Daniel Carradice

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.

Systematic review of compression following treatment for varicose veins

Consensus regarding compression following treatment of varicose veins has yet to be reached. This systematic review aims to establish the optimal compression regimen after venous treatment.

Endovenous thermal ablation for healing venous ulcers and preventing recurrence

BACKGROUNDnVenous leg ulcers represent the worst extreme within the spectrum of chronic venous disease. Affecting up to 3% of the adult population, this typically chronic, recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The current mainstay of treatment for venous leg ulcers is compression therapy, which has been shown to enhance ulcer healing rates. Open surgery on the veins in the leg has been shown to reduce ulcer recurrence rates, but it is an unpopular option and many patients are unsuitable. The efficacy of the newer, minimally-invasive endovenous thermal techniques has been established in uncomplicated superficial venous disease, and these techniques are now beginning to be used in the management of venous ulceration, though the evidence for this treatment is currently unclear. It is hypothesised that, when used with compression, ablation may further reduce pressures in the leg veins, resulting in improved rates of healing. Furthermore, since long-term patient concordance with compression is relatively poor, it may prove more popular, effective and cost-effective to provide a single intervention to reduce recurrence, rather than life-long treatment with compression.nnnOBJECTIVESnTo determine the effects of superficial endovenous thermal ablation on the healing, recurrence and quality of life of people with active or healed venous ulcers.nnnSEARCH METHODSnIn August 2013 we searched Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions on the language of publication but there was a date restriction based on the fact that superficial endovenous thermal ablation is a comparatively new medical technology.nnnSELECTION CRITERIAnRandomised clinical trials comparing endovenous thermal ablative techniques with compression therapy alone for venous leg ulcers were eligible for inclusion. Trials had to report on at least one objective measure of ulcer healing (primary outcome) such as proportion of ulcers healed at a given time point, time to complete healing, change in ulcer size, proportion of ulcers recurring over a given time period, or at a specific point, and ulcer-free days. Secondary outcomes sought included patient-reported quality of life, economic data and adverse events.nnnDATA COLLECTION AND ANALYSISnDetails of potentially eligible studies were extracted and summarised using a data extraction table. Data extraction and validity assessment were performed independently by two review authors, and any disagreements resolved by consensus or by arbitration of a third review author.nnnMAIN RESULTSnNo eligible randomised controlled trials were identified. There is an absence of evidence regarding the effects of superficial endovenous thermal ablation on ulcer healing, recurrence or quality of life of people with venous leg ulcer disease.nnnAUTHORS CONCLUSIONSnThe review identified no randomised controlled trials on the effects on ulcer healing, recurrence or quality of life, of superficial endovenous thermal ablation in people with active or healed venous leg ulcers. Adequately-powered, high quality randomised controlled trials comparing endovenous thermal ablative interventions with compression therapy are urgently required to explore this new treatment strategy. These should measure and report outcomes that include time to ulcer healing, ulcer recurrence, quality of life and cost-effectiveness.

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

BACKGROUNDnThis 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.nnnMETHODSnPatients 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.nnnRESULTSnOf 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.nnnCONCLUSIONSnThe 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.

Compression regimes after endovenous ablation for superficial venous insufficiency--A survey of members of the Vascular Society of Great Britain and Ireland.

Introduction The optimal compression regime following ultrasound guided foam sclerotherapy (UGFS), radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) for varicose veins is not known. The aim of this study was to document current practice. Methods Postal questionnaire sent to 348 consultant members of the Vascular Society of Great Britain and Ireland. Results Valid replies were received from 41% (nu2009=u2009141) surgeons representing at least 68 (61%) vascular units. UGFS was used by 74% surgeons, RFA by 70% and EVLA by 32%, but fewer patients received UGFS (median 30) annually, than endothermal treatment (median 50) – Pu2009=u20090.019. All surgeons prescribed compression: following UGFS for median seven days (range two days to three months) and after endothermal ablation for 10 days (range two days to six weeks) – Pu2009=u20090.298. Seven different combinations of bandages, pads and compression stockings were reported following UGFS and four after endothermal ablation. Some surgeons advised changing from bandages to stockings from five days (range 1–14) after UGFS. Following endothermal ablation, 71% used bandages only, followed by compression stockings after two days (range 1–14). The majority of surgeons (87%) also treated varicose tributaries: 65% used phlebectomy, the majority (65%) synchronously with endothermal ablation. Concordance of compression regimes between surgeons within vascular units was uncommon. Only seven units using UGFS and six units using endothermal ablation had consistent compression regimes. Conclusion Compression regimes after treatments for varicose veins vary significantly: more evidence is needed to guide practice.

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 2u2009ml 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 10u2009cm 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 10u2009ml of 8.4% sodium bicarbonate to 1u2009l 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), pu2009<u20090.001) and postoperative pain score at the end of the treatment day (1.8 (0.3–2.8) versus 3.0 (1.2–5.2), pu2009=u20090.033). 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.

Endovenous laser ablation versus mechanochemical ablation with ClariVein ® in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial

BackgroundEndovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. Preliminary experiences with MOCA showed good results and less post-procedural pain.Methods/DesignThe Laser Ablation versus Mechanochemical Ablation (LAMA) trial is a single-centre randomised controlled trial in which 140 patients will be randomly allocated to EVLA or MOCA. All patients with primary truncal superficial venous insufficiency (SVI) who meet the eligibility criteria will be invited to participate in this trial. The primary outcomes are intra-procedural pain and technical efficacy at 1xa0year, defined as complete occlusion of target vein segment and assessed using duplex ultrasound. Secondary outcomes are post-procedural pain, analgesia use, procedure time, clinical severity, generic and disease-specific quality of life, bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA. Both groups will be evaluated on an intention-to-treat basis.DiscussionThe aim of the LAMA trial is to establish whether MOCA is superior to the current first-line treatment, EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing a more acceptable treatment with an enhanced recovery. The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.Trial registrationClinicalTrials.gov identifier: NCT02627846, registered 8 December 2015EudraCT number: 2015-000730-30REC ref: 15/YH/0207R&D ref: R1788

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.