Endovenous Laser Ablation for Short Saphenous Vein Incompetence N. Nwaejike,1,2,3 P.D. Srodon,1 and C. Kyriakides,1,2,3 London, United Kingdom
Conventional surgery for short saphenous vein (SSV) incompetence has a high incidence of recurrence and is associated with neurovascular injury. The aim of this study was to evaluate the safety and efficacy of endovenous laser ablation (EVLA) as an alternative to open surgery for SSV incompetence. Data were prospectively collected for all patients undergoing EVLA for SSV disease in our unit, including clinical outcomes and postoperative duplex. There were 368 EVLA procedures performed from April 2004 through December 2007, of which 66 (18%) were for SSV incompetence. Six (9%) SSV procedures were for recurrent disease after conventional surgery. Forty (61%) procedures were performed under local anesthesia, including four patients who underwent bilateral procedures at the same session. There were no intraoperative complications, and there was no evidence of neurovascular injury. During a median follow-up of 14 months (interquartile range 6-24) there was no clinical or duplex evidence of recurrence and no recanalization of the SSV. Our early results suggest that EVLA is a safe alternative to conventional surgery for the treatment of SSV incompetence in patients with C2eC4 disease. Bilateral procedures have been performed under local anesthesia.
INTRODUCTION Conventional surgery for short saphenous vein (SSV) incompetence can be technically demanding as the anatomic location of the saphenopopliteal junction (SPJ) is variable,1 and it is associated with recurrence rates of up to 50% at 3 years.2 Neurovascular injury following recurrent varicose vein surgery is a common cause for medical litigation.3 Endovenous laser ablation (EVLA) is a percutaneous minimally invasive technique where the target
vein is cannulated under duplex ultrasound guidance and ablated with laser energy. EVLA is an established treatment option for long saphenous vein incompetence,1,2,4-10 with comparable success rates to conventional surgery.4,5 However, there is less evidence for its role in treating SSV disease. The aim of this study was to investigate the safety and efficacy of EVLA as an alternative to conventional surgery for SSV disease in clinical practice.
MATERIALS AND METHODS Presented at the Venous Forum Prize Session, annual meeting of the Vascular Society, Manchester, UK, November 28-30, 2007, and the International Symposium on Endovascular Therapy, Hollywood, FL, January 20-24, 2008. 1 Department of Vascular and Endovascular Surgery, Bart’s and the London NHS Trust, London, UK. 2
The London Independent Hospital, Stepney Green, London, UK.
3
Queen Mary’s School of Medicine and Dentistry, University of London, London, UK. Correspondence to: Costantinos Kyriakides, Department of Vascular and Endovascular Surgery, Bart’s and the London NHS Trust, The Royal London Hospital, Whitechapel, London E1 1BB, UK, E-mail:
[email protected] Ann Vasc Surg 2009; 23: 39-42 DOI: 10.1016/j.avsg.2008.04.010 Ó Annals of Vascular Surgery Inc. Published online: July 10, 2008
From April 2004 EVLA was offered to all patients with symptomatic SSV incompetence confirmed on preoperative duplex, without any selection criteria. Informed consent was obtained for EVLA in accordance with the National Institute for Health and Clinical Excellence (NICE) recommendations.11 Procedures were performed under either local (LA) or general (GA) anesthesia, depending on patient and surgeon preference, with a strict aseptic technique. Patients were placed in the prone position with protection of pressure points and in reverse Trendelenberg to distend the veins. The SSV and SPJ were 39
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mapped with duplex ultrasound and marked with an indelible pen. The leg was prepared and draped in a similar way to conventional surgery. Under duplex ultrasound control the SSV was cannulated with a 21-gauge introducer needle, a 0.018-inch guidewire was passed, a 4-French sheath was introduced over this, and the guidewire was then removed. An 810 nm Vari-LaseÒ laser fiber (Vascular Solutions, Minneapolis, MN) was passed through the sheath and positioned 2 cm distal to the SPJ under ultrasound control, with secondary confirmation of the fiber tip position by a guide light through the fiber, which is visible percutaneously. A solution of 380 mL normal saline containing 20 mL of 1% lidocaine with adrenaline 1:200,000 was injected into a plane around the vein under duplex ultrasound guidance. Usually, 100-200 mL is required (depending on the length of vein treated) to compress the vein onto the laser fiber, provide tumescent anesthesia/analgesia, and minimize heatrelated damage to adjacent tissues.4 The operating table was then tilted to the Trendelenberg position to collapse the vein onto the laser fiber. With standard laser precautions in place and power settings at 10 W, laser energy was delivered as the laser fiber with its sheath was slowly withdrawn from the leg. Treatment was stopped 1 cm above the needle entry point, and the laser was switched off and withdrawn with the catheter. Varicosities that were marked preoperatively were removed at this point by hook phlebectomies through microstab incisions and dressed with steristrips. A full-length thromboembolism deterrent stocking was applied at the end of the procedure. Oral analgesia (1 g of paracetamol/6 hr and 50 mg of diclofenac sodium/8 hr) was prescribed for 5 days, and patients were instructed to resume normal daily activities immediately. Outcome measures were immediate postprocedure duplex by one of the two operating surgeons. In addition, clinical and duplex assessment were performed within 6 postoperative weeks by one of the two operating surgeons. Patients were then free to attend as required over the following 24 months, for further clinical review and duplex ultrasound by one of the operating surgeons.
RESULTS From April 2004 to December 2007 we performed 368 EVLA procedures, of which 66 (18%) were for SSV incompetence. The mean age of the patients treated for SSV disease was 47 years (range 23-80), 39 (59%) were female, and median body mass index
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was 25 (interquartile range 22-28). Clinical severity (using the Clinical, Etiological, Anatomical, and Pathological [CEAP] classification12,13) on presentation was between C2 and C4 (Table I). Sixty limbs had primary varicose veins, while previous SSV surgery had been performed in six (9%) limbs; all patients had SSV incompetence confirmed on preoperative duplex assessment. Forty (61%) cases were done under LA. Mean length of vein treated was 18 cm (range 5-33), mean energy delivered was 955 J (range 1352,800), and mean energy density delivered was 53 J/cm. Thirteen (20%) patients had EVLA only, 52 (79%) had EVLA with multiple phlebectomies, and one (1%) patient had EVLA with sclerotherapy. Five patients underwent bilateral SSV EVLA as one procedure, four of whom were done under LA. There were no intraoperative complications, and immediate postprocedure duplex confirmed echogenic thrombus formation in all target SSVs with no popliteal vein thrombus. All patients were discharged from hospital on the same day. All patients attended their first follow-up appointment within the first 6 postoperative weeks. There was no clinical evidence of recurrence and no incidence of sural nerve injury in terms of either sensory deficit or paresthesia. In addition, all target veins remained thrombosed on duplex ultrasound. Minor complications included two patients who had a phlebectomy site hematoma and two patients who had superficial thrombophlebitis which required treatment with non-steroidal antiinflammatory drugs. All had resolved completely by the 3-month review (100% attendance). Fifteen patients attended for further clinical review and duplex ultrasound. Median time postprocedure was 14 months (interquartile range 6-24). There was no gross recurrence on clinical examination and no recanalization of the SSV on duplex ultrasound.
DISCUSSION EVLA for treating long saphenous vein insufficiency has been approved by NICE since March 200411 and has had Food and Drug Administration (FDA) approval since 2002.14 First described by Navarro et al. in 2001,6 its use is gradually becoming more widespread as its benefits become apparent. It is increasingly requested by patients as it is well tolerated and minimally invasive. In some practices it is offered as an office-based procedure under LA.14 EVLA for long saphenous disease is associated with less scarring, less bruising, faster recovery, and faster
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EVLA for SSV incompetence
Table I. Preoperative clinical classification (CEAP) Superficial/reticular veins only, C1 Simple varicose veins only, C2 Ankle edema of venous origin, C3 Skin pigmentation in the gaiter area, C4 Healed venous ulcer, C5 Active venous ulcer, C6
0 limbs 48 limbs 15 limbs 3 limbs 0 limbs 0 limbs
return to normal activity, as well as lower early recurrence rates.5 There are much less data, however, for the advantages of EVLA in SSV disease. A major difficulty with open ligation of the SPJ is the variability in its position. In 10% of cases the SPJ is located below the popliteal fossa, in 30-40% of cases the SSV terminates above the popliteal fossa, and in some cases the SSV may not drain into the popliteal vein.15 Even with preoperative duplex marking it can be difficult to get adequate exposure to reliably locate and ligate the SPJ through a cosmetically acceptable incision. Open surgery may lead to iatrogenic damage to the common peroneal nerve and popliteal vein and artery, wound infection, and incomplete operations.9 The latter may explain the high incidence of recurrence. It is noted that 9% of our procedures were required for persistent SPJ incompetence following inadequate conventional surgery. EVLA offers many potential advantages over conventional surgery for SSV disease; e.g., the procedure is performed with on-table duplex imaging, giving safe and reliable identification of the variable anatomy. Therefore, the potentially hazardous and time-consuming dissection of the popliteal fossa is completely avoided. We had a 100% success rate in obliterating the SSV by EVLA, with minor complications that were treated conservatively. Significantly, there was no neurovascular injury. Previous series have reported incidences of transient sural nerve neuropraxia after SSV EVLA: 3/ 68 limbs using an average energy density of 66.3 J/cm and 12 W power1 and 3/172 limbs using an active power of 10-14 W at a pullback rate of 3-5 mm/sec.16 In our series of 66 limbs, we treated the SSV with a mean energy density of 53 J/cm. This lower energy density achieves successful functional obliteration of the SSV with no recanalization and no incidence of iatrogenic thermal injury to the sural nerve. Bilateral open ligation of the SPJ is generally avoided because of the potential hazards, as described above. We found that bilateral EVLA procedures were well tolerated by our five patients, four of whom
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were done under LA. This approach avoids recurrent visits by the patients for surgery. In 40% of our patients EVLA was performed under LA. The perceived advantages of LA procedures include earlier ambulation to prevent deep vein thrombosis and treatment of SVI in patients with cardiovascular or respiratory contraindications for a GA. The advantages of EVLA are particularly relevant for recurrent disease where scar tissue distorts the anatomy, making surgical exploration of the popliteal fossa technically challenging. In contrast, the six EVLA procedures that were for recurrent disease after inadequate open surgery were technically no more challenging to EVLA procedures for primary disease and were not associated with any significant complication.
CONCLUSION In conclusion, we have demonstrated that EVLA is a safe, effective, and well-tolerated alternative to conventional surgery for the treatment of SSV incompetence in patients with C2eC4 disease. EVLA with phlebectomies as well as bilateral procedures are well tolerated by patients under LA. At a mean energy density of 53 J/cm, no sural nerve injury was observed. Long-term follow-up will dictate whether this will prove to be a durable procedure.
We thank Gloria Okojie from Barts and the London NHS Trust for her help with data collection and analysis for this project.
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