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Journal of Vascular Surgery Jan 2022Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The... (Meta-Analysis)
Meta-Analysis
Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for the treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were reported. Since the 2011 guidelines, several studies and a few systematic reviews comparing CEA and CAS have been reported, and the role of medical management has been reemphasized. In the present publication, we have updated and expanded on the 2011 guidelines with specific emphasis on five areas: (1) is CEA recommended over maximal medical therapy for low-risk patients; (2) is CEA recommended over transfemoral CAS for low surgical risk patients with symptomatic carotid artery stenosis of >50%; (3) the timing of carotid intervention for patients presenting with acute stroke; (4) screening for carotid artery stenosis in asymptomatic patients; and (5) the optimal sequence of intervention for patients with combined carotid and coronary artery disease. A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (grades of recommendation assessment, development, and evaluation) approach, as was used for other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low-risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin scale score, 0-2), carotid revascularization is considered appropriate for symptomatic patients with >50% stenosis and should be performed as soon as the patient is neurologically stable after 48 hours but definitely <14 days after symptom onset. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients with an increased risk of carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. For patients with symptomatic carotid stenosis of 50% to 99%, who require both CEA and coronary artery bypass grafting, we suggest CEA before, or concomitant with, coronary artery bypass grafting to potentially reduce the risk of stroke and stroke/death. The sequencing of the intervention depends on the clinical presentation and institutional experience.
Topics: Cardiovascular Agents; Carotid Stenosis; Clinical Decision-Making; Consensus; Endarterectomy, Carotid; Endovascular Procedures; Evidence-Based Medicine; Humans; Risk Assessment; Risk Factors; Treatment Outcome
PubMed: 34153348
DOI: 10.1016/j.jvs.2021.04.073 -
Medicine Apr 2021Prolonged hospitalization and immobility of critical care patients elevate the risk of long-term physical and cognitive impairments. However, the therapeutic effects of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Prolonged hospitalization and immobility of critical care patients elevate the risk of long-term physical and cognitive impairments. However, the therapeutic effects of early mobilization have been difficult to interpret due to variations in study populations, interventions, and outcome measures. We conducted a meta-analysis to assess the effects of early mobilization therapy on cardiac surgery patients in the intensive care unit (ICU).
METHODS
PubMed, Excerpta Medica database (EMBASE), Cumulative Index of Nursing and Allied Health Literature (CINAHL), Physiotherapy Evidence Database (PEDro), and the Cochrane Library were comprehensively searched from their inception to September 2018. Randomized controlled trials were included if patients were adults (≥18 years) admitted to any ICU for cardiac surgery due to cardiovascular disease and who were treated with experimental physiotherapy initiated in the ICU (pre, post, or peri-operative). Data were extracted by 2 reviewers independently using a pre-constructed data extraction form. Length of ICU and hospital stay was evaluated as the primary outcomes. Physical function and adverse events were assessed as the secondary outcomes. Review Manager 5.3 (RevMan 5.3) was used for statistical analysis. For all dichotomous variables, relative risks or odds ratios with 95% confidence intervals (CI) were presented. For all continuous variables, mean differences (MDs) or standard MDs with 95% CIs were calculated.
RESULTS
The 5 studies with a total of 652 patients were included in the data synthesis final meta-analysis. While a slight favorable effect was detected in 3 out of the 5 studies, the overall effects were not significant, even after adjusting for heterogeneity.
CONCLUSIONS
This population-specific evaluation of the efficacy of early mobilization to reduce hospitalization duration suggests that intervention may not universally justify the labor barriers and resource costs in patients undergoing non-emergency cardiac surgery.
PROSPERO RESEARCH REGISTRATION IDENTIFYING NUMBER
CRD42019135338.
Topics: Cardiac Surgical Procedures; Early Ambulation; Humans; Intensive Care Units; Length of Stay; Physical Functional Performance; Physical Therapy Modalities; Randomized Controlled Trials as Topic
PubMed: 33847630
DOI: 10.1097/MD.0000000000025314 -
International Journal of Environmental... Sep 2020The objective effects of early mobilization on physical function in patients after cardiac surgery remain unknown. The purpose of the present study was to clarify the... (Meta-Analysis)
Meta-Analysis
The objective effects of early mobilization on physical function in patients after cardiac surgery remain unknown. The purpose of the present study was to clarify the effects of early mobilization on physical function in patients after cardiac surgery through meta-analysis. Four electronic databases were searched on 2 August 2019. We used search keywords related to "early mobilization", "cardiac surgery", and "randomized controlled trials". All randomized controlled trials conducting early mobilization after cardiac surgery were included. We defined early mobilization as the application of physical activity within the first five postoperative days. Citations and data extraction were independently screened in duplicate by two authors. The meta-analysis was conducted using random-effects modeling with EZR software. The primary outcome was the distance walked during the six-minute walking test at hospital discharge. Six randomized controlled trials comprising 391 patients were included following screening of 591 studies. All studies included coronary artery bypass grafting as the cardiac surgery conducted. Early mobilization started on postoperative days 1-2 and was conducting twice daily. Early mobilization showed a trend of being combined with respiratory exercise or psychoeducation. The meta-analysis showed that the distance walked during the 6-min walking test improved by 54 m (95% confidence interval, 31.1-76.9; I = 52%) at hospital discharge. The present study suggested that early mobilization after cardiac surgery may improve physical function at discharge.
Topics: Cardiac Surgical Procedures; Coronary Artery Bypass; Early Ambulation; Exercise; Female; Humans; Male
PubMed: 32998202
DOI: 10.3390/ijerph17197091 -
The Cochrane Database of Systematic... May 2021The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery.
OBJECTIVES
To assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. We considered CR programmes consisting of exercise training with or without another intervention (such as an intervention with a psycho-educational component).
SEARCH METHODS
We searched the Cochrane Central Register of Clinical Trials (CENTRAL), in the Cochrane Library; MEDLINE (Ovid); Embase (Ovid); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO); PsycINFO (Ovid); Latin American Caribbean Health Sciences Literature (LILACS; Bireme); and Conference Proceedings Citation Index-Science (CPCI-S) on the Web of Science (Clarivate Analytics) on 10 January 2020. We searched for ongoing trials from ClinicalTrials.gov, Clinical-trials.com, and the World Health Organization International Clinical Trials Registry Platform on 15 May 2020.
SELECTION CRITERIA
We included randomised controlled trials that compared exercise-based CR interventions with no exercise training. Trial participants comprised adults aged 18 years or older who had undergone heart valve surgery for heart valve disease (from any cause) and had received heart valve replacement or heart valve repair. Both percutaneous and surgical procedures were included.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data. We assessed the risk of systematic errors ('bias') by evaluating risk domains using the 'Risk of bias' (RoB2) tool. We assessed clinical and statistical heterogeneity. We performed meta-analyses using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence for primary outcomes (all-cause mortality, all-cause hospitalisation, and health-related quality of life).
MAIN RESULTS
We included six trials with a total of 364 participants who have had open or percutaneous heart valve surgery. For this updated review, we identified four additional trials (216 participants). One trial had an overall low risk of bias, and we classified the remaining five trials as having some concerns. Follow-up ranged across included trials from 3 to 24 months. Based on data at longest follow-up, a total of nine participants died: 4 CR versus 5 control (relative risk (RR) 0.83, 95% confidence interval (CI) 0.26 to 2.68; 2 trials, 131 participants; GRADE quality of evidence very low). No trials reported on cardiovascular mortality. One trial reported one cardiac-related hospitalisation in the CR group and none in the control group (RR 2.72, 95% CI 0.11 to 65.56; 1 trial, 122 participants; GRADE quality of evidence very low). We are uncertain about health-related quality of life at completion of the intervention in CR compared to control (Short Form (SF)-12/36 mental component: mean difference (MD) 1.28, 95% CI -1.60 to 4.16; 2 trials, 150 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD 2.99, 95% CI -5.24 to 11.21; 2 trials, 150 participants; GRADE quality of evidence very low), or at longest follow-up (SF-12/36 mental component: MD -1.45, 95% CI -4.70 to 1.80; 2 trials, 139 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD -0.87, 95% CI -3.57 to 1.83; 2 trials, 139 participants; GRADE quality of evidence very low). AUTHORS' CONCLUSIONS: Due to lack of evidence and the very low quality of available evidence, this updated review is uncertain about the impact of exercise-CR in this population in terms of mortality, hospitalisation, and health-related quality of life. High-quality (low risk of bias) evidence on the impact of CR is needed to inform clinical guidelines and routine practice.
Topics: Adult; Aortic Valve; Cardiac Rehabilitation; Exercise; Exercise Tolerance; Female; Heart Valve Prosthesis Implantation; Humans; Male; Middle Aged; Mitral Valve; Physical Conditioning, Human; Randomized Controlled Trials as Topic; Resistance Training; Return to Work; Time Factors
PubMed: 33962483
DOI: 10.1002/14651858.CD010876.pub3 -
Lancet (London, England) Mar 2018Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease.... (Comparative Study)
Comparative Study Meta-Analysis Review
Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data.
BACKGROUND
Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies.
METHODS
We did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics.
FINDINGS
We included 11 randomised trials involving 11 518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06-1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09-1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19-1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86-1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87-1·33; p=0·52), regardless of diabetes status and SYNTAX score.
INTERPRETATION
CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies.
FUNDING
None.
Topics: Coronary Artery Bypass; Coronary Artery Disease; Humans; Percutaneous Coronary Intervention; Stents; Survival Rate; Treatment Outcome
PubMed: 29478841
DOI: 10.1016/S0140-6736(18)30423-9 -
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 -
Journal of the American Heart... Jan 2023Background The Ross operation appears to restore normal survival in young and middle-aged adults with aortic valve disease. However, there are limited data comparing it... (Meta-Analysis)
Meta-Analysis Review
Background The Ross operation appears to restore normal survival in young and middle-aged adults with aortic valve disease. However, there are limited data comparing it with conventional aortic valve replacement. Herein, we compared outcomes of the Ross procedure with mechanical and bioprosthetic aortic valve replacement (M-AVR and B-AVR, respectively). Methods and Results MEDLINE and EMBASE were searched through March 2022 to identify randomized controlled trials and propensity score-matched studies that investigated outcomes of patients aged ≥16 years undergoing the Ross procedure, M-AVR, or B-AVR. The systematic literature search identified 2 randomized controlled trials and 8 propensity score-matched studies involving a total of 4812 patients (Ross: n=1991; M-AVR: n=2019; and B-AVR: n=802). All-cause mortality was significantly lower in the Ross procedure group compared with M-AVR (hazard ratio [HR] [95% CI], 0.58 [0.35-0.97]; =0.035) and B-AVR (HR [95% CI], 0.32 [0.18-0.59]; <0.001) groups. The reintervention rate was lower after the Ross procedure and M-AVR compared with B-AVR, whereas it was higher after the Ross procedure compared with M-AVR. Major bleeding rate was lower after the Ross procedure compared with M-AVR. Long-term stroke rate was lower following the Ross procedure compared with M-AVR and B-AVR. The rate of endocarditis was also lower after the Ross procedure compared with B-AVR. Conclusions Improved long-term outcomes of the Ross procedure are demonstrated compared with conventional M-AVR and B-AVR options. These results highlight a need to enhance the recognition of the Ross procedure and revisit current guidelines on the optimal valve substitute for young and middle-aged patients.
Topics: Adult; Humans; Middle Aged; Aortic Valve; Aortic Valve Insufficiency; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Network Meta-Analysis; Retrospective Studies; Treatment Outcome; Adolescent; Young Adult
PubMed: 36565200
DOI: 10.1161/JAHA.122.027715 -
European Journal of Vascular and... Mar 2020The objective was to investigate whether endovascular aneurysm repair (EVAR) has better peri-operative and late clinical outcomes than open repair for non-ruptured... (Meta-Analysis)
Meta-Analysis
Editor's Choice - Endovascular vs. Open Repair for Abdominal Aortic Aneurysm: Systematic Review and Meta-analysis of Updated Peri-operative and Long Term Data of Randomised Controlled Trials.
OBJECTIVE
The objective was to investigate whether endovascular aneurysm repair (EVAR) has better peri-operative and late clinical outcomes than open repair for non-ruptured abdominal aortic aneurysm.
METHODS
Electronic bibliographic sources (MEDLINE, EMBASE, and CENTRAL) were searched up to July 2019 using a combination of thesaurus and free text terms to identify randomised controlled trials (RCTs) comparing the outcomes of EVAR and open repair. The systematic review was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) or risk difference (RD) and 95% confidence interval (CI). A time to event data meta-analysis was performed using the inverse variance method and the results were reported as summary hazard ratio (HR) and 95% CI.
RESULTS
Seven RCTs reporting a total of 2 983 patients were included in quantitative synthesis. Three of the trials reported long term follow up that extended to 15.8 years, 14.2 years, and 12.5 years. Meta-analysis found significantly lower odds of 30 day (OR, 0.36; 95% CI 0.20-0.66) and in hospital mortality with EVAR (RD -0.03; 95% CI -0.04 to -0.02). Meta-analysis of the three trials reporting long term follow up found no significant difference in all cause mortality at any time between EVAR and open repair (HR 1.02; 95% CI 0.93-1.13; p = .62). The hazard of all cause (HR 0.62; 95% CI 0.42-0.91) and aneurysm related death within six months (HR 0.42; 95% CI 0.24-0.75) was significantly lower in patients who underwent EVAR, but with further follow up, the pooled hazard estimate moved in favour of open surgery; in the long term (>8 years) the hazard of aneurysm related mortality was significantly higher after EVAR (HR 5.12; 95% CI 1.59-16.44). The risk of secondary intervention (HR 2.13; 95% CI 1.69-2.68), aneurysm rupture (OR, 5.08; 95% CI 1.11-23.31), and death due to rupture (OR, 3.57; 95% CI 1.87-6.80) was significantly higher after EVAR, but the risk of death due to cancer was not significantly different between EVAR and open repair (OR, 1.03; 95% CI 0.84-1.25).
CONCLUSION
Compared with open surgery, EVAR results in a better outcome during the first six months but carries an increased risk of aneurysm related mortality after eight years.
Topics: Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Postoperative Complications; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome
PubMed: 31899100
DOI: 10.1016/j.ejvs.2019.11.030 -
Reviews in Cardiovascular Medicine Jun 2020Infective endocarditis (IE) represents one of the most challenging clinical entities, requiring a multidisciplinary approach. The increasing number of surgical and... (Meta-Analysis)
Meta-Analysis
Infective endocarditis (IE) represents one of the most challenging clinical entities, requiring a multidisciplinary approach. The increasing number of surgical and transcatheter heart valves replacements performed annually lead to a higher incidence of prosthetic valve endocarditis. Transcatheter aortic valve implantation (TAVI) brought a new alternative for the treatment of aortic stenosis and a new subgroup of IE with its features. We aimed to compare the incidence of IE in TAVI and surgical valve replacement (SAVR) to identify risk factors for TAVI-IE, evaluate the possible impact on mortality, and clarify the best treatment strategies. A digital scan in PubMed and SCOPUS databases was performed. 68 publications were selected to perform a meta-analysis and systematic review on epidemiology, risk factors, and mortality predictors in TAVI-IE. No significant difference in IE rate was noted between patients with TAVI and those with SAVR for in-hospital, early, mid-term and late IE. Male gender, intubation, new pacemaker implantation IE and CKD were correlated with TAVI-IE. Surgical treatment was performed in 22.3% of cases. Overall mortality for the pooled cohort was 38.3%. In a multivariate logistic regression model, surgical treatment and self-expandable device were linked to lower mortality in TAVI-IE. Even if the invasive procedure can trigger bacteremia, exposing the TAVI valve to future infection, no significant difference in IE rate was noted in our analysis between patients with TAVI and those with SAVR for in-hospital, early, mid-term and late IE. Surgical treatment of TAVI-IE can be a viable option in patients with a prohibitive risk score.
Topics: Aged; Aged, 80 and over; Endocarditis; Female; Heart Valve Prosthesis; Humans; Incidence; Male; Middle Aged; Prognosis; Prosthesis-Related Infections; Risk Assessment; Risk Factors; Transcatheter Aortic Valve Replacement
PubMed: 32706214
DOI: 10.31083/j.rcm.2020.02.68 -
European Journal of Vascular and... Mar 2020
Topics: Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Consensus; Endovascular Procedures; Evidence-Based Medicine; Humans; Prosthesis-Related Infections; Risk Factors; Treatment Outcome
PubMed: 32035742
DOI: 10.1016/j.ejvs.2019.10.016