THE ENDOVENOUS LASER THERAPY FOR THE MANAGEMENT OF VARICOSE VEINS Affiliation

Varicose veins of the lower limb are common condi on affec ng majority of people worldwide and has great effect on quality of life. The defini ve therapy being surgery with stripping of the veins which is associated with surgical complica ons, prolong recovery me and significant recurrence. Endovenous laser therapy (EVLT) is a minimally invasive procedure which is widely used for the treatment of varicose veins with excellent results.


INTRODUCTION
Varicose veins are the tortuous, widened veins in the subcutaneous ssue of the leg.It is one of the most common benign vascular disease in the world which can affect up to 1 25 percent of women and 15 percent of men.In majority of the pa ents it is due to saphenofemoral incompetence and great saphenous vein (GSV) reflux leading to increase in venous pressure resul ng in dilated, tortuous veins in the lower limbs which if le untreated can severely affect the 2 quality of life.The ul mate goal of treatment is to eliminate the source of reflux in order to control symptoms and progression of the disease.In past conven onal surgery was considered as the gold standard which involved saphenofemoral liga on, GSV stripping and phlebectomy of the residual varicosi es which was associated with various drawbacks and procedure related complica ons.
Recently, minimally invasive endovenous techniques have been developed as alterna ves to conven onal surgery.Endovenous Laser Therapy (EVLT) is one of the most promising techniques which were first introduced in 1998 by Spanish phlebologist, Carlos Bone for the management 3 of varicose veins.EVLT has be er outcome than the conven onal surgery in terms of reduced post-opera ve pain, post-interven on bleeding, hematoma along with decrease rate of wound infec on, early recovery and return 4 to normal life.Moreover studies have shown that EVLT has 4,5 less recurrence rate due to reduced neovascularisa on.The aim of this study is to evaluate the safety, efficacy and surgical outcome of EVLT which can be considered as an alterna ve to the conven onal surgery for the management of varicose veins.

METHODOLOGY
This is a prospec ve study of 40 pa ents who underwent EVLT at the affiliated hospital of Inner Mongolia University for the Na onali es from October 2016 to September 2017.The study was approved by the Ins tu onal Review Board of the university.All pa ents with primary symptoma c varicose veins with sapheno-femoral incompetence or great saphenous vein (GSV) reflux were included in the study.A er thorough history and a complete physical examina on, pa ents were scheduled for duplex scanning of the affected lower limbs to document the patency of the deep veins and evaluate the extent and severity of the reflux in the superficial venous system.The skin overlying the incompetent source of venous reflux was marked.The indica on of treatment were pa ents preference; large varicose veins with cramp and ache, eczema, and ulcera on.The pa ent's informa on and data were recorded during the hospital stay in the proforma for EVLT with the informed consent.Following discharge, the pa ents were followed up to six months.The variables recorded and analyzed were mean opera ng me, intra-opera ve blood loss, dura on of hospital stay, return to normal ac vity, complica ons and the recanaliza on.

Exclusion Criteria
1. Pa ent with coagulopathy 2. Pregnant, breast feeding pa ents 3. Pa ent with recurrent varicose veins 4. Suspected or proven DVT

Opera ve technique
All pa ents underwent EVLT in spinal anesthesia using an 810 nm diode laser (L.H.H Medical, Beijing, China) with 600 µm op cal fiber.A er proper steriliza on and draping of the target limb, a 2-3 cm incision was performed in the groin to expose and ligate the great saphenous vein (GSV) and its tributaries at the saphenofemoral junc on (SFJ).A er liga on of the proximal GSV, the access to the distal part of GSV was achieved through a puncture with an 18G canula at the medial malleolus.On canula on, a J-p 0.035 inch ultra smooth hydrophilic guide wire was inserted into the vein up to the SFJ.A 5F catheter was placed in to the GSV over the guide wire.The guide wire was removed and replaced with 600 µm op cal fiber connected to 810 nm diode laser with the laser p posi oned 1-2 cm below the SFJ and was confirmed by the red beam of light from the laser p through the skin.A er proper confirma on of the fiber p, the laser energy was fired in pulse mode and the laser along with the catheter was slowly withdrawn at the rate of 3-5 mm per second.Manual compression was applied over the red aiming beam which could be visualized through the skin.The compression assists in be er laser fiber and vessel endothelial contact leading to complete shrinkage and occlusion of the vein.A laser emission power of 16W, 14W and 12W was maintained at thigh, knee and calf respec vely.Finally the varicosi es caused by tributaries of GSV were treated with mul ple percutaneous introduc ons of laser fiber through an 18G needle.
The groin incision was closed and elas c bandage was applied for five days which was switched to compression stockings for six weeks.NSAIDs were prescribed rou nely for postopera ve pain.Early ambula on was advised and the pa ents were encouraged to resume normal ac vity as soon as possible.Majority of the pa ents were discharged on the second post opera ve day with further assessment a er one week, one, three and six months.Follow up was aimed to assess symptoma c improvement, residual or recurrent varicose veins, post opera ve complica ons including pain, swelling, hypoesthesia, ecchymosis and burn.Doppler ultrasound was performed to document the recanalisa on of the GSV.(E) Guide wire removed and replaced with 600µmop cal fiber, the laser energy fired.
(F) Mul ple percutaneous introduc ons of laser fiber for the varicosi es caused by the tributaries of GSV.

RESULT
Sta s cal data analysis was performed using Microso office Excel 2007 and IBM SPSS Sta s cs 20.Among forty pa ents treated with EVLT, there were 24 female (60%) and 16 male (40%) with mean age of 52 yrs and about 60% of pa ents having symptoms of varicose veins for more than five years.The commonest presenta ons were lower limb cramp, ache and swelling whereas two pa ents presented with venous leg ulcer.The mean opera ve me was 80 minutes with intra-opera ve blood loss of <50 ml in 33 pa ents (82.5%) and >50 ml in 7 pa ents (17.5%); the mean blood loss being 52 ml.Similarly 34 pa ents (85%) were ambulated within 48 hours whereas 6 pa ents (15%) were ambulated a er 48 hours.The mean dura on of hospital stay was 2.5 days with 36 pa ents (90%) pa ents returning to the normal ac vity in ten days.Postopera ve complica ons included swelling and indura ons which was the most common complica on in 10 pa ents (25%) followed by hypoesthesia in 8 (20%), ecchymosis in 7 (17.5%)and skin burn in 4 pa ents (10%).The procedure related complica ons were gradually subsided within one month a er surgery.There was no incidence of deep vein thrombosis, pulmonary embolism, wound infec on or hematoma.Doppler ultrasound was performed in all pa ents to monitor the recanalisa on of the GSV.Short term recurrence was noted in one pa ent (2.5%) within a month which was managed with repeat EVLT.Hence the overall success rate for GSV abla on was 97.5% at six months.There was minimal postopera ve pain and the preopera ve symptoms were resolved within a month.obesity and prolong standing.Varicose veins may be asymptoma c but many pa ents present with a wide range of symptoms based on the severity of insufficiency ranging from cramp, aches, heaviness, itching, edema, swelling, hyper pigmenta on and some mes venous leg ulcers.The commonest presenta ons in our series were lower limb cramp, ache and swelling with two pa ents presen ng with venous leg ulcer.The condi on is some mes considered to be a cosme c problem and given low priority for treatment leading to increased morbidity and cost of management.

Complica ons
The tradi onal surgical method of liga on of GSV and its tributaries at the SFJ and stripping of the GSV has been considered as the gold standard in the treatment of 9 varicose veins.However, the recurrence rate of as high as double saphenous vein system or incomplete procedure.Apart from recurrence, there have been numerous drawbacks of the conven onal surgery which includes prolonged use of anesthesia, long surgical scar, increased hospital stay, wound infec on, hematoma, and paresthesia.
However, during the last decade the conven onal surgical method has been replaced by several minimal invasive techniques developed to treat the incompetent GSV, such as endovenous laser therapy (EVLT), radiofrequency 13 abla on (RFA) and ultrasound guided foam sclerotherapy.These treatment methods aims to reduce risk, morbidity, and cost while leading to acceptable short and long term results.Among the minimal invasive procedures, the EVLT has been gaining populari es as it offers reduced postopera ve pain, post interven on bleeding and perisaphenous vein hematoma along with decreased rate of wound infec on and poten ally shorter periods of absenteeism from work.In addi on neovascularisa on is significantly reduced which causes decreased incidence of 4,5,7,13 varicose vein recurrence.
The EVLT acts by heatinduced collagen shrinkage, followed by fibro c sealing of the vein lumen.Hence, in order to destroy a vein with laser, the vein wall must absorb enough energy to result in genera ng so much heat as to damage its en re layer.We have been able to achieve excellent result using EVLT technique.
EVLT was first introduced by Carlos Bone in the year 1999 for the treatment of GSV insufficiency using a 810 nm diode The majority of published studies reports a success rate of about 100% at one week a er the procedure however the success rate declines over me, but remains over 90% in a large [15][16][17] number of case series.Timperman et al. in their series of EVLT showed that the vein occlusion is related to the amount of energy delivered to the vein wall; lower the energy given, higher the probability of reopening or non-18 occlusion of the vein.There may also be technical errors that can result in inadequate vein wall hea ng, such as the rapid withdrawal of the laser fiber or the insufficient vein emptying without direct contact of the laser fiber with the vein wall that may ul mately lead to reopening or nonocclusion of the vein.
Min et al. treated 499 limbs with EVLT using an 810 nm diode laser with 600µm fiber and followed up for 2 years.They achieved GSV occlusion rate of 98% and 93% at 1 month and  from 0 to 7 % in various literatures.Some authors support that the recanalisa on of a vein is unlikely 25 if the vein remains occluded at 12 months.However, there have been reports of recanalisa on reported at 2 and 3 17,24 years a er EVLT.
The majority of recurrences occur within the first 3 months.In our series, recanalisas on was noted in 2.5% which occurred within a month of EVLT.Similarly the dura on of opera ve me for EVLT is short with a mean of 80 minutes in our series.Similar results have been reported by Chang et  Although EVLT may have reduced complica ons as compared to conven onal surgery, it may be associated with specific side effects related to laser such as DVT, pulmonary embolism and skin burns.The likelihood of DVT with a 2-3 weeks.Indura ons along the length of the saphenous vein was the most common complica on present in 25% of our pa ents which was self limi ng and subsided in 3 -4 weeks.Similar incidence of indura ons has been reported in major series of EVLT ranging from 55 -100 7 ,14 ,1 5,1 9,23 %.
About 20% of our pa ents experienced hypoesthesia of the affected limb which has also been 4, 23, documented in major series with 1 -36.5 % involvement. 26Other complica ons such as DVT, Pulmonary embolism, hematoma, wound infec on, and phlebi s were not encountered in our study.
These studies suggest that improvements in disease specific quality of life and pa ent sa sfac on are similar for surgery and EVLT however return to normal ac vity and work in most of the studies occurs earlier a er EVLT.In addi on, EVLT in expert hands seems to be a less me consuming procedure with rare major complica ons and limited procedure related disturbances such as postopera ve pain or ecchymosis, indura ons, hypoesthesia, phlebi s which in most cases are self limi ng.

CONCLUSION
EVLT for varicose veins is a safe, feasible and efficient minimally invasive technique which can replace the conven onal surgery as it has shown excellent results without any major complica ons.However large sample size with long follow up study should be conducted for assessing the long term benefits.

RECOMMENDATION
It is recommended that EVLT should be widely performed as an alterna ve to the conven onal surgery.It is a safe and easy procedure with minimal visible scar and excellent outcome in short period of me.

LIMITATIONS
The limita ons of our study include small sample size and short follow up.

Figure 1 :
Figure 1: Opera ve Procedure of EVLT; (A) Skin marking overlying the incompetent source of venous reflux with the help of duplex scan.(B) Establishing the access to the distal part of GSV through puncture with a 18G canula at the medial malleolus; (C) Inser on of a J-p 0.035 inch ultra smooth hydrophilic guide wire into the vein up to the SFJ.(D) Placement of 5F catheter into the GSV over the guide wire;

3 laser.
However in 2001 Min et al. and Navarro et al. were the first to publish the case series sugges ng EVLT might be 4,14 successful in the treatment of large varicosi es.Since then, mul ple case series have been published with successful closure rate of 94-99% with improvement in the appearance 15-17 of superficial varicosi es and relief of symptoms.

17 2
years respec vely.Huang et al. from china had a 100% 19 occlusion rate in 230 GSV at 2 weeks a er EVLT.A large single centre study conducted by Ravi et al. in United States on 1091 limbs treated with EVLT achieved an occlusion rate 20 of 95 % at 1 year follow up.Similarly an Italian report by Agus et al. performed EVLT on 1076 limbs where they 16 achieved successful occlusion of 97% at 3 years.Two studies from Germany by Proebstle et al. and Schwarz et al. who documented an occlusion rate of 96% and 100% at 3 15,21 months respec vely.Almeida et al. from the United states also achieved similar occlusion rate of 92% at 500 22 days in 819 limbs with EVLT.Our results are comparable with the above series in achieving 97.5% occlusion rate in 40 pa ents at six months follow up.The clinical outcome of large studies on EVLT is illustrated in

Table 1 : Complica ons a er EVLT DISCUSSION Varicose
veins is a common medical condi on in Western 1 countries predominantly affec ng women.However a study conducted by Evans et al in England concluded that about 40% of men and 32% of women were affected with 6 varicose veins in the Bri sh popula on.It affects nearly 10 -40% of Chinese popula on and is one of the major vascular 7 problem in the country.The incidence of varicose veins increases with age and is most commonly due to valvular incompetence of the SFJ and the GSV which leads to reflux of blood and increase in venous pressure resul ng in dilated and tortuous veins of lower limb.The risk factors for the development are old age, female sex, posi ve family history and pregnancy precipitated by modern sedentary lifestyle,

Table 2 :
15,16,17,19,20,21,23various studies on EVLTThe rate of venous recanalisa on a er EVLT is significantly less as compared to conven onal surgery and may vary15,16,17,19,20,21,23 al. and Gerard et al. with a mean 26, 27 opera ve me of 122 and 60 minutes respec vely.There have been many trials comparing the significance of EVLT with the conven onal surgery.Caradice et al. carried out a study in 280 pa ents by dividing into two groups, one We experienced superficial skin burn in 10% of our pa ents which is high in comparison to the major published series but comparable with the smaller series of EVLT.Ecchymosis was the present in 17.5 % of our pa ent which was due to mul ple micro perfora ons of the venous wall due to high temperature of laser.It has been reported in several studies during the early period a er EVLT, with an incidence of 23•0-100 %, which is generally self limi ng and resolves 16,17,20in larger series is less than 1%.Proebstle et al reported 15 DVT a er EVLT in a pa ent with polycythemia vera.Similarly Schwarz et al. reported DVT in 1.2 % (2 pa ents) 3,4,14,23,26