Compression for preventing recurrence of venous ulcers.

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. Most leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or damaged valves. Venous ulcer prevention and treatment typically involves the application of compression bandages/stockings to improve venous return and thus reduce pressure in the legs. Other treatment options involve removing or repairing veins. Most venous ulcers heal with compression therapy, but ulcer recurrence is common. For this reason, clinical guidelines recommend that people continue with compression treatment after their ulcer has healed. This is an update of a Cochrane review first published in 2000 and last updated in 2014. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) for preventing recurrence of venous leg ulcers. SEARCH METHODS: In August 2023, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, three other databases, and two ongoing trials registries. We also scanned the reference lists of included studies and relevant reviews and health technology reports. There were no restrictions on language, date of publication, or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that evaluated compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected studies, assessed risk of bias, and extracted data. Our primary outcome was reulceration (ulcer recurrence anywhere on the treated leg). Our secondary outcomes included duration of reulceration episodes, proportion of follow-up without ulcers, ulceration on the contralateral leg, noncompliance with compression therapy, comfort, and adverse effects. We assessed the certainty of evidence using GRADE methodology. MAIN RESULTS: We included eight studies (1995 participants), which were published between 1995 and 2019. The median study sample size was 249 participants. The studies evaluated different classes of compression (UK class 2 or 3 and European (EU) class 1, 2, or 3). Duration of follow-up ranged from six months to 10 years. We downgraded the certainty of the evidence for risk of bias (lack of blinding), imprecision, and indirectness. EU class 3 compression stockings may reduce reulceration compared with no compression over six months (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.27 to 0.76; 1 study, 153 participants; low-certainty evidence). EU class 1 compression stockings compared with EU class 2 compression stockings may have little or no effect on reulceration over 12 months (RR 1.70, 95% CI 0.67 to 4.32; 1 study, 99 participants; low-certainty evidence). There may be little or no difference in rates of noncompliance over 12 months between people using EU class 1 stockings and people using EU class 2 stockings (RR 1.22, 95% CI 0.40 to 3.75; 1 study, 99 participants; low-certainty evidence). UK class 2 hosiery compared with UK class 3 hosiery may be associated with a higher risk of reulceration over 18 months to 10 years (RR 1.55, 95% CI 1.26 to 1.91; 5 studies, 1314 participants; low-certainty evidence). People who use UK class 2 hosiery may be more compliant with compression treatment than people who use UK class 3 hosiery over 18 months to 10 years (RR for noncompliance 0.69, 95% CI 0.49 to 0.99; 5 studies, 1372 participants; low-certainty evidence). There may be little or no difference between Scholl UK class 2 compression stockings and Medi UK class 2 compression stockings in terms of reulceration (RR 0.77, 95% CI 0.47 to 1.28; 1 study, 166 participants; low-certainty evidence) and noncompliance (RR 0.97, 95% CI 0.84.1 to 12; 1 study, 166 participants; low-certainty evidence) over 18 months. No studies compared different lengths of compression (e.g. below-knee versus above-knee), and no studies measured duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. AUTHORS' CONCLUSIONS: Compression with EU class 3 compression stockings may reduce reulceration compared with no compression over six months. Use of EU class 1 compression stockings compared with EU class 2 compression stockings may result in little or no difference in reulceration and noncompliance over 12 months. UK class 3 compression hosiery may reduce reulceration compared with UK class 2 compression hosiery; however, higher compression may lead to lower compliance. There may be little to no difference between Scholl and Medi UK class 2 compression stockings in terms of reulceration and noncompliance. There was no information on duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. More research is needed to investigate acceptable modes of long-term compression therapy for people at risk of recurrent venous ulceration. Future trials should consider interventions to improve compliance with compression treatment, as higher compression may result in lower rates of reulceration.

Balneotherapy for chronic venous insufficiency.

BACKGROUND: Chronic venous insufficiency (CVI) is a progressive and common disease that affects the superficial and deep venous systems of the lower limbs. CVI is characterised by valvular incompetence, reflux, venous obstruction or a combination of these symptoms, with consequent distal venous hypertension. Clinical manifestations of CVI include oedema, pain, skin changes, ulcerations and dilated skin veins in the lower limbs. It places a large financial burden on health systems. There is a wide variety of treatment options for CVI, ranging from surgery and medication to compression and physiotherapy. Balneotherapy (treatments involving water) may be a relatively cheap and efficient way to deliver physiotherapy to people with CVI. This is an update of a review first published in 2019. OBJECTIVES: To assess the effectiveness and safety of balneotherapy for the treatment of people with chronic venous insufficiency. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 28 June 2022. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing balneotherapy to no treatment or other types of treatment for CVI. We also included studies that used a combination of treatments. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. disease severity, 2. health-related quality of life (HRQoL) and 3. ADVERSE EFFECTS: Our secondary outcomes were 1. pain, 2. oedema, 3. leg ulcer incidence and 4. skin pigmentation changes. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included nine randomised controlled trials involving 1126 participants with CVI. Seven studies evaluated balneotherapy versus no treatment, one study evaluated balneotherapy versus a phlebotonic drug (melilotus officinalis), and one study evaluated balneotherapy versus dryland exercises. We downgraded our certainty in the evidence due to a lack of blinding of participants and investigators, participant-reported outcomes and imprecision. Balneotherapy versus no treatment Balneotherapy compared to no treatment probably results in slightly improved disease severity signs and symptoms scores as assessed by the Venous Clinical Severity Score (VCSS; mean difference (MD) -1.75, 95% confidence interval (CI) -3.02 to -0.49; 3 studies, 671 participants; moderate-certainty evidence). Balneotherapy compared to no treatment may improve HRQoL as assessed by the Chronic Venous Insufficiency Quality of Life Questionnaire 2 (CIVIQ2) at three months, but we are very uncertain about the results (MD -10.46, 95% CI -19.21 to -1.71; 2 studies, 153 participants; very low-certainty evidence). The intervention may improve HRQoL at 12 months (MD -4.48, 95% CI -8.61 to -0.36; 2 studies, 417 participants; low-certainty evidence). It is unclear if the intervention has an effect at six months (MD -2.99, 95% CI -6.53 to 0.56; 2 studies, 436 participants; low-certainty evidence) or nine months (MD -6.40, 95% CI -13.84 to 1.04; 1 study, 59 participants; very low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on the occurrence of adverse effects. The main adverse effects were thromboembolic events (odds radio (OR) 0.35, 95% CI 0.09 to 1.42; 3 studies, 584 participants; low-certainty evidence), erysipelas (OR 2.58, 95% CI 0.65 to 10.22; 2 studies, 519 participants; low-certainty evidence) and palpitations (OR 0.33, 95% CI 0.01 to 8.52; 1 study, 59 participants; low-certainty evidence). No studies reported any serious adverse effects. Balneotherapy compared with no treatment may improve pain scores slightly at three months (MD -1.12, 95% CI -1.35 to -0.88; 2 studies, 354 participants; low-certainty evidence); and six months (MD -1.02, 95% CI -1.25 to -0.78; 2 studies, 352 participants; low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on oedema (measured by leg circumference) at 24 days to three months, but we are very uncertain about the results (standardised mean difference (SMD) 0.32 cm, 95% CI -0.70 to 1.34; 3 studies, 369 participants; very low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on the incidence of leg ulcers at 12 months, but we are very uncertain about the results (OR 1.06, 95% CI 0.27 to 4.14; 2 studies, 449 participants; very low-certainty evidence). Balneotherapy compared with no treatment may slightly reduce skin pigmentation changes as measured by the pigmentation index at 12 months (MD -3.60, 95% CI -5.95 to -1.25; 1 study, 59 participants; low-certainty evidence). Balneotherapy versus melilotus officinalis For the comparison balneotherapy versus a phlebotonic drug (melilotus officinalis), there was little or no difference in pain symptoms (OR 0.29, 95% CI 0.03 to 2.87; 1 study, 35 participants; very low-certainty evidence) or oedema (OR 0.21, 95% CI 0.02 to 2.27; 1 study, 35 participants; very low-certainty evidence), but we are very uncertain about the results. The study reported no other outcomes of interest. Balneotherapy versus dryland exercise For the comparison balneotherapy versus dryland exercise, evidence from one study showed that balneotherapy may improve HRQoL as assessed by the Varicose Vein Symptom Questionnaire (VVSymQ), but we are very uncertain about the results (MD -3.00, 95% CI -3.80 to -2.20; 34 participants, very low-certainty evidence). Balneotherapy compared with dryland exercises may reduce oedema (leg volume) after five sessions of treatment (right leg: MD -840.70, 95% CI -1053.26 to -628.14; left leg: MD -767.50, 95% CI -910.07 to -624.93; 1 study, 34 participants, low-certainty evidence). The study reported no other outcomes of interest. AUTHORS' CONCLUSIONS: For the comparison balneotherapy versus no treatment, we identified moderate-certainty evidence that the intervention improves disease severity signs and symptoms scores slightly, low-certainty evidence that it improves pain and skin pigmentation changes, and very low-certainty evidence that it improves HRQoL. Balneotherapy compared with no treatment made little or no difference to adverse effects, oedema or incidence of leg ulcers. Evidence comparing balneotherapy with other interventions was very limited. To ensure adequate comparison between trials, future trials should standardise measurements of outcomes (e.g. disease severity signs and symptoms score, HRQoL, pain and oedema) and follow-up time points.

Heparin Attenuates Visceral Apoptosis in a Swine Model of Hemorrhagic Shock and Reperfusion Injury.

BACKGROUND: The use of unfractionated heparin in hypovolemic shock, aortic clamping, and visceral reperfusion is still not established, despite evidence of inhibition of early cell damage. This study investigated the potential protective effect of unfractionated heparin on hepatic and renal apoptosis in a porcine ischemia and reperfusion model. METHODS: Twenty-one male swine (Sus scrofa) were divided into 3 groups: sham (n = 5), heparin (n = 8), and nonheparin (n = 8). The heparin and nonheparin groups underwent hypovolemic shock for 30 min, supraceliac aortic clamping for 1 h and reperfusion for 3 h. Unfractionated heparin 200 mg/kg was administered to the heparin group during aortic clamping. Hemodynamic and laboratory parameters were monitored, including aminotransferase and serum urea. Histological lesion scores were applied to hematoxylin and eosin-stained liver and kidney sections. Apoptosis quantification was performed by caspase-3 immunohistochemistry. RESULTS: The proposed model caused a severe cardiocirculatory disturbance in the heparin and nonheparin groups, observed by the carotid-femoral pressure gradient and lactic acidosis. There was no significant difference in hemodynamic and laboratory parameters between these two groups. The mean values of liver and renal histological lesion scores did not present any significant differences. Caspase-3 immunoexpression was lower in the heparin than the nonheparin group for both liver and kidney. CONCLUSIONS: Attenuation of liver and kidney cell apoptosis in pigs undergoing systemic heparinization suggests a potential use for heparin in modulating cell death under critical hemodynamic conditions.

Balneotherapy for chronic venous insufficiency.

BACKGROUND: Chronic venous insufficiency (CVI) is a progressive and common disease that affects the superficial and deep venous systems of the lower limbs. CVI is characterised by valvular incompetence, reflux, venous obstruction, or a combination of these with consequent distal venous hypertension. Clinical manifestations of CVI include oedema, pain, skin changes, ulcerations and dilated skin veins in the lower limbs. It can result in a large financial burden on health systems. There is a wide variety of treatment options or therapies for CVI, ranging from surgery and medication to compression and physiotherapy. Balneotherapy (treatments involving water) is a relatively cheap option and potentially efficient way to deliver physical therapy for people with CVI. OBJECTIVES: To assess the efficacy and safety of balneotherapy for the treatment of people with chronic venous insufficiency (CVI). SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED and CINAHL databases, the World Health Organization International Clinical Trials Registry Platform and the Clinical Trials.gov trials register to August 2018. We searched the LILACS and IBECS databases. We also checked references, searched citations and contacted study authors to identify additional studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing balneotherapy with no treatment or other types of treatment for CVI. We also included studies that used a combination of treatments. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed studies retrieved by the search strategies. Both review authors independently assessed selected studies for complete analysis. We resolved conflicts through discussion. We attempted to contact trial authors for missing data, obtaining additional information. For binary outcomes (leg ulcer incidence and adverse events), we presented the results using odds ratio (OR) with 95% confidence intervals (CI). For continuous outcomes (disease severity, health-related quality of life (HRQoL), pain, oedema, skin pigmentation), we presented the results as a mean difference (MD) with 95% CI. MAIN RESULTS: We included seven randomised controlled trials with 891 participants (outpatients in secondary care). We found no quasi-randomised controlled trials. Six studies (836 participants) evaluated balneotherapy versus no treatment. One study evaluated balneotherapy versus a phlebotonic drug (melilotus officinalis) (55 participants). There was a lack of blinding of participants and investigators, imprecision and inconsistency, which downgraded the certainty of the evidence.For the balneotherapy versus no treatment comparison, there probably was no improvement in favour of balneotherapy in disease severity signs and symptom score as assessed using the Venous Clinical Severity Score (VCSS) (MD -1.66, 95% CI -4.14 to 0.83; 2 studies, 484 participants; moderate-certainty evidence). Balneotherapy probably resulted in a moderate improvement in HRQoL as assessed by the Chronic Venous Insufficiency Questionnaire 2 (CVIQ2) at three months (MD -9.38, 95% CI -18.18 to -0.57; 2 studies, 149 participants; moderate-certainty evidence), nine months (MD -10.46, 95% CI -11.81 to -9.11; 1 study; 55 participants; moderate-certainty evidence), and 12 months (MD -4.99, 95% CI -9.19 to -0.78; 2 studies, 455 participants; moderate-certainty evidence). There was no clear difference in HRQoL between balneotherapy and no treatment at six months (MD -1.64, 95% CI -9.18 to 5.89; 2 studies, 445 participants; moderate-certainty evidence). Balneotherapy probably slightly improved pain compared with no treatment (MD -1.23, 95% CI -1.33 to -1.13; 1 study; 390 participants; moderate-certainty evidence). There was no clear effect related to oedema between the two groups at 24 days (MD 43.28 mL, 95% CI -102.74 to 189.30; 2 studies, 153 participants; very-low certainty evidence). There probably was no improvement in favour of balneotherapy in the incidence of leg ulcers (OR 1.69, 95% CI 0.82 to 3.48; 2 studies, 449 participants; moderate-certainty evidence). There was probably a reduction in incidence of skin pigmentation changes in favour of balneotherapy at 12 months (pigmentation index: MD -3.59, 95% CI -4.02 to -3.16; 1 study; 59 participants; low-certainty evidence). The main complications reported included erysipelas (OR 2.58, 95% CI 0.65 to 10.22; 2 studies, 519 participants; moderate-certainty evidence), thromboembolic events (OR 0.35, 95% CI 0.09 to 1.42; 3 studies, 584 participants; moderate-certainty evidence) and palpitations (OR 0.33, 95% CI 0.01 to 8.52; 1 study; 59 participants; low-certainty evidence), with no clear evidence of an increase in reported adverse effects with balneotherapy. There were no serious adverse events reported in any of the studies.For the balneotherapy versus a phlebotonic drug (melilotus officinalis) comparison, we observed no clear difference in pain symptoms (OR 0.29, 95% CI 0.03 to 2.87; 1 study; 35 participants; very low-certainty evidence) and oedema (OR 0.21, 95% CI 0.02 to 2.27; 1 study; 35 participants; very low-certainty evidence). This single study did not report on the other outcomes of interest. AUTHORS' CONCLUSIONS: We identified moderate- to low-certainty evidence that suggests that balneotherapy may result in a moderate improvement in pain, quality of life and skin pigmentation changes and has no clear effect on disease severity signs and symptoms score, adverse effects, leg ulcers and oedema when compared with no treatment. For future studies, measurements of outcomes such as disease severity sign and symptom score, quality of life, pain and oedema and choice of time points during follow-up must be standardised for adequate comparison between trials.

Protocol for a systematic review and meta-analysis of interventions for pathologic perforator veins in chronic venous disease.

INTRODUCTION: Perforator veins (PVs) play an important role in the development of chronic venous insufficiency and ulceration. Procedures to eliminate incompetence and reflux in PV may include open surgery, subfascial endoscopic surgery, intravenous ablation techniques and sclerotherapy. With the aim of filling the evidence gap, this is a protocol for a systematic review that will assess the effects of any form of intervention for the treatment of pathologic PVs of the lower limbs in patients with chronic venous disease. METHODS AND ANALYSIS: Systematic searches will be carried out in MEDLINE, EMBASE, Cochrane CENTRAL, IBECS and LILACS databases at a minimum without date or language restrictions for relevant randomised controlled trials (RCTs) and quasi-RCTs (trials in which the method of allocation is not truly random). In addition, a search will also be carried out in the WHO International Clinical Trials Registry Platform, in the clinical trial registries of ClinicalTrials.gov and in the grey literature source OpenGrey.eu. The RCT and quasi-RCT comparison techniques isolated or in combination for treating PVs will be considered. Three review authors will independently perform data extraction and quality assessments of data from included studies, and any disagreements will be resolved by discussion. The primary outcomes will be wound healing and pain. Secondary outcomes will include oedema, adverse events, recurrence or recanalisation, quality of life and economic aspects. The Cochrane handbook will be used for guidance. If the results are not appropriate for a meta-analysis in RevManV.5 software (eg, if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed. ETHICS AND DISSEMINATION: Ethics committee approval is not necessary. We intend to update the public registry used in this review, report any important protocol amendments and publish the results in a widely accessible journal. PROSPERO REGISTRATION NUMBER: CRD42018092974.

Risk factors and short and medium-term survival after open and endovascular repair of abdominal aortic aneurysms.

BACKGROUND: Infrarenal abdominal aortic aneurysms (AAA) are responsible for high rates of rupture-associated morbidity and mortality and can be treated by open or endovascular surgery. OBJECTIVES: To analyze risk factors and survival associated with surgical and endovascular AAA treatment methods. METHODS: A retrospective, longitudinal study involving 41 patients who underwent endovascular or open AAA repair, whether elective or emergency, over a 48-month period, with analysis of preoperative comorbidities, 30-day and 1-year survival, in-hospital mortality, length of hospital stay, transfusion of blood products, duration of surgery, and development of acute kidney failure. Inferential statistics and survival analysis considered a 95% CI and p < 0.05 as significant. RESULTS: Twelve of the 41 patients were treated with open surgery and 29 with endovascular techniques. The majority were male (75%), with an average age of 71 (range: 56 - 90 years). There were no differences in demographic or risk factors between the groups. Overall survival rates for open and endovascular repair were different for both 30 days (37 vs. 72%, p = 0.01) and 360 days (37 vs. 67%, p = 0.01). However, survival rates in elective cases were similar at 30 days (71 vs. 76%, p = 0.44) and 360 days (both 71%, p = 0.34). Endovascular repair showed shorter length of hospital stay (3.0 vs. 4.4 days; p = 0.02) and duration of surgery (111 vs. 163 min; p < 0.01) compared to open repair. CONCLUSIONS: There was no difference in short- or medium-term survival of AAA patients treated electively with endovascular or open surgery. Hospital stays and duration of surgery were both shorter with minimally invasive treatment.