Endovenous Laser Ablation (EVLA) in Patients With Varicose Great Saphenous Vein (GSV) and Incompetent Saphenofemoral Junction (SFJ): An Ambulatory Single Center Experience - PDF Document

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  1. Vascular and Endovascular Surgery Volume 43 Number 2 April/May 2009 178-184 # 2009 The Author(s) 10.1177/1538574408326182 http://ves.sagepub.com Endovenous Laser Ablation (EVLA) in Patients With Varicose Great Saphenous Vein (GSV) and Incompetent Saphenofemoral Junction (SFJ): An Ambulatory Single Center Experience Mohammad Reza Zafarghandi, MD, Shahram Akhlaghpour, MD, Halimeh Mohammadi, MD, and Ali Abbasi, MD Objectives: To evaluate treatment results for varicose great saphenous vein (GSV) using endovenous laser ablation (EVLA) in an ambulatory single center. Material and methods: We prospectively studied 77 limbs with varicose GSV in 74 patients who were treated using 980-nm EVL with a 600-mm laser fiber and the power settings of 10-25 Watts. The patients were followed using color Doppler ultrasound. Results: Continued closure of treated GSV was found in 98.3% of the legs evaluated at 3-week follow-up (n ¼ 60). At 3- and 6-month intervals, 94.1% and 97% successful occlusion was achieved, respectively. The main complications of the procedure included prolonged leg pain (2 cases), hyperestheasia (one case) and lidocaine sensitivity (one case). Conclusion: EVLA treatment of the GSV is a safe and highly effective method complications in midterm follow-up. It is feasible in ambulatory settings and the patients return to their daily activities early after intervention. accompanied with few Keywords: saphenous varicose veins endovenous laser ablation (EVLA); great vein; saphenofemoral junction (SFJ); factors such as hereditary, age, gender, pregnancy, hydrodynamic muscular compartment forces, and gravitational hydrostatic forces are influential.3,4 The treatment of varicose GSV reduces the symptoms and the complication rate of venous insuf- ficiency and increases the patient’s quality of life.5,6 The conventional surgical strategy for incompetent GSVs involves high ligation and stripping of saphenofemoral junction (SFJ) and phlebectomy of residual varicosities. This is usually performed as an in-hospital procedure under general anesthesia with a 2- to 3-week recovery period.7,8Additionally, recurrence occurs in approximately one third of cases after 5 years, and it is associated with the development of scars, postoperative pain, wound infection, and saphenous nerve injury.6,9,10 Introduction Varicose veins of the lower extremities are one of the most common medical problems, as it affects up to 32% of women and 40% of men.1The majority (60%-70%) are due to saphenofemoral and great saphenous vein (GSV) incompetence.2 Several From the Departments of Cardiovascular Surgery (MRZ) and Basic and Clinical Research (AA), Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran; and Departments of Interventional Radiology (SA), Department of Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran. Address correspondence to: Mohammad Reza Zafarghandi, Tehran Heart Center, Tehran University of Medical Sciences, North Kargar Street, Tehran mrzafarghandi@gmail.com. 1411713138, Iran; e-mail: 178 Downloaded from http://ves.sagepub.com at Ebsco Electronic Journals Service (EJS) on May 25, 2009

  2. EVLA in Patients With Varicose GSV and Incompetent SFJ / Zafarghandi et al 179 To improve efficiency and to reduce postopera- tive morbidity and recovery period, minimally inva- sive endovenous techniques have been developed as alternatives to conventional surgery. Endovenous laser ablation (EVLA) is one of the newer minimally invasive techniques proposed with a success rate of 88% to 100%.3,5,11Endovenous laser ablation is usually performed under local anesthesia in an out- patient setting and results in thermal ablation of the GSV.12,13To treat the residual varicosities, delayed injection sclerotherapy or multiple phlebectomies can be performed at the time of initial therapy.14 Although previous series report GSV occlusion rates of 95% to 98% for EVLA, limited reports have the published midterm and long-term outcomes with this technique. Endovenous laser ablation has been applied among the Iranian patients in the Noor Varicosis Clinic, Tehran, Iran, after it was approved by the Food and Drug Administration (FDA) in the United States.15This prospective study was conducted to describe the feasibility and midterm outcome of patients with varicose GSV using EVLA in an ambulatory setting. symptomatic varicose GSV and primary saphenofe- moral incompetence, were aged above 18 years, and were considered eligible for EVLA. Technique of EVLA In a clean treatment room, the leg was disinfected with deconex SOLARSEPT (Borer Chemie AG, Zuchwil, Switzerland) and then was covered with sterile cloths. A linear transducer (7.50 MHz linear probe, Ultima-Pro 10, Ukraine) was similarly disin- fected and used to identify the GSV, SFJ, the venous branches, the incompetent perforators, and the deep venous system before the procedure. Initially, the course of GSV was identified, and a suitable puncture point was chosen along its course. The local anesthesia was performed using 2 mL of 0.25% lidocaine injection under ultrasound (US) guidance around the venous puncture site. The venous access was obtained with a needle puncture using a 14-gauge needle under US guidance. The GSV was cannulated adjacent to the knee because of its larger diameter, linear course, and the smaller risk of nerve injury. After the entrance to the varicose vein was established, a guide wire was passed through the hollow needle into the GSV. After the guide wire was in place, the needle was removed and a small cutaneous incision of 2 mm was made, an introducer 5-Fr dilator and sheath was passed over the guide wire. Subsequently, the guide wire and dilator were removed when the sheath was at or beyond the junction. The catheter tip was positioned 2 cm distal to the SFJ, and perivenous tumescent anesthesia was achieved by infiltrating 100 to 150 mL of 0.25% lidocaine along the length of the vein under US control. Then, a 600-mm laser fiber was inserted into the catheter, which was then withdrawn by 2.5 to 5 cm below SFJ to allow the fiber to protrude beyond the catheter tip. For EVLA, the device used was a 980-nm wavelength diode laser, high power up to 90 W, and pulse-mode operation (Diod 90W, LISA, Germany). Before activation of the laser, individuals in the treatment room wore the protective laser goggles. The laser was always used in the pulse mode. Depending on personal preference, the power settings of 10, 12, 14, 15, 20, and 25 W were applied (Figure 1). Pulsed laser therapy was delivered from 2.5 to 5 cm below the SFJ and the fiber was pulled back 5 mm after 3 pulses. Approximately 1 cm Methods Patient Selection All the patients with GSV varicosity and primary SFJ incompetence who visited the Noor Varicose Clinic, Tehran, Iran, from September 2005 to July 2007 were primarily enrolled in the study. The investiga- tion was approved by the Institutional Review Board, overseeing the participation of humans in research at Tehran University of Medical Sciences. This study conforms to the principles outlined in the Declaration of Helsinki. For all patients, sufficient general knowledge about the aims and conditions of the study was given and informed consent was obtained. All the patients underwent clinical examination and color Doppler ultrasonography (DUS) as part of their initial outpatient assessment. Patients were not considered for the study if they were taking warfarin or if they were unsuitable for EVLA. The exclusion criteria were failure to palpate the distal pulses, inability to walk, thrombosis or incom- petence of the deep venous system, and the severe underlying disease. A total of 74 consecutive patients (77 limbs) were included in the study. They had Downloaded from http://ves.sagepub.com at Ebsco Electronic Journals Service (EJS) on May 25, 2009

  3. 180 Vascular and Endovascular Surgery / Vol. 43, No. 2, April/May 2009 venous system was assessed in all patients with color DUS and if not normal, these patients were excluded from the analysis. The first follow-up visit was sched- uled after 3 weeks if there were no complications. In the follow-up, the patients were assessed at 3 weeks, 3 months, and 6 months. The principal out- come measures were abolition of reflux in the treated varicose of GSV. A vascular surgeon and an interven- tionist evaluated any residual or recurrent varicose veins. Ineachsession, the entirelasered area (ie,from the site of cannulation to the SFJ) was observed, patients’ complaints were recorded, and the course of the vein and location of SFJ were identified with color DUS. Careful DUS assessment of the SFJ was conducted by holding the probe longitudinally, hori- zontally, and at different angles to identify any patent tributaries. The operation technique was considered successful if the vein was noncompressible through thefull course,therewasnoflowobservedinthevein, the diameter of the vein was reduced on inspection, and fibrosis was palpable. 4000.00 3000.00 Energy (J) 2000.00 1000.00 0.00 10 12 14 15 20 25 Power (W) Figure 1. izontal box plot lines indicate medians and quartiles; extensions indicate 1.5 interquartile range, and circles indicate statistical outliers and extreme values). Energy required at different power values (hor- around the puncture site was pulsed. At the comple- tion of the procedure, the laser was deactivated before the fiber was withdrawn from the skin. All the steps were performed under US guidance and clo- sure of the vein was documented by US. The limbs were then dressed and covered with elastic bandage for 1 to 2 weeks. All the patients were advised to return for the first follow-up after 3 weeks and to be visited earlier in the clinic if complications ensued. After ensuring the closure of the GSV, scler- otherapy of the incompetent perforators, branch ves- sels, and incomplete closure of the GSV was performed using 2% sodium tetradecyl sulphate (STS; trombovar, S.p.A. Bouty Laboratory, Milano, Italy) in the same or next visit. The largest vein as the feeder was identified, STS was injected under US guidance, and compression was applied. After that the smaller veins were injected. Results In all procedures, EVLA was technically successful. Demographic and clinical data of the study patients are shown in Table 1. Of the 74 patients (77 legs) who were treated using EVLA, 58 patients (60 limbs) returned for 3-week follow-up. The GSV was occluded in all 59 (98.33%) limbs at 3 weeks (with no evidence of failure, no flow, and noncompressible vein). In 1 case, the GSV was not closed up to 10 cm from the SFJ with no more reflux in the course of the vein. At 3 months, 48 (50 limbs) patients continued the DUS follow-up. The recurrence of varicose GSV was not seen in 47 (94%) limbs. All the 3 recanaliza- tions, including the previous case, were found in the proximal GSV (ie, less than 10 cm) with no reflux to the lower leg. One of the patients underwent scler- otherapy for the open segment of the GSV. For 30 (31 limbs) patients, 6-month follow-up was available. Only 1 other patient developed the reflux of GSV at the mid-thigh portion. Considering the 1 patient who was treated by EVLA þ sclerother- apy, the success rate was 97% at 6-month follow-up. About 60 (78%) patients required sclerotherapy dur- ing or after EVLA session for small varicose veins or perforators. Assessment Incompetence of the SFJ and the course of GSV were assessed clinically in the standing and supine position and then, the full course of the vein was assessed using the color DUS examination. All the visible incompetent perforators were also evaluated with color DUS and if necessary, branch vessels and perforators were treated with sclerotherapy in com- bination with EVLA. During the procedure, the deep Downloaded from http://ves.sagepub.com at Ebsco Electronic Journals Service (EJS) on May 25, 2009

  4. EVLA in Patients With Varicose GSV and Incompetent SFJ / Zafarghandi et al 181 thrombosis to deep venous systems or iliac vessels. No significant complications such as deep vein thrombosis or pulmonary embolism occurred. All patients returned to normal activity within 2 days. Table 1. Demographic and Clinical Characteris- tics of the Patients (n ¼ 74) % of Patients (n), Mean + SD Characteristics 43.48 + 14.24 Age (year) Gender ? Male ? Female Family history of vein varicosis Varicose GSV ? Unilateral, left ? Unilateral, right ? Bilateral EVLA ? Unilateral, left ? Unilateral, right ? Bilateral Laser Power (W) ? 10 ? 12 ? 14 ? 15 ? 20 ? 25 Length of varicose GSV (cm) Linear endovenous energy density (J/cm) No of Perforators None <3 3-5 >5 No of sclerotherapy None <3 3-5 >5 Discussion 45.95 (34) 54.95 (40) 42.89 (31) For treatment of saphenous vein varicosity with incompetent SFJ, the classic and most recognized intervention has been surgical ligation with or with- out stripping.16The advantage of ligation alone is the perseverance of the vein for possible future bypass procedures, but this method has a high recurrence rate (45%-71%). Stripping with ligation is associated with an excellent early outcome because the incom- petent vessel is totally removed and it is more accepted due to lower recurrence rates (18%-29%). However, it has more scarring, pain, and paresthesia at the stripping site compared to ligation alone.17-19 Because of the problems in the above-mentioned methods and also the need for longer hospitalization and anesthesia, general or spinal, pain after surgery, the invasive nature of the procedure, aesthetic prob- lem due to scar, limitations in the activity for a long period, risk of bleeding, infection of the wound, and paresthesia, minimally invasive techniques have been developed. During the past few years, EVLA has evolved into an accepted option for eliminating venous reflux. Endovenous laser ablation has rapidly become the treatment of choice for treating saphenous vein insufficiency. The mechanism of laser-induced thermal damage consists of indirect heating of the vein wall by endovenous steam bubble formation, resulting in thrombotic occlusion of the vessel, and of direct damage of the vein wall as a consequence of closer contact between the laser fiber tip and the wall itself.20-22Heating the collagen of the venous walls results in contraction and destruction of the endothelium, the thickness of the wall increases and, therefore, resulting in venous fibrosis.5 Immediate closure of the vein is reported in all of the reviewed studies,6which was also achieved in our study. Although a success rate of 100% a week after EVLA is reported in most studies, success rate decreases with time. In our 3-month follow-up, the success rate was 94.11%, and 1 patient with recana- lization of the mid-thigh was treated by sclerotherapy for the open segment of the vein. Excepting this patient, the successful closure of GSV remained in 47.3 (35) 45.95 (34) 6.75 (5) 47.3 (35) 47.65 (36) 4.05 (3) 1.3 (1) 46.7 (36) 2.6 (2) 11.7 (9) 36.3 (28) 1.3 (1) 41 + 9 43.9 + 11.9 13.0 (10) 37.7 (29) 42.9 (43) 5.2 (4) 77.9 (60) 20.8 (16) 31.2 (24) 41.5 (32) 7.8 (6) NOTES: EVLA ¼ endovenous laser ablation; GSV ¼ great saphenous vein; SD ¼ standard deviation. Minor complications, however, were quite com- mon and included ecchymosis and slight pain after the procedure, all of which improved after a few days without any intervention. However, 1 patient had prolonged ecchymosis with local edema for 1 month. Two cases required analgesics for severe and pro- longed pain (5 and 10 days). Another patient com- plained of hyperesthesia treatment. One patient reported mild convulsions, probably due to lidocaine sensitivity, which was resolved using hydrocortisone. One patient reported heaviness of the foot, but future investigations revealed insufficiency of the small saphenous vein that was treated with sclerotherapy successfully. There were no reports regarding progress of for 1 month after Downloaded from http://ves.sagepub.com at Ebsco Electronic Journals Service (EJS) on May 25, 2009

  5. 182 Vascular and Endovascular Surgery / Vol. 43, No. 2, April/May 2009 97% of patients 6 months after the procedure. Our findings were comparable with the previous studies. Min et al, who used a similar method for GSV varic- osities, reported that 93% of 499 GSV were occluded 2 years after therapy.5An Italian work group reported a success rate of 97% in 1000 patients with a follow-up of 3 years.13Another large study with more than 1250 limbs treated, showed a success rate of approximately 95%.23Sharif et al reported long saphenous vein occlusion in 100% and 96% at 3 and 12 months after EVLA, respectively.24In 2 other studies, Navarro et al25and Oh et al26have reported success rates of 100% at 4- and 3-month follow-up, respectively. Timperman27has achieved 95% success in treatment of great and small saphenous vein at 9 months after the procedure, and Chang and Chua28reported 97% success rate in 2-year follow-up. Some studies report success rates lower than 90%, which may be due to the characteristics of the vari- cose veins they treated, for example, very large or tortous, or associated large insufficient perforator.6 Although the different studies have proven the good efficacy and safety of EVLA for the treatment of venous reflux, the optimallaserparameters, includ- ing the wavelength, the type of administering laser energy, the pulse duration, and the amount of energy per surface area still remain controversial. In this study, we applied the wavelength 980 nm and the power settings of 10 to 25 W. Several wavelengths, 810, 940, 980, 1064, and 1320 nm, have been pro- posed20,23,25,28,29and the wavelengths 810, 940, and 980 nm have been most commonly used. At these wavelengths, power is usually set between 10 and 15 W. The energy is administered endovenously, either in a pulsed fashion or continuously with a con- stant pullback of the laser fiber. At these parameters, the average linear endovenous (LEED), which is commonly used to report the dose administered to the vein ranges from 20 to 140 J/cm.30-32Transfer of laser energy to the vein wall via direct circumferential contact is the predominant mechanism of action of EVLA, but excessive tissue damage with vein wall perforation may occur mainly at the point ofdirect contact between the fiber tip and vessel wall. In the current study, the LEED mean of 43.9 + 11.9 J/cm resulted in 97% success rate at 6 months after surgery. However, it was not our aim to standardize the laser parameters, which in itself is in need of further investigations. Sclerotherapy has had excellent outcome in treatment of varicose veins with diameter of 3 to 4 mm but high recurrence rate was observed in larger veins, and therefore, it is not practical in varicose GSV. The most important point in sclerotherapy is the absence of large varicose veins and incompe- tence at the SFJ. If there are large varicose veins such as great and small saphenous vein, these large varicosities have to be managed before sclerother- apy.8,33Therefore, severe varicosity of tributaries may require adjunctive procedures such as micro- phlebectomy or sclerotherapy after EVLA treatment of GSV.34In our study, we used sclerotherapy for 60 (78.9%) limbs with 1 to 9 perforator veins. Although the minimally invasive EVLA reduces classical surgical side effects, it may be associated with specific adverse events. Consistent with the prior studies,4,5,11,13the most common self-limited or minor complications included slight pain, minor burning,bruising,andabnormalsensationoftheskin. The serious complications of endovenous ablation are few. Wound infections should be rare with the use of aseptic techniques. Saphenous nerve injury following laser therapy of the GSV occurs rarely.15Among 3 case series that included 2750 limbs, only 1 lung emboli was found.3,13,35Our patients had none of the mentioned problems. Use anesthesia will increase the risk of DVT because the patient will not be able to stand and walk immedi- ately5,22postprocedure. In our patients, we always performed EVLA with local anesthesia, without premedication, and made the patients walk immedi- ately postprocedure. We believe that this is the primary reason why there was no DVT in our series, despite the simultaneous use of sclerotherapy in some patients. Prospectively, we assessed the initial feasibility and outcomes of EVLA treatment for Iranian patients with varicose GSV and incompetent SFJ in an ambulatory setting. However, our study had some limitations. Our patients have been followed for mid- term period and their long-term outcome was not predicted. From the technical point of view, we empirically used a different range of laser power, and therefore, the choice of the laser parameters was not accessible. During the study, we encountered a considerable number of patients who were lost to follow-up. However, we can assume that the majority had no serious adverse effects to complain of and therefore obtain a good estimate, as we advised and urged the patients earnestly to return or call us for any possible problems after the procedures.35 of general/regional energy density Downloaded from http://ves.sagepub.com at Ebsco Electronic Journals Service (EJS) on May 25, 2009

  6. EVLA in Patients With Varicose GSV and Incompetent SFJ / Zafarghandi et al 183 Conclusions 9. van Rij AM, Jiang P, Solomon C, Christie RA, Hill GB. Recurrence after varicose vein surgery: a prospective long-term clinical study with duplex ultrasound scanning and air plethysmography. J Vasc Surg. 2003;38:935-943. 10. Dwerryhouse S, Davies B, Harradine K, Earnshaw JJ. 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;29:589-592. 11. Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser treatment for varicose veins. Br J Surg. 2005;92:1189-1194. 12. Strirling M, Shortell CK. Endovascular treatment of var- icose veins. Semin Vasc Surg. 2006;19:109-115. 13. Agus GB, Mancini S, Magi G. for the IEWG. The first 1000 cases of Italian Endovenous-laser Working Group (IEWG). Rationale, and long-term outcomes for the 1999-2003 period. Int Angiol. 2006;25:209-215. 14. Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ. Randomized clinical trial compar- ing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg. 2008;95:294-301. 15. Golan JF, Glenn DM. Laser and radiofrequency endove- nous ablation of venous reflux. Perspect Vasc Surg Endovasc Ther. 2008;20:75-79. 16. Teruya TH, Ballard JL. New approaches for the treat- ment of varicose veins. 2004;84:1397-1417. 17. McMullin GM, Coleridge Smith PD, Scurr JH. Objec- tive assessment of high ligation without stripping the long saphenous vein. Br J Surg. 1991;78:1139-1142. 18. Sarin S, Scurr JH, Coleridge Smith PD. Assessment of stripping the long saphenous vein in the treatment of primary varicose veins. Br J Surg. 1992;79:889-893. 19. Winterborn RJ, Earnshaw JJ. Crossectomy and great saphenous vein stripping. J Cardiovasc Surg (Torino). 2006;47:19-33. 20. Proebstle TM, Lehr HA, Kargl A, et al. Endovenous treatment of the greater saphenous vein with a 940-nm diode laser: thrombotic occlusion after endoluminal thermal damage by laser-generated steam bubbles. J Vasc Surg. 2002;35:729-736. 21. Min RJ, Khilnani NM. Endovenous laser ablation of var- icose veins. J Cardiovasc Surg (Torino). 2005;46:395-405. 22. Yilmaz S, Ceken K, Alparslan A, Sindel T, Lu ¨leci E. Endovenous laser ablation for saphenous vein insuffi- ciency: immediate and short-term results of our first 60 procedures. Diagn Interv Radiol. 2007;13:156-163. 23. de Medeiros CA, Luccas GC. Comparison of endove- nous treatment with an 810 nm laser versus conven- tional stripping of the great saphenous vein in patients with primary varicose veins. Dermatol Surg. 2005;31: 1685-1694. 24. Sharif MA, Lau LL, Lee B, Hannon RJ, Soong CV. 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