Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials.

BACKGROUND AND PURPOSE: We report patient enrollment and retention by race and ethnicity in the CREST (Carotid Revascularization Endarterectomy Versus Stent Trial) and assess potential effect modification by race/ethnicity. In addition, we discuss the challenge of detecting differences in study outcomes when subgroups are small and the event rate is low. METHODS: We compared 2502 patients by race, ethnicity, baseline characteristics, and primary outcome (any periprocedural stroke, death, or myocardial infarction and subsequent ipsilateral stroke up to 10 years). RESULTS: Two hundred forty (9.7%) patients were minority by race (6.1%) or ethnicity (3.6%); 109 patients (4.4%) were black, 32 (1.3%) Asian, 2332 (93.4%) white, 11 (0.4%) other, and 18 (0.7%) unknown. Ninety (3.6%) were Hispanic, 2377 (95%) non-Hispanic, and 35 (1.4%) unknown. The rate of the primary end point for all patients was 10.9%±0.9% at 10 years and did not differ by race or ethnicity (Pinter>0.24). CONCLUSIONS: The proportion of minorities recruited to CREST was below their representation in the general population, and retention of minority patients was lower than for whites. Primary outcomes did not differ by race or ethnicity. However, in CREST (like other studies), the lack of evidence of a racial/ethnic difference in the treatment effect should be interpreted with caution because of low statistical power to detect such a difference. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Cognitive changes after surgery vs stenting for carotid artery stenosis.

OBJECTIVES: Cognitive function has not been evaluated systematically in the context of carotid endarterectomy (CEA) versus carotid artery stenting (CAS). Cognitive decline can occur from microembolization or hypoperfusion during CEA or CAS. Carotid revascularization may, however, also improve cognitive dysfunction resulting from chronic hypoperfusion. We compared cognitive outcomes in consecutive asymptomatic patients undergoing CAS or CEA. METHODS: This is a prospective nonrandomized single-center study of patients with asymptomatic carotid stenosis ≥ 70% undergoing CAS or CEA using standard techniques. Neurologic symptoms were evaluated by history, physical examination, and the National Institutes of Health Stroke Scale. A 50-minute cognitive battery was performed 1 to 3 days before and 4 to 6 months after CEA/CAS. The tests (Trail Making Tests A/B, Processing Speed Index (PSI) of the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III), Boston Naming Test, Working Memory Index (WMI) of the Wechsler Memory Scale - Third Edition (WMS-III), Controlled Oral Word Association, and Hopkins Verbal Learning Test) for six cognitive domains (motor speed/coordination and executive function, psychomotor speed, language (naming), working memory/concentration, verbal fluency, and learning/memory) were conducted by a neuropsychologist. The primary analysis of impact of treatment modality was a normalized cognitive change score. RESULTS: Forty-six patients underwent prepost testing (CEA = 25, CAS = 21). Women comprised 36% of the cohort, mean preprocedural stenosis was 84%, and 54% were right-sided lesions. All patients were successfully revascularized without periprocedural complications. The scores for each test improved after CEA except WMI, which decreased in 20 of 25 patients. Improvement occurred in all tests after CAS except PSI, which decreased in 18 of 21 patients. In addition to comparing the changes in individual test scores, overall cognitive change was measured by calculating the change in composite cognitive score (CCS) postprocedure versus baseline. To compute the CCS, the raw scores from each test were transformed into z scores and then averaged to calculate each patient's composite score. The composite score at baseline was then compared with that from the postprocedure testing. The CCS improved after both CEA and CAS, and the changes were not significantly different between the groups (.51 vs .47; P = NS). CONCLUSIONS: Carotid revascularization results in an overall improvement in cognitive function. There are no differences in the composite scores of five major cognitive domains between CEA and CAS. When individual tests are compared, CEA results in a reduction in memory, while CAS patients show reduced psychomotor speed. Larger studies will help confirm these findings.

Colocutaneous fistula after suction lipoplasty: case report and literature review.

Suction lipoplasty is considered to be a relatively safe procedure but is not without complications, some of which are lethal. Colonic injury after liposuction has not been reported so far, although small intestinal perforations are known to occur. We present a case of colocutaneous fistula after suction lipoplasty that was successfully managed nonoperatively. A 56-year-old man with history of abdominoplasty presented with feculent discharge from the abdominal wall 7 days after liposuction. A computed tomography scan of the abdomen showed free intraperitoneal air, with a suspected transverse colonic fistula to the skin. After drainage of abdominal wall abscess, he recovered and the fistula spontaneously closed. Abdominal wall hernias, abdominal operations, and immunosuppression are risk factors for abdominal and intestinal perforations after lipoplasty. Low output colocutaneous fistulae after lipoplasty may close spontaneously unlike small intestinal perforations.

Outcome of carotid artery stenting for primary versus restenotic lesions.

Carotid artery stenting (CAS) for restenosis (RS) after carotid endarterectomy (CEA) is presumed to have fewer complications than CAS for primary atherosclerotic (PA) lesions. It has been proposed that interventionalists may limit themselves to CAS for RS initially, while they gain additional experience during their learning curve. However, there are few studies objectively comparing the outcomes of the two groups of patients to substantiate this assumption. We analyzed prospectively collected data on CAS performed at our institution from 1996 to April 2006. Complication rates were compared between CAS performed for RS versus PA lesions. Specific end points studied included in-hospital and 30-day stroke and death rates. The incidence of transient ischemic attack (TIA) was also recorded. Patient demographic features (gender, age, hypertension, diabetes mellitus, coronary artery disease, smoking, hypercholesterolemia, and presence of preoperative neurological symptoms) were recorded. A neurologist examined all patients before and after CAS. Patients with previous CAS with in-stent RS and tandem common carotid artery-internal carotid artery or arch ostial stenoses were excluded from this analysis. CAS procedures (n = 217) performed on 210 patients fulfilled inclusion criteria for this study. Indications for CAS included RS (n = 118, 54%) and PA (n = 99, 46%). The two groups were well matched for all demographic features except hypercholesterolemia, which was more common in the PA group. Thirty-day stroke and stroke + death rates for the entire series were 2.8% and 4.1%, respectively. Within this cohort, 30-day stroke and stroke + death rates were not significantly different between the RS (2.5% and 5.1%) and PA (3.0% and 3.0%) groups. Within the RS group, these outcomes were also similar when patients treated for late recurrence (>24 months after CEA, n = 49) were compared to those treated for early recurrence (< or = 24 months after CEA, n = 67). Only when stroke and TIA were combined was a difference observed between the late recurrence (10.0%) and the early recurrence (1.5%) groups (p = 0.049). Contrary to general opinion, 30-day stroke and stroke + mortality rates from CAS for RS versus PA were not significantly different. Lower neurological event rates were only seen in CAS for early RS compared with late RS after endarterectomy when TIAs were included as an end point in the analysis. CAS for RS must therefore not be considered a low-risk procedure. Technical proficiency for CAS must be equivalent regardless of the etiology of the stenosis. These observations also underscore the need for appropriate patient selection and close follow-up of all patients undergoing CAS.

Septic embolization from stented arteriovenous fistula.

Anastomotic stenosis of an arteriovenous fistula is often amenable to percutaneous intervention (angioplasty and stenting) and unlikely to be complicated by infection. A 69-year-old man underwent pre-emptive arteriovenous fistula construction that required interval placement of a covered stent for juxta-anastomotic stenosis. The patient presented 1 year after the intervention with systemic sepsis that required stent graft explantation and revision. This is a unique case report showing an infected stent graft, placed to restore secondary patency, that was later found to be the source of bacteremia and septic pulmonary emboli.

Quality Initiative to Reduce Cardiac CT Angiography Radiation Exposure in Patients with Congenital Heart Disease.

BACKGROUND: The use of cardiac computed tomography angiography (CCTA) as a complementary diagnostic modality to echocardiography in patients with congenital heart diseases (CHDs) is expanding in low- and middle-income countries. The adoption of As Low As Reasonably Achievable techniques is not widespread, resulting in significant unintended radiation exposure, especially in children. Simple quality improvement measures geared toward reducing radiation dose can have a impact on patient safety in resource-limited centers in low- and middle-income countries. OBJECTIVES: To determine how a quality improvement initiative can reduce radiation exposure during CCTA in patients with CHD. METHODS: We designed a key driver -based quality initiative to reduce radiation dose during CCTA for CHD using protocol optimization, communication, and training and implementation as the drivers for intervention. Preintervention variables (radiation exposure, scanning protocols, and image quality) were collected from September 2012 to July 2016 and compared with variables in the postimplementation phase (February 2017 to July 2017). We compared quantitative and categorical variables using the chi-square test. Linear regression analysis was used to evaluate the effect of various factors on radiation dose. RESULTS: We documented a reduction in the effective dose in the postintervention versus preintervention phase (mean, 2.0 versus 21 mSv, P < 0.0001, respectively). Linear regression showed that the optimal organizational levels are associated with the same reduction in radiation. This finding shows that the time factor translates a combination of organizational and technical factors that contributed to the reduction in radiations. CONCLUSIONS: Our project showed a reduction in CCTA-associated radiation exposure.

Well leg compartment syndrome after robotic prostatectomy: a word of caution.

Compartment syndrome of the lower extremity is a rare complication that can occur following prolonged surgery in the lithotomy position. We report the case of a 45-year-old man who developed compartment syndrome in the post-operative period after radical robotic prostatectomy. Four-compartment fasciotomy helped prevent serious sequelae from the injury. Young males with a high body mass index undergoing prolonged surgery in the lithotomy position are particularly at risk for developing this complication. The early diagnosis and implementation of preventive measures will facilitate timely management.

Duplex ultrasound velocity criteria for the stented carotid artery.

OBJECTIVES: Ultrasound velocity criteria for the diagnosis of in-stent restenosis in patients undergoing carotid artery stenting (CAS) are not well established. In the present study, we test whether ultrasound velocity measurements correlate with increasing degrees of in-stent restenosis in patients undergoing CAS and develop customized velocity criteria to identify residual stenosis > or =20%, in-stent restenosis > or =50%, and high-grade in-stent restenosis > or =80%. METHODS: Carotid angiograms performed at the completion of CAS were compared with duplex ultrasound (DUS) imaging performed immediately after the procedure. Patients were followed up with annual DUS imaging and underwent both ultrasound scans and computed tomography angiography (CTA) at their most recent follow-up visit. Patients with suspected high-grade in-stent restenosis on DUS imaging underwent diagnostic carotid angiograms. DUS findings were therefore available for comparison with luminal stenosis measured by carotid angiograms or CTA in all these patients. The DUS protocol included peak-systolic (PSV) and end-diastolic velocity (EDV) measurements in the native common carotid artery (CCA), proximal stent, mid stent, distal stent, and distal internal carotid artery (ICA). RESULTS: Of 255 CAS procedures that were reviewed, 39 had contralateral ICA stenosis and were excluded from the study. During a mean follow-up of 4.6 years (range, 1 to 10 years), 23 patients died and 64 were lost. Available for analysis were 189 pairs of ultrasound and procedural carotid angiogram measurements; 99 pairs of ultrasound and CTA measurements during routine follow-up; and 29 pairs of ultrasound and carotid angiograms measurements during follow-up for suspected high-grade in-stent restenosis > or =80% (n = 310 pairs of observations, ultrasound vs carotid angiograms/CTA). The accuracy of CTA vs carotid angiograms was confirmed (r(2) = 0.88) in a subset of 19 patients. Post-CAS PSV (r(2) = .85) and ICA/CCA ratios (r(2) = 0.76) correlated most with the degree of stenosis. Receiver operating characteristic analysis demonstrated the following optimal threshold criteria: residual stenosis > or =20% (PSV >or =150 cm/s and ICA/CCA ratio > or =2.15), in-stent restenosis > or =50% (PSV > or =220 cm/s and ICA/CCA ratio > or =2.7), and in-stent restenosis > or =80% (PSV 340 cm/s and ICA/CCA ratio > or =4.15). CONCLUSIONS: Progressively increasing PSV and ICA/CCA ratios correlate with evolving restenosis within the stented carotid artery. Ultrasound velocity criteria developed for native arteries overestimate the degree of in-stent restenosis encountered. These changes persist during long-term follow-up and across all grades of in-stent restenosis after CAS. The proposed new velocity criteria accurately define residual stenosis >or =20%, in-stent restenosis >or =50%, and high-grade in-stent restenosis > or =80% in the stented carotid artery.

Noninvasive identification of the unstable carotid plaque.

Intraplaque hemorrhage, enlarging lipid cores, and their proximity to the flow lumen are important determinants of carotid plaque rupture and neurological complications. We developed an image-analysis method for B-mode ultrasound, pixel distribution analysis (PDA), for preprocedural identification of these high-risk features in carotid plaques. This technique may improve selection of patients for carotid endarterectomy and carotid artery stenting. Forty-two patients with high-grade carotid stenosis in 45 arteries, 18 symptomatic and 27 asymptomatic, underwent preoperative ultrasound. Intraplaque hemorrhage, lipid, fibromuscular tissue, calcium, lipid core area, and distance from the flow lumen were quantified using pixel intensities of tissues in control subjects. These findings were contrasted between symptomatic and asymptomatic plaques and correlated with histology. Inter- and intraobserver variabilities were determined for this technique. Pixel intensities of control tissues were discrete and significantly different from each other (median: blood 0, lipid 27, muscle 45.5, fibrous tissue 204, and calcium 245). There was more intraplaque hemorrhage (p<0.001) and lipid (p=0.002) but less calcium (p<0.001) within symptomatic plaques. Lipid cores were larger (p=0.005) and their distance from the flow lumen was lower (p=0.01) in symptomatic plaques. Intraplaque hemorrhage, lipid, fibromuscular tissue, calcium, lipid core size, and distance from flow lumen measured by PDA correlated with histology. No significant inter- or intraobserver variabilities were observed in these measurements. PDA accurately identified more intraplaque hemorrhage and lipid, less calcium, and larger lipid cores located closer to the flow lumen in symptomatic patients with carotid stenosis. These data indicate that PDA may be used to identify high-risk carotid atherosclerotic plaques and thereby improve the selection of patients requiring treatment.

Observer variability of iliac artery measurements in endovascular repair of abdominal aortic aneurysms.

Accurate measurement of iliac arteries is essential for successful delivery of aortic endografts without iliac limb endoleak. Although intravascular ultrasound measurements may be reliable, they require an invasive procedure. Therefore, helical computed tomography (hCT) has become the most commonly used modality for obtaining preprocedure arterial diameter measurements. The accuracy of hCT remains ill-defined, however, because an anatomic gold standard with which to compare the measurements is not available. We therefore assessed inter- and intraobserver variability of hCT measurements. We also applied accepted cutoff measurements to determine the clinical impact of observer variability in predicting the need for adjunctive iliac access and iliac limb seal procedures. hCT scans were analyzed in 30 patients who had undergone successful placement of a bifurcated endograft (26 Ancure, 4 Aneurex). Mean age of patients was 75 years, the male/female ratio was 27:3. Three blinded observers measured transverse diameters (maximal aortic aneurysm [Amax], narrowest infrarenal aortic neck [Amin], maximal common iliac [Imax], and narrowest iliac artery [Imin]). Inter- and intraobserver variability was calculated as standard deviation of mean pair differences according to the method of Bland and Altman. The true incidence of adjunctive procedures to facilitate delivery of the device into the aorta and ensure iliac limb seal was compared with that predicted by the observers to obtain sensitivity, specificity, and positive (PPV) and negative predictive value (NPV) for the measurements. Interobserver variability of iliac measurements was higher than intraobserver variability (p < 0.05). Interobserver variability of Amax ranged from 4.37 to 10.73% of the mean Amax. Conversely, variability of Amin was 8.91-18.89%, that of Imax was 12.11-22.23%, and that of Imin was 10.51-18.73% (p < 0.05 vs. Amax). Therefore, interobserver variability influenced aortic neck and iliac diameter twice as much as it did aneurysm measurements. To successfully place 30 endografts we performed 8 adjunctive access procedures (4 angioplasties, 4 common iliac artery conduits) and 17 adjunctive procedures in 60 limbs to ensure limb seal (9 unilateral IIA coil embolizations, 8 stents). We used 8.5 (Ancure) and 8.0 (Aneurex) mm as lower limits of acceptability for uncomplicated access, and 13.4 (Ancure) and 16 (Aneurex) mm as the upper limits of acceptability for uncomplicated iliac limb seal. These limits were applied to measurements from the three observers to predict need for adjunctive access or iliac seal procedures in this cohort. Sensitivity, specificity, PPV, and NPV of these observer measurements for a need to perform additional access procedures were 0.67, 0.80, 0.55, and 0.87; the same values for a need to perform additional seal procedures were 0.71, 0.74, 0.52, and 0.86, respectively. Interobserver variability was approximately 20% of measured iliac diameter. This explains why helical CT measurements were noted to have low PPV in predicting the need for an adjunctive access or limb seal procedure. These data establish PPV and NPV for hCT and provide objective evidence for the need to improve iliac artery imaging. Until more accurate imaging becomes available, we recommend oversizing of iliac limbs by 10-20% in patients with wide landing zones and that surgeons be prepared to resolve unexpected iliac artery access or seal problems intraoperatively.

Technical challenges in a program of carotid artery stenting.

OBJECTIVES: Successful carotid artery stenting (CAS) involves gaining access to the common carotid artery, characterizing and crossing the lesion, deploying an anti-embolic device and stent, and retrieving the anti-embolic device. These steps are critical determinants of the complexity of the procedure. The frequency with which technical challenges are encountered during CAS is ill-defined. The purpose of this investigation was to review the incidence and types of technical challenges encountered during CAS and determine their effect on outcome. METHODS: Data were prospectively collected for 194 consecutive CAS procedures (177 patients) and separated into group 1, standard CAS technique, and group 2, procedures with technical challenges requiring modifications to the technique. Technical challenges were defined as difficult femoral arterial access (aortoiliac occlusive disease), complex aortic arch anatomy (elongated or bovine arch, deep takeoff of the innominate artery, tandem stenoses (CCA, innominate artery), difficult internal carotid artery anatomy (tortuosity, high-grade stenosis), and circumferential internal carotid artery calcification. The incidence of technical challenges, types of technical modifications required, and effect on outcomes were determined. RESULTS: Fifty technically challenging situations (26%) were encountered in 194 CAS procedures (group 2), which required advanced technical skills. Standard methods were used in the other 144 procedures (group 1, 74%). No significant differences in 30-day stroke and death rates were noted between the groups (group 1, 3.1%; group 2, 2.0%; P = .564). CONCLUSIONS: Twenty-six percent of the procedures required a modification in the standard technique for successful CAS. Circumferential calcification and severe tortuosity continue to be relative contraindications to CAS. Recognition of these technical challenges and increasing facility with the methods to manage them will enable expanded use of CAS without increased morbidity and mortality.

Carotid artery closure for endarterectomy does not influence results of angioplasty-stenting for restenosis.

OBJECTIVE: Carotid angioplasty and stenting (CAS) has been recommended by some authors for the management of postendarterectomy restenosis. However, some authors have expressed concern about the influence of primary closure and patch angioplasty performed during carotid endarterectomy (CEA) on the incidence rate of complications after CAS. METHODS: We analyzed our consecutive series of 54 CAS procedures performed for restenosis after prior CEA. These procedures accounted for 75% of the 72 CAS procedures performed at our institution for all indications during the last 4 years. Of these 54 patients, 28 (52%) were men and 26 (48%) were women, with a mean age of 69 years. The mean clinical follow-up period was 18 months (range, 1 to 48 months). The mean interval between prior CEA and CAS was 16 months (range, 6 to 62 months). Nineteen patients were symptomatic (35%), and 35 were asymptomatic (65%). The mean severity of restenosis was 84% +/- 7% (standard deviation). The mean residual stenosis after CAS was 8% +/- 3% (standard deviation). RESULTS: Among the 54 prior CEAs, eight cases were performed with primary closure (15%), five procedures used patch closure with autologous vein (9%), and 41 operations used Dacron patch closures (76%). All patients were managed successfully with CAS with predeployment angioplasty with low profile balloons, self-expanding stents, and poststent angioplasty to approximate the transverse diameter of the carotid artery. No instances of contrast extravasation, arterial disruption, or subintimal dissection were observed. One stroke (1.8%), a retinal infarction with partial field of vision loss, occurred in a patient with prior CEA and Dacron patch closure, and no deaths were observed in the series. CONCLUSION: Performance of CAS for restenosis after CEA with autologous or synthetic patch angioplasty was technically successful in all 54 procedures. The method of closure of the arteriotomy during CEA, primary closure or patch angioplasty, did not influence the incidence of complications.

Pixel distribution analysis of B-mode ultrasound scan images predicts histologic features of atherosclerotic carotid plaques.

BACKGROUND: The correlation of B-mode ultrasonographic morphology with histologic characteristics of atherosclerotic carotid plaques remains ill-defined. The classification of plaques with recently reported measures of plaque echogenicity and heterogeneity has been unsatisfactory. We used computer-assisted duplex ultrasound (DU) scan image analysis to determine echogenicity of specific tissues in control subjects. This information was used to quantify each tissue in imaged carotid plaques with pixel distribution analysis (PDA). These objective observations then were quantitatively compared with plaque histology in symptomatic and asymptomatic patients. METHODS: We performed standardized DU scanning of healthy tissues in 10 volunteer subjects and of 20 carotid artery plaques (7 symptomatic and 13 asymptomatic) in 19 patients with carotid stenosis. The plaques underwent histologic analysis after carotid endarterectomy. The grayscale intensity ranges of blood, lipid, fibromuscular tissue, and calcium were calculated in the control subjects. With computer-assisted image analysis, B-mode images of plaques were linearly scaled to normalize data. Pixel distribution within the images then was analyzed. The grayscale ranges of known tissues obtained from control subjects helped define the amount of intraplaque hemorrhage, lipid, fibromuscular tissue, and calcium within carotid plaque images. This analysis was correlated with tissue composition measurements on histologic sections of excised plaques. RESULTS: The median grayscale intensity (range) in control subjects was 2 (0 to 4) for blood, 12 (8 to 26) for lipid, 53 (41 to 76) for muscle, 172 (112 to 196) for fibrous tissue, and 221 (211 to 255) for calcium. PDA-derived predictions for blood, lipid, fibromuscular tissue, and calcium within carotid plaques correlated significantly with the histologic estimates of each tissue respectively (blood: P =.012; lipid: P =.0006; fibromuscular: P =.035; and calcium: P =.0001). A significantly higher amount of blood and lipid was seen within symptomatic plaques compared with asymptomatic ones (P =.0048 and P =.026, respectively). Conversely, a larger amount of calcification was noted within asymptomatic plaques (P =.0002). CONCLUSION: Computer-assisted PDA of DU scan images accurately quantified intraplaque hemorrhage, fibromuscular tissue, calcium, and lipid. Symptomatic plaques had lower calcium content but larger amounts of intraplaque hemorrhage and lipid. Quantitative PDA may be used to determine carotid plaque tissue composition to assist in the identification of symptomatic and potentially unstable asymptomatic plaques.

In-stent recurrent stenosis after carotid artery stenting: life table analysis and clinical relevance.

OBJECTIVES: Carotid artery stenting has been proposed as an alternative to carotid endarterectomy in cerebral revascularization. Although early results from several centers have been encouraging, concerns remain regarding long-term durability of carotid artery stenting. We report the incidence, characteristics, and management of in-stent recurrent stenosis after long-term follow-up of carotid artery stenting. METHODS: Carotid artery stenting (n = 122) was performed in 118 patients between September 1996 and March 2003. Indications included recurrent stenosis after previous carotid endarterectomy (66%), primary lesions in patients at high-risk (29%), and previous ipsilateral cervical radiation therapy (5%). Fifty-five percent of patients had asymptomatic stenosis; 45% had symptomatic lesions. Each patient was followed up with serial duplex ultrasound scanning. Selective angiography and repeat intervention were performed when duplex ultrasound scans demonstrated 80% or greater in-stent recurrent stenosis. Data were prospectively recorded, and were statistically analyzed with the Kaplan-Meier method and log-rank test. RESULTS: Carotid artery stenting was performed successfully in all cases, with the WallStent or Acculink carotid stent. Thirty-day stroke and death rate was 3.3%, attributable to retinal infarction (n = 1), hemispheric stroke (n = 1), and death (n = 2). Over follow-up of 1 to 74 months (mean, 18.8 months), 22 patients had in-stent recurrent stenosis (40%-59%, n = 11; 60%-79%, n = 6; > or =80%, n = 5), which occurred within 18 months of carotid artery stenting in 13 patients (60%). None of the patients with in-stent recurrent stenosis exhibited neurologic symptoms. Life table analysis and Kaplan-Meier curves predicted cumulative in-stent recurrent stenosis 80% or greater in 6.4% of patients at 60 months. Three of five in-stent recurrent stenoses occurred within 15 months of carotid artery stenting, and one each occurred at 20 and 47 months, respectively. Repeat angioplasty was performed once in 3 patients and three times in 1 patient, and repeat stenting in 1 patient, without complications. One of these patients demonstrated asymptomatic internal carotid artery occlusion 1 year after repeat intervention. CONCLUSIONS: Carotid artery stenting can be performed with a low incidence of periprocedural complications. The cumulative incidence of clinically significant in-stent recurrent stenosis (> or =80%) over 5 years is low (6.4%). In-stent restenosis was not associated with neurologic symptoms in the 5 patients noted in this cohort. Most instances of in-stent recurrent stenosis occur early after carotid artery stenting, and can be managed successfully with endovascular techniques.

Carotid artery stenting: analysis of data for 105 patients at high risk.

OBJECTIVES: Carotid artery stenting (CAS) has been recommended as an alternative to carotid endarterectomy (CEA) by some clinicians. However, recently published clinical trials have reported 30-day stroke and death rates of 10% to 12%. This prompted review of our experience with CAS in patients at high risk, to document our results and guide further use of CAS. METHODS: From September 1996 to the present, we performed 114 consecutive CAS procedures in 105 patients. Sixty-three patients were men (60%) and 42 patients were women (40%), with mean age of 70 years (range, 45-93 years). Indications for CAS included recurrent stenosis after previous CEA in 74 patients (65%), primary lesions in 32 patients at high risk (28%), and carotid stenosis with previous ipsilateral radiation therapy in 8 patients (7%). Asymptomatic stenosis (>80%) was managed in 70 patients (61%), and symptomatic lesions (>50%) were treated in 44 patients (39%). RESULTS: CAS was technically successful in all patients. Mean severity of stenosis before CAS was 87% +/- 6%, compared with 9% +/- 4% after CAS. Two patients (1.9%) died, 1 of reperfusion-intracerebral hemorrhage and 1 of myocardial infarction 10 days after discharge; and 1 patient (0.95%) had a stroke (retinal infarction), for a 30-day stroke and death rate of 2.85%. Two patients (1.9%) had transient neurologic events. No cranial nerve deficits were noted. No neurologic complications have been noted in the last 27 patients (26%). CONCLUSIONS: A 30-day stroke and death rate of 2.85% in our experience demonstrates acceptability of CAS as an alternative to repeat operation or primary CEA in patients at high risk or in patients with radiation-induced stenosis. We recommend further clinical investigation of CAS and participation in clinical trials by vascular surgeons.