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Revista Da Associacao Medica Brasileira... May 2019The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to...
The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.
Topics: Brazil; Chronic Pain; Clinical Decision-Making; Embolization, Therapeutic; Female; Humans; Pelvic Pain; Pelvis; Reproducibility of Results; Syndrome; Treatment Outcome; Varicose Veins
PubMed: 31066803
DOI: 10.1590/1806-9282.65.4.518 -
International Journal of Surgery... May 2019The need for patients to wear compression stockings after varicose vein surgery and the duration of compressions tocking therapy has been debated. This study isa... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The need for patients to wear compression stockings after varicose vein surgery and the duration of compressions tocking therapy has been debated. This study isa meta-analysis of randomized controlled trials (RCTs) to determine the optimal duration of compression stocking therapy after endovenous thermal ablation (ETA) of the great saphenous vein.
METHODS
The PubMed, Embase, and Cochrane Library databases were searched before January 2019. Individual effect sizes were standardized, and a meta-analysis was conducted to calculate the pooled effect size by using a random effects model. The primary outcome was the severity of pain in the postoperative period. Secondary outcomes were quality of life (QoL), leg volume, bruising scores, consumptionof analgesic agents, recovery time off work, satisfaction, and the incidence rates of postoperative complications including paresthesia and phlebitis.
RESULTS
Five RCTsinvolving775 patients were reviewed. The long-duration (1-2 weeks) group significantly reduced postoperative pain at 1 week (mean difference [MD] 1.19; 95% confidence interval [CI]: 0.58-1.80) and recovery time off work (MD: 1.01 day, 95% CI: 0.06-1.96)when compared with the short-duration (24-48 h) group. However, the mean pain scores at 2 (0.1; 95% CI: 0-0.2) and 6 weeks postoperatively (-0.3; 95% CI: -1.09-0.49) did not differ significantly between the two groups. Moreover, the incidence rates of complication, paresthesia, and phlebitis did not differ significantly between the short-duration and long-duration groups.
CONCLUSION
The use of compression therapy for a long time (1-2 weeks) is better than short-term (24-48 h) use in terms of postoperative pain at 1 week and recovery off work. Hence, we recommend the prescription of 1-week compression stocking therapy after ETA in routine clinical practice. However, the available evidence is of variable quality, further well-structured RCTs with improved standardization of compression treatment, types of stockings, and target populations are warranted.
Topics: Catheter Ablation; Humans; Postoperative Complications; Saphenous Vein; Stockings, Compression; Time Factors; Treatment Outcome; Varicose Veins; Vascular Surgical Procedures
PubMed: 30959134
DOI: 10.1016/j.ijsu.2019.03.024 -
Revista Brasileira de Enfermagem 2019To identify evidence about the effects of growth factor application on venous ulcer healing. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To identify evidence about the effects of growth factor application on venous ulcer healing.
METHOD
Systematic review and meta-analysis, including Randomized Clinical Trials. Searches: Ovid MEDLINE, EMBASE, CINAHL, Cochrane CENTRAL, LILACS, Web of Science, Digital Library of Theses and Dissertations; Google Scholar and list of references.
RESULTS
802 participants were recruited from the 10 included studies: 472 in the intervention group (growth factors) and 330 as control. The relative risk for the complete healing outcome was 1.06 [95% CI 0.92-1.22], p = 0.41. Participants who received Platelet-Rich Plasma and Epidermal Growth Factor showed a slight tendency to achieve complete healing, but without statistical relevance (p <0.05). Most of the studies were classified as moderate risk of bias.
CONCLUSION
The effect of the application of growth factors for complete healing in venous ulcers is not clear, and clinical trials with methodological quality are required for more accurate recommendations.
Topics: Humans; Intercellular Signaling Peptides and Proteins; Randomized Controlled Trials as Topic; Treatment Outcome; Varicose Ulcer; Wound Healing
PubMed: 30916287
DOI: 10.1590/0034-7167-2017-0865 -
International Wound Journal Aug 2019Compression therapy is the mainstay of treatment for patients with venous leg ulcers. Current gold standard is 4 layer bandaging, which has a significant impact on...
Compression therapy is the mainstay of treatment for patients with venous leg ulcers. Current gold standard is 4 layer bandaging, which has a significant impact on patients comfort, ability to wear their own shoes, and quality of life, as well as taking significant time to apply, and losing compression over time. This systematic review aims to evaluate the use of Velcro wrap devices for the treatment of venous ulceration. Preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines were used to identify articles reporting the use of Velcro wrap devices in patients with venous ulceration. Sixteen articles were identified (14 case series, 1 randomised trial, and 1 audit) reporting on 192 patients. There were reports of improved time to healing, reduced cost by >50%, reduced number and duration of nursing appointments, and improved quality of life in patients in Velcro wrap devices. Although the evidence remains poor, Velcro devices have potential to improve outcomes for patients with venous ulceration and further good quality studies should be undertaken to evaluate these further.
Topics: Adult; Aged; Aged, 80 and over; Compression Bandages; Female; Humans; Male; Middle Aged; Varicose Ulcer; Wound Healing
PubMed: 30900365
DOI: 10.1111/iwj.13116 -
European Journal of Vascular and... Jun 2019The aim was to summarise the evidence for the relationship between vein diameters and clinical severity, and elucidate the relationship between diameters and health...
OBJECTIVE/BACKGROUND
The aim was to summarise the evidence for the relationship between vein diameters and clinical severity, and elucidate the relationship between diameters and health related quality of life (HRQoL) METHODS: A systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. The MEDLINE and Embase databases were searched from 1946 to 31 August 2018. Reference lists of included studies were searched for further relevant papers. Full text studies in English reporting the relationship between great and small saphenous vein diameters and clinical severity and/or HRQoL scores measured using validated instruments were included. All study designs were included. Studies that did not include relationships between these parameters, non-English studies, and studies focusing on non-truncal veins were excluded. Two reviewers independently performed the study selection, data extraction, and risk of bias assessment.
RESULTS
Eleven eligible studies were identified, reporting on 2,732 limbs (range 22-681). Four studies correlated truncal vein diameter with both clinical severity and HRQoL, while seven reported only on clinical severity measures. Multiple instruments were used to quantify HRQoL and clinical severity. Seven studies assessed the relationship with CEAP class, with the majority observing a positive correlation between vein diameter and disease severity. Four studies found weak correlations with VCSS, with one showing correlations with VCSS components. No significant relationship between diameters and HRQoL scores was reported. One study also revealed no correlation with Aberdeen Varicose Vein Questionnaire improvements post-treatment. The majority of studies failed to include C and C participants.
CONCLUSIONS
While further studies are required to improve the level of evidence, the existing literature suggests that truncal vein diameters correlate with clinical severity. Diameters are a poor predictor of HRQoL, with no relationship to patients' perceived impact of chronic venous disease. As such, vein diameter should not be used as a measure to decide who needs venous intervention.
Topics: Chronic Disease; Clinical Decision-Making; Humans; Patient Selection; Peripheral Vascular Diseases; Predictive Value of Tests; Prognosis; Quality of Life; Risk Factors; Saphenous Vein; Severity of Illness Index; Surveys and Questionnaires
PubMed: 30850282
DOI: 10.1016/j.ejvs.2019.01.024 -
Ontario Health Technology Assessment... 2019People with chronic venous insufficiency who develop leg ulcers face a difficult condition to treat. Venous leg ulcers may persist for long periods of time and have a...
BACKGROUND
People with chronic venous insufficiency who develop leg ulcers face a difficult condition to treat. Venous leg ulcers may persist for long periods of time and have a negative impact on quality of life. Treatment requires frequent health care provider visits, creating a substantial burden across health care settings.The objective of this health technology assessment was to evaluate the effectiveness, safety, cost-effectiveness, budget impact, and patient experiences of compression stockings for prevention of venous leg ulcer recurrence.
METHODS
We conducted a systematic review of the literature to identify randomized trials and observational studies examining the effectiveness of compression stockings in reducing the risk of recurrence of venous leg ulcers after healing and/or reported on the quality of life for patients and any adverse events from the wearing of compression stockings. We performed a literature search to identify studies and evaluated the quality of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.We conducted a cost-utility analysis with a 5-year time horizon from the perspective of the Ontario Ministry of Health and Long-Term Care. We compared compression stockings to usual care (no compression stockings) and simulated a hypothetical cohort of 65-year-old patients with healed venous ulcers, using a Markov model. Model input parameters were obtained primarily from the published literature. In addition, we used Ontario costing sources and consultation with clinical experts. We estimated quality-adjusted life years gained and direct medical costs. We conducted sensitivity analyses and a budget impact analysis to estimate the additional costs required to publicly fund compression stockings in Ontario. All costs are presented in 2018 Canadian dollars.We spoke to people who recently began using compression stockings and those who have used them for many years to gain an understanding of their day-to-day experience with the management of chronic venous insufficiency and compression stockings.
RESULTS
One randomized controlled trial reported that the recurrence rate was significantly lower at 12 months in people who were assigned to the compression stocking group compared with people assigned to the control group (risk ratio 0.43, 95% CI, 0.27-0.69; = .001) (GRADE: Moderate). Three randomized controlled trials reported no significant difference in recurrence rates between the levels of pressure. One randomized controlled trial also reported that the risk of recurrence was six times higher in those who did not adhere to compression stockings than in those who did adhere. One single-arm cohort study showed that the recurrence rate was considerably higher in people who did not adhere or had poor adherence (79%) compared with those who adhered to compression stockings (4%).Compared with usual care, compression stockings were associated with higher costs and with increased quality-adjusted life years. We estimated that, on average, the incremental cost-effectiveness ratio of compression stockings was $27,300 per quality-adjusted life year gained compared to no compression stockings. There was some uncertainty in our results, but most simulations (> 70%) showed that the incremental cost-effectiveness ratio remained below $50,000 per quality-adjusted life-year. We estimated that the annual budget impact of funding compression stockings would range between $0.95 million and $3.19 million per year over the next five years.People interviewed commonly reported that chronic venous insufficiency had a substantial impact on their day-to-day lives. There were social impacts from the difficulty or inability to walk and emotional impacts from the loss of independence and fear of ulcer recurrence. There were barriers to the wearing of compression stockings, including replacement cost and the difficulty of putting them on; however, most people interviewed reported that using compression stockings improved their condition and their quality of life.
CONCLUSIONS
The available evidence shows that, compared with usual care, compression stockings are effective in preventing venous leg ulcer recurrence and likely to be cost-effective. In people with a healed venous leg ulcer, wearing compression stockings helps to reduce the risk of recurrence by about half. Publicly funding compression stockings for people with venous leg ulcers would result in additional costs to the Ontario health care system over the next 5 years. Despite concerns about cost and the daily chore of wearing compression stockings, most people interviewed felt that compression stockings provided important benefits through reduction of swelling and prevention of recurrence.
Topics: Cost-Benefit Analysis; Health Care Costs; Humans; Leg Ulcer; Markov Chains; Patient Satisfaction; Recurrence; Secondary Prevention; Stockings, Compression; Varicose Ulcer
PubMed: 30828407
DOI: No ID Found -
The Cochrane Database of Systematic... Mar 2019Venous leg ulcers are complex, costly, and their prevalence is expected to increase as populations age. Venous congestion is a possible cause of venous leg ulcers, which... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Venous leg ulcers are complex, costly, and their prevalence is expected to increase as populations age. Venous congestion is a possible cause of venous leg ulcers, which subfascial endoscopic perforator surgery (SEPS) attempts to address by removing the connection between deep and superficial veins (perforator veins). The effectiveness of SEPS in the treatment of venous leg ulcers, however, is unclear.
OBJECTIVES
To assess the benefits and harms of subfascial endoscopic perforator surgery (SEPS) for the treatment of venous leg ulcers.
SEARCH METHODS
In March 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of interventions that examined the use of SEPS independently or in combination with another intervention for the treatment of venous leg ulcers.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies for inclusion, extracted data, assessed risk of bias, and assessed the certainty of evidence using the GRADE approach.
MAIN RESULTS
We included four RCTs with a total of 322 participants. There were three different comparators: SEPS plus compression therapy versus compression therapy (two trials); SEPS versus the Linton procedure (a type of open surgery) (one trial); and SEPS plus saphenous surgery versus saphenous surgery (one trial). The age range of participants was 30 to 82, with an equal spread of male and female participants. All trials were conducted in hospital settings with varying durations of follow-up, from 18 months to 6 years. One trial included participants who had both healed and active ulcers, with the rest including only participants with active ulcers.There was the potential for reporting bias in all trials and performance bias and detection bias in three trials. Participants in the fourth trial received one of two surgical procedures, and this study was at low risk of performance bias and detection bias.SEPS + compression therapy versus compression therapy (2 studies; 208 participants)There may be an increase in the proportion of healed ulcers at 24 months in people treated with SEPS and compression therapy compared with compression therapy alone (risk ratio (RR) 1.17, 95% confidence interval (CI) 1.03 to 1.33; 1 study; 196 participants); low-certainty evidence (downgraded twice, once for risk of bias and once for imprecision).It is uncertain whether SEPS reduces the risk of ulcer recurrence at 24 months (RR 0.85, 95% CI 0.26 to 2.76; 2 studies; 208 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).The included trials did not measure or report the following outcomes; time to complete healing, health-related quality of life (HRQOL), adverse events, pain, duration of hospitalisation, and district nursing care requirements.SEPS versus Linton approach (1 study; 39 participants)It is uncertain whether there is a difference in ulcer healing at 24 months between participants treated with SEPS and those treated with the Linton procedure (RR 0.95, 95% CI 0.83 to 1.09; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).It is also uncertain whether there is a difference in risk of recurrence at 60 months: (RR 0.47, 95% CI 0.10 to 2.30; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).The Linton procedure is possibly associated with more adverse events than SEPS (RR 0.04, 95% CI 0.00 to 0.60; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).The outcomes time to complete healing, HRQOL, pain, duration of hospitalisation and district nursing care requirements were either not measured, reported or data were not available for analysis.SEPS + saphenous surgery versus saphenous surgery (1 study; 75 participants)It is uncertain whether there is a difference in ulcer healing at 12 months between participants treated with SEPS and saphenous surgery versus those treated with saphenous surgery alone (RR 0.96, 95% CI 0.64 to 1.43; 1 study; 22 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).It is also uncertain whether there is a difference in the risk of recurrence at 12 months: (RR 1.03, 95% CI 0.15 to 6.91; 1 study; 75 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).Finally, we are uncertain whether there is an increase in adverse events in the SEPS group (RR 2.05, 95% CI 0.86 to 4.90; 1 study; 75 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).The outcomes time to complete healing, HRQOL, serious adverse events, pain, duration of hospitalisation, and district nursing care requirements were either not measured, reported or data were not available for analysis.
AUTHORS' CONCLUSIONS
The role of SEPS for the treatment of venous leg ulcers remains uncertain. Only low or very low-certainty evidence was available for inclusion. Due to small sample sizes and risk of bias in the included studies, we were unable to determine the potential benefits and harms of SEPS for this purpose. Only four studies met our inclusion criteria, three were very small, and one was poorly reported. Further high-quality studies addressing the use of SEPS in venous leg ulcer management are likely to change the conclusions of this review.
Topics: Adult; Aged; Aged, 80 and over; Compression Bandages; Female; Humans; Male; Middle Aged; Postoperative Complications; Randomized Controlled Trials as Topic; Recurrence; Saphenous Vein; Time Factors; Varicose Ulcer; Vascular Surgical Procedures; Veins; Wound Healing
PubMed: 30827037
DOI: 10.1002/14651858.CD012164.pub2 -
International Wound Journal Jun 2019To assess the efficacy and safety of endovenous laser treatment (EVLT) and high ligation (HL) for limb varicosity using meta-analysis. Multiple databases including... (Comparative Study)
Comparative Study Meta-Analysis
To assess the efficacy and safety of endovenous laser treatment (EVLT) and high ligation (HL) for limb varicosity using meta-analysis. Multiple databases including PubMed, Springer, Excerpta Medica Database, Ovid Technologies, and China Journal Full-text database were searched for relevant studies in English or Chinese, and full-text articles were used to compare EVLT and HL for limb varicosity. Review Manager 5.0 was used to estimate the effects of the results among eligible articles. Forest plots, sensitivity analysis, and bias analysis of the included articles were also conducted. Initial screening yielded 1031 studies, 11 randomised controlled trials involving 1145 limb varicosity patients met the inclusion criteria in this study. The results of the heterogeneity test suggested that intraoperative blood loss mean difference (MD) = -6.31[-9.03, -3.60], P < 0.00001), operative time (MD) = -39.76[-42.27, -37.24], P < 0.00001), rate of complications (odds ratio [OR] = 0.37[0.22, 0.61], P < 0.0001), and recurrence (OR = 0.28[0.16, 0.49], P < 0.0001) were significantly different. Although both EVLT and HL have their own merits and demerits, EVLT is a more effective and safe method to treat limb varicosity.
Topics: Adult; Aged; Aged, 80 and over; Female; Humans; Laser Therapy; Ligation; Lower Extremity; Male; Middle Aged; Treatment Outcome; Varicose Veins
PubMed: 30767406
DOI: 10.1111/iwj.13083 -
Journal of Vascular Surgery. Venous and... Mar 2019This systematic review and meta-analysis aimed to assess whether compression stockings or other interventions reduce the incidence of venous ulceration after acute deep... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review and meta-analysis aimed to assess whether compression stockings or other interventions reduce the incidence of venous ulceration after acute deep venous thrombosis.
METHODS
We searched PubMed and Embase for randomized controlled trials (RCTs), restricted to English, Spanish, and Hebrew, related to post-thrombotic syndrome and venous ulceration in participants with confirmed deep venous thrombosis. Our primary statistical assessment was the Peto odds ratio (OR).
RESULTS
Our search generated 23 RCTs meeting inclusion and exclusion criteria, summing 6162 patients and 146 ulcerative events. Trials were categorized into compression, low-molecular-weight heparin (LMWH), procedural thrombolysis, medical thrombolysis, or miscellaneous. Six compression trials were identified, of which five were included in meta-analysis. Compression compared with placebo did not reduce venous ulceration (OR, 0.915; 95% confidence interval [CI], 0.475-1.765), and long-term compression was not superior to short-term compression (OR, 1.36; 95% CI, 0.014-1.31). Four LMWH trials were identified but were not subjected to meta-analysis because of intertrial heterogeneity. One trial, comparing extended tinzaparin with warfarin, demonstrated eight ulcers in the warfarin group and one ulcer in the LMWH group (relative risk, 0.125; P < .05). Three procedural thrombolysis trials were pooled into meta-analysis; fewer ulcerative events occurred in procedural thrombolysis patients, but the effect was not significant (OR, 0.677; 95% CI, 0.338-1.358). Eight medical thrombolysis trials were identified. Pooled analysis of five trials demonstrated a protective effect on ulceration in streptokinase patients vs standard heparinization (OR, 0.125; 95% CI, 0.021-0.739). However, these trials were of poor-quality study design, had small sample size, and had poor overall outcomes. Miscellaneous studies included a trial of hidrosmina, a vasoactive flavonoid, and a trial comparing 6-month warfarin treatment with 6 weeks; neither trial had significant outcomes. Intertrial heterogeneity was not adequately assessed with the I value as venous ulceration is a rare event; the Grading of Recommendations Assessment, Development, and Evaluation evidence for most trials was very low, with the exception of procedural thrombolysis trials, for which it was low.
CONCLUSIONS
We found insufficient evidence to assess whether compression or other interventions protect against venous ulceration. To develop guidelines for treatment decisions related to prevention of venous ulceration, high-powered RCTs investigating venous leg ulcers as a primary outcome are required.
Topics: Anticoagulants; Heparin, Low-Molecular-Weight; Humans; Postthrombotic Syndrome; Randomized Controlled Trials as Topic; Risk Factors; Stockings, Compression; Thrombolytic Therapy; Treatment Outcome; Varicose Ulcer; Venous Thrombosis
PubMed: 30660582
DOI: 10.1016/j.jvsv.2018.12.009 -
British Journal of Haematology Dec 2018Chronic venous disease (CVD) represents a significant healthcare burden. Thrombophilia is proposed as a risk factor, particularly for post-thrombotic CVD. A systematic...
Chronic venous disease (CVD) represents a significant healthcare burden. Thrombophilia is proposed as a risk factor, particularly for post-thrombotic CVD. A systematic review was performed to determine the relationship between thrombophilia and non-thrombotic CVD. MEDLINE and Embase databases were searched from 1946 up to March 2018. Case-control studies, cohort studies or randomised clinical trials reporting on thrombophilias in non-thrombotic lower limb CVD in adult patients were included. Non-English and post-thrombotic syndrome studies were excluded. Study selection and data extraction were performed by two reviewers. Fifteen studies were included, reporting on 916 cases and 1261 controls. Studies largely focused on venous ulceration and investigated multiple haemostatic factors. An association between thrombophilia and non-thrombotic CVD was identified, with greater prevalence and factor concentration alteration reported in patients compared to controls. Concomitant thrombophilia presence was associated with earlier CVD onset. Relationship strength varied, with commoner aetiologies showing clearer correlation than rarer ones. Thrombophilia is associated with non-thrombotic CVD but the mechanism is unclear and causation cannot be determined. Future research should focus on prospective studies with larger populations and identify adjunct therapies targeting thrombophilia.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies; Antithrombins; Blood Coagulation Factors; Chronic Disease; Female; Fibrinolysis; Humans; Hyperhomocysteinemia; Lower Extremity; Lupus Coagulation Inhibitor; Male; Middle Aged; Mutation; Prothrombin; Risk Factors; Thrombophilia; Varicose Ulcer; Vascular Diseases; Veins; Young Adult
PubMed: 30488425
DOI: 10.1111/bjh.15692