The Efficacy of Transcarotid Artery Revascularization With Flow Reversal System Compared to Carotid Endarterectomy: A Systematic Review and Meta-Analysis.
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SUBMITTER: Gao J
PROVIDER: S-EPMC8640218 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Objectives Transcarotid arterial revascularization (TCAR) is associated with a lower risk of stroke or death than transfemoral carotid artery stenting (TF-CAS). TCAR infers a lower risk of cranial nerve injury and a similar risk of myocardial infarction (MI) than carotid endarterectomy (CEA). There have been no comparative studies on the cost of TCAR, TF-CAS, and CEA, which may have important implications for institutional support for the new modality to address carotid artery stenosis. Our aim was to compare the estimated cost profiles of TCAR, TF-CAS, and CEA. Methods A review was performed on Medicare patients who underwent TCAR, TF-CAS, or CEA between January 1, 2020, and December 31, 2020. Demographics, comorbidities, operative details, and postoperative complications were reviewed. Acute stroke presentations and elective procedures were included. Cost data were obtained from the hospital's finance department. Quantitative variables were compared using analysis of variance, and categorical variables were compared using the chi-square analysis. Results In total, 21 TCAR, 97 TF-CAS, and 26 CEA patients were initially identified. After removing the non-Medicare patients, 17 TCAR, 57 TF-CAS, and 13 CEA patients were included in the analysis. In-hospital stroke, MI, and mortality included three deaths in TF-CAS patients. At 30 days, the stroke rates for TCAR, TF-CAS, and CEA groups were 0%, 1.8%, and 0%, respectively. The payments for TCAR, TF-CAS, and CEA were $15,400 ± 2,100, $23,400 ± 11,800 and $14,300 ± 5,700 (p=0.001), respectively. The estimated costs for TCAR, TF-CAS, and CEA were $10,500 ± 3,300, $13,800 ± 14,300, and $12,400 ± 6,000 (p=0.575), respectively. The profit margins for TCAR, TF-CAS, and CEA were $5,100 ± 3,100, $9,600 ± 12,100, and $1,900 ± 6,400 (p=0.032), respectively. There was no significant difference in American Society of Anesthesiologists (ASA) scores (p=0.635) or age (p=0.485) among the three groups. The length of hospital stay was not significantly different (p=0.107). The TF-CAS maintained the highest profit margin (p<0.001) when matched for the same diagnosis-related code (without complications or comorbidities). Urgency classification within the TF-CAS group included 45 elective, four urgent, and eight emergent cases. The profit margin was significantly higher for the elective group than for the emergent group (p=0.002) but not different for elective versus urgent (p=0.503) or urgent versus emergent (p=0.102). All patients who underwent TCAR and CEA were elective. Conclusion The hospital reimbursement and profit margins are higher for TF-CAS than for TCAR. With the increasing data now demonstrating similar outcomes with TF-CAS and CEA, further research is required to examine the long-term cost-effectiveness of TCAR and how this will compare to TF-CAS.
| S-EPMC8957897 | biostudies-literature
Project description:ImportanceA transcarotid artery revascularization (TCAR) device was approved by the US Food and Drug Administration in 2015 for carotid revascularization in patients at high risk for stroke, cranial nerve injury, or major cardiac event. It is unclear how the introduction of TCAR has changed the use of carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS).ObjectiveTo quantify the temporal changes in the operative approach to carotid revascularization (CEA vs TFCAS vs TCAR), and to identify patient and disease characteristics commonly associated with each approach.Design, setting, and participantsThis retrospective cohort study obtained data from the Vascular Quality Initiative database from January 1, 2015, to December 31, 2019. Patients with carotid artery stenosis who underwent CEA, TFCAS, or TCAR were included. Data were analyzed from January to April 2022.ExposuresMonth and year of surgery as well as patient risk status.Main outcomes and measuresNumber and proportion of carotid revascularization procedures by operative approach.ResultsA total of 108 676 patients (mean [SD] age 56.6 [12.5] years; 66 684 men [61.4%]) were included in the analysis. The most common operative approach overall was CEA (n = 81 508 [75.0%]), followed by TFCAS (n = 15 578 [14.3%]) and TCAR (n = 11 590 [10.7%]). The number of procedures increased over the study period (16 754 in 2015 vs 27 269 in 2019; P < .001). In 2015, CEA was used in 84.9% of all cases, followed by TFCAS (14.4%) and TCAR (0.8%). In 2019, CEA was used in 64.8% of cases, followed by TCAR (21.9%) and TFCAS (13.3%). The proportional use of CEA decreased by 5.0% (95% CI, -7.4% to -2.6%) per year, and TCAR use increased by 5.3% (95% CI, 2.3%-8.3%) per year. Among patients at high risk, the change was greater: CEA use decreased by 7.8% (95% CI, -11.9% to -3.8%) per year, TFCAS decreased by 4.8% (95% CI, -9.5% to -0.14%) per year, and TCAR increased by 12.6% (95% CI, 7.1%-18.1%) per year. Multinomial logistic regression showed that patient risk status was the most important characteristic associated with TCAR compared with CEA (relative risk ratio, 36.10; 95% CI, 29.24-44.66; P < .001) and TFCAS (relative risk ratio, 14.10; 95% CI, 11.86-16.66; P < .001). Linear regression revealed no association between year of surgery and in-hospital myocardial infarction, stroke, or mortality.Conclusions and relevanceResults of this study indicate that TCAR has become the dominant carotid revascularization approach, surpassing TFCAS and CEA in patients at high risk for stroke, cranial nerve injury, or cardiovascular events. Patient high-risk status was the main characteristic associated with a stenting approach, highlighting the perceived importance of carotid stenting therapies in this patient population.
| S-EPMC9482062 | biostudies-literature
Project description:ImportanceCarotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known.ObjectiveTo compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk.Design, setting, and participantsThis retrospective propensity-matched cohort study was conducted from August 2016 to August 2019 with follow-up until August 31, 2020, using data from the multicenter Vascular Quality Initiative Carotid Artery Stent and Carotid Endarterectomy registries. Patients with standard surgical risk, defined as those lacking Medicare-defined high medical or surgical risk characteristics and undergoing transcarotid artery revascularization (n = 2962) or carotid endarterectomy (n = 35 063) for atherosclerotic carotid disease. In total, 760 patients were excluded for treatment of multiple lesions or in conjunction with other procedures.ExposuresTranscarotid artery revascularization vs carotid endarterectomy.Main outcomes and measuresThe primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke.ResultsAfter 1:3 matching, 2962 patients undergoing transcarotid artery revascularization (mean [SD] age, 70.4 [6.9] years; 1910 [64.5%] male) and 8886 undergoing endarterectomy (mean [SD] age, 70.0 [6.5] years; 5777 [65.0%] male) were identified. There was no statistically significant difference in the risk of the primary composite end point between the 2 cohorts (transcarotid 3.0% vs endarterectomy 2.6%; absolute difference, 0.40% [95% CI, -0.43% to 1.24%]; relative risk [RR], 1.14 [95% CI, 0.87 to 1.50]; P = .34). Transcarotid artery revascularization was associated with a higher risk of 1-year ipsilateral stroke (1.6% vs 1.1%; absolute difference, 0.52% [95% CI, 0.03 to 1.08]; RR, 1.49 [95% CI, 1.05 to 2.11%]; P = .02) but no difference in 1-year all-cause mortality (2.6% vs 2.5%; absolute difference, -0.13% [95% CI, -0.18% to 0.33%]; RR, 1.04 [95% CI, 0.78 to 1.39]; P = .67).Conclusions and relevanceIn this study, the risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke was similar in patients undergoing transcarotid artery revascularization compared with those undergoing endarterectomy for carotid stenosis.
| S-EPMC10028539 | biostudies-literature
Project description:IntroductionIn recent years, the transcarotid artery revascularisation (TCAR) with flow reversal technique has been developed to treat carotid artery stenosis. The superiority of TCAR over transfemoral carotid artery stenting has been demonstrated. However, the safety and efficacy of TCAR and carotid endarterectomy remain unclear. This study aims to introduce a protocol for a systematic review and meta-analysis to compare the morbidity and mortality rates between TCAR and carotid endarterectomy in the treatment of atherosclerotic carotid artery stenosis.Methods and analysisThis protocol was drafted using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement. Herein, major databases will be searched, including Medline, Web of Science, Embase and the Cochrane Library, and randomised controlled trials and high-quality observational studies will be included. We will screen all studies published from January 2000 to March 2021. Bias risk will be evaluated using the Cochrane Collaboration criteria or Methodological Index for Non-randomised Studies criteria, depending on the study type. Two reviewers will select eligible studies and extract the data independently. The primary outcome will include stroke or death during the perioperative period and follow-up. Subgroup and sensitivity analyses will be performed to explore any potential sources of heterogeneity. Specific results will be described in a narrative form when available eligible studies are insufficient for meta-analysis. Publication bias will be assessed using a funnel plot.Ethics and disseminationThis study will summarise and analyse the existing literature; hence, ethics approval will not be required. The final results may be published at a relevant academic conference or in a journal.Prospero registration numberCRD42020178691.
| S-EPMC8098965 | biostudies-literature
Project description:Stroke occurs more commonly after carotid artery stenting than after carotid endarterectomy. Details regarding stroke type, severity, and characteristics have not been reported previously. We describe the strokes that have occurred in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).CREST is a randomized, open-allocation, controlled trial with blinded end-point adjudication. Stroke was a component of the primary composite outcome. Patients who received their assigned treatment within 30 days of randomization were included. Stroke was adjudicated by a panel of board-certified vascular neurologists with secondary central review of clinically obtained brain images. Stroke type, laterality, timing, and outcome were reported. A periprocedural stroke occurred among 81 of the 2502 patients randomized and among 69 of the 2272 in the present analysis. Strokes were predominantly minor (81%, n=56), ischemic (90%, n=62), in the anterior circulation (94%, n=65), and ipsilateral to the treated artery (88%, n=61). There were 7 hemorrhages, which occurred 3 to 21 days after the procedure, and 5 were fatal. Major stroke occurred in 13 (0.6%) of the 2272 patients. The estimated 4-year mortality after stroke was 21.1% compared with 11.6% for those without stroke. The adjusted risk of death at 4 years was higher after periprocedural stroke (hazard ratio, 2.78; 95% confidence interval, 1.63-4.76).Stroke, particularly severe stroke, was uncommon after carotid intervention in CREST, but stroke was associated with significant morbidity and was independently associated with a nearly 3-fold increased future mortality. The delayed timing of major and hemorrhagic stroke after revascularization suggests that these strokes may be preventable.
| S-EPMC3638912 | biostudies-literature
Project description:BackgroundThe 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.Methods and resultsCardiac 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.ConclusionsIn 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.Clinical trial registrationURL: http://www.ClinicalTrials.gov. Unique identifier: NCT00004732.
| S-EPMC3173718 | biostudies-literature
Project description:Importance:The Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) showed greater safety of carotid artery stenting (CAS) in patients younger than 70 years and carotid endarterectomy (CEA) in those older than 70 years. It is unknown how the result of CREST has influenced carotid revascularization choices in the United States. Objective:To evaluate national patterns in CAS performance in patients older than 70 years in the post-CREST (2011-2014) compared with the pre-CREST (2007-2010) era. Design, Setting, and Participants:All adults older than 70 years undergoing carotid revascularization in the United States from 2007 to 2014 were retrospectively identified from the 2007-2014 National Inpatient Sample using International Classification of Disease, Ninth Revision procedural codes. From 61 324 882 unweighted hospitalizations contained in the 2007-2014 National Inpatient Sample, 494 733 weighted carotid revascularization admissions in adults older than 70 years were identified using International Classification of Disease, Ninth Revision procedural codes. Main Outcomes and Measures:The proportion of CAS performed in all age groups over time was estimated and multivariable-adjusted models were used to compare the odds of receiving CAS in the pre-CREST with those in the post-CREST era in adults older than 70 years. Results:A total of 41.8% of all patients were women, and mean (SE) age at presentation was 78.1 (0.03) years. A total of 16.3% of CAS and 10.1% of CEA procedures were performed in patients with symptomatic stenosis. The proportion of patients older than 70 years receiving CAS increased from 11.9% in the pre-CREST to 13.8% in the post-CREST era (P = .005). In multivariable models, the odds of receiving CAS increased by 13% in all patients older than 70 years in the post-CREST compared with the pre-CREST period (odds ratio [OR], 1.13, 95% CI, 1.00-1.28, P = .04), including symptomatic women (OR, 1.31, 1.05-1.65, P = .02). Symptomatic stenosis (OR 1.39; 95% CI, 1.27-1.52; P < .001), congestive heart failure (OR, 1.48; 95% CI, 1.35-1.63; P < .001), and peripheral vascular disease (OR, 1.35; 95% CI, 1.27-1.43; P < .001) were associated with higher odds of CAS; comorbid hypertension (OR, 0.70; 95% CI, 0.66-0.74; P < .001), smoking (OR, 0.84; 95% CI, 0.78-0.91; P < .001), and weekend admission (OR, 0.77; 95% CI, 0.68-0.88; P < .001) were negatively associated with the odds of CAS. Conclusions and Relevance:Despite concerns for higher periprocedural complications with CAS in elderly patients, the odds of CAS increased in the post-CREST compared with pre-CREST era in patients older than 70 years, including symptomatic women.
| S-EPMC5833495 | biostudies-literature
Project description:ObjectivePrevious studies on carotid endarterectomy and transfemoral carotid artery stenting demonstrated that perioperative outcomes differed according to preoperative neurologic injury severity, but this has not been assessed in transcarotid artery revascularization (TCAR). In this study, we examined contemporary perioperative outcomes in patients who underwent TCAR stratified by specific preprocedural symptom status.MethodsPatients who underwent TCAR between 2016 and 2021 in the Vascular Quality Initiative were included. We stratified patients into the following groups based on preprocedural symptoms: asymptomatic, recent (symptoms occurring <180 days before TCAR) ocular transient ischemic attack (TIA), recent hemispheric TIA, recent stroke, or formerly symptomatic (symptoms occurring >180 days before TCAR). First, we used trend tests to assess outcomes in asymptomatic patients versus those with an increasing severity of recent neurologic injury (recent ocular TIA vs recent hemispheric TIA vs recent stroke). Then, we compared outcomes between asymptomatic and formerly symptomatic patients. Our primary outcome was in-hospital stroke/death rates. Multivariable logistic regression was used to adjust for demographics and comorbidities across groups.ResultsWe identified 18,477 patients undergoing TCAR, of whom 62.0% were asymptomatic, 3.2% had a recent ocular TIA, 7.6a % had recent hemispheric TIA, 18.0% had a recent stroke, and 9.2% were formerly symptomatic. In patients with recent symptoms, we observed higher rates of stroke/death with increasing neurologic injury severity: asymptomatic 1.1% versus recent ocular TIA 0.8% versus recent hemispheric TIA 2.1% versus recent stroke 3.1% (Ptrend < .01). In formerly symptomatic patients, the rate of stroke/death was higher compared with asymptomatic patients, but this difference was not statistically significant (1.7% vs 1.1%; P = .06). After risk adjustment, compared with asymptomatic patients, there was a higher odds of stroke/death in patients with a recent stroke (odds ratio [OR], 2.8; 95% confidence interval [CI], 2.1-3.7; P < .01), a recent hemispheric TIA (OR, 2.0; 95% CI, 1.3-3.0; P < .01), and former symptoms (OR, 1.6; 95% CI, 1.1-2.5; P = .02), but there was no difference in stroke/death rates in patients with a recent ocular TIA (OR, 0.9; 95% CI, 0.4-2.2; P = .78).ConclusionsAfter TCAR, compared with asymptomatic status, a recent stroke and a recent hemispheric TIA were associated with higher stroke/death rates, whereas a recent ocular TIA was associated with similar stroke/death rates. In addition, a formerly symptomatic status was associated with higher stroke/death rates compared with an asymptomatic status. Overall, our findings suggest that classifying patients undergoing TCAR as symptomatic versus asymptomatic may be an oversimplification and that patients' specific preoperative neurologic symptoms should instead be used in risk assessment and outcome reporting for TCAR.
| S-EPMC9613587 | biostudies-literature
Project description:ObjectivesThe purpose of this study was to compare health-related quality of life (HRQOL) outcomes in patients treated with carotid artery stenting (CAS) versus carotid endarterectomy (CEA).BackgroundIn CREST (Carotid Revascularization Endarterectomy versus Stenting Trial), the largest randomized trial of carotid revascularization to date, there was no significant difference in the primary composite endpoint, but rates of stroke and myocardial infarction (MI) differed between CAS and CEA. To help guide individualized clinical decision making, we compared HRQOL among patients enrolled in the CREST study. We also performed exploratory analyses to evaluate the association between periprocedural complications and HRQOL.MethodsWe measured HRQOL at baseline, and after 2 weeks, 1 month, and 1 year among 2,502 patients randomly assigned to either CAS or CEA in the CREST study. The HRQOL was assessed using the Medical Outcomes Study Short-Form 36 (SF-36) and 6 disease-specific scales designed to study HRQOL in patients undergoing carotid revascularization.ResultsAt both 2 weeks and 1 month, CAS patients had better outcomes for multiple components of the SF-36, with large differences for role physical function, pain, and the physical component summary scale (all p < 0.01). On the disease-specific scales, CAS patients reported less difficulty with driving, eating/swallowing, neck pain, and headaches but more difficulty with walking and leg pain (all p < 0.05). However, by 1 year, there were no differences in any HRQOL measure between CAS and CEA. In the exploratory analyses, periprocedural stroke was associated with poorer 1-year HRQOL across all SF-36 domains, but periprocedural MI or cranial nerve palsy were not.ConclusionsAmong patients undergoing carotid revascularization, CAS is associated with better HRQOL during the early recovery period as compared with CEA-particularly with regard to physical limitations and pain-but these differences diminish over time and are not evident after 1 year. Although CAS and CEA are associated with similar overall HRQOL at 1 year, event-specific analyses confirm that stroke has a greater and more sustained impact on HRQOL than MI. (Carotid Revascularization Endarterectomy versus Stenting Trial [CREST]; NCT00004732)
| S-EPMC3253735 | biostudies-literature
Project description: Not available
| S-EPMC7041119 | biostudies-literature