Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomized controlled feasibility trial.

BACKGROUND: Venous leg ulcers (VLUs) are typically painful and heal slowly. Compression therapy offers high healing rates; however, improvements are not usually sustained. Exercise is a low-cost, low-risk and effective strategy for improving physical and mental health. Little is known about the feasibility and efficacy of supervised exercise training used in combination with compression therapy patients with VLUs. OBJECTIVES: To assess the feasibility of a 12-week supervised exercise programme as an adjunct therapy to compression in patients with VLUs. METHODS: This was a two-centre, two-arm, parallel-group, randomized feasibility trial. Thirty-nine patients with venous ulcers were recruited and randomized 1 : 1 either to exercise (three sessions weekly) plus compression therapy or compression only. Progress/success criteria included exercise attendance rate, loss to follow-up and patient preference. Baseline assessments were repeated at 12 weeks, 6 months and 1 year, with healing rate and time, ulcer recurrence and infection incidents documented. Intervention and healthcare utilization costs were calculated. Qualitative data were collected to assess participants' experiences. RESULTS: Seventy-two per cent of the exercise group participants attended all scheduled exercise sessions. No serious adverse events and only two exercise-related adverse events (both increased ulcer discharge) were reported. Loss to follow-up was 5%. At 12 months, median ulcer healing time was lower in the exercise group (13 vs. 34·7 weeks). Mean National Health Service costs were £813·27 for the exercise and £2298·57 for the control group. CONCLUSIONS: The feasibility and acceptability of both the supervised exercise programme in conjunction with compression therapy and the study procedures is supported.

Systematic review of carotid artery procedures and the volume-outcome relationship in Europe.

BACKGROUND: Hospitals that conduct more procedures on the carotid arteries may achieve better outcomes. In the context of ongoing reconfiguration of UK vascular services, this systematic review was conducted to evaluate the relationship between the volume of carotid procedures and outcomes, including mortality and stroke. METHODS: Searches of electronic databases identified studies that reported the effect of hospital or clinician volume on outcomes. Reference and citation searches were also performed. Inclusion was restricted to European populations on the basis that the model of healthcare delivery is similar across Europe, but differs from that in the USA and elsewhere. Analyses of hospital and clinician volume, and carotid endarterectomy (CEA) and carotid artery stenting (CAS) were conducted separately. RESULTS: Eleven eligible studies were identified (233 411 participants), five from the UK, two from Sweden, one each from Germany, Finland and Italy, and a combined German, Austrian and Swiss population. All studies were observational. Two large studies (179 736 patients) suggested an inverse relationship between hospital volume and mortality (number needed to treat (NNT) as low as 165), and combined mortality and stroke (NNT as low as 93), following CEA. The evidence was less clear for CAS; multiple analyses in three studies did not identify convincing evidence of an association. Limited data are available on the relationship between clinician volume and outcome in CAS; in CEA, an inverse relationship was identified by two of three small studies. CONCLUSION: The evidence from the largest and highest-quality studies included in this review support the centralization of CEA.

Systematic review and meta-analysis of additional technologies to enhance angioplasty for infrainguinal peripheral arterial occlusive disease.

BACKGROUND: There are several additional techniques designed to enhance conventional percutaneous transluminal balloon angioplasty (PTA). This systematic review assessed current evidence on the clinical effectiveness of additional techniques for infrainguinal peripheral arterial occlusive disease (PAD). METHODS: Relevant electronic databases, including MEDLINE, were searched in May 2011. The population comprised participants with symptomatic PAD undergoing endovascular treatment for disease distal to the inguinal ligament. Interventions were additional techniques compared with conventional PTA. Main outcome measures were restenosis and need for reintervention. Randomized clinical trials (RCTs) of clinical effectiveness were assessed for quality and data were extracted. Where appropriate, meta-analysis was undertaken to produce risk ratios (RRs). RESULTS: Forty RCTs were selected. Meta-analysis showed a significant benefit in reducing restenosis rates at 6 months for self-expanding stents (RR 0.49) and drug-coated balloons (RR 0.40), and at 12 months for endovascular brachytherapy (RR 0.63). There was also evidence that use of a stent-graft significantly reduced restenosis compared with PTA, as did drug-eluting stents compared with bare-metal stents. Meta-analysis showed that use of drug-coated balloons was associated with significantly lower reintervention rates than PTA alone at 6 months (RR 0.24) and 24 months (RR 0.27) of follow-up. There was also evidence of significantly lower reintervention rates for self-expanding stents at 6 months. Other techniques did not show significant treatment effects for restenosis or reintervention. CONCLUSION: The conclusions of this review should be tempered by small sample sizes, lack of clinical outcome measures and differing outcome definitions, making direct comparison across trials difficult. However, self-expanding stents, drug-eluting stents and drug-coated balloons appeared to be the most promising technologies worthy of future study.

Cost-effectiveness analysis of enhancements to angioplasty for infrainguinal arterial disease.

BACKGROUND: The aim was to perform an economic evaluation of the cost-effectiveness of endovascular enhancements to percutaneous transluminal balloon angioplasty (PTA) with bail-out bare metal stents for infrainguinal peripheral arterial disease. METHODS: The following interventions were considered: PTA with no bail-out stenting, PTA with bail-out drug-eluting stents, drug-coated balloons, primary bare metal stents, primary drug-eluting stents, endovascular brachytherapy, stent-grafts and cryoplasty. A discrete-event simulation model was developed to assess the relative cost-effectiveness of the interventions from a health service perspective over a lifetime. Populations of patients with intermittent claudication (IC) and critical leg ischaemia (CLI) were modelled separately. Univariable and probabilistic sensitivity analyses were undertaken. Effectiveness was measured by quality-adjusted life-years (QALYs). RESULTS: For both patient populations, the use of drug-coated balloons dominated all other options by having both lower lifetime costs and greater effectiveness. For willingness-to-pay thresholds between £0 and £100,000 per additional QALY, the probability of drug-coated balloons being cost-effective was at least 58.3 per cent for patients with IC and at least 72.2 per cent for patients with CLI. Sensitivity analyses showed that the results were robust to different assumptions regarding the clinical benefits attributable to the interventions. CONCLUSION: The use of drug-coated balloons represents a cost-effective alternative to the use of PTA with bail-out bare metal stents.

Randomized controlled trial and cost-effectiveness analysis of silver-donating antimicrobial dressings for venous leg ulcers (VULCAN trial).

BACKGROUND: Antimicrobial silver dressings are used beneath graduated compression in the treatment of venous ulceration. There is little information on whether their use is effective. This was a prospective randomized trial and cost-effectiveness analysis of silver-donating versus non-silver low-adherence dressings in the treatment of venous leg ulcers. METHODS: Patients were randomized between the two types of dressing. The primary outcome measure was complete ulcer healing at 12 weeks. Secondary outcomes included time to healing, quality of life and cost-effectiveness. RESULTS: A total of 213 patients were recruited. There was no difference between the dressings in the proportion of ulcers healed at 12 weeks (59.6 per cent for silver and 56.7 per cent for control dressings). Mean utility scores for the EuroQol 5D and Short Form 6D were similar in both groups at 1, 3, 6 and 12 months. Compared with the control group the antimicrobial group had an incremental cost of pounds sterling 97.85 and an incremental quality-adjusted life year gain of 0.0002, giving an incremental cost-effectiveness ratio of pounds sterling 489 250 for the antimicrobial dressings. CONCLUSION: No significant differences were found in either primary or secondary endpoints. There was no evidence to support the routine use of silver-donating dressings beneath compression for venous ulceration. REGISTRATION NUMBER: ISRCTN 72485131 (http://www.controlled-trials.com).

Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial).

OBJECTIVES: To establish the cost-effectiveness of surgery and sclerotherapy for the treatment of varicose veins. DESIGN: Randomised controlled trials (RCTs) were carried out for conservative treatment, sclerotherapy and surgery for varicose veins. An economic analysis was carried out alongside the randomised trial. Economic modelling was undertaken based on the primary data collection and a literature review (database searches undertaken in April 2000 and updated in March 2001). SETTING: Primary data collection was from a large district general hospital and a teaching hospital both in England over a 2-year period from January 1999. Cost-effectiveness analysis and economic modelling were carried out using an NHS perspective. PARTICIPANTS: A total of 1009 patients were recruited. INTERVENTIONS: Thirty-four patents were randomised in Group 1 (minor varicose veins with no reflux, randomised between conservative treatment and sclerotherapy), 77 in Group 2 (moderate varicose veins with reflux, randomised between surgery and sclerotherapy) and 246 in Group 3 (severe varicose veins with reflux, randomised between conservative treatment and surgery). The remaining 652 patients formed the observational part of the study. MAIN OUTCOME MEASURES: The cost-effectiveness analysis was based on NHS treatment costs for the 2002--3 financial year, and utilities based on the Short Form 6D (SF-6D) preference-based health measure. For the clinical trial, the outcome measures were health-related quality of life (HRQoL) [Short Form with 36 Items (SF-36), EuroQol quality of life questionnaire (EQ-5D), visual analogue scale (VAS) and standard gamble], symptomatic relief, anatomical extent (for which a new classification was developed and validated), patient satisfaction and the incidence of complications. RESULTS: Of the RCTs, only the Group 3 trial was large enough to provide clear results. This showed that surgical treatment produced better results than conservative treatment in terms of HRQoL, symptomatic relief, anatomical extent and patient satisfaction. Clinical outcomes of surgery and sclerotherapy showed significant improvement in the extent of varicose veins, symptomatic and HRQoL parameters. Cost-effectiveness analysis based on the Group 3 trial showed that the surgery produced an estimated discounted benefit of 0.054 quality-adjusted life-year (QALY) over a 2-year period, with an additional discounted cost of pound 387.45, giving an incremental cost-effectiveness ratio (ICER) of pound 7175 per QALY. Economic modelling suggested that surgery produced a still greater benefit when considered with a 10-year time horizon, with an ICER of pound 1936 per QALY. Injection sclerotherapy produced an incremental benefit of approximately 0.044 QALY at a cost of pound 155 when compared with conservative treatment, giving an ICER of pound 3500 per QALY. When surgery was compared with sclerotherapy, surgery produced greater benefit with a lower ICER (showing extended dominance). CONCLUSIONS: Standard surgical treatment of varicose veins by saphenofemoral ligation, stripping and multiple phlebectomies is a clinically effective and cost-effective treatment for varicose veins, with an ICER well below the threshold normally considered appropriate for the funding of treatments within the NHS. Injection sclerotherapy also appears to be cost-effective, but produces less overall benefit, with a higher ICER than surgery for patients with superficial venous reflux. In minor varicose veins without reflux, sclerotherapy is likely to provide a small average benefit with acceptable cost-effectiveness. Research is needed into methods for accurate and acceptable utility evaluations for conditions with relatively minor effect on HRQoL and also for a validated and standardised method of classification for varicose veins.

Dressings for healing venous leg ulcers.

BACKGROUND: Venous leg ulcers, sometimes called varicose or stasis ulcers, are a consequence of damage to the valves in the veins of the legs, leading to raised venous pressure. Venous ulcers are characterised by a cyclical pattern of healing and recurrence. The main treatment is the application of compression, either in the form of compression bandages or hosiery. Dressings are usually applied beneath the compression to aid healing, comfort and to control exudate. Wounds heal quicker in a moist environment and dressings are used to absorb excess fluid or retain fluid in an otherwise dry wound in order to achieve a 'moist wound environment'. There are a large number of dressing products and types available. It is unclear whether particular dressings aid healing of leg ulcers. OBJECTIVES: To assess the effectiveness of wound dressings for the treatment of venous leg ulcers. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register (April 2006) and CENTRAL (issue 1, 2006) and several other electronic databases (up to April 2005). Manufacturers of dressing products were contacted for unpublished studies. SELECTION CRITERIA: Randomised controlled trials that evaluated dressings for the treatment of venous leg ulcers. There was no restriction in terms of source, date of publication or language. Ulcer healing was the primary endpoint. DATA COLLECTION AND ANALYSIS: Data from eligible studies were extracted and summarised using a data extraction sheet by two authors independently. MAIN RESULTS: 42 randomised controlled studies were identified that met the inclusion criteria. The main dressing types that were evaluated were hydrocolloids (n = 23), foams (n = 6), alginates (n = 4), hydrogel dressings (n = 6) and a group of miscellaneous dressings (n = 3). In none of the comparisons was there evidence that any one dressing type was better than others in terms of number of ulcers healed. Current evidence does not suggest that hydrocolloids are more effective than simple low adherent dressings used beneath compression (9 trials; relative risk for healing with hydrocolloid 1.09 (95% CI 0.89 to 1.34)). For other comparisons there was insufficient evidence. AUTHORS' CONCLUSIONS: The type of dressing applied beneath compression has not been shown to affect ulcer healing. For the majority of dressing types there was insufficient data to allow us to draw strong conclusions except for hydrocolloid compared with a low adherent dressing. The result of the meta-analysis indicate no significant difference in healing rates between hydrocolloid dressings and simple, low-adherent dressings when used beneath compression. Decisions regarding which dressing to apply should be based on local costs of dressings and practitioner or patient preferences.

Surgery versus sclerotherapy for the treatment of varicose veins.

BACKGROUND: Varicose veins are a relatively common condition and account for around 54,000 in-patient hospital episodes per year. The two most common interventions for varicose veins are surgery and sclerotherapy. However, there is little comparative data regarding their effectiveness. OBJECTIVES: To identify whether the use of surgery or sclerotherapy should be recommended for the management of primary varicose veins. SEARCH STRATEGY: Thirteen electronic bibliographic databases were searched covering biomedical, science, social science, health economic and grey literature (including current research). In addition, the reference lists of relevant articles were checked and various health services research-related resources were consulted via the internet. These included health economics and HTA organisations, guideline producing agencies, generic research and trials registers, and specialist sites. SELECTION CRITERIA: All studies that were described as randomised controlled trials comparing surgery with sclerotherapy for the treatment of primary varicose veins were identified. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted and summarised data from the eligible studies using a data extraction sheet for consistency. All studies were cross-checked independently by the reviewers. MAIN RESULTS: A total of 2306 references were found from our searches, 61 of which were identified as potential trials comparing surgery and sclerotherapy. However, only nine randomised trials, described in a total of 14 separate papers, fulfilled the inclusion criteria. Fifty trials were excluded and one trial is ongoing and is due for completion in 2004. The trials used a variety of outcome measures and classification systems which made direct comparison between trials difficult. However, the trend was for sclerotherapy to be evaluated as significantly better than surgery at one year; after one year (sclerotherapy resulted in worse outcomes) the benefits with sclerotherapy were less, and by three to five years surgery had better outcomes. The data on cost-effectiveness was not adequately reported. REVIEWERS' CONCLUSIONS: There was insufficient evidence to preferentially recommend the use of sclerotherapy or surgery. There needs to be more research that specifically examines both costs and outcomes for surgery and sclerotherapy.

Surgery for varicose veins: use of tourniquet.

BACKGROUND: Varicose vein surgery is a common surgical procedure but there is no consensus regarding the best surgical technique. The use of tourniquets during varicose vein surgery has been advocated as a means of reducing the potential for blood loss during the operation. OBJECTIVES: To identify whether the use of a tourniquet should be recommended when undertaking surgery for the management of primary varicose veins. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group trials register (last searched November 2001), thirteen electronic bibliographic databases, including the Cochrane Controlled Trials Register (CCTR) (last searched Issue 3, 2001), covering biomedical science, social science, health economic and grey literature (including current research). In addition, the reference lists of relevant articles were checked and various health services research related resources were consulted via the Internet. These included health economics and HTA organisations, guideline producing agencies, generic research and trials registers, and specialist sites. SELECTION CRITERIA: All studies described as randomised controlled trials that examined the use of tourniquets during surgery for patients with primary varicose veins were included. DATA COLLECTION AND ANALYSIS: Data from eligible studies were extracted and summarised independently by two reviewers. All studies were cross-checked independently by the reviewers. MAIN RESULTS: A total of twenty published papers and nineteen studies were identified. Only three of these were randomised controlled trials and were included in the review. Sixteen studies were excluded as they were non-randomised and one was a duplicate study. All three trials had a small sample size and reported the trial design, outcome measures and analysis poorly. There were also variations in the outcome measures used between the trials. In addition, there was no consistency on the reporting of mean and medians for blood loss during the operation. It was therefore not possible to pool the data to perform meta-analysis. However, the reported blood loss when using a tourniquet was between 0 and 16mls compared to between 107 to 133mls when not using a tourniquet (p<0.01). REVIEWER'S CONCLUSIONS: Although there were significant quality issues with the available evidence, the use of a tourniquet would appear to reduce blood loss during surgery. There were no reported differences between the use or non-use of a tourniquet in terms of complications and morbidity. However, the available trials were not of sufficient size to detect rarer complications such as nerve damage.

Case mix and outcome of patients referred to the vascular service at a district general hospital.

A prospective audit has been carried out to evaluate the trends in case mix and initial management of vascular surgical referrals to a single surgeon at a district general hospital. Over a 3-year period there were 1096 new emergency or routine referrals from a population of approximately 450,000. A total of 613 of these patients underwent vascular procedures, with a further 297 procedures subsequently being undertaken on the same patients during the period of the audit. There was a steady increase in the total number referred with little change in case mix with regard to age or diagnosis. Elderly patients had more severe symptoms and were less likely to be treated by minimally invasive means. The number of patients undergoing angioplasty or thrombolysis increased steadily without any corresponding reduction in the number of surgical procedures. It is concluded that there is a steady trend towards increasing vascular surgical workload which is not easily explained by a change in disease incidence or case mix. Elderly patients appear unlikely to be referred unless symptoms are severe and there are few referrals of elderly patients who might benefit from minimally invasive treatments.

The outcome of varicose vein surgery at 10 years: clinical findings, symptoms and patient satisfaction.

BACKGROUND: Data on long-term outcomes of varicose vein surgery are sparse, and 'success' rates vary substantially depending on the method of assessment. This study used a variety of methods to evaluate patients 10 years after operation. METHODS: A consecutive cohort of 100 patients was identified, of whom 70 (151 operated limbs) were reviewed--50 by clinical and Doppler examination, and all by structured questionnaire. RESULTS: A few months after operation, symptoms were 'cured' or 'much better' in 89% of patients, and remained so at 10 years in 77%. Only 30% patients were completely free of recurrent varicose veins at 10 years (both by self- and clinician-assessment): 44% had 'just a few' varicosities while 26%, had varicose veins 'as badly as before'. Only 24 patients (34%) were not 'generally pleased' at 10 years, because of continuing symptoms (3), recurrent varicosities (13), and other miscellaneous reasons. CONCLUSIONS: Although some recurrence of varicose veins is frequent 10 years after operation, surgery provides long-term relief of symptoms in the great majority of patients.

Organisation of vascular surgical services: evolution or revolution?

The trend towards subspecialisation in hospital services is likely to lead to the development of vascular surgery as a separate specialty. If vascular surgery is to emerge as a high quality service then vascular emergencies--a substantial component of the workload--should be dealt with by surgeons with adequate training, and all patients should have equal access to the service. A specialist vascular surgical unit would have to be large enough to make efficient use of other services that it needs, such as radiology, and so may require the amalgamation of smaller health district units. Because of the differing local degrees of subspecialisation, national or regional strategies for vascular surgery must be developed.

Practical tips from clinical nurses: opinions about children visiting.

Children visiting parents in the ICU is still controversial. Here are six different opinions about children visiting from ICU nurses, an infection control practitioner, and even a parent. All view points are important to consider in providing access of children to their critically ill parents. Interestingly, even nurses who do not generally support child visitation have allowed children's visits in special circumstances and found the experience positive.

A systematic review of compression hosiery for uncomplicated varicose veins.

OBJECTIVE: Compression hosiery is widely used in the prevention and management of symptoms related to varicose veins. However, there are still gaps and questions in relation to its benefit. This review seeks to examine the current evidence regarding the effectiveness of compression hosiery in the treatment of varicose veins. METHOD: Prospective, randomized controlled trials (RCTs) evaluating compression hosiery in the treatment of varicose veins were sought. Where RCTs were unavailable other evidence was included. Studies were included if they evaluated the application of compression to patients with a diagnosis of varicose veins. Twelve electronic bibliographic databases and 18 internet-based research resources were searched. Inclusion or exclusion of trials was decided by two reviewers acting independently. RESULTS: The search strategy identified 25 studies. Eleven were RCTs or systematic reviews, 12 non-randomized studies and two guidelines. No consensus was found regarding the class of compression needed for the effective management of varicose veins. Wearing compression improved symptom management, but could be confounded by the exclusion of high number of non-compliant patients within the trials. Wearing compression to slow the progression, or prevent the reoccurrence of varicose veins could not be supported by the current published evidence. CONCLUSION: The evidence for the benefit of compression hosiery for varicose veins was equivocal. The published literature was often contradictory and had methodological flaws.