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Background— It has been demonstrated recently that carotid stenting can be performed safely in patients ≥80 years of age. However, it is uncertain whether these patients will derive benefit because longevity after revascularization is an important consideration. This study was conducted to determine survival and predictors of mortality of selected elderly patients after stenting. Methods and Results— One hundred forty-two consecutive elderly patients who were non–high risk for stenting underwent 153 procedures. Patients had either symptomatic stenosis ≥50% or asymptomatic stenosis ≥70%. Demographics and in-hospital outcomes were entered into a database; subsequent outcomes and mortality data were obtained retrospectively. Mean±SD age was 83.3±3.1 years. Symptomatic patients accounted for 28%. Overall survival at 3 years was 76% (85% at 2 years). At 1 year, 1 fatal stroke had occurred, with 97% of survivors (n=114) free of neurological events (neurological status was undetermined in the remaining 3%). Predictors of mortality were remote (≥6 months) transient ischemic attack or cerebrovascular accident, smoking history, and creatinine clearance (hemoglobin level showed a strong trend toward achieving significance); for the asymptomatic subgroup, predictors of mortality were smoking history, previous carotid endarterectomy, hemoglobin level, and increasing age. In particular, symptom status and sex were not independent predictors of mortality. Conclusions— This study demonstrates that in selected elderly patients, a high proportion (85%) survived 2 years and >75% survived 3 years after stenting. Carotid stenting may be considered a revascularization option in such patients. Better selection of patients using the predictors of mortality may help to reduce unwarranted procedures and to optimize survival likelihood.

Carotid artery disease is a major cause of ischemic stroke, the risk of which is directly related to the severity of stenosis and presence of symptoms.1,2 Stroke is the third leading cause of death in the United States, with approximately three quarters of a million strokes per year. Stroke is the leading cause of functional impairment, with more than 20% of survivors requiring institutional care and up to one third having a permanent disability.3 More worrisome, however, is the fact that as the population ages, the number of patients having strokes appears to be increasing.4 The pathophysiology of stroke may be broadly classified as hemorrhagic, embolic, or ischemic. The majority of strokes are caused by embolic events due to atheroemboli from the carotid artery, the ascending aorta, and arch vessels or cardiac thromboembolism from the left atrium or ventricle. It is estimated that carotid artery stenosis is responsible for 15% to 20% of all strokes.5 As percutaneous treatment options expand, there is uncertainty about appropriate therapy for carotid disease. This document will focus on 3 current controversies: (1) carotid artery revascularization in asymptomatic patients, (2) carotid artery stenting (CAS) in patients who are considered to be at increased surgical risk for carotid endarterectomy (CEA), and (3) the current role for CAS in patients at average surgical risk. ### Prevalence and Natural History The prevalence of asymptomatic extracranial carotid stenosis (≥50%) in persons >65 years of age is estimated to be between 5% and 10%, whereas ≤1% of patients are estimated to have a severe narrowing (>80%).6 In asymptomatic patients with ≥50% carotid artery stenoses, the annual risk of stroke is between 1% and 4.3%.2,7 Long-term (10- to 15-year) cohort studies in asymptomatic patients with moderate to severe carotid stenosis demonstrate an ipsilateral stroke rate between 0.9% and 1.1% per …

Objective To prospectively evaluate outcomes of high-risk patients undergoing bilateral carotid artery stenting (CAS). Methods A total of 747 patients at increased risk for carotid endarterectomy (CEA) were enrolled in a prospective registry at 47 US sites of the Boston Scientific EPI: A Carotid Stenting Trial for Risk Surgical Patients (BEACH) trial. Among them, 78 (10.4%) patients underwent contralateral CAS > 30 days after the primary CAS procedure. Patients were followed at 1, 6, and 12 months, and annually thereafter for 3 years. The primary endpoint was the cumulative incidence of non Q-wave myocardial infarction within 24 hours, periprocedural (≤30 days) death, stroke or Q-wave MI, and late ipsilateral stroke or death due to neurological events from 31 days up to 12 months. The bilateral patients are independent from the pivotal cohort. Results Mean follow-up was 885 + 320 days in the bilateral and 861 + 343 in the pivotal group. The primary endpoint occurred in 6.8% (5/73) of the bilateral patients and 8.9% (40/447) of the pivotal group ( P = .66). There were no statistically significant differences between the bilateral and the pivotal groups with regard to any of the components of the primary or secondary endpoints. The univariate 1-year major adverse event (MAE) free survival was 93.6% and 91.6% in the bilateral and pivotal groups, respectively ( P = .55). Multivariate logistic regression analysis with adjustment for various clinical baseline factors revealed no differences in the primary endpoint when comparing the bilateral with the pivotal groups at 30 days (odds ratio [OR]: 0.8673, 95% confidence interval [CI] 0.4590-1.6389, P = .66) or 1 year (OR: 0.9102, 95% CI 0.5503-1.5053, P = .73). Conclusions Bilateral carotid stenting is an effective treatment strategy in patients determined to be at high-risk for CEA with no increase in morbidity or mortality results extended out to one year in a prospective multicenter trial.

Objectives: The multicenter, single-arm BEACH (Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients) evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EX/EZ Emboli Protection System (Boston Scientific, Natick, Massachusetts). Background: Carotid artery stent (CAS) placement offers a less invasive alternative for high-risk surgical carotid endarterectomy (CEA) patients. Methods: The trial enrolled 480 pivotal patients who were candidates for carotid revascularization but considered high surgical risk due to pre-specified anatomic criteria and/or medical comorbidities. The primary end point (all stroke, death, or Q-wave myocardial infarction [MI] through 30 days; non-Q-wave MI through 24 h; and ipsilateral stroke or neurologic death through 1 year) was compared with a proportionally weighted objective performance criterion (OPC) of 12.6% for published surgical endarterectomy results in similar patients, plus a pre-specified noninferiority margin of 4%. Results: Among pivotal patients, 41.2% were at high surgical risk due to comorbid risk factors, and 58.8% due to anatomic risk factors; 76.7% were asymptomatic with flow-limiting carotid stenosis >80%. At 1 year, the composite primary end point occurred in 8.9% (40 of 447), with a repeat revascularization rate of 4.7%. With an upper 95% confidence limit of 11.5% for the primary composite end point, the BEACH trial results met the pre-specified criteria for noninferiority relative to the calculated OPC plus noninferiority margin (16.6%) for historical surgical CEA outcomes in similar patients (p < 0.0001 for noninferiority). Conclusions: The BEACH trial results demonstrate that CAS with the WALLSTENT plus FilterWire embolic protection is non-inferior (equivalent or better than) to CEA at 1-year in high-surgical-risk patients (Boston Scientific Embolic Protection, Inc. [EPI]: A Carotid Stenting Trial for High-Risk Surgical Patients [BEACH]; http://clinicaltrials.gov/ct2/show/NCT00316108?term=NCT00316108r NCT00316108).

Background: The BEACH trial evaluated the outcomes of carotid artery stent placement with distal emboli protection, using the Carotid Wallstent® and the FilterWire EX®/EZTM, in patients at high surgical risk for carotid endarterectomy (CEA). Methods: We enrolled 747 patients at high surgical risk for CEA due to prespecified anatomical criteria and/or medical comorbidities. The trial included both symptomatic (>50% carotid artery stenosis) as well as asymptomatic (>80% carotid artery stenosis) high surgical risk patients. Three groups of patients were included in the trial. The Roll-in (R) group (n = 189/747, [25%]) included up to nine patients per site for familiarization of the device and protocol; the Pivotal (P) group (n = 480/747, [65%]) was intended for presentation to the FDA for consideration of device approval; and a Bilateral (B) registry group (n = 78/747, [10%]) was included because of the need to treat patients with bilateral carotid artery disease. In the 480 Pivotal patients, anatomic criteria represented the most frequent high-risk surgical category for enrollment (58.8%), followed by prior CEA (34.2%), multivessel (≥2) coronary artery disease (21.7%), and contralateral carotid occlusion (18.1%). Results: The technical success rate for stent deployment and FilterWire EX/EZ deployment and retrieval was 98.2%. The mean postprocedure angiographic diameter stenosis in the Pivotal group was reduced to 10.8%, while the overall procedure success rate (

Objectives We report intravascular ultrasound (IVUS) findings after crush-stenting of bifurcation lesions. Background Preliminary results with the crush-stent technique are encouraging; however, isolated reports suggest that restenosis at the side branch (SB) ostium continues to be a problem. Methods Forty patients with bifurcation lesions underwent crush-stenting with the sirolimus-eluting stent. Postintervention IVUS was performed in both branches in 25 lesions and only the main vessel (MV) in 15 lesions; IVUS analysis included five distinct locations: MV proximal stent, crush area, distal stent, SB ostium, and SB distal stent. Results Overall, the MV minimum stent area was larger than the SB (6.7 ± 1.7 mm2vs. 4.4 ± 1.4 mm2, p 60% of non-left main lesions. Conclusions In the majority of bifurcation lesions treated with the crush technique, the smallest minimum stent area appeared at the SB ostium. This may contribute to a higher restenosis rate at this location.

An advanced six-ring morpholino backbone c-myc antisense (AVI-4126) was shown to inhibit c-myc expression and intimal hyperplasia after local catheter delivery in a porcine balloon injury model. The purpose of this study was to investigate the effects of an AVI-4126-eluting phosphorylcholine-coated (PC) stent on c-myc expression restenosis and vascular healing after stent implantation in porcine coronary arteries. PC stents were loaded with AVI-4126 using soak trap. Nine pigs underwent AVI-4126 PC coronary stent implantation (two stents/animal). Two to six hours postprocedure, three pigs were sacrificed and stented segments were analyzed by Western blot for c-myc expression. In chronic experiments, six pigs (12 stent sites) were sacrificed at 28 days following intervention and vessels were perfusion-fixed. High-performance liquid chromatography analysis of plasma samples showed minimal presence of the antisense. Western blot analysis of the stented vessels demonstrated inhibition of c-myc expression at 2 and 6 hr after procedure. Quantitative histologic morphometry showed that the neointimal area was significantly reduced (by 40%) in the antisense-coated group compared with control (2.3 ± 0.7 vs. 3.9 ± 0.8 mm2, respectively; P = 0.0077). Immunostaining and electron microscopy demonstrated complete endothelialization, without fibrin deposition, thrombosis, or necrosis in all implanted stents. In the porcine coronary model, an advanced c-myc-eluting PC stent blocked c-myc expression and significantly inhibited myointimal hyperplasia and allowed complete reendothelialization and healing response. Catheter Cardiovasc Interv 2004;61:518–527. © 2004 Wiley-Liss, Inc.

Hypothesis The antisense phosphorodiamidate morpholino oligomer (PMO), AVI-4126, has been effective in reducing neointimal formation in animal models following delivery by pluronic gels, local delivery catheters and coated stents. Greater flexibility of repeated-dosage regimens and reduced procedure complexity may be provided by systemic injection of AVI-4126 bound to perfluorobutane gas microbubble carriers. The purpose of this study was to investigate the effects of perfluorocarbon gas microbubble carrier (PGMC)-based systemic delivery of AVI-4126 on expression of the c- myc in vascular tissue and restenosis after stent implantation. Methods Seven pigs underwent stent implantation (3 stents/animal). Five pigs received IV injection of PGMC and 2 mg of AVI-4126 (AVI BioPharma). Two served as control. Four hours postprocedure, 3 pigs were sacrificed and stented segments analyzed by high-performance liquid chromatography (HPLC) and Western blot. In chronic experiments, 4 pigs (12 stent sites) were sacrificed at 28 days. Results HPLC analysis of plasma samples of treated animals showed minimal presence of AVI-4126. HPLC of the treated arteries demonstrated easily detected concentrations of AVI-4126. Western blot analysis of the stented vessels demonstrated modest inhibition of c- myc . Morphometry showed that the neointimal area was significantly reduced in the AVI-4126/PGMC group compared with control (2.63±1.99 vs. 4.77±.1.71 mm 2 , respectively, P Conclusion In the porcine coronary stent model, systemic targeted delivery of AVI-4126 using PGMC carrier significantly inhibited neointimal formation.

Background and purpose: Most peri-procedural neurological events associated with carotid angioplasty and stenting are due to cerebral embolization. This study was undertaken to determine the safety and efficacy of the distal balloon protection using Guard Wire® temporary occlusion and aspiration system (PercuSurge) in patients with obstructive carotid stenosis during carotid stenting. Methods: A total of 90 patients underwent carotid artery stenting with distal balloon protection. Stenting was performed using coaxial system with 6F-90 cm sheath through femoral approach, pre-dilatation, placement of the stent and stent dilatation. Patients were pre-treated with anti-platelet medication. Results: In our more recent experience with 465 stented carotid arteries without distal protection, the complication rate was 4.5% (including two retinal emboli and two hyperperfusion syndromes). In symptomatic patients 80 years of age the complication rate was 3%. In symptomatic and asymptomatic patients >80, the complication rate was unacceptable, at 21% and 12%, respectively. With distal balloon protection, the complication rate in patients >80 decreased to 3.7%. Balloon protection placement was successful in all patients. Conclusion: The application of distal balloon protection system in carotid stenting was associated with favorable immediate and short-term outcome especially among patients >80 years of age.

Background Neointimal hyperplasia after PTCA is an important component of restenosis. Methods and Results Cultures of rabbit endothelial cells and smooth muscle cells (SMCs) were irradiated with different doses of nonablative infrared (1064-nm) radiation. Normalized viability index detected with nondestructive Alamar Blue assay and direct cell count were studied. Our experiments demonstrated dose-dependent cytostatic or cytotoxic effects of laser irradiation. We also evaluated the long-term effect of endoluminal nonablative infrared laser irradiation on neointimal hyperplasia in a rabbit balloon injury model. PTCA of both iliac arteries of 23 New Zealand White rabbits was performed. One iliac artery was subjected to intra-arterial subablative infrared irradiation via a diffuse tip fiber. The contralateral vessel served as control. The diet was supplemented with 0.25% cholesterol and 2% peanut oil for 10 days before and 60 days after PTCA. Morphometry after 60 days showed that intimal areas were 0.76±0.18 and 1.85±0.30 mm 2 in the laser and control arteries, respectively ( P =2.2×10 −11 ). Conclusions We conclude that nonablative infrared laser inhibited neointimal hyperplasia after PTCA in cholesterol-fed rabbits for up to 60 days.

Background and Purpose — Ambulatory procedures increase patient comfort and enhance cost-effectiveness. We sought to determine the feasibility and safety of ambulatory carotid stenting. Methods — A selected group of patients was admitted and discharged the same day after the carotid stenting procedure. Immediate and short-term outcomes are reported. Results — A total of 98 ambulatory carotid stenting procedures (98 hemispheres in 92 patients) were performed. There were 66 men (72%), and the mean age was 70±9 years. Of the patients, 28% had neurological symptoms related to the treated artery within 3 months before the procedure. Sixteen percent of the patients had prior carotid endarterectomy, 4% had prior ipsilateral neck radiation, and 8% had complete occlusion of the contralateral internal carotid artery. Successful access site hemostasis was ensured in all patients with suture-mediated vascular closure devices in 96 (98%) and manual compression in 2. Clinical follow-up was available for 96% of the patients at a mean time of 6±4 months. There were no neurological events, deaths, repeated procedures, or major access site complications. Conclusions — Ambulatory carotid stenting is both safe and feasible. This approach will enhance the applicability of the procedure by increasing patient comfort and potentially reducing procedural costs.

Background —Carotid stenting is a less invasive percutaneous procedure than carotid endarterectomy for the treatment of carotid stenosis. Reports suggest that it can be performed with periprocedural complication rates similar to those of carotid endarterectomy. The purpose of this study was to determine short- and long-term outcomes in the largest prospective cohort of carotid stenting patients. Methods and Results —This study followed 528 consecutive patients (604 hemispheres/arteries) undergoing carotid stenting. There was a 0.6% (n=3) fatal stroke rate and 1% (n=5) nonstroke death rate at 30 days. The major stroke rate was 1% (n=6), and the minor stroke rate was 4.8% (n=29). The overall 30-day stroke and death rate was 7.4% (n=43). Over the 5-year study period, the 30-day minor stroke rate improved from 7.1% (n=7) for the first year to 3.1% (n=5) for the fifth year ( P Conclusions —Experience from a single group of operators demonstrates that carotid stenting can be performed with an acceptable 30-day complication rate. Late follow-up also demonstrates a low rate of fatal and nonfatal stroke. These results suggest that carotid stenting may be comparable to carotid endarterectomy, and it underscores the clinical equipoise and premise for the National Institute of Health–supported, randomized Carotid Revascularization Endarterectomy Versus Stent Trial comparing carotid stenting with carotid endarterectomy.

There is an increasing trend to rely on duplex ultrasound rather than angiography to measure an internal carotid artery stenosis. The aim of this study was to determine the validity of ultrasound assessment of carotid stenosis performed in community based vascular laboratories. We compared ultrasound with angiography in 225 patients referred to us for carotid intervention. Mild lesions were diagnosed by ultrasound with a sensitivity of 54%, specificity of 89%, and a positive predictive value of 89% compared with angiography. Severe lesions had a sensitivity of 93%, a specificity of 67%, and a positive predictive value of 45%. Receiver operator characteristic curves demonstrated the optimal ultrasound cut-off value of 66% stenosis as a predictor of >60% stenosis measured angiographically, is associated with a false positive rate of 38%, and a false negative rate of 9%. Similarly, if a cut-off of 76% on ultrasound is used to predict >70% stenosis measured angiographically, it would be associated with a 29% false positive rate and a false negative rate of 11%. Despite the value of non-invasive testing for carotid disease, duplex ultrasonography performed in non-accredited and some accredited laboratories may produce highly variable results. Using ultrasound as the sole diagnostic test to determine the severity of a carotid stenosis may result in a high number of inappropriate operations and a large proportion of patients who may not be offered treatment due to false negative diagnoses.

Patients may develop simultaneous symptoms of atherosclerotic vascular disease from different arterial beds. A concurrent minimally invasive approach to the management of these clinical situations may be an advantage over conventional surgical procedures. This study describes two separate case series of patients undergoing coronary/peripheral (n = 38) and peripheral/peripheral procedures (n = 10). Technical and clinical success was achieved in all patients. There were two periprocedural complications (retroperitoneal bleed and septicemia) in the coronary/peripheral series and no complications in the peripheral/peripheral series. We also present five case reports to illustrate the utility of hybrid procedures in various clinical settings. This study suggests that the use of simultaneous or sequential minimally invasive procedures appears to be a safe and feasible strategy for the treatment of patients with symptoms from more than one vascular bed. Cathet Cardiovasc Intervent 2001;52:154-161.

Purpose: To present the results of a multicenter registry established to collect data on carotid stent procedures in patients with restenosis following carotid endarterectomy. Methods: The procedural details, outcomes, and late follow-up results were collected from 14 centers in the United States. Thirty-day and late stroke and death rates were analyzed. Results: Three hundred and thirty-eight patients (201 men; 71 ± 8 years) underwent carotid stenting in 358 arteries. The average duration from carotid endarterectomy was 5.5 ± 7.3 years. Sixty-one percent of the patients were asymptomatic. The overall 30-day stroke and death rate was 3.7%. The minor stroke rate was 1.7% (6/358), and the major nonfatal stroke rate was 0.8% (3/358). The fatal stroke rate was 0.3% (1/358), and the nonstroke-related death rate was 0.9% (3/338). There was 1 (0.3%) fatal and 1 (0.3%) nonfatal stroke during the follow-up period. The overall 3-year rate of freedom from all fatal and nonfatal strokes was 96% ± 1% (±SE). Conclusions: Carotid artery stenting can be performed in patients with restenosis following carotid endarterectomy with 30-day complication rates comparable to those of most published studies on repeat carotid endarterectomy. Results of late follow-up suggest that this technique is durable and efficacious.

The use of digital technology in the cardiac catheterization laboratory is expanding at a rapid pace. The cost-effectiveness of this new technology is yet to be proven. The aims of this study were to determine the direct cost differences of digital versus analog media (CDs) for the storage of diagnostic cardiac catheterizations and to explore the factors influencing these differences. Procedural costs of all diagnostic angiograms (n = 109), from three physicians, performed in an analog catheterization laboratory (room A) and a digital catheterization laboratory (room C) were compared during a 9-month period. The mean procedural cost was higher in room A than in room C ($1,102 vs. $1,087, P < 0.001). This cost difference was eliminated when recording media costs were excluded from analysis ($1,079 vs. $1,080, P = 0.931). Therefore, we conclude there is a procedural cost savings in a cardiac catheterization room that uses digital CDs versus cineangiogram film as the archival media. Cathet. Cardiovasc. Intervent. 49:246-250, 2000.

Purpose: To present our experience with carotid artery stenting as an alternative treatment to endarterectomy in patients with radiation-induced carotid artery occlusive disease. Methods and Results: Fourteen patients (10 males; mean age 61 years, range 52 to 79) underwent percutaneous stenting of 15 carotid arteries for severe radiation-induced extracranial stenoses. Technical success was achieved in all patients, with reduction of the mean stenosis from 77% ± 6% to 8% ± 2%. In 2 patients, ipsilateral vertebral artery lesions were stented concomitantly. One patient had a minor stroke after the procedure but recovered fully in 2 days. No other complications were encountered. Nine (64%) patients had 6-month follow-up imaging (angiography or duplex scanning) that showed no evidence of restenoses (obstruction ≥50%). At 18 ± 2 months, 3 (21%) patients had died from unrelated causes. No neurological events occurred, and no repeat carotid artery interventions were required in the remaining patients. Conclusions: Carotid stenting is an effective treatment option for severe radiation-induced carotid artery occlusive disease.

Percutaneous revascularization techniques have dramatically altered traditional approaches to the management of both coronary and peripheral vascular disease. Their major advantage is that they are less invasive than conventional surgical procedures, offering revascularization without the risk of general anesthesia and with lesser procedural morbidity and mortality, shorter hospital stay, and lower cost. In patients with comorbidities that increase their risk of surgical complications, percutaneous revascularization techniques are the procedures of choice. The Achilles heel of balloon angioplasty, the higher risk of lesion recurrence, restenosis, has been markedly reduced with the use of endovascular stents. Over the past 20 years, percutaneous angioplasty and stenting have become accepted alternatives to surgical revascularization of aortoiliac, renal, femoropopliteal, subclavian, brachiocephalic, and dialysis access lesions. The most recent application of percutaneous intervention has been to explore its clinical utility and safety for stroke prevention in stenotic extracranial carotid arteries.

Occlusion angioplasty has represented a challenge since the introduction of the procedure. We report the successful use of a new, stiff, highly torquable, Teflon-coated wire, the Shinobi wire, in nine coronary occlusions and have included the detailed description of three representative cases. In the discussion we have reviewed the current literature on devices used in coronary occlusions. Cathet. Cardiovasc. Intervent. 48:100–104, 1999. © 1999 Wiley-Liss, Inc.

Purpose: To examine the impact of age upon the development of neurological and major systemic complications during or after carotid artery stenting. Methods: We reviewed the complications that occurred in patients undergoing elective carotid stent implantation between September 1994 and August 1996. The study population was then divided into 3 groups according to age: ≥ 80 (group A), 75 to 79 (group B), and ≤ 74 (group C) years. The rates of death, major and minor stroke, and myocardial infarction were compared among the groups, as well as with the rates reported by the major carotid endarterectomy (CEA) trials. Results: During the study period, 182 patients (216 vessels) were treated with carotid stenting. There were 19 (10.4%) complications: 1 (0.5%) death, 2 (1.1%) major strokes, 15 (8.2%) minor strokes, and 1 (0.5%) myocardial infarction. Neurological complications were clearly related to increased age with rates of 25.0% in group A versus 8.6% in group C (p = 0.042). The overall per patient rate of death or major stroke was 1.6% (1.4% per vessel). Conclusions: Increasing age has a negative impact on the rate of complications in carotid stent patients. However, the majority of those complications are minor. The relative roles of medical therapy, stenting, and CEA in patients > 80 years of age must await the results of randomized trials.

Background Conventional balloon angioplasty of very long de novo coronary lesions or very long coronary dissection caused by angioplasty is associated with low success and high complication rates. Multiple intracoronary stents have been used to treat both conditions, although long-term efficacy has not been defined. Methods and Results Between June 1993 and December 1995, 47 consecutive patients underwent native coronary angioplasty and stenting with 4 or more stents covering at least 2 consecutive diseased coronary segments. Preangioplasty and poststenting diameter stenoses were 81% ± 13% and 21% ± 12%, respectively. Reference vessel diameters were 3.53 ± 0.55 mm proximal to the stents and 2.95 ± 0.62 mm distal to the stents. Average lesion length was 63 ± 20 mm. The number of stents used was 4.5 ± 1 per vessel (from 4 to 7). Gianturco Roubin I stents were used in all patients. Coronary Palmaz-Schatz stents were used as supplementary stents in 3 patients. Angiographic success was 100%. In-hospital outcomes include 1 death, 1 coronary bypass surgery, no Q-wave myocardial infarction, and 7 non–Q-wave myocardial infarctions. Long-term follow-up at 430 ± 199 days was completed in all patients. Thirty-five (76%) patients were asymptomatic, 8 (17%) had class 1 or 2 angina, 1 had a myocardial infarction, 13 (28%) underwent repeat angioplasty, 2 patients had subsequent elective bypass surgery, and 3 died during follow-up. Conclusions Multiple intracoronary stents for very long lesions or dissection can be performed with acceptable immediate and long-term outcomes. (Am Heart J 1999;137:292-7.)

Stenting of the internal carotid artery is facilitated by stenting across the carotid bifurcation and sizing the diameter of a self-expanding stent to the large common carotid segment. This usually results in marked oversizing of the self-expanding stent in the internal carotid segment. This study was done to determine the relationship between stent oversizing and late luminal loss index after stenting of the internal carotid artery. Between September 1995 and March 1997, there were 165 patients (189 vessels) who underwent successful carotid stenting with self-expanding stents. Fifty-nine patients (63 vessels) had six-month follow-up carotid angiograms and on-line quantitative angiographic analysis. The mean reference diameter of the internal carotid arteries was 4.93 ± 1.31 mm. Nominal stent size was 5 mm in 4 patients, 6 mm in 6 patients, 8 mm in 106 patients, 10 mm in 77 patients, and 12 mm in 1 patient. The average stent/patient was 1.03 ± 0.16. There were three patients who had more than 50% diameter renarrowing at follow-up. The mean late loss index was 0.25 ± 0.41. By linear regression analysis, there was no clear linear relationship between stent oversizing and late loss index after stenting (correlation coefficient = -0.21, P = 0.09). When analysis of variance with linear contrast was used to analyze six groups of different stent/artery ratios (from 1.4 to ≥ 2), late loss indexes are significantly lower in the groups of high stent/artery ratio than the groups of low stent/artery ratio (P = 0.01). The process of oversizing of self-expanding stents deployed in the internal carotid artery does not appear to be associated with late restenosis and high stent/artery ratio seems to be associated with low late loss index. Cathet. Cardiovasc. Diagn. 45:139–143, 1998. © 1998 Wiley-Liss, Inc.

Carotid artery stenting is being investigated as a therapeutic strategy for the management of bifurcation stenosis. Palmaz stents were deployed successfully in the carotid arteries of 112 patients using high-pressure balloon inflations. In 11 out of 70 patients who came for 6-mo follow-up angiography, a stent collapse was noted. Carotid ultrasound was able to detect stent collapse in only two patients at follow-up. Only one patient who had collapse of stent along its entire length was symptomatic at follow-up. Repeat balloon angioplasty was performed in 5 patients, 3 of whom had a Wallstent deployed within the Palmaz stent. Conclusion Stent collapse was observed in a significant number of Palmaz stents within 6 mo of placement in the carotid arteries. These observations should influence the choice of stents for the treatment of extracranial carotid disease. Cathet. Cardiovasc. Diagn. 41:137–140, 1997. © 1997 Wiley-Liss, Inc.

Angioplasty of aorto-ostial stenosis is associated with lower procedural success and a higher complication rate. The aim of the present study was to compare the acute and long-term results of balloon and new device angioplasty in 110 consecutive patients with right coronary ostial lesions. Patients were divided into 3 groups according to the angioplasty device used: group I (balloon only, n = 26), group II (debulking devices including excimer laser, directional and rotational atherectomy, n = 26), group III (stent, n = 58). Procedural success was highest in group III (96%) followed by group I (88%), and group II (77%). In-hospital complications were similar among the groups (p = NS). Patients in group III achieved the highest acute gain (2.61 mm) followed by groups II (1.92 mm), and I (1.39 mm, p

We describe a patient who underwent stenting of both internal carotid arteries and two coronary arteries. Two combined carotid and coronary procedures were done 4 wk apart to revascularize the patient. The first procedure was complicated by a minor stroke with good recovery. At 6 mo of follow-up, he is asymptomatic and without angiographic restenosis. Cathet. Cardiovasc. Diagn. 40:202–206, 1997. © 1997 Wiley-Liss, Inc.

Intravascular ultrasound guidance has been suggested as a prerequisite before managing patients receiving slotted tubular stents without anticoagulation. The purpose of this prospective observational study was to determine if patients receiving this stent can be similarly managed following angiographic guided stent deployment without intravascular ultrasound assistance. A total of 137 patients receiving slotted tubular stents were selected to receive a protocol of aspirin 325 mg and ticlopidine 250 mg for 30 days following the satisfaction of certain angiographic criteria. These criteria were: adequate coverage of intimal dissections, absence of residual filling defects, and normal (TIMI III) flow in the stented vessel at the end of the procedure. The stenting procedure was planned in 68% of patients and unplanned in 32% of patients. During the 30 day clinical follow period there were no stent thrombosis events, no Q-wave myocardial infarctions, and no deaths. Non-Q-wave myocardial infarction occurred in 3 patients (2.2%), hemorrhage requiring blood transfusion in 3 patients (2.2%), and 1 patient (0.7%) developed a pseudo-aneurysm of the cannulated femoral artery. These data indicate that patients receiving slotted tubular stents with optimal angiographic results can be safely managed with the combination of aspirin and ticlopidine without anticoagulation or the need for intravascular ultrasound guidance.

Background and Purpose Endarterectomy for recurrent carotid stenosis after endarterectomy has a significantly higher complication rate than the original operation. Angioplasty and stenting may offer a useful alternative treatment for these patients. Methods Between September 1994 and April 1996, 22 patients had 25 carotid arteries treated with angioplasty and stenting for postendarterectomy restenosis. All patients had an independent neurological examination and National Institutes of Health Stroke Scale evaluation before and after the procedure. Patients were treated with aspirin and ticlopidine. All patients were requested to return at 6 months for follow-up angiography. The mean patient age was 69±7 years, and the mean elapsed time from endarterectomy was 73±69 months. Seventy-seven percent of the patients were symptomatic. Results Mean stenosis was reduced from 79±13% before the procedure to 1.8±3.6% after stenting. One patient had a minor stroke, for a complication rate of 4% per treated artery. In the eight patients who returned for 6-month angiography, mean stenosis was 19.4±4.4% and restenosis (≥50% stenosis) did not occur. Conclusions In a small series, angioplasty and stenting appear to be safe and well tolerated for the treatment of postendarterectomy restenosis.

Background The balloon-expandable coil stent has been proved effective in the management of acute and threatened closure after coronary balloon angioplasty and has been shown to reduce restenosis in patients with suboptimal results after coronary balloon angioplasty. Coronary artery stenting has been limited by the occurrence of stent thrombosis and comorbidity related to anticoagulation. This study was undertaken to determine whether anticoagulation may be removed from poststenting protocols, thus reducing comorbidity without increasing stent thrombosis. Methods and Results Between September 1994 and May 1995, 369 patients received balloon-expandable coil stents in native coronary arteries at our institution. Of these patients, 216 were selected for a protocol of aspirin and ticlopidine (for 1 month) without anticoagulation. Eligibility for this protocol followed satisfaction of certain procedural and angiographic criteria. These criteria included adequate coverage of intimal dissections, absence of residual filling defects, and normal (TIMI grade 3) flow in the stented vessel after high-pressure balloon inflations. Intravascular ultrasound was not used to guide stent deployment. The stenting procedure was planned in 37% of patients and unplanned in 63% of patients, including 25 (12%) for acute or threatened closure. During the 30-day follow-up period, stent thrombosis occurred in 2 patients (0.9%), there was 1 death (0.5%), and 2 patients (0.9%) underwent coronary bypass surgery. Vascular access-site complications occurred in 4 patients (1.9%), and bleeding that required blood transfusion occurred in 4 patients (1.9%). Conclusions Patients who receive the coronary balloon-expandable coil stent with optimal angiographic results without intravascular ultrasound guidance can be managed safely with a combination of aspirin and ticlopidine without anticoagulation.

This study was performed to determine the risk factors for restenosis after successful carotid stenting. Of 222 patients who underwent successful carotid stenting, 179 (81%) had a follow-up study (carotid ultrasound and/or angiogram). Restenosis rate was 6.7% (14 of 195) for vessels. By univariate analysis, restenosis rates were significantly different between men and women (4% vs 15.4%, p = 0.018) and ageor =75 versus75 years (3.8% vs 16%, p = 0.013). By multivariate analysis, older age (odds ratio [OR] 1.107, p = 0.015), female sex (OR 3.519, p = 0.001), implantation of multiple stents (OR 2.363, p = 0.019), and postprocedural percent stenosis (OR 1.067, p = 0.054) were associated with increased incidence of restenosis.

Background. Neointimal hyperplasia causes a high rate of hemodialysis synthetic graft failure. Thus, therapies that inhibit neointimal hyperplasia are urgently needed. The Coll-R is a sirolimus-eluting collagen matrix designed for intra-operative perivascular implantation around the graftvenous anastomosis. Sirolimus is an anti-proliferative drug that has proven clinical utility in suppressing neointimal tissue growth in coronary artery disease when delivered locally to the vascular wall by an endovascular drug eluting stent. Methods. A cohort of 12 chronic hemodialysis patients underwent surgical placement of 13 polytetrafluoroethylene grafts 1 Coll-R and were followed for up to 24 months. The primary endpoint was safety (freedom from device related adverse events). Secondary endpoints were pharmacokinetics of sirolimus release, success of Coll-R implantation and primary unassisted graft patency. Results. There were no technical failures, infections, vascular anastomotic or wound-healing problems. Whole blood sirolimus levels rose to a mean peak of 4.8 ng/mL at 6 h and fell to

The balloon-expandable, stainless steel, flexible coil stent is a useful device for managing acute or threatened closure after percutaneous transluminal coronary angioplasty.1–5 Use of the device is associated with thrombosis of the stented vessel in a small but important group of patients.3,6–10 The clinical, angiographic, and procedural factors associated with stent thrombosis with this device are still unknown. The objective of this study was to define predictors of stent thrombosis occurring within the ftrst month after stenting with this device.

Femoral artery pseudoaneurysm formation is a significant problem in patients undergoing cardiac catheterization and interventional cardiac procedures. It is especially more common with the use of anticoagulant and antiplatelet therapy and the use of intracoronary stents. We describe our initial experience with clinically guided bedside compression of femoral pseudoaneurysms in such patients. Eleven patients, 10 undergoing coronary angioplasty (including 3 with intracoronary stents) and 1 undergoing diagnostic cardiac catheterization, developed a femoral pseudoaneurysm. All patients had a femoral bruit and 9 had an expansile groin hematoma. The diagnosis was confirmed in each case by Doppler ultrasound. Seven patients were receiving heparin while 4 were on oral anticoagulants at the time of detection of the pseudoaneurysm. These patients underwent clinically guided graded external compression to close the pseudoaneurysm neck while maintaining femoral arterial flow. External compression for 104.1 ± 63 min resulted in successful clinical resolution of pseudoaneurysm in all patients without complications. The results were confirmed by Doppler ultrasound at least 12 hr later. Bedside compression of femoral pseudoaneurysms guided by clinical clues is simple and appears to be an effective and safe technique to manage this iatrogenic problem. © 1993 Wiiey-Liss, Inc.

A 61-year-old man underwent carotid stenting with the distal-balloon protection system for symptomatic carotid artery stenosis. During the procedure, progressive elevation of the systolic blood pressure occurred, reaching a peak of 220 mm Hg immediately following deflation of the distal balloon. This was associated with severe headaches and progressive deterioration in the mental status to a coma. Head CT scan showed massive subarachnoidal hemorrhage contralateral to the stented side and a secondary intracerebral hemorrhage. Despite immediate successful blood pressure control, his condition deteriorated and he died 2 days later.

Objectives: The purpose of this study was to examine the outcome of carotid stenting using bivalirudin and the influence of vascular closure devices (VCD) on the incidence and severity of peri-procedural hypotension. Background: Bivalirudin, a short-acting direct thrombin inhibitor, has been shown to be an effective anticoagulant in coronary interventions, with less risk of bleeding compared with heparin. Routine use of VCD has become the standard of care, facilitating patient ambulation after percutaneous carotid and coronary interventions. The combined use of these two therapies (bivalirudin and VCD) may improve outcomes in carotid interventions where prolonged patient immobilization may exacerbate hypotension following stenting. Methods: A total of 514 patients underwent 536 carotid stenting procedures in the 3-year period from September 2004 to September 2007. All patients received adjunctive bivalirudin, with and without VCD. This cohort was analyzed for peri-procedural and 30-day clinical outcomes and length of hospitalization. Results: Thirty-day stroke and death rate was 1.7%. A total of 83 patients (15.4%) experienced intra- or post-procedural hypotension (systolic BP < 80 mm Hg). There were four (0.7%) major bleeding complications requiring transfusion, and length of stay was delayed more than 24 hr in five patients (0.93%), all of whom were in the manual compression group. Conclusions: This was a negative study, with no significant difference on prolonged hypotensive events in patients with vascular closure device and bivalirudin, compared with those with manual compression and bivalirudin. Vascular closure devices were safe and effective with a low incidence of complications. In carotid artery stenting, bivalirudin is safe with low incidence of major bleeding and acceptable 30-day adverse event rates (stroke and death). © 2010 Wiley-Liss, Inc.

The prospectively collected data of 1,001 multivessel coronary disease patients who underwent percutaneous transluminal coronary angioplasty (PTCA) was analyzed after categorization into single vessel angioplasty (SVA; group I) and multiple vessel angioplasty (MVA; group II) PTCA groups, which were each compartmentalized into “simple” (group A) and “complex” (group B) cohorts. Patients were assigned to the SVA or MVA group according to the physician's pre-PTCA assessment of how many lesions would be attempted (intention to treat) and not the number of lesions actually attempted. A “simple” patient was more likely than a “complex” patient to be clinically improved after PTCA whether or not the patient had a single dilatation (90% vs 78%; P < 0.05) or multiple dilatations (97% vs 94%; P < 0.05). Similarly, a lesion(s) was more likely to be successfully dilated in the “simple” than in the “complex” group (SVA: 90% vs 82%, P < 0.05; MVA: 97% vs 91%, P < 0.05). In addition, occluded vessels in the MVA group were more likely to be recanalized than in the SVA group (73% vs 44%, P < 0.05). Group I-A patients had a significantly increased (10%) incidence of emergency bypass surgery. Follow-up, at 84 months, showed that “simple” cohorts had a better survival than the “complex” cohorts (MVA: 95% vs 71%, P < 0.05; SVA: 90% vs 72%, P < 0.05); and, nearly two thirds of all successful PTCA patients were angina free. The acute outcome of PTCA in multivessel coronary disease patients is most likely to be successful in “simple” patient cohorts regardless of the number of lesions dilated. Thus, patients with isolated lesions and no concomitant problems should be part of the interventionist's initial multivessel experience with more complex situations being attempted only after refinement of his/her interventional skills. (J Interven Cardiol 1991:4:2)

Purpose: To report a case of carotid artery stenting for asymptomatic carotid restenosis performed in an outpatient setting. Methods and Results: A 68-year-old man with right carotid restenosis after repeat carotid endarterectomy underwent carotid angioplasty and stenting on an ambulatory basis. The procedure to implant a Smart stent required 45 minutes; the femoral access site was closed with a puncture closure device. The patient experienced no sequelae to this procedure and is well 6 months after treatment. Conclusions: Outpatient delivery of percutaneous carotid stenting may be feasible in appropriately selected patients.

Angioplasty using the percutaneous popliteal approach was utilized in 50 patients (PTS) to recanalize 59 occluded superficial femoral arteries which had been unsuccessfully canalized by using the antegrade approach because of either a flush origin occlusion or inability to maintain the guide wire in the true lumen. All PTS had claudication; 8 had rest pain; 3 had non-healing ulcers. The laser Probe was used in 17 cases and the Rotablator in 3 cases. Occlusion length varied between 1 and 40 cm: 7 lesions were less than 10 cm (group 1); 9 were between 10 and 20 cm (group 2); and 43 were greater than 20 cm (group 3). An angiographic success was obtained in 48/59 lesions (81%): 14/16 (87%) in groups 1 and 2 and 34/43 (79%) in group 3. Three PTS needed complementary common femoral endarterectomy and one required percutaneous aspiration of a thromboembolus. Complications included: arterial perforation and/or dissection (without clinical sequelae) in 11 and a popliteal hematoma in 1 PT. One patient with a severely ischemic leg underwent successful emergency vascular surgery, while another limb salvage patient required below-knee amputation. There was no worsening of limb ischemia from any popliteal approach attempt. At discharge, 39 patients (78%) whose outcome would have been unsuccessful with the traditional antegrade approach were clinically improved after utilizing the popliteal approach to achieve a successful angioplasty procedure.

The long-term patency of saphenous vein graft (SVG) lesions after intervention has been shown to be improved with new interventional techniques such as stents. Long-term outcome of patients undergoing successful angioplasty of totally occluded old SVGs with new devices is unknown. From July 1994 to June 1996, 19 patients with totally occluded old SVGs had successful angioplasty with new interventional techniques. Mean SVG age was 123 +/- 8 mo. Thrombolysis in myocardial infarction trial (TIMI) flow was 0 in all target lesions. TIMI 2 or 3 flow was restored after angioplasty in all patients. Intracoronary urokinase, transluminal extractional atherectomy, and stenting were used in 14, 12, and 6 patients, respectively. There was one in-hospital death due to ongoing myocardial infarction, no recurrent infarction, and no repeat angioplasty or bypass surgery in the hospital. At follow-up of 21 +/- 1 mo, there was one sudden death and one myocardial infarction. Five patients had repeat coronary bypass surgery, and 4 had repeat angioplasty. Thirteen patients remained asymptomatic, and 4 had angina. The long-term outcome of patients who had successful reopening of occluded old SVGs is encouraging in this small sample.

Carotid artery stenting, compared with carotid endarterectomy, is emerging as an effective and less invasive method of revascularization for extracranial carotid artery stenosis. Carotid stenting is established as the treatment of choice for certain high-risk patient subsets, and ongoing clinical trials are evaluating this method across a broader clinical spectrum, including asymptomatic patients. For carotid stenting to reach its full potential, an acceptable risk of periprocedural complications, particularly in low-risk patients, must be ensured (the “3% rule”). The present article provides an in-depth review of carotid stenting, with special emphasis on the process of risk stratification pertaining to clinical, anatomic, and procedural considerations necessary to optimize procedural safety and patient outcomes.

Earlier studies demonstrated that perfluorobutane gas microbubble carrier (PGMC) adheres to injured arteries and enhances the drug uptake specifically into the cells of the denuded vessel segment. The purpose of this study was to investigate the effect of PGMC-based systemic delivery of Rapamycin on expression of p27 in vascular tissue and restenosis in porcine coronary arteries after stent implantation. Eight pigs underwent coronary stent implantation (three stents per animal). Five pigs were treated with i.v. injection of PGMC with 2 mg of Rapamycin and three animals served as control. Four hours postprocedure, three pigs were sacrificed and stented segments were analyzed by high-performance liquid chromatography (HPLC) and Western blot. In chronic experiments, five pigs (15 stent sites) were sacrificed at 28 days following intervention and vessels were perfusion-fixed. HPLC of the treated arteries demonstrated high drug concentration in the vessel tissue, and Western blot analysis showed elevated expression of p27 at 4 hr postprocedure. Histomorphometry revealed significantly reduced (by 40%) neointimal formation in the PGMC/Rapamycin group compared with controls (1.84 +/- 0.84 vs. 4.77 +/- 1.71 mm2, respectively; P < 0.001). In the porcine coronary model, site-specific systemic delivery of Rapamycin utilizing PGMC resulted in overexpression of p27 and a significant reduction of neointimal formation within the stented segments.

This prospective nonrandomized study was performed comparing aspirin alone (n = 46) versus aspirin and ticlopidine (p = 338) following native coronary artery stenting. There were significantly more stent thrombosis events in the aspirin-only group than in the aspirin and ticlopidine group (6.5% vs 0.9%, p = 0.02) and significantly more Q-wave myocardial infarctions and cardiac-related deaths in the aspirin-only group than in the aspirin and ticlopidine group (6.5% vs 0%, p = 0.002 and 4.4% vs 0.3% p = 0.02, respectively).

Pseudo-aneurysm following diagnostic or interventional procedures is a well-recognized complication. Ultrasound guided compression repair is routinely used to close an uncomplicated pseudo-aneurysm. We describe a patient with a femoral artery pseudo-aneurysm following iliac angioplasty and stenting in which ultrasound guided compression repair failed. Pseudoaneurysm was successfully closed by transcutaneous coil embolization technique.

A case-controlled study was performed comparing hospitalization costs and length of hospital stay in a group of patients managed with antiplatelet therapy only, versus a group treated with anticoagulation using warfarin after coronary artery stenting. The patients managed with antiplatelet therapy alone had significantly reduced total hospitalization costs and a significantly reduced average hospital stay than patients managed with anticoagulation.

Carotid artery stenting has evolved rapidly over the last decade and is currently being practiced in many medical centers. Since the pioneering work of Dotter 1 and Gruentzig 2 on percutaneous vascular intervention some 30 years ago, few procedures have met the vigorous scrutiny and criticism that has been encountered by carotid artery stenting. Given the potential for procedural neurologic complications and the existence of a well-validated surgical therapy, caution has always been warranted. But in the case of carotid artery stenting, opposition based on less valid motives 3 has caused delays in the federal approval of advanced devices and techniques, slowed progress in clinical trials, created confusion in reimbursement policy, and has resulted in inequitable access for patients who might benefit. Despite resistance, carotid artery stenting has become widely accepted as a viable alternative to carotid endarterectomy (CEA). In this chapter, we review the development of the technique, the clinical and technical management of patients who undergo carotid artery stenting, current results, and future directions.

This study shows that cerebrovascular and peripheral arterial diseases frequently co-exist in patients with coronary artery disease who undergo percutaneous coronary interventions. These 2 conditions are associated with adverse in-hospital and 1-year outcomes and independently predict early and 1-year mortality.

Estrogen can inhibit intimal proliferation and accelerate endothelial regeneration after angioplasty. This suggests that estrogen may prevent in-stent restenosis. Unlike other therapies to prevent restenosis, estrogen may also not delay endothelial regrowth, thereby avoiding the risk of late stent thrombosis. The purpose of this work was to determine the effect of a 17β-estradiol–eluting stent on neointimal formation in a porcine model. Each artery of six pigs was randomized to either a control, low-dose, or high-dose 17β-estradiol–eluting stent. All animals were sacrificed at 30 days for histopathological analysis. There was a 40% reduction in intimal area in the high-dose stents compared with control stents (2.54 ± 1.0 vs. 4.13 ± 1.1 mm2, for high dose vs. control, respectively; P < 0.05). There was complete endothelial regeneration at 30 days and similar inflammatory response to stenting on histopathology in all the stent groups. This is the first study to show that 17β-estradiol–eluting stents are associated with reduced neointimal formation without affecting endothelial regeneration in the pig model of in-stent restenosis. Estrogen-coated stents may have a potential benefit in the prevention and treatment of in-stent restenosis. Cathet Cardiovasc Intervent 2002;57:266–271. © 2002 Wiley-Liss, Inc.