M, Bjoern L, Blemins A, Eklof B. Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years. J Vasc Surg 2013 Aug;58(2):421 –6.
12. Christenson JT, Gueddi S, Gemayel G, Bounameaux H.. Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up. J Vasc Surg 2010 Nov;52(5):1234–41.
13. Pronk P et al. randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results. Eur J Vasc Endovasc Surg 2010 Nov;40(5):649–56.
14. De Medeiros CAF, Luccas GC. Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins. Dermatol Surg 2005 Dec;31(12):1685–94.
15. Kalteis M et al. High ligation combined with stripping and endovenous laser ablation of the great saphenous vein: early results of a randomized controlled study. J Vasc Surg 2008 Apr;47(4):822–9.
16. Kabnick LS et al. Outcome of different endovenous laser wavelengths for great saphenous vein ablation. J Vasc Surg 2006 Jan;43(1):88–88.e7.

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