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Timing of procedural stroke and death in asymptomatic patients undergoing carotid endarterectomy: individual patient analysis from four RCTs. Poorthuis M H F,Bulbulia R,Morris D R,Pan H,Rothwell P M,Algra A,Becquemin J-P,Bonati L H,Brott T G,Brown M M,Calvet D,Eckstein H-H,Fraedrich G,Gregson J,Greving J P,Hendrikse J,Howard G,Jansen O,Mas J-L,Lewis S C,de Borst G J,Halliday A, The British journal of surgery BACKGROUND:The effectiveness of carotid endarterectomy (CEA) for stroke prevention depends on low procedural risks. The aim of this study was to assess the frequency and timing of procedural complications after CEA, which may clarify underlying mechanisms and help inform safe discharge policies. METHODS:Individual-patient data were obtained from four large carotid intervention trials (VACS, ACAS, ACST-1 and GALA; 1983-2007). Patients undergoing CEA for asymptomatic carotid artery stenosis directly after randomization were used for the present analysis. Timing of procedural death and stroke was divided into intraoperative day 0, postoperative day 0, days 1-3 and days 4-30. RESULTS:Some 3694 patients were included in the analysis. A total of 103 patients (2·8 per cent) had serious procedural complications (18 fatal strokes, 68 non-fatal strokes, 11 fatal myocardial infarctions and 6 deaths from other causes) [Correction added on 20 April, after first online publication: the percentage value has been corrected to 2·8]. Of the 86 strokes, 67 (78 per cent) were ipsilateral, 17 (20 per cent) were contralateral and two (2 per cent) were vertebrobasilar. Forty-five strokes (52 per cent) were ischaemic, nine (10 per cent) haemorrhagic, and stroke subtype was not determined in 32 patients (37 per cent). Half of the strokes happened on the day of CEA. Of all serious complications recorded, 44 (42·7 per cent) occurred on day 0 (20 intraoperative, 17 postoperative, 7 with unclear timing), 23 (22·3 per cent) on days 1-3 and 36 (35·0 per cent) on days 4-30. CONCLUSION:At least half of the procedural strokes in this study were ischaemic and ipsilateral to the treated artery. Half of all procedural complications occurred on the day of surgery, but one-third after day 3 when many patients had been discharged. 10.1002/bjs.11441
Risk Prediction Tools to Improve Patient Selection for Carotid Endarterectomy Among Patients With Asymptomatic Carotid Stenosis. Keyhani Salomeh,Madden Erin,Cheng Eric M,Bravata Dawn M,Halm Ethan,Austin Peter C,Ghasemiesfe Mehrnaz,Abraham Ann S,Zhang Alysandra J,Johanning Jason M JAMA surgery Importance:Randomized clinical trials have demonstrated that patients with asymptomatic carotid stenosis are eligible for carotid endarterectomy (CEA) if the 30-day surgical complication rate is less than 3% and the patient's life expectancy is at least 5 years. Objective:To develop a risk prediction tool to improve patient selection for CEA among patients with asymptomatic carotid stenosis. Design, Setting, and Participants:In this cohort study, veterans 65 years and older who received both carotid imaging and CEA in the Veterans Administration between January 1, 2005, and December 31, 2009 (n = 2325) were followed up for 5 years. Data were analyzed from January 2005 to December 2015. A risk prediction tool (the Carotid Mortality Index [CMI]) based on 23 candidate variables identified in the literature was developed using Veterans Administration and Medicare data. A simpler model based on the number of 4 key comorbidities that were prevalent and strongly associated with 5-year mortality was also developed (any cancer in the past 5 years, chronic obstructive pulmonary disease, congestive heart failure, and chronic kidney disease [the 4C model]). Model performance was assessed using measures of discrimination (eg, area under the curve [AUC]) and calibration. Internal validation was performed by correcting for optimism using 500 bootstrapped samples. Main Outcome and Measure:Five-year mortality. Results:Among 2325 veterans, the mean (SD) age was 73.74 (5.92) years. The cohort was predominantly male (98.8%) and of white race/ethnicity (94.4%). Overall, 29.5% (n = 687) of patients died within 5 years of CEA. On the basis of a backward selection algorithm, 9 patient characteristics were selected (age, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, any cancer diagnosis in the past 5 years, congestive heart failure, atrial fibrillation, remote stroke or transient ischemic attack, and body mass index) for the final logistic model, which yielded an optimism-corrected AUC of 0.687 for the CMI. The 4C model had slightly worse discrimination (AUC, 0.657) compared with the CMI model; however, the calibration curve was similar to the full model in most of the range of predicted probabilities. Conclusions and Relevance:According to results of this study, use of the CMI or the simpler 4C model may improve patient selection for CEA among patients with asymptomatic carotid stenosis. 10.1001/jamasurg.2018.5119
Carotid endarterectomy for asymptomatic carotid stenosis is safe in octogenarians. Glousman Brandon Neil,Sebastian Raul,Macsata Robyn,Kuang Xiangyu,Yang Alexander,Patel Darshan,Amdur Richard,Ricotta John,Sidawy Anton N,Nguyen Bao-Ngoc Journal of vascular surgery OBJECTIVE:Carotid endarterectomy (CEA) is the gold standard to prevent a recurrent stroke in symptomatic patients with carotid stenosis. However, in the modern era, the benefit of CEA in asymptomatic octogenarian patients has come into question. This study investigates real-world outcomes of CEA in asymptomatic octogenarians. METHODS:Patients who underwent CEA for asymptomatic carotid stenosis were identified in the American College of Surgeons National Surgical Quality Improvement Program CEA-targeted database from 2012 to 2017. They were stratified into two groups: octogenarians (≥80 years old) and younger patients (<80 years old). The 30-day outcomes evaluated included mortality and major morbidities such as stroke, cardiac events, pulmonary, and renal dysfunction. Multivariable logistic regression was used for data analysis. RESULTS:We identified 13,846 patients with asymptomatic carotid stenosis who underwent an elective CEA including 2509 octogenarians and 11,337 younger patients. Octogenarians were more likely to be female and less likely to be diabetic or smokers compared with younger patients. There was no difference in preoperative use of statins or antiplatelet therapy. Examination of 30-day outcomes revealed that octogenarians had slightly higher mortality (1.2% vs 0.5%; odds ratio, 2.1; 95% confidence interval, 1.3-3.4; P < .01), and a higher risk of return to the operating room (3.3% vs 2.3%; odds ratio, 1.4; 95% confidence interval, 1.1-1.9; P = .01). However, there was no difference between octogenarians and younger patients in adverse cardiac events or pulmonary, renal, or wound complications. Twenty-five octogenarian and 138 younger patients suffered from periprocedural stroke at a similar rate (1.0% vs 1.2%; P = .54). Stroke/death occurred for 51 of 2509 patients (2.0%) in the older group and 184 of 11,337 patients (1.6%) in the younger group, a difference that was not significant (P = .15). CONCLUSIONS:The 30-day outcomes of CEA in octogenarians are comparable with those in younger patients. Although the octogenarians had slightly higher mortality than younger patients, the absolute risk of mortality was still low at 1.2%. Therefore, CEA is safe in asymptomatic carotid stenosis in octogenarians. Overall life expectancy and preoperative functional status, rather than age, should be the major determinants in the decision to operate. 10.1016/j.jvs.2019.05.054
Contemporary outcomes after carotid endarterectomy in high-risk anatomic and physiologic patients. Rao Vaishnavi,Liang Patric,Swerdlow Nicholas,Li Chun,Solomon Yoel,Wyers Mark,Schermerhorn Marc Journal of vascular surgery OBJECTIVE:Current guidelines state that the acceptable 30-day postoperative stroke/death rate after carotid endarterectomy (CEA) is <3% for asymptomatic patients and <6% for symptomatic patients. The Centers for Medicare and Medicaid Services has identified certain high-risk characteristics used to define patients at highest risk for CEA for whom carotid artery stenting would be reimbursed. We evaluated the impact of the Centers for Medicare and Medicaid Services physiologic and anatomic high-risk criteria on major adverse event rates after CEA in asymptomatic and symptomatic patients. METHODS:We retrospectively reviewed all patients undergoing CEA from 2011 to 2017 in the American College of Surgeons National Surgical Quality Improvement Program vascular targeted database. Patients with high-risk anatomic or physiologic characteristics were identified by a predefined variable and were compared with normal-risk patients. The primary outcome was 30-day stroke/death, stratified by symptom status. RESULTS:We identified 25,788 patients undergoing CEA, of whom 60% were treated for asymptomatic carotid disease. Among all patients, high-risk physiology or anatomy was associated with higher rates of 30-day stroke/death compared with normal-risk patients (physiologic risk, 4.6% vs 2.3% [P < .001]; anatomic risk, 3.6% vs 2.3% [P < .001]). Patients who met criteria for high-risk physiology or anatomy also had higher rates of cardiac events (physiologic risk, 3.1% vs 1.6% [P < .001]; anatomic risk, 2.3% vs 1.6% [P < .01]), but only patients with high-risk anatomy had higher rates of cranial nerve injury (physiologic risk, 2.4% vs 2.5% [P = .81]; anatomic risk, 4.3% vs 2.5% [P < .001]). Asymptomatic patients with high-risk physiology or anatomy had higher rates of 30-day stroke/death, especially in the physiologic high-risk group (physiologic risk, 4.7% vs 1.5% [P < .001]; anatomic risk, 2.6% vs 1.5% [P < .01]), compared with normal-risk patients. However, among symptomatic patients, differences in stroke/death were seen only with high-risk anatomic patients and not with high-risk physiologic patients (physiologic risk, 4.6% vs 3.4% [P = .12]; anatomic risk, 4.8% vs 3.4% [P = .01]). CONCLUSIONS:As currently selected, contemporary real-world outcomes after CEA in asymptomatic carotid disease patients meeting high-risk physiologic criteria show an unacceptably high 30-day stroke/death rate, well above the 3% threshold. These results suggest the need for better selection of patients and preoperative optimization before elective CEA. 10.1016/j.jvs.2019.05.041
A Systematic Review and Meta-Analysis of Transcarotid Artery Revascularization with Dynamic Flow Reversal Versus Transfemoral Carotid Artery Stenting and Carotid Endarterectomy. Naazie Isaac N,Cui Christina L,Osaghae Ikponmwosa,Murad Mohammad H,Schermerhorn Marc,Malas Mahmoud B Annals of vascular surgery BACKGROUND:Transfemoral carotid artery stenting (TFCAS) was introduced as a less invasive option for carotid revascularization in patients at high risk for complications from carotid endarterectomy (CEA). The increased perioperative stroke and death risk of TFCAS has however prevented TFCAS from widespread acceptance as an alternative to CEA in high-risk patients. Recent research suggests that transcarotid artery revascularization (TCAR) may be associated with a low stroke and death risk and potentially meet the needs of patients at high surgical risk. We aimed to estimate the 30-day risk of stroke or death of TCAR and compare it to TFCAS and CEA. METHODS:We searched PubMed, Cochrane, Embase, and Scopus for studies of patients treated with TCAR. Meta-analysis was conducted when appropriate. A logistic-normal random-effects model with logit transformation was used to estimate the pooled event rates after TCAR. Pooled Mantel-Haenszel odds ratios (ORs) of events comparing TCAR to TFCAS and CEA were calculated using a fixed-effects model. Heterogeneity among studies was quantified with the chi-squared statistic of the likelihood ratio (LR) test that compares the random-effects and fixed-effects models. RESULTS:Nine nonrandomized studies evaluating 4012 patients who underwent TCAR were included. The overall 30-day risks after TCAR were stroke/death, 1.89% (95% confidence interval [CI]: 1.50, 2.37); stroke, 1.34% (95% CI: 1.02,1.75); death, 0.76% (95% CI: 0.56, 1.08); myocardial infarction (MI), 0.60% (95% CI: 0.23, 1.59); stroke/death/MI, 2.20% (95% CI: 1.31, 3.69); cranial nerve injury (CNI), 0.31% (95% CI: 0.12, 0.83). The failure rate of TCAR was 1.27% (95% CI: 0.32, 4.92). Two nonrandomized studies suggested that TCAR was associated with lower risk of stroke and death as compared with TFCAS (1.33% vs. 2.55%, OR: 0.52, 95% CI: 0.36, 0.74 and 0.76% vs. 1.46%, OR: 0.52, 95% CI: 0.32, 0.84, respectively). Four nonrandomized studies suggested that TCAR was associated with a lower risk of CNI (0.54% and 1.84%, OR: 0.52, 95% CI: 0.36, 0.74) than CEA, but no statistically significant difference in the 30-day risk of stroke, stroke/death, or stroke/death/MI. CONCLUSIONS:Among patients undergoing TCAR with dynamic flow reversal for carotid stenosis the 30-day risk of stroke or death was low. The perioperative stroke/death rate of TCAR was similar to that of CEA while CNI risk was lower. Larger prospective studies are needed to account for confounding factors and provide higher certainty. 10.1016/j.avsg.2020.05.070
In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative. Schermerhorn Marc L,Liang Patric,Dakour-Aridi Hanaa,Kashyap Vikram S,Wang Grace J,Nolan Brian W,Cronenwett Jack L,Eldrup-Jorgensen Jens,Malas Mahmoud B Journal of vascular surgery OBJECTIVE:Transcarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting. However, outcome comparisons between TCAR and carotid endarterectomy (CEA) are needed to confirm the safety of TCAR outside of highly selected patients and providers. METHODS:We compared in-hospital outcomes of patients undergoing TCAR and CEA from January 2016 to March 2018 using the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project registry and the Society for Vascular Surgery Vascular Quality Initiative CEA database, respectively. The primary outcome was a composite of in-hospital stroke and death. RESULTS:A total of 1182 patients underwent TCAR compared with 10,797 patients who underwent CEA. Patients undergoing TCAR were older (median age, 74 vs 71 years; P < .001) and more likely to be symptomatic (32% vs 27%; P < .001); they also had more medical comorbidities, including coronary artery disease (55% vs 28%; P < .001), chronic heart failure (20% vs 11%; P < .001), chronic obstructive pulmonary disease (29% vs 23%; P < .001), and chronic kidney disease (39% vs 34%; P = .001). On unadjusted analysis, TCAR had similar rates of in-hospital stroke/death (1.6% vs 1.4%; P = .33) and stroke/death/myocardial infarction (MI; 2.5% vs 1.9%; P = .16) compared with CEA. There was no difference in rates of stroke (1.4% vs 1.2%; P = .68), in-hospital death (0.3% vs 0.3%; P = .88), 30-day death (0.9% vs 0.4%; P = .06), or MI (1.1% vs 0.6%; P = .11). However, on average, TCAR procedures were 33 minutes shorter than CEA (78 ± 33 minutes vs 111 ± 43 minutes; P < .001). Patients undergoing TCAR were also less likely to incur cranial nerve injuries (0.6% vs 1.8%; P < .001) and less likely to have a postoperative length of stay >1 day (27% vs 30%; P = .046). On adjusted analysis, there was no difference in terms of stroke/death (odds ratio, 1.3; 95% confidence interval, 0.8-2.2; P = .28), stroke/death/MI (odds ratio, 1.4; 95% confidence interval, 0.9-2.1, P = .18), or the individual outcomes. CONCLUSIONS:Despite a substantially higher medical risk in patients undergoing TCAR, in-hospital stroke/death rates were similar between TCAR and CEA. Further comparative studies with larger samples sizes and longer follow-up will be needed to establish the role of TCAR in extracranial carotid disease management. 10.1016/j.jvs.2018.11.029