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Obesity Surgery Jan 2019Durability is a key requirement for the broad acceptance of bariatric surgery. We report on durability at and beyond 10 years with a systematic review and meta-analysis... (Meta-Analysis)
Meta-Analysis
Long-Term Outcomes After Bariatric Surgery: a Systematic Review and Meta-analysis of Weight Loss at 10 or More Years for All Bariatric Procedures and a Single-Centre Review of 20-Year Outcomes After Adjustable Gastric Banding.
INTRODUCTION
Durability is a key requirement for the broad acceptance of bariatric surgery. We report on durability at and beyond 10 years with a systematic review and meta-analysis of all reports providing data at 10 or more years and a single-centre study of laparoscopic adjustable gastric banding (LAGB) with 20 years of follow-up.
METHODS
Systematic review with meta-analysis was performed on all eligble reports containing 10 or more years of follow-up data on weight loss after bariatric surgery. In addition, a prospective cohort study of LAGB patients measuring weight loss and reoperation at up to 20 years is presented.
RESULTS
Systematic review identified 57 datasets of which 33 were eligible for meta-analysis. Weighted means of the percentage of excess weight loss (%EWL) were calculated for all papers included in the systematic review. Eighteen reports of gastric bypass showed a weighted mean of 56.7%EWL, 17 reports of LAGB showed 45.9%EWL, 9 reports of biliopancreatic bypass +/- duodenal switch showed 74.1%EWL and 2 reports of sleeve gastrectomy showed 58.3%EWL. Meta-analyses of eligible studies demonstrated comparable results. Reoperations were common in all groups. At a single centre, 8378 LAGB patients were followed for up to 20 years with an overall follow-up rate of 54%. No surgical deaths occurred. Weight loss at 20 years (N = 35) was 30.1 kg, 48.9%EWL and 22.2% total weight loss (%TWL). Reoperation rate was initially high but reduced markedly with improved band and surgical and aftercare techniques.
CONCLUSION
All current procedures are associated with substantial and durable weight loss. More long-term data are needed for one-anastomosis gastric bypass and sleeve gastrectomy. Reoperation is likely to remain common across all procedures.
Topics: Bariatric Surgery; Gastroplasty; Humans; Obesity, Morbid; Reoperation; Treatment Outcome; Weight Loss
PubMed: 30293134
DOI: 10.1007/s11695-018-3525-0 -
Journal of Vascular Surgery Jun 2019Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on...
Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.
Topics: Cardiac Imaging Techniques; Cardiology; Chronic Disease; Consensus; Evidence-Based Medicine; Heart Function Tests; Humans; Ischemia; Peripheral Arterial Disease; Predictive Value of Tests; Risk Factors; Terminology as Topic; Treatment Outcome
PubMed: 31159978
DOI: 10.1016/j.jvs.2019.02.016 -
Journal of the American College of... Jan 2022The guideline for coronary artery revascularization replaces the 2011 coronary artery bypass graft surgery and the 2011 and 2015 percutaneous coronary intervention...
2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
AIM
The guideline for coronary artery revascularization replaces the 2011 coronary artery bypass graft surgery and the 2011 and 2015 percutaneous coronary intervention guidelines, providing a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization as well as the supporting documentation to encourage their use.
METHODS
A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered.
STRUCTURE
Coronary artery disease remains a leading cause of morbidity and mortality globally. Coronary revascularization is an important therapeutic option when managing patients with coronary artery disease. The 2021 coronary artery revascularization guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with coronary artery disease who are being considered for coronary revascularization, with the intent to improve quality of care and align with patients' interests.
Topics: American Heart Association; Cardiology; Coronary Artery Disease; Humans; Myocardial Revascularization; United States
PubMed: 34895950
DOI: 10.1016/j.jacc.2021.09.006 -
Journal of Vascular Surgery Aug 2018The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily decisions are often made using anecdotal or low-quality evidence.
METHODS
We searched multiple databases through May 7, 2017, for prospective studies with at least 1-year follow-up that evaluated patient-relevant outcomes of infrainguinal revascularization procedures in adults with CLTI. Independent pairs of reviewers selected articles and extracted data. Random-effects meta-analysis was used to pool outcomes across studies.
RESULTS
We included 44 studies that enrolled 8602 patients. Periprocedural outcomes (mortality, amputation, major adverse cardiac events) were similar across treatment modalities. Overall, patients with infrapopliteal disease had higher patency rates of great saphenous vein graft at 1 and 2 years (primary: 87%, 78%; secondary: 94%, 87%, respectively) compared with all other interventions. Prosthetic bypass outcomes were notably inferior to vein bypass in terms of amputation and patency outcomes, especially for below knee targets at 2 years and beyond. Drug-eluting stents demonstrated improved patency over bare-metal stents in infrapopliteal arteries (primary patency: 73% vs 50% at 1 year), and was at least comparable to balloon angioplasty (66% primary patency). Survival, major amputation, and amputation-free survival at 2 years were broadly similar between endovascular interventions and vein bypass, with prosthetic bypass having higher rates of limb loss. Overall, the included studies were at moderate to high risk of bias and the quality of evidence was low.
CONCLUSIONS
There are major limitations in the current state of evidence guiding treatment decisions in CLTI, particularly for severe anatomic patterns of disease treated via endovascular means. Periprocedural (30-day) mortality, amputation, and major adverse cardiac events are broadly similar across modalities. Patency rates are highest for saphenous vein bypass, whereas both patency and limb salvage are markedly inferior for prosthetic grafting to below the knee targets. Among endovascular interventions, percutaneous transluminal angioplasty and drug-eluting stents appear comparable for focal infrapopliteal disease, although no studies included long segment tibial lesions. Heterogeneity in patient risk, severity of limb threat, and anatomy treated renders direct comparison of outcomes from the current literature challenging. Future studies should incorporate both limb severity and anatomic staging to best guide clinical decision making in CLTI.
Topics: Amputation, Surgical; Blood Vessel Prosthesis Implantation; Chronic Disease; Clinical Decision-Making; Drug-Eluting Stents; Endovascular Procedures; Evidence-Based Medicine; Graft Occlusion, Vascular; Humans; Ischemia; Limb Salvage; Patient Selection; Peripheral Arterial Disease; Risk Factors; Saphenous Vein; Time Factors; Treatment Outcome
PubMed: 29804736
DOI: 10.1016/j.jvs.2018.01.066 -
JAMA Surgery Mar 2014The prevalence of obesity and outcomes of bariatric surgery are well established. However, analyses of the surgery impact have not been updated and comprehensively... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
The prevalence of obesity and outcomes of bariatric surgery are well established. However, analyses of the surgery impact have not been updated and comprehensively investigated since 2003.
OBJECTIVE
To examine the effectiveness and risks of bariatric surgery using up-to-date, comprehensive data and appropriate meta-analytic techniques.
DATA SOURCES
Literature searches of Medline, Embase, Scopus, Current Contents, Cochrane Library, and Clinicaltrials.gov between 2003 and 2012 were performed.
STUDY SELECTION
Exclusion criteria included publication of abstracts only, case reports, letters, comments, or reviews; animal studies; languages other than English; duplicate studies; no surgical intervention; and no population of interest. Inclusion criteria were a report of surgical procedure performed and at least 1 outcome of interest resulting from the studied surgery was reported: comorbidities, mortality, complications, reoperations, or weight loss. Of the 25,060 initially identified articles, 24,023 studies met the exclusion criteria, and 259 met the inclusion criteria.
DATA EXTRACTION AND SYNTHESIS
A review protocol was followed throughout. Three reviewers independently reviewed studies, abstracted data, and resolved disagreements by consensus. Studies were evaluated for quality.
MAIN OUTCOMES AND MEASURES
Mortality, complications, reoperations, weight loss, and remission of obesity-related diseases.
RESULTS
A total of 164 studies were included (37 randomized clinical trials and 127 observational studies). Analyses included 161,756 patients with a mean age of 44.56 years and body mass index of 45.62. We conducted random-effects and fixed-effect meta-analyses and meta-regression. In randomized clinical trials, the mortality rate within 30 days was 0.08% (95% CI, 0.01%-0.24%); the mortality rate after 30 days was 0.31% (95% CI, 0.01%-0.75%). Body mass index loss at 5 years postsurgery was 12 to 17. The complication rate was 17% (95% CI, 11%-23%), and the reoperation rate was 7% (95% CI, 3%-12%). Gastric bypass was more effective in weight loss but associated with more complications. Adjustable gastric banding had lower mortality and complication rates; yet, the reoperation rate was higher and weight loss was less substantial than gastric bypass. Sleeve gastrectomy appeared to be more effective in weight loss than adjustable gastric banding and comparable with gastric bypass.
CONCLUSIONS AND RELEVANCE
Bariatric surgery provides substantial and sustained effects on weight loss and ameliorates obesity-attributable comorbidities in the majority of bariatric patients, although risks of complication, reoperation, and death exist. Death rates were lower than those reported in previous meta-analyses.
Topics: Adult; Bariatric Surgery; Body Mass Index; Humans; Obesity; Observational Studies as Topic; Outcome Assessment, Health Care; Postoperative Complications; Randomized Controlled Trials as Topic; Reoperation; Risk Assessment; Weight Loss
PubMed: 24352617
DOI: 10.1001/jamasurg.2013.3654 -
International Journal of Surgery... Apr 2020Laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy are the most common procedures performed in bariatric surgery and both have been demonstrated... (Meta-Analysis)
Meta-Analysis
Comparative analysis of weight loss and resolution of comorbidities between laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass: A systematic review and meta-analysis based on 18 studies.
BACKGROUND
Laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy are the most common procedures performed in bariatric surgery and both have been demonstrated to have significant effectiveness in treating morbid obesity. However, comparative analysis of their effectiveness has not been well studied. This comparative analysis was conducted to determine whether Laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy have the same mid- and long-term outcomes in weight loss, resolution of obesity comorbidities and adverse events (AEs) of treatment.
METHODS
We searched the Cochrane Library, PubMed, Embase and Web of Science databases from the establishment of the database to January 1, 2020 for both randomized control trials and non-randomised interventional studies that studied Laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy with respect to weight loss outcomes, resolution of obesity comorbidities and AEs of treatment. Standardised mean differences, risk ratios and odds ratio with 95% confidence intervals were calculated to compare the outcomes of the groups. Two reviewers assessed the quality of the trials and extracted the data independently. All statistical analyses were performed using the standard statistical procedures in Review Manager 5.2.
RESULTS
We included 20 studies (N = 2917 participants) in this meta-analysis. Our results showed no significant difference in excess weight loss between Laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy, with pooled Standardised mean differences of -0.16 (95% confidence interval: -0.52 to 0.19; P = 0.36) based on randomized control trials and 0.07 (95% confidence interval: -0.10 to 0.24; P = 0.41) based on non-randomised interventional studies. Further, the pooled results showed no significant differences in midterm and long-term weight loss outcomes between the comparative groups. Similarly, no significant difference was found in type 2 diabetes mellitus resolution. The pooled results indicated that patients receiving laparoscopic sleeve gastrectomy experienced fewer postoperative complication and reoperation rates, with pooled risk ratios of 1.66 (95% confidence interval: 1.33 to 2.07; P < 0.00001) and 1.73 (95% confidence interval: 1.14 to 2.62; P = 0.01), respectively. Laparoscopic Roux-en-Y gastric bypass was superior to laparoscopic sleeve gastrectomy in managing dyslipidemia, hypertension and gastroesophageal reflux disease.
CONCLUSIONS
The present meta-analysis indicated that both Laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy had the same effectiveness in resulting in excess weight loss and type 2 diabetes mellitus resolution. However, patients who received laparoscopic sleeve gastrectomy experienced fewer postoperative complication and reoperation rates than those who received Laparoscopic Roux-en-Y gastric bypass. Laparoscopic Roux-en-Y gastric bypass was superior in the management of dyslipidemia, hypertension and gastroesophageal reflux disease.
Topics: Comorbidity; Diabetes Mellitus, Type 2; Gastrectomy; Gastric Bypass; Gastroesophageal Reflux; Humans; Hypertension; Laparoscopy; Obesity, Morbid; Odds Ratio; Postoperative Complications; Reoperation; Second-Look Surgery; Weight Loss
PubMed: 32151750
DOI: 10.1016/j.ijsu.2020.02.035 -
The Cochrane Database of Systematic... Aug 2014Bariatric (weight loss) surgery for obesity is considered when other treatments have failed. The effects of the available bariatric procedures compared with medical... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Bariatric (weight loss) surgery for obesity is considered when other treatments have failed. The effects of the available bariatric procedures compared with medical management and with each other are uncertain. This is an update of a Cochrane review first published in 2003 and most recently updated in 2009.
OBJECTIVES
To assess the effects of bariatric surgery for overweight and obesity, including the control of comorbidities.
SEARCH METHODS
Studies were obtained from searches of numerous databases, supplemented with searches of reference lists and consultation with experts in obesity research. Date of last search was November 2013.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing surgical interventions with non-surgical management of obesity or overweight or comparing different surgical procedures.
DATA COLLECTION AND ANALYSIS
Data were extracted by one review author and checked by a second review author. Two review authors independently assessed risk of bias and evaluated overall study quality utilising the GRADE instrument.
MAIN RESULTS
Twenty-two trials with 1798 participants were included; sample sizes ranged from 15 to 250. Most studies followed participants for 12, 24 or 36 months; the longest follow-up was 10 years. The risk of bias across all domains of most trials was uncertain; just one was judged to have adequate allocation concealment.All seven RCTs comparing surgery with non-surgical interventions found benefits of surgery on measures of weight change at one to two years follow-up. Improvements for some aspects of health-related quality of life (QoL) (two RCTs) and diabetes (five RCTs) were also found. The overall quality of the evidence was moderate. Five studies reported data on mortality, no deaths occurred. Serious adverse events (SAEs) were reported in four studies and ranged from 0% to 37% in the surgery groups and 0% to 25% in the no surgery groups. Between 2% and 13% of participants required reoperations in the five studies that reported these data.Three RCTs found that laparoscopic Roux-en-Y gastric bypass (L)(RYGB) achieved significantly greater weight loss and body mass index (BMI) reduction up to five years after surgery compared with laparoscopic adjustable gastric banding (LAGB). Mean end-of-study BMI was lower following LRYGB compared with LAGB: mean difference (MD) -5.2 kg/m² (95% confidence interval (CI) -6.4 to -4.0; P < 0.00001; 265 participants; 3 trials; moderate quality evidence). Evidence for QoL and comorbidities was very low quality. The LRGYB procedure resulted in greater duration of hospitalisation in two RCTs (4/3.1 versus 2/1.5 days) and a greater number of late major complications (26.1% versus 11.6%) in one RCT. In one RCT the LAGB required high rates of reoperation for band removal (9 patients, 40.9%).Open RYGB, LRYGB and laparoscopic sleeve gastrectomy (LSG) led to losses of weight and/or BMI but there was no consistent picture as to which procedure was better or worse in the seven included trials. MD was -0.2 kg/m² (95% CI -1.8 to 1.3); 353 participants; 6 trials; low quality evidence) in favour of LRYGB. No statistically significant differences in QoL were found (one RCT). Six RCTs reported mortality; one death occurred following LRYGB. SAEs were reported by one RCT and were higher in the LRYGB group (4.5%) than the LSG group (0.9%). Reoperations ranged from 6.7% to 24% in the LRYGB group and 3.3% to 34% in the LSG group. Effects on comorbidities, complications and additional surgical procedures were neutral, except gastro-oesophageal reflux disease improved following LRYGB (one RCT). One RCT of people with a BMI 25 to 35 and type 2 diabetes found laparoscopic mini-gastric bypass resulted in greater weight loss and improvement of diabetes compared with LSG, and had similar levels of complications.Two RCTs found that biliopancreatic diversion with duodenal switch (BDDS) resulted in greater weight loss than RYGB in morbidly obese patients. End-of-study mean BMI loss was greater following BDDS: MD -7.3 kg/m² (95% CI -9.3 to -5.4); P < 0.00001; 107 participants; 2 trials; moderate quality evidence). QoL was similar on most domains. In one study between 82% to 100% of participants with diabetes had a HbA1c of less than 5% three years after surgery. Reoperations were higher in the BDDS group (16.1% to 27.6%) than the LRYGB group (4.3% to 8.3%). One death occurred in the BDDS group.One RCT comparing laparoscopic duodenojejunal bypass with sleeve gastrectomy versus LRYGB found BMI, excess weight loss, and rates of remission of diabetes and hypertension were similar at 12 months follow-up (very low quality evidence). QoL, SAEs and reoperation rates were not reported. No deaths occurred in either group.One RCT comparing laparoscopic isolated sleeve gastrectomy (LISG) versus LAGB found greater improvement in weight-loss outcomes following LISG at three years follow-up (very low quality evidence). QoL, mortality and SAEs were not reported. Reoperations occurred in 20% of the LAGB group and in 10% of the LISG group.One RCT (unpublished) comparing laparoscopic gastric imbrication with LSG found no statistically significant difference in weight loss between groups (very low quality evidence). QoL and comorbidities were not reported. No deaths occurred. Two participants in the gastric imbrication group required reoperation.
AUTHORS' CONCLUSIONS
Surgery results in greater improvement in weight loss outcomes and weight associated comorbidities compared with non-surgical interventions, regardless of the type of procedures used. When compared with each other, certain procedures resulted in greater weight loss and improvements in comorbidities than others. Outcomes were similar between RYGB and sleeve gastrectomy, and both of these procedures had better outcomes than adjustable gastric banding. For people with very high BMI, biliopancreatic diversion with duodenal switch resulted in greater weight loss than RYGB. Duodenojejunal bypass with sleeve gastrectomy and laparoscopic RYGB had similar outcomes, however this is based on one small trial. Isolated sleeve gastrectomy led to better weight-loss outcomes than adjustable gastric banding after three years follow-up. This was based on one trial only. Weight-related outcomes were similar between laparoscopic gastric imbrication and laparoscopic sleeve gastrectomy in one trial. Across all studies adverse event rates and reoperation rates were generally poorly reported. Most trials followed participants for only one or two years, therefore the long-term effects of surgery remain unclear.
Topics: Adult; Female; Gastric Bypass; Gastroplasty; Humans; Ligation; Male; Obesity, Morbid; Randomized Controlled Trials as Topic; Weight Loss
PubMed: 25105982
DOI: 10.1002/14651858.CD003641.pub4 -
Journal of the American Heart... Nov 2020Background Coronary artery bypass grafting (CABG) is known to improve heart function and quality of life, while rates of surgery-related mortality are low. However,... (Meta-Analysis)
Meta-Analysis
Background Coronary artery bypass grafting (CABG) is known to improve heart function and quality of life, while rates of surgery-related mortality are low. However, delirium and cognitive decline are common complications. We sought to identify preoperative, intraoperative, and postoperative risk or protective factors associated with delirium and cognitive decline (across time) in patients undergoing CABG. Methods and Results We conducted a systematic search of Medline, PsycINFO, EMBASE, and Cochrane (March 26, 2019) for peer-reviewed, English publications reporting post-CABG delirium or cognitive decline data, for at least one risk factor. Random-effects meta-analyses estimated pooled odds ratio for categorical data and mean difference or standardized mean difference for continuous data. Ninety-seven studies, comprising data from 60 479 patients who underwent CABG, were included. Moderate to large and statistically significant risk factors for delirium were as follows: (1) preoperative cognitive impairment, depression, stroke history, and higher European System for Cardiac Operative Risk Evaluation (EuroSCORE) score, (2) intraoperative increase in intubation time, and (3) postoperative presence of arrythmia and increased days in the intensive care unit; higher preoperative cognitive performance was protective for delirium. Moderate to large and statistically significant risk factors for acute cognitive decline were as follows: (1) preoperative depression and older age, (2) intraoperative increase in intubation time, and (3) postoperative presence of delirium and increased days in the intensive care unit. Presence of depression preoperatively was a moderate risk factor for midterm (1-6 months) post-CABG cognitive decline. Conclusions This meta-analysis identified several key risk factors for delirium and cognitive decline following CABG, most of which are nonmodifiable. Future research should target preoperative risk factors, such as depression or cognitive impairment, which are potentially modifiable. Registration URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42020149276.
Topics: Cognitive Dysfunction; Coronary Artery Bypass; Coronary Artery Disease; Delirium; Humans; Postoperative Complications; Risk Factors
PubMed: 33164631
DOI: 10.1161/JAHA.120.017275 -
Critical Care (London, England) May 2023Cytokine adsorption using the CytoSorb® adsorber has been proposed in various clinical settings including sepsis, ARDS, hyperinflammatory syndromes, cardiac surgery or... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Cytokine adsorption using the CytoSorb® adsorber has been proposed in various clinical settings including sepsis, ARDS, hyperinflammatory syndromes, cardiac surgery or recovery after cardiac arrest. The aim of this analysis is to provide evidence for the efficacy of the CytoSorb® adsorber with regard to mortality in various settings.
METHODS
We searched PubMed, Cochrane Library database and the database provided by Cytosorbents™ (01.1.2010-29.5.2022). We considered randomized controlled trials and observational studies with control groups. The longest reported mortality was defined as the primary endpoint. We computed risk ratios and 95%-confidence intervals and used DerSimonian and Lairds random effects model. We analysed all studies combined and divided them into the subgroups: sepsis, cardiopulmonary bypass surgery (CPB), other severe illness, SARS-CoV-2 infection and recovery from cardiac arrest. The meta-analysis was registered in advance (PROSPERO: CRD42022290334).
RESULTS
Of an initial 1295 publications, 34 studies were found eligible, including 1297 patients treated with CytoSorb® and 1314 controls. Cytosorb® intervention did not lower mortality (RR [95%-CI]: all studies 1.07 [0.88; 1.31], sepsis 0.98 [0.74; 1.31], CPB surgery 0.91 [0.64; 1.29], severe illness 0.95 [0.59; 1.55], SARS-CoV-2 1.58 [0.50; 4.94]). In patients with cardiac arrest, we found a significant survival advantage of the untreated controls (1.22 [1.02; 1.46]). We did not find significant differences in ICU length of stay, lactate levels, or IL-6 levels after treatment. Of the eligible 34 studies only 12 were randomized controlled trials. All observational studies showed moderate to serious risk of bias.
INTERPRETATION
To date, there is no evidence for a positive effect of the CytoSorb® adsorber on mortality across a variety of diagnoses that justifies its widespread use in intensive care medicine.
Topics: Cytokines; Adsorption; Thoracic Surgery; Cardiopulmonary Bypass; Postoperative Complications
PubMed: 37259160
DOI: 10.1186/s13054-023-04492-9 -
JAMA Aug 2022The role of ticagrelor with or without aspirin after coronary artery bypass graft surgery remains unclear. (Comparative Study)
Comparative Study Meta-Analysis
IMPORTANCE
The role of ticagrelor with or without aspirin after coronary artery bypass graft surgery remains unclear.
OBJECTIVE
To compare the risks of vein graft failure and bleeding associated with ticagrelor dual antiplatelet therapy (DAPT) or ticagrelor monotherapy vs aspirin among patients undergoing coronary artery bypass graft surgery.
DATA SOURCES
MEDLINE, Embase, and Cochrane Library databases from inception to June 1, 2022, without language restriction.
STUDY SELECTION
Randomized clinical trials (RCTs) comparing the effects of ticagrelor DAPT or ticagrelor monotherapy vs aspirin on saphenous vein graft failure.
DATA EXTRACTION AND SYNTHESIS
Individual patient data provided by each trial were synthesized into a combined data set for independent analysis. Multilevel logistic regression models were used.
MAIN OUTCOMES AND MEASURES
The primary analysis assessed the incidence of saphenous vein graft failure per graft (primary outcome) in RCTs comparing ticagrelor DAPT with aspirin. Secondary outcomes were saphenous vein graft failure per patient and Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events. A supplementary analysis included RCTs comparing ticagrelor monotherapy with aspirin.
RESULTS
A total of 4 RCTs were included in the meta-analysis, involving 1316 patients and 1668 saphenous vein grafts. Of the 871 patients in the primary analysis, 435 received ticagrelor DAPT (median age, 67 years [IQR, 60-72 years]; 65 women [14.9%]; 370 men [85.1%]) and 436 received aspirin (median age, 66 years [IQR, 61-73 years]; 63 women [14.5%]; 373 men [85.5%]). Ticagrelor DAPT was associated with a significantly lower incidence of saphenous vein graft failure (11.2%) per graft than was aspirin (20%; difference, -8.7% [95% CI, -13.5% to -3.9%]; OR, 0.51 [95% CI, 0.35 to 0.74]; P < .001) and was associated with a significantly lower incidence of saphenous vein graft failure per patient (13.2% vs 23.0%, difference, -9.7% [95% CI, -14.9% to -4.4%]; OR, 0.51 [95% CI, 0.35 to 0.74]; P < .001). Ticagrelor DAPT (22.1%) was associated with a significantly higher incidence of BARC type 2, 3, or 5 bleeding events than was aspirin (8.7%; difference, 13.3% [95% CI, 8.6% to 18.0%]; OR, 2.98 [95% CI, 1.99 to 4.47]; P < .001), but not BARC type 3 or 5 bleeding events (1.8% vs 1.8%, difference, 0% [95% CI, -1.8% to 1.8%]; OR, 1.00 [95% CI, 0.37 to 2.69]; P = .99). Compared with aspirin, ticagrelor monotherapy was not significantly associated with saphenous vein graft failure (19.3% vs 21.7%, difference, -2.6% [95% CI, -9.1% to 3.9%]; OR, 0.86 [95% CI, 0.58 to 1.27]; P = .44) or BARC type 2, 3, or 5 bleeding events (8.9% vs 7.3%, difference, 1.7% [95% CI, -2.8% to 6.1%]; OR, 1.25 [95% CI, 0.69 to 2.29]; P = .46).
CONCLUSIONS AND RELEVANCE
Among patients undergoing coronary artery bypass graft surgery, adding ticagrelor to aspirin was associated with a significantly decreased risk of vein graft failure. However, this was accompanied by a significantly increased risk of clinically important bleeding.
Topics: Aged; Aspirin; Coronary Artery Bypass; Female; Graft Occlusion, Vascular; Hemorrhage; Humans; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Saphenous Vein; Ticagrelor; Treatment Outcome
PubMed: 35943473
DOI: 10.1001/jama.2022.11966