Neuromuscular electrical stimulation for the treatment of diabetic sensorimotor polyneuropathy: A prospective, cohort, proof-of-concept study.

OBJECTIVE: To assess a potential efficacy signal, safety and feasibility of neuromuscular electrical stimulation (NMES) therapy as an adjunct to standard care in patients with diabetic sensorimotor polyneuropathy (DSPN). METHODS: In this single-centre, prospective, cohort, proof-of-concept study, 25 patients with DSPN consented to at least one daily 30-minute NMES therapy session (Revitive® IX) for 10 weeks, with 20 patients completing the study. The primary outcome measure was nerve conductivity assessed using a nerve conduction study of the sural, superficial peroneal, common peroneal and tibial nerves at 10 weeks compared to baseline. Secondary outcomes included superficial femoral artery (SFA) haemodynamics during NMES therapy compared to rest and quality-of-life at 10 weeks compared to baseline. RESULTS: At 10 weeks, there were significant increases in sural sensory nerve action potential amplitude and conduction velocity (p < 0.001), superficial peroneal sensory nerve action potential amplitude (p = 0.001) and conduction velocity (p = 0.002), common peroneal nerve conduction velocity (p = 0.004) and tibial nerve compound muscle action potential amplitude (p = 0.002) compared to baseline. SFA volume flow and time-averaged mean velocity significantly increased (p ≤ 0.003) during NMES compared to rest. Patient-reported Michigan Neuropathy Screening Instrument scores significantly decreased (p = 0.028) at 10 weeks compared to baseline. Three unrelated adverse events occurred, and 15 participants adhered to treatment. CONCLUSIONS: NMES therapy as an adjunct to standard care for 10 weeks significantly increased lower limb nerve conductivity in patients with DSPN and may be beneficial in the treatment of DSPN.

COmpressioN following endovenous TreatmenT of Incompetent varicose veins by sclerotherapy (CONFETTI).

OBJECTIVE: The evidence for post-foam sclerotherapy compression stockings for varicose veins is limited. Thus, we examined the effects of post-procedural compression stockings on varicose vein patients undergoing foam sclerotherapy. METHODS: The CONFETTI study was a prospective, single-center, randomized controlled trial. Patients with foam sclerotherapy-suitable varicose veins were randomly assigned to the compression group (CG) or the no compression stockings group (NCG) for 7 days. The primary outcome was post-procedural pain measured on a 100-mm visual analog scale for 10 days. Secondary outcomes included clinical severity, generic and disease-specific quality of life scores, return to normal activities and/or work, occlusion rates, degree of ecchymosis, CG compliance, and complications. Patients were reviewed at 2 weeks and 6 months. RESULTS: A total of 139 patients were consented to and randomly assigned. The intention-to-treat analysis included 15 patients who did not receive the allocated intervention. Both groups had similar baseline characteristics. Of the patients, 63.3% and 55.4% returned for follow-up at 2 weeks and 6 months, respectively. Most of the veins treated were tributaries. The CG experienced significantly lower pain scores than the NCG, with median scores of 7 mm and 19 mm, respectively (Mann-Whitney U-test; P = .001). At 2 weeks, no differences were observed in ecchymosis or the time to return to normal activities or work. Both groups showed improvements in clinical severity and quality of life, and occlusion rates were comparable. The NCG experienced one deep venous thrombosis and superficial thrombophlebitis, whereas the CG experienced two superficial thrombophlebitis. CONCLUSIONS: The CONFETTI study suggests that short-term post-procedural compression stockings are beneficial for reducing post-procedure pain.

Study protocol for neuromuscular stimulation for rehabilitation after general and vascular surgery: a pilot randomised clinical study.

OBJECTIVES: To investigate the acceptability and safety of neuromuscular stimulation (NMES) as an adjunct for rehabilitation after vascular and general surgery. METHODS AND ANALYSIS: Prospective, single-centre, single-blind, parallel group, randomised controlled study. This study will be conducted in a single-centre, secondary care setting (National Healthcare Service Hospital) in the UK. All patients aged over 18 years undergoing vascular or general surgery with Rockwood Frailty Score of 3 or above on admission. Exclusion is inability or unwillingness to participate in trial, implanted electrical device, pregnancy and acute deep vein thrombosis. Target number of recruitment is 100. Participants will be randomly assigned to active NMES group (group A) or placebo NMES group (group B) prior to surgery. Participants will be blinded and asked to use the NMES device, 1-6 sessions daily (30 min per session) after surgery in addition to standard National Health Service rehabilitation care until discharge. The primary study outcomes are acceptability and safety of NMES assessed by the device satisfaction questionnaire on discharge and adverse events recorded during hospital stay. The secondary outcomes are the postoperative recovery and cost-effectiveness compared between two groups, assessed by various activity tests, mobility and independence measures and questionnaires. ETHICS AND DISSEMINATION: Ethical approvals were provided by London-Harrow Research Ethics Committee (REC) and the Health Research Authority (HRA), Ref: 21/PR/0250. Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04784962.

Left common iliac vein diameter in patients referred for lower limb venous duplex ultrasound.

INTRODUCTION: Evidence regarding ultrasound assessment of left common iliac vein diameter (LCIV) is limited. Extensive work is currently being undertaken worldwide on non-thrombotic iliac vein lesions to identify patients who may benefit from intervention to alleviate symptoms of chronic venous obstruction. Interventions include long-term stent implantation to improve vein diameter stenosis. This study aimed to assess a cohort of symptomatic venous patients and the diameter of the LCIV in these patients. METHODS: : Retrospective medical records review of all patients attending a tertiary vascular surgery centre who underwent a venous duplex ultrasound assessment between April 2017 and February 2018 were analysed for assessment of LCIV. Medical records of those patients with documented LCIV diameter were assessed over 18 months of follow-up. RESULTS: : A total of 672 (271 males, 401 females) LCIV diameter measurements were collected. The age of the patients ranged from 21 to 95 years (mean = 56.38). Median LCIV diameter overall was 7.64 mm (IQR 5.80mm-9.00 mm). 40 patients (6%) were reported to have a LCIV diameter measurement of < 4 mm, 8 (20%) male and 32 female (80%). 17 of these 40 patients (47.5%) were treated conservatively. Median LCIV diameter was 3.4 mm (IQR 2.5-3.7). 21 of these 40 patients (52.5%) underwent superficial venous intervention only, with a median LCIV diameter of 3.5 mm (IQR 3.2-3.7) and 2 out of these 40 patients (5%) underwent deep venous stenting (2/2 female - 100%), with a median LCIV diameter of 2.9 (IQR 2.9-2.9). No patients underwent both superficial and deep venous treatment in this 40 patient cohort. In those undergoing superficial venous intervention, 4 (19%) underwent repeat treatment. The two deep venous stenting patients underwent magnetic resonance venogram and venogram with intravascular ultrasound to allow stent placement, which confirmed a narrowed left common iliac vein. Primary stent patency at 18 months was 100%. CONCLUSION: In this large study cohort of venous duplex assessments the median vein diameter was 7.64 mm and 40 patients out of 672 had a vein diameter smaller than 4 mm. 2 patients underwent deep venous stenting with primary patency of 100%.

Prevention and Management Strategies for Diabetic Neuropathy.

Diabetic neuropathy (DN) is a common complication of diabetes that is becoming an increasing concern as the prevalence of diabetes rapidly rises. There are several types of DN, but the most prevalent and studied type is distal symmetrical polyneuropathy, which is the focus of this review and is simply referred to as DN. It can lead to a wide range of sensorimotor and psychosocial symptoms and is a major risk factor for diabetic foot ulceration and Charcot neuropathic osteoarthropathy, which are associated with high rates of lower limb amputation and mortality. The prevention and management of DN are thus critical, and clinical guidelines recommend several strategies for these based on the best available evidence. This article aims to provide a narrative review of DN prevention and management strategies by discussing these guidelines and the evidence that supports them. First, the epidemiology and diverse clinical manifestations of DN are summarized. Then, prevention strategies such as glycemic control, lifestyle modifications and footcare are discussed, as well as the importance of early diagnosis. Finally, neuropathic pain management strategies and promising novel therapies under investigation such as neuromodulation devices and nutraceuticals are reviewed.

Pathogenesis of Distal Symmetrical Polyneuropathy in Diabetes.

Distal symmetrical polyneuropathy (DSPN) is a serious complication of diabetes associated with significant disability and mortality. Although more than 50% of people with diabetes develop DSPN, its pathogenesis is still relatively unknown. This lack of understanding has limited the development of novel disease-modifying therapies and left the reasons for failed therapies uncertain, which is critical given that current management strategies often fail to achieve long-term efficacy. In this article, the pathogenesis of DSPN is reviewed, covering pathogenic changes in the peripheral nervous system, microvasculature and central nervous system (CNS). Furthermore, the successes and limitations of current therapies are discussed, and potential therapeutic targets are proposed. Recent findings on its pathogenesis have called the definition of DSPN into question and transformed the disease model, paving the way for new research prospects.

Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial.

Importance: Endovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time, and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE). Objective: To assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment. Design, Setting, and Participants: The Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at 3 sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis, or serious arterial disease. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks, and 3, 6, and 12 months. Interventions: Patients with primary truncal vein incompetence were randomized to receive either MOCA or CAE. Main Outcomes and Measures: The primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores. Results: Of 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. Overall, 155 truncal veins treated (92.8%) were great saphenous veins. Demographic data and baseline status were comparable between treatment groups. A total of 73 patients (47%) underwent adjunctive treatment of varicosities. Overall median (IQR) maximum pain score after truncal treatment was 23 mm (10-44) on the VAS and 3 (2-5) on the number scale, showing no significant difference in median (IQR) pain measured by VAS (MOCA, 24 [11.5-44.7] mm vs CAE, 20 [9.0-42.0] mm; P = .23) or by number scale (MOCA, 4 [2-5] vs CAE, 3 [2-4]; P = .18). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease-specific QoL scores, and complete occlusion rates. Four patients treated with CAE developed minor complications (superficial thrombophlebitis and thrombus extensions). Conclusions and Relevance: To our knowledge, this was the first randomized clinical trial directly comparing nontumescent ablation techniques. The study demonstrated that the MOCA and CAE techniques have a similar periprocedural pain score. Trial Registration: ClinicalTrials.gov Identifier: NCT03392753.

Abdominal aortic aneurysm clinical practice guidelines: a methodological assessment using the AGREE II instrument.

OBJECTIVES: Abdominal aortic aneurysm (AAA) clinical practice guidelines (CPGs) provide evidence-based information on patient management; however, methodological differences exist in the development of CPGs. This study examines the methodological quality of AAA CPGs using a validated assessment tool. METHODS: Medline, EMBASE and online CPG databases were searched from 1946 to 31 October 2021. Full-text, English language, evidence-based AAA CPGs were included. Consensus-based CPGs, summaries of CPGs or CPGs which were only available on purchase were excluded. Five reviewers assessed their quality using the Appraisal of Guidelines for Research and Evaluation II instrument. An overall guideline assessment scaled score of ≥80% was considered as the threshold to recommend CPG use in clinical practice. RESULTS: Seven CPGs were identified. Scores showed good inter-reviewer reliability (intraclass correlation coefficient 0.943, 95% CI 0.915 to 0.964). On average, CPGs performed adequately with mean scaled scores of over 50% in all domains. However, between CPGs, significant methodological heterogeneity was observed in all domains. Four CPGs scored ≥80% (European Society of Cardiology, the Society of Vascular Surgery, the European Society of Vascular Surgery and the National Institute of Health and Care Excellence), supporting their use in clinical practice. CONCLUSIONS: Four CPGs were considered of adequate methodological quality to recommend their use in clinical practice; nonetheless, these still showed areas for improvement, potentially through performing economic analysis and trial application of recommendations. A structured approach employing validated CPG creation tools should be used to improve rigour of AAA CPGs. Future work should also evaluate recommendation accuracy using validated appraisal tools.

Cost-effectiveness analysis of current varicose veins treatments.

OBJECTIVE: To analyze the effectiveness and cost effectiveness of technologies for treatment of varicose veins over 5 years-conservative care, surgery (high ligation and stripping), ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA), and radiofrequency ablation (RFA), mechanochemical ablation (MOCA), and cyanoacrylate glue occlusion (CAE). METHODS: A systematic review was updated and used to construct a Markov decision model. Outcomes were reintervention on the truncal vein, retreatment of residual varicosities and quality-adjusted life years (QALY) and costs over 5 years. RESULTS: UGFS has a significantly greater reintervention rate than other procedures; there is no significant difference between the other procedures. The cost per QALY of EVLA vs UGFS in our base-case model is £16,966 ($23,700) per QALY, which is considered cost effective in the UK. RFA, MOCA, and CAE have greater procedure costs than EVLA with no evidence of greater benefit for patients. CONCLUSIONS: EVLA is the most cost-effective therapeutic option, with RFA a close second, in adult patients requiring treatment in the upper leg for incompetence of the GSV. MOCA, UGFS, CAE, conservative care, and high ligation and stripping are not cost effective at current prices in the UK National Health Service. MOCA and CAE seem to be promising, but further evidence on the effectiveness, reinterventions, and health-related quality of life is needed, as well as how cost effectiveness may vary across settings and reimbursement systems.

Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration: DAVE trial.

INTRODUCTION: Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. METHODS AND ANALYSIS: This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. ETHICS AND DISSEMINATION: Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN21541209.

Randomized Controlled Trial of Compression After Endovenous Thermal Ablation of Varicose Veins (COMETA Trial).

BACKGROUND: The 21st century has witnessed a rise in the use of endovenous thermal ablation. Being highly clinically and cost-effective and improving the quality of life of patients, they are now considered to be the "gold-standard" treatment for varicose veins. Post-intervention management, especially in terms of postoperative compression, however, remains unclear. As a result, a randomized study was undertaken to investigate the effects of wearing compression stockings after varicose vein treatment. METHOD: Patients with saphenous vein reflux undergoing treatment with endothermal ablation (with or without concurrent phlebectomies) were randomized to receive either 7 days of compression stockings or no stockings. The primary outcome measure for this study was the pain score over the first 10 postoperative days. The pain scores, clinical score, time to return to normal activities, and ecchymosis were assessed. Patients were followed-up at 2 weeks and 6 months post-ablation. RESULTS: In total, 206 patients were randomized, 49% of them to the compression group. The mean age was 49.7 (±16) years and approximately 51% of the population was male. The median pain score in the compression group using a visual analog scale was significantly lower on days 2-5, compared to the no compression group. Those having concurrent phlebectomies and compression stockings also had significantly better pain scores on days 1-3, day 5, and day 7. Improvement in the median venous clinical severity score was noted at 6-month follow-up, but this was not significant. No difference in the generic- or disease-specific quality of life was observed and the time to return to activities was similar. There were no differences in the degree of ecchymosis between the 2 groups and both groups had similar occlusion rates. CONCLUSIONS: These results indicate that wearing compression stockings after endothermal ablation is advantageous in the first few days after treatment and is especially beneficial for those having concurrent phlebectomies.

A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status.

BACKGROUND: This randomised controlled trial investigates the dosing effect of neuromuscular electrical stimulation (NMES) in patients with chronic venous disease (CVD). METHODS: Seventy-six patients with CEAP C3-C5 were randomised to Group A (no NMES), B (30 minutes of NMES daily) or C (60 minutes of NMES daily). Primary outcome was percentage change in Femoral Vein Time Averaged Mean Velocity (TAMV) at 6 weeks. Clinical severity scores, disease-specific and generic quality of life (QoL) were assessed. RESULTS: Seventy-six patients were recruited - mean age 60.8 (SD14.4) and 47:29 male. Six patients lost to follow-up. Percentage change in TAMV (p<0.001) was significantly increased in Groups B and C. Aberdeen Varicose Veins Questionnaire Score (-6.9, p=0.029) and Venous Clinical Severity Score (-4, p-0.003) improved in Group C, and worsened in Group A (+1, p=0.025). CONCLUSIONS: Daily NMES usage increases flow parameters, with twice daily usage improving QoL and clinical severity at 6 weeks in CVD patients.

Reducing the risk of venous thromboembolism following superficial endovenous treatment: A UK and Republic of Ireland consensus study.

OBJECTIVES: Venous thromboembolism is a potentially fatal complication of superficial endovenous treatment. Proper risk assessment and thromboprophylaxis could mitigate this hazard; however, there are currently no evidence-based or consensus guidelines. This study surveyed UK and Republic of Ireland vascular consultants to determine areas of consensus. METHODS: A 32-item survey was sent to vascular consultants via the Vascular and Endovascular Research Network (phase 1). These results generated 10 consensus statements which were redistributed (phase 2). 'Good' and 'very good' consensus were defined as endorsement/rejection of statements by >67% and >85% of respondents, respectively. RESULTS: Forty-two consultants completed phase 1. This generated seven statements regarding risk factors mandating peri-procedural pharmacoprophylaxis and three statements regarding specific pharmacoprophylaxis regimes. Forty-seven consultants completed phase 2. Regarding venous thromboembolism risk factors mandating pharmacoprophylaxis, 'good' and 'very good' consensus was achieved for 5/7 and 2/7 statements, respectively. Regarding specific regimens, 'very good' consensus was achieved for 3/3 statements. CONCLUSIONS: The main findings from this study were that there was 'good' or 'very good' consensus that patients with any of the seven surveyed risk factors should be given pharmacoprophylaxis with low-molecular-weight heparin. High-risk patients should receive one to two weeks of pharmacoprophylaxis rather than a single dose.

A methodologic assessment of lymphedema clinical practice guidelines.

OBJECTIVE: The objective of this review was to determine the methodologic quality of current lymphedema clinical practice guidelines (CPGs) to assist health care professionals in selecting accessible, high-quality guidance and to identify areas for improvement in future CPGs. METHODS: MEDLINE, Embase, online CPG databases, and reference lists of included guidelines were searched up to January 31, 2020. Full-text CPGs reporting on evidence-based recommendations in lymphedema diagnosis or management in English were included. CPGs based on expert consensus, CPG summaries, or CPGs that were not freely available were excluded. Two reviewers identified eligible CPGs, extracted data, and assessed their quality independently using the Appraisal of Guidelines for Research and Evaluation II instrument. Significant scoring discrepancies were discussed with a third reviewer. An overall scaled quality score of ≥80% was the threshold to recommend guideline use. RESULTS: Six relevant CPGs were identified. One was subsequently excluded as its full text could not be obtained. Overall, there was very good inter-reviewer reliability of scores with intraclass correlation coefficient of 0.952 (95% confidence interval, 0.921-0.974). No single CPG scored highest in all domains, with methodologic heterogeneity observed. Poor performance was noted in domain 5 (mean scaled score, 23.8% ± 17.1%) and domain 6 (22.9% ± 26.7%). No CPG achieved an overall scaled quality score of ≥80%, with the top CPG scoring 79.2%. CONCLUSIONS: According to the defined threshold, no lymphedema CPG was considered adequate for use in clinical practice. All current lymphedema CPGs have areas for improvement with elements of methodologic quality lacking, particularly with respect to rigor of development. A structured approach, guided by the use of CPG creation tools and checklists such as the Appraisal of Guidelines for Research and Evaluation II instrument, should help CPG development groups in improving the quality of future CPGs. This is of particular importance in a complex, multidisciplinary condition such as lymphedema.

The good, bad and the ugly of the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis trial from the viewpoint of clinicians.

OBJECTIVE: Acute deep venous thrombosis (DVT) can be complicated by post-thrombotic syndrome, which is associated with significant morbidity and healthcare costs. The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) was the largest and most controversial randomized controlled trial evaluating the use of pharmacomechanical catheter-directed thrombolysis (CDT) for the prevention of post-thrombotic syndrome after acute DVT. This study aimed to evaluate clinicians' opinion on the ATTRACT trial and its impact on clinical practice. METHODS: An online survey consisting of 10 core multiple choice items and a maximum of five follow-up open-ended questions was delivered to vascular surgeons, interventional radiologists, hematologists, and interventional cardiologists affiliated with 10 international societies between April 23 and July 1, 2019. Clinicians' views on the main limitations of the ATTRACT trial, its impact on patient selection for thrombolysis and the need for a new trial were evaluated. RESULTS: Out of 15,650 contacted clinicians, 451 (3%) completed the survey, with 74% vascular surgeons, 24% interventional radiologists, 2% hematologists, and 0.2% interventional cardiologists. The majority of respondents (79%) were aware of the results of the ATTRACT trial before completing the survey and routinely performed pharmacomechanical CDT (PCDT) in their centers (70%). Only 20% of clinicians considered ATTRACT to be a well-designed and well-performed trial. The inclusion of femoropopliteal DVT was reported as the main limitation of the trial by 55% of respondents. Despite half of the participating clinicians reporting no change in their clinical practice, equal number of clinicians (14%) were encouraged and discouraged from treating iliofemoral DVT. More than one-half of the respondents thought that the use of PCDT would be defensible in a court of law despite the increased risk of bleeding reported in the study. Nearly two-thirds of participating clinicians recommended performing a trial limited to iliofemoral DVT, with a follow-up period of 5 years, quality of life as the primary outcome measure, and standardization of thrombolysis protocol across the trial sites. CONCLUSIONS: ATTRACT failed to provide the long-awaited indisputable evidence on the use of PCDT. Surveyed clinicians were aware of the limitations of this trial and the need for further evidence on the subject.

A Narrative Review of the Use of Neuromuscular Electrical Stimulation in Individuals With Diabetic Foot Ulceration.

This review aims to summarize the evidence reported on the use of neuromuscular electrical stimulation (NMES) in individuals with diabetic foot ulceration (DFU). A systematic search of EMBASE and MEDLINE databases was performed in February 2019, using search terms relating to the domains DFU and NMES. All primary evidence assessing outcomes of NMES in DFU were included. Of 344 references obtained from database searching, 7 met the inclusion criteria and included a total of 140 participants, 77 of whom had DFU. All included studies used prospective designs. Two studies demonstrated improvements in chronic ulcer healing with NMES use; however, in each study, only 3 of the included participants had DFU and subgroup analyses based on ulcer etiology was omitted. The remaining 5 studies were produced by the same research group and positive effects of NMES (in combination with heat therapy) on DFU healing were consistently demonstrated. They reported significantly better healing rates with NMES in DFU than in nondiabetic wounds of a similar grade (healing rate: 70.0 ± 32.3% in DFU vs 38.4 ± 22.3% in nondiabetic ulcers [P < .01]). These studies did not provide data assessing the isolated effects of NMES without concomitant heat exposure. Data on device tolerability and compliance were lacking. The existing data support a potential role for NMES in individuals with DFU; however, the identified studies inadequately controlled for confounding and were underpowered. Given the significant morbidity and mortality associated with DFU, higher quality evidence is needed to assess the adjunctive role for NMES in this group.

Cyanoacrylate glue embolisation for varicose veins - A novel complication.

BACKGROUND: Non-thermal non-tumescent methods for varicose vein treatment have rapidly gained popularity in recent years due to clinical efficacy comparable to other endovenous methods, but with a superior safety and tolerability profile. Cyanoacrylate is an adhesive that rapidly polymerises during endovenous treatment to cause rapid occlusion of veins and initiate vein fibrosis. METHOD: Cyanoacrylate glue treatment is known to cause complications such as phlebitis, cellulitis and deep vein thrombosis in rare instances. We present the first reported case of cyanoacrylate extravasation with chronic foreign body reaction in a patient nine months after initial treatment. RESULTS: We discuss the aetiology of this complication, its treatment, patient outcome and its significance to both clinicians and patients. CONCLUSION: Cyanoacrylate glue embolisation can, in rare instances, lead to extravasation and chronic foreign body reaction, necessitating surgical intervention. The relative novelty of cyanoacrylate glue embolisation in the treatment of varicose veins requires clinicians to monitor for rare complications during its use in clinical practice. Patients should be aware of the rare risk of glue extravasation and foreign body reaction for fully informed consent prior to treatment.

Median arcuate ligament syndrome.

BACKGROUND: Median arcuate ligament syndrome (MALS) describes the clinical presentation associated with direct compression of the celiac artery by the median arcuate ligament. The poorly understood pathophysiologic mechanism, variable symptom severity, and unpredictable response to treatment make MALS a controversial diagnosis. METHODS: This review summarizes the literature pertaining to the pathophysiologic mechanism, presentation, diagnosis, and management of MALS. A suggested diagnostic workup and treatment algorithm are presented. RESULTS: Individuals with MALS present with signs and symptoms of foregut ischemia, including exercise-induced or postprandial epigastric pain, nausea, vomiting, and weight loss. Consideration of MALS in patients' diagnostic workup is typically delayed. Currently, no group consensus agreement as to the diagnostic criteria for MALS exists; duplex ultrasound, angiography, and gastric exercise tonometry are used in different combinations and with varying diagnostic values throughout the literature. Surgical management involves decompression of the median arcuate ligament's constriction of the celiac artery; robotic, laparoscopic, endoscopic retroperitoneal, and open surgical intervention can provide effective symptom relief, but long-term follow-up data (>5 years) are lacking. Patients treated nonoperatively appear to have worse outcomes. CONCLUSIONS: MALS is an important clinical entity with significant impact on affected individuals. Presenting symptoms, patient demographics, and radiologic signs are generally consistent, as is the short-to medium-term (<5 years) response to surgical intervention. Future prospective studies should directly compare long-term symptomatic and quality of life outcomes after nonoperative management with outcomes after open, laparoscopic, endoscopic retroperitoneal, and robotic celiac artery decompression to enable the development of evidence-based guidelines for the management of MALS.