-
Wounds : a Compendium of Clinical... Jan 2020This study evaluates the clinical and cost effectiveness of a 2-layer compression system (2LBA; 3M Coban Two-Layer Compression System; 3M, St Paul, MN) compared with... (Comparative Study)
Comparative Study
OBJECTIVE
This study evaluates the clinical and cost effectiveness of a 2-layer compression system (2LBA; 3M Coban Two-Layer Compression System; 3M, St Paul, MN) compared with other 2-layer (2LB) and 4-layer (4LB) compression systems in patients with noninfected venous leg ulcers (VLUs).
METHODS
The MEDLINE, EMBASE, CINAHL, Cochrane Library, National Health Service (NHS) Economic Evaluation, and EconLit databases were searched from inception up to January 2017. The MEDLINE search was updated on March 31, 2017. Study selection, quality assessment, and data synthesis were undertaken in accordance with recommended standards. Findings were presented narratively.
RESULTS
In total, 5 studies (N = 1509 patients) of mixed methodological quality were included. At 6 months, 2LBA achieved better ulcer healing in comparison with 2LBB (odds ratio [OR], 1.57; 95% confidence interval [CI], 1.10-2.24; P = .03) and 4LBA (OR, 1.93, 95% CI, 1.26-2.97; P = .05) in patients with newly diagnosed ulcers only. For a combined population with newly diagnosed and existing VLUs, healing outcomes were OR, 2.87; 95% CI, 1.06-7.77; P = .04, and OR, 16.51; 95% CI, 2.08-131.37; P = .008, for 2LBs and 4LBs, respectively. Results on slippage were inconclusive. Adverse events were infrequent and did not differ significantly between interventions. Lower 6-month NHS costs for the combined population (£2413 vs. £2707 or £2648) and for newly diagnosed patients (£3045 vs. £3842 or £4480) were observed comparing 2LBA with 2LBB or 4LBA. Also, 2LBA was associated with better health-related quality of life (HRQoL) at 6 months.
CONCLUSIONS
Based on these findings, 2LBA may result in lower treatment costs and better ulcer healing and HRQoL compared with other multicomponent therapies, especially in patients with newly diagnosed VLUs. However, further high-quality research is needed, especially for outcomes such as slippage and bandage wear time.
Topics: Compression Bandages; Cost-Benefit Analysis; Health Care Costs; Humans; Quality of Life; Treatment Outcome; Varicose Ulcer; Wound Healing
PubMed: 32155127
DOI: No ID Found -
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 -
Journal of Vascular Surgery. Venous and... May 2020Several randomized controlled trials (RCTs) have compared different interventions for chronic venous insufficiency (CVI) management, but mixed comparison of these... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Several randomized controlled trials (RCTs) have compared different interventions for chronic venous insufficiency (CVI) management, but mixed comparison of these interventions is lacking. The aim of this network meta-analysis was to compare VenaSeal closure system (Medtronic, Minneapolis, Minn) with endovenous laser ablation (EVLA), radiofrequency ablation (RFA), mechanochemical ablation, sclerotherapy, and surgery for management of CVI to achieve anatomic success (complete closure of treated vein within 6 months after intervention) as the primary outcome and health-related quality of life (HRQoL; EuroQol-5 Dimension, Aberdeen Varicose Vein Questionnaire), Venous Clinical Severity Score (VCSS), pain scores, and adverse events as secondary outcomes.
METHODS
A systematic review of journal databases was undertaken, and RCTs between January 1996 and September 2018 comparing different treatment options were included. Risk of bias and quality of publications were assessed using the Cochrane bias tool; Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used for study selection and reporting. Twenty RCTs comprising 4570 patients were analyzed. Data for anatomic success, VCSS, HRQoL, pain score, and adverse events were extracted and analyzed using mixed treatment comparison in a network meta-analysis. A Bayesian fixed or random effects model was selected for analysis. Rank probability graphs were generated for various treatments and corresponding ranks obtained to estimate their probability of being best. Relative treatment effects were calculated in terms of log odds ratios for anatomic success and adverse events. Mean difference was calculated for VCSS, HRQoL, and pain score.
RESULTS
For the primary outcome measure (anatomic success), VenaSeal system had the highest probability of being ranked first (P = .980); RFA was ranked second (P = .365), EVLA third (P = .397), surgery fourth (P = .290), mechanochemical ablation fifth (P = .695), and sclerotherapy sixth (P = .982). For secondary outcome measures, VenaSeal system ranked third for VCSS (P = .332), fifth for EuroQol-5 Dimension (P = .420), and third for Aberdeen Varicose Vein Questionnaire (P = .300). Although, VenaSeal system was slightly inferior to some of the other interventions for HRQoL, the 95% credible interval of log odds ratio indicated insufficient evidence for any concrete conclusion to be drawn. VenaSeal system ranked first in reduction of postoperative pain score from baseline (P = .690) and was lowest in occurrence of adverse events (P = .650). Odds of occurrence of adverse events was 3.3 times in the sclerotherapy arm, 2.7 times in the EVLA arm, 1.6 times with surgery, and 1.1 times with RFA vs VenaSeal system arm.
CONCLUSIONS
VenaSeal system is a promising therapeutic option for anatomic success at 6 months, with fewer occurrences of adverse events (wound and groin infection, pulmonary embolism) in CVI patients compared with other interventions in this study. Additional economic analysis including cost-effectiveness analysis would provide interesting perspectives on real-world insights to patients, payers, and providers.
Topics: Adolescent; Adult; Aged; Chronic Disease; Embolization, Therapeutic; Female; Humans; Laser Therapy; Male; Middle Aged; Network Meta-Analysis; Pain, Postoperative; Quality of Life; Radiofrequency Ablation; Randomized Controlled Trials as Topic; Risk Factors; Saphenous Vein; Sclerotherapy; Time Factors; Treatment Outcome; Venous Insufficiency; Young Adult
PubMed: 32063522
DOI: 10.1016/j.jvsv.2019.12.061 -
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 -
Journal of Vascular Surgery. Venous and... Mar 2020The objective of this study was to assess the effectiveness, safety, and quality of care afforded by cyanoacrylate ablation (CA) vs existing options in treating great... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The objective of this study was to assess the effectiveness, safety, and quality of care afforded by cyanoacrylate ablation (CA) vs existing options in treating great saphenous vein incompetence.
METHODS
We conducted a systematic review; used the Grading of Recommendations Assessment, Development, and Evaluation framework; assessed the quality of randomized clinical trials using the Cochrane risk of bias tool; and performed a meta-analysis on the available comparative measurements.
RESULTS
Three comparative studies, two randomized controlled trials and one observational study comprising 1057 participants, were included for effectiveness assessment purposes. The safety assessment also included 10 case series. Available evidence allowed comparison of CA with radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) but not with other treatments. The comparative effectiveness analysis showed that whereas all three treatments reduced disease severity, none was significantly better than any other in terms of effectiveness. In terms of safety, however, CA devices gave rise to fewer adverse events and less severity at 12 months of follow-up than did EVLA or RFA. Other important advantages of CA over EVLA or RFA were linked to quality of care; patients reported less pain during intervention with CA than with RFA or EVLA devices and registered shorter intervention and recovery times. Furthermore, tumescent anesthesia and compression bandages were not necessary, making this technique more comfortable for the patients than endothermal techniques.
CONCLUSIONS
Compared with EVLA and RFA, CA treatments yield comparable effectiveness outcomes and lead to less frequent and fewer mild adverse events, without difference in major adverse events. Furthermore, CA devices have advantages in terms of quality of care indicators, such as pain during intervention, treatment and recovery times, lower use of anesthesia, and zero use of compression bandages after treatment.
Topics: Cyanoacrylates; Embolization, Therapeutic; Endovascular Procedures; Humans; Laser Therapy; Postoperative Complications; Quality Indicators, Health Care; Radiofrequency Ablation; Risk Factors; Saphenous Vein; Treatment Outcome; Venous Insufficiency
PubMed: 31917181
DOI: 10.1016/j.jvsv.2019.09.010 -
International Wound Journal Apr 2020Pain is a serious problem for patients with leg ulcers. Research mainly focuses on dressing-related pain; however, chronic background pain may be just as devastating.... (Meta-Analysis)
Meta-Analysis
Pain is a serious problem for patients with leg ulcers. Research mainly focuses on dressing-related pain; however, chronic background pain may be just as devastating. Our main objective was to describe the prevalence and characteristics of wound-related background pain in persons with chronic venous leg ulcers. We performed a systematic review to synthesise data from quantitative studies. Studies were eligible if they reported original baseline- or cross-sectional data on background pain in chronic venous leg ulcers. The initial search identified 2454 publications. We included 36 descriptive and effect studies. The pooled prevalence of wound-related background pain (from 10 studies) was 80% (95% CI 65-92%). The mean pain intensity score (from 27 studies) was 4 (0-10 numeric rating scale) (95% CI 3.4-4.5). Other pain characteristics could not be synthesised. We identified few sufficiently high-quality studies on prevalence and intensity of wound-related background pain in patients with chronic venous leg ulcers. Four of five persons experience mild to moderate pain. Because of poor quality of pain assessment and report, we believe that the available research does not provide a sufficiently nuanced understanding of background pain in this patient group.
Topics: Chronic Disease; Humans; Pain; Pain Measurement; Varicose Ulcer; Wound Healing
PubMed: 31898398
DOI: 10.1111/iwj.13296 -
Journal of Vascular Surgery. Venous and... Nov 2019Endovenous thermal ablation (TA) offers an effective initial treatment option for superficial venous incompetence of the lower limb. These techniques offer lower... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Endovenous thermal ablation (TA) offers an effective initial treatment option for superficial venous incompetence of the lower limb. These techniques offer lower complication rates with similar efficacy to traditional open surgery. In recent years, nonthermal ablation (NTA) in the form of mechanochemical ablation and cyanoacrylate vein ablation has been suggested to further reduce perioperative morbidity. This study aimed to compare the use of both thermal and nonthermal endovenous ablative techniques in the management of superficial venous incompetence.
METHODS
A search of online databases including MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane database was last performed in January 2019. Comparative studies comparing NTA with TA were included. The primary outcome was technical success. Secondary outcomes included operative pain, complications, modification of disease severity, and quality of life.
RESULTS
Six studies describing the outcomes of 1236 participants and 1256 truncal ablations were included for analysis. Follow-up ranged from 6 weeks to 36 months. With regard to overall technical success, 458 of 483 (94.8%) receiving NTA and 521 of 553 (94.2%) undergoing TA had successful truncal ablation on follow-up ultrasound imaging at the study end point (pooled risk ratio, 1.01; 95% confidence interval [CI], 0.99-1.04). Subgroup analysis identified no difference in success between groups during immediate, 6-month, 12-month, or >12-month follow-up periods. Postprocedural pain was generally lower in those undergoing NTA with a mean difference of -18.11 (95% CI, -36.7 to 0.48). Techniques experienced significatly lower rates of ecchymosis (risk ratio, 0.43; 95% CI, 0.23-0.78), with no difference identified with regard to rates of paresthesia, phlebitis, and skin pigmentation. Further assessment of quality of life (mean difference, -0.27; 95% CI, -0.57 to 0.04) and Venous Clinical Severity Score (-0.52; 95% CI, -1.05 to 0.01) revealed no difference between groups. Included data were deemed of moderate methodologic quality.
CONCLUSIONS
Nonthermal techniques are as effective as standard TA in the first year and, in some studies, may be associated with less procedural pain. These data suggest that NTA offers an alternative and safe means to treat superficial venous disease. There is, however, a need for further powered trials with larger numbers of patients and longer follow-up to definitively examine this hypothesis.
Topics: Ablation Techniques; Embolization, Therapeutic; Endovascular Procedures; Humans; Postoperative Complications; Risk Factors; Treatment Outcome; Varicose Veins; Venous Insufficiency
PubMed: 31627874
DOI: 10.1016/j.jvsv.2019.06.009 -
The Cochrane Database of Systematic... Sep 2019Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) characterised by chronic complaints such as oedema and skin changes including;...
BACKGROUND
Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) characterised by chronic complaints such as oedema and skin changes including; venous ectasia, varicose veins, redness, eczema, hyperpigmentation, and in severe cases fibrosis of the subcutaneous adipose in the affected limb. These chronic complaints are the effects of venous outflow restriction that can cause symptoms such as heaviness, itching, pain, cramps, and paraesthesia. Twenty to fifty percent of people with DVT develop post-thrombotic complications. Several non-pharmaceutical measures are used for prevention of PTS during the acute phase of DVT. These include elevation of the legs and compression therapy. There have been limited studies regarding the effectiveness of compression therapy for prevention or treatment of PTS. As a result, clinicians and guidelines differ in their assessment of compression therapy during treatment of DVT and in the treatment of PTS. This is an update of a review first published in 2003.
OBJECTIVES
To assess the effectiveness of compression therapy for treatment of post-thrombotic syndrome, including elastic compression stockings and mechanical devices compared with no intervention, placebo and with each other.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries on 2 July 2018.
SELECTION CRITERIA
We included trials that evaluated compression therapy for the treatment of PTS. The primary outcomes were severity of PTS and adverse effects. There were no restrictions on date or language. Two review authors (SA, DNK) independently assessed whether potentially relevant studies met the inclusion criteria.
DATA COLLECTION AND ANALYSIS
One review author extracted and summarised data and one review author (DNK) verified them. We resolved disagreements by discussion. We assessed methodological study quality with the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of the evidence supporting the outcomes assessed in this review.
MAIN RESULTS
We identified four trials, with 116 participants, investigating the effectiveness of compression therapy for treatment of PTS. The methodology used by each trial was too heterogeneous to perform a meta-analysis, so we reported our findings narratively.Two trials studied the effect of graduated elastic compression stockings (GECS) on improvement of PTS symptoms. One study reported beneficial haemodynamic effects, while the other found no benefits on PTS severity compared to placebo (very low-certainty evidence). There was very limited evidence available for adverse effects and quality of life (QoL). The two studies did not report on compliance rates during the study period.Two trials studied the effects of intermittent mechanical compression devices. Both reported improvement in PTS severity (low-certainty evidence). Improvement of the severity of PTS was defined by treatment 'success' or 'failure'. Only one study comparing compression devices evaluated adverse effects and QoL. Although 9% of the participants experienced adverse effects such as leg swelling, irritation, superficial bleeding, and skin itching (moderate-certainty evidence), QoL was improved (moderate-certainty evidence). Studies did not assess compliance using intermittent mechanical compression devices.None of the studies evaluated patient satisfaction.
AUTHORS' CONCLUSIONS
There is very low-certainty evidence regarding the use of GECS for treatment of PTS as assessed by two small studies of short duration. One study reported beneficial haemodynamic effects, while one found no benefits on PTS severity compared to control/placebo stockings. There is very limited evidence for adverse effects, patient satisfaction, QoL, and compliance rates. There is low-certainty evidence favouring use of intermittent pneumatic compression devices compared to a control device for the treatment of severity owing to different measurements used by the studies reporting on this outcome and small studies of short duration. There is moderate-certainty evidence of improved QoL but possible increased adverse effects related to compression device use owing to small studies of short duration. High-certainty evidence to support the use of compression therapy in prevention of PTS is lacking and any conclusions drawn from current evidence should be interpreted with care. Further research is needed to assess whether compression can result in long-term reduction and relief of the symptoms caused by PTS, or prevent deterioration and leg ulceration.
Topics: Humans; Postthrombotic Syndrome; Quality of Life; Randomized Controlled Trials as Topic; Stockings, Compression; Venous Thrombosis
PubMed: 31531971
DOI: 10.1002/14651858.CD004177.pub2 -
International Angiology : a Journal of... Aug 2019Lower limb varicose veins can be treated effectively with endovenous ablation procedures or with minimally invasive open techniques. However, these procedures may cause...
INTRODUCTION
Lower limb varicose veins can be treated effectively with endovenous ablation procedures or with minimally invasive open techniques. However, these procedures may cause pain and discomfort, and surgical stripping can be associated with long recovery times. We investigated whether venoactive drugs (VAD) used to treat chronic venous disease (CVD), provide benefits to patients recovering from a surgical or endovenous varicose vein procedure.
EVIDENCE ACQUISITION
We conducted a systematic review of the literature to identify clinical trials investigating VAD therapy before, during, or after a surgical, endovenous, or sclerotherapy procedure for varicose veins. Records retrieved from the PubMed and Embase databases were screened for relevant studies. Full-length articles in English were obtained for analysis.
EVIDENCE SYNTHESIS
We identified five clinical trials investigating the effects of VAD on recovery after surgery, endovenous ablation, or sclerotherapy. Studies were conducted in Russia, Italy, and Czech Republic and varied considerably in design, but all were unblinded open-label studies. All studies reported the use of micronized purified flavonoid fraction (MPFF); in one study, sulodexide was also used. Three studies reported significantly less post-procedural pain with MPFF treatment, with one reporting no significant effect. Two studies reported significant reductions in post-procedural bleeding with MPFF treatment. Three out of four studies reported greater symptomatic improvement with MPFF treatment.
CONCLUSIONS
Appropriate treatment with MPFF may help reduce post-procedural pain, hemorrhage, and CVD-specific symptoms. While adjunct VAD treatment seems promising, high-quality placebo-controlled studies are needed to unequivocally demonstrate its benefits.
Topics: Catheter Ablation; Chronic Disease; Flavones; Humans; Pain, Postoperative; Quality of Life; Randomized Controlled Trials as Topic; Sclerotherapy; Treatment Outcome; Varicose Veins
PubMed: 31284708
DOI: 10.23736/S0392-9590.19.04216-0 -
European Journal of Vascular and... Aug 2019The objective of this systematic review and meta-analysis was to summarise available randomised controlled trials (RCTs) of EVLA efficacy, and to define the differences... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The objective of this systematic review and meta-analysis was to summarise available randomised controlled trials (RCTs) of EVLA efficacy, and to define the differences in success rate of variations in wavelength, administered energy, outcome definition, and follow up period.
METHODS
A literature search was conducted in Embase, Medline (Ovid-SP), Cochrane Central Database, and Web of Science from inception to November 2017. RCTs with follow up of more than three months were included. The studied outcome was the proportion of patients with EVLA treatment success, defined as absence of reflux or occlusion of the great saphenous vein (GSV). Pooled proportions of anatomical success were compared. Subgroup and meta-regression analysis included wavelengths (short [810, 940, and 980 nm], long [1470, 1500, and 1920 nm]), amount of energy (≤50 J/cm, > 50 J/cm), follow up (≤1 year, > 1 year), outcome definition (occlusion, no reflux), and quality of the studies (low risk of bias, unclear/high risk of bias).
RESULTS
Twenty-eight RCTs, with a total of 2829 GSVs were included. The overall success rate of EVLA was 92% (95% CI 90-94%, I = 68%). In subgroup analysis, no statistically significant differences were found for long or short wavelengths (95% [95% CI 91-97%] vs. 92% [95% CI 89-94%], p = .15), high or low administered energy (93% [95% CI 89-95%] vs. 92% [95% CI 90-94%], p = .99), long or short follow up (89% [95% CI 84-93%] vs. 93% [95% CI 91-95%], p = .13) and outcome definition (occlusion group 94% [95% CI 91-96%] vs. absence of reflux group 91% [95% CI 87-94%], p = .26). Studies with low risk of bias reported a significantly higher success rate than high or unclear risk of bias (93% [95% CI 90-95%] vs. 89% [95% CI 83-93%], p = .04).
CONCLUSIONS
The overall success rate of EVLA is high (92%), even with increasing follow up. Commonly used parameters of EVLA (wavelength, administered energy, and outcome definition) have no influence on the treatment success rate.
Topics: Endovascular Procedures; Humans; Laser Therapy; Postoperative Complications; Risk Factors; Saphenous Vein; Time Factors; Treatment Outcome; Venous Insufficiency
PubMed: 31230868
DOI: 10.1016/j.ejvs.2018.10.036