Nehemiah Samuel

Modelling the effect of venous disease on quality of life

A clear understanding of the relationship between venous reflux, clinical venous disease and the effects on quality of life (QoL) remains elusive. This study aimed to explore the impact of venous disease, and assess any incremental direct effect of progressive disease on health‐related QoL, with the ultimate aim to model venous morbidity.

Angiotensin converting enzyme inhibitors effect on endothelial dysfunction: A meta-analysis of randomised controlled trials

OBJECTIVE Several studies have assessed the effect of angiotensin converting enzyme inhibitors (ACEIs) on endothelial dysfunction as measured by brachial flow-mediated vasodilatation (FMD). We conducted a meta-analysis to investigate this effect in comparison to placebo or no treatment and to other antihypertensive agents. METHODS MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1996 to October 2010 on randomised controlled trials (RCTs) that assessed the effect of ACEIs on brachial FMD versus placebo or no treatment and ACEIs versus angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs) and β-blockers. Data from included studies were pooled with use of random effects meta-analysis of the weighted mean change differences between the comparator groups. Heterogeneity across studies was assessed with the I(2) statistic. RESULTS In 10 trials including 1129 patients, treatment with ACEIs (n = 498) versus placebo or no treatment (n = 503) significantly improved brachial FMD (pooled mean change difference 1.26%, 95% C.I. 0.46-2.07, p = 0.002 with significant heterogeneity). In 11 trials which included 805 patients, treatment with ACEIs (n = 264) had a significant effect on brachial FMD when compared with other antihypertensives (ARBs, CCBs and β-blockers) (n = 420) (pooled mean change difference 0.89%, 95% C.I. 0.22-1.56, p = 0.009, I(2) = 83%, p for heterogeneity < 0.00001). In 7 trials, treatment with ACEIs had no significant effect on FMD when compared with ARBs (pooled mean change difference = 0.21%, 95% C.I. -0.24 to 0.66, p = 0.36, I(2) = 0%). However, in 4 trials ACEIs significantly improved FMD when compared with CCBs (pooled mean change difference 2.15%, 95% C.I. 0.55-3.75, p = 0.009, I(2) = 90%, p for heterogeneity < 0.00001). When compared with β-blockers in 4 trials, ACEIs also had a significant effect on FMD (pooled mean change difference = 0.59%, 95% C.I. 0.05-1.13, p = 0.03, I(2) = 34%, p for heterogeneity = 0.21). CONCLUSIONS This study shows that ACEIs improve brachial FMD which is a marker of endothelial function in patients with endothelial dysfunction caused by various conditions and are superior to CCBs and β-blockers. There was no significant difference between ACEIs and ARBs effect on brachial FMD.

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.

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.

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.

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.

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.)

Saphenopopliteal ligation and stripping of small saphenous vein: does extended stripping provide better results?

Objective Saphenopopliteal ligation (SPL) for venous insufficiency is a challenging procedure, with mixed results being reported. The role of stripping of the small saphenous vein (SSV) is contentious. This prospective observational study aimed to assess the risks and benefits of this procedure. Methods Fifty patients underwent SPL under general anaesthesia by a single surgeon in a tertiary referral vascular centre. The aim was to perform inversion stripping in each case, but in a proportion this was not possible. Patients were grouped into SPL with short segment excision ≤5 cm (n = 23) and SPL with extended stripping >5 cm (n = 27). Outcome measures included venous clinical severity scores (VCSS), quality of life (QoL), Aberdeen varicose vein questionnaire (AVVQ), patient satisfaction, recurrence and complication rates. Results Intragroup analysis demonstrated statistically significant improvements in VCSS (P < 0.001), and QoL measures (generic and disease-specific AVVQ) (P < 0.050) with both treatments. Intergroup analysis demonstrated statistically significant superior VCSS scores at one year (P = 0.001), AVVQ at three months and one year (P < 0.05), and cosmetic satisfaction at one year (P = 0.011) in the SPL extended stripping group. There was no difference in clinical recurrence 1/23 (4.3%) versus 1/27 (3.7%) (P = 0.900) or complication rates (P > 0.050). Conclusions SPL with or without stripping is an effective procedure improving clinical severity and QoL in the short term. Early outcomes favour SPL with extended stripping to offer greater improvement in disease-specific QoL, venous severity and cosmesis. With this small sample, there is no evidence of increased complications following stripping, or increased short-term recurrence without it. Greater numbers and follow-up are required to make firm conclusions.

A reply to the letter re: Saphenopopliteal ligation and stripping of small saphenous vein: does extended stripping provide better results?

Dear readers, thank you for your comments. Our response to your comments may sound repetitive as indeed this report stemmed from a retrospective subgroup analysis of prospectively collected data which were being collected comprehensively to evaluate the pragmatic risks and benefits of conventional surgery per se for small saphenous insufficiency. We did aim to perform extended SSV stripping in every patient and in those for whom this was not possible; the subsequent observed results were inferior to extended stripped group. With lack of consensus and paucity of evidence on the best surgical technique for SSV incompetence, the reported clinical and quality of life comparative outcomes based on intra-operative subgroups is by far the only unabridged evidence that we could reflectively evaluate to guide our own practice. This may introduce an unintentional selection bias as alluded to by the reader. This evidence may not be as strong as an RCT of stripping SSV versus not; however, it does not seem unreasonable to state that this study does suggest benefits when extended stripping is technically possible as opposed to when it is not. Complications in both groups were predominantly minor and self-resolving. The sural nerve sensory disturbance at the end of 1-year follow-up persisted in two and one patients of the short excision and extended stripping groups, respectively. These small numbers albeit in a relatively small group of patients is underpowered to detect a difference in complications and recurrence as acknowledged in the paper. This should however not blur the positive results of objectively determined venous severity and patient perceived QoL benefits and cosmetic satisfaction in favour of SSV stripping. The growing trend to treat such patients with minimally invasive endovenous ablative techniques suggests an adequately powered RCT as evidence to influence the verdict on whether or not to strip the SSV is unlikely. We would therefore standby our evidence, albeit somewhat circumstantial, that the SSV should be stripped where possible.

Midterm Results of a Randomized Controlled Trial Comparing Endovenous Laser Ablation and Surgery for the Treatment of Small Saphenous Insufficiency

anesthesia. Two studies were conducted to evaluate the feasibility of a novel biodegradable implant, polyglycolic acid (PGA), to occlude incompetent great saphenous veins (GSV) without tumescent anesthesia. Methods: TAHOE I and TAHOE II were prospective, single-arm studies using the same PGA implant. Slight modifications were made to the TAHOE II protocol (eg, removed mandate for heparin use and postprocedure compression). TAHOE I was conducted at three sites in Europe and enrolled 51 patients; TAHOE II was conducted at one site in the Dominican Republic and enrolled 30 patients. After treatment patients returned at 1 day, 1, 2, and 6 weeks, and 3 and 6 months. Vein occlusion, reflux, postprocedure pain (0-10), quality-of-life (CIVIQ2), Venous Clinical Severity Score (VCSS), and adverse events were assessed at each visit. Results: Occlusion and reflux-free rates are summarized in Table I. Initial occlusion and reflux-free rates were >90% in both studies. Change in CIVIQ2 scores and VCSS scores to 6 months are summarized in Table II. CIVIQ2 scores were elevated at 1 day but showed improvement at 6 weeks that was sustained through 6 months. VCSS improved after day 1 and through to 6 months. Pain (median [IQR]) at day 1 was 2.0 (0,3) in the TAHOE I study and 2.5 (0,5) in the TAHOE II study but decreased to 0 (0,0) from 2 weeks to 6 months for both groups. The most commonly reported adverse events were induration (20% TAHOE I, 41.4% TAHOE II), erythema (12% TAHOE I, 48.3% TAHOE II), fever (34.5% TAHOE II), nausea (34.5% TAHOE II), and phlebitis (8% TAHOE I); all resolved by 6 weeks. No patient experienced neuropraxia. Conclusions: Tumescent-free PGA implantation resulted in high initial GSV occlusion with recanalization appearing in some patients at 3 months postprocedure. PGA is promising, but requires modification to achieve higher long-term occlusion and reflux-free rates.