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Journal of Vascular Surgery. Venous and... Jul 2023We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency.
METHODS
We performed a systematic review in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement and a Bayesian network meta-analysis. The primary end points were great saphenous vein (GSV) closure and venous clinical severity score (VCSS) improvement. A meta-regression using GSV diameter as a covariate was undertaken for the two primary end points.
RESULTS
We included 14 studies and 4177 patients, with a mean follow-up of 25.7 months. Radiofrequency ablation (RFA; odds ratio [OR], 3.99; 95% confidence interval [CI], 1.82-10.53), cyanoacrylate ablation (CAC; OR, 3.09; 95% CI, 1.35-8.37), and endovenous laser ablation (EVLA; OR, 2.72; 95% CI, 1.23-7.38) displayed increased odds for GSV closure compared with mechanochemical ablation (MOCA). MOCA inferiority compared with RFA (mean difference [MD], 0.96; 95% CI, 0.71-1.20), EVLA (MD, 0.94; 95% CI, 0.61-1.24), and CAC (MD, 0.89; 95% CI, 0.65-1.15) was also depicted regarding VCSS improvement. EVLA resulted in an increased risk of postoperative paresthesia compared with MOCA (risk ratio [RR], 9.61; 95% CI, 2.32-62.29), CAC (RR, 7.90; 95% CI, 2.44-38.16), and RFA (RR, 6.96; 95% CI, 2.31-28.04). Although the overall analysis identified nonstatistically significant differences for Aberdeen varicose vein questionnaire score improvement, thrombophlebitis, ecchymosis, and pain, further investigation revealed an increase pain profile for EVLA at 1470 nm compared with RFA (MD, 3.22; 95% CI, 0.93-5.47) and CAC (MD, 3.04; 95% CI, 1.05-4.97). A sensitivity analysis displayed a persistent underperformance of MOCA compared with RFA (OR, 4.33; 95% CI, 1.15-55.54) for GSV closure and both RFA (MD, 0.99; 95% CI, 0.22-1.77) and CAC (MD, 0.84; 95% CI, 0.08-1.65) regarding VCCS improvement. Although no regression model reached statistical significance, the GSV closure regression model revealed a trend for considerably decreased efficacy for both CAC and MOCA with larger GSV diameters compared with RFA and EVLA.
CONCLUSIONS
Although our analysis has produced skepticism regarding the efficacy of MOCA in the mid-term period for VCSS improvement and GSV closure rates, CAC showed equivalent results compared with both RFA and EVLA. Additionally, CAC displayed a decreased risk of postprocedural paresthesia and pigmentation and induration compared with EVLA. Also, both RFA and CAC had an improved pain profile compared with EVLA 1470 nm. The potential underperformance of nonthermal, nontumescent ablation modalities in ablating large GSVs necessitates further research.
Topics: Humans; Network Meta-Analysis; Bayes Theorem; Paresthesia; Treatment Outcome; Venous Insufficiency; Saphenous Vein; Pain
PubMed: 37030442
DOI: 10.1016/j.jvsv.2023.03.011 -
Journal of Vascular Surgery. Venous and... Jan 2021Compression after sclerotherapy is commonly used, although the evidence base for this practice is unclear. This study aims to summarize and assess the evidence for...
BACKGROUND
Compression after sclerotherapy is commonly used, although the evidence base for this practice is unclear. This study aims to summarize and assess the evidence for compression therapy after sclerotherapy to inform clinical practice.
METHODS
A systematic review was performed according to PRISMA guidelines via Medline and EMBASE databases (1946 to December 31, 2019) by two reviewers. Full-text, English-language studies comparing compression type and/or duration in adult chronic venous disease patients undergoing liquid or foam sclerotherapy were included.
RESULTS
Nine studies were identified: five using liquid sclerotherapy, three foam sclerotherapy and one using both. Studies had short follow-up periods (6-24 weeks) and reported on clinical outcomes, quality of life, side effects and complications. In C1 patients undergoing liquid sclerotherapy, any duration of stocking use significantly decreased telangiectasia and reticular vein number and size compared with no compression. No significant difference in clinical symptoms or quality of life was seen when comparing compression duration after liquid or foam sclerotherapy in tributary or truncal veins in C2 to C6 patients. Greater superficial vein resolution was seen with stockings compared with bandages in C2 patients undergoing liquid sclerotherapy to tributary veins. A comparison of stockings vs bandaging revealed differing thrombophlebitis rates but no significant difference in pigmentation. In C2 to C6 patients undergoing foam sclerotherapy, use of 35 mm Hg stockings significantly improved post-treatment symptoms compared with 23 mm Hg stockings. This review was limited by heterogeneity of outcome measurements and the variety of comparisons between compression types and durations.
CONCLUSIONS
Postsclerotherapy compression may have beneficial clinical outcomes at short-term follow-up; however, evidence is lacking regarding its type, class, length, and duration. Further trials are required to guide the optimal management of postsclerotherapy patients.
Topics: Adult; Aged; Aged, 80 and over; Chronic Disease; Compression Bandages; Female; Humans; Male; Middle Aged; Sclerosing Solutions; Sclerotherapy; Stockings, Compression; Treatment Outcome; Vascular Diseases
PubMed: 32791308
DOI: 10.1016/j.jvsv.2020.07.011 -
Fertility and Sterility Apr 2018To systematically review and appraise the existing evidence in relation to the efficacy and safety of pulsatile gonadotropin-releasing hormone (pGnRH) for the treatment... (Meta-Analysis)
Meta-Analysis
Efficacy and safety of pulsatile gonadotropin-releasing hormone therapy among patients with idiopathic and functional hypothalamic amenorrhea: a systematic review of the literature and a meta-analysis.
OBJECTIVE
To systematically review and appraise the existing evidence in relation to the efficacy and safety of pulsatile gonadotropin-releasing hormone (pGnRH) for the treatment of women with hypothalamic amenorrhea (HA).
DESIGN
Systematic review and meta-analysis.
SETTING
Not applicable.
PATIENT(S)
A total of 35 studies (three randomized and 32 observational) encompassing 1,002 women with HA.
INTERVENTION(S)
None.
MAIN OUTCOME MEASURE(S)
Primary outcomes: ovulation rate (OvR), pregnancy per ovulatory cycle rate (POR), and live birth per ovulatory cycle rate (LBOR).
SECONDARY OUTCOMES
multiple gestation (MG), ovarian hyperstimulation syndrome (OHSS), and superficial thrombophlebitis (ST) rates. The summary measures were expressed as proportions and 95% confidence intervals (CI).
RESULT(S)
Pulsatile GnRH treatment appears to achieve high OvRs. A trend toward high PORs and LBORs among women with HA is demonstrated. SC pGnRH achieves comparable OvR compared with IV pGnRH. The incidence of OHSS is low and of mild severity. Treatment with pGnRH is associated with low but slightly higher MG rates compared with the general population. IV administered pGnRH is rarely associated with ST.
CONCLUSION(S)
The high OvRs leading to a high rate of singleton pregnancies and the low likelihood of OHSS render the pGnRH treatment modality both effective and safe for the treatment of women with HA of either primary or secondary origin.
Topics: Adolescent; Adult; Amenorrhea; Female; Fertility Agents, Female; Gonadotropin-Releasing Hormone; Humans; Hypothalamus; Infertility, Female; Live Birth; Ovulation; Ovulation Induction; Pregnancy; Pregnancy Rate; Pulse Therapy, Drug; Risk Assessment; Risk Factors; Treatment Outcome; Young Adult
PubMed: 29605411
DOI: 10.1016/j.fertnstert.2017.12.028 -
The Journal of Maternal-fetal &... May 2022Complication rates associated with peripherally inserted central catheters (PICCs) in the general population are variable, and rates specific to pregnant women are... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Complication rates associated with peripherally inserted central catheters (PICCs) in the general population are variable, and rates specific to pregnant women are unclear. We conducted a systematic review and meta-analysis to estimate the rate of PICC-associated complications in pregnant women.
METHODS
We searched published literature for records discussing PICC use in pregnant or postpartum women. We included studies with primary data regarding rates of maternal complications from PICC use. The primary outcomes were maternal infection (cellulitis, sepsis), venous thromboembolism (VTE), or combined major complication rate. Secondary outcomes were superficial thrombophlebitis or mechanical failure. Meta-analysis was performed using STATA 12 with the METAN and METAPROP software routines. Pooled estimates with 95%CI were calculated using random-effects models.
RESULTS
After the removal of duplicates, the primary search yielded 318 articles, with 5 being included for final analysis. The pooled rate of combined infectious and thromboembolic complications was 26% (95%CI = 6-53%). For secondary outcomes the pooled rate of infectious complications was 18% (95%CI = 4-39%), VTE 6% (95%CI = 0-18%), mechanical failure 7% (95%CI = 3-12%), and superficial thrombophlebitis 1% (95%CI = 0-3%). There was significant statistical heterogeneity between studies for all outcomes calculated.
CONCLUSION
There are limited data regarding complication rates due to PICC use in pregnancy, with a high level of heterogeneity among existing studies. The risk of VTE appears comparable to PICC-associated VTE in the non-pregnant hospitalized population. The risk of infection associated with PICC use was the most variable, with rates ranging from 4% to 37%. This suggests that infection risk may be modifiable and further studies are needed to assess interventions that may lower this risk.
Topics: Catheter-Related Infections; Catheterization, Central Venous; Catheterization, Peripheral; Catheters; Central Venous Catheters; Female; Humans; Pregnancy; Retrospective Studies; Risk Factors; Sepsis; Venous Thromboembolism
PubMed: 32441173
DOI: 10.1080/14767058.2020.1769591 -
Haemophilia : the Official Journal of... May 2012Thrombotic adverse events (AEs) after clotting factor concentrate administration are rare but the actual rate is unknown. A systematic review of prospective studies... (Review)
Review
Thrombotic adverse events to coagulation factor concentrates for treatment of patients with haemophilia and von Willebrand disease: a systematic review of prospective studies.
Thrombotic adverse events (AEs) after clotting factor concentrate administration are rare but the actual rate is unknown. A systematic review of prospective studies (1990-2011) reporting safety data of factor concentrates in patients with haemophilia A (HA), haemophilia B (HB) and von Willebrand disease (VWD) was conducted to identify the incidence and type of thrombotic AEs. In 71 studies (45 in HA, 15 HB, 11 VWD) enrolling 5528 patients treated with 27 different concentrates (20 plasma-derived, 7 recombinant), 20 thrombotic AEs (2 HA, 11 HB, 7 VWD) were reported, including two major venous thromboembolic episodes (both in VWD patients on prolonged replacement for surgery). The remaining thrombotic AEs were superficial thrombophlebitis, mostly occurring at infusion sites in surgical patients and/or during concentrate continuous infusion. The overall prevalence was 3.6 per 10(3) patients (3.6 per 10(4) for severe AEs) and 1.13 per 10(5) infusions, with higher figures in VWD than in haemophilia. Thrombotic AEs accounted for 1.9% of non-inhibitor-related AEs. Thrombosis-related complications occurred in 10.8% of patients with central venous access devices (CVADs) reported in six studies, the risk increasing with time of CVAD use. Data from prospective studies over the last 20 years suggest that the risk of thrombotic AEs from factor concentrate administration is small and mainly represented by superficial thrombophlebitis. These findings support the high degree of safety of products currently used for replacement treatment.
Topics: Blood Coagulation Factors; Hemophilia A; Hemophilia B; Humans; Incidence; Prospective Studies; Thrombosis; von Willebrand Diseases
PubMed: 22335611
DOI: 10.1111/j.1365-2516.2012.02758.x -
The Cochrane Database of Systematic... Jul 2014Since hypercoagulability might result in recurrent miscarriage, anticoagulant agents could potentially increase the chance of live birth in subsequent pregnancies in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Since hypercoagulability might result in recurrent miscarriage, anticoagulant agents could potentially increase the chance of live birth in subsequent pregnancies in women with unexplained recurrent miscarriage, with or without inherited thrombophilia.
OBJECTIVES
To evaluate the efficacy and safety of anticoagulant agents, such as aspirin and heparin, in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 October 2013) and scanned bibliographies of all located articles for any unidentified articles.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that assessed the effect of anticoagulant treatment on live birth in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia were eligible. Interventions included aspirin, unfractionated heparin (UFH), and low molecular weight heparin (LMWH) for the prevention of miscarriage. One treatment could be compared with another or with no-treatment (or placebo).
DATA COLLECTION AND ANALYSIS
Two review authors (PJ and SK) assessed the studies for inclusion in the review and extracted the data. If necessary they contacted study authors for more information. We double checked the data.
MAIN RESULTS
Nine studies, including data of 1228 women, were included in the review evaluating the effect of either LMWH (enoxaparin or nadroparin in varying doses) or aspirin or a combination of both, on the chance of live birth in women with recurrent miscarriage, with or without inherited thrombophilia. Studies were heterogeneous with regard to study design and treatment regimen and three studies were considered to be at high risk of bias. Two of these three studies at high risk of bias showed a benefit of one treatment over the other, but in sensitivity analyses (in which studies at high risk of bias were excluded) anticoagulants did not have a beneficial effect on live birth, regardless of which anticoagulant was evaluated (risk ratio (RR) for live birth in women who received aspirin compared to placebo 0.94, (95% confidence interval (CI) 0.80 to 1.11, n = 256), in women who received LMWH compared to aspirin RR 1.08 (95% CI 0.93 to 1.26, n = 239), and in women who received LMWH and aspirin compared to no-treatment RR 1.01 (95% CI 0.87 to 1.16) n = 322).Obstetric complications such as preterm delivery, pre-eclampsia, intrauterine growth restriction and congenital malformations were not significantly affected by any treatment regimen. In included studies, aspirin did not increase the risk of bleeding, but treatment with LWMH and aspirin increased the risk of bleeding significantly in one study. Local skin reactions (pain, itching, swelling) to injection of LMWH were reported in almost 40% of patients in the same study.
AUTHORS' CONCLUSIONS
There is a limited number of studies on the efficacy and safety of aspirin and heparin in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia. Of the nine reviewed studies quality varied, different treatments were studied and of the studies at low risk of bias only one was placebo-controlled. No beneficial effect of anticoagulants in studies at low risk of bias was found. Therefore, this review does not support the use of anticoagulants in women with unexplained recurrent miscarriage. The effect of anticoagulants in women with unexplained recurrent miscarriage and inherited thrombophilia needs to be assessed in further randomised controlled trials; at present there is no evidence of a beneficial effect.
Topics: Abortion, Habitual; Anticoagulants; Antiphospholipid Syndrome; Aspirin; Enoxaparin; Female; Heparin, Low-Molecular-Weight; Humans; Live Birth; Nadroparin; Pregnancy; Pregnancy Complications, Hematologic; Randomized Controlled Trials as Topic; Thrombophilia
PubMed: 24995856
DOI: 10.1002/14651858.CD004734.pub4 -
Dermatologic Surgery : Official... Aug 2009In the last decade, minimally invasive techniques have been introduced in the treatment of lower extremity varicosities. Of these therapies, endovenous laser ablation is... (Review)
Review
BACKGROUND
In the last decade, minimally invasive techniques have been introduced in the treatment of lower extremity varicosities. Of these therapies, endovenous laser ablation is the most widely accepted and used treatment option for insufficient great and short saphenous veins.
OBJECTIVE
To present a review of reported common and rare and minor and major complications associated with endovenous laser ablation.
METHODS
A systematic review of studies and case reports on endovenous laser ablation-induced complications. The complications were classified as minor or major according to the Society of Interventional Radiology Standards of Practice Committee guidelines on reporting complications. A case-series of complications after endovenous laser ablation is presented.
RESULTS
Ecchymoses and pain are frequently reported side effects of endovenous laser ablation. Nerve injury, skin burns, deep vein thrombosis and pulmonary embolism seldom occur. An exceptional complication is a material or device that by accident remains inside the body after the procedure. Ecchymosis, pain, induration, skin burns, dysesthesia, superficial thrombophlebitis, and hematoma were classified as minor complications. Deep vein thrombosis and nerve injury were classified as major complications.
CONCLUSION
Endovenous laser ablation may be considered a safe treatment of lower extremity varicosities. The incidence of common side effects may decrease with better laser parameters.
Topics: Ecchymosis; Humans; Laser Therapy; Male; Middle Aged; Pain; Postoperative Complications; Saphenous Vein; Varicose Veins
PubMed: 19469796
DOI: 10.1111/j.1524-4725.2009.01215.x -
The Cochrane Database of Systematic... Dec 2018Epistaxis (nosebleed) most commonly affects children and the elderly. The majority of episodes are managed at home with simple measures. In more severe cases medical... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Epistaxis (nosebleed) most commonly affects children and the elderly. The majority of episodes are managed at home with simple measures. In more severe cases medical intervention is required to either cauterise the bleeding vessel, or to pack the nose with various materials. Tranexamic acid is used in a number of clinical settings to stop bleeding by preventing clot breakdown (fibrinolysis). It may have a role in the management of epistaxis as an adjunct to standard treatments, reducing the need for further intervention.
OBJECTIVES
To determine the effects of tranexamic acid (oral, intravenous or topical) compared with placebo, no additional intervention or any other haemostatic agent in the management of patients with epistaxis.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register (via CRS Web); Central Register of Controlled Trials (CENTRAL) (via CRS Web); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 29 October 2018.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of tranexamic acid (in addition to usual care) compared with usual care plus placebo, usual care alone or usual care plus any other haemostatic agent, to control epistaxis in adults or children.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. The primary outcomes were control of epistaxis: re-bleeding (as measured by the proportion of patients re-bleeding within a period of up to 10 days) and significant adverse effects (seizures, thromboembolic events). Secondary outcomes were control of epistaxis as measured by the time to stop initial bleeding (the proportion of patients whose bleeding is controlled within a period of up to 30 minutes); severity of re-bleeding (as measured by (a) the proportion of patients requiring any further intervention and (b) the proportion of patients requiring blood transfusion); length of hospital stay and other adverse effects. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
We included six RCTs (692 participants). The overall risk of bias in the studies was low. Two studies assessed oral administration of tranexamic acid, given regularly over several days, and compared it to placebo. In the other four studies, a single application of topical tranexamic acid was compared with placebo (one study) and a combination of epinephrine and lidocaine or phenylephrine (three studies). All participants were adults.Tranexamic acid versus placeboFor our primary outcome, control of epistaxis: re-bleeding (proportion re-bleeding within 10 days), we were able to pool data from three studies. The pooled result demonstrated a benefit of tranexamic acid compared to placebo, the risk of re-bleeding reducing from 67% to 47% (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.56 to 0.90; three studies; 225 participants; moderate-quality evidence).When we compared the effects of oral and topical tranexamic acid separately the risk of re-bleeding with oral tranexamic acid reduced from 69% to 49%, RR 0.73 (95% CI 0.55 to 0.96; two studies, 157 participants; moderate-quality evidence) and with topical tranexamic acid it reduced from 66% to 43%, RR 0.66 (95% CI 0.41 to 1.05; single study, 68 participants). We rated the quality of evidence provided by the single study as low, therefore it is uncertain whether topical tranexamic acid is effective in stopping bleeding in the 10-day period after a single application.No study specifically sought to identify and report our primary outcome: significant adverse effects (i.e. seizures, thromboembolic events).The secondary outcome time to stop initial bleeding (proportion with bleeding controlled within 30 minutes) was measured in one study using topical tranexamic acid and there was no evidence of a difference at 30 minutes (RR 0.79, 95% CI 0.56 to 1.11; 68 participants; low-quality evidence).No studies reported the proportion of patients requiring any further intervention (e.g. repacking, surgery, embolisation).One study of oral tranexamic acid reported the proportion of patients requiring blood transfusion and found no difference between groups: 5/45 (11%) versus 6/44 (14%) (RR 0.81, 95% CI 0.27 to 2.48; 89 participants; low-quality evidence).Two studies reported hospital length of stay. One study reported a significantly shorter stay in the oral tranexamic acid group (mean difference (MD) -1.60 days, 95% CI -2.49 to -0.71; 68 participants). The other study found no evidence of a difference between the groups.Tranexamic acid versus other haemostatic agentsWhen we pooled the data from three studies the proportion of patients whose bleeding stopped within 10 minutes was significantly higher in the topical tranexamic acid group compared to the group receiving another haemostatic agent (70% versus 30%: RR 2.35, 95% CI 1.90 to 2.92; 460 participants) (moderate-quality evidence).Adverse effects across all studiesFive studies recorded 'adverse effects' in a general way. None found any difference between the groups in the occurrence of minor adverse effects (e.g. mild nausea and diarrhoea, 'bad taste' of gel). In one study a patient developed a superficial thrombophlebitis of both legs following discharge, however it is not reported in which group this occurred. No "other serious adverse effect" was reported in any study.
AUTHORS' CONCLUSIONS
We found moderate-quality evidence that there is probably a reduction in the risk of re-bleeding with the use of either oral or topical tranexamic acid in addition to usual care in adult patients with epistaxis, compared to placebo with usual care. However, the quality of evidence relating solely to topical tranexamic acid was low (one study only), so we are uncertain whether or not topical tranexamic acid is effective in stopping bleeding in the 10-day period after a single application. We found moderate-quality evidence that topical tranexamic acid is probably better than other topical agents in stopping bleeding in the first 10 minutes.There have been only three RCTs on this subject since 1995. Since then there have been significant changes in nasal cauterisation and packing techniques (for example, techniques including nasal endoscopy and more invasive approaches such as endoscopic sphenopalatine artery ligation). New trials would inform us about the effectiveness of tranexamic acid in light of these developments.
Topics: Administration, Oral; Administration, Topical; Antifibrinolytic Agents; Blood Transfusion; Epinephrine; Epistaxis; Humans; Length of Stay; Lidocaine; Phenylephrine; Placebos; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Tranexamic Acid
PubMed: 30596479
DOI: 10.1002/14651858.CD004328.pub3