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Journal of Clinical Oncology : Official... Jun 2023To conduct an update of the ASCO venous thromboembolism (VTE) guideline.
PURPOSE
To conduct an update of the ASCO venous thromboembolism (VTE) guideline.
METHODS
After publication of potentially practice-changing clinical trials, identified through ASCO's signals approach to updating, an updated systematic review was performed for two guideline questions: perioperative thromboprophylaxis and treatment of VTE. PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) published between November 1, 2018, and June 6, 2022.
RESULTS
Five RCTs provided information that contributed to changes to the 2019 recommendations. Two RCTs addressed direct factor Xa inhibitors (either rivaroxaban or apixaban) for extended thromboprophylaxis after surgery. Each of these postoperative trials had important limitations but suggested that these two oral anticoagulants are safe and effective in the settings studied. An additional three RCTs addressed apixaban in the setting of VTE treatment. Apixaban was effective in reducing the risk of recurrent VTE, with a low risk of major bleeding.
RECOMMENDATIONS
Apixaban and rivaroxaban were added as options for extended pharmacologic thromboprophylaxis after cancer surgery, with a weak strength of recommendation. Apixaban was also added as an option for the treatment of VTE, with high quality of evidence and a strong recommendation.Additional information is available at www.asco.org/supportive-care-guidelines.
Topics: Humans; Venous Thromboembolism; Rivaroxaban; Anticoagulants; Hemorrhage; Neoplasms
PubMed: 37075273
DOI: 10.1200/JCO.23.00294 -
BMJ (Clinical Research Ed.) Mar 2022To systematically compare the effect of direct oral anticoagulants and low molecular weight heparin for thromboprophylaxis on the benefits and harms to patients... (Meta-Analysis)
Meta-Analysis
Benefits and harms of direct oral anticoagulation and low molecular weight heparin for thromboprophylaxis in patients undergoing non-cardiac surgery: systematic review and network meta-analysis of randomised trials.
OBJECTIVE
To systematically compare the effect of direct oral anticoagulants and low molecular weight heparin for thromboprophylaxis on the benefits and harms to patients undergoing non-cardiac surgery.
DESIGN
Systematic review and network meta-analysis of randomised controlled trials.
DATA SOURCES
Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL), up to August 2021.
REVIEW METHODS
Randomised controlled trials in adults undergoing non-cardiac surgery were selected, comparing low molecular weight heparin (prophylactic (low) or higher dose) with direct oral anticoagulants or with no active treatment. Main outcomes were symptomatic venous thromboembolism, symptomatic pulmonary embolism, and major bleeding. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for network meta-analyses. Abstracts and full texts were screened independently in duplicate. Data were abstracted on study participants, interventions, and outcomes, and risk of bias was assessed independently in duplicate. Frequentist network meta-analysis with multivariate random effects models provided odds ratios with 95% confidence intervals, and GRADE (grading of recommendations, assessment, development, and evaluation) assessments indicated the certainty of the evidence.
RESULTS
68 randomised controlled trials were included (51 orthopaedic, 10 general, four gynaecological, two thoracic, and one urological surgery), involving 45 445 patients. Low dose (odds ratio 0.33, 95% confidence interval 0.16 to 0.67) and high dose (0.19, 0.07 to 0.54) low molecular weight heparin, and direct oral anticoagulants (0.17, 0.07 to 0.41) reduced symptomatic venous thromboembolism compared with no active treatment, with absolute risk differences of 1-100 per 1000 patients, depending on baseline risks (certainty of evidence, moderate to high). None of the active agents reduced symptomatic pulmonary embolism (certainty of evidence, low to moderate). Direct oral anticoagulants and low molecular weight heparin were associated with a 2-3-fold increase in the odds of major bleeding compared with no active treatment (certainty of evidence, moderate to high), with absolute risk differences as high as 50 per 1000 in patients at high risk. Compared with low dose low molecular weight heparin, high dose low molecular weight heparin did not reduce symptomatic venous thromboembolism (0.57, 0.26 to 1.27) but increased major bleeding (1.87, 1.06 to 3.31); direct oral anticoagulants reduced symptomatic venous thromboembolism (0.53, 0.32 to 0.89) and did not increase major bleeding (1.23, 0.89 to 1.69).
CONCLUSIONS
Direct oral anticoagulants and low molecular weight heparin reduced venous thromboembolism compared with no active treatment but probably increased major bleeding to a similar extent. Direct oral anticoagulants probably prevent symptomatic venous thromboembolism to a greater extent than prophylactic low molecular weight heparin.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42018106181.
Topics: Anticoagulants; Hemorrhage; Heparin, Low-Molecular-Weight; Humans; Network Meta-Analysis; Postoperative Complications; Pulmonary Embolism; Randomized Controlled Trials as Topic; Surgical Procedures, Operative; Treatment Outcome; Venous Thromboembolism
PubMed: 35264372
DOI: 10.1136/bmj-2021-066785 -
Journal of the American College of... May 2021It is increasingly recognized that non-opioid analgesia is an important analgesia in the perioperative period. Specifically, NSAIDs (nonsteroidal anti-inflammatory... (Meta-Analysis)
Meta-Analysis
BACKGROUND
It is increasingly recognized that non-opioid analgesia is an important analgesia in the perioperative period. Specifically, NSAIDs (nonsteroidal anti-inflammatory drugs) have been touted as an adjunct, or even replacement, for opioids. However, uptake of NSAIDs has been slow due to concern for side effects, including bleeding. We sought to understand the risk of bleeding caused by NSAIDs in the perioperative period.
STUDY DESIGN
A physician-librarian team performed a search of electronic databases (MEDLINE, EMBASE), using search terms covering the targeted intervention (use of NSAIDs) and outcomes of interest (surgical complications, bleeding), limited to English language articles of any date. We performed a systematic review and meta-analysis of the data.
RESULTS
A total of 2,521 articles were screened, and 229 were selected on the basis of title and abstract for detailed assessment. Including reference searching, 74 manuscripts met inclusion criteria spanning years 1987-2019. These studies included 151,031 patients. Studies included 12 types of NSAIDs, the most common being ketorolac, diclofenac, and ibuprofen, over a wide-range of procedures, from otorhinolaryngology (ENT), breast, abdomen, plastics, and more. More than half were randomized control trials. The meta-analyses for hematoma, return to the operating room for bleeding, and blood transfusions showed no difference in risk in any of 3 categories studied between the NSAID vs non-NSAID groups (p = 0.49, p = 0.79, and p = 0.49, respectively). Quality scoring found a wide range of quality, with scores ranging from lowest quality of 12 to highest quality of 25, out of a total of 27 (average = 16).
CONCLUSIONS
NSAIDs are unlikely to be the cause of postoperative bleeding complications. This literature covers a large number of patients and remains consistent across types of NSAIDs and operations.
Topics: Analgesia; Anti-Inflammatory Agents, Non-Steroidal; Blood Loss, Surgical; Blood Transfusion; Diclofenac; Humans; Ibuprofen; Ketorolac; Pain, Postoperative; Pain, Procedural; Perioperative Period; Postoperative Hemorrhage; Surgical Procedures, Operative; Treatment Outcome
PubMed: 33515678
DOI: 10.1016/j.jamcollsurg.2021.01.005 -
Lancet (London, England) Jan 2022Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis.
METHODS
We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days.
FINDINGS
Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years [SD 13·7], 259 [51·3%] women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76-3·33; p<0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83-3·54; p<0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0-2) than best medical therapy alone (122 [45·9%] of 266 vs 46 [19·3%] of 238; p<0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 [16·5%] of 266 vs 46 [19·3%] of 238) or symptomatic intracerebral haemorrhage (14 [5·3%] of 266 vs eight [3·3%] of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12-24 h (common OR 5·86 [95% CI 3·14-10·94]) than those randomly assigned within 6-12 h (1·76 [1·18-2·62]; p=0·0087).
INTERPRETATION
These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6-24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6-24 h time window.
FUNDING
Stryker Neurovascular.
Topics: Cerebral Hemorrhage; Endovascular Procedures; Humans; Postoperative Hemorrhage; Randomized Controlled Trials as Topic; Thrombectomy; Thrombotic Stroke; Time-to-Treatment; Treatment Outcome
PubMed: 34774198
DOI: 10.1016/S0140-6736(21)01341-6 -
Expert Review of Gastroenterology &... Oct 2022Current guidelines recommend aspirin maintenance for high-risk endoscopic procedures. Some Asian physicians noticed increasing postoperative bleeding in patients taking... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVE
Current guidelines recommend aspirin maintenance for high-risk endoscopic procedures. Some Asian physicians noticed increasing postoperative bleeding in patients taking aspirin. We aimed to explore whether risk of postoperative hemorrhage due to aspirin differs in the East and the West.
METHODS
PubMed, EMBASE and Cochrane library database were systematically reviewed. We only included trials that met our criteria.
RESULTS
There is significant association between aspirin and postoperative bleeding (P < 0.001), especially in Eastern population (data from Japan, Korea, Turkey and China, P < 0.001). Result from the West (data from America, Canada and Australia) had no statistical significance (P = 0.07). For Easterners, aspirin increased bleeding risk after endoscopic submucosal dissection (ESD) and endoscopic sphincterotomy (EST). For Westerners, aspirin increased bleeding risk post endoscopic mucosal resection (EMR). For patients undergoing ESD, those who continued to receive aspirin had higher bleeding risk than patients who interrupted it for more than 7 days (P = 0.005).
CONCLUSION
Aspirin increases risk of postoperative hemorrhage. Easterners are more likely to suffer from bleeding after aspirin administration than Westerners. Stopping aspirin for more than 7 days may be advisable to control bleeding post ESD for patients with low risk of thrombosis.
Topics: Humans; Aspirin; Platelet Aggregation Inhibitors; Gastrointestinal Hemorrhage; Retrospective Studies; Postoperative Hemorrhage; Endoscopic Mucosal Resection; Stomach Neoplasms; Gastric Mucosa
PubMed: 36245097
DOI: 10.1080/17474124.2022.2137489 -
Neurosurgical Focus Oct 2023Tranexamic acid (TXA) is an antifibrinolytic drug associated with reduced blood loss in a range of surgical specialties, including neurosurgery, orthopedic surgery, and... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Tranexamic acid (TXA) is an antifibrinolytic drug associated with reduced blood loss in a range of surgical specialties, including neurosurgery, orthopedic surgery, and cardiac surgery. Concerns about venous thromboembolism and seizures from intravenous (IV) TXA have led to increased use of topical TXA. Given the relative scarcity of the literature on topical TXA compared with that on IV TXA within neurosurgery, the authors aimed to conduct a systematic review and meta-analysis on the safety, efficacy, and optimal administration of topical TXA in a wide range of spinal procedures and pathologies.
METHODS
The PRISMA guidelines, Cochrane risk of bias tool, and Newcastle-Ottawa Scale were used to extract randomized controlled trials and high-quality case-control and cross-sectional/cohort studies (adult studies only) from PubMed, Web of Science, Cochrane Library, and Embase published between 2016 and 2023. Studies were analyzed by two independent reviewers for variables including dosage, TXA administration route, type of spine procedure, blood loss, adverse events including thromboembolism and infection, postoperative hemoglobin level, and hospitalization length. Pooled analysis comparing intraoperative and postoperative blood loss, postoperative hemoglobin levels, and hospitalization length of stay on the basis of route of TXA administration was conducted.
RESULTS
Four cohort studies, 1 cross-sectional study, 1 case-control study, and 12 randomized controlled trials, together involving 2045 patients, were included. The most common route of topical TXA administration was via TXA in saline solution. Other routes of topical TXA included retrograde injection and TXA-soaked Gelfoam. In pooled analysis, topical TXA significantly reduced visible blood loss (standardized mean difference [SMD] -0.22, 95% CI -0.45 to -0.00001), postoperative blood loss (SMD -1.63, 95% CI -2.03 to -1.22), and length of hospital stay (SMD -1.02, 95% CI -1.42 to -0.61), as well as higher postoperative hemoglobin (SMD 0.59, 95% CI 0.34-0.83), compared with non-TXA controls. No significant differences in outcomes were found between topical and IV TXA or between combined (topical and IV) and IV TXA. Thromboembolism and infection rates did not significantly differ between any TXA administration group and non-TXA controls.
CONCLUSIONS
In pooled analyses, topical TXA was associated with decreased perioperative blood loss in a wide range of scenarios, including cervical spine surgery and thoracolumbar trauma, as well as in patients with a thromboembolic history.
Topics: Humans; Tranexamic Acid; Cross-Sectional Studies; Case-Control Studies; Blood Loss, Surgical; Postoperative Hemorrhage; Thromboembolism; Hemoglobins
PubMed: 37778051
DOI: 10.3171/2023.7.FOCUS23363 -
World Neurosurgery Feb 2022Surgical management of aneurysmal subarachnoid hemorrhage (SAH) often involves red blood cell (RBC) transfusion, which increases the risk of postoperative complications.... (Review)
Review
OBJECTIVE
Surgical management of aneurysmal subarachnoid hemorrhage (SAH) often involves red blood cell (RBC) transfusion, which increases the risk of postoperative complications. RBC transfusion guidelines report on chronically critically ill patients and may not apply to patients with SAH. Our study aims to synthesize the evidence to recommend RBC transfusion thresholds among adult patients with SAH undergoing surgery.
METHODS
A systematic review was conducted using PubMed, Google Scholar, and Web of Science electronic databases according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines to critically assess primary articles discussing RBC transfusion thresholds and describe complications secondary to RBC transfusion in adult patients with SAH in the perioperative period.
RESULTS
Sixteen articles meeting our search strategy were reviewed. Patients with SAH who received blood transfusion were older, female, had World Federation of Neurosurgical Societies grade IV-V and modified Fisher grade 3-4 scores, and presented with more comorbidities such as hypertension, diabetes, and cardiovascular and pulmonary diseases. In addition, transfusion was associated with multiple postoperative complications, including higher rates of vasospasms, surgical site infections, cardiovascular and respiratory complications, increased postoperative length of stay, and 30-day mortality. Analysis of transfused patients showed that a higher hemoglobin (>10 g/dL) goal after SAH was safe and that patients may benefit from a higher whole hospital stay hemoglobin nadir, as shown by a reduction in risk of cerebral vasospasm and improvement in clinical outcomes (level B class II).
CONCLUSIONS
Among patients with SAH, the benefits of reducing cerebral ischemia and anemia are shown to outweigh the risks of transfusion-related complications.
Topics: Adult; Anemia; Erythrocyte Transfusion; Female; Hemoglobins; Humans; Subarachnoid Hemorrhage; Transfusion Reaction; Vasospasm, Intracranial
PubMed: 34890850
DOI: 10.1016/j.wneu.2021.12.007 -
International Urogynecology Journal Apr 2023Vaginal packing is often used after vaginal hysterectomy to reduce the risk of haemorrhagic and infectious complications, but the procedure may impair spontaneous... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Vaginal packing is often used after vaginal hysterectomy to reduce the risk of haemorrhagic and infectious complications, but the procedure may impair spontaneous bladder emptying and necessitate permanent bladder catheterization, which itself increases the risk of urinary infection, patient bother, delayed discharge, and increased costs. This systematic review was aimed at assessing the complications and outcomes associated with vaginal packing after vaginal hysterectomy.
METHODS
We conducted a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement, using the Population, Interventions, Comparators, Outcomes, and Study design (PICOS) framework to define eligibility. Following data synthesis and subgroup analyses, we assessed the certainty of evidence according to GRADE guidance and formulated a clinical recommendation.
RESULTS
The review included four clinical trials (involving 337 participants). These provided no clear evidence that vaginal packing led to clinically meaningful reductions in adverse effects, such as vaginal bleeding, hematoma formation, or postoperative vaginal cuff infection. Overall, the intervention produced no clear benefit regarding the predefined outcomes.
CONCLUSIONS
Routine vaginal packing after vaginal hysterectomy had no clear benefit on outcomes. We therefore advise against this procedure.
Topics: Female; Humans; Hysterectomy, Vaginal; Postoperative Complications; Uterine Hemorrhage; Hematoma; Research Design; Hysterectomy
PubMed: 36018354
DOI: 10.1007/s00192-022-05331-1 -
Survey of Ophthalmology 2022Pars plana vitrectomy (PPV) and scleral buckling (SB) are two of the most common surgical treatments for rhegmatogenous retinal detachment (RRD). This meta-analysis... (Meta-Analysis)
Meta-Analysis Review
Pars plana vitrectomy (PPV) and scleral buckling (SB) are two of the most common surgical treatments for rhegmatogenous retinal detachment (RRD). This meta-analysis compares the efficacy and safety of PPV and SB for RRD. A systematic literature review was performed using Ovid MEDLINE, EMBASE and Cochrane CENTRAL from 2000 to June, 2021. Comparative studies, randomized controlled trials and observational studies investigating PPV and SB for RRD repair were included. The primary endpoint was final best- corrected visual acuity (BCVA). Secondary endpoints were reattachment rates, total operation time, and incidence of adverse events. Subgroup analyses including phakic status, presence of PVR-C or greater at baseline, and macular attachment status were conducted. Across 41 studies (8 RCTs, 33 observational studies), 5,401 SB and 10,546 PPV eyes were included. SB achieved a statistically significant, but likely not clinically significant, better final BCVA than PPV (0.38 ± 0.53 vs. 0.33 ± 0.53 logMAR (20/48 vs. 20/43 Snellen); weighted mean difference [WMD]: 0.07; 95% confidence interval: [0.02-0.11]; P = 0.005). SB had a better final BCVA compared to PPV in observational studies (P = 0.007) but not in RCTs (P = 0.21). SB had a lower incidence of post-operative cataract formation (P < 0.00001) and iatrogenic breaks (P < 0.00001), but a higher incidence of choroidal/subretinal hemorrhage (P = 0.007), choroidal detachment (P = 0.004), and residual subretinal fluid (RSRF) (P < 0.00001). Primary (86.5% vs. 84.8%; P = 0.13) and final (96.7% vs. 97.7%; P = 0.12) reattachment rates were similar between PPV and SB. PPV had a significantly higher primary reattachment rate in RCTs (P = 0.02) but not in observational studies (P = 0.30). SB was associated with a better final BCVA than PPV; however, this result was primarily driven by observational studies and phakic patients who developed cataracts. Primary and final reattachment rates were similar between the comparators. SB was associated with a significantly lower incidence of iatrogenic breaks and cataracts, while PPV was associated with a reduced risk of choroidal detachment, subretinal hemorrhage, and RSRF.
Topics: Cataract; Choroidal Effusions; Hemorrhage; Humans; Iatrogenic Disease; Retinal Detachment; Retrospective Studies; Scleral Buckling; Treatment Outcome; Vitrectomy
PubMed: 34896191
DOI: 10.1016/j.survophthal.2021.12.005 -
Surgery May 2023The aim of this meta-analysis and systematic review was to evaluate the association between intraoperative bile cultures and postoperative complications of patients... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The aim of this meta-analysis and systematic review was to evaluate the association between intraoperative bile cultures and postoperative complications of patients undergoing pancreaticoduodenectomy.
METHODS
A detailed literature search was performed from January 2015 to July 2022 in PubMed, Web of Science, Google Scholar, and EMBASE for related research publications. The data were extracted, screened, and graded independently. An analysis of pooled data was performed, and a risk ratio with corresponding confidence intervals was calculated and summarized.
RESULTS
A total of 8 articles were included with 1,778 pancreaticoduodenectomy patients who had an intraoperative bile culture performed. A systematic review demonstrated that some of the most common organisms isolated in a positive intraoperative bile culture were Enterococcus species, Klebsiella species, and E. coli. Four studies also showed that specific microorganisms were associated with specific postoperative complications (surgical site infection and intra-abdominal abscess). The postoperative complications that were evaluated for an association with a positive intraoperative bile culture were surgical site infections (risk ratio = 2.33, 95% confidence interval [1.47-3.69], P < .01), delayed gastric emptying (risk ratio = 1.23, 95% confidence interval [0.63-2.38], P = n.s.), 90-day mortality (risk ratio = 0.68, 95% confidence interval [0.01-52.76], P = n.s.), postoperative pancreatic hemorrhage (risk ratio = 1.70, 95% confidence interval [0.33-8.74], P = n.s.), intra-abdominal abscess (risk ratio = 1.70, 95% confidence interval [0.38-7.56], P = n.s.), and postoperative pancreatic fistula (risk ratio = 0.97, 95% confidence interval [0.72-1.32], P = n.s.).
CONCLUSION
The cumulative data suggest that a positive intraoperative bile culture has no association with predicting the postoperative complications of delayed gastric emptying, 90-day mortality, postoperative pancreatic hemorrhage, intra-abdominal abscess, or postoperative pancreatic fistula. However, the data also suggest that a positive intraoperative bile culture was associated with a patient developing a surgical site infection.
Topics: Humans; Pancreaticoduodenectomy; Surgical Wound Infection; Pancreatic Fistula; Bile; Gastroparesis; Escherichia coli; Pancreatic Diseases; Postoperative Hemorrhage; Abdominal Abscess; Postoperative Complications
PubMed: 36707272
DOI: 10.1016/j.surg.2022.12.012