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Plexus anesthesia versus general anesthesia in patients for carotid endarterectomy with patch angioplasty: Protocol for a systematic review with meta-analyses and Trial Sequential Analysis of randomized clinical trials.

ABSTRACT: Introduction:Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of plexus anesthesia or general anesthesia in traditional carotid endarterectomy is, to date, not unequivocally proven to be superior to one other. A systematic review is needed for evaluation of benefits and harms to determine which technique, plexus anesthesia or general anesthesia is more effective for traditional carotid endarterectomy in patients with symptomatic carotid stenosis. Methods and outcomes:The review will be conducted according to this protocol following the recommendations of the 'Cochrane Handbook for Systematic Reviews' and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomized Clinical Trials comparing plexus anesthesia versus general anesthesia in traditional carotid endarterectomy will be included. Primary outcomes will be postoperative death and/ or stroke (<30 days) and serious adverse events. Secondary outcomes will be non-serious adverse events.We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. We will use Trial Sequential Analysis to assist the evaluation of imprecision in Grading of Recommendations Assessment, Development and Evaluation. However, if pooled point-estimates of all trials are similar to pooled point-estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the Trial Sequential Analysis adjusted confidence interval precision of the estimate achieved in all trials as the result of our meta-analyses. Ethics and dissemination:The proposed systematic review will collect and analyze secondary data from already performed studies therefore ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.

SUBMITTER: Marsman MS

PROVIDER: S-EPMC6997585 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Plexus anesthesia versus general anesthesia in patients for carotid endarterectomy with patch angioplasty: Protocol for a systematic review with meta-analyses and Trial Sequential Analysis of randomized clinical trials.

Marsman M S MS Wetterslev J J Keus F F van Aalst D D van Rooij F G FG Heyligers J M M JMM Moll F L FL Jahrome A Kh AK Vriens P W H E PWHE Koning G G GG

International journal of surgery protocols 20200117

<h4>Introduction</h4>Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of plexus anesthesia or general anesthesia in traditional carotid endarterectomy is, to date, not unequivocally proven to be superior to one other. A systematic review is needed for evaluation of benefits and harms to determine which technique, plexus anesthesia or general anesthesia is more effective for traditiona ...[more]

PMID: 32025593

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Project description:IntroductionTraditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of patch angioplasty to restore the arterial wall after longitudinal endarterectomy is, to date, not unequivocally proven to be superior to eversion technique. A systematic review is needed for evaluation of benefits and harms of the eversion technique versus the traditional endarterectomy with patch angioplasty in patients with symptomatic carotid stenosis.Methods and outcomesThe review will be conducted according to this protocol following the recommendations of the 'Cochrane Handbook for Systematic Reviews' and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomised clinical trials comparing eversion technique versus endarterectomy with patch angioplasty in patients with a symptomatic stenosis of the internal carotid artery will be included. Primary outcomes are all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes are 30-day stroke and mortality rate, symptomatic arterial restenosis or occlusion and non-serious adverse events. The databases Cochrane Central Register of Controlled Trials, PubMed/MEDLINE and EMBASE will be searched (November 2019). We will primarily base our conclusions on meta-analyses of trials with overall low-risk of bias. We will use trial sequential analysis to assist the evaluation of imprecision in Grading of Recommendations, Assessment, Development and Evaluation. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the trial sequential analysis adjusted precision of the estimate achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse data from published studies, therefore, ethical approval is not required. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentation at conferences.Prospero registration numberCRD42019119361.

Project description:BackgroundPatch angioplasty in conventional carotid endarterectomy is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke compared with primary closure. A systematic review of randomized clinical trials is needed to compare outcomes (benefits and harms) of both techniques.MethodsSearches (CENTRAL, PubMed/MEDLINE, EMBASE, and other databases) were last updated 3rd of January 2021. We included randomized clinical trials comparing carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall in patients with a symptomatic and significant (> 50%) carotid stenosis. Primary outcomes are defined as all-cause mortality and serious adverse events.ResultsWe included 12 randomized clinical trials including 2187 participants who underwent 2335 operations for carotid stenosis comparing carotid endarterectomy with patch closure (1280 operations) versus carotid endarterectomy with primary closure (1055 operations). Meta-analysis comparing carotid endarterectomy with patch angioplasty versus carotid endarterectomy with primary closure may potentially decrease the number of patients with all-cause mortality (RR 0.53; 95% CI 0.26 to 1.08; p = 0.08, best-case scenario for patch), serious adverse events (RR 0.73; 95% CI 0.56 to 0.96; p = 0.02, best-case scenario for patch), and the number of restenosis (RR 0.41; 95% CI 0.23 to 0.71; p < 0.01). Trial sequential analysis demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All the patient-relevant outcomes were at low certainty of evidence according to The Grading of Recommendations Assessment, Development, and Evaluation.ConclusionsThis systematic review showed no conclusive evidence of a difference between carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall on all-cause mortality, < 30 days mortality, < 30 days stroke, or any other serious adverse events. These conclusions are based on data from 15 to 35 years ago, obtained in trials with very low certainty according to GRADE, and should be interpreted cautiously. Therefore, we suggest conducting new randomized clinical trials patch angioplasty versus primary closure in carotid endarterectomy in symptomatic patients with an internal carotid artery stenosis of 50% or more. Such trials ought to be designed according to the Standard Protocol Items: Recommendations for Interventional Trials statement (Chan et al., Ann Intern Med 1:200-7, 2013) and reported according to the Consolidated Standards of Reporting Trials statement (Schulz et al., 7, 2010). Until conclusive evidence is obtained, the standard of care according to guidelines should not be abandoned.Systematic review registrationPROSPERO CRD42014013416 . Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419 .

Project description:IntroductionUse of patch angioplasty in carotid endarterectomy (CEA) is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke. The objective is to conduct a systematic review with meta-analysis and trial sequential analysis as well as Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments comparing the benefits and harms of CEA with primary closure of the arterial wall versus CEA with patch angioplasty in patients with a symptomatic and significant carotid stenosis.Methods and analysisThe review shall be conducted according to this published protocol following the recommendations of the 'Cochrane' and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomised clinical trials comparing CEA with primary closure of the arterial wall versus CEA with patch angioplasty (regardless of used patch materials) in human adults with a symptomatic and significant carotid stenosis will be included. Primary outcomes are all-cause mortality at maximal follow-up, health-related quality of life and serious adverse events. Secondary outcomes are symptomatic or asymptomatic arterial occlusion or restenosis, and non-serious adverse events. We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the precision achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse secondary data from published studies therefor ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.Prospero registration numberCRD42014013416.

Project description:Background and purposeCarotid endarterectomy (CEA) with patch angioplasty produces greater results than with primary closure; however, there remains uncertainty on the optimal patch material in CEA. A systematic review of randomized controlled trials (RCTs) was performed to evaluate the effect of angioplasty using venous patch versus synthetic patch material, and Dacron patch versus polytetrafluoroethelene (PTFE) patch material during CEA.MethodsA multiple electronic health database screening was performed including the Cochrane library, Pubmed, Ovid, EMBASE and Google Scholar on all randomized controlled trials (RCTs) published before November 2012 that compared the outcomes of patients undergoing CEA with venous patch versus synthetic patch. RCTs were included if they compared carotid patch angioplasty with autologus venous patch versus synthetic patch material, or compared one type of synthetic patch with another.ResultsThirteen RCTs were identified. Ten trials, involving 1946 CEAs, compared venous patch with synthetic patch materials. Two trials, involving 400 CEAs in 380 patients, compared Dacron patch with PTFE patch. The hemostasis time in CEA with PTFE patch was significantly longer than with venous patch (P<0.0001), and longer than with Dacron patch (P<0.0001). There was no significant difference of mortality rate, stroke rate, restenosis, and operative time in CEA with venous patch versus synthetic patch material, or in CEA with Dacron patch versus PTFE patch (all P>0.05). One RCT of 95 CEAs in 92 patients compared bovine pericardium with Dacron patch, and demonstrated a statistically significant decrease in intraoperative suture line bleeding with bovine pericardium compared with Dacron patch (P<0.001).ConclusionsThe hemostasis time in CEA with PTFE patch was longer than with venous patch or Dacron patch. The overall perioperative and long-term mortality rate, stroke rate, restenosis, and operative time were similar when using venous patch versus synthetic patch material or Dacron patch versus PTFE patch material during CEA. More data are required to clarify differences between different patch materials.

Project description:Background: Patients undergoing carotid endarterectomy (CEA) for severe carotid stenosis are vulnerable to postoperative delirium, a complication frequently associated with poor outcome. This study investigated the impact of processed electroencephalogram (EEG)-guided anesthesia management on the incidence of postoperative delirium in patients undergoing CEA. Methods: This single-center, prospective, randomized clinical trial on 255 patients receiving CEA under general anesthesia compared the outcomes of patient state index (PSI) monitoring [SEDLine Brain Function Monitor (Masimo, Inc, Irvine, CA)] (standard group, n = 128) with PSI combined with density spectral array(DSA) -guided monitoring (intervention group, n = 127) to reduce the risk of intraoperative EEG burst suppression. All patients were monitored by continuous transcranial Doppler ultrasound (TCD) and near-infrared spectroscopy (NIRS) to avoid perioperative cerebral hypoperfusion or hyperperfusion. According to the surgical process, EEG suppression time was calculated separately for three stages: S1 (from anesthesia induction to carotid artery clamping), S2 (from clamping to declamping), and S3 (from declamping to the end of surgery). The primary outcome was incidence of postoperative delirium according to the Confusion Assessment Method algorithm during the first 3 days post-surgery, and secondary outcomes were other neurologic complications and length of hospital stay. Results: There were no episodes of cerebral hypoperfusion or hyperperfusion according to TCD and NIRS monitoring in either group during surgery. The incidence of postoperative delirium within 3 days post-surgery was significantly lower in the intervention group than the standard group (7.87 vs. 28.91%, P < 0.01). In the intervention group, the total EEG suppression time and the EEG suppression time during S2 and S3 were shorter (Total, 0 "0" vs. 0 "1.17" min, P = 0.04; S2, 0 "0" vs. 0 "0.1" min, P < 0.01; S3, 0 "0" vs. 0 "0" min, P = 0.02). There were no group differences in incidence of neurologic complications and length of postoperative hospital stay. Conclusion: Processed electroencephalogram-guided general anesthesia management, consisting of PSI combined with DSA monitoring, can significantly reduce the risk of postoperative delirium in patients undergoing CEA. Patients, especially those exhibiting hemodynamic fluctuations or receiving surgical procedures that disrupt cerebral perfusion, may benefit from the monitoring of multiple EEG parameters during surgery. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03622515.

Dataset Information

Plexus anesthesia versus general anesthesia in patients for carotid endarterectomy with patch angioplasty: Protocol for a systematic review with meta-analyses and Trial Sequential Analysis of randomized clinical trials.

Publications

Plexus anesthesia versus general anesthesia in patients for carotid endarterectomy with patch angioplasty: Protocol for a systematic review with meta-analyses and Trial Sequential Analysis of randomized clinical trials.

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