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Journal of Vascular Surgery. Venous and... Apr 2024We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment... (Review)
Review
Comparative effectiveness of non-compounded polidocanol 1% endovenous microfoam (Varithena) ablation versus endovenous thermal ablation utilizing a systematic review and network meta-analysis.
OBJECTIVE
We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence via network meta-analysis of published comparative evidence.
METHODS
We conducted a systematic literature review following best practices, including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized and nonrandomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis.
RESULTS
We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates.
CONCLUSIONS
Polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.
PubMed: 38679141
DOI: 10.1016/j.jvsv.2024.101896 -
Scientific Reports Mar 2020Although current guidelines recommend performing endoscopy within 12 hours for acute variceal bleeding (AVB), the optimal timing remains controversial. This study... (Meta-Analysis)
Meta-Analysis
Although current guidelines recommend performing endoscopy within 12 hours for acute variceal bleeding (AVB), the optimal timing remains controversial. This study aimed to assess the effect of endoscopy timing on the mortality and rebleeding rates in AVB through a systematic review and meta-analysis of all eligible studies. PubMed, Cochrane Library, and Embase were searched for relevant publications up to January 2019. Overall mortality, rebleeding rate, and other clinical outcomes were determined. For the non-randomized studies, the risk of bias assessment tool was used to assess the methodological quality of the included publications. The Mantel-Haenszel random-effects model of the RevMan software (Cochrane) and the inverse variance method were used to analyse binary end points and continuous outcomes, respectively. This meta-analysis included five studies with 854 and 453 participants who underwent urgent (≤12 hours) and non-urgent endoscopies (>12 hours), respectively. All the included studies were retrospective in nature, because of obvious ethical issues. No significant differences in the severity indexes were found between the urgent and non-urgent groups. Three studies showed 6-week mortality and the others in-hospital mortality as main outcomes. No significant difference in overall mortality rate was found between the groups (odds ratio [OR]: 0.72, 95% confidence interval [CI]: 0.36-1.45, p = 0.36). The rebleeding rate was similar between the two groups (OR: 1.21, 95% CI: 0.76-1.93, p = 0.41). Other outcomes such as successful haemostasis, need for salvage therapy, length of hospital stay, and number of blood transfusions were also similar between the groups. We demonstrated that endoscopy timing does not affect the mortality or rebleeding rate of patients with AVB. Therefore, an appropriate timing of endoscopy would be more important than an urgent endoscopy depending on each patient's condition.
Topics: Endoscopy, Digestive System; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Humans; Time Factors; Varicose Veins
PubMed: 32132589
DOI: 10.1038/s41598-020-60866-x -
The Journal of International Medical... May 2022The appearance of severe vulvovaginal varicosities (VVs) is challenging in pregnancy. The management of VVs may require a multidisciplinary approach, including...
The appearance of severe vulvovaginal varicosities (VVs) is challenging in pregnancy. The management of VVs may require a multidisciplinary approach, including radiologists, vascular surgeons, and obstetricians. We report a rare case of enormous VVs and pubic varicosities and summarize similar cases in the literature. A woman in her 20s with a full-term pregnancy visited our hospital for severe VVs and pubic varicosities. She had been in a spoke maternity unit where a cesarean section was scheduled. After a multidisciplinary evaluation, we offered her the chance to have a vaginal delivery (VD). The woman had an uneventful VD, and VVs disappeared after 40 days. A comprehensive literature search on this topic showed 11 cases of VVs during pregnancy (five VDs and six cesarean sections). The presence of VVs represented the indication for surgery in 70% of cases. Severe complications occurred in 20% of VDs vs. 50% of CSs. In pregnant women with VVs, the risk-benefit ratio suggests a chance of having VD.
Topics: Cesarean Section; Delivery, Obstetric; Female; Humans; Pregnancy; Pregnancy Complications, Cardiovascular; Vaginal Diseases; Varicose Veins; Vulvar Diseases; Young Adult
PubMed: 35635336
DOI: 10.1177/03000605221097764 -
The Cochrane Database of Systematic... Jan 2020It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg ulcers is directed towards correcting poor arterial blood supply, for example by correcting arterial blockages (either surgically or pharmaceutically). If the blood supply has been restored, these arterial ulcers can heal following principles of good wound-care. Dressings and topical agents make up a part of good wound-care for arterial ulcers, but there are many products available, and it is unclear what impact these have on ulcer healing. This is the third update of a review first published in 2003.
OBJECTIVES
To determine whether topical agents and wound dressings affect healing in arterial ulcers. To compare healing rates and patient-centred outcomes between wound dressings and topical agents.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 28 January 2019.
SELECTION CRITERIA
Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) evaluating dressings and topical agents in the treatment of arterial leg ulcers were eligible for inclusion. We included participants with arterial leg ulcers irrespective of method of diagnosis. Trials that included participants with mixed arterio-venous disease and diabetes were eligible for inclusion if they presented results separately for the different groups. All wound dressings and topical agents were eligible for inclusion in this review. We excluded trials which did not report on at least one of the primary outcomes (time to healing, proportion completely healed, or change in ulcer area).
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted information on the participants' characteristics, the interventions, and outcomes using a standardised data extraction form. Review authors resolved any disagreements through discussion. We presented the data narratively due to differences in the included trials. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, used twice a day by 40 participants with arterial leg ulcers, for eight weeks or until healing, whichever was sooner. One compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life.
AUTHORS' CONCLUSIONS
There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.
Topics: Administration, Topical; Arteries; Bandages, Hydrocolloid; Humans; Leg Ulcer; Occlusive Dressings; Ointments; Randomized Controlled Trials as Topic; Varicose Ulcer; Wound Healing
PubMed: 31978262
DOI: 10.1002/14651858.CD001836.pub4 -
Surgery Journal (New York, N.Y.) Apr 2020One-third of adults in the United States and United Kingdom suffer from varicose veins. -butyl-2-cyanoacrylate (NBCA) glue is a novel endovascular, nontumescent,...
One-third of adults in the United States and United Kingdom suffer from varicose veins. -butyl-2-cyanoacrylate (NBCA) glue is a novel endovascular, nontumescent, nonthermal ablation technique for treatment of this condition. It has proved effective in multiple studies since its first use in 2013. The aim of this systematic review is to assess the efficacy of NBCA in ablating primary truncal varicose veins and eliminating reflux compared with existing endovascular techniques. Secondary outcomes include complications and quality of life. PRISMA was used as a guide and studies were screened for risk of bias and methodological quality. Subjects had to be ≥18 years of age and followed-up posttreatment with color Duplex ultrasound (DUS). Eligibility criteria included saphenofemoral junction (SFJ) or saphenopopliteal junction (SPJ) incompetence with reflux down truncal veins lasting >0.5 seconds on DUS interrogation and a Clinical, Etiological, Anatomical, and Pathophysiological classification of venous disorders ranging between C1 and C6. Out of 2,910 patients (3,220 veins) in 17 studies, 1,981 were administered NBCA, 445 radiofrequency ablation (RFA), and 484 endovenous laser ablation (EVLA) with mean procedure times of 25.7, 23.2, and 28.7 minutes, respectively. Mean recruitment period was 9 months (1-36 months) and followed-up for an average of 12.3 months (1-36 months). The majority were C2 to C3. Two-year occlusion rates were 93.7, 90.9, and 91.5% for NBCA, RFA, and EVLA, respectively. NBCA-treated patients experienced the least complications, with bruising, phlebitis, and pain being the most prevalent. Quality of life improved equally in all three modalities. NBCA is simple to administer, safe, and effective even without compression stockings. Further studies are required to assess longer-term benefit and the effect of anticoagulation on vein obliteration.
PubMed: 32577526
DOI: 10.1055/s-0040-1708866 -
Journal of Vascular Surgery. Venous and... Jan 2024The purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs). (Review)
Review
OBJECTIVE
The purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs).
METHODS
Literature searches were conducted in Embase, Medline, Cochrane, and CINAHL databases from inception to December 22, 2021. Eligible studies reported prognostic models aimed at developing, validating, and adjusting multivariable prognostic models that include multiple prognostic factors combined, and that predicted clinical outcomes. Methodological quality was assessed using the CHARMS checklist and PROBAST short form questionnaire.
RESULTS
Thirteen studies were identified, of which three were validation studies of previously published models, four reported derivation and validation of models, and the remainder reported derivation models only. There was substantial heterogeneity in the model characteristics, including 11 studies focused on wound healing outcomes reporting 91 different predictors. Three studies shared similar predicted outcomes, follow-up timepoint and used a Cox proportional hazards model. However, these models reported different predictor selection methods and different predictors and it was therefore not feasible to summarize performance, such as discriminative ability.
CONCLUSIONS
There are no standout risk prediction models in the literature with promising clinical application for patients with VLUs. Future research should focus on developing and validating high-performing models in wider VLU populations.
Topics: Humans; Prognosis; Varicose Ulcer; Wound Healing
PubMed: 37689364
DOI: 10.1016/j.jvsv.2023.06.017 -
The International Journal of Lower... Jun 2024The venous leg ulcers are debilitating, painful, and often unresponsive to advanced dressing treatments, so drugs used locally and systematically are essential adjuvant... (Meta-Analysis)
Meta-Analysis
The venous leg ulcers are debilitating, painful, and often unresponsive to advanced dressing treatments, so drugs used locally and systematically are essential adjuvant therapy-pentoxifylline (PTX) whose anti-inflammatory effects may offer a promising avenue to treat venous leg ulcers. However, the current results are controversial. To further evaluate the efficacy and safety of PTX, we performed an updated meta-analysis of randomized placebo-controlled trials of PTX in the treatment of venous leg ulcers. We systematically searched multiple electronic databases PubMed, Web of Science, Embase, the Cochrane Library, the Cochrane Central Register of Controlled Trials, China Science and Technology Journal Database, WanFang Data, China National Knowledge Infrastructure, and the Chinese Biomedical Literature Database to identify eligible studies. Randomized clinical trials of pentoxifylline versus placebo treatment in patients with venous leg ulcers were considered for inclusion. The primary outcomes included ulcer healing rate and the incidence of adverse events after treatment. The secondary outcomes were the ulcer significant improvement (the ulcer size shrank by more than 60% after treatment) rate, mean duration of complete wound healing and changes in mean ulcer size. A meta-analysis and qualitative analysis were conducted to estimate endpoints. A total of 13 randomized clinical trials, including 921 individuals, were finally included. Compared with placebo, pentoxifylline significantly improved the ulcer healing rate (RR = 1.59, 95%CI 1.22 to 2.07, < .001) and significant improvement rate (RR = 2.36, 95%CI 1.31 to 4.24, = .004) while increased the incidence of gastrointestinal disturbances (RR = 2.29, 95%CI 1.04 to 5.03, = .04) at the same time. Moreover, pentoxifylline also shortened mean duration of complete wound healing ( = .007) and shrank ulcer size ( = .02). Currently available evidence suggests that pentoxifylline could help venous leg ulcers heal more quickly and effectively. However, the evidence is insufficient to prove the results due to moderate-certainty evidence. Large-scale, well-designed randomized clinical trials are warranted.
Topics: Humans; Pentoxifylline; Randomized Controlled Trials as Topic; Treatment Outcome; Varicose Ulcer; Wound Healing
PubMed: 34779680
DOI: 10.1177/15347346211050769 -
International Wound Journal Feb 2023We performed a meta-analysis to evaluate the effect of low-frequency ultrasound as an added treatment for chronic wounds. A systematic literature search up to May 2022... (Meta-Analysis)
Meta-Analysis
We performed a meta-analysis to evaluate the effect of low-frequency ultrasound as an added treatment for chronic wounds. A systematic literature search up to May 2022 was performed and 838 subjects with chronic wounds at the baseline of the studies; 412 of them were using the low-frequency ultrasound (225 low-frequency high-intensity contact ultrasound for diabetic foot wound ulcers, and 187 low-frequency low-intensity non-contact ultrasound for a venous leg wound ulcers), and 426 were using standard care (233 sharp debridements for diabetic foot wound ulcers and 193 sham treatments for venous leg wound ulcers). Odds ratio (OR), and mean difference (MD) with 95% confidence intervals (CIs) were calculated to assess the effect of low-frequency ultrasound as an added treatment for chronic wounds using the dichotomous, and contentious methods with a random or fixed-effect model. The low-frequency high-intensity contact ultrasound for diabetic foot wound ulcers had significantly lower non-healed diabetic foot wound ulcers at ≥3 months (OR, 0.37; 95% CI, 0.24-0.56, P < .001), a higher percentage of diabetic foot wound ulcers area reduction (MD, 17.18; 95% CI, 6.62-27.85, P = .002) compared with sharp debridement for diabetic foot wound ulcers. The low-frequency low-intensity non-contact ultrasound for a venous leg wound ulcers had a significantly lower non-healed venous leg wound ulcers at ≥3 months (OR, 0.31; 95% CI, 0.15-0.62, P = .001), and higher percentage venous leg wound ulcers area reduction (MD, 18.96; 95% CI, 2.36-35.57, P = .03) compared with sham treatments for a venous leg wound ulcers. The low-frequency ultrasound as an added treatment for diabetic foot wound ulcers and venous leg wound ulcers had significantly lower non-healed chronic wound ulcers at ≥3 months, a higher percentage of chronic wound ulcers area reduction compared with standard care. The analysis of outcomes should be with caution because of the low sample size of all the 17 studies in the meta-analysis and a low number of studies in certain comparisons.
Topics: Humans; Diabetic Foot; Ulcer; Ultrasonography; Varicose Ulcer; Wound Healing
PubMed: 35855676
DOI: 10.1111/iwj.13893 -
Alimentary Pharmacology & Therapeutics May 2022The presence of esophageal varices is considered a relative contraindication to transesophageal echocardiography (TEE) by cardiology professional societies, so... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The presence of esophageal varices is considered a relative contraindication to transesophageal echocardiography (TEE) by cardiology professional societies, so gastroenterologists are often consulted to perform upper endoscopy prior to TEE in patients with cirrhosis.
AIM
To perform a systematic review to quantify the risk of bleeding complications in patients with cirrhosis following TEE.
METHODS
Two reviewers searched Ovid MEDLINE, MEDLINE In-Process and EMBASE databases from January 1992 to May 2021 for studies reporting bleeding complications from TEE in patients with cirrhosis. We calculated the pooled incidence rate of bleeding events using the metaprop command with a random effect model.
RESULTS
We identified 21 studies comprising 4050 unique patients with cirrhosis; 9 studies (n = 3015) assessed the risk of intraoperative TEE during liver transplant (LT) and 12 studies (n = 1035) assessed bleeding risk in patients undergoing TEE for other indications. The pooled incidence of bleeding post-TEE was 0.37% (95% CI 0.04-0.94%) across all studies. Bleeding complications were low among patients undergoing TEE during LT as well as those undergoing TEE for other diagnostic reasons (0.97% vs. 0.004%) and among studies with mean MELD >18 compared to those with mean MELD <18 (0.43% vs. 0.08%). Few studies had a comparator arm, and data on patient-level factors impacting bleeding complications (including degree of liver dysfunction and coagulopathy) were limited across studies.
CONCLUSIONS
The risk of bleeding complications following TEE is low in patients with cirrhosis, suggesting TEE is safe and risk stratification with upper endoscopy may not be necessary.
Topics: Echocardiography, Transesophageal; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Humans; Incidence; Liver Cirrhosis; Varicose Veins
PubMed: 35343613
DOI: 10.1111/apt.16860 -
Journal of Comparative Effectiveness... Sep 2020Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). To evaluate the quality of life (QoL) of...
Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. VLUs impact patients' physical, functional and psychological status and reduce QoL. A total 75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Payers' coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.
Topics: Cost-Benefit Analysis; Health Care Costs; Humans; Leg Ulcer; Quality of Life; Skin, Artificial; Varicose Ulcer; Wound Healing
PubMed: 32969709
DOI: 10.2217/cer-2020-0076