Initially Clinical Experiences in Treating 27 Cases of Varicose Veins
with EVLT plus Trivex
Shiyan Ren1*, Erqiang Ye1, Liu Peng2, Xuejun Tian1
Abstract: We reported our preliminary experiences of the new surgical endoscope technique, Endovenous laser treatment (EVLT) plus Trans-illuminated Varicose Vein Extraction (Trivex), a system for the management of varicose veins to prospectively evaluate the safety, efficacy and clinical benefits of this new surgical device. Twenty-nine great saphenous veins (GSV) in 27 patients of clinical stages C2-6, EP, AS, P, PR with incompetent GSV proven by means of duplex scanning were treated with EVLT and Trivex. Since half a month after procedure, patients wore elastic stockings for 3 months to enhance the effect of procedure. Patients were followed up on months 0.5, 1, 3 and 6 to evaluate the efficacy and complications of the treatment. Patients had no relapse of the varicose vein and had few side effects such as numbness and blister due to the laser burn. So EVLT plus Trivex is a safe, minimally invasive approach for GSV, and the short-term results are satisfactory and impressive.
Key words: EVLT; Trivex; varicose veins; saphenous veins
About 25% female and 15% male suffered from lower extremity superficial venous insufficiency [1, 2] and chronic venous insufficiency, such as venous ulcers, is often solely caused by superficial venous disorders [3, 4]. Great saphenous vein (GSV) is the major vein of the superficial venous system. GSV reflux is often related to large superficial varices. Aim of treating GSV is to eliminate the source of reflux by ablating the incompetent veins. The traditional approach in treatment of varicose veins is high ligation and stripping, which has considerable side effects of surgery. Endovenous laser treatment (EVLT) is the new minimally invasive technique. We performed 27 patients with varicose veins using the EVLT plus trans-illuminated varicose vein extraction (Trivex), and reported our early initial experiences of this new technique.
MATERIALS AND METHODS
A total of 27 patients treated at China-Japan Friendship Hospital and the Second Hospital of Tsinghua University from April to December in 2004 were selected based on CEAP classification and ultrasound scan for this endovenous procedure. All patients were provided the informed consent for the procedure and awarded of the alternative treatment available risks involved, and other issues conforming to the standard of care for informed consent practices. All patients had reflux of over 5 seconds in the GSV.
Patients with varicose veins caused by incompetence of the saphenous-femoral junction (SFJ) with GSV reflux were demonstrated by duplex US imagine. Ultrasound scan was used to select the patients with GSV with maximal diameter of 10mm in supine position and without a tortuous. The GSV was markedly prior to the surgery on skin from the distal point at the ankle to the SFJ. The Boyd's perforator was clearly marked.
The operation was done with epidural anesthesia with the patient in a supine position. Our procedure was according to the literature with some modification. GSV was accessed at the ankle percutanously with intravenous cannula or via small surgical incision in case of failure in intravenous cannula. If difficulties were encountered in inserting GSV, access can be obtained 5-10 cm below the knee. A guide wire was entered via the IV canula, then the cannula was taken out, and the 5-F introducer sheath was brought over a J-shaped guide wire. Length of the sheath varied depending on the length of GSV to be treated. The sterile, bare-tipped 600Ž╠m diameter laser fiber was passed prograde through the sheath and positioned in the proximity of the GSV in order to obliterate branches of the GSV. The critical point was to be sure that distal end of the laser fiber was positioned 2 cm below the SFJ with the confirmation of direct visualization of the red aiming beam of the laser fiber through the skin. Introluminal position in the GSV was determined by aspiration of non-pulsatile venous blood. During the treatment, manual pressure was applied over the red aiming beam for squeezing away venous blood and allowing venous wall to contact with laser fiber tip closely. Energy was released while the laser fiber was withdrawn slowly at 5 mm per pulse. The parameters we used were 12W with 1s pulse duration. Laser energy was released directly into the blood vessel lumen to damage endothelial of the vein and venous wall and thus caused subsequent fibrosis.
Since the tortuous veins are difficult to be obliterated with laser fiber, Trivex was applied for patients with obvious and severe varicosities. Trivex includes the trans-illuminator, irrigator and the powered resector. The trans-illuminator and irrigator were used to visualize the varicosities and infuse tumescent anesthesia (one liter saline containing 1mg of epinephrine and 20ml of 2% lidocaine) before and after resection, and it aided in partial exsanguinations of the veins, hemostasis, and pain relief. The resector was placed immediately under or next to the varicosities in the subcutaneous tissue. The veins were then suctioned into the rotating blade, and simultaneously they were cut into small pieces and then were suctioned and removed.
A total of 27 patients, including 12 men and 15 women, were found to be incompetent of the GSV. The gender ratio found in our study was related to the figures in the literature. The youngest patients was 30 years and eldest was 78, with average at 45 years. The character of the treated patients was showed in table 1.
Table 1. Characteristics of the treated patients
Character of the treated patientsNumberNumbers of patients treated27Male12Female15Right legs11Left legs16Age range30-78Average age45CEAP classification4CEAP classification after surgery1.3Mean surgical time (minutes)55 (30 -120)Percutanous access to the veins at ankle18Surgical access at the knee15Mean hospital stay (days)3 (1-6)
After being treated with EVLT and Trivex, all patients wore the roll-on elastic bandage (PKU-SUG-Medical, Beijing). We had 8 patients failed to access at the ankle percutaneously and therefore we accessed the GSV at the knee level surgically with a small incision. In two patients, we encountered difficulties in introducing the laser fiber into the vein, and thus small incisions at the groin were made to dissect and ligate the proximal side of the GSV and introduce the laser fiber downward the distal side of GSV to obliterate it. In case of severe varicose veins or thrombosis, we incised over the lesions for removal the lesion and ligating the perforating veins . For instance, one patient had venous thrombosis in the varicose vein and was demonstrated with round solid mass on the course of the vein below the right knee (Fig. 1, 2); we incised the round mass and removed it, then inserted the laser fiber into the proximal side of the vein. The number and size of incision in our new procedure were fewer and smaller than those in traditional operation (Fig. 3).
Fig. 1 Varicose vein on left leg before (left panel) and after (right panel) treatment with VELT plus Trivex for 12 days
Fig. 2 Venous thromboses removed from patient in figure 1 (left panel) and longitudinal transaction of the mass showing the thrombi in the vein (right panel)
Fig. 3 Traditional procedure or management of varicose veins has the centipede like
surgical scars and long hospital stay
Patients could walk immediately after the procedures, but we requested the patients to rest on bed for 6 hours with movement of feet and then encouraged them to walk. The post-operative complications consisted of second-degree burn on the course of GSV, and the burn faded away with minimal discoloration of the skin within 2 weeks. 6 patients had saphenous nerve anesthesia demonstrated with numbness and the symptoms disappeared within 2-3 months (Table 2).
Table 2. Complications during or after procedure
ComplicationsNumbers of patientsM/FSideDuring surgeryAfter surgeryEdema of foot32M/1F2R/1L+Hematoma1MR+Numbness52M/1F2L/1R+Blister of burn22M2R+
M=Male, F=Female, R=Right, L=Left
During the procedure, small incisions about 4-15mm in length were made to insert laser fiber or Trivex equipment, and the sutures were removed 10-14 days after the surgery, then the elastic stocking were used to enhance the effect of procedure. All the patients were followed up on 0.5,1,3, 6 months and 1, 2, 3 years, including the clinical features and the ultrasound scan, within 6 months of follow-up, no relapse of the GSV was found in these 27 patients.
For the last decade, minimally invasive techniques in management of venous disorders have developed greatly, including Trans-illuminated Powered Phlebectomy, Radiofrequency Ablation Greater Saphenous Vein Closure, Laser Ablation Greater Saphenous Vein (EVLT), Subfascial Endoscopic Perforator Surgery and Percutaneous Vein Valve Bioprosthesis. EVLT belongs to minimally invasive surgery, and it has reduced the number and size of incisions, surgical time and recovery time, even operative morbidity. In our hospital, EVLT can be done within 5-10min, and the Trivex in 10-15min. Furthermore, the results were as durable as that of the open procedures with increased patient satisfaction. The mean hospital stay in our hospital is 3 days. In fact, we encourage the patients to be discharged on the following day of the procedure, however, due to the medical insurance issue and low cost of hospital stay, most patients preferred to stay in hospital longer.
EVLT has a few preventable side effects. We have encountered several complications of EVLT. When varicose vein was accessed with cannula and after the obliteration of the veins, we found the hematoma occurred around the external side of ankle, which was due to inappropriate handle or failure of compression of the obliterated vein, and the blood overflowed from the damaged vessel. Blisters or second degree of burn caused by laser heat could be found on 1-2 days after the procedure. This resulted from the inappropriate amount of power the laser released and the wrong position of the laser fiber. We used 12W in upper legs and 10W in lower legs with frequency of 1 second per pulse to minimize the heat burn, and also we assured to insert the laser fiber into the right spot in the veins in order to obliterate the veins precisely.
Trans-illuminated Varicose Vein Extraction (Trivex), or Trans-illuminated Powered Phlebectomy (TIPP) is a mechanical method of ablating branch varicosities. Trivex involves small surgical incision and an operative time of 16~20 minutes . The Trivex or TIPP technique developed by Chesire et al. has been utilized since early 2000, when the initial clinical trials were completed . Advantages of this minimally invasive surgical technique include short operative time, few incisions, and accurate removal of varicosities due to better visualization. Complications of Trivex consist primarily of bruises, hematoma and fat necrosis, which are similar to adverse events of traditional excision and can be minimized with experiences . Saphenous nerve companies with course of saphenous vein below the knee, and therefore it is not surprising to have numbness following the procedures due to the damage of saphnous nerve. There were 5 of 27 treated patients who complained of numbness after the Trivex treatment, but the numbness did not influence daily life such as walking. The best way to avoid this complication is to ablate the varicose vein exactly and to damage the vicinal tissues as less as possible.
In conclusion, both EVLT and Trivex have their advantages, and when combined, performed as an outpatient procedure with few small incisions, they can improve the clinical outcome. FurthermoreúČinpatients have less hospital stay, surgical scars and even post-operative morbidity compared with traditional open procedures. Our short-term outcomes are satisfactory and consistent with that in literatures [5-7]. However, the long-term results are under follow-up and require further evaluation.
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(Edited by Xiaoman Ling, Yanling Xiao and Lian Hu )
*Corresponding to Shiyan Ren, male, MD, associate Chief Surgeon, English Editor of World Journal of Gastroenterology. He once received his postdoctoral training of UCSF-Stanford Medical Center,USA and continued his study in UBC-BCCA,Canada; Main research fields: micro-invasive surgery such as EVLT and Trivex, liver transplantation; Tel: 010-86214220; E-mail: email@example.com
1 General Surgery, Second University Hospital, Tsinghua University, Beijing, Postcode: 100049
2 Cardiovascular Surgery, China-Japan Friendship Hospital, Beijing, Postcode: 100029