Eur J Vasc Endovasc Surg 32, 725e729 (2006) doi:10.1016/j.ejvs.2006.06.002, available online at http://www.sciencedirect.com on Combined Endovenous Laser Therapy and Ambulatory Phlebectomy: Refinement of a New Technique A. Mekako,* J. Hatfield, J. Bryce, M. Heng, D. Lee, P. McCollum and I. Chetter Academic Vascular Surgery Unit, Hull Royal Infirmary, Hull, UK Objective. Sclerotherapy (IS) or ambulatory phlebectomy (AP) are required as subsequent interventions in majority of cases following endovenous laser therapy (EVLT). We assessed whether AP performed concomitantly with EVLT (EVLTAP), is effective, acceptable, and reduces subsequent requirement for interventions. Method. 67 patients (70 limbs) with great saphenous varicosities underwent EVLTAP. Pain was assessed on days 1, 4 and 7 using a visual analogue scale (VAS) of 0 to 10. Clinical and ultrasound assessments were done at 1, 6 and 12 weeks (no ultrasound at 6 weeks). Residual varicosities underwent further AP or IS. Patients satisfaction with the cosmetic outcome and overall treatment was assessed at 12 weeks using a VAS rating. Results. 49 patients (70%) completed follow-up. Median pain scores were 1.6 (IQR 0.2e4.8), 0.3 (0e1.4) and 0.2 (0e1.1) on days 1, 4 and 7 respectively. Ultrasound demonstrated 69 (99%) and 47 (96%) occluded long saphenous veins at 1 and 12 weeks respectively. Subsequent IS or AP was performed on 3 (4%) or 1 (1%) limbs respectively. Cosmetic satisfaction was 9.6 (IQR 8.9e10) and overall satisfaction 9.8 (IQR 9.3e10). Conclusion. EVLTAP produces excellent results, is feasible and acceptable, and obviates need for subsequent procedures in the short-term. Keywords: Endovenous laser therapy; EVLT; EVLTAP; Ambulatory phlebectomy; Sclerotherapy. Introduction Lower limb varicose veins are common, affecting 40% of men and 32% of women in the United Kingdom. 1 Many patients are asymptomatic, but complaints may range from subjective symptoms such as aching, leg heaviness, pruritus, and muscle cramps, to more objective features of oedema, eczema, lipodermatosclerosis and ulceration. 2e4 There is a correlation between symptoms and extent of reflux. 5 Patients may seek treatment because of these symptoms or because of cosmetic appearance. Although not commonly addressed, patients concerns, worries or fears about their varicose veins are important reasons for seeking treatment. 4 By far the vast majority (60e80%) of varicose veins arise from incompetence of the sapheno-femoral junction (SFJ) and great saphenous vein (GSV) reflux. 5,6 Successful long term surgical treatment of varicose *Corresponding author. A. Mekako, MBBS, MSc, MRCS, Academic Vascular Surgery Unit, Alderson House, Hull Royal Infirmary, Anlaby Road, Hull HU3 2JZ, UK. E-mail address: Anthony.Mekako@hey.nhs.uk veins aims to eliminate the highest point of reflux and the incompetent segments of veins. 7e9 For long saphenous varicosities, the procedure of choice is SFJ ligation, GSV stripping to the knee level and multiple avulsions of varicosities. 2,7e10 Surgery usually requires general anaesthesia and is associated with significant perioperative morbidity, increased cost of hospitalisation and delayed return to normal activities and work. 3,8,10,11 Recurrence rates vary from 20% to 80% depending on definition and timing. 11e14 In recent years, minimally invasive techniques of varicose veins treatment have emerged as alternatives to surgery. Endovenous delivery of laser energy was first reported in 1999, 15 and endovenous laser ablation of the GSV was achieved 2 years later. 8 Excellent GSV occlusion rates at 5 years follow up have been reported, with clinical improvement of symptoms. 16 Complications following EVLT are infrequent, however 30%e99% of patients require secondary treatment of residual varicosities, usually in the form of compression sclerotherapy post EVLT. 11 The need for secondary sclerotherapy with its associated potential complications, may be a relative limitation to the otherwise high patient acceptability of EVLT. 1078 5884/000725 + 05 $32.00/0 Ó 2006 Elsevier Ltd. All rights reserved.
726 A. Mekako et al. This study aims to assess if combining EVLTand ambulatory phlebectomy as a single procedure (EVLTAP), is feasible, effective and acceptable to patients. Methods Patients The study population comprised 67 patients (31 men and 36 women; median age 49 [IQR 35e58] years) with varicose veins secondary to isolated SFJ incompetence and GSV reflux confirmed by duplex ultrasound scan. Patients were C2 (n ¼ 45), C4 (n ¼ 24) and C5 (n ¼ 1) according to the CEAP classification. Patients were selected by screening the day-case varicose veins waiting list, and inviting patients listed for SFJ ligation, GSV stripping and phlebectomies for duplex scanning. Patients who matched our local suitability criteria were offered EVLTAP. Patients with small saphenous varicosities, anterolateral thigh branch incompetence, previous varicose vein surgery and GSV with a diameter of less than 5 mm at the knee were excluded. All patients signed an informed consent form before undergoing EVLTAP. 70 unilateral procedures were carried out in these patients (3 patients with bilateral varicose veins underwent staged procedures). The study was approved by the Hull and East Riding Local Research Ethics Committee and carried out in accordance with the Helsinki Declaration. Technique description All procedures commenced with laser ablation of the incompetent GSV. The SFJ was identified by DUS in the upright position and the course of the GSV followed down to the knee, with intermittent skin markings. The patient was positioned in the reverse trendelenburg position and skin preparation and draping carried out. The peri-genicular entry point into the GSV was again identified and 1e2 mlof1% plain lignocaine infiltrated into the skin. Percutaneous entry into the GSV was gained, using a 19-guage needle under ultrasound guidance. In 2 patients where percutaneous cannulation of the GSV at the knee was impossible due to small vein size, open cannulation was achieved via a stab wound. A 0.035-inch diameter J guide wire was inserted through the needle, which was subsequently removed. A 5 Fg catheter was introduced over the guide wire and positioned within the GSV, immediately distal to the SFJ. Its position was confirmed by ultrasound, and the aspiration of non-pulsatile blood. A sterile bare-tipped laser fibre, 600 mm in diameter was introduced into the catheter to its first mark (which placed its tip flush with the end of the catheter). The catheter was then withdrawn to the second mark on the fibre, while keeping the position of the laser fibre fixed. This resulted in protrusion of 2 cm of the bare-tipped laser fibre beyond the catheter tip. The fibre was locked in the catheter in this position. The patient was then positioned in Trendelenburg position to aid vein emptying. Tumescent local anaesthetic solution was infiltrated along the whole length of the GSV to be ablated, using a 0.9 mm 180 mm needle under ultrasound guidance. Tumescent anaesthetic solution was prepared by diluting 30 ml of 2% lignocaine (with 1:200,000 adrenaline), in 500 ml of saline). Tumescent local anaesthetic was also infiltrated around branch varicosities. Total local anaesthetic used in each case, did not exceed recommended maximum safe dose of 7 mg/kg per patient. Laser energy was delivered endovenously using an 810 nm diode laser generator (Diomed Ltd, Cambridge, United Kingdom). 12 or 14 W power in pulsed or continuous mode was utilised. During the laser ablation process, manual compression was applied to the limb over the tip of the laser fibre to aid vein wall apposition and improve heat conduction. Following laser ablation of the GSV from groin to knee, incisions of 1e2 mm were made over varicosities, which were then removed using toothed mosquito artery forceps or Müller hooks. Steri-strips and gauze dressings were applied to stab wounds. Panelast Ò (Lohmann & Rauscher International GmbH & Co. KG) elastic adhesive bandage was applied to the whole length of the treated limb post procedure and left in place until the first follow up at 1 week, when it was changed to a class II (30e 40 mm Hg) full-length graduated support stocking that was worn for a further 5 weeks, except during sleep and baths. All patients were asked to walk immediately after the procedure, and to return to normal activities as soon as they felt comfortable. A 1-week course of non-steroidal anti-inflammatory drugs was prescribed for all patients with no contraindication to their use. Outcome measures Patients were assessed for pain, GSV occlusion rates on duplex ultrasound scan (DUS), subsequent interventions, and satisfaction. Pain was assessed on days 1, 4 and 7 using a visual analogue scale (VAS) rating of 0 cm (no pain) to 10 cm (worst imaginable pain). This was entered in a diary
New Technique for Varicose Veins Laser Therapy 727 given to patients at the completion of the procedure and reviewed at 1-week follow up. DUS was performed at 1 and 12 weeks post procedure to assess SFJ and GSV occlusion. Reflux was defined as greater than 0.5 seconds retrograde flow. All scans were performed by the same investigator to avoid inter observer variability. After 6 weeks, any patient who had residual varicosities was offered either injection sclerotherapy or further ambulatory phlebectomy. Patient satisfaction was assessed at 12 weeks using a VAS rating of 0 cm (completely dissatisfied) to 10 cm (completely satisfied). Patient satisfaction with cosmetic outcome and overall treatment were assessed. The overall treatment satisfaction was a composite assessment that included treatment deliveries, length of procedure, follow up treatment and recovery. It gave an indication of patient acceptability of the procedure. Data from this study were found to be of nonnormal distribution and the descriptors used here are the median and inter-quartile range (IQR). Results Total mean laser energy used was 83.3 Joules/cm (range 44.5e158.4 Joules/cm). Median duration of procedure was 69 (IQR 60e80) minutes. Patient follow up was 100% at 1 week (n ¼ 70 limbs) and 97% at 6 weeks (n ¼ 68 limbs); 1 patient was lost to follow up, while 1 patient missed appointment but attended the 12 week visit. At the time of analysis of results, 70% (n ¼ 49 limbs) had been assessed at 12 weeks. There were no major complications of treatment such as skin burns, deep venous thrombosis, neuralgia or infection of phlebectomy sites. Several patients had minor transient bruising. 1 patient who did not take non-steroidal antiinflammatory drugs (NSAIDs) had thrombophlebitis at 1 week follow up. This settled with NSAID treatment. 1 patient had hyperpigmentation over the ablated GSV; this was noticed at 6-week follow up and persisted through the 12-week follow up. Median pain score (Fig. 1) on day 1 was 1.6 (IQR 0.2e4.8); on day 4 was 0.3 (IQR 0e1.4) and on day 7 was 0.2 (IQR 0e1.1). SFJ occlusion was seen in 97% (n ¼ 68 of 70 limbs) at 1 week and 96% (n ¼ 47 of 70 limbs) at 12 weeks. GSV occlusion rate was 99% (69 of 70 limbs) at 1 week, and 96% (47 of 49 limbs) at 12 weeks. Three limbs (4%) in three patients underwent injection sclerotherapy after 6 weeks, for residual varicosities. All 3 patients had thread veins. 1 patient (w1%) Fig. 1. Pain scores on days 1, 4 and 7. The bar within box represents median score; box represents interquartile range; whiskers represent lowest and highest scores. underwent further ambulatory phlebectomy for residual varicosities. Median patient satisfaction with cosmetic appearance was 9.6 (IQR 8.9e10) and for overall satisfaction with treatment was 9.8 (IQR 9.3e10) (Fig. 2). 47 of the 49 patients (96%) who attended 12-week follow up said they would have EVLTAP again. Fig. 2. Patient Satisfaction Rating with EVLTAP at 12 weeks. The bar within box represents median score; box represents interquartile range; whiskers represent lowest and highest scores (10 ¼ completely satisfied).
728 A. Mekako et al. Discussion GSV laser ablation has been used in clinical practice for about 5 years, although few studies have reported follow-up data for this period. We have been performing EVLT combined with ambulatory phlebectomy for 18 months. Most practitioners perform EVLT as an office procedure, with the majority of patients requiring subsequent adjunctive therapies. This requires several hospital visits for treatment, which may be unappealing to patients 17 and may reduce cost effectiveness. 18 EVLTAP does not significantly increase patient discomfort or pain. Patients in this study reported minimal pain, comparable to that reported by practitioners of staged treatments. Unlike the experience of Min and Khilnani, 16 our patients did not complain of delayed tightness in the lower limb following EVLT. This may be because we routinely prescribed non steroidal anti inflammatory medications post procedure. The absence of this delayed tightness did not appear to herald treatment failure. In our experience, EVLTAP took a median time of 69 minutes (IQR 60e80) to perform. This is not unduly prolonged when compared with several series in which EVLT has been performed alone. 19,20 It is realised that length of procedure is dependent on length of treated vein and operator experience. At the 3 months scan, 2 limbs (4%) demonstrated reflux in the proximal segment of the GSV. We defined reflux as a retrograde flow of >0.5 seconds, as recommended for superficial veins. 21 These 2 cases were performed early in the series, and were associated with total laser energy delivery below the recommended 70 J/cm for technical and clinical success. 16 These patients went on to have repeat laser ablation (not reincluded in this series). A small number of other veins also treated with less than 70 J/cm remained occluded at 3 months, thus suggesting that other factors may have contributed to the early failure. SFJ occlusion/ competence was defined as flush occlusion of the GSV at the SFJ with any patent terminal segment of the GSV at the junction no greater than 5 mm. Although GSV occlusion is more significant than SFJ occlusion following EVLT, we chose to monitor SFJ occlusion because of the possibility of developing reflux in the tributaries around the SFJ if it is not occluded, or is incompetent. Using this technique of flush occlusion has not resulted in any definite case of thrombus extension into the common femoral vein (CFV) in this series, or in the over 100 limbs done later and not included in this present series. We have had one case of a small eccentric thrombus in the CFV close to the SFJ, which was not contiguous with the non-thrombotic occlusion of the GSV. This may have been due to migration of the tip of the laser fibre during tumescent anaesthetic infiltration. Like Min and Khilnani, 16 we now reconfirm the position of the laser tip post tumescent anaesthesia prior to firing, to ensure correct positioning of the fibre tip. At 6 week follow up, 3 patients had thread veins that had become more prominent post laser ablation, while 1 patient had several small residual varices. None of these patients had DUS evidence of treatment failure. The patients with thread veins underwent successful treatment with compression sclerotherapy. The single patient, who had residual varices, successfully underwent further ambulatory phlebectomy. These 4 limbs accounted for fewer than 6% of the 68 limbs seen at 6 weeks. This represents a vast reduction in the proportion of patients needing subsequent adjunctive procedures following EVLT only (30%e99%). EVLTAP was associated with high levels of patient satisfaction with cosmetic appearance and overall treatment. We assessed satisfaction in 2 areas to show that in addition to cosmetic outcome, patients were also satisfied with the whole EVLTAP procedure, and found it acceptable. Most previous studies have assessed patients acceptance of EVLT in a qualitative way, and as in our study, they have demonstrated an overwhelming acceptance of EVLT. The overwhelming majority of our patients would have the procedure again. This is an indirect evidence for acceptability of EVLTAP. In summary, we have found the combined procedure of EVLTAP to be a feasible option, and propose it as an alternative to present EVLT only procedure. EVLTAP is not unduly prolonged, and not associated with pain that limits immediate return to normal activities. It is acceptable to patients, and vastly reduces the number of sequential treatments required. We would however recommend a randomised controlled trial to compare the two treatment options. References 1 EVANS CJ, FOWKES FG, RUCKLEY CV, LEE AJ. 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