Carotid endarterectomy remains the standard of care, even in high-risk surgical patients

OBJECTIVE: This study tested the hypothesis that high-risk patients can undergo carotid endarterectomy without associated increased risk of stroke, transient ischemic attack (TIA), or death. SUMMARY BACKGROUND DATA: Carotid endarterectomy (CEA) has clearly been shown to be effective in reducing the risk of stroke in selected symptomatic and asymptomatic patients with extracranial carotid stenosis. However, recently, carotid angioplasty with stenting (CAS) has been suggested as an alternative treatment in high-risk surgical patients. METHODS: Medical records for consecutive patients who underwent CEA from 1996 to 2001 were reviewed for demographics, medical history, and hospital course. High-risk patients were defined as those experiencing a myocardial infarction (MI) or an exacerbation of congestive heart failure (CHF) within 4 weeks before CEA; unstable angina; steroid-dependent chronic obstructive pulmonary disease (COPD); prior ipsilateral CEA, neck dissection or irradiation; high carotid bifurcation; and those with combined cardiac-carotid procedures. Poor postoperative outcome was defined as stroke, TIA, or death within 30 days. Univariate, multivariate, and Kaplan-Meier analysis were used as appropriate. RESULTS: Four hundred twenty-nine patients underwent 499 CEAs, of which 84 (17%) were considered high risk. The overall stroke-death rate among all patients was 2.8%. A total of 11 postoperative strokes (2.2%), 7 TIAs (1.4%), and 3 deaths (0.6%) occurred within 30 days after surgery. There was no difference in 30-day poor outcome between high- and low-risk patients (4.8% vs. 4.1%, P = 0.77). When these risk factors were assessed independently, those with recent MI were at higher risk for poor outcome (odds ratio [OR], 13.3; 95% confidence interval [CI], 2.2-82.0; P = 0.03). Multivariate analysis also revealed that a history of contralateral stroke or TIA conferred an increased risk of poor outcome (OR, 3.0; 95% CI, 1.1-8.4; P = 0.02), whereas use of preoperative angiotensin-converting enzyme inhibitors was associated with reduced risk (OR, 0.36; 95% CI, 0.11-1.0; P = 0.05), as was a history of hyperlipidemia (OR, 0.33; 95% CI, 0.13-0.87; P = 0.03). By log-rank analysis, 12-month survival was significantly worse in the high-risk group as compared with the low-risk (96% vs. 91%, P = 0.03). CONCLUSIONS: Patients considered a surgical high risk can undergo CEA without any worse outcome compared with those patients deemed low risk. The benefit of CAS will likely be marginal, and only controlled clinical trials will be able to determine if certain subgroups demonstrate improved outcome with CAS. Carotid endarterectomy remains the standard of care, even in high-risk surgical patients.     

Clinical and radiographic risk factors for operative stroke and death in the European carotid surgery trial.

OBJECTIVES: carotid endarterectomy is associated with significant morbidity and mortality. A better understanding of the relationships between baseline characteristics and outcome may help to reduce the risks of surgery. In order to make accurate and unbiased estimates of surgical risk it is important to study cohorts of patients that were established prospectively, where independent physicians assessed outcome, and where the decision to analyse and report the results was not data-dependent. The surgical arm of the European Carotid Surgery Trial (ECST) is such a cohort. METHODS: the 30-day outcome of carotid endarterectomy was analysed in ECST surgery patients in relation to their baseline clinical and angiographic characteristics. The severity of operative strokes was compared with that of strokes that occurred in the medical group. RESULTS: 1729 patients underwent trial surgery. There were 17 deaths (1.0%, 95% CI=0.6-1.6) and 105 non-fatal major strokes (6.1%, 95% CI=5.0-7.3) within 30 days of surgery. The risk of major stroke or death was 7.1% (95% CI=5.9-8.4). The risk of disabling or fatal stroke was 3.0% (95% CI=2.1-3.8). The ratio of disabling to non-disabling operative strokes was similar to that in the medical group. Several baseline characteristics predicted the operative risk of stroke and death in univariate analyses, but only four were independent risk factors in a multiple regression analysis: presentation with cerebral TIA vs ocular ischaemic events only (HR=2.99, 95% CI=1.33-6.69, p=0.008); female sex (HR=2.04, 95% CI=1.37--3.06, p=0.001); systolic hypertension (HR=1.01 per 10 mmHg, 95% CI=1.00-1.02, p=0.03) and peripheral vascular disease (HR=2.17, 95% CI=1.17-2.89, p=0.001). CONCLUSIONS: the operative risk of stroke and death in the ECST was comparable with other prospective studies and trials in which patients were assessed postoperatively by both a physician and a surgeon. Case fatality and disability after operative stroke are similar to strokes that occur on medical treatment only. Several baseline patient characteristics predict surgical risk and it may be possible to use these characteristics to aid patient selection and surgical audit.     

Safety of endovascular treatment of carotid artery stenosis compared with surgical treatment: a meta-analysis

BACKGROUND AND PURPOSE: Since publication of previous meta-analyses comparing endovascular and surgical treatment of patients with carotid artery stenosis, two further large-scale trials have been conducted, almost doubling the number of patients available for analysis. Therefore, it is justified to update these meta-analyses. METHODS: Relevant trials were identified by a search of the literature using an electronic database. Trials with a nonrandomized patient allocation were not included. We focused on events within 30 days after intervention and made two sets of analysis: one with all trials and one with large trials exclusively including symptomatic patients. RESULTS: Only Endartérectomie Versus Angioplastie chez les patients ayant une Sténose carotide Symptomatique Serrée (EVA3S) and Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE) were identified to be included in the updated meta-analysis. In total, 2985 patients were included in eight trials of which 89% were symptomatic. In contrast to previous analyses, this meta-analysis found a significant difference between the odds ratios of any stroke or death within 30 days after treatment with a disadvantage of endovascular treatment when analysing all trials (odds ratio [OR], 1.38; 95% confidence interval [CI] 1.04-1.83; P = .024). Significant heterogeneity was found for this analysis (P = .03). The increase of the odds of suffering from disabling stroke or death in the endovascular compared with the surgical group was not significant in the analysis of all trials (OR, 1.37; 95% CI, 0.92-2.04; P = .12); no heterogeneity was found for this analysis (P = .27). In the analysis of the large trials with symptomatic patients, the OR for the endpoint any stroke or death was 1.29 (95% CI 0.94-1.76; P = .11); with a hint for heterogeneity (P = .10). For the endpoint disabling stroke or death, the OR was 1.33 (95% CI 0.89-1.93; P =.17) without any heterogeneity (P = .58). CONCLUSION: The expressiveness of this meta-analysis is limited by the heterogeneity of some tests. The main result is that surgical treatment still remains the gold standard for treatment of patients with symptomatic carotid artery stenosis, who do not have an increased surgical risk. Carotid artery stenting is neither safer than nor as safe as carotid endarterectomy in large clinical trials when short-term stroke and death rates are taken into account. Further recruitment into ongoing randomized trials is strongly recommended.     

A systematic review of outcome following synchronous carotid endarterectomy and coronary artery bypass: influence of surgical and patient variables.

OBJECTIVES: Outcomes after synchronous carotid endarterectomy (CEA) plus coronary artery bypass (CABG) relative to surgical and patient based variables. DESIGN: Systematic review of 94 published series (7863 synchronous procedures). RESULTS: 11.5% of patients died or suffered a stroke/myocardial infarction in the peri-operative period (95% CI 10.1-12.9). The risk of death/stroke appeared to significantly diminish in studies published between 1993-2002, compared with 1972-1992 (7.2% (95% CI 6.5-9.1) versus 10.7% (95% CI 8.9-12.5), p = 0.03). However, increasing operative experience was not associated with significantly lower risks of death/stroke; (1-49 cases (9.6% (95% CI 7.5-11.8); 50-99 cases (9.1% (95% CI 6.4-11.8); 100+ cases (8.4% (95% CI 6.9-10.1) (p = 0.64)). Patients with severe bilateral carotid disease were significantly more likely to suffer death and/or stroke compared to patients with unilateral disease (odds ratio 2.5, 95% CI 1.4-5.0, p = 0.001). Similarly, patients with a prior history of stroke/transient ischaemic attack (TIA) were significantly more likely to suffer a further stroke than asymptomatic patients (odds ratio 1.8, 95% CI 1.1-2.8, p = 0.008). There was no difference in the risk of death/stroke relative to the timing of CEA (pre- versus on-cardiopulmonary bypass), but recent small studies indicate that improved outcomes might be achieved by performing CABG 'off-bypass'. CONCLUSIONS: Synchronous CEA + CABG is associated with a not insignificant cardiovascular risk. No comparable information is available for similar patients undergoing CABG without prophylactic CEA.     

Carotid Endarterectomy Versus Carotid Stenting: an Updated Review of Randomized Trials and Subgroup Analyses

Atherosclerotic disease of the carotid arteries is responsible for a significant portion of ischemic strokes. Carotid endarterectomy (CEA) is currently the accepted standard of treatment for patients with severe symptomatic carotid stenosis. In the past few years, however, carotid angioplasty and stenting (CAS) has emerged as a potential alternative endovascular treatment strategy for this disorder. In fact, spurred by the positive results of single center studies and small, pivotal randomized trials, some even consider CAS as the treatment modality of choice, especially in presumably surgical high-risk patients. Yet, randomized trials directly comparing CAS with CEA are sparse and have produced conflicting results.

The aim of this article is to review the current trial data on this issue and to define the role of these techniques for the management of two important subgroups of patients.

An updated meta-analysis of seven randomized trials comparing CEA with CAS demonstrates that CAS is associated with a significantly increased risk of any stroke or death within 30 days (OR. 1.41, 95% CI 1.07-1.87, p<0.05). Focusing on patients with a symptomatic carotid stenosis, there was also a significant difference in the odds of treatment-related stroke and death between CAS and CEA (OR, 1.41; CI 1.05 to 1.88, p < 0.05). Data on all disabling strokes and deaths within 30 days was available from five trials. The odds of disabling stroke or death at 30 days were similar in the endovascular and surgical group (OR, 1.33, 95% CI 0.89 to 1.98).

Overall, these data do not justify a blind enthusiasm for CAS and a widespread use of this procedure for the treatment of carotid artery stenosis. On the other hand, a closer inspection of the current literature on elderly patients and those with a contralateral carotid occlusion clearly indicates that CAS and CEA already now have a complementary role. While elderly patients should preferentially be treated with CEA, CAS appears to be the treatment of choice in patients with a symptomatic carotid artery stenosis and a contralateral carotid occlusion in experienced centers.     

Association between operator specialty and outcomes after carotid artery revascularization

Objective

To examine the association between operator specialty and 30-day outcomes among patients undergoing carotid endarterectomy and carotid artery stenting.

Carotid endarterectomy versus carotid stenting: an updated review of randomized trials and subgroup analyses

Atherosclerotic disease of the carotid arteries is responsible for a significant portion of ischemic strokes. Carotid endarterectomy (CEA) is currently the accepted standard of treatment for patients with severe symptomatic carotid stenosis. In the past few years, however, carotid angioplasty and stenting (CAS) has emerged as a potential alternative endovascular treatment strategy for this disorder. In fact, spurred by the positive results of single center studies and small, pivotal randomized trials, some even consider CAS as the treatment modality of choice, especially in presumably surgical high-risk patients. Yet, randomized trials directly comparing CAS with CEA are sparse and have produced conflicting results. The aim of this article is to review the current trial data on this issue and to define the role of these techniques for the management of two important subgroups of patients. An updated meta-analysis of seven randomized trials comparing CEA with CAS demonstrates that CAS is associated with a significantly increased risk of any stroke or death within 30 days (OR. 1.41, 95% CI 1.07-1.87, p < 0.05). Focusing on patients with a symptomatic carotid stenosis, there was also a significant difference in the odds of treatment-related stroke and death between CAS and CEA (OR, 1.41 ; CI 1.05 to 1.88, p < 0.05). Data on all disabling strokes and deaths within 30 days was available from five trials. The odds of disabling stroke or death at 30 days were similar in the endovascular and surgical group (OR, 1.33, 95% CI 0.89 to 1.98). Overall, these data do not justify a blind enthusiasm for CAS and a widespread use of this procedure for the treatment of carotid artery stenosis. On the other hand, a closer inspection of the current literature on elderly patients and those with a contralateral carotid occlusion clearly indicates that CAS and CEA already now have a complementary role. While elderly patients should preferentially be treated with CEA, CAS appears to be the treatment of choice in patients with a symptomatic carotid artery stenosis and a contralateral carotid occlusion in experienced centers.     

Carotid artery disease and stroke during coronary artery bypass: a critical review of the literature.

OBJECTIVES: to determine the role of carotid artery disease in the pathophysiology of stroke after coronary artery bypass (CABG). DESIGN: systematic review of the literature. RESULTS: the risk of stroke after CABG was 2% and remained unchanged between 1970-2000. Two-thirds occurred after day 1 and 23% died. 91% of screened CABG patients had no significant carotid disease and had a <2% risk of peri-operative stroke. Stroke risk increased to 3% in predominantly asymptomatic patients with a unilateral 50-99% stenosis, 5% in those with bilateral 50-99% stenoses and 7-11% in patients with carotid occlusion. Significant predictive factors for post-CABG stroke included; (i) carotid bruit (OR 3.6, 95% CI 2.8-4.6), (ii) prior stroke/TIA (OR 3.6, 95% CI 2.7-4.9) and (iii) severe carotid stenosis/occlusion (OR 4.3, 95% CI 3.2-5.7). However, the systematic review indicated that 50% of stroke sufferers did not have significant carotid disease and 60% of territorial infarctions on CT scan/autopsy could not be attributed to carotid disease alone. CONCLUSIONS: carotid disease is an important aetiological factor in the pathophysiology of post-CABG stroke. However, even assuming that prophylactic carotid endarterectomy carried no additional risk, it could only ever prevent about 40-50% of procedural strokes.     

Examination of the interaction between method of anesthesia and shunting with carotid endarterectomy

BackgroundAlthough the choice of anesthesia during carotid endarterectomy (CEA) does not seem to increase the risk of perioperative stroke, it might affect the outcomes of shunting during CEA. This study aims to evaluate whether the choice of anesthesia modifies the association between shunting and in-hospital stroke/death after CEA.MethodsWe retrospective reviewed all CEA cases performed between 2003 and 2017 in the Vascular Quality Initiative. Patients were divided into three groups: (1) no shunting during CEA (n = 29,227 [48.4%]), (2) routine shunting (n = 28,673 [47.5%]), and (3) selective shunting based on an intraoperative indication (n = 2499 [4.1%]). Multivariable logistic regression analysis was used to study the interaction between anesthesia (local anesthesia [LA]/regional anesthesia [RA] vs general anesthesia [GA]) and intraoperative shunting (no shunting vs routine and selective shunting) during CEA in predicting the risk of in-hospital stroke/death after CEA.ResultsThe final cohort included 60,399 patients. The majority of CEA cases (90.2%) were performed under GA. Of the study cohort, 29,227 (48.4%) underwent CEA without shunting, 28,673 patients (47.5%) had routine shunting, and the remaining (n = 2499 [4.1%]) were selectively shunted. The interaction between intraoperative shunting and anesthesia in predicting in-hospital stroke/death was statistically significant (P < .05). When CEA is performed under LA/GA, routine shunting was associated with 3.5 times the adjusted odds of in-hospital stroke/death after CEA (odds ratio [OR], 3.5; 95% confidence interval [CI], 1.8-6.8; P < .001) compared with no shunting, whereas selective shunting was associated with 7.1 the odds (OR, 7.1; 95% CI, 3.5-14.7; P < .001). In contrast, under GA, there was no significant association between routine shunting and in-hospital stroke/death (OR, 1.2; 95% CI, 1.0-1.5; P = .12), whereas selective shunting was associated with 1.7 times the odds (OR, 1.7; 95% CI, 1.2-2.4; P < .01) compared with not performing shunting during CEA.ConclusionsThe use of LA/RA is associated with increased odds of stroke/death compared with GA when intraoperative shunting is performed. The effect of anesthesia is more pronounced in patients who develop clamp-related ischemia and undergo selective shunting. More controlled studies are needed to explain these findings and validate them.     

Protected carotid stenting in high-surgical-risk patients: the ARCHeR results

BACKGROUND: Carotid endarterectomy is the standard of care for most patients with severe extracranial carotid bifurcation disease. However, its safety and efficacy in patients with significant surgical risk are unclear. The ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk patients) trial was performed to determine whether carotid artery stenting with embolic protection is a safe and effective alternative to endarterectomy in high-surgical-risk patients. METHODS: The ARCHeR trial is a series of three sequential, multicenter, nonrandomized, prospective studies. Forty-eight sites enrolled 581 high-surgical-risk patients between May 2000 and September 2003. Patients with severe carotid artery stenosis (angiographically defined, symptomatic > or =50%, or asymptomatic > or =80%) had an ACCULINK nitinol stent implanted. The ACCUNET filter embolic protection system was added to the procedure in the final 2 studies (422 patients). The primary efficacy end point was a composite of periprocedural (< or =30 days) death, stroke, and myocardial infarction, plus ipsilateral stroke between days 31 and 365. RESULTS: The 30-day rate of death/stroke/myocardial infarction was 8.3% (95% confidence interval [CI], 6.2%-10.8%), and that of stroke/death was 6.9% (95% CI, 5.0%-9.3%). Most (23/32) strokes were minor, of which more than half (12/23) returned to baseline National Institutes of Health Stroke Scale scores within 30 days. The 30-day major/fatal stroke rate was 1.5% (95% CI, 0.7%-2.9%). No hemorrhagic strokes were observed in the study. Ipsilateral cerebrovascular accident occurred in 1.3% between 30 days and 1 year, thus giving a primary composite end point of 30-day death/stroke/myocardial infarction plus ipsilateral stroke at 1 year of 9.6% (95% CI, 7.2%-12.0%), which is below the 14.4% historical control comparator. Target lesion revascularization at 12 months and 2 years was 2.2% and 2.9%, respectively. CONCLUSIONS: The ARCHeR results demonstrate that extracranial carotid artery stenting with embolic filter protection is not inferior to historical results of endarterectomy and suggest that carotid artery stenting is a safe, durable, and effective alternative in high-surgical-risk patients.     

Age modifies the efficacy and safety of carotid artery revascularization procedures

BackgroundSeveral randomized clinical trials have shown that carotid artery endarterectomy (CEA) is safer than carotid artery stenting (CAS) in the elderly. However, those studies were limited by their strict inclusion criteria that might make their findings inapplicable to real-world practice. Therefore, the aim of this study was to evaluate the association of age with the efficacy of CEA and CAS in a population-based registry.MethodsThe Vascular Quality Initiative database was inquired (2005-2017). The primary outcome was 30-day and 2-year stroke and a combined outcome of stroke/death. Logistic regression models with age-by-treatment interaction term were fitted adjusting for patients' characteristics. Restricted cubic spline modelling was also implemented. Two-year events were assessed via survival analysis methods.ResultsOverall, 89,853 patients were included, 26.9% were less than 65 years of age, 39.1% were 65 to 74 years of age, and 34.1% were 75 years of age or older. The CAS-to-CEA odds of 30-day stroke became significant at age 56.5 and doubled at age 72.5 years. After CEA, the risk of stroke rose by 1.3-fold when age increased from 76 to 85 (odds ratio [OR], 1.30; 95% confidence interval [CI], 1.05-1.62). Yet after CAS, when age increased from 65 to 71 years, the OR of stroke was 1.36 (95% CI, 1.04-1.76); from 71 to 76 years, the OR was 1.47 (95% CI, 1.10-1.96), and from 76 to 85 years the OR was 1.38 (95% CI, 1.06-1.81). The superiority of CEA with increasing age extended to 2 years after the procedure. The CAS-to-CEA 2-year hazard of stroke was significant at age 53 and it doubled at 71.5 years.ConclusionsIn this multicenter registry, we confirmed the effect modification role that age plays in the safety and efficacy of carotid revascularizations. The risk-adjusted effectiveness of CAS was particularly sensitive to patient age, whereas CEA performance was relatively stable across various age strata. Of note, the observed effect was more pronounced and a decade earlier than what previously reported in the ideal setting of a randomized clinical trial.     

Determinants of outcome after carotid endarterectomy

Background: The efficacy of carotid endarterectomy for selected patients has been evaluated with randomized controlled clinical trials. The generalizability of these studies to average surgical practice remains an important public health concern. Objective: The objective of the study was to determine the predictors of outcome after carotid endarterectomy on a regional basis. Patients and Methods: The study was designed as a retrospective cohort study and included all consecutive patients presented for carotid endarterectomy at the 8 University of Toronto–affiliated hospitals in the period from January 1, 1994, to December 31, 1996. The main outcome measure was 30-day postoperative stroke or death rate. Results: During the study interval, 1280 primary carotid endarterectomies were performed. The overall combined stroke and death rate was 6.3% for all patients who underwent endarterectomy (4.0% for patients who were asymptomatic). The significant predictors of poor outcome were the following: presenting symptoms (odds ratio, 1.74; 95% confidence interval [CI], 0.96, 3.12), low surgeon volume (<6 cases per year; odds ratio, 3.98; 95% CI, 1.65, 9.58), and left-sided surgery (odds ratio, 1.72; 95% CI, 1.07, 2.76). Conclusion: These data suggest that adoption of the recommendations of the symptomatic carotid endarterectomy trials is appropriate. However, endarterectomy for asymptomatic lesions remains of uncertain benefit on a regional basis and must be individualized to the experience of the specific surgeon. The surgeon volume/outcome relationship that is identified in this study suggests a need for a minimum volume threshold for this procedure. (J Vasc Surg 1998;28:1051-8.)     

Eversion vs conventional carotid endarterectomy: a systematic review.

OBJECTIVE: to determine whether eversion carotid endarterectomy (CEA) was safe and more effective than conventional CEA. METHODS: controlled trials comparing eversion vs conventional technique for CEA were identified from the Cochrane Stroke Review Group database plus additional hand searching. Researchers were contacted to identify additional published and unpublished studies. Randomised and pseudorandomised trials comparing eversion to conventional techniques in patients undergoing CEA were examined. Outcomes included stroke and death, carotid restenosis/occlusion, and local complications. RESULTS: five trials were included comprising 2465 patients and 2590 arteries. There were no significant differences in the rate of perioperative stroke or death (1.7% vs 2.6%, odds ratio [OR] 0.44, 95% confidence interval [CI] 0.10-1.82) and stroke during follow-up (1.4% vs 1.7%; OR: 0.84; 95% CI: 0.43-1.64) between eversion and conventional CEA techniques. Eversion CEA was associated with a significantly lower rate of restenosis >50% during follow-up (2.5% vs 5.2%, OR: 0.48, 95% CI: 0.32-0.72). There were no statistically significant differences in local complications between the eversion and conventional group. When eversion procedures were compared with patch procedures only, non-significant differences were found in primary outcomes. CONCLUSIONS: eversion CEA may be associated with low risk of arterial occlusion and restenosis. However, numbers are too small to definitively assess the benefits and disadvantages of eversion CEA. Reduced restenosis rates did not appear to be associated with clinical benefit in terms of reduced stroke risk, either perioperatively or later. Until further evidence is available, the choice of the CEA technique should be based on the experience and familiarity of the individual surgeon.     

Association between the choice of anesthesia and in-hospital outcomes after carotid artery stenting

ObjectiveSeveral prior studies have shown lower risk of myocardial infarction (MI) in carotid artery stenting (CAS) compared with carotid endarterectomy. This is likely because the majority of endarterectomies are performed under general anesthesia (GA), whereas CAS is mainly performed under local anesthesia (LA). Performing CAS under GA may reverse its minimally invasive benefits. The aim of this study was to compare the safety profile of CAS-GA with that of CAS-LA.MethodsA retrospective analysis of the Vascular Quality Initiative database from 2005 to 2017 was performed. Primary outcomes included major adverse cardiac events (MACE), a composite of in-hospital death and MI, and postoperative neurologic events. Multivariable logistic models, and coarsened exact matching were used to evaluate the association between the primary outcomes and anesthesia technique.ResultsOf 12,919 CAS cases performed, 2024 (15.7%) were under GA. Comparing CAS-GA with CAS-LA in the overall cohort, CAS-GA had significantly higher crude rates of in-hospital mortality (2.1% vs 0.5%), MI (1.3% vs 0.7%), composite MACE (3.1% vs 1.2%), and ipsilateral stroke (2.3% vs 1.6%). Patients undergoing CAS-GA also had higher rates of dysrhythmia (3.0% vs 2.2%), acute congestive heart failure (1.6% vs 0.7%) and perioperative hypertension (13.2% vs 9.4%), and were more likely to have a length of hospital stay of more than 4 days (prolonged length of stay) (17.6% vs 8.5%) compared with those undergoing CAS-LA. On multivariable analysis, CAS-GA had a 2.3 times higher odds of in-hospital mortality compared with CAS-LA (OR, 2.52; 95% CI, 1.26-5.03), a 1.9 times the odds of MACE (OR, 1.87; 95% CI, 1.15-3.03), and a 2.3 times the odds of acute congestive heart failure (OR, 2.29; 95% CI, 1.26-4.15; all P < .05). In addition, these patients had a 43% higher odds of developing perioperative hypertension (OR, 1.43; 95% CI, 1.09-1.87; P = .01) and almost 2 times the odds of a prolonged length of stay (OR, 1.82; 95% CI, 1.41-2.35; P < .001). The adjusted odds of stroke, dysrhythmia and reperfusion syndrome were not significantly different between the two groups. Additional analysis using coarsened exact matching showed similar results.ConclusionsIn addition to the established increase risk of perioperative stroke/death with CAS compared with carotid endarterectomy, performing it under GA seems to be associated with increased cardiac complications, length of stay, and consequently hospitalization costs. Pending future data from prospective, randomized, controlled trials to validate our findings, there is evidence to suggest that it may be better to perform CAS under LA, especially in medically high-risk patients.     

The Vascular Quality Initiative 30-day stroke/death risk score calculator after transfemoral carotid artery stenting

ObjectiveCarotid artery stenting (CAS) was introduced as an alternative carotid revascularization procedure in patients deemed to be at high risk for carotid endarterectomy. Although techniques and selection criteria for patients have dramatically improved, CAS continues to have higher risk of stroke and death in comparison to carotid endarterectomy. Several risk factors are known to be associated with worse outcomes. Whereas knowledge of these independent factors is helpful, clinical decision-making is further refined when these are considered in aggregate. This study aimed to develop a score to predict the risk of stroke/death after transfemoral CAS (TFCAS).MethodsWe analyzed the Vascular Quality Initiative CAS data set from 2010 to 2018. Lesions due to trauma, dissection, or transcarotid artery stenting and cases performed without an embolic protection device were excluded. Univariable and multivariable logistic regression methods with bootstrapping (1000 repetitions) were used to identify predictors associated with 30-day stroke/death. Stepwise backward selection for variables was used to achieve model parsimony. A risk score was made by converting regression coefficients for each predictor to integers from which probability was calculated. Scores were grouped into simplified categories.ResultsWe identified 10,753 patients undergoing TFCAS during the study period with a combined 30-day stroke/death rate of 4.1%. On multivariable adjustment, independent predictors of 30-day stroke/death included age (odds ratio [OR], 1.05; 95% confidence interval [CI], 1.03-1.06; P < .001), nonwhite race (OR, 1.42; 95% CI, 1.16-1.74; P = .001), diabetes (OR,1.34; 95% CI, 1.08-1.67; P = .01), coronary artery disease (OR, 1.40; 95% CI, 1.13-1.73; P = .001), congestive heart failure (OR, 1.41; 95% CI, 1.07-1.85; P = .02), symptomatic status (OR, 2.11; 95% CI, 1.64-2.72; P < .001), and contralateral occlusion (OR, 1.64; 95% CI, 1.22-2.19; P = .001). On the other hand, preoperative use of statins (OR, 0.074; 95% CI, 0.59-0.93; P = .02) and dual antiplatelet therapy (P2Y₁₂ inhibitors and aspirin; OR, 0.46; 95% CI, 0.32-0.66; P < .001) were associated with a significant reduction in stroke/death after TFCAS. The model had a C statistic of 69.0%. The coefficients of these predictors were used to develop a risk score calculator that estimates the probability of 30-day stroke/death after TFCAS.ConclusionsIn an analysis of 10,753 patients undergoing TFCAS between 2010 and 2018, significant predictors of perioperative stroke or death included old age, nonwhite race, symptomatic status, diabetes, coronary artery disease, congestive heart failure, and contralateral occlusion in addition to perioperative dual antiplatelet therapy and statin use. These variables were used to develop a risk score calculator that estimates the probability of 30-day stroke/death after TFCAS. External validation of this tool in different populations of patients and data sets is warranted to evaluate its predictive performance.     

Operative outcome of simultaneous carotid and valvular surgery

Background

Operative outcome of simultaneous carotid endarterectomy and valvular surgery has not been clarified. We retrospectively reviewed short-term and long-term outcomes after carotid endarterectomy combined with valvular replacement.

Methods

Seventy-nine patients (50 men and 29 women. mean age, 68.9 ± 6.9 years; range, 53.3 to 78.7 years) underwent carotid endarterectomy combined with valve replacement from February 1985 to April 2002. Indication of carotid endarterectomy was more than 75% carotid stenosis with or without ulceration. Thirteen patients had history of stroke. Endarterectomy was performed under mild hypothermia with cardiopulmonary bypass in all cases. Positions of replaced valves were aortic in 64 patients, mitral in 10, and mitral and aortic in 5 patients.

Results

There were 8 early deaths (10.1%). Early neurologic complications occurred in 8 patients (10.1%); two late events were observed. Double valve replacement was an independent risk factor for early death (p = 0.039; odds ratio = 25.6). For early stroke we found no statistically significant risk factor. Myocardial infarction (p = 0.022; odds ratio = 3.0) and age more than 70 years (p = 0.03; odds ratio = 2.5) were independent risk factors for premature death; we found no independent risk factor for late stroke. Permanent impairment or death as a stroke consequence was seen in 5 patients, 3 of them had ipsilateral strokes, 2 had contralateral strokes.

Conclusions

Endarterectomy can be safely performed combined with aortic valve surgery. Concomitant mitral or double valve replacement cannot be judged reliably because of the small number of patients, but they might be a high risk.     

Risk factors for peri-operative stroke complicating carotid endarterectomy: selective analysis of a prospective audit of 1000 consecutive operations

BACKGROUND: The aim of the present study was to investigate the role of potential clinical risk factors in the causation of peri-operative stroke associated with carotid endarterectomy. With the change in carotid endarterectomy practice from the use of a shunt to high-dose thiopental for cerebral protection (a previously undocumented method), it was essential to identify accurately the causes of all perioperative strokes. METHODS: A prospective audit was undertaken of 1000 carotid endarterectomies in which the causes and pathology of all peri-operative strokes were documented. The roles of advanced age, female gender, hypertension, previous stroke, contralateral carotid stenosis >70%, and contralateral carotid occlusion as potential causes of peri-operative stroke were defined. Results were statistically analysed using odds ratio and Fisher's exact test. RESULTS: None of the potential risk factors was statistically significant for peri-operative stroke. Female gender was associated with a significant risk of peri-operative stroke due to operative site thrombosis. Complications at the endarterectomy site were the commonest cause of stroke. CONCLUSIONS: Prospective audit is a useful tool for identifying causes of peri-operative stroke and indicating the need for modifications to surgical clinical management which might improve outcomes for carotid endarterectomy.     

High-risk carotid endarterectomy: challenges for carotid stent protocols.

BACKGROUND: Carotid angioplasty and stenting is under investigation in clinical trials as an alternative to endarterectomy. Some clinicians have hypothesized that stenting would be applicable for patients at high risk who need carotid revascularization. To further test this hypothesis, we stratified our carotid endarterectomy procedures according to current carotid stent protocols. METHODS: We reviewed our computerized registry and the clinical charts of patients who underwent carotid endarterectomy. Each procedure was categorized as high risk or low risk, according to the following six separate high-risk factors: 1, severe cardiac dysfunction; 2, the requirement for combined coronary and carotid vascularization; 3, severe pulmonary dysfunction; 4, contralateral internal carotid artery occlusion; 5, previous ipsilateral carotid endarterectomy; and 6, anatomically limited access for carotid endarterectomy. Rates of stroke at 30 days, cardiac complications, and death were tabulated. RESULTS: Between January 1, 1998, and December 31, 2000, 415 carotid endarterectomies were performed on 389 patients. Ninety-eight procedures (23.6%) were classified as high risk on the basis of the following factors: 1, severe cardiac dysfunction (n = 30); 2, requirement for combined coronary and carotid revascularization (n = 14); 3, severe pulmonary dysfunction (n = 8); 4, contralateral carotid occlusion (n = 31); 5, previous ipsilateral carotid endarterectomy (n = 25); and 6, anatomically limited access (n = 4). Seven patients had ipsilateral postoperative strokes (1.7%), with two additional patients having contralateral hemispheric strokes. One patient died from exacerbation of congestive heart failure 9 days after undergoing a second carotid endarterectomy. The total stroke and death rate was 2.6% for all the patients. Two of the 98 procedures in the high-risk group were complicated with ipsilateral stroke (2.0%) as compared with six of the 317 low-risk procedures (1.9%; P = 1). Six procedures were complicated with cardiac dysfunction after surgery, including myocardial infarction, congestive heart failure, or the new onset of atrial fibrillation. Three cardiac complications occurred in the low-risk group (1%), and three occurred in the high-risk group (3.1%; P =.15). CONCLUSION: This series shows that patients at high risk can undergo carotid endarterectomy with stroke rates equivalent to the rates of patients at low risk. The cardiac morbidity rate may be increased in the high-risk group. Carotid stenting is unlikely to offer any improvement in stroke risk as compared with carotid endarterectomy, but stenting may reduce non-stroke morbidity rates associated with some high-risk cases.     

Sekundärprophylaxe symptomatischer Karotisstenosen

The SPACE trial compared risk and effectiveness of stent-protected angioplasty (CAS) versus carotid endarterectomy (CEA) in patients with symptomatic stenoses. In the intention-to-treat analysis of the entire study population of 1,214 patients, primary endpoint events (ipsilateral stroke or death occurring between randomization and day 30) occurred in 6.92% of the CAS group and 6.45% of the CEA group. The 95% confidence interval (CI) of the absolute risk difference ranged from –1.94% to +2.87%; therefore, superiority could not be proven. The same was true for the per-protocol analysis. No significant differences between the two treatment groups were found either for the primary endpoint or for any of the secondary endpoints. There were also no differences found regarding short-term prevention. The endpoint of ipsilateral ischemic stroke up to 1 year plus any periprocedural stroke or death occurred in 8.7% of the CAS patients and 7.6% of the CEA patients [odds ratio (OR) 1.16; 95% CI 0.76–1.75]. Following the per-protocol analysis, this endpoint occurred in 8.7% of the CAS patients compared with 6.7% of the CEA patients (OR 1.32; 95% CI 0.85–2.05). Recurrent stenoses, defined as at least 70% following ultrasound criteria, were significantly more common in the CAS group (ITT data: 7.7% vs. 4.1%; OR 1.98; 95%CI 1.19–3.28). Surgery remains the gold standard for treating patients with symptomatic carotid artery stenosis. However, in the hands of an experienced practitioner with a proven low periprocedural complication rate, stenting is an alternative treatment option.     

Perioperative strokes after 1001 consecutive carotid endarterectomy procedures without an electroencephalogram: incidence, mechanism, and recovery

HYPOTHESIS: That alternative methods of cerebral protection, especially routine shunting of all patients undergoing general anesthesia or shunting on the basis of neurologic assessment with the patient awake under cervical plexus block, result in outcomes of carotid endarterectomy comparable with those reported using electroencephalographic monitoring. DESIGN: Retrospective review of cases from a vascular registry established in 1990. SETTING: Tertiary care center. PATIENTS: Consecutive sample of 1001 patients who underwent carotid endarterectomy. INTERVENTIONS: Carotid endarterectomy procedures were performed without electroencephalographic monitoring, using general anesthesia with routine shunting or using regional anesthesia. MAIN OUTCOME MEASURES: Overall stroke and mortality rates and cause and consequence of the postoperative strokes. RESULTS: There were 14 nonfatal strokes (1.4%) and 2 deaths (0.2%), for a combined stroke and death rate of 1.6%. Nine (64%) of the 14 strokes appeared to result from a technical error during the endarterectomy. Mild deficits were noted after 7 strokes (50%), with the remainder resulting in deficits that required inpatient rehabilitation. Twelve patients with strokes (86%) eventually returned home without need for assistance. CONCLUSIONS: Most postoperative strokes in this series were due to technical errors. Overall, even in patients with strokes initially requiring inpatient rehabilitation, there was good recovery of function. Low stroke and mortality rates can be achieved in carotid endarterectomy without the use of electroencephalographic monitoring.