Servier – Phlebolymphology

Endovenous therapies of saphenous veins, the evidence.
R. van den Bos

Endovenous thermal ablation (EVTA) techniques are commonly used and very effective for saphenous vein insufficiency and are recommended as first-choice treatments in several national guidelines (UK, USA, and Holland). The author presented the first large meta-analysis on great saphenous vein (GSV) treatment from randomized controlled trials (RCTs) only (Siribumrungwong et al. Eur J Vasc Endovasc Surg. 2012;44:214-223). This study analyzed the efficacy, complications, postoperative pain, time to return to normal activities, and QOL scores.

Endovenous laser ablation (EVLA), radiofrequency ablation (RFA), and surgery were equally effective. Ultrasound-guided foam sclerotherapy (UGFS) was 10% to 15% less effective than surgery and EVTA. EVTA has less postoperative complications than surgery (less wound infections, less hematoma, lower pain scores, quicker return to work, and no difference in venous thromboembolism). The short saphenous vein is best treated with EVTA or UGFS (complex treatment because of anatomy; more sural nerve injury after surgery than after EVTA; the puncture site in EVTA should be in the upper half of the calf). There is no evidence that EVLA wavelength matters. There is evidence that the fiber tip influences postoperative pain and bruising by perforations. Less perforations and less pain are seen with a tulip tip compared with the bare tip. After RFA, there seems to be less pain than after EVLA.

The author concluded that: (i) EVTA is the first choice for GSV; (ii) EVTA and UGFS are the first choice for the small saphenous vein (SSV); (iii) wavelength does not matter; (iv) tulip tip is less painful than bare tip; (v) RFA is less painful than EVLA; and (vi) there is no evidence from RCTs regarding mechanicochemical ablation (MOCA), glue, and steam, yet.

Medium-term follow-up after the different techniques: RCT comparing surgery, chemical, and thermal ablation.
L. Rasmussen

The author presented his study comparing the 3-year outcomes after treatment of varicose veins by radiofrequency ablation (ClosureFast, CLF), laser ablation (EVLA), ultrasound-guided foam sclerotherapy (UGFS), or high ligation and stripping. A total of 500 patients (580 legs) were randomized to one of the treatments. Results: At 3 years, 8 (Kaplan-Meier (KM) estimate, 7%), 8 (KM estimate, 6.8%), 31 (KM estimate, 26.4%), and 8 (KM estimate, 6.5%) of the GSVs were recanalized or had a failed stripping procedure (P<0.01) from treatment with CLF, EVLA, UGFS, and high ligation and stripping, respectively. In addition, 17 (KM estimate, 14.9%), 24 (KM estimate, 20%), 20 (KM estimate, 19.1%), and 22 (KM estimate, 20.2%) legs developed recurrent varicose veins from treatment with CLF, EVLA, UGFS, and high ligation and stripping, respectively (NS). The patterns of reflux and location of recurrent varicose veins were not different between the groups. Within 3 years after treatment, 12 (KM estimate, 11.1%), 14 (KM estimate, 12.5%), 37 (KM estimate, 31.6%), and 18 (KM estimate, 15.5%) legs were retreated in the CLF, EVLA, UGFS, and stripping groups, respectively (P<0.01). Venous Clinical Severity Score (VCSS), 36-Item Short Form Health Survey (SF- 36), and Aberdeen QOL scores improved significantly in all groups with no difference between the groups. He concluded that all treatment modalities were efficacious and resulted in a similar improvement in VCSS and QOL. However, more recanalization and reoperations were seen after UGFS.

Quality of life after varicose vein surgery. Does the current evidence favor one method over another?
A. Mansilha

Quality of life (QOL), internationally defined by the World Health Organization as “the product of the interplay between social, health, economic, and environmental conditions, which affect human and social development,” has gradually increased its importance, once it reflects the patient’s perspective and sensitivity regarding the influence of the disease in daily life.

Nowadays, there is a growing interest for patient-reported outcomes and the use of QOL questionnaires in patients suffering from CVD, which can provide important information regarding burden of illness that otherwise would not be able to be obtained. The association established between QOL (based on QOL questionnaires) and the severity of disease progression, highlights the importance of patients’ QOL assessments.

Despite all this growing interest in the patient’s perspective and the large number of surgeries performed every year, there is a deficiency in the published data regarding QOL life assessments in patients with varicose veins. Several physician-generated measurements tools have been used, such as the Clinical, Etiologic, Anatomic, and Pathophysiologic classification (CEAP classification) and the Venous Severity Scoring System (VSSS). Nevertheless, patient-generated QOL tools have gained significant relief, which enables monitoring disease progression and response to treatment, as well as assessing quality of care provided and allowing the provision of important information not properly expressed by the statistical values of morbidity and mortality that physicians traditionally use.

Among the patient-generated measurement tools, generic instruments, such as the 36-Item Short Form Health Survey (SF-36) or Nottingham Health Profile (NHP), allow comparisons across populations of patients with different diseases, while diseasespecific instruments, such as the Chronic Venous Insufficiency Questionnaire (CIVIQ), Venous Insufficiency Epidemiological and Economic Study–Quality of Life questionnaire (VEINES-QOL), the Aberdeen Varicose Vein Questionnaire (AVVQ), or Charing Cross Venous Ulceration Questionnaire (CXVUQ), are more sensitive to key dimensions of quality of life that are affected by specific diseases.

Is Endothermal Heat Induced Thrombosis (EHIT) depending on the learning curve?
L. Kabnick

Endothermal Heat Induced Thrombosis (EHIT) of the great saphenous vein is an expected outcome after endovenous ablation, but what remains unclear is the clinical outcome of patients who present with this entity in close proximity to, or with an extension into, the common femoral vein. With an incidence in the literature ranging from 0% to 16% (1 to 3), this has gained the attention of physicians treating this disease process. The following is the description for EHIT Classification: Class 1, venous thrombosis to the superficial-deep junction (ie, saphenofemoral junction or saphenopopliteal junction, but not extending into the deep system); Class 2, nonocclusive venous thrombosis, with an extension into the deep system of a cross-sectional area less than 50%; Class 3, nonocclusive venous thrombosis into the deep venous system, with an extension into the deep system of a cross-sectional area more than 50%; and Class 4, occlusive deep vein thrombosis of the common femoral vein. The author presented the experience of his center regarding EHIT, examining the extent of echogenicity within the thermally induced thrombosis, and comparing it with de novo thrombosis seen within a typical deep venous thrombosis (DVT). From October 2007 to December 2010 at the New York University Vein Center, 2672 procedures (Endovenous laser ablation [EVLA], 662; radiofrequency ablation [RFA], 2010) were performed. There were 78 EHIT II (EVLA, 21 vs RFA, 57) resulting in a total of 2.9%. Of note, there was a diminishing trend among interventionalists: first year, 5.2%; second year, 1.8%; and third year, 0.4%. He concluded that EHIT II rates may differ in patients treated using EVLA as compared with RFA and that frequency of EHIT II may diminish with increasing institutional experience. He finished by stating that, in his opinion, the presence of EHIT II will not reach 0.

When can the treatment of venous reflux for open ulcers (C6) be justified?
M. Gohel

The author started by stating that venous ulcers are a distressing and expensive condition, which is increasingly common as the population aged more than 65-yearsold is estimated to grow in the next twenty years. Then, he described the different forms of reflux: (i) isolated superficial reflux (50% to 60%); (ii) superficial and segmental deep reflux (25% to 30%); and (iii) superficial and total deep reflux (10% to 15%).

In fact, the importance of treatment of venous reflux in patients with chronic venous ulceration was demonstrated unequivocally in the ESCHAR trial (Effect of Surgery and Compression on Healing And Recurrence; Gohel MS et al. BMJ. 2007;335:83). Superficial venous surgery resulted in a significantly lower ulcer recurrence rate at 4 years.

However, no healing benefit was seen, resulting in the perception among many clinicians that there is no role for treating superficial reflux in patients with C6 disease. However, there are many reasons to challenge this dogma. The influence of treating superficial reflux is likely to have been significantly underestimated in the ESCHAR trial. Twenty percent of patients in the surgery group refused to have surgery (but were analyzed on intention to treat). The median delay to surgery was 7 weeks and surgical interventions would be considered suboptimal by modern endovenous standards, with residual reflux frequently seen (a quarter of the procedures were saphenofemoral junction [SFJ] or saphenopopliteal junction [SPJ] ligations alone). Moreover, the rapid and widespread adoption of office-based, endovenous interventions has meant that many patients are now entirely suitable and willing to undergo minimally invasive endovenous ablation procedures. In addition, it is unreasonable to extrapolate the findings of a study where patients were generally compliant with compression, to the overall leg ulcer population, where compression therapy is often poorly tolerated. In fact, the author suggested that superficial reflux should be treated if effective compression is not achieved.

Recent nonrandomized studies have proposed that excellent venous ulcer healing rates can be achieved by aggressive ablation of superficial reflux with ultrasoundguided foam sclerotherapy, far higher than published healing rates with compression alone (Kulkami et al. Phlebology. 2013;28:140-146). For these reasons, the Early Venous Reflux Ablation ulcer study (EVRA) was planned. Recently, researchers have started recruiting patients at six centers in the UK. The study aims to evaluate the role of early endovenous ablation of superficial reflux (within 2 weeks), in addition to compression bandaging in patients with chronic venous ulceration. The primary outcome is time to ulcer healing.

The author concluded that the perception that there is no benefit in treating superficial venous reflux in patients with active venous ulceration (C6) is probably not justified. There is strong rationale for reflux ablation in patients who have poor compliance with compression. The results of the EVRA ulcer study should help clarify whether early superficial venous intervention should become an early part of treatment for all patients with venous ulcers.

Is it safe to treat varicose veins by thermal ablation below the knee?
P. Gloviczki

Thermal injuries to the saphenous or sural nerves have been major concerns that limited widespread use of endovenous thermal ablations below the knee (BK). Incidence of nerve injuries as high as 39% have been reported with stripping of the BK segment of the great saphenous vein (GSV). Meanwhile, BK-GSV reflux is reported in up to 81% of patients, increasing to 91% at 2 years following above the knee (AK) GSV ablation.

Ignoring the refluxing BK-GSV is reported to result in residual symptoms and a need for reintervention in nearly half of the patients.

The author’s group recently presented results of patients treated with thermal ablation of the BK-GSV (Gifford et al. J Vasc Surg: Venous Lymph Dis. 2013;1:112). The study included 387 patients treated between January 2010 and August 2012. Results of 38 patients who underwent thermal ablation of the BK-GSV on 47 limbs were retrospectively reviewed. There were 22 females and 16 males, with a mean age of 51 years. Twentyseven limbs were treated for simple varicose veins (Clinical, Etiologic, Anatomic, and Pathophysiologic classification (CEAP) of C1-C3) and 20 for advanced insufficiency (C4-C6). Ablation was performed in 45 limbs (97%) utilizing the VenaCure EVLTTM laser vein treatment (AngioDynamics, Queensbury, NY) and 2 limbs using radiofrequency ablation (RFA) with the ClosureFAST system (VNUS Medical Technologies, San Jose, CA). Mean GSV length ablated was 51.6 cm (range, 26 to 65 cm). Ambulatory stab phlebectomies of branch varicosities were performed simultaneously in 37 (79%) limbs. All patients had tumescent anesthesia with circumferential injection immediately around the saphenous vein. All limbs were evaluated with ultrasound within 24 hours. There were no skin burns or evidence of endovenous heat-induced thrombosis. Transient hyperesthesia occurred in one patient (2.1%), which resolved in two weeks. Reinterventions were not needed during follow-up, despite two early recanalizations.

Excellent results of small saphenous vein endovenous thermal ablations have been reported in the literature, with minor sensory deficits in 2.2% to 7.5%, with a lower chance of nerve injury when the vein was punctured at the mid-calf level and using large amounts of tumescent infusion, without an effect on recanalization rates. Routine visualization of the nerve using ultrasound was also reported. Paresthesia rates as high as 8% to 13% were observed after thermal ablation of the BK-GSV.

The author concluded that endovenous ablation below the knee can be performed safely, with a low rate of minor complications. Neuralgia cannot be completely excluded with thermal ablations of below the knee saphenous veins; however, evidence in the literature suggests that puncturing at mid-calf level and using large amount of tumescent anesthesia will result in a lower probability of nerve injury. Nevertheless, further studies are needed to investigate the benefit of routine duplex scanning of the sural or saphenous nerves and to determine what type of anesthesia can or cannot be used for these patients.

Clarivein: the answer to avoiding heat treatment?
A. Davies

Ablation of truncal varicose veins has undergone significant changes in the last 10 years. The development of endothermal techniques (ET) to ablate truncal veins has led ET to replace classic surgery. Meanwhile, ET generally involves the use of tumescent anesthesia. However, even less invasive techniques are being developed. Clarivein is a mechanical and chemical technique that does not require tumescent anesthesia. Clarivein has a rotating tip that agitates and sensitizes the endothelium. Simultaneously, a sclerosant drug is sprayed from the tip of the catheter ensuring precise longitudinal and radial drug delivery, occluding the vein. The early outcomes show similar results at year 1 compared with ET (Elias S et al. Phlebology. 2013;1:10-14). It would seem, on basic modeling, that it is as cost-effective as ET. Techniques of retrograde ablation may have a particular role in the management of patients with venous ulceration.

The author concluded that Clarivein is a novel technique that has many potential benefits over endothermal ablation and the results of ongoing randomized controlled trials will help determine whether potential benefits exist.