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Title: Extracranial Carotid Artery Stenting in Surgically High-Risk Patients Using the Carotid Wallstent Endoprosthesis:Midterm Clinical and Ultrasound Follow-Up Results

Abstract

The purpose of this study was to evaluate the feasibility, safety and midterm outcome of elective implantation of the Carotid Wallstent (registered) in patients considered to be at high surgical risk. In a prospective study, 54 carotid artery stenoses in 51 patients were stented over a 24-month period. Three patients underwent bilateral carotid artery stenting. Institutional inclusion criteria for invasive treatment of carotid occlusive disease (carotid endarterectomy or carotid artery stenting) are patients presenting with a 70% or more symptomatic stenosis and those with an 80% or more asymptomatic stenosis having a life-expectancy of more than 1 year. All patients treated by carotid artery stenting were considered at high risk for carotid endarterectomy because of a hostile neck (17 patients-31.5%) or because of severe comorbidities (37 patients-68.5%). No cerebral protection device was used. Of the 54 lesions, 33 (61.1%) were symptomatic and 21 (38.8%) were asymptomatic. Follow-up was performed by physical examination and by duplex ultrasonography at 1 month, 6 months, 1 year and 2 years after the procedure. All 54 lesions could be stented successfully without periprocedural stroke. Advert events during follow-up (mean 13.9 {+-} 5.7 months) were non-stroke-related death in 6 patients (11.1%), minor stroke in 4 stentedmore » hemispheres(7.4%), transient ipsilateral facial pain in 1 patient (1.8%),infection of the stented surgical patch in 1 patient (1.8%) and asymptomatic in stent restenosis in 4 patients (7.4%). The percutaneous implantation of the Carotid Wallstent (registered) , even without cerebral protection device, appears to be a safe procedure with acceptable clinical and ultrasonographic follow-up results in patients at high surgical risk. But some late adverse events such as ipsilateral recurrence of non-disabling (minor) stroke or in stent restenosis still remain real challenging problems.« less

Authors:
 [1];  [2];  [3];  [4];  [5]; ;  [4]
  1. Departmentof Interventional Radiology, Leuven, University Hospitals (Belgium), E-mail: geert.maleux@uz.kuleuven.ac.be
  2. Department of Vascular Surgery, Leuven, University Hospitals (Belgium)
  3. Department ofNeurology, Leuven, University Hospitals (Belgium)
  4. Department ofVascular Surgery, Leuven, University Hospitals (Belgium)
  5. Departmentof Interventional Radiology, Leuven, University Hospitals (Belgium)
Publication Date:
OSTI Identifier:
21088369
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 26; Journal Issue: 4; Other Information: DOI: 10.1007/s00270-003-0039-4; Copyright (c) 2003 Springer-Verlag New York, Inc.; www.springer-ny.com; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CAROTID ARTERIES; NECK; PAIN; PATIENTS; SURGERY; ULTRASONOGRAPHY; VASCULAR DISEASES

Citation Formats

Maleux, Geert, Bernaerts, Pauwel, Thijs, Vincent, Daenens, Kim, Vaninbroukx, Johan, Fourneau, Inge, and Nevelsteen, Andre. Extracranial Carotid Artery Stenting in Surgically High-Risk Patients Using the Carotid Wallstent Endoprosthesis:Midterm Clinical and Ultrasound Follow-Up Results. United States: N. p., 2003. Web. doi:10.1007/S00270-003-0039-4.
Maleux, Geert, Bernaerts, Pauwel, Thijs, Vincent, Daenens, Kim, Vaninbroukx, Johan, Fourneau, Inge, & Nevelsteen, Andre. Extracranial Carotid Artery Stenting in Surgically High-Risk Patients Using the Carotid Wallstent Endoprosthesis:Midterm Clinical and Ultrasound Follow-Up Results. United States. doi:10.1007/S00270-003-0039-4.
Maleux, Geert, Bernaerts, Pauwel, Thijs, Vincent, Daenens, Kim, Vaninbroukx, Johan, Fourneau, Inge, and Nevelsteen, Andre. Fri . "Extracranial Carotid Artery Stenting in Surgically High-Risk Patients Using the Carotid Wallstent Endoprosthesis:Midterm Clinical and Ultrasound Follow-Up Results". United States. doi:10.1007/S00270-003-0039-4.
@article{osti_21088369,
title = {Extracranial Carotid Artery Stenting in Surgically High-Risk Patients Using the Carotid Wallstent Endoprosthesis:Midterm Clinical and Ultrasound Follow-Up Results},
author = {Maleux, Geert and Bernaerts, Pauwel and Thijs, Vincent and Daenens, Kim and Vaninbroukx, Johan and Fourneau, Inge and Nevelsteen, Andre},
abstractNote = {The purpose of this study was to evaluate the feasibility, safety and midterm outcome of elective implantation of the Carotid Wallstent (registered) in patients considered to be at high surgical risk. In a prospective study, 54 carotid artery stenoses in 51 patients were stented over a 24-month period. Three patients underwent bilateral carotid artery stenting. Institutional inclusion criteria for invasive treatment of carotid occlusive disease (carotid endarterectomy or carotid artery stenting) are patients presenting with a 70% or more symptomatic stenosis and those with an 80% or more asymptomatic stenosis having a life-expectancy of more than 1 year. All patients treated by carotid artery stenting were considered at high risk for carotid endarterectomy because of a hostile neck (17 patients-31.5%) or because of severe comorbidities (37 patients-68.5%). No cerebral protection device was used. Of the 54 lesions, 33 (61.1%) were symptomatic and 21 (38.8%) were asymptomatic. Follow-up was performed by physical examination and by duplex ultrasonography at 1 month, 6 months, 1 year and 2 years after the procedure. All 54 lesions could be stented successfully without periprocedural stroke. Advert events during follow-up (mean 13.9 {+-} 5.7 months) were non-stroke-related death in 6 patients (11.1%), minor stroke in 4 stented hemispheres(7.4%), transient ipsilateral facial pain in 1 patient (1.8%),infection of the stented surgical patch in 1 patient (1.8%) and asymptomatic in stent restenosis in 4 patients (7.4%). The percutaneous implantation of the Carotid Wallstent (registered) , even without cerebral protection device, appears to be a safe procedure with acceptable clinical and ultrasonographic follow-up results in patients at high surgical risk. But some late adverse events such as ipsilateral recurrence of non-disabling (minor) stroke or in stent restenosis still remain real challenging problems.},
doi = {10.1007/S00270-003-0039-4},
journal = {Cardiovascular and Interventional Radiology},
number = 4,
volume = 26,
place = {United States},
year = {Fri Aug 15 00:00:00 EDT 2003},
month = {Fri Aug 15 00:00:00 EDT 2003}
}
  • PurposeThis prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).Materials and MethodsThe study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and themore » rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis.ResultsOf the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31–365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.ConclusionResults through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.« less
  • Purpose. This prospective study was undertaken to determine the success rate, complications, and outcome of carotid artery stenting (CAS) without the use of cerebral protection devices. Methods. During 12 months, 94 high-grade stenoses of the carotid artery in 91 consecutive patients were treated. Sixty-six (70%) of the stenoses were symptomatic and 28 (30%) were asymptomatic. Results. In all 94 carotid stenoses CAS was successfully performed. During the procedure and within the 30 days afterwards, there were 2 deaths and 3 major strokes in the 66 symptomatic patients, resulting in a combined death and stroke rate of 5 of 66 (7%).more » Only one of these complications, a major stroke, occurred during the procedure. In the 6-month follow-up, one additional major stroke occurred in a originally symptomatic patient resulting in a combined death and stroke rate of 6 of 66 (10%) for symptomatic patients at 6 months. No major complications occurred in asymptomatic patients during the procedure or in the 6-month follow-up period. At 6 months angiographic follow-up the restenosis rate with a degree of >50% was 3 of 49 (6%) and the rate with a degree of {>=}70% was 1 of 49 (2%). Conclusions. Cerebral embolization during CAS is not the only cause of the stroke and death rate associated with the procedure. The use of cerebral protection devices during the procedure may therefore not prevent all major complications following CAS.« less
  • Purpose: To present mature results of high-dose-rate brachytherapy (HDR-BT) as monotherapy for intermediate- and high-risk prostate cancer. Methods and Materials: From 1995 through 2012, 190 patients, 79 with intermediate-risk and 111 with high-risk prostate cancer, were treated with HDR-BT alone using 48 Gy/8 fractions, 54 Gy/9 fractions, or 45.5 Gy/7 fractions over 4 to 5 days. Neoadjuvant with or without adjuvant androgen deprivation therapy was administered to 139 patients, 35 intermediate- and 104 high-risk. Results: Median follow-up time was 92 months (range, 10-227 months), with a minimum of 2 years for surviving patients. Respective rates of cause-specific survival, overall survival, metastasis-free survival, and biochemical no evidence ofmore » disease for the intermediate-risk patients were 100%, 100%, 96%, and 93% at 5 years, and 100%, 96%, 91%, and 91% at 8 years. Corresponding rates for the high-risk patients were 97%, 93%, 84%, and 81% at 5 years, and 93%, 81%, 74%, and 77% at 8 years. The cumulative incidence of late grade 2 to 3 genitourinary toxicity was 5% at 5 years and 10% at 8 years, and that of late grade 3 was 0 at 5 years and 1% at 8 years. The cumulative incidence of late grade 2-3 gastrointestinal toxicity was 4% at 5 years and 6% at 8 years, and that of late grade 3 was 0 at 5 years and 2% at 8 years. No grade 4 or 5 toxicity was detected. Conclusions: Our single-institution study with a median 8-year follow-up showed that HDR-BT as monotherapy was safe and effective for patients with intermediate- and high-risk prostate cancer.« less
  • Uterine artery embolization (UAE) in patients with a large fibroid burden is controversial. Anecdotal reports describe serious complications and limited clinical results. We report the long-term clinical and magnetic resonance (MR) results in a large series of women with a dominant fibroid of >10 cm and/or an uterine volume of >700 cm{sup 3}. Seventy-one consecutive patients (mean age, 42.5 years; median, 40 years; range, 25-52 years) with a large fibroid burden were treated by UAE between August 2000 and April 2005. Volume reduction and infarction rate of dominant fibroid and uterus were assessed by comparing the baseline and latest follow-upmore » MRIs. Patients were clinically followed at various time intervals after UAE with standardized questionnaires. There were no serious complications of UAE. During a mean follow-up of 48 months (median, 59 months; range, 6-106 months), 10 of 71 patients (14%) had a hysterectomy. Mean volume reduction of the fibroid and uterus was 44 and 43%. Mean infarction rate of the fibroid and overall fibroid infarction rate was 86 and 87%. In the vast majority of patients there was a substantial improvement of symptoms. Clinical results were similar in patients with a dominant fibroid >10 cm and in patients with large uterine volumes by diffuse fibroid disease. In conclusion, our results indicate that the risk of serious complications after UAE in patients with a large fibroid burden is not increased. Moreover, clinical long-term results are as good as in other patients who are treated with UAE. Therefore, a large fibroid burden should not be considered a contraindication for UAE.« less
  • The purpose of this study was to prospectively evaluate the incidence of retinal emboli during carotid angioplasty and stenting (CAS) and to correlate emboli with clinical findings and transcranial Doppler (TCD)-detected cerebral embolic load. Between 2001 and 2005, 33 CAS procedures in 32 patients (23 [72%] male, 19 [58%] symptomatic, mean age 72.5 years [range 54.6 to 83.9]) scheduled for CAS were included in this study. Bilateral fundoscopy with retinal photography was performed by an experienced ophthalmologist immediately before, immediately after (fundoscopy only), and 1 day after the procedure and again at long-term follow-up (mean 37 months). Visual field testingmore » was performed before CAS and again at long-term follow-up. TCD-detected cerebral emboli were stratified to five procedural phases: wiring, predilatation, stent placement, postdilatation, and cerebral protection device (CPD) use (if applicable). To establish correlation between TCD data and retinal embolization, Mann-Whitney test was used, and P < 0.05 was considered statistically significant. All procedures were performed successfully. In five of 33 procedures (15%), new retinal emboli were found. Two of the procedures with emboli had small retinal infarcts. Three of five were performed using CPDs versus seven of 28 that had no retinal emboli (P = not significant). Two of four patients (50%) with previous radiation therapy to the neck had new retinal emboli versus three of 29 patients (10%) who had no previous radiation therapy (P = 0.038). None of the other patient characteristics was associated with retinal embolization. In 30 (91%) of patients with an adequate acoustic temporal window for TCD monitoring, there was no statistically significant correlation between TCD data and the incidence of retinal emboli. No visual field defects were found. On long-term follow-up, all retinal emboli and retinal infarcts had resolved. Retinal embolization during CAS is not uncommon, and it occurs in both protected and unprotected procedures. Most retinal emboli are clinically silent.« less