Endovenous laser ablation for the treatment of recurrent varicose vein disease – A single centre experience

Endovenous laser ablation for the treatment of recurrent varicose vein disease – A single centre experience

International Journal of Surgery 8 (2010) 299e301 Contents lists available at ScienceDirect International Journal of Surgery journal homepage: www.t...

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International Journal of Surgery 8 (2010) 299e301

Contents lists available at ScienceDirect

International Journal of Surgery journal homepage: www.theijs.com

Endovenous laser ablation for the treatment of recurrent varicose vein disease e A single centre experience N. Nwaejike a, b, P.D. Srodon a, C. Kyriakides a, b, * a b

Department of Vascular and Endovascular Surgery, Bart’s and The London NHS Trust, The Royal London Hospital, Whitechapel, London E1 1BB, UK Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, UK

a r t i c l e i n f o

a b s t r a c t

Article history: Received 25 January 2010 Accepted 3 February 2010 Available online 20 March 2010

Introduction: Varicose vein surgery for recurrent disease can result from inadequate primary surgery. Redo open surgery is more difficult to perform than primary surgery and can be associated with a higher incidence of neurovascular injury and infection. In this study we evaluate EVLA, a percutaneous technique that uses intra-operative duplex ultrasound as an option for the treatment of recurrent varicose veins. Materials and Methods: Data prospectively collected on patients who had EVLA for varicose veins were obtained from our dedicated vascular registry. From November 2004 to December 2008 we performed 586 EVLA procedures, 77 procedures were for recurrent varicose veins. Results: The mean age was 52  12.77 years, range 28e80; and 48 (62%) were female. 64 (83%) cases were for recurrent LSV disease, 13 (17%) cases for recurrent SSV disease and all patients had LSV or SSV incompetence confirmed on preoperative duplex assessment. Median duration since primary surgery was 60 months (range 2e360). Mean length of vein treated was LSV e 36 cm  14.5 (6e73) and SSV e 14.5 cm  7.35 (5e24); mean energy delivered was LSV 3102J  1053 (150e4656) and SSV e 693J  396 (135e1216). 17 patients had bilateral EVLA for recurrent disease at the same setting with one patient having bilateral procedures under local anaesthetic. There was an incidence of pulmonary embolism 10 days post EVLA and two patients required further phlebectomies post EVLA for residual varices that were present pre-operatively. Median follow-up was 18 months (range 1e38), with no clinical recurrence and no recannalisation of the treated LSV or SSV on duplex ultrasound. Conclusions: In our experience EVLA can be safely performed for recurrent varicose vein disease. In our experience Redo EVLA is not more difficult than primary EVLA to perform. Ó 2010 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

Keywords: EVLA Varicose veins Laser

1. Introduction Ligation and stripping of varicose veins has a recurrence rate of up to 40% at 5 years and 20% of all varicose vein operations are for recurrence.1 Surgery for recurrent disease (redo surgery) is potentially hazardous because scar tissue distorts the normal architecture making identification of the target anatomy difficult. As a result there is potentially a greater risk of iatrogenic injury to neighbouring structures during dissection in redo surgery compared to primary surgery. The more extensive and difficult dissections sometimes required in redo surgery, and hence longer operating

* Corresponding author at: Department of Vascular and Endovascular Surgery, Bart’s and the London NHS Trust, The Royal London Hospital, Whitechapel, London E1 1BB, UK. Tel.: þ44 (0) 2073777020; fax: þ44 (0) 2073777684. E-mail address: [email protected] (C. Kyriakides).

times, mean longer exposure to general anaesthetic for patients compared to primary surgery. Haemostasis is more difficult in redo surgery and hence a higher risk of haematoma formation; this with longer operating times and the disruption of normal tissue blood flow in scar tissue make wound infections more common following redo surgery compared to primary surgery. During the past decade, increased interest in venous disorders and the development of minimally invasive treatment options such as Endovenous Laser Ablation (EVLA), has led to advancement in the management of varicose veins. EVLA allows delivery of laser energy directly into the blood vessel lumen to produce irreversible occlusion with subsequent fibrosis. The resultant functional obliteration of the saphenous vein is less invasive than open surgery, avoids major dissection and can be performed under local anaesthetic as a day case, requiring no hospital stay.2,3 We evaluate the use of EVLA as an alternative to redo open surgery for the treatment of recurrent varicose vein disease.

1743-9191/$ e see front matter Ó 2010 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.ijsu.2010.02.012

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2. Material and methods

Table 2 Distribution of cases.

Data prospectively collected on patients who had EVLA for varicose veins were obtained from our dedicated vascular registry and showed that from November 2004 to December 2008 we performed 586 EVLA procedures of which 77 (13%) were for recurrent varicose veins. 67 patients had previous ligation  stripping  multiple phlebectomies; 6 patients had previous multiple phlebectomies only; 4 patients had previous sclerotherapy and the median duration since primary surgery at time of EVLA was 60 months (range 2e360). Informed consent had been obtained for EVLA in accordance with The National Institute for Health and Clinical Excellence (NICE) recommendations.4 Procedures were performed either under local (LA) or general anaesthesia (GA), depending on patient and surgeon preference, with strict aseptic technique. The procedure is the same for primary and redo surgery with no modifications and is as described in previous publications.5,6 With the patients adequately positioned the venous anatomy is mapped with duplex ultrasound and marked with an indelible pen. A 600-nm laser fiber (Diomed) is then positioned under ultrasound guidance with the tip positioned 2 cm distal to the SFJ or SPJ to avoid propagation of clot into the deep veins. Tumescent local anaesthetic (100e200 mls of 0.2% Lignocaine) with adrenaline is injected around the vein under ultrasound guidance. After appropriate laser safety precautions, laser energy is delivered at 100 J/cm to the LSV and 50 J/cm to the SSV as the laser fiber with its sheath is slowly withdrawn from the leg. Treatment is stopped about 1cm above the needle entry point, the laser is switched off, laser and catheter are removed then the puncture site controlled with a compressive dressing to achieve haemostasis. Multiple phlebectomies are then performed as required through micro-stab incisions to sites marked pre-operatively with the patient standing. These incisions are then controlled with pressure dressings. Class 2 graduated compression stockings are required for 2 weeks (at all times for the first week, then daytime only for the second week). Oral analgesia is prescribed for at least 5 days, a combination of Paracetamol and Diclofenac sodium is preferred if there are no contraindications. 3. Results Median post operative follow-up was 18 months (range 1e38). Patients had EVLA for recurrent disease with multiple phlebectomies for varicosities as one procedure. Clinical classification (CEAP)7,8 on presentation was between C2 and C5 (Table 1). The mean age of the patients at treatment for recurrent disease was 52  12.77 years, range 28e80; 48 (62%) were female; and median body mass index was 25 (range 22e28). 64 (83%) cases were for recurrent LSV disease, 13 (17%) cases for recurrent SSV disease and all patients had LSV or SSV incompetence confirmed on preoperative duplex assessment. 69 (90%) cases were done under a general anaesthetic. 17 patients had bilateral EVLA for recurrent disease at the same setting with one patient having bilateral procedures under local anaesthetic. The distribution of cases is shown in Table 2.

Table 1 Pre-operative clinical classification (CEAP). (Superficial/reticular veins only) C1 (Simple varicose veins only) C2 (Ankle oedema of venous origin) C3 (Skin pigmentation in the gaiter area) C4 (Healed venous ulcer) C5 (Active venous ulcer) C6

0 limbs 32 limbs 20 limbs 19 limbs 6 limbs 0 limbs

Total no of cases Mean length of vein treated (cm) Mean energy delivered (J)

Recurrent LSV

Recurrent SSV

64 (83%) 36  14.5 (range 6e73) 3102  1053 (range 150e4656)

13 (17%) 14.5  7.35 (range 5e24) 693  396 (range 135e1216)

There were no intra-operative complications and immediate post-procedure duplex ultrasound confirmed echogenic thrombus formation in all target veins with no deep vein thrombus. All patients were discharged from hospital the same day. One patient presented to the emergency room 10 days following bilateral EVLA for bilateral LSV disease with a pulmonary embolism.9 At 6-week review two patients were found to have residual varices, present pre-operatively, which were subsequently treated by phlebectomies. At the 6-week review, there was no clinical evidence of recurrence and no incidence of nerve injury either in terms of sensory deficit or paraesthesia. Over a median follow-up of 18 months (range 1e38), there was no clinical recurrence and no recannalisation of the treated LSV or SSV on duplex ultrasound. 4. Discussion Following primary open surgery, reasons for recurrence include inadequate initial operations where the site of valvular incompetence is not treated as the anatomy can be quite variable e.g. in a duplicate system where the wrong vein is ligated and stripped. Failure to appreciate that there may be more than one site of incompetence pre-operatively can also lead to early failure of the operation if all sites of incompetence are not dealt with.10 A contentious issue is neo-vascularisation where re-growth of tiny vein branches develop through scar tissue providing a new connection between deep and superficial vein even after initial ‘adequate’ primary surgery.11,12 Traditional redo open surgical treatment of recurrent varicose vein disease is the ligation and division of the saphenous trunk which is sometimes followed by stripping and avulsion phlebectomy of tributaries. Scar tissue from the previous surgery can complicate this procedure by distorting the normal anatomy making dissection more difficult. With redo open surgery there is an increased incidence of surgical complications (paresthesia, bleeding, infection and scarring), increased in-hospital costs and prolonged recovery periods.10 EVLA was approved by the National Institute for Health and Clinical Excellence (NICE) in March 2004. First described by Navarro et al. (2001) for the treatment of incompetent long saphenous vein segments,13 EVLA avoids the complications of open surgery with better outcomes. The use of on-table ultrasound makes EVLA more precise and there is less risk of inadequate surgery as the whole length of varicose vein can be visualized during the procedure. The EVLA procedure has been associated with minimal scarring (as there is no groin incision), less bruising, faster recovery and return to normal activity as well as lower recurrence rates.14 EVLA can be accompanied by injection sclerotherapy or multiple avulsions for the removal of residual varicosities. Our practice includes multiple phlebectomies via stab incisions for all visible varicosities after EVLA therapy during the same session.5,6 These varicosities are marked pre-operatively with the patient in the standing position and with input from the patient. This way the patient is less likely to present at a follow-up clinic complaining that offending varices are still present postoperatively.

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There was an incidence of a pulmonary embolism (PE) in a 70 yr old lady patient who had underwent bilateral EVLA for recurrent LSV disease 10 days earlier.9 BTS guidelines15 list potential risk factors for PE, and in this patient they included advanced age, previous bilateral ligation and stripping of the proximal great saphenous vein a year earlier, malignancy and phlebitic tributary varices. She had no clinical signs of a DVT on presentation with the PE and subsequent duplex ultrasound showed no propagation of thrombus from the treated LSVs to the deep veins. Because of this, it is unclear if this lady’s PE was a direct consequence of the EVLA procedure, but she was treated successfully and made a full recovery. Clinical success of EVLA is defined as permanent occlusion of the treated vein segments, abolition of reflux, successful elimination of related varicose veins and improvement in the clinical classification of the limb by a certain time interval after the procedure.2,16 Min et al. (2003) showed successful occlusion on follow-up Duplex ultrasound in 490/499 (98%) limbs at 1 month, 390/396 (98.5%) limbs at 6 months, 310/318 (97.5%) limbs at 1 year and 113/121 (93.4%) limbs at 2 years. 40 patients in the same study were followed up to 3 years with no new recurrence; most recurrences were found to occur by 3 months, with no new recurrences after 9 months.17 Over a median follow-up of 18 months (range 1e38), we found no clinical evidence of recurrence and no recannalisation of the treated LSV or SSV on duplex ultrasound. Comparing EVLA to ligation and stripping; clinical success rates of EVLA in larger series vary from 93 to 98%17,18 compared to traditional ligation and stripping at 77e82%.19,20 There is also a difference in recovery time; EVLA patients are encouraged to resume normal activity immediately with most returning to normal activity and work with 1e2 days,17 but series have shown patients after ligation and stripping on average return to normal activity at 3.9 days and return to work at 12.4 days.21 5. Conclusions Our study shows EVLA as a viable alternative option in the treatment of recurrent varicose veins. It avoids the perils of dissecting through scar tissue from previous operations. EVLA is also a safer and more precise treatment as the use of on-table ultrasound guides the surgeon to the desired target anatomy with less risk of incomplete surgery and undesirable iatrogenic injury to the patient. Conflict of interest statement None declare. Funding None.

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Ethical approval Ethical approval was granted for this review as for an audit of clinical practise. References 1. Ravi R, Rodriguez-Lopez JA, Trayler EA, Barrett DA, Ramaiah V, Diethrich EB. Endovenous ablation of incompetent saphenous veins: a large single-center experience. J Endovasc Ther 2006;13(2):244e8. 2. Min RJ, Khilnani NM. Endovenous laser ablation of varicose veins. J Cardiovasc Surg (Torino) 2005;46(4):395e405. 3. Min RJ, Khilnani NM. Endovenous laser treatment of saphenous vein reflux. Tech Vasc Interv Radiol 2003;6(3):125e31. 4. IPG052. Endovenous laser treatment of the long saphenous vein - information for people considering the procedure, and for the public. National Institute for Clinical Excellence, http://www.nice.org.uk/nicemedia/pdf/IPG052publicinfo.pdf; March 2004. 5. Durai R, Srodon PD, Kyriakides C. Endovenous laser ablation for superficial venous insufficiency. Int J Clin Pract; 2008. 6. Nwaejike N, Srodon PD, Kyriakides C. Endovenous laser ablation for short saphenous vein incompetence. Ann Vasc Surg; 2008. 7. Beebe HG, Bergan JJ, Bergqvist D, Eklof B, Eriksson I, Goldman MP, et al. Classification and grading of chronic venous disease in the lower limbs. A consensus statement. Eur J Vasc Endovasc Surg 1996;12(4):487e91 [discussion 491e2]. 8. Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, et al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004;40(6):1248e52. 9. Nwaejike N, Srodon P, Kyriakides C. Pulmonary embolism following endovenous laser ablation of the great saphenous vein. J Rad Case Reports 2008; 2(2):9e12. 10. Belardi P, Lucertini G. Advantages of the lateral approach for re-exploration of the sapheno-femoral junction for recurrent varicose veins. Cardiovasc Surg 1994;2(6):772e4. 11. Egan B, Donnelly M, Bresnihan M, Tierney S, Feeley M. Neovascularization: an “innocent bystander” in recurrent varicose veins. J Vasc Surg 2006; 44(6):1279e84. discussion 1284. 12. van Rij AM, Jones GT, Hill GB, Jiang P. Neovascularization and recurrent varicose veins: more histologic and ultrasound evidence. J Vasc Surg 2004; 40(2):296e302. 13. Navarro L, Min RJ, Bone C. Endovenous laser: a new minimally invasive method of treatment for varicose veinsepreliminary observations using an 810 nm diode laser. Dermatol Surg 2001;27(2):117e22. 14. Min R, Khilnani N, Zimmet S. Endovenous laser treatment of saphenous vein reflux: long-term results. J Vasc Interv Radiol 2003;14:991e6. 15. The British Thoracic Society Standards of Care Committee PEGDG. BTS guidelines for the management of suspected acute pulmonary embolism. Thorax 2003;48:470e84. 16. Elkof B, Rutherford R, et al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004;40(6):1248e52. 17. Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reflux: long-term results. J Vasc Interv Radiol 2003;14(8):991e6. 18. Navarro, Salat. Endolaser e a three year follow-up report: Implication on crossectomy and ligation and stripping. In: 16th Annual Congress American College of Phlebology, Nov 2002; Nov 2002. 19. Dwerryhouse Davies, Harradine Earnshaw. Stripping the long saphenous vein reduces the rate of reoperation for recurrent varicose veins: five-year results of a randomized trial. J Vasc Surg 1999;29:589e92. 20. Sarin S, Scurr JH, Smith PD. Assessment of stripping the long saphenous vein in the treatment of primary varicose veins. Br J Surg 1992;79:889e93. 21. Lurie F, et al. Prospective randomized study of endovenous radiofrequency obliteration (Closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surg 2003;38(2):207e14.