Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy.

BACKGROUND: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. METHODS: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. FINDINGS: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91-1·32; p=0·21). INTERPRETATION: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. FUNDING: UK Medical Research Council and Health Technology Assessment Programme.

Editor's Choice - Risk of Stroke before Revascularisation in Patients with Symptomatic Carotid Stenosis: A Pooled Analysis of Randomised Controlled Trials.

OBJECTIVE: Current guidelines recommending rapid revascularisation of symptomatic carotid stenosis are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today. The risk of stroke and its predictors among patients with symptomatic carotid stenosis awaiting revascularisation in recent randomised controlled trials (RCTs) and in medical arms of earlier RCTs was assessed. METHODS: The pooled data of individual patients with symptomatic carotid stenosis randomised to stenting (CAS) or endarterectomy (CEA) in four recent RCTs, and of patients randomised to medical therapy in three earlier RCTs comparing CEA vs. medical therapy, were compared. The primary outcome event was any stroke occurring between randomisation and treatment by CAS or CEA, or within 120 days after randomisation. RESULTS: A total of 4 754 patients from recent trials and 1 227 from earlier trials were included. In recent trials, patients were randomised a median of 18 (IQR 7, 50) days after the qualifying event (QE). Twenty-three suffered a stroke while waiting for revascularisation (cumulative 120 day risk 1.97%, 95% confidence interval [CI] 0.75 - 3.17). Shorter time from QE until randomisation increased stroke risk after randomisation (χ2 = 6.58, p = .011). Sixty-one patients had a stroke within 120 days of randomisation in the medical arms of earlier trials (cumulative risk 5%, 95% CI 3.8 - 6.2). Stroke risk was lower in recent than earlier trials when adjusted for time between QE and randomisation, age, severity of QE, and degree of carotid stenosis (HR 0.47, 95% CI 0.25 - 0.88, p = .019). CONCLUSION: Patients with symptomatic carotid stenosis enrolled in recent large RCTs had a lower risk of stroke after randomisation than historical controls. The added benefit of carotid revascularisation to modern medical care needs to be revisited in future studies. Until then, adhering to current recommendations for early revascularisation of patients with symptomatic carotid stenosis considered to require invasive treatment is advisable.

Impact of hospital safety-net status on clinical outcomes following carotid artery revascularization.

BACKGROUND: High hospital safety-net burden has been associated with inferior clinical outcomes. We aimed to characterize the association of safety-net burden with outcomes in a national cohort of patients undergoing carotid interventions. METHODS: The 2010-2017 Nationwide Readmissions Database was used to identify adults undergoing carotid endarterectomy and carotid artery stenting. Hospitals were classified as low (LBH), medium, or high safety-net burden (HBH) based on the proportion of uninsured or Medicaid patients. Multivariable models were developed to evaluate associations between HBH and outcomes. RESULTS: Of an estimated 540,558 hospitalizations for a carotid intervention, 28.5% were at HBH. Patients treated at HBH were more likely to be admitted non-electively (28.7% vs 20.2%, P < .001), have symptomatic presentation (11.0% vs 7.7%, P < .001), and undergo carotid artery stenting (18.7% vs 8.9%, P < .001). After adjustment, HBH remained associated with increased odds of postoperative stroke (AOR 1.19, P = .023, Ref = LBH), non-home discharge (AOR 1.10, P = .026), 30-day readmissions (AOR 1.14, P < .001), and 31-90-day readmissions (AOR 1.13, P < .001), but not in-hospital mortality (AOR 1.18, P = .27). HBH was linked to increased hospitalization costs (ß +$2,169, P = .016). CONCLUSION: HBH was associated with postoperative stroke, non-home discharge, readmissions, and increased hospitalization costs after carotid revascularization. Further studies are warranted to alleviate healthcare inequality and improve outcomes at safety-net hospitals.

State of the Union in Open Neurovascular Training.

BACKGROUND: The evolution of minimally invasive endovascular approaches and training paradigms has reduced open neurovascular case exposure for neurosurgical residents. There are no published estimates of open neurovascular case volumes during residency or Committee on Advanced Subspecialty Training (CAST) accredited fellowships. METHODS: Case volumes from residency programs submitting data for CAST accredited fellowship applications were collected and analyzed. The study period covered the academic years of 2013-2016. Case index volumes were calculated to provide an estimate of total volume of cases each trainee participated in a given year. The case index volume was defined as the total volume of cases per year divided by the total training complement. RESULTS: Over the study period, institutional data from 46 programs were available. Of those programs, 9 programs had CAST accredited open cerebrovascular fellowships. Across all 46 programs, the median number of vascular cases was 246 (interquartile range [IQR]: 148-340), whereas the median number of open vascular cases was 105 (IQR: 67-152). The median number of open aneurysm cases among programs with CAST cerebrovascular fellowships was 80 (IQR: 54-103) and among programs without CAST cerebrovascular fellowships was 34 (IQR: 24-63). The median open aneurysm case index volume for trainees at programs with and without CAST cerebrovascular fellowships was 23 (IQR: 14-29) and 19 (IQR: 11-24). CONCLUSIONS: Strong neurovascular training can be obtained through dedication and planning. Completion of a CAST accredited cerebrovascular fellowship will often more than double aneurysm case exposure of trainees.

Examining variation in Medicare payments and drivers of cost for carotid endarterectomy.

BACKGROUND: There is a growing interest in providing high quality and low-cost care to Americans. A pursuit exists to measure not only how well hospitals are performing but also at what cost. We examined the variation in costs associated with carotid endarterectomy (CEA), to determine which components contribute to the variation and what drives increased payments. MATERIALS AND METHODS: Patients undergoing CEA between 2009 and 2012 were identified in the Medicare provider and analysis review database. Hospital quintiles of cost were generated and variation examined. Multivariable logistic regression was performed to identify independent predictors of high-payment hospitals for both asymptomatic and symptomatic patients undergoing CEA. RESULTS: A total of 264,018 CEAs were performed between 2009 and 2012; 250,317 were performed in asymptomatic patients in 2302 hospitals and 13,701 in symptomatic patients in 1851 hospitals. Higher payment hospitals had a higher percentage of nonwhite patients and comorbidity burden. The largest contributors to variation in overall payments were diagnosis-related groups, postdischarge, and readmission payments. After accounting for clustering at the hospital level, independent predictors of high-payment hospitals for all patients were postoperative stroke, length of stay, and readmission ,whereas in the symptomatic group, additional drivers included yearly volume and serious complications. CONCLUSIONS: CEA Medicare payments vary nationwide with diagnosis-related group, readmission, and postdischarge payments being the largest contributors to overall payment variation. In addition, stroke, length of stay, and readmission were the only independent predictors of high payment for all patients undergoing CEA.

Clinical Effect and Cost-Effectiveness of Screening for Asymptomatic Carotid Stenosis: A Markov Model.

OBJECTIVE/BACKGROUND: The cost-effectiveness of screening depends on the cost of screening, prevalence of asymptomatic carotid artery stenosis (ACAS), and the potential effect of medical intervention in reducing the risk of stroke. The aim of the study was to determine the threshold values for these parameters in order for screening for ACAS to be cost-effective. METHODS: The clinical effect and cost-effectiveness of ultrasound screening for ACAS with subsequent initiation of preventive therapy versus not screening was assessed in a Markov model with a lifetime perspective. Key parameters, including stroke risk, all cause mortality, and costs, were based on contemporary published data, population statistics, and data from an ongoing screening program in Uppsala county (population 300,000), Sweden. Prevalence of ACAS (2%) and the rate of best medical treatment (BMT; 40%) were based on data from a male Swedish population recently screened for ACAS. The required stroke risk reduction from BMT, incremental cost-efficiency ratio (ICER), absolute risk reduction for stroke (ARR), and number needed to screen (NNS) were calculated. RESULTS: Screening was cost-effective at an ICER of €5744 per incremental quality adjusted life year (QALY) gained. ARR was 135 per 100,000 screened, NNS was 741, and QALYs gained were 6700 per 100,000 invited. At a willingness to pay (WTP) threshold of €50,000 per QALY the minimum required stroke risk reduction from BMT was 22%. The assumed degree of stroke risk reduction was the most important determinant of cost-efficiency. CONCLUSION: A moderate (22%) reduction in the risk of stroke was required for an ACAS screening strategy to be cost-effective at a WTP of €50,000/QALY. Targeting populations with a higher prevalence of ACAS could further improve cost-efficiency.

De-adoption and exnovation in the use of carotid revascularization: retrospective cohort study.

Objective To determine physician characteristics associated with exnovation (scaling back on use) and de-adoption (abandoning use) of carotid revascularization.Design Retrospective longitudinal cohort study.Setting Medicare claims linked to the Doximity database provider registry, 2006-13.Participants 9158 physicians who performed carotid revascularization on Medicare patients between 2006 and 2013.Main outcome measures The primary outcomes were the number of carotid revascularization procedures for each physician per year at the end of the sample period, and the percentage change in the volume of carotid revascularization procedures.Results At baseline (2006-07), 9158 physicians performed carotid revascularization. By 2012-13 the use of revascularization in this cohort had declined by 37.7%, with two thirds attributable to scaling back (exnovation) rather than dropping the procedure entirely (de-adoption). Compared with physicians with fewer than 12 years of experience, those with more than 25 years of experience decreased use by an additional 23.0% (95% confidence interval -36.7% to -9.2%). The lowest rates of decline occurred in physicians specializing in vascular or thoracic surgery, for whom the procedures accounted for a large share of revenue. Physicians with high proportions of patients aged more than 80 years or with asymptomatic carotid stenosis were less likely to reduce their use of carotid revascularization.Conclusion Surgeons with more experience and the lowest share in carotid revascularization practice reduced their use of the procedure the most. These practice factors should be considered in quality improvement efforts when the evidence base evolves away from a specific treatment.

Carotid Endarterectomy and Carotid Artery Stenting in the US Medicare Population, 1999-2014.

Importance: Carotid endarterectomy and carotid artery stenting are the leading approaches to revascularization for carotid stenosis, yet contemporary data on trends in rates and outcomes are limited. Objective: To describe US national trends in performance and outcomes of carotid endarterectomy and stenting among Medicare beneficiaries from 1999 to 2014. Design, Setting, and Participants: Serial cross-sectional analysis of Medicare fee-for-service beneficiaries aged 65 years or older from 1999 to 2014 using the Medicare Inpatient and Denominator files. Spatial mixed models adjusted for age, sex, and race were fit to calculate county-specific risk-standardized revascularization rates. Mixed models were fit to assess trends in outcomes after adjustment for demographics, comorbidities, and symptomatic status. Exposures: Carotid endarterectomy and carotid artery stenting. Main Outcomes and Measures: Revascularization rates per 100 000 beneficiary-years of fee-for-service enrollment, in-hospital mortality, 30-day stroke or death, 30-day stroke, myocardial infarction, or death, 30-day all-cause mortality, and 1-year stroke. Results: During the study, 937 111 unique patients underwent carotid endarterectomy (mean age, 75.8 years; 43% women) and 231 077 underwent carotid artery stenting (mean age, 75.4 years; 49% women). There were 81 306 patients who underwent endarterectomy in 1999 and 36 325 in 2014; national rates per 100 000 beneficiary-years decreased from 298 in 1999-2000 to 128 in 2013-2014 (P < .001). The number of patients who underwent stenting ranged from 10 416 in 1999 to 22 865 in 2006 (an increase per 100 000 beneficiary-years from 40 in 1999-2000 to 75 in 2005-2006; P < .001); by 2014, there were 10 208 patients who underwent stenting and the rate decreased to 38 per 100 000 beneficiary-years (P < .001). Outcomes improved over time despite increases in vascular risk factors (eg, hypertension prevalence increased from 67% to 81% among patients who underwent endarterectomy and from 61% to 70% among patients who underwent stenting) and the proportion of symptomatic patients (all P < .001). There were adjusted annual decreases in 30-day ischemic stroke or death of 2.90% (95% CI, 2.63% to 3.18%) among patients who underwent endarterectomy and 1.13% (95% CI, 0.71% to 1.54%) among patients who underwent stenting; an absolute decrease from 1999 to 2014 was observed for endarterectomy (1.4%; 95% CI, 1.2% to 1.5%) but not stenting (-0.1%; 95% CI, -0.5% to 0.4%). Rates for 1-year ischemic stroke decreased after endarterectomy (absolute decrease, 3.5% [95% CI, 3.2% to 3.7%]; adjusted annual decrease, 2.17% [95% CI, 2.00% to 2.34%]) and stenting (absolute decrease, 1.6% [95% CI, 1.2% to 2.1%]; adjusted annual decrease, 1.86% [95% CI, 1.45%-2.26%]). Additional improvements were noted for in-hospital mortality, 30-day stroke, myocardial infarction, or death, and 30-day all-cause mortality as well as within demographic subgroups. Conclusions and Relevance: Among fee-for-service Medicare beneficiaries, the performance of carotid endarterectomy declined from 1999 to 2014, whereas the performance of carotid artery stenting increased until 2006 and then declined from 2007 to 2014. Outcomes improved despite increases in vascular risk factors.

Physician specialty and variation in carotid revascularization technique selected for Medicare patients.

OBJECTIVE: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy (CEA) for select patients with carotid atherosclerosis. We hypothesized that the choice of CAS vs CEA varies as a function of treating physician specialty, which would result in regional variation in the relative use of these treatment types. METHODS: We used Medicare claims (2002-2010) to calculate annual rates of CAS and CEA and examined changes by procedure type over time. To assess regional preferences surrounding CAS, we calculated the proportion of revascularizations by CAS, across hospital referral regions, defined according to the Dartmouth Atlas of Healthcare. We then examined relationships between patient factors, physician specialty, and regional use of CAS. RESULTS: The annual number of all carotid revascularization procedures decreased by 30% from 2002 to 2010 (3.2 to 2.3 per 1000; P = .005). Whereas rates of CEA declined by 35% during these 8 years (3.0 to 1.9 per 1000; P < .001), CAS utilization increased by 5% during the same interval (0.30 to 0.32 per 1000; P = .014). Variation in utilization of carotid revascularization varied across the Unites States, with some regions performing as few as 0.7 carotid procedure per 1000 beneficiaries (Honolulu, Hawaii) and others performing nearly 8 times as many (5.3 per 1000 in Houma, La). Variation in procedure type (CEA vs CAS) was evident as well, as the proportion of carotid revascularization procedures that were constituted by CAS varied from 0% (Casper, Wyo, and Meridian, Miss) to 53% (Bend, Ore). The majority of CAS procedures were performed by cardiologists (49% of all CAS cases), who doubled their rates of CAS during the study period from 0.07 per 1000 in 2002 to 0.15 per 1000 in 2010. CONCLUSIONS: Variation in rates of carotid revascularization exists. Whereas rates of carotid revascularization have declined by more than 30% in recent years, utilization of CAS has increased. The proportion of all carotid revascularization procedures performed as CAS varies markedly by geographic region, and regions with the highest proportion of cardiologists perform the most CAS procedures. Evidence-based guidelines for carotid revascularization will require a multidisciplinary approach to ensure uniform adoption across specialties that care for patients with carotid artery disease.

The Association of Publication of Center for Medicaid and Medicare Services Guidelines for Carotid Artery Angioplasty and Stenting (CAS) and CREST Results on the Utilization of CAS in Carotid Revascularization.

BACKGROUND: Since the 2004 approval of carotid artery angioplasty and stenting (CAS), there have been 2 seminal publications about CAS reimbursement (Center for Medicaid and Medicare Several guidelines [CMSG]; 2008) and clinical outcomes (Carotid Revascularization Endarterectomy versus Stent Trial [CREST]; 2010). We explored trends in CAS utilization after these publications nationally. METHODS: The most recent datasets of the nationwide inpatient sample (NIS) was queried for patients undergoing carotid revascularization. Utilization proportions of CAS were calculated quarterly from 2005 to 2011 for NIS. Three-time intervals related to CMSG and CREST publication were selected 2005-2008, 2008-2010, and after 2010. Logistic regression with piecewise linear trend for time was used to estimate different trends in CAS utilization for overall samples and for neurologically asymptomatic and symptomatic cases. RESULTS: The majority (95%) of the carotid revascularizations were performed on asymptomatic patients. Overall, CAS utilization constituted 12.5% of carotid revascularization procedures with a significant period increase of CAS; from 9.4% to 14%; P < 0.001. There was a small but significant decrease in the rate of CAS utilization after CMSG were published corresponding to a 2% decline in the odds ratio (OR) of CAS per quarter (OR, 0.98; 95% confidence interval, 0.97-0.99; P = 0.001). After CREST, CAS utilization continued to increase in both NIS but the rate of increase did not change significantly from the prepublication to the postpublication time interval. The odds of in-hospital mortality and postoperative stroke were independently and significantly higher for CAS patients in both overall and within the symptomatic cohorts. In all 3 periods of the study, and compared to carotid endarterectomy, the odds of mortality and postoperative stroke were significantly higher among patients who underwent CAS. CONCLUSIONS: Although overall utilization of CAS increased since 2005, it was not uniformly associated by the publication of CMSG or CREST. Despite increased utilization, the odds of adverse outcomes were independently higher among CAS patients.

Racial and insurance based disparities in the treatment of carotid artery stenosis: a study of the Nationwide Inpatient Sample.

BACKGROUND AND PURPOSE: Minorities and uninsured/underinsured patients have poorer access to healthcare system resources, especially preventative treatments. We sought to determine whether racial and insurance based disparities existed in the treatment of carotid artery stenosis. METHODS: Using the Nationwide Inpatient Sample, hospitalizations for carotid artery stenting and carotid endarterectomy for symptomatic and asymptomatic carotid artery stenosis from 2005 to 2011 were identified. We calculated χ(2) tests, and bivariate and multivariable logistic regression models were fit to assess differences in the characteristics of patients receiving carotid revascularization for asymptomatic compared with symptomatic carotid artery stenosis. Demographic characteristics studied included race/ethnicity (white, black, Hispanic, Asian/Pacific Islander) and primary payer status (Medicare, Medicaid, private insurance, self-pay and no charge). RESULTS: Between 2005 and 2011, 890 680 patients underwent carotid revascularization for the treatment of carotid artery stenosis (92.1% asymptomatic and 7.9% symptomatic). Multivariate logistic regression analysis demonstrated that Medicaid (OR=0.87, 95% CI 0.83 to 0.92, p<0.0001) and self-pay patients (OR=0.48, 95% CI 0.45 to 0.51, p<0.0001) had a lower odds of being revascularized for asymptomatic carotid artery stenosis compared with private insurance patients. Black (OR=0.81, 95% CI -0.77 to 0.84, p<0.0001) and Hispanic (OR=0.86, 95% CI -0.83 to 0.90, p<0.0001) patients had significantly lower odds of revascularization for asymptomatic carotid artery stenosis compared with white patients. CONCLUSIONS: Minorities and self-pay/Medicaid patients were less likely to receive carotid revascularization when asymptomatic-rather they were more likely to have treatment only after symptoms had developed. These findings suggest possible disparities in the degree of morbidity related to carotid artery stenosis, the likelihood of early detection, and/or the likelihood of treatment conditional on indication.

US nationwide trends in carotid revascularization: is there a clinical opportunity cost associated with the introduction of novel medical devices?

OBJECTIVES: Nationwide practice patterns during the implementation of novel technology, such as carotid angioplasty and stenting (CAS) and embolic protection devices (EPD), and the clinical impact thereof have received less attention. METHODS: The Nationwide Inpatient Sample, constituting a 20% representative sample of non-federal US hospitals, was analyzed from years 1998 to 2007. Hospital outcome was stratified into in-hospital mortality (IHM), long-term facility discharge, and home/ short-term facility discharge (HSF). RESULTS: Discharge outcome improved for CAS over the decade. However, this improvement occurred in two phases with a period of worsening (2003-2005) in between. During this transition period, the risk of IHM following CAS was increased (RR 1.29-2.43) and was lower for good outcome (HSF: RR 0.97-0.99) when compared with 2002/2003. During the same transition period, carotid endarterectomy (CEA) was associated with a lower risk of IHM (RR 0.75-1.00), but also a lower risk of HSF (RR 0.98-0.99). CONCLUSIONS: The results lead to the hypothesis that the nationwide introduction of CAS-EPD may have been associated with temporary increases in in-hospital mortality and discharge morbidity. If such 'clinical opportunity costs' exist with the widespread introduction and adoption of new medical technology with proven efficacy in randomized trials, effective mechanisms are needed for mitigation or prevention during the transition period.

Hispanic ethnicity is associated with increased costs after carotid endarterectomy and carotid stenting in the United States.

OBJECTIVE: We have previously demonstrated an adverse impact of black race and Hispanic ethnicity on the outcomes of carotid endarterectomy (CEA) and carotid artery stenting (CAS). The current study was undertaken to examine the influence of race and ethnicity on the cost of CEA and CAS. METHODS: The Nationwide Inpatient Sample (2005-2009) was queried using ICD-9 codes for CEA and CAS in patients with carotid artery stenosis. The primary outcome was total hospital charges. Multivariate analysis was performed using a generalized linear model adjusting for age, sex, race, comorbidities (Charlson index), high-risk status, procedure type, symptomatic status, year, insurance type, and surgeon and hospital operative volumes and characteristics. RESULTS: Hispanic and black patients were more likely to have a symptomatic presentation, and were more likely to undergo either CEA or CAS by low-volume surgeons at low-volume hospitals (P < 0.05, all). They were also less likely to have private insurance or Medicare (P < 0.001). Overall, CEA was less expensive than CAS over the 4-y study period ($29,502 ± $104 versus $46,713 ± $409, P < 0.001). Total hospital charges after CEA were increased in both blacks ($39,562 ± $843) and Hispanics ($45,325 ± $735) compared with whites on univariate analysis ($28,403 ± $101, P < 0.001). After CAS, total hospital charges were similarly increased in both blacks ($51,770 ± $2085) and Hispanics ($63,637 ± $2766) compared with whites on univariate analysis ($45,550 ± $412, P < 0.001). On multivariable analysis, however, only Hispanic ethnicity remained independently associated with increased charges after both CEA (exponentiated coefficient 1.18; 95% CI [1.15-1.20]; P < 0.001) and CAS (exponentiated coefficient 1.17; 95% CI [1.09-1.24]; P < 0.001). CONCLUSION: Hispanic ethnicity was independently associated with increased hospital charges after both CEA and CAS. The increased charges seen in black patients were explained, in part, by decreased surgeon operative volume and increased postoperative complications. Further efforts are warranted to contain costs in minorities undergoing carotid revascularization.

[The assessment of prognosis of carotid endarterectomy by cliniсal-mathematical method].

We examined 127 patients with atherosclerotic stenosis of carotid arteries who underwent carotid endarterectomy (CEAE). In the most of patients (85%), CEAE slowed the progression of chronic cerebral ischemia leading to the stabilization or improvement of neurologic and/or neuropsychological status. The analysis of the data allowed to suggest a mathematical model for predicting the outcome of the surgery.

Regional versus general anesthesia for carotid endarterectomy: the American College of Surgeons National Surgical Quality Improvement Program perspective.

BACKGROUND: The ideal anesthetic technique for carotid endarterectomy remains a matter of debate. This study used the American College of Surgeons National Surgical Quality Improvement Program to evaluate the influence of anesthesia modality on outcomes after carotid endarterectomy. METHODS: Postoperative outcomes were compared for American College of Surgeons National Surgical Quality Improvement Program patients undergoing carotid endarterectomy between 2005 and 2009 with either general or regional anesthesia. A separate analysis was performed on a subset of patients matched on propensity for undergoing carotid endarterectomy with regional anesthesia. RESULTS: For the entire sample of 24,716 National Surgical Quality Improvement Program patients undergoing carotid endarterectomy and the propensity-matched cohort of 8,050 patients, there was no difference in the 30-day postoperative composite stroke/myocardial infarction/death rate based on anesthetic type. Within the matched cohort, the rate of other complications did not differ (2.8% regional vs. 3.6% general anesthesia; P = .07), but patients receiving regional anesthesia had shorter operative (99 ± 36 minutes vs 119 ± 53 minutes; P < .0001) and anesthesia times (52 ± 29 minutes vs. 64 ± 37 minutes; P < .0001) and were more likely to be discharged the next day (77.0% vs 64.4%; P < .0001). CONCLUSION: Anesthesia technique does not impact patient outcomes after carotid endarterectomy, but may influence overall cost of care.

Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy.

BACKGROUND: Randomized clinical trials often encounter slow enrollment. Failing to meet sample size requirements has scientific, financial, and ethical implications. AIMS: We report interventions used to accelerate recruitment in a large multicenter clinical trial that was not meeting prespecified enrollment commitments. METHODS: The Carotid Revascularization Endarterectomy vs. Stenting Trial began randomization in December 2000. To accelerate enrollment, multiple recruitment tactics were initiated, which included expanding the number of sites, hiring a recruitment director (May 2003), broadening eligibility criteria (April 2005), branding with a study logo, Web site, and recruitment materials, increasing site visits by study leadership, sending e-mails to the site teams after every enrollment, distributing electronic newsletters, and implementing investigator and coordinator conferences. RESULTS: From December 2000 through May 2003, 14 sites became active (54 patients randomized), from June 2003 through April 2005, 44 sites were added (404 patients randomized), and from May 2005 through July 2008, 54 sites were added (2044 patients randomized). During these time intervals, the number of patients enrolled per site per year was 1·5, 3·6, and 5·6. For the single years 2004 to 2008, the mean monthly randomization rates per year were 19·7, 38·1, 56·4, 53·0, and 54·7 (annualized), respectively. Enrollment was highest after recruitment tactics were implemented: 677 patients in 2006, 636 in 2007, and 657 in 2008 (annualized). The prespecified sample size of 2502 patients, 47% asymptomatic, was accomplished on July 2008. CONCLUSIONS: Aggressive recruitment tactics and investment in a full-time recruitment director who can lead implementation may be effective in accelerating recruitment in multicenter trials.

Carotid endarterectomy and carotid artery stenting utilization trends over time.

BACKGROUND: Carotid endarterectomy (CEA) has been the standard in atherosclerotic stroke prevention for over 2 decades. More recently, carotid artery stenting (CAS) has emerged as a less invasive alternative for revascularization. The purpose of this study was to investigate whether an increase in stenting parallels a decrease in endarterectomy, if there are specific patient factors that influence one intervention over the other, and how these factors may have changed over time. METHODS: Using a nationally representative sample of US hospital discharge records, data on CEA and CAS procedures performed from 1998 to 2008 were obtained. In total, 253,651 cases of CEA and CAS were investigated for trends in utilization over time. The specific data elements of age, gender, payer source, and race were analyzed for change over the study period, and their association with type of intervention was examined by multiple logistic regression analysis. RESULTS: Rates of intervention decreased from 1998 to 2008 (P < 0.0001). Throughout the study period, endarterectomy was the much more widely employed procedure. Its use displayed a significant downward trend (P < 0.0001), with the lowest rates of intervention occurring in 2007. In contrast, carotid artery stenting displayed a significant increase in use over the study period (P < 0.0001), with the highest intervention rates occurring in 2006. Among the specific patient factors analyzed that may have altered utilization of CEA and CAS over time, the proportion of white patients who received intervention decreased significantly (P < 0.0001). In multivariate modeling, increased age, male gender, white race, and earlier in the study period were significant positive predictors of CEA use. CONCLUSIONS: Rates of carotid revascularization have decreased over time, although this has been the result of a reduction in CEA despite an overall increase in CAS. Among the specific patient factors analyzed, age, gender, race, and time were significantly associated with the utilization of these two interventions.

Neurointerventional procedural volume per hospital in United States: implications for comprehensive stroke center designation.

BACKGROUND AND PURPOSE: Availability of neurointerventional procedures is recommended as a necessary component of a comprehensive stroke center by various regulatory guidelines that also emphasize adequate procedural volumes. We studied the volumes of neurointerventional procedures performed in various hospitals across the United States with subsequent comparisons with rates of minimum procedural volumes recommended by various professional bodies or used in clinical trials to ensure adequate operator experience. METHODS: We reviewed the Nationwide Inpatient Sample database in the United States for the years 2005 to 2008. Using International Classification of Disease-Clinical Modification, 9th revision, and Medicare severity diagnosis-related group codes, we identified among hospitals that admit stroke patients those that met the minimum criteria for overall and individual procedural volumes specified in various guidelines. We then compared the characteristics between the high-volume hospitals that performed at least 100 cervicocerebral angiograms and met ≥1 other procedural criterion (n=79) and low-volume hospitals (n=958). RESULTS: Proportions of hospitals that met individual procedural volume criteria over the 4-year period according to procedure were: cervicocerebral angiography (7.0%-7.8%); endovascular acute ischemic stroke treatments (0.4%-2.6%); carotid angioplasty/stent placement (3.0%-5.3%); intracranial angioplasty/stent placement (0.3%-1.3%); and aneurysm embolization (1.3%-2.6%). There were significant trends for increasing numbers of all the endovascular procedures except intracranial angioplasty/stent placement over the course of 4 years. The high-volume hospitals were more likely to be urban teaching hospitals (70.9% versus 13.1%; P<0.001), had larger bed size (79.7% versus 26.9%; P<0.001), and had significantly higher rates of hemorrhagic stroke admissions and lower rates of transient ischemic attack admissions. Urban teaching location/status (OR, 8.92; CI, 4.3-18.2; P<0.001) and large bed size (OR, 4.40; CI, 2.0-9.5; P<0.001) remained as independent predictors of a high-volume hospital when adjusted for age, gender, risk factors, and stroke subtype. CONCLUSIONS: There are very few hospitals in the United States that meet all the neurointerventional procedural volume criteria for all endovascular procedures recommended to ensure adequate operator experience. Our results support the creation of specialized regional centers for ensuring adequate procedural volume within treating hospitals.