Recent studies have demonstrated that transcarotid artery revascularization (TCAR) has comparable outcomes to the surgical gold standard, carotid endarterectomy (CEA). However, few studies have ...analyzed the cost of TCAR, and no study has evaluated its cost-effectiveness. The purpose of this study is to conduct a cost-effectiveness analysis comparing TCAR with CEA for carotid artery stenosis.
We built a Markov microsimulation using transition probabilities and utilities from existing literature for symptomatic patients undergoing TCAR or CEA. Costs were derived from literature then converted to 2019 dollars. The model included six health states with monthly cycle lengths: surgery, death, alive after surgery, alive after myocardial infarction, alive after stroke, and alive after stroke and death. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness.
For symptomatic patients, CEA cost $7821 for 2.85 QALYs, whereas TCAR cost $19154 for 2.92 QALYs, leading to an ICER of $152,229 per QALY gained in the TCAR arm. Sensitivity analysis demonstrated that our model was most sensitive to probability of restenosis, costs of TCAR, and costs of CEA. Probabilistic sensitivity analysis demonstrated TCAR would be considered cost-effective in 49% of iterations.
This study found that, although 5-year costs for TCAR were greater than CEA, TCAR afforded greater QALYs than CEA. TCAR became cost-effective at 6 years of follow-up.
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The risk of periprocedural stroke or death is higher after carotid artery stenting (CAS) than carotid endarterectomy (CEA) for the treatment of symptomatic carotid stenosis. However, long-term ...outcomes have not been sufficiently assessed. We sought to combine individual patient-level data from the four major randomised controlled trials of CAS versus CEA for the treatment of symptomatic carotid stenosis to assess long-term outcomes.
We did a pooled analysis of individual patient-level data, acquired from the four largest randomised controlled trials assessing the relative efficacy of CAS and CEA for treatment of symptomatic carotid stenosis (Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial). The risk of ipsilateral stroke was assessed between 121 days and 1, 3, 5, 7, 9, and 10 years after randomisation. The primary outcome was the composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke up to 10 years after randomisation (postprocedural risk). Analyses were intention-to-treat, with the risk of events calculated using Kaplan-Meier methods and Cox proportional hazards analysis with adjustment for trial.
In the four trials included, 4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years. 21 (0·4%) patients immediately withdrew consent after randomisation and were excluded. Median length of follow-up across the studies ranged from 2·0 to 6·9 years. 129 periprocedural and 55 postprocedural outcome events occurred in patients allocated CEA, and 206 and 57 for those allocated CAS. After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46–0·79) for CEA and 0·64% (0·49–0·83) for CAS. Nonetheless, the periprocedural and postprocedural risks combined favoured CEA, with treatment differences at 1, 3, 5, 7, and 9 years all ranging between 2·8% (1·1–4·4) and 4·1% (2·0–6·3).
Outcomes in the postprocedural period after CAS and CEA were similar, suggesting robust clinical durability for both treatments. Although long-term outcomes (periprocedural and postprocedural risks combined) continue to favour CEA, the similarity of the postprocedural rates suggest that improvements in the periprocedural safety of CAS could provide similar outcomes of the two procedures in the future.
None.
Background and Purpose. This study is aimed at assessing the differences in postoperative stroke, myocardial infarction (MI), and mortality in patients with symptomatic carotid artery stenosis (sCAS) ...treated with early or late carotid endarterectomy (CEA) to determine and compare the safety of different operation timing. Design. A systematic document retrieval of studies published in the past 10 years reporting periprocedural stroke/mortality/MI after carotid endarterectomy (CEA) related to the time between CEA and qualifying neurological symptoms. The application database has “PubMed, EMbase and Cochrane databases.” RevMan5.3 software provided by the Cochrane collaboration was used for meta-analysis. Results. A systematic literature search was conducted in databases. A total of 10 articles were included in this study. They were divided into early CEA and delayed CEA with operation within 48 h, 1 w, or 2 w after onset of neurological symptoms. Incidence of the postoperative stroke in patients undergoing delayed CEA (≥48 h) was significantly higher than patients with delayed CEA (<48 h) (OR=2.14, 95% CI: 1.43-3.21, P=0.0002). The postoperative mortality of patients after delayed CEA (≥48 h) was significantly higher than patients after early CEA (<48 h) (OR=1.35, 95% CI: 1.06-1.71, P=0.02). The risk of postoperative mortality of patients treated with delayed CEA (≥7 d) was significantly higher than patients after the early CEA group (<7 d) (OR=1.69, 95% CI: 1.21-2.32, P=0.001). Conclusion. Early CEA is safe and effective for a part of patients with symptomatic carotid stenosis, but a comprehensive preoperative evaluation of patients with carotid stenosis must be performed.
Carotid endarterectomy may significantly reduce the risk of stroke in people with recently symptomatic, severe carotid artery stenosis. However, there are significant perioperative risks that may be ...reduced by performing the operation under local rather than general anaesthetic. This is an update of a Cochrane Review first published in 1996, and previously updated in 2004 and 2008.
To determine whether carotid endarterectomy under local anaesthetic: (1) reduces the risk of perioperative stroke and death compared with general anaesthetic; (2) reduces the complication rate (other than stroke) following carotid endarterectomy; and (3) is acceptable to patients and surgeons.
We searched the Cochrane Stroke Group Trials Register (September 2013), MEDLINE (1966 to September 2013), EMBASE (1980 to September 2013) and Index to Scientific and Technical Proceedings (ISTP) (1980 to September 2013). We also handsearched relevant journals, and searched the reference lists of articles identified.
Randomised trials comparing the use of local anaesthetic to general anaesthetic for carotid endarterectomy were considered for inclusion.
Three review authors independently assessed trial quality and extracted data. We calculated a pooled Peto odds ratio (OR) and corresponding 95% confidence interval (CI) for the following outcomes that occurred within 30 days of surgery: stroke, death, stroke or death, myocardial infarction, local haemorrhage, cranial nerve injuries, and shunted arteries.
We included 14 randomised trials involving 4596 operations, of which 3526 were from the single largest trial (GALA). In general, reporting of methodology in the included studies was poor. All studies were unable to blind patients and surgical teams to randomised treatment allocation and for most studies the blinding of outcome assessors was unclear. There was no statistically significant difference in the incidence of stroke within 30 days of surgery between the local anaesthesia group and the general anaesthesia group. The incidence of strokes in the local anaesthesia group was 3.2% compared to 3.5% in the general anaesthesia group (Peto OR 0.92, 95% CI 0.67 to 1.28). There was no statistically significant difference in the proportion of patients who had a stroke or died within 30 days of surgery. In the local anaesthesia group 3.6% of patients had a stroke or died compared to 4.2% of patients in the general anaesthesia group (Peto OR 0.85, 95% CI 0.63 to 1.16). There was a non-significant trend towards lower operative mortality with local anaesthetic. In the local anaesthesia group 0.9% of patients died within 30 days of surgery compared to 1.5% of patients in the general anaesthesia group (Peto OR 0.62, 95% CI 0.36 to 1.07). However, neither the GALA trial or the pooled analysis were adequately powered to reliably detect an effect on mortality.
The proportion of patients who had a stroke or died within 30 days of surgery did not differ significantly between the two types of anaesthetic techniques used during carotid endarterectomy. This systematic review provides evidence to suggest that patients and surgeons can choose either anaesthetic technique, depending on the clinical situation and their own preferences.
The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) found a higher risk of stroke after carotid artery stenting and a higher risk of myocardial infarction (MI) after carotid ...endarterectomy.
Cardiac biomarkers and ECGs were performed before and 6 to 8 hours after either procedure and if there was clinical evidence of ischemia. In CREST, MI was defined as biomarker elevation plus either chest pain or ECG evidence of ischemia. An additional category of biomarker elevation with neither chest pain nor ECG abnormality was prespecified (biomarker+ only). Crude mortality and risk-adjusted mortality for MI and biomarker+ only were assessed during follow-up. Among 2502 patients, 14 MIs occurred in carotid artery stenting and 28 MIs in carotid endarterectomy (hazard ratio, 0.50; 95% confidence interval, 0.26 to 0.94; P=0.032) with a median biomarker ratio of 40 times the upper limit of normal. An additional 8 carotid artery stenting and 12 carotid endarterectomy patients had biomarker+ only (hazard ratio, 0.66; 95% confidence interval, 0.27 to 1.61; P=0.36), and their median biomarker ratio was 14 times the upper limit of normal. Compared with patients without biomarker elevation, mortality was higher over 4 years for those with MI (hazard ratio, 3.40; 95% confidence interval, 1.67 to 6.92) or biomarker+ only (hazard ratio, 3.57; 95% confidence interval, 1.46 to 8.68). After adjustment for baseline risk factors, both MI and biomarker+ only remained independently associated with increased mortality.
In patients randomized to carotid endarterectomy versus carotid artery stenting, both MI and biomarker+ only were more common with carotid endarterectomy. Although the levels of biomarker elevation were modest, both events were independently associated with increased future mortality and remain an important consideration in choosing the mode of carotid revascularization or medical therapy.
URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00004732.
Reliable data on the risk of carotid endarterectomy (CEA) in relation to timing of surgery are necessary to plan CEA most effectively, to adjust risks for case-mix, and to understand the mechanisms ...of operative stroke.
We performed a systematic review of all studies published from 1980 to 2008 inclusive that reported the risk of stroke and death due to CEA in relation to the time between presenting symptom and surgery. Pooled estimates of risk by the time since the last event were obtained by Mantel-Haenszel meta-analysis.
Of 494 published operative series, only 47 stratified risk by timing of surgery. The pooled absolute risks of stroke and death after urgent CEA were high in patients with stroke-in-evolution (20.2%, 95% CI 12.0 to 28.4) and in patients with crescendo TIA (11.4%, 6.1 to 16.7), with no trends toward reduced risks in more recent studies. However, there was no significant difference between early and later CEA in neurologically stable patients with recent TIA or nondisabling stroke (<1 week versus > or = 1 week, OR=1.2, 0.9 to 1.7, P=0.17; <2 weeks versus > or = 2 weeks, OR=1.2, 0.9 to 1.6, P=0.13).
Emergency endarterectomy for stroke-in-evolution has a high operative risk, but the risk may be somewhat lower in patients with crescendo TIA. Surgery in the first week in neurologically stable patients with TIA or minor stroke is not associated with a substantially higher operative risk than delayed surgery. More data are required on the risk and benefit of more urgent surgery for TIA and minor stroke and for early versus delayed surgery in patients with major nondisabling stroke.
In Germany, all surgical and endovascular procedures on the carotid bifurcation must be documented in a statutory nationwide quality assurance database. We aimed to analyze the association between ...procedural and perioperative variables and in-hospital stroke or death rates after carotid endarterectomy.
Between 2009 and 2014, overall 142 074 elective carotid endarterectomy procedures for asymptomatic or symptomatic carotid artery stenosis were documented in the database. The primary outcome of this secondary data analysis was in-hospital stroke or death. Major stroke or death, stroke, and death, each until discharge were secondary outcomes. Adjusted relative risks (RRs) were assessed by multivariable multilevel regression analyses.
The primary outcome occurred in 1.8% of patients, with a rate of 1.4% in asymptomatic and 2.5% in symptomatic patients, respectively. In the multivariable analysis, lower risks of stroke or death were independently associated with local anesthesia (versus general anesthesia: RR, 0.85; 95% confidence interval CI, 0.75-0.95), carotid endarterectomy with patch plasty compared with primary closure (RR, 0.71; 95% CI, 0.52-0.97), intraoperative completion studies by duplex ultrasound (RR, 0.74; 95% CI, 0.63-0.88) or angiography (RR, 0.80; 95% CI, 0.71-0.90), and perioperative antiplatelet medication (RR, 0.83; 95% CI, 0.71-0.97). No shunting and a short cross-clamp time were also associated with lower risks; however, these are suspected to be confounded.
Local anesthesia, patch plasty compared with primary closure, intraoperative completion studies by duplex ultrasound or angiography, and perioperative antiplatelet medication were independently associated with lower in-hospital stroke or death rates after carotid endarterectomy.
Objective This study compared, at a national level, trends in utilization, mortality, and stroke after carotid angioplasty and stenting (CAS) and carotid endarterectomy (CEA) from 2005 to 2007. ...Methods The Nationwide Inpatient Sample (NIS) was queried for patient discharges with International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) codes for CAS and CEA. The primary outcomes were in-hospital mortality, stroke, hospital charges, and discharge disposition. Subgroup analyses were performed to evaluate these outcomes by neurologic presentation using χ2 and multivariable logistic regression. Results Of the 404,256 discharges for carotid revascularization, CAS utilization was 66% higher in 2006 than in 2005 (9.3% vs 14%, P = .0004). Crude mortality, stroke, and median charges remained higher for CAS than for CEA; discharge to home was more common after CEA. Results improved from 2005 to 2007. By logistic regression of the total cohort from 2005 to 2006, CAS was independently predictive of mortality (odds ratio OR, 1.47; 95% confidence interval CI, 1.08-2.00; P < .0001). Independent predictors of stroke included CAS (OR, 1.43; 95% CI, 1.18-1.73; P < .0001) and symptomatic disease (OR, 2.4; 95% CI, 2.06-2.93; P < .0001). Among subgroups based on neurological presentation, regression showed that CAS significantly increased the odds of stroke in asymptomatic patients (OR, 1.6; 95% CI, 1.2-2.0; P = .0003). Among symptomatic patients, CAS increased the odds of in-hospital death (OR, 3.0; 95% CI, 1.7-5.1, P < .0001) and trended toward significance for stroke (OR, 1.7; 95% CI, 1.0-2.8; P = .0569). Conclusion Utilization of CAS has increased from the years 2005 to 2007 with some improvements in the outcome. Despite improvements in outcome, resource utilization remains significantly higher for CAS than CEA.
Temporary interruption of cerebral blood flow during carotid endarterectomy can be avoided by using a shunt across the clamped section of the carotid artery. This may improve outcome. This is an ...update of a Cochrane review originally published in 1996 and previously updated in 2009.
To assess the effect of routine versus selective or no shunting during carotid endarterectomy, and to assess the best method for selecting people for shunting.
We searched the Cochrane Stroke Group Trials Register (last searched August 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2013, Issue 8), MEDLINE (1966 to August 2013), EMBASE (1980 to August 2013) and Index to Scientific and Technical Proceedings (1980 to August 2013). We handsearched journals and conference proceedings, checked reference lists, and contacted experts in the field.
Randomised and quasi-randomised trials of routine shunting compared with no shunting or selective shunting, and trials that compared different shunting policies in people undergoing carotid endarterectomy.
Three review authors independently performed the searches and applied the inclusion criteria. For this update, we identified two new relevant randomised controlled trials.
We included six trials involving 1270 participants in the review: three trials involving 686 participants compared routine shunting with no shunting, one trial involving 200 participants compared routine shunting with selective shunting, one trial involving 253 participants compared selective shunting with and without near-infrared refractory spectroscopy monitoring, and the other trial involving 131 participants compared shunting with a combination of electroencephalographic and carotid pressure measurement with shunting by carotid pressure measurement alone. In general, reporting of methodology in the included studies was poor. For most studies, the blinding of outcome assessors and the report of prespecified outcomes were unclear. For routine versus no shunting, there was no significant difference in the rate of all stroke, ipsilateral stroke or death up to 30 days after surgery, although data were limited. No significant difference was found between the groups in terms of postoperative neurological deficit between selective shunting with and without near-infrared refractory spectroscopy monitoring, However, this analysis was inadequately powered to reliably detect the effect. There was no significant difference between the risk of ipsilateral stroke in participants selected for shunting with the combination of electroencephalographic and carotid pressure assessment compared with pressure assessment alone, although again the data were limited.
This review concluded that the data available were too limited to either support or refute the use of routine or selective shunting in carotid endarterectomy. Large scale randomised trials of routine shunting versus selective shunting are required. No method of monitoring in selective shunting has been shown to produce better outcomes.
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