Pilot Trial of Neuromuscular Stimulation in Human Subjects with Chronic Venous Disease.

INTRODUCTION: Neuromuscular stimulation (NMES) has been shown to improve peripheral blood flow in healthy people. We investigated the effect of bilateral leg NMES on the symptoms of chronic venous disease. METHODS: Forty subjects were recruited from four groups: healthy, superficial insufficiency, deep insufficiency, and deep obstruction. Haemodynamic venous measurements were taken from the right femoral vein with ultrasound, laser Doppler fluximetry from the left hand and foot. Devices were then worn for 4-6 hours per day, for 6 weeks. Haemodynamic measurements were repeated at week 6. Quality of life questionnaires were taken at week 0, 6 and 8. RESULTS: The mean age was 48.7, BMI 28.6kg/m2, and maximum calf circumference 39.0 cm. Twenty-four subjects were men. NMES increased femoral vein peak velocity, TAMV and volume flow by 55%, 20%, 36% at 20 minutes (all p<0.05), which was enhanced at week 6 (PV and TAMV p<0.05). Mean increases in arm and leg fluximetry were 71% and 194% (both p<0.01). Leg swelling was reduced by mean 252.7 mL (13%, p<0.05) overall; 338.9 mL (16%, p<0.05) in venous disease. For those with venous pathology, scores for disease specific and generic quality of life questionnaires improved. Those with C4-6 disease benefitted the most, with improvements in VDS score of 1, AVVQ of 6, and SF-12 of 10. CONCLUSION: NMES improves venous haemodynamic parameters in chronic venous disease, which is enhanced by regular use. NMES reduces leg oedema, improves blood supply to the skin of the foot, and may positively affect quality of life. CLINICAL TRIALS: This trial was registered with www.clinicaltrials.org.uk (NCT02137499).

Neuromuscular electrical stimulation for the prevention of venous thromboembolism.

Objective Venous thromboembolism, encompassing deep vein thrombosis and pulmonary embolism, is a significant cause of morbidity and mortality, affecting one in 1000 adults per year. Neuromuscular electrical stimulation is the transcutaneous application of electrical impulses to elicit muscle contraction, preventing venous stasis. This review aims to investigate the evidence underlying the use of neuromuscular electrical stimulation in thromboprophylaxis. Methods The Medline and Embase databases were systematically searched, adhering to PRISMA guidelines, for articles relating to electrical stimulation and thromboprophylaxis. Articles were screened according to a priori inclusion and exclusion criteria. Results The search strategy identified 10 randomised controlled trials, which were used in three separate meta-analyses: five trials compared neuromuscular electrical stimulation to control, favouring neuromuscular electrical stimulation (odds ratio of deep vein thrombosis 0.29, 95% confidence interval 0.13-0.65; P = .003); three trials compared neuromuscular electrical stimulation to heparin, favouring heparin (odds ratio of deep vein thrombosis 2.00, 95% confidence interval 1.13-3.52; P = .02); three trials compared neuromuscular electrical stimulation as an adjunct to heparin versus heparin only, demonstrating no significant difference (odds ratio of deep vein thrombosis 0.33, 95% confidence interval 0.10-1.14; P = .08). Conclusion Neuromuscular electrical stimulation significantly reduces the risk of deep vein thrombosis compared to no prophylaxis. It is inferior to heparin in preventing deep vein thrombosis and there is no evidence for its use as an adjunct to heparin.

Inferior vena cava filters for prevention of venous thromboembolism in obese patients undergoing bariatric surgery: a systematic review.

OBJECTIVE: The use of inferior vena cava (IVC) filters for prevention of venous thromboembolism (VTE) in bariatric surgery is a contentious issue. We aim to review the evidence for the use of IVC filters in bariatric surgical patients, describe trends in practice, and discuss challenges in developing evidence-based guidelines. BACKGROUND: The incidence of VTE in modern bariatric procedures with traditional methods of thromboprophylaxis, such as sequential calf compression devices and perioperative low molecular weight heparin, is approximately 2%. METHODS: A systematic review of the literature was conducted according to PRISMA guidelines. We searched Medline up until July 2013 with the terms "bariatric filter" and "gastric bypass filter." Two investigators independently screened search results according to an agreed list of eligibility criteria. RESULTS: Eighteen studies were included. There were no randomized controlled trials. Data from controlled cohort studies suggest that those who undergo IVC filter insertion preoperatively may be at higher risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE). A small cohort of patients with multiple risk factors for VTE benefitted from reduced PE-related mortality after preoperative IVC filter insertion. Data from 12 case series reporting VTE outcomes from a total of 497 patients who underwent preoperative IVC filter insertion demonstrated DVT rates of 0% to 20.8% and PE rates ranging from 0% to 6.4%. CONCLUSIONS: Published data reporting the safety and efficacy of IVC filter use in bariatric surgical patients is highly heterogeneous. There is no evidence to suggest that the potential benefits of IVC filters outweigh the significant risks of therapy.

Venous injuries in pediatric trauma: Systematic review of injuries and management.

BACKGROUND: Diagnosis of vascular injury in pediatric trauma is challenging as clinical signs may be masked by physiologic compensation. We aimed to (1) investigate the prevalence of noniatrogenic pediatric venous injuries, (2) discuss options in management of traumatic venous injury, and (3) investigate mortality from venous injury in pediatric trauma. Our objective was to provide the practicing clinician with a summary of the published literature and to develop an evidence-based guide to the diagnosis and management of traumatic venous injuries in children. METHODS: A systematic review of published literature (PubMed) describing noniatrogenic traumatic venous injury in the pediatric population (<17 years) was performed according to PRISMA [Preferred Reporting Items for Systematic Reviews and Meta-Analyses] guidelines. Data were retrieved systematically under the following headings: Study Design, Population Demographics (dates of recruitment, mean age, mechanism of injury), Diagnostic Approach, Vessel Injured, Management (operative technique), and Mortality. RESULTS: Thirteen articles were included in this systematic review. In total, 508 noniatrogenic traumatic venous injuries were reported in children between the year 1957 and present day. Mechanisms of injury included blunt trauma from seat belt-related injury and fall from height or penetrating trauma from gunshot and foreign object. Injury to the inferior vena cava was most frequently reported, followed by femoral vein and internal jugular injuries. Primary repair was the most frequently reported technique for surgical repair (38%), followed by ligation (25%) and end-to-end anastomosis (15%). Mortality in pediatric trauma patients who had venous injury was reported as 0% to 67% in published series, highest in the series in which the most frequently reported injury was of the inferior vena cava. CONCLUSION: Traumatic venous injury in the pediatric population is uncommon but may be associated with significant morbidity and mortality. Intra-abdominal venous injuries are associated with high mortality from exsanguination. Early diagnosis and intervention are therefore essential in such cases. LEVEL OF EVIDENCE: Systematic review, level IV.

The Future of Phlebology in Europe.

BACKGROUND: Worldwide superficial and deep venous diseases are common and associated with significant individual and socioeconomic morbidity. Increasing burden of venous disease requires Phlebology to define itself as an independent specialty representing not only patients but the multidisciplinary physicians involved in venous care. METHODS & RESULTS: In this article the scope of venous disease in Europe and subsequent future governance for treatment in the region is discussed. Superficial venous disease is common with 26.9-68.6% of European populations reported to have C2-C6 disease according to the CEAP (Clinical severity, Aetiology, Anatomy and Pathophysiology) scoring system. However, a significant disparity is observed in the treatment of superficial venous disease across Europe. Post thrombotic syndrome (PTS) after deep vein thrombosis (DVT) contributes to the increasing burden of deep venous disease. Aggressive thrombus removal for acute ileofemoral DVT provides a cost-effective 14.4% risk reduction in the development of PTS. Additionally, deep venous lesions requiring endovascular intervention are being increasingly performed to prevent recurrent thrombosis. The European College of Phlebology (ECoP) has been formed to provide a responsible body for the care of the European patient with venous disease. The role of the ECoP includes unifying European member states through standardised guideline production, identification of research strategy and provision of training and accreditation of physicians. CONCLUSION: Creation of a European venous disease specific speciality will provide a patient centred approach through understanding of the impact of disease in the region and delivery of high quality diagnostics and treatment from an appropriately certified Phlebologist.

The calf muscle pump revisited.

BACKGROUND: Chronic venous disease (CVD) defines the spectrum of manifestations of venous disease that originate as a result of ambulatory venous hypertension. Thus far, the role of the calf muscle pump in the development and potentiation of CVD has been overlooked and understated in the clinical setting, with much greater emphasis placed on reflux and obstruction. The aim of this review is to explore the level of significance that calf muscle pump function or dysfunction bears on the development and potentiation of CVD. METHODS: EMBASE and MEDLINE databases were searched with keywords "calf" AND "muscle" AND "pump" AND "venous" AND "insufficiency" AND ("lower limb*" OR "leg*"), screened for cross-sectional and longitudinal studies relating to chronic venous insufficiency, highlighting the role of the calf muscle pump in CVD and the extent to which the calf muscle pump is impaired in these cases. This resulted in the inclusion of 10 studies. RESULTS: Compared with healthy subjects, patients with CVD have a reduced ejection fraction (15.9%; P < .001) and an increased venous filling index (4.66 mL/s; P < .001), indicating impairment in calf muscle pump ejection ability as well as poor venous competence. Calf muscle pump dysfunction is present in 55% of patients with CVD in the literature, but this did not reach significance on meta-analysis. Isotonic exercise programs in patients with active and healed ulcers have been shown to increase calf muscle pump function but not venous competence. DISCUSSION: Calf muscle pump failure is a therapeutic target in the treatment of CVD. Evidence suggests that isotonic exercise treatment may be an effective method of increasing the hemodynamic performance of the calf muscle pump. CONCLUSIONS: This review emphasizes the requirement for more attention to be placed on the treatment of calf muscle pump failure in cases of CVD by use of exercise treatment programs or other methods, which may be of clinical importance in managing symptomatic disease. To establish this in routine clinical practice, these results would need to be replicated in appropriate clinical trials. It would also be logical to look at other modifiable muscle pumps, such as the thigh and foot, and to explore the potential benefit of electrical devices acting on the leg (eg, electrical muscular or neuromuscular stimulation), especially for those patients in whom exercise capacity is limited.

Retrograde mechanochemical ablation of the small saphenous vein for the treatment of a venous ulcer.

We present the first case of retrograde ablation of the small saphenous vein to treat active venous ulceration. A 73-year-old gentleman with complicated varicose veins of the left leg and a non-healing venous ulcer despite previous successful endovenous treatment to his left great saphenous vein underwent mechanochemical ablation of his small saphenous vein with the ClariVein® system, under local anaesthetic, using a retrograde cannulation technique. Post-operatively the patient had improved symptomatically and the ulcer size had reduced. This report highlights that patients with small saphenous vein incompetence and active ulceration can be treated successfully with retrograde mechanochemical ablation.

Scoring systems for the post-thrombotic syndrome.

OBJECTIVE: To assess each of the scoring systems used to diagnose and classify post-thrombotic syndrome, a common chronic complication of deep vein thrombosis. The design of the study was a systematic review of the literature pertaining to post-thrombotic syndrome. METHODS: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines by a search of PubMed (1948 to September 2011) using the search terms "post-thrombotic syndrome," "postthrombotic syndrome," "post-phlebitic syndrome," and "postphlebitic syndrome." A manual reference list search was also carried out to identify further studies that would be appropriate for inclusion. The various scoring systems in use were identified and assessed against a list of criteria to determine their validity for use. For outcome measures, each scoring system was assessed for specific criteria, including interobserver reliability, association with ambulatory venous pressures, ability to assess severity of post-thrombotic syndrome, ability to assess change in condition over time, and association with patient-reported symptom severity. RESULTS: The Villalta, Ginsberg, Brandjes, Widmer, CEAP, and Venous Clinical Severity Score systems all were assessed for the stated outcome measures. From their use in the literature, only the Villalta score was able to fulfill all the criteria described. The main criticism of the Villalta score in the literature appears to be its use of subjective measures. To that end, we propose that use of a venous disease-specific quality-of-life questionnaire in combination with the Villalta score may help standardize the subjective criteria. CONCLUSIONS: The Villalta score, combined with a venous disease-specific quality-of-life questionnaire, should be considered the "gold standard" for the diagnosis and classification of post-thrombotic syndrome.

Cyanoacrylate glue for the treatment of great saphenous vein incompetence in the anticoagulated patient.

The Sapheon Venaseal Closure System (Sapheon Inc, Santa Rosa, Calif), using cyanoacrylate glue, has provided a new modality of treatment, with patients treated without both tumescent anesthesia and postoperative compression. We present the first case of great saphenous vein occlusion performed using glue while the patient was fully anticoagulated with warfarin. This was tolerated well, and the treated vein showed complete early occlusion at 8 weeks; however at 6 months, extensive recanalization was demonstrated on duplex imaging.