Tom Wallace

Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins.

Introduction: No randomized clinical trial comparing treatment options for small saphenous vein (SSV) incompetence exists, and there is no clear evidence that this axis behaves the same as the great saphenous vein after treatment. This means that the existing literature base, centered on the treatment of great saphenous vein incompetence cannot simply be extrapolated to inform the management of SSV insufficiency. This trial compares the gold standard of conventional surgery and endovenous laser ablation (EVLA) in the management of SSV incompetence. Methods: Patients with unilateral, primary saphenopopliteal junction incompetence and SSV reflux were randomized equally into parallel groups receiving either surgery or EVLA. Patients were assessed at baseline and weeks 1, 6, 12, and 52. Outcomes included successful abolition of axial reflux on duplex, visual analog pain scores, recovery time, complication rates, Venous Clinical Severity Score, and quality of life profiling. Results: A total of 106 patients were recruited and randomized to surgery (n = 53) or EVLA (n = 53). Abolition of SSV reflux was significantly higher after EVLA (96.2%) than surgery (71.7%) (P < 0.001). Postoperative pain was significantly lower after EVLA (P < 0.05), allowing an earlier return to work and normal function (P < 0.001). Minor sensory disturbance was significantly lower in the EVLA group (7.5%) than in surgery (26.4%) (P = 0.009). Both groups demonstrated similar improvements in Venous Clinical Severity Score and quality of life. Conclusion: EVLA produced the same clinical benefits as conventional surgery but was more effective in addressing the underlying pathophysiology and was associated with less periprocedural morbidity allowing a faster recovery. (Registration number: NCT00841178.)

Comparison of 12-W Versus 14-W Endovenous Laser Ablation in the Treatment of Great Saphenous Varicose Veins 5-Year Outcomes From a Randomized Controlled Trial

Introduction: Endovenous laser ablation (EVLA) has been demonstrated to be an effective treatment for lower limb varicose veins in the short and midterm results. This study reports the 5-year outcomes of EVLA technique at different power settings. Methods: Patients with primary symptomatic, unilateral varicose veins secondary to saphenofemoral junction (SFJ) incompetence and great saphenous vein (GSV) reflux were recruited and randomized to either 12W (intermittent laser withdrawal) or 14W (continuous laser withdrawal). They were assessed at baseline, 1, 6, 12, 52, 104 weeks, and 5 years. Outcome measures included: Venous Clinical Severity Score (VCSS), pain scores, time taken to return to normal functions, complications, recurrence, quality of life (QoL), and duplex ultrasound findings. Results: 76 consecutive patients, M: F 30:46, median age 54(IQR: 37.3-59) years were randomized. Intragroup analysis: Significant improvement was seen in both groups in VCSS, pain scores, Aberdeen varicose vein questionnaire (AVVQ) scores, Shortform-36 (SF-36) and Euroqol (EQ-5D) domains over the follow-up period (P < 0.05). Intergroup analysis: Over 5 years, clinically recurrent varicosities and duplex detected SFJ incompetence was less frequent and patient satisfaction with cosmetic outcome significantly higher in the 14W group (P < 0.05). There was no significant difference between the groups in duration of procedure, postoperative pain scores, return to normal functioning, complications, VCSS, disease specific (AVVQ) and generic (SF36, EQ-5D) QoL measures (P > 0.05). Conclusion: Late outcomes following EVLA were superior for the 14W continuous power settings achieving better long term venous occlusion and lowered recurrence rates without increasing post-operative morbidity. Hence 14W continuous setting should be the energy delivery mode of choice.

Endovenous laser ablation in the treatment of small saphenous varicose veins: does site of access influence early outcomes?

Objective: The study was performed to evaluate the clinical and technical efficacy of endovenous laser ablation (EVLA) of small saphenous varicosities, particularly in relation to the site of endovenous access. Methods: Totally 59 patients with unilateral saphenopopliteal junction incompetence and small saphenous vein reflux underwent EVLA (810 nm, 14 W diode laser) with ambulatory phlebectomies. Small saphenous vein access was gained at the lowest site of truncal reflux. Patients were divided into 2 groups: access gained above mid-calf (AMC, n = 33) and below mid-calf (BMC, n = 26) levels. Outcomes included Venous Clinical Severity Scores (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), patient satisfaction, complications, and recurrence rates. Results: Both groups demonstrated significant improvement in VCSS, AVVQ, generic quality of life Short Form 36, and EuroQol scores (P < .05) up to 1 year. No differences were seen between AMC and BMC groups for complications (phlebitis: 2 [6%] and 1 [3.8%], P > .05; paresthesia: 2 [6%] and 5 [19%], P = .223) and recurrence (3 [9%] and 1 [3.8%], P = .623), respectively. Conclusions: The site of access in our study does not appear to influence complications specifically neural injury or recurrence rates.

A randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins

BACKGROUND This randomized clinical trial compared endovenous laser ablation (EVLA) and surgical ligation with attempted stripping in the treatment of small saphenous vein (SSV) insufficiency. The early results demonstrated that EVLA was more likely to eradicate axial reflux and was also associated with a faster recovery, lower periprocedural pain, and fewer sensory complications. The aim of this 2-year follow-up was to establish whether these benefits remained stable over time and whether these improved technical outcomes were associated with less clinical recurrence. METHODS Patients with primary saphenopopliteal junction and SSV reflux were randomized to EVLA or saphenopopliteal junction ligation and attempted stripping/excision. Outcomes assessed at 2 years included the presence of residual or recurrent reflux, clinical recurrence, sensory complications, the need for secondary intervention, and patient-reported quality of life on the Aberdeen Varicose Veins Questionnaire, SF-36, and EuroQol. RESULTS Of 106 patients who were equally randomized and successfully treated according to the protocol, 88 (83%) were successfully assessed at 2 years. The groups were comparable at baseline. At 2 years, EVLA remained superior to surgery in eradicating axial reflux in 36 patients (81.2%) compared with 29 (65.9%) in the surgery group (P = .002). There was no significant difference in clinical recurrence (EVLA: seven of 44 [16%] vs surgery: 10 of 44 [23%]; P = .736), sensory disturbance (EVLA: one [2.4%] vs surgery vs three [6.8%]; P = 1.000) or any quality of life domain. CONCLUSIONS The results of treatment of SSV insufficiency with EVLA appear durable up until 2 years. The study does not appear to suggest that the improved abolition of reflux after EVLA compared with surgery is associated with superior outcomes than those seen after surgery by this time point, because equal effect was shown in both groups. The sensory disturbance associated with surgery appears to settle over this time frame. EVLA is therefore superior in the short-term and not inferior by 2 years.

A comparison of the effectiveness of treating those with and without the complications of superficial venous insufficiency.

Objective:To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency (SVI) have greater benefits from treatment than those with only symptomatic varicose veins. Background:A commonly held view is that SVI is only a minor ailment, yet randomized clinical trials (RCTs) show that treatment improves quality of life (QoL) and is cost-effective. In an effort to curb the treatment costs of this common disorder, rationing is applied in many health care systems, often limiting the reimbursement of treatment to those with soft tissue changes. Methods:This cohort study draws its data from an interventional RCT. After informed consent, consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation. This analysis differentially studies the outcomes of patients with simple varicose veins (C2: n = 191) and soft tissue complications (C3–4: n = 76). Effectiveness outcomes measured up to 1 year included the following: Qol [short form 36 (SF36), EuroQol, and the Aberdeen Varicose Veins Questionnaire], clinical recurrence, and the need for secondary procedures. Multivariable regression analysis was used to control for potential confounding factors. Results:Both groups saw significant improvements in QoL. All improvements were equal between groups apart from the SF36 domain of Bodily Pain, where C2 saw an improvement of 12.8 [95% confidence interval (CI): 4.8–20.8] points over C3–4 participants (P = 0.002), who also suffered more recurrence [odds ratio (OR) = 2.7, 95% CI: 1.2–6.1, P = 0.022] and required more secondary procedures (OR = 4.4, 95% CI: 1.2–16.3, P = 0.028). Conclusions:This study suggests that rationing by clinical severity contradicts the evidence. Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence. Trial registration:NCT00759434 Clinicaltrials.gov

Defining the optimum tumescent anaesthesia solution in endovenous laser ablation.

Objectives To produce a tumescent anaesthesia solution with physiological pH for endovenous thermal ablation and evaluate its influence on peri- and postoperative pain, clinical and quality of life outcomes, and technical success. Methods Tumescent anaesthetic solution (0.1% lidocaine with 1:2,000,000 epinephrine) was titrated to physiological pH by buffering with 2 ml incremental aliquots of 8.4% sodium bicarbonate. Patients undergoing great saphenous vein endovenous laser ablation and ambulatory phlebectomy were studied before and after introduction of buffered tumescent anaesthetic. Primary outcome was perioperative pain measured on a 10 cm visual analogue scale. Secondary outcomes were daily pain scores during the first postoperative week, complications, time to return to normal activity, patient satisfaction, generic and disease-specific quality of life, and technical success. Patients were assessed at baseline, and at 1, 6 and 12 weeks following the procedure. Results A physiological pH was achieved with the addition of 10 ml of 8.4% sodium bicarbonate to 1 l of standard tumescent anaesthetic solution. Sixty-two patients undergoing great saphenous vein endovenous laser ablation with phlebectomy were recruited before and after the introduction of buffered tumescent anaesthetic solution. Baseline and operative characteristics were well matched. The buffered solution was associated with significantly lower (median (interquartile range)) periprocedural pain scores (1 (0.25–2.25) versus 4 (3–6), p < 0.001) and postoperative pain score at the end of the treatment day (1.8 (0.3–2.8) versus 3.0 (1.2–5.2), p = 0.033). There were no significant differences in postoperative pain scores between the groups at any other time. There were no significant differences in other clinical outcomes between the groups. Both groups demonstrated significant improvements in generic and disease-specific quality of life, with no intergroup differences. Both groups demonstrated 100% ultrasonographic technical success at all time points. Conclusions Buffering of tumescent anaesthetic solution during endovenous thermal ablation is a simple, safe, inexpensive and effective means of reducing perioperative and early postoperative pain.

A systematic review of the compression regimes used in randomised clinical trials following endovenous ablation

Objectives There is insufficient evidence to inform guidelines on the optimal compression strategy following ablation for varicose veins. This study aimed to identify the practice of key opinion leaders performing randomised clinical trials involving endovenous ablation. Method A systematic review of MEDLINE/EMBASE/CENTRAL was performed identifying the compression strategies used in randomised clinical trials where at least one comparator arm underwent endovenous ablation. Results Thirty-four randomised clinical trials were identified. At least 14 different compression products were used, with at least 6 different pressures in 7 different regimes with durations from 2 to 84 days. There was no evidence of any convergence of practice over time. Conclusions A lack of evidence as to the optimal strategy for compression has resulted in a marked variation in clinical practice. There is no suggestion that this variation is becoming less over time indicating that experience is not helping to form a consensus and, therefore, further research is required.

Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: A systematic review

OBJECTIVE Dialkylcarbomoyl chloride (DACC)-coated dressings (Leukomed Sorbact and Cutimed Sorbact) irreversibly bind bacteria at the wound surface that are then removed when the dressing is changed. They are a recent addition to the wound care professionals armamentarium and have been used in a variety of acute and chronic wounds. This systematic review aims to assess the evidence supporting the use of DACC-coated dressings in the clinical environment. METHOD We included all reports of the clinical use of DACC-coated dressings in relation to wound infection. Medline, Embase, CENTRAL and CINAHL databases were searched to September 2016 for studies evaluating the role of DACC-coated dressings in preventing or managing wound infections. RESULTS We identified 17 studies with a total of 3408 patients which were included in this review. The DACC-coating was suggested to reduce postoperative surgical site infection rates and result in chronic wounds that subjectively looked cleaner and had less bacterial load on microbiological assessments. CONCLUSION Existing evidence for DACC-coated dressings in managing chronic wounds or as a surgical site infection (SSI) prophylaxis is limited but encouraging with evidence in support of DACC-coated dressings preventing and treating infection without adverse effects.

Evolution of an endovenous laser ablation practice for varicose veins

Objective: We aimed to assess the evolution of an endovenous laser ablation (EVLA) practice in the management of varicose veins in a university teaching hospital vascular surgical unit, over five years. Methods: This was a retrospective review of a prospectively collected database of patients undergoing EVLA for great saphenous vein incompetence and followed up for a year. For inter- and intragroup comparison, patients were divided into three groups: group A: endovenous access generally established at the perigenicular level (n = 105); group B: when practice changed to gain access at lowest point of demonstrable reflux (n = 70); and group C: when tumescence delivery changed from manual injections to delivery via peristaltic pump (n = 49). Outcomes including pain scores, time taken to return to normal functioning, quality of life (QoL), venous clinical severity scores (VCSS) and complication rates were evaluated. Results: Intergroup analysis: increase in the length of vein treated and laser density delivered was observed over time, even as median procedure duration decreased (P < 0.001). An increase in sensory disturbance was noticed in group C (P = 0.047) while better Aberdeen Varicose Vein Questionnaire (AVVQ) (P = 0.004), SF-36® physical domains (P < 0.05) and patient satisfaction with treatment (P = 0.025) were recorded in the same group at 52 weeks. No significant difference was observed in technical failure, pain scores, return to normal functioning, VCSS and recurrence rates post-intervention. Intragroup analysis: QoL measures (AVVQ, SF-36®, EQ-5D) and VCSS scores demonstrated significant improvement at 12 and 52 weeks compared with baseline (P < 0.05). Conclusions: Increase in length of vein treated and energy delivery seems to improve short-term outcomes; however, operators need to be wary of a possible concurrent increase in paraesthetic complications.

IF08. A Randomized Controlled Trial Comparing Endovenous Laser Ablation vs Mechanochemical Ablation in the Treatment of Superficial Venous Incompetence: The LAMA Trial

reduced by the use of drug-coated balloons. However, dose, coating composition, and technology are decisive for efficacy. Methods: The study prospectively randomized 200 Chinese patients with peripheral arterial occlusive disease to treatment with new paclitaxel-coated or standard uncoated balloon catheters. The primary end point was angiographic late lumen loss (LLL) at 6 months measured by a blinded core laboratory. Secondary angiographic end points (6 months) and specific clinical end points (1 year) were binary restenosis, anklebrachial index, Rutherford stage, clinically driven target lesion revascularization (TLR), and amputation. Results: The patient population was 74% male, 66 years old, 31% smokers, and 55% diabetic. They were at Rutherford stage 2 to 5, lesion length was 150 mm, 25% in-stent restenosis, 55% occlusion or partial occlusion, and 20% provisional stenting. LLL at 6 months was available for 89%, clinical follow-up for >95% per group. LLL was 0.05 6 0.73 mm for coated balloons and 1.15 6 0.89 mm for uncoated balloons (P < .001); correspondingly, restenosis rate was 22.5% vs 70.8% (P < .001). After 1 year, the TLR rate was 7.2% vs 39.6% (P < .001). Rutherford class and ankle-brachial index improved more markedly in the coated group (P < .046 and .023, respectively). One major amputation was recorded in the control group. No coating-related adverse events were observed for doses of up to 43 mg paclitaxel/patient. After 24 months, primary patency was 64.6% vs 31.4% and the TLR rate was 13.5% vs 41.1%. There were no significant between-group differences in the rates of death and major amputation. Conclusions: In this medium-sized trial with long superficial femoral artery lesions, use of paclitaxel-coated balloon catheters markedly improved angiographic and clinical outcome of interventions despite advanced disease in the majority of patients.