Effect of frailty syndrome on the outcomes of patients with carotid stenosis

BackgroundFrailty syndrome confers a greater risk of morbidity and mortality after operative interventions. The aim of the present study was to assess the effect of frailty on the outcomes after carotid interventions, including both carotid endarterectomy (CEA) and carotid artery stenting (CAS).MethodsWe performed an 8-year (2005-2012) retrospective analysis of the National Surgery Quality and Improvement Program database, including patients who had undergone CEA or CAS for carotid artery stenosis. A modified frailty index score was calculated. Frail status was defined as a modified frailty index score of ≥0.27. The outcome measures were inpatient complications, mortality, failure to rescue (FTR), hospital length of stay, and 30-day readmissions. Multivariable regression analysis was performed to study the association between frailty and the perioperative outcomes.ResultsThe data from 37,875 patients were included. Of the 37,875 patients, 95.7% had undergone CEA, and 27.3% of the patients were frail (27% of the CEA and 26% of the CAS groups had qualified as frail). Overall, 11.7% of the patients had experienced complications, 2.2% had died, and 6.7% had been readmitted after discharge. On regression analysis, after controlling for age, gender, albumin level, type of surgery, and American Society of Anesthesiologists class, frail status was an independent predictor of complications (23.5% vs 7.2%; P < .001), mortality (5.2% vs 1.1%; P = .02), FTR (12.1% vs 4.7%; P = .02), and 30-day readmissions (14.9% vs 3.7%; P = .03). On subanalysis of the patients who had undergone CAS, no association was found between frail status and the occurrence of complications (odds ratio [OR], 1.5; 95% confidence interval [CI], 0.8-3.2), mortality (OR, 1.2; 95% CI, 0.6-2.7), FTR (OR, 0.9; 95% CI, 0.4-2.3), and 30-day readmission rate (OR, 1.1; 95% CI, 0.5-3.1).ConclusionsFrailty syndrome was associated with morbidity and mortality among patients undergoing surgical interventions for carotid stenosis. In the present study, frailty was associated with significant mortality and morbidity for those who had undergone CEA but not for those who had undergone CAS. However, the present study was not designed to determine the optimal treatment of frail patients. Incorporating frailty status into the treatment algorithm (CEA vs CAS) might provide a more accurate risk assessment and improve patient outcomes.     

In-hospital outcomes alone underestimate rates of 30-day major adverse events after carotid artery stenting

ObjectiveOutcome studies using databases collecting only hospital discharge data underestimate morbidity and mortality because of failure to capture postdischarge events. The proportion of postdischarge major adverse events is well characterized in patients undergoing carotid endarterectomy (CEA) but has yet to be characterized after carotid artery stenting (CAS).MethodsWe retrospectively reviewed all patients undergoing CAS from 2011 to 2017 using the American College of Surgeons National Surgical Quality Improvement Program procedure targeted database to evaluate rates of 30-day major adverse events, stratified by in-hospital and postdischarge occurrences. The primary outcome was 30-day stroke/death. Multivariable analysis using purposeful selection was used to identify independent factors associated with in-hospital, postdischarge, and 30-day stroke/death events.ResultsOf the 899 patients undergoing CAS, reporting of in-hospital outcomes alone would yield a stroke/death rate of 2.7%, substantially underestimating the 30-day stroke/death rate of 4.0%. In fact, 35% of stroke/deaths, 27% of strokes, 73% of deaths, 35% of cardiac events, and 35% of stroke/death/cardiac events occurred after discharge. More postdischarge stroke/death events occurred after treatment of symptomatic compared with asymptomatic patients (47% vs 27%; P < .001). During this same study period, the 30-day stroke/death rate after CEA was 2.6%, with similar proportions of postdischarge strokes (28% vs 27%; P = .51) compared with CAS but lower proportions of postdischarge deaths (55% vs 73%; P < .001). After CAS, patients experiencing postdischarge stroke/death events had a shorter postoperative length of stay compared with patients with in-hospital stroke/death (1 [1-2] vs 5 [3-10] days; P < .001). Chronic obstructive pulmonary disease was independently associated with postdischarge stroke/death (odds ratio [OR], 4.4; 95% confidence interval [CI], 1.2-16; P = .02) after CAS. Nonwhite ethnicity was independently associated with overall 30-day stroke/death (OR, 3.4; 95% CI, 1.4-7.9; P < .01), whereas statin use was associated with not having stroke/death within 30 days (OR, 0.5; 95% CI, 0.2-1.0; P = .049).ConclusionsMore than one-quarter of perioperative strokes occur following discharge after both CAS and CEA. A higher proportion of postdischarge deaths occur after CAS in symptomatic patients, which may reflect treatment of a population of higher risk patients. Further investigation is needed to elucidate the cause of postdischarge stroke to develop methods to reduce these complications.     

Predictors of midterm high-grade restenosis after carotid revascularization in a multicenter national database

BackgroundRestenosis after carotid revascularization is clinically challenging. Several studies have looked into the management of recurrent restenosis; however, studies looking into factors associated with restenosis are limited. This study evaluated the predictors of restenosis after carotid artery stenting (CAS) and carotid endarterectomy (CEA) using a large national database.MethodsPatients undergoing CEA or CAS in the Vascular Quality Initiative data set (2003-2016) were analyzed. Patients with no follow-up (33%) and those who had prior ipsilateral CEA or CAS were excluded. Significant restenosis was defined as ≥70% diameter-reducing stenosis, target artery occlusion or peak systolic velocity ≥300 cm/s, or repeated revascularization. Kaplan-Meier survival analysis and bootstrapped Cox regression models with stepwise forward and backward selection were used.ResultsA total of 35,720 procedures were included (CEA, 31,329; CAS, 4391). No significant difference in restenosis rates was seen between CEA and CAS at 2 years (7.7% vs 9.4% [P = .09]; hazard ratio [HR], 0.99; 95% confidence interval [CI], 0.79-1.25; P = .97). However, after adjustment for age, sex, and symptomatic status at the time of the index operation, CAS patients who had postoperative restenosis were more likely to have a symptomatic presentation (odds ratio, 2.2; 95% CI, 1.2-4.0; P = .01) and to undergo repeated revascularization at 2 years (HR, 1.75; 95% CI, 1.3-2.4; P < .001) compared with patients who had restenosis after CEA. Predictors of restenosis after CAS included a common carotid artery lesion (HR, 1.65; 95% CI,1.06-2.57; P = .03), whereas age (HR, 0.91; 95% CI, 0.84-0.99; P = .03) and dilation after stent placement (HR, 0.53; 95% CI, 0.39-0.72; P < .001) were associated with decreased restenosis at 2 years. Predictors of restenosis after CEA included female sex (HR, 1.55; 95% CI, 1.38-1.74; P < .001), prior neck irradiation (HR, 2.35; 95% CI, 1.66-3.30; P < .001), and prior bypass surgery (HR, 1.29; 95% CI, 1.01-1.65; P = .04). On the other hand, factors associated with decreased restenosis after CEA included age (HR, 0.95; 95% CI, 0.92-0.98; P < .001), black race (HR, 0.57; 95% CI, 0.37-0.89; P = .01), patching (HR, 0.61; 95% CI, 0.47-0.79; P < .001), and completion imaging (HR, 0.70; 95% CI, 0.52-0.95; P = .02).ConclusionsOur results show no significant difference in restenosis rates at 2 years between CEA and CAS. Restenosis after CAS is more likely to be manifested with symptoms and to undergo repeated revascularization compared with that after CEA. Poststent ballooning after CAS and completion imaging and patching after CEA are associated with decreased hazard of restenosis; however, further research is needed to assess longer term outcomes and to balance the risks vs benefits of certain practices, such as poststent ballooning.     

Clinical impact of sex on carotid revascularization

BackgroundThe impact of sex in the management of carotid disease is unclear in the current literature. Therefore, we evaluated the effect of sex on perioperative outcomes following carotid endarterectomy (CEA) and carotid artery stenting (CAS).MethodsWe included patients who underwent CEA or CAS between 2012 and 2017 in the Vascular Quality Initiative database. Our primary outcome was perioperative stroke/death. Secondary outcomes were in-hospital stroke, 30-day mortality, and in-hospital MI. We compared perioperative outcomes between female and male patients, stratified by treatment modality and symptom status, and used multivariable regression to account for differences in baseline characteristics.ResultsA total of 83,436 patients underwent either a CEA (71,383) or CAS (12,053). Asymptomatic and symptomatic CEA females were less likely to be on a preoperative antiplatelet agent, when compared to males. Females overall, were less likely to be on a preoperative statin and more likely to have chronic obstructive pulmonary disease. Within the CAS cohort, females were more likely to have a previous ipsilateral CEA. There were no differences between males and females in major adverse events following CEA for asymptomatic disease. Following CEA for symptomatic disease, there was no difference in stroke/death rate or in-hospital stroke. However, females experienced a higher 30-mortality after adjustment (univariate: 1.0% vs 0.7%, P = .04; adjusted: odds ratio [OR], 1.4:1.02-1.94). Following CAS for asymptomatic disease, females experienced a higher rate of perioperative stroke/death (2.9% vs 1.9% P = .02; OR, 1.5: 1.05-2.03) and in-hospital stroke (2.1% vs 1.2% P = .01; OR, 1.8: 1.20-2.60). There were no differences in outcomes for symptomatic females vs males undergoing CAS.ConclusionsFemales with carotid disease less frequently receive optimal medical treatment with antiplatelet agents and statins. This is an important target area for quality improvement issue in both females and males. Furthermore, among symptomatic CEA patients the female sex is associated with higher mortality and among asymptomatic CAS patients, females experience higher rates of stroke/death. These findings suggest that careful patient selection is necessary in the treatment of female patients. Quality improvement projects should be created to further investigate and eliminate the disparities of optimal medical management between the sexes.     

The effect of clinical coronary disease severity on outcomes of carotid endarterectomy with and without combined coronary bypass

ObjectiveThe management of patients with carotid stenosis and symptomatic coronary artery disease (CAD) is challenging. This study assessed the impact of clinical coronary disease severity on carotid endarterectomy (CEA) with and without combined coronary artery bypass (CCAB).MethodsUsing the Vascular Quality Initiative, patients with symptomatic CAD who underwent CCAB or isolated CEA (ICEA) from 2003 to 2017 were identified. Patients were stratified by CAD severity: stable angina (SA) and recent myocardial infarction/unstable angina (UA). Primary outcomes, including perioperative stroke, myocardial infarction (MI), and stroke/death/MI (SDM), were assessed between procedures within each CAD cohort.ResultsThere were 9098 patients identified: 887 CCAB patients (215 [24%] SA, 672 [76%] UA) and 8211 ICEA patients (6385 [78%] SA, 1826 [22%] UA). Overall, CCAB patients had higher rates of stroke (2.6% vs 1.3%; P = .002) and SDM (7.3% vs 3.5%, P < .001) but similar rates of MI (0.9% vs 1.6%; P = .12) compared with ICEA patients. In SA patients, no difference was seen in stroke (ICEA 1.2% vs CCAB 1.9%; P = .36), MI (1.3% vs 1.4%; P = .95), or SDM (2.9% vs 4.7%; P = .13). In UA patients, no difference was seen in stroke (ICEA 1.6% vs CCAB 2.8%; P = .06), but ICEA patients had higher rates of MI (2.4% vs 0.7%; P = .01) and CCAB patients had higher rates of SDM (8.2% vs 5.5%; P = .01). After logistic regression in the UA cohort, predictors of MI included ICEA (odds ratio [OR], 2.7; 95% confidence interval [CI], 1.1-7.0; P = .04) and carotid symptomatic status (OR, 2.1; 95% CI, 1.1-3.8; P = .01); carotid symptomatic status also predicted stroke (OR, 2.0; 95% CI, 1.1-3.6; P = .03), but CCAB did not.ConclusionsIn patients with symptomatic CAD, both clinical CAD severity and operative strategy affect outcomes. In SA patients, CCAB does not increase perioperative morbidity. However, CCAB in UA patients prevents MI while not appreciably increasing stroke risk. This suggests that coronary revascularization before or concomitant with CEA should be considered in UA patients but that prioritizing coronary intervention is less important in SA patients.     

Impact of plaque dilation before carotid artery stent deployment

ObjectivePlaque stability is of utmost importance for stroke prevention in the perioperative period (within 24 hours) following carotid artery stenting (CAS). Although carotid plaque is entrapped between stent struts after stent deployment, postdilation can cause a scissoring effect on the plaque, increasing the risk of postprocedural embolic events due to plaque prolapse. Maximum carotid plaque dilation before stent deployment may reduce this risk. This study analyzed the effect of maximum dilation of the carotid plaque before stent deployment (max-pre-SD) or after stent deployment (post-SD) on macroscopic plaque debris, hemodynamic depression (HD), and immediate major adverse events.MethodsThis prospective nonrandomized multicenter study analyzed patients treated for carotid artery stenosis with CAS from January 2014 to August 2016. Clinical and morphologic characteristics and operative details were analyzed with logistic regression analysis for macroscopic debris and HD. The number of microembolic signals (MESs) was assessed by transcranial Doppler and analyzed.ResultsA total of 309 patients were enrolled and treated with standard CAS performed using a proximal occlusion cerebral embolic protection device; 149 received max-pre-SD and 160 were treated with post-SD. Technical success was achieved in 100% of cases. Macroscopic debris and HD were significantly different between the two groups in favor of max-pre-SD (P < .001). A significant difference in intraprocedural MESs between the groups was detected. Compared with post-SD, max-pre-SD significantly reduced mean MES counts (8.1% vs 68.1%; P < .001). Patients treated with post-SD had a significantly increased risk of MESs in the immediate postoperative period compared with patients treated with max-pre-SD (41.9% vs 1.3%; P < .001).This result was mainly due to the small number of events encountered. Patients treated with post-SD had a 12-fold increased risk of macroscopic debris collection (odds ratio [OR], 12.36; 95% confidence interval [CI], 5.68-26.87; P < .001) and an 18 times increase in HD risk (OR, 17.80; 95% CI, 5.27-60.17; P < .001) compared with patients treated with max-pre-SD. The heterogeneous, mainly echolucent plaque type significantly highly increased the risk of macroscopic debris (OR, 78.45; 95% CI, 8.70-707.09; P < .001) while acting as a protective factor against HD (OR, 0.02; 95% CI, 0.006-0.11; P < .001) along with echogenic or echolucent complex plaques with irregular surface plaque types (OR, 0.10; 95% CI, 0.031-0.336; P < .001). No significant differences between groups (max-pre-SD group and post-SD) were detected in immediate major adverse events (minor stroke, 2.0% and 2.5% [P = .461]; major stroke, 0% and 0.6% [P = .334], respectively).ConclusionsMax-pre-SD seems to be a safe and feasible technical modification to the CAS procedure. Macroscopic debris, HD, and MESs are significantly reduced compared with CAS with post-SD. Further research with larger, randomized cohorts of patients is required to establish the superiority of this technical modification.     

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.     

Contemporary outcomes after carotid endarterectomy in high-risk anatomic and physiologic patients

ObjectiveCurrent 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.MethodsWe 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.ResultsWe 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]).ConclusionsAs 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.     

Insurance status is associated with urgent carotid endarterectomy and worse postoperative outcomes

ObjectiveUnderinsured patients can experience worse preoperative medical optimization. We aimed to determine whether insurance status was associated with carotid endarterectomy (CEA) urgency and postoperative outcomes.MethodsWe analyzed the Society for Vascular Surgery Vascular Quality Initiative Carotid Endarterectomy dataset from January 2012 to January 2021. Univariable and multivariable methods were used to analyze the differences across the insurance types for the primary outcome variable: CEA urgency. The analyses were limited to patients aged <65 years to minimize age confounding across insurers. We also examined differences in preoperative medical optimization and symptomatic disease and postoperative outcomes. A secondary analysis was performed to examine the effect of CEA urgency on the postoperative outcomes.ResultsA total of 27,331 patients had undergone first-time CEA. Of these patients, 4600 (17%) had Medicare, 3440 (13%) had Medicaid, 17,917 (65%) had commercial insurance, and 1374 (5%) were uninsured. The Medicaid and uninsured patients had higher rates of urgent operation compared with Medicare (20.0% and 34.7% vs 14.4%; P < .001), with no differences in the commercial group vs the Medicare group. Additionally, Medicaid and uninsured patients had lower rates of aspirin, statin, and/or antiplatelet use (93.6% and 93.5% vs 95.8%; P < .001) and higher rates of symptomatic disease (42.1% and 57.6% vs 36.2%; P < .001) compared with Medicare patients. The rate of perioperative stroke/death was higher for the Medicaid and uninsured patients than for the Medicare patients (1.63% and 1.89% vs 1.02%; P = .017 and P = .01, respectively), with no differences in the commercial group. Multivariable analysis demonstrated that compared with Medicare, Medicaid and uninsured status were associated with increased odds of an urgent operation (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.1-1.5; and OR, 2.3; 95% CI, 2.0-2.7, respectively), symptomatic disease (OR, 1.2; 95% CI, 1.1-1.4; and OR, 2.2; 95% CI, 1.9-2.5, respectively), and perioperative stroke/death (OR, 1.6; 95% CI, 1.1-2.4; and OR, 1.8; 95% CI, 1.1-3.0, respectively) and a decreased odds of aspirin, statin, and/or antiplatelet use (OR, 0.71; 95% CI, 0.6-0.9; and OR, 0.76; 95% CI, 0.6-0.99, respectively). Additionally, the rates of perioperative stroke/death were higher for patients who had required urgent surgery compared with elective surgery (2.8% vs 1.0%; P < .001). Multivariable analysis demonstrated increased odds of perioperative stroke/death for patients who had required urgent surgery (OR, 2.4; 95% CI, 1.9-3.1).ConclusionsMedicaid and uninsured patients were more likely to require urgent CEA, in part because of poor preoperative medical optimization. Additionally, urgent operation was independently associated with worse postoperative outcomes. These results highlight the need for improved preoperative follow-up for underinsured populations.     

Anatomic eligibility for transcarotid artery revascularization and transfemoral carotid artery stenting

ObjectiveTranscarotid artery revascularization (TCAR) has emerged as an alternative to transfemoral carotid artery stenting (tfCAS). We investigated the proportion of carotid arteries undergoing revascularization procedures that would be eligible for TCAR based on anatomic criteria and how many arteries at high anatomic risk for tfCAS would be amenable to TCAR.MethodsWe performed a retrospective review of consecutive patients who underwent carotid endarterectomy or carotid stenting between 2012 and 2015. Patients were excluded if computed tomography angiography of the neck was not performed within 6 months of the procedure. We assessed TCAR eligibility on the basis of the instructions for use of the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif) and high anatomic risk for tfCAS on the basis of anatomic factors known to make carotid cannulation more difficult or hazardous.ResultsOf the 118 patients and 236 carotid arteries identified, 12 carotid arteries were excluded for presence of an occluded internal carotid artery (ICA). Of the remaining 224 carotid arteries, 72% were eligible for TCAR on the basis of the instructions for use criteria; 100% had 4- to 9-mm ICA diameters, 100% had ≥6-mm common carotid artery (CCA) diameter, 75% had ≥5-cm clavicle to carotid bifurcation distance, and 96% lacked significant CCA puncture site plaque. In addition, 7% of carotid arteries had bifurcation anatomy unfavorable for stenting; thus, of the entire cohort of arteries examined, 68% were eligible for TCAR. Hyperlipidemia (odds ratio [OR], 6.7; 95% confidence interval [CI], 1.7-26; P < .01), chronic obstructive pulmonary disease (OR, 3.5; 95% CI, 1.5-8.3; P < .01), and older age (OR, 1.1; 95% CI, 1.0-1.1; P < .01) were independently associated with TCAR ineligibility, whereas white race (OR, 0.2; 95% CI, 0.0-1.0; P = .048) and beta-blocker use (OR, 0.3; 95% CI, 0.1-0.7; P < .01) were independently associated with TCAR eligibility. In addition, 24% of carotid arteries were considered to be at high risk for tfCAS for the presence of a type III aortic arch (7.6%), severe aortic calcification (3.3%), tandem CCA lesions (7.1%), moderate to severe stenosis at the carotid ostium (8.9%), and tortuous distal ICA precluding embolic filter placement (4.5%). Active smoking (OR, 4.4; 95% CI, 1.9-10; P < .01), hyperlipidemia (OR, 4.0; 95% CI, 1.2-14; P = .03), and older age (OR, 1.1; 95% CI, 1.0-1.1; P = .02) were independently associated with tfCAS ineligibility, whereas preoperative aspirin (OR, 0.1; 95% CI, 0.0-0.4; P < .001) or clopidogrel (OR, 0.3; 95% CI, 0.1-0.8; P = .01) use was associated with tfCAS eligibility. Of the arteries that were considered to be at high risk for tfCAS, 69% were eligible for TCAR.ConclusionsThe majority of carotid arteries in individuals selected for revascularization meet TCAR eligibility, making TCAR a viable treatment option for many patients.     

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.     

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.     

In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative

ObjectiveTranscarotid 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.MethodsWe 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.ResultsA 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.ConclusionsDespite 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.     

Surgeon specialty significantly affects outcome of asymptomatic patients after carotid endarterectomy

BackgroundThis study evaluates the impact of surgical specialty, specifically vascular surgery (VS) versus non-VS (NVS; namely, cardiac surgery, thoracic surgery, general surgery, or neurosurgery) on perioperative carotid endarterectomy (CEA) outcomes stratified by symptom status on presentation.MethodsThe National Surgical Quality Improvement Program Vascular Procedure Targeted database was queried for elective asymptomatic or symptomatic CEA (excluding concomitant CEA and cardiac surgery) from 2011 to 2016. Data were stratified by VS versus NVS and symptom presentation. Primary end points were 30-day stroke and stroke/death; secondary end points included perioperative complications. Multivariable logistic regression determined predictors of all assessed primary outcomes and propensity-weight analysis was used to confirm results.ResultsOverall, 21,060 CEA (12,671 [59%] asymptomatic) were identified with 19,687 (93%) done by VS. In the asymptomatic CEA cohort, VS had lower unadjusted stroke (1.3% vs 2.4%; P = .021) and stroke/death (1.7% vs 3.2%; P = .006) rates. In addition, VS had fewer deaths (0.6% vs 1.3%; P = .033) and pulmonary complications (1.6% vs 2.7%; P = .036). After risk adjustment, the NVS asymptomatic cohort predicted stroke (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.1-3.1; P = .032), driven by neurosurgery (OR, 3.1; 95% CI, 1.3-7.2; P = .008). This NVS cohort also predicted stroke/death (OR, 1.8; 95% CI, 1.1-2.9; P = .013), driven by neurosurgery (OR, 2.5; 95% CI, 1.1-5.7; P = .035). After propensity weighting, these differences persisted (stroke: OR, 1.9; 95% CI, 1.1-3.3; P = .030; stroke/death: OR, 1.9; 95% CI, 1.2-3.0; P = .011). Among symptomatic CEA, there was no difference between VS and NVS in unadjusted primary end points of stroke (3.1% vs 4.2%; P = .106) or stroke/death (3.8% vs 4.6%; P = .275). However, in this cohort, VS had fewer major complications (12.7% vs 15.5%; P = .029).ConclusionsThis study identifies the VS specialty as having significantly better outcomes after CEA in patients presenting with asymptomatic disease than NVS specialty, as evidenced by lower rates of stroke and stroke death, which persisted after risk adjustment and propensity weighting. This difference in stroke and stroke/death was not apparent in the symptomatic cohort; however, NVS did have increased unadjusted rates of major complications. Although this finding may reflect multiple factors, including higher operative volume, training, or technical approach, these differences in 30-day CEA outcomes may be crucial for the proper interpretation of ongoing national outcome trials such as CREST2.     

Prediction of long-term mortality for patients with severe asymptomatic de novo carotid stenosis undergoing carotid endarterectomy (PREMY2SE-CEA): Derivation and validation of a novel risk score

ObjectiveThe aim of the present study was to develop and validate a risk prediction model for the prediction of long-term mortality for patients with severe asymptomatic de novo carotid stenosis undergoing carotid endarterectomy (PREMY²SE-CEA).MethodsData were collected retrospectively from a dedicated database of consecutive patients who had undergone elective CEA for severe (>70% using the NASCET [North American Symptomatic Carotid Endarterectomy Trial] criteria) asymptomatic carotid stenosis at two Italian University Hospitals from 2008 through 2016. Internal validation of the score was performed after random sampling in a 3:1 fashion. The primary end point of the PREMY²SE-CEA risk score was the 5-year mortality.ResultsOf the 1214 patients, 901 were included in the derivation cohort and 313 in the validation cohort. Using multivariable logistic regression with backward elimination, a parsimonious model was derived. A risk score incorporating eight risk factors was generated and found to be highly predictive of long-term mortality in the derivation (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.28-1.41; P < .001) and validation (OR, 1.29; 95% CI, 1.21-1.37; P <.001) cohorts. The discrimination power in the receiver operating characteristic curve analysis was C = 0.775 (95% CI, 0.74-.80), and the optimism-corrected area under the curve in the bootstrapped samples was 0.761 (P < .001). A strong correlation was found between the predicted and actual mortality rates in the validation cohort (r = 0.71; P < .001).ConclusionsIn the present study, we have described the development, evaluation, and validation of a risk prediction model (PREMY²SE-CEA) for long-term mortality after CEA in asymptomatic patients. Physicians could use the PREMY²SE-CEA risk scoring tool to complement their estimates of life expectancy and prompt selective consideration of prophylactic CEA to improve the long-term benefits of interventions.     

In-hospital outcomes after carotid endarterectomy for stroke stratified by modified Rankin scale score and time of intervention

ObjectiveAlthough the benefits of carotid endarterectomy (CEA) for treating symptomatic carotid stenosis are well known, the optimal timing of intervention after acute stroke and whether the optimal timing will vary with preoperative stroke severity has remained unclear. Therefore, we assessed the effect of stroke severity and timing of the intervention on the postoperative outcomes for patients who had undergone CEA for stroke.MethodsWe identified all patients in the Vascular Quality Initiative who had undergone CEA from 2012 to 2020 for prior stroke. The patients were stratified using the preoperative modified Rankin scale score (mRS score, 0-5) and time to CEA after stroke onset (≤2 days, 3-14 days, 15-90 days, 91-180 days). After univariate comparisons, the patients were stratified into the following mRS cohorts for further analysis: 0 to 1, 2, 3 to 4, and 5. The primary outcome was in-hospital stroke/death.ResultsWe identified 15,601 patients, of whom 30% had had an mRS score of 0, 34% an mRS score of 1, 17% an mRS score of 2, 11% an mRS score of 3, 8% an mRS score of 4, and 1% an mRS score of 5. Overall, 9.3% of the patients had undergone CEA within ≤2 days, 46% within 3 to 14 days, 36% in 15 to 90 days, and 8.4% within 90 to 180 days. A decreasing mRS score and an increasing time to CEA were associated with lower rates of perioperative stroke/death (P_trend < .01). After risk adjustment, with CEA at 3 to 14 days as the comparator group, the mRS score 0 to 1 group had had a higher incidence of stroke/death after CEA within ≤2 days (3.6% vs 2.0%; odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2-2.7). The mRS score 2 group had had a similar incidence of stroke/death after CEA within ≤2 days (4.4% vs 3.9%; OR, 1.2; 95% CI, 0.6-2.3) but a lower incidence after CEA at 15 to 90 days (2.1% vs 3.9%; OR 0.5; 95% CI, 0.3-0.96). The mRS score 3 to 4 group had had a higher incidence of stroke/death after CEA within ≤2 days (8.0% vs 3.8%; OR, 2.4; 95% CI, 1.5-3.9) but a similar incidence of stroke/death after CEA at 15 to 90 days (3.0% vs 3.8%; OR, 0.8; 95% CI, 0.5-1.3). For the mRS score 5 group, the stroke/death rates were ≥6.5% across all the time to CEA groups. However, the low sample size limited meaningful comparisons.ConclusionsPatients with minimal disability after stroke (mRS score, 0-1) seemed to benefit from CEA within 3 to 14 days. However, those with severe disability (mRS score 5) have a very high risk from CEA at any time point given the poor outcomes. In contrast to the current guidelines, patients with mild disability (mRS score 2) could benefit from delaying CEA to 15 to 90 days, and those with moderate disability (mRS score 3-4) might benefit from CEA within 3 to 90 days given the acceptable in-hospital outcomes. These data should be considered within the context of the clinical situation in the weeks after index event to determine the net benefit of delayed CEA.     

Impact of residual stenosis on clinical outcomes when performing carotid artery stenting without postdilation

ObjectiveMany centers consider postdilation if the final angiography after carotid artery stenting (CAS) shows residual stenosis of >30% to 40%. Postdilation has been demonstrated to potentially increase the risk of developing neurologic events. This study aimed to investigate the safety of CAS without postdilation regardless of the degree of residual stenosis.MethodsWe retrospectively investigated 191 patients who underwent transfemoral CAS without postdilation intendedly. All cases underwent mild predilation and self-expanding stent implantation. We divided the patients into a residual stenosis of ≥40% group (n = 69 [36.1%]) and a residual stenosis of <40% group (n = 122 [63.9%]) according to their final angiography. We compared the procedural (within 30 days after CAS) and nonprocedural (afterward) adverse cardiovascular events and in-stent restenosis between the two groups. We also investigated the incidence of perioperative hemodynamic depression between the groups and the changes in residual stenosis over the follow-up time.ResultsPatients in the residual stenosis of ≥40% group had a higher preoperative stenosis rate and a greater proportion of severely calcified lesions than those in the <40% group. There was one procedural cardiac death (0.5%), five strokes (2.6%), and four myocardial infarctions (2.1%). A total of 2.9% had stroke or death procedurally in the residual stenosis of ≥40% group and 3.2% in the residual stenosis of <40% group (P > .950). The median nonprocedural follow-up time was 22 months, with a total of six deaths and four strokes. The cumulative 2-year death or stroke rate was 6.2%, with 5.9% in the residual stenosis of ≥40% group versus 6.7% in the residual stenosis of <40% group (P = .507). There were two cases of in-stent restenosis in the residual stenosis of ≥40% group and three in the residual stenosis of <40% group (P = .927). The difference in the peak systolic velocity of the target lesion between groups at 3 months after CAS was no longer present, and residual stenosis stabilized at 10% to 20% at 6 months in both groups. The patients showed an association between increasing hemodynamic depression incidence and residual stenosis in a significantly graded response (P = .021).ConclusionsResidual stenosis after carotid stenting without postdilation is not associated with a risk of postoperative adverse events. This study provides evidence for the feasibility of a no postdilation strategy for CAS.     

Periprocedural P2Y12 inhibitors improve perioperative outcomes after carotid stenting by primarily decreasing strokes

ObjectiveThe continuation of antiplatelet agents in the periprocedural period around carotid stenting (CAS) procedures is felt to be mandatory to minimize the risk of periprocedural stroke. However, the optimal antiplatelet regimen is unclear, with some advocating dual antiplatelet therapy, and others supporting the use of P2Y₁₂ inhibitors alone. The objective of this study was to evaluate the periprocedural effect of P2Y₁₂ inhibitors for CAS.MethodsThe Vascular Quality Initiative was used from years 2007 to 2020. All transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TF-CAS) procedures were included. Patients were stratified based on perioperative use of P2Y₁₂ inhibitors as well as symptomatic status. Primary end points were perioperative neurological events (strokes and transient ischemic attacks). Secondary end points were mortality and myocardial infarction.ResultsA total of 31,036 CAS procedures were included for analysis, with 49.8% TCAR and 50.2% TF-CAS cases; 63.8% of patients were male and 82.3% of patients were on a P2Y₁₂ inhibitor. P2Y₁₂ inhibitor use was more common in males, asymptomatic patients, those older than 70 years, and concurrent statin use. P2Y₁₂ inhibitors were more likely to be used in TCAR cases than in TF-CAS cases (87.3% vs 76.8%; P < .001). The rate of periprocedural neurological events in the whole cohort was 2.6%. Patients on P2Y₁₂ inhibitors were significantly less likely to experience a periprocedural neurological event (2.3% vs 3.9%; P < .001) and mortality (0.6% vs 2.1%; P < .001) than those who were not on a P2Y₁₂ inhibitor. There was no effect on the rates of myocardial infarction. On multivariate analysis, both symptomatic and asymptomatic patients on P2Y₁₂ inhibitors were significantly less likely to develop perioperative neurological events. Additionally, the use of P2Y₁₂ inhibitors demonstrated an independent significant effect in reducing of the rate of perioperative stroke (odds ratio, 0.29; 95% confidence interval, 0.25-0.33). Finally, additional analysis of the types of P2Y₁₂ inhibitors used revealed that all seemed to be equally effective in decreasing the periprocedural neurological event rate.ConclusionsThe use of perioperative P2Y₁₂ inhibitors seems to markedly decrease the perioperative neurological event rate with TCAR and TF-CAS in both symptomatic and asymptomatic patients and should be strongly considered. Patients with contraindications to P2Y₁₂ inhibitors may not be appropriate candidates for any CAS procedure. Additionally, alternative types of P2Y₁₂ inhibitors seem to be equally effective as clopidogrel. Finally, an analysis of the Vascular Quality Initiative demonstrates that, even for TCAR cases, only 87.3% of patients seem to be on P2Y₁₂ inhibitors in the periprocedural period, leaving room for significant improvement.     

Comparison of outcomes in women and men following carotid interventions in the Washington state's Vascular Interventional Surgical Care and Outcomes Assessment Program

Background

The benefit for carotid endarterectomy (CEA) to prevent a potential stroke has been shown to be less beneficial for women compared with men and the risk of carotid stenting (CAS) is higher in women than men. We hypothesized that a community-based Washington state registry data would also reveal increased morbidity and mortality for women undergoing carotid interventions.

Patients with moderate to severe strokes (NIHSS score >10) undergoing urgent carotid interventions within 48 hours have worse functional outcomes

ObjectiveIncreasing evidence suggests that urgent carotid intervention after a nondisabling stroke is safe. However, the functional outcome of such patients has not been quantified for various degrees of stroke. We aimed to determine whether increased presenting stroke severity and timing to intervention are associated with poor functional outcomes in patients undergoing urgent carotid endarterectomy (CEA) or carotid artery stenting (CAS) after an acute transient ischemic attack or stroke.MethodsWe reviewed all urgent carotid interventions from January 2013 through April 2017 at a single tertiary referral center. Preoperative variables analyzed included admission stroke severity, calculated by National Institutes of Health Stroke Scale (NIHSS). The primary end point was the patient's neurologic functional independence at discharge, quantified by the modified Rankin scale (mRS) score (≤2, functionally independent; ≥3, dependent). Primary complications were defined as new or worsened stroke, intracranial hemorrhage, and death.ResultsA total of 120 urgent carotid interventions (CEA, n = 96; CAS, n = 22; 1 CEA with middle cerebral artery aspiration thrombectomy and 1 carotid embolectomy) were performed. Bivariate analysis demonstrated a correlation between admission NIHSS score and mRS score when patients were divided into groups with an admission NIHSS score ≤10 and >10 (P = .0029). Patients presenting with larger strokes (NIHSS score >10) were 3.4 times more likely (95% confidence interval [CI], 1.2-9.6; P = .024) to have functional dependence (mRS score ≥3) at discharge than patients presenting with minor to moderate strokes (NIHSS score ≤10). Patients undergoing CEA or CAS before 48 hours were also associated with a worse discharge mRS score compared with those undergoing carotid interventions after 48 hours (odds ratio, 3.5; 95% CI, 1.4-8.7; P = .007). Even when emergent carotid interventions were excluded from the subgroup of patients undergoing CEA or CAS within 48 hours, discharge mRS correlated with time to procedure (days 1- 2 compared with >2 days). The odds of having discharge functional dependence (mRS score ≥3) were 3.4 times more likely for patients with the procedure performed at 1 to 2 days compared with >2 days (95% CI, 1.3-9.1; P = .014).ConclusionsUrgent carotid intervention performed in patients with moderate or severe strokes (NIHSS score >10) and before 48 hours is associated with functional dependence (mRS score ≥3) on hospital discharge. By demonstrating a clear correlation between admission NIHSS score and interval time to procedure with independent neurologic functional outcomes, these data aid in clinical decision-making for this high-risk subpopulation of patients who present with acute symptomatic carotid lesions.