BACKGROUND: Minimally invasive techniques to treat great saphenous varicose veins include ultrasound-guided foam sclerotherapy (USGFS), radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). Compared with conventional surgery (high ligation and stripping (HL/S)), proposed benefits include fewer complications, quicker return to work, improved quality of life (QoL) scores, reduced need for general anaesthesia and equivalent recurrence rates. The full text is available from: http://dx.doi.org/10.1002/14651858. CD005624.pub2.The abstract is also available in the Portuguese, French and Spanish languages from: http://summaries.cochrane.org/pt/CD005624/ablacaoendovenosa-por-radiofrequencia-e-laser-e-escleroterapia-com-espumaversus-cirurgia-convencional-para-o-tratamento-de-varizes. COMMENTSWith the advent of new techniques for treating varicose veins, many studies are needed in order to compare the new procedures with the gold-standard treatment, i.e. conventional surgery with removal of either the great or the small saphenous vein and excision of tributaries presenting insufficiency. In this review, many data were flawed or did not lead to a conclusion that would be capable of showing significant details regarding the best technique. It can be expected that treatments with laser, radiofrequency or foam sclerotherapy may lead to recanalization of the treated veins, since these do not remove the veins but only stop the flow of blood through the lumen. Recurrence of varicose veins within four months suggests that there was an error in marking out the varicose veins before the operation and failure of the planned removal of the saphenous vein or the dilated tributaries. Some technical details of the surgery may differ, such as segmental removal of the great saphenous vein under general anesthesia. This procedure is not customary in many centers, and complete removal of the saphenous vein with intrathecal or regional blockade is preferred. Other extremely necessary data include comparison of the costs of the fiber laser and radiofrequency equipment, costs of procedures and costs of hospitalization when necessary.
BACKGROUND: Minimally invasive techniques to treat great saphenous varicose veins include ultrasound-guided foam sclerotherapy (USGFS), radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). Compared with conventional surgery (high ligation and stripping (HL/S)), proposed benefits include fewer complications, quicker return to work, improved quality of life (QoL) scores, reduced need for general anaesthesia and equivalent recurrence rates. OBJECTIVE: To review available randomized controlled clinical trials (RCT) data comparing USGFS, RFA, EVLT to HL/S for the treatment of great saphenous varicose veins. METHODS: Search methods: The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialized Register (July 2010) and CENTRAL (The Cochrane Library 2010, Issue 3). In addition the authors performed a search of EMBASE (July 2010). Manufacturers of EVLT, RFA and sclerosant equipment were contacted for trial data. Selection criteria: All RCTs of EVLT, RFA, USGFS and HL/S were considered for inclusion. Primary outcomes were recurrent varicosities, recanalization, neovascularization, technical procedure failure or need for reintervention, patient quality of life (QoL) scores and associated complications. Secondary outcomes were type of anaesthetic, procedure duration, hospital stay and cost. Data collection and analysis: CN, RE, VB, PC, HB and GS independently reviewed, assessed and selected trials which met the inclusion criteria. CN and RE extracted data. The Cochrane Collaboration's tool for assessing risk of bias was used. CN contacted trial authors to clarify details. MAIN RESULTS: Thirteen reports from five studies with a combined total of 450 patients were included. Rates of recanalization were higher following EVLT compared with HL/S, both early (within four months) (5/149 versus 0/100; odds ratio (OR) 3.83, 95% confidence interval (CI) 0.45 to 32.64) and late recanalization (after four months) (9/118 versus 1/80; OR 2.97; 95% CI 0.52 to 16.98), although these results were not statistically significant. Technical failure rates favoured EVLT over HL/S (1/149 versus 6/100; OR 0.12, 95% CI 0.02 to 0.75). Recurrence following RFA showed no difference when compared with surgery. Recanalization within four months was observed more frequently following RFA compared with HL/S although not statistically significant (4/105 versus 0/88; OR 7.86, 95% CI 0.41 to 151.28); after four months no difference was observed. Neovascularization was observed more frequently following HL/S compared with RFA, but again this was not statistically significant (3/42 versus 8/51; OR 0.39, 95% CI 0.09 to 1.63). Technical failure was observed less frequently follow
These data have shown variable improvements following venous interventions. PROMs are likely to have significant implications for health care in the NHS on a number of levels including provision of funding and future planning of services.
Introduction Approximately 5000 major lower-limb amputations (MLLA) for PAD occur per-annum in the UK with clinical outcomes being poor for this high-risk cohort of patients. Existing evidence suggests that anaemic surgical patients have an increased 30-day mortality, but this has not been explored in the context of MLLA. Recent prioritization processes suggested that MLLAs are a target area for research into outcome improvement. This cohort study evaluates the impact of anaemia on the outcome of MLLA to understand if optimization might improve outcomes. Methods All PAD patients undergoing MLLA during 2015–2018 at a tertiary vascular centre were reviewed. Patients were stratified into groups; non-anaemia (>12 g/dL), mild-anaemia (12-10 g/dL) and severe-anaemia (<10 g/dL) by pre-operative haemoglobin (Hb). Primary outcome was overall survival by Kaplan–Meier. Secondary outcomes included length of stay (LOS), post-operative blood-transfusion, surgical-site infection (SSI) and myocardial infarction (MI). Cox-proportional-hazard and receiver-operator characteristics (ROC) analyses were conducted. Results 345 patients were followed up over (mean) 23 months. 105 were non-anaemic, 111 mildly anaemic and 129 severely anaemic. Patients with severe-anaemia had a higher incidence of heart and renal failure ( p = 0.003) than those with non- or mild-anaemia. Overall survival worsened significantly with increasing anaemia ( p = 0.001). LOS was significantly longer in mild-anaemia which is 26 (16–43) days, ( p = 0.006) and severe-anaemia of 28 days (17–40), ( p < 0.001) compared to non-anaemia of 18 (10–30) days. Post-operative blood-transfusion (RBC) was required more frequently in 70.5% of severely anaemic patients ( p < 0.001), compared to mildly anaemic (24.3%) and non-anaemic (7.6%) patients, with those receiving RBCs having a significantly worse survival. There was no difference in MI, SSI or wound dehiscence. Anaemia was significantly associated with mortality; (HR 1.7 (1.04–2.78), p = 0.03). A minimum-Hb of 10.4 g/L (by ROC) was identified as a cutoff Hb for an increased risk of mortality. Conclusion Pre-operative anaemia is associated with worse outcome following MLLA, with increasing severity of anaemia associated with increasing mortality and RBC transfusion being potentially detrimental. More work is required to prospectively evaluate this relationship in this complex and multi-morbid cohort of patients.
As authors of a systematic review on the treatment of varicose veins, we closely scrutinized the recent publication by Christenson et al 1 for potential inclusion. Christenson et al randomized the treatment of 200 limbs with primary varicose veins to receive conventional surgery or endovenous laser ablation.The primary outcome measure was closure of the great saphenous vein. Secondary outcome measures included general health quality of life measures (Short Form 36) and diseasespecific measures (Aberdeen Varicose Vein Symptom Severity Score and Venous Clinical Severity Score). Postoperative complications, time to return to normal activity, and pain scores (mean use of analgesics and a visual analog scale score) were noted.After contacting the corresponding author, we confirmed that 40 patients underwent treatment of bilateral varicose veins, although this was not clear from the article itself. All patients with bilateral varicose veins were treated on the same day. We also confirmed that patient's limbs were randomized, not the patients themselves. In fact, eight patients underwent surgery on one limb and laser treatment on the other on the same day.Clear biases result from this methodology, especially regarding the postoperative quality of life scores. The high proportion of bilaterally treated patients also affects pain scores. Time to return to work is also published, but limbs cannot return to work independently of one another. Trials that randomize and analyze results according to number of limbs rather than the number of patients as the unit of analysis result in the standard error of the treatment effect being much smaller than it should be.The shortcomings in this trial mean that the results must be taken with caution. Greater effort must be made in the future to publish trial data with greater transparency, and future trialists must heed the pitfall of randomizing patients' limbs rather than the patients themselves. Investigators must give further thought on how to approach the problems of including, randomizing, and treating patients with bilateral disease.
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