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Castrucci T, Sciarra A, Siani A, Accrocca F, Ianni G, Cancellieri R, Gandini R, Vona S, Borlizzi A, Bartoli S. Carotid artery stenting with flow inversion cerebral protection and MicroNet-covered stent. THE JOURNAL OF CARDIOVASCULAR SURGERY 2024; 65:221-230. [PMID: 39007555 DOI: 10.23736/s0021-9509.24.13067-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 07/16/2024]
Abstract
BACKGROUND The study aims to evaluate the association of proximal flow-inversion cerebral protection and MicroNet-covered CGuard stents in reducing early and late embolic events in carotid artery stenting procedures. METHODS From 2018 to 2023, we performed 204 procedures in 180 patients with flow inversion cerebral protection and CGuard stents at the Vascular Surgery Unit of Sant'Eugenio Hospital in Rome. Cerebral protection was achieved with a Flow-Gate2 catheter connected to a peripheral vein. The tip balloon is inflated in the CCA to obtain an effective endoclamping, the pressure difference between the carotid bifurcation and the venous compartment ensures a constant back flow with wash-out in the venous compartment. Inclusion criteria were: life expectancy of >12 months, target lesions indicating treatment according to ESVS Guidelines, increased surgical risk due to comorbidities or anatomic issues. ECD follow-up was performed immediately postoperatively, at 30 days, 6 and 12 months, and subsequently annually. RESULTS The treatment protocol was successfully implemented in 99% of cases. No major strokes occurred, while one minor stroke (0.5%) occurred within 8 hours of the procedure, regressing in the following months. One perioperative death (0.5%) due to cerebral hemorrhage occurred three hours after the procedure. All patients remained asymptomatic, with no short or medium-term neurological score deterioration. One hemodynamically significant restenosis (0.5%) was detected at the 6-month follow-up. All patients completed the 6 months follow-up, though 6 (3%) were lost at the 12-month appointment. CONCLUSIONS Our prospective monocentric study has demonstrated the effectiveness and safety of the FlowGate2 flow inversion cerebral protection system in association with MicroNet covered CGuard stent.
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Affiliation(s)
| | - Aira Sciarra
- Vascular Surgery Unit, Sant'Eugenio Hospital, Rome, Italy
| | - Andrea Siani
- Vascular Surgery Unit, Sant'Eugenio Hospital, Rome, Italy
| | | | - Giulia Ianni
- Vascular Surgery Unit, Sant'Eugenio Hospital, Rome, Italy
| | | | - Roberto Gandini
- Interventional Radiology Unit, Tor Vergata University, Rome, Italy
| | - Simona Vona
- Vascular Surgery Unit, Tor Vergata University, Rome, Italy
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Gabrielli R, Siani A, Smedile G, Rizzo AR, Accrocca F, Bartoli S. Carotid Artery Stenting versus Carotid Endarterectomy in Terms of Neuroprotection DW-MRI Detected and Neuropsychological Assessment Impairment. Ann Vasc Surg 2024; 98:68-74. [PMID: 37392855 DOI: 10.1016/j.avsg.2023.05.046] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2023] [Revised: 05/28/2023] [Accepted: 05/31/2023] [Indexed: 07/03/2023]
Abstract
BACKGROUND Carotid artery stenting (CAS) versus carotid endarterectomy (CEA) is well issue known, but the purpose of this study is to compare CAS versus CEA in terms of asymptomatic Diffusion-weighted magnetic resonance imaging (DW-MRI) demonstrated microembolic scattering of infarction and neuropsychological assessment impairment. METHODS We performed a prospective, observational, cohort study on 211 consecutive carotid revascularizations at our institution. Patients were divided into 2 different cohorts: CEA was performed in n = 116 patients (Group A); CAS was performed in n = 95 (Group B). Adverse events were collected at 30 days and 6 months postoperative. Differences in terms of DW-MRI demonstrated microembolic scattering of infarction were analyzed and considered significative for P ≤ 0.05. Secondary objectives were: major and minor stroke, neuropsychological assessment impairment, death, myocardial infarction (MI). RESULTS CEA was associated with a significative decreased rate of asymptomatic DW-MRI demonstrated microembolic scattering of infarction (13.8% vs. 51%; P = 0.0001) and of 6 months neuropsychological assessments impairment (0.8 vs. 7.4) (P = 0.04) in asymptomatic patients. There was no significant difference between 2 groups in terms of comorbidities. Stroke rates were similar at 30 days (1.7% CEA vs. 4.1% CAS) and 6 months (2.6% CEA vs. 5.3% CAS P = 0.32). There were no differences in terms of central neurological events, death, transient ischemic attack, MI between the groups. The composite end point of stroke/death/MI at 6 months postoperatively was 2.6% vs. 6.3% (P = 0.19). CONCLUSIONS According to these results, CEA achieved better outcomes compared to patients treated by CAS with distal filter in terms of asymptomatic microembolic event and impairment National Institutes of Health Stroke Scale scale and neuropsychological assessments. Limitations of the study lead to limited conclusions only in the specific population and not generalized. Further, comparative randomized studies are warranted.
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Affiliation(s)
- Roberto Gabrielli
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy.
| | - Andrea Siani
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Gianluca Smedile
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Anna Rita Rizzo
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Federico Accrocca
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Stefano Bartoli
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
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Terakado T, Matumaru Y, Ishikawa E. Stenting of the Common Carotid Artery Ostium: Balloon Catheter Lifting-Up Technique With a Gooseneck Snare. Vasc Endovascular Surg 2023; 57:811-815. [PMID: 37212169 DOI: 10.1177/15385744231178179] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/23/2023]
Abstract
Endovascular revascularization of a stenotic lesion requires appropriate stent positioning. In particular, stenting of the common carotid artery (CCA) ostium makes it difficult to avoid proptosis into the aorta. Furthermore, the guiding catheter may become unstable during the stenting because of its position under the aortic arch. To resolve these problems, we performed antegrade stenting for a patient with a symptomatic stenotic left CCA ostium that was treated by lifting a balloon-guiding catheter with a gooseneck snare. Our patient was a 74-year-old man who presented to the hospital with main complaints of right hemiparesis and motor aphasia. A left cerebral infarction due to severe stenotic left CCA ostium was diagnosed. A CT perfusion study showed decreased cerebral blood flow in the left hemisphere. Stenting of the stenotic left CCA ostium was performed using an antegrade approach. A balloon-guiding catheter positioned under the aortic arch was inflated and lifted from the right brachiocephalic artery using a gooseneck snare. The guiding catheter was stabilized during stenting. This method is highly effective for stenting CCA ostium.
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Affiliation(s)
- Toshitsugu Terakado
- Department of Neurosurgery, Koyama Memorial Hospital, Kashima, Ibaraki, Japan
| | - Yuji Matumaru
- Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan
| | - Eiichi Ishikawa
- Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan
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Gorgulu S, Sahin M, Norgaz NT, Pala S, Sarı M, Yalcin AA, Sipahi I. Carotid artery stenting without embolic protection: A randomized multicenter trial (the CASWEP trial). Interv Neuroradiol 2023; 29:419-425. [PMID: 35469509 PMCID: PMC10399495 DOI: 10.1177/15910199221094388] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/08/2022] [Accepted: 03/24/2022] [Indexed: 12/24/2022] Open
Abstract
BACKGROUND Carotid artery stenting (CAS) with a carotid protection device (CPD) has become the standard practice in patients with severe carotid stenosis and high surgical risk. However, the clinical efficacy and safety of CPDs are still controversial issues. We aimed to compare the clinical outcomes of the CAS without CPD with CAS combined with CPD. METHODS This is a multicenter randomized prospective study registered with http://clinicaltrials.gov (NCT02781181). After the exclusion, 279 patients were enrolled (139 patients in the CAS with CPD group and 140 patients in the CAS without CPD group). The primary outcome was a combination of peri-procedural in-hospital transient ischemic attack (TIA), ipsilateral stroke, or death. The secondary outcome was new ischemic brain lesions on post-procedural diffusion-weighted magnetic resonance imaging (DW-MRI). RESULTS Two patients died in CAS without CPD group, one patient died in CAS with CPD group. TIA was only seen in patients who underwent CAS under protection (n = 5). The combined primary outcome of TIA, ipsilateral stroke, and death rate was not different between groups (5.7% vs. 2.8%; p = 0.254). New defects were noted on the post-procedural DW-MRI in 28% of patients in the CPD group and 27% of patients in the no CPD group (p = 0.881). CONCLUSIONS This study suggests that CAS without CPD is not associated with higher rates of peri-procedural TIA, stroke, and death or new ischemic brain lesions on post-procedural DW-MRI compared to CAS with CPD in selected symptomatic and asymptomatic patients with significant carotid artery stenosis provided that there is no visible thrombus.
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Affiliation(s)
- Sevket Gorgulu
- Department of Cardiology, Acibadem University Medical Faculty, Istanbul, Turkey
| | - Muslum Sahin
- Department of Cardiology, Istinye University Medical Faculty, Istanbul, Turkey
| | | | - Selçuk Pala
- Department of Cardiology, University of Health Sciences, Kartal Kosuyolu High Speciality Educational and Research Hospital, Istanbul, Turkey
| | - Munevver Sarı
- Department of Cardiology, University of Health Sciences, Kartal Kosuyolu High Speciality Educational and Research Hospital, Istanbul, Turkey
| | - Ahmet Arif Yalcin
- Department of Cardiology, University of Health Sciences, Mehmet Akif Ersoy Chest and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
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Ong CW, Kumar GP, Zuo K, Koh LB, Charles CJ, Ho P, Leo HL, Cui F. A novel coating method to reduce membrane infolding through pre-crimping of covered stents – Computationaland experimental evaluation. Comput Biol Med 2022; 145:105524. [DOI: 10.1016/j.compbiomed.2022.105524] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2021] [Revised: 04/12/2022] [Accepted: 04/12/2022] [Indexed: 11/24/2022]
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In Silico Hemodynamics and Filtering Evaluation of a Commercial Embolic Protection Device. Ann Biomed Eng 2021; 49:2659-2670. [PMID: 34405319 DOI: 10.1007/s10439-021-02846-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/08/2021] [Accepted: 08/01/2021] [Indexed: 10/20/2022]
Abstract
During the last years, several kinds of Embolic Protection Devices (EPD) have been developed, with the aim of minimizing complication caused by thrombi generated during Carotid Artery Stenting (CAS). These devices are capable of capturing small particles generated during the intervention, avoiding cerebral stroke and improving the outcomes of the surgery. However, they have associated complications, like the increase on flow resistance associated by their use or the lack of knowledge on their actual filtration efficiency for thrombi of low size. Current work proposes a validated computational methodology in order to predict the hemodynamic features and filtering efficiency of a commercial EPD. It will be observed how Computational Fluid Dynamics predicts pressure drop with fair agreement with the experimental measurements. Finally, this work analyzes the filtration efficiency and the influence of the distribution of injected particles on this parameter. The capabilities of the filter for retaining particles of diameter below the pore size is, additionally, discussed.
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Güner A, Çelik Ö, Topel Ç, Arif Yalçın A, Kalçık M, Uzun F, Altunova M, Örten M, Akman C, Güner EG, Ertürk M. The effect of complex vascular anatomy on silent new ischemic cerebral lesions in carotid artery stenting procedures (from the COMPLEX-CAS Trial). Vascular 2021; 30:292-300. [PMID: 33896290 DOI: 10.1177/17085381211010016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
BACKGROUND Carotid artery stenting is a minimally invasive, durable alternative treatment option, which is an alternative to the reference method, carotid endarterectomy, for patients with carotid artery stenosis; however, silent new ischemic cerebral lesions (SNICLs) after carotid artery stenting remain as a matter of concern. Hence, we aimed to assess the effect of complex vascular anatomy on silent new ischemic cerebral lesions in carotid artery stenting procedures. METHODS We prospectively evaluated 122 patients (mean age: 69.5 ± 7.1 years, male:83) who underwent carotid artery stenting for carotid artery revascularization. The patients having symptomatic transient ischemic attack or stroke after carotid artery stenting were excluded. The presence of a new hyperintense lesions on diffusion-weighted imaging without any neurological findings was considered as the SNICL. Patients were classified into two groups as DWI-positive and DWI-negative patients. RESULTS Among the study population, 32 patients (26.2%) had SNICLs. The DWI-positive group had a significantly higher common carotid artery (CCA)-internal carotid artery (ICA) angle, older age, more frequent history of stroke, a higher proportion of type III aortic arch, and longer fluoroscopy time than the DWI-negative group. High CCA-ICA angle was identified as one of the independent predictors of SNICL (OR (odds ratio) = 1.103 95%CI (confidence interval): (1.023-1.596); p = 0.034), and CCA-ICA angle higher than 34.5 degrees predicted SNICL with a sensitivity of 62.5% and a specificity of 62.2% (area under the curve: 0.680; 95% CI: 0.570 to 0.789; p = 0.003). CONCLUSIONS The higher CCA-ICA angle may predict pre-procedure SNICL risk in carotid artery stenting and may have clinical value in the management of patients with carotid artery stenosis.
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Affiliation(s)
- Ahmet Güner
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Ömer Çelik
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Çağdaş Topel
- Department of Radiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Ahmet Arif Yalçın
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Macit Kalçık
- Department of Cardiology, Faculty of Medicine, Hitit University, Çorum, Turkey
| | - Fatih Uzun
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Mehmet Altunova
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Murat Örten
- Department of Neurology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Cemalettin Akman
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Ezgi Gültekin Güner
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Mehmet Ertürk
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
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Gabrielli R, Castrucci T, Siani A, Accrocca F, Rizzo AR, Spinelli A, Cancellieri R, Bartoli S. Common carotid artery endovascular clamping for neuroprotection during carotid stenting: Flow-gate system as an innovative treatment approach. Catheter Cardiovasc Interv 2021; 97:E71-E78. [PMID: 32985787 DOI: 10.1002/ccd.29287] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2020] [Revised: 08/19/2020] [Accepted: 09/13/2020] [Indexed: 11/11/2022]
Abstract
OBJECTIVES We here report our clinical experience in CAS management through common carotid artery endovascular clamping with FlowGate2 system. METHODS Forty-five patients were enrolled with de novo asymptomatic internal carotid artery stenosis ≥70%. Cerebral protection during the stenting procedure was achieved using a unique endovascular clamping technique developed in our Institution which includes: (a) the occlusion of the common carotid artery only, through inflatable balloons integrated in the FlowGate2 Balloon Guide Catheter system; (b) flow inversion connecting catheter to 16 G blood cannula previously placed in arm vein; (c) after the placement of the stent, the flow inversion is maintained for 30 s to allow debris washout. The related primary end-point was the rate of Diffusion-weighted imaging magnetic resonance (DWI) micro-embolic scattering of infarction. The patient's clinical and the neurological status were assessed prior, during and after intervention, at discharge. RESULTS Transient clamping intolerance was observed in two patients (2/45; 4%). One minor stroke (1/45; 2%) occurred 8 hr the procedure with DWI ipsilateral micro-embolic lesions. No major strokes or deaths were observed at 3 months follow-up. DWI demonstrated ipsilateral micro-embolic scattering of infarction, in one asymptomatic patient. In all patients, no worst changes in NIHSS scale assessment were recorded at 1, 3, and 6 months. CONCLUSIONS Our data confirmed the efficacy of FlowGate2 in terms of neuroprotection during CAS. To our knowledge, these are the first published data on this innovative approach developed in our institution. A large controlled trial is ongoing to confirm preliminary evidences.
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Affiliation(s)
- Roberto Gabrielli
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Tommaso Castrucci
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Andrea Siani
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Federico Accrocca
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Anna Rita Rizzo
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
| | - Alessio Spinelli
- Unit of Interventional Radiology, "S. Eugenio" Hospital, Rome, Italy
| | | | - Stefano Bartoli
- Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy
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Kim MS, Rho MH, Hong HP, Park HJ, Chung PW, Won YS. Comparison of Embolic Protection with Proximal and Distal Protection Devices: Periprocedural Complications, Clinical Outcomes, and Cerebral Embolic Lesions on Diffusion-Weighted Magnetic Resonance Imaging. World Neurosurg 2019; 135:e731-e737. [PMID: 31899400 DOI: 10.1016/j.wneu.2019.12.121] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2019] [Revised: 12/19/2019] [Accepted: 12/20/2019] [Indexed: 12/17/2022]
Abstract
OBJECTIVE Two main types of embolic protection devices have been used during carotid artery stenting (CAS): distal protection devices (DPDs) and proximal protection devices (PPDs). We compared the complications, clinical outcomes, and new ischemic lesions on diffusion-weighted magnetic resonance imaging (DWI) studies between patients who had undergone CAS using a DPD or PPD. METHODS We performed a retrospective review of the data from patients who had undergone CAS from March 2010 to January 2016. The periprocedural and 30-day adverse events and new ischemic lesions on DWI studies after CAS were evaluated. RESULTS CAS was performed in 103 patients (DPD, n = 60; PPD, n = 43). The number of patients with new ischemic lesions was greater in the DPD than in the PPD group (78% vs. 56%; P = 0.014). Most lesions (>90%) were tiny (≤3 mm), and the average number of new tiny lesions per patient was significantly greater in the DPD than in the PPD group (mean, 9.6 vs. 4.0; P = 0.008). No significant differences in the periprocedural or 30-day adverse rates were noted between the 2 groups. Intolerance during the procedure occurred in 5 patients (12%) in the PPD group, 4 of whom had poor collateral circulation. CONCLUSIONS The number of new ischemic lesions per patient and the incidence of ischemic lesions found on DWI were significantly greater in the DPD than in the PPD group. The lack of differences in the periprocedural and 30-day adverse rates between the 2 groups suggests that cerebral microemboli might not be associated with the clinical outcomes. For patients with poor collateral status, DPDs should be used preferentially to avoid the neurologic compromise associated with PPDs.
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Affiliation(s)
- Myung Sub Kim
- Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Myung Ho Rho
- Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
| | - Hyun Pyo Hong
- Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Hee Jin Park
- Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Pil Wook Chung
- Department of Neurology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Yu Sam Won
- Department of Neurosurgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
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Caliste X, Laser A, Darling RC. CEA vs. stent in patients with acute strokes: are they equally effective? THE JOURNAL OF CARDIOVASCULAR SURGERY 2019; 61:133-142. [PMID: 31603298 DOI: 10.23736/s0021-9509.19.11137-8] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
INTRODUCTION Stroke is the 3rd leading cause of death worldwide with 15 million strokes annually. Extracranial carotid stenosis contributes to major stroke morbidity and mortality as a significant etiology of ischemic strokes. For acute stroke, in addition to optimal medical management, patients may be candidates for carotid endarterectomy and/or carotid stenting for secondary stroke reduction. This paper set out to review the data currently available regarding equivalency of the two intervention options. EVIDENCE ACQUISITION A comprehensive literature review was performed through PubMed and other sources using the key words carotid endarterectomy, carotid artery stent, acute stroke, symptomatic carotid stenosis, flow reversal, TCAR. Studies which solely evaluated patients with asymptomatic disease were ineligible for the study. EVIDENCE SYNTHESIS Review of landmark trials such as NASCET and CREST in addition to more recent studies demonstrates the effectiveness of surgical management with carotid endarterectomy of acute stroke. Carotid stenting has also been shown to have acceptable outcomes in certain patient populations. CONCLUSIONS Carotid endarterectomy continues to demonstrate effectiveness and safety for management of acute stroke, while carotid stenting has limitations. Carotid artery stenting has been shown to be non-inferior in some patient populations, but more recent and future technologic developments may expand the potential acceptable patient selection criteria.
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Affiliation(s)
- Xzabia Caliste
- Division of Vascular Surgery, Albany Medical Center Hospital, Albany Medical College, Albany, NY, USA
| | - Adriana Laser
- Division of Vascular Surgery, Albany Medical Center Hospital, Albany Medical College, Albany, NY, USA -
| | - R Clement Darling
- Division of Vascular Surgery, Albany Medical Center Hospital, Albany Medical College, Albany, NY, USA
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Barrett H, Cunnane E, Hidayat H, O Brien J, Kavanagh E, Walsh M. Calcification Volume Reduces Stretch Capability and Predisposes Plaque to Rupture in an in vitro Model of Carotid Artery Stenting. Eur J Vasc Endovasc Surg 2017; 54:431-438. [DOI: 10.1016/j.ejvs.2017.07.022] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/26/2017] [Accepted: 07/21/2017] [Indexed: 01/18/2023]
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Paraskevas KI, Veith FJ. Transcervical access, reversal of flow and mesh-covered stents: New options in the armamentarium of carotid artery stenting. World J Cardiol 2017; 9:416-421. [PMID: 28603588 PMCID: PMC5442409 DOI: 10.4330/wjc.v9.i5.416] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/14/2016] [Revised: 01/22/2017] [Accepted: 03/22/2017] [Indexed: 02/06/2023] Open
Abstract
In the last 25 years, the very existence of carotid artery stenting (CAS) has been threatened on a number of occasions. The initial disappointing results that even lead to the discontinuation of an early randomized controlled trial have improved considerably with time. Novel devices, advanced stent and equipment technology, alternative types of access and several types of filters/emboli protecting devices have been reported to reduce stroke/death rates during/after CAS and improve CAS outcomes. The present review will provide a description of the various technology advances in the field that aim to reduce stroke and death rates associated with CAS. Transcervical access, reversal of flow and mesh-covered stents are currently the most promising tools in the armamentarium of CAS.
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Moteki Y, Niimi Y, Sato S, Inoue T, Shima S, Okada Y. Effectiveness of the Combined Use of Distal Filter Protection Device and Mo.Ma Ultra: Technical Note. J Stroke Cerebrovasc Dis 2016; 25:2627-2631. [PMID: 27476338 DOI: 10.1016/j.jstrokecerebrovasdis.2016.07.003] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2016] [Revised: 05/16/2016] [Accepted: 07/02/2016] [Indexed: 10/21/2022] Open
Abstract
BACKGROUND Although Mo.Ma Ultra is an embolic protection device for interrupting the anterograde blood flow to the internal carotid artery, incomplete blood stagnation is often observed. We report the effectiveness of the combined use of a distal filter protection device and Mo.Ma Ultra (Medtronic, Minneapolis, MN). MATERIALS AND METHODS Our case series comprises 10 consecutive patients (11 carotid arteries) who underwent carotid artery stenting (CAS) using Mo.Ma Ultra and FilterWire EZ (Boston Scientific, Natick, MA). RESULTS The superior thyroid artery originated from the proximal side of the bifurcation of the common carotid artery, except for 1 artery. Although complete blood stagnation was observed in 6 arteries, filter debris was detected in 3 of these 6 arteries. Positive postoperative findings on diffusion-weighted magnetic resonance imaging were observed in 3 cases (3 arteries). Only 1 patient had transient neurological deficits. CONCLUSION The combined use of a distal filter protection device and Mo.Ma Ultra could provide a more reliable embolic protection in CAS.
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Affiliation(s)
- Yosuke Moteki
- Department of Neuroendovascular Therapy, St. Luke's International Hospital, Tokyo, Japan.
| | - Yasunari Niimi
- Department of Neuroendovascular Therapy, St. Luke's International Hospital, Tokyo, Japan
| | - Shinsuke Sato
- Department of Neurosurgery, St. Luke's International Hospital, Tokyo, Japan
| | - Tatsuya Inoue
- Department of Neurosurgery, St. Luke's International Hospital, Tokyo, Japan
| | - Shogo Shima
- Department of Neurosurgery, St. Luke's International Hospital, Tokyo, Japan
| | - Yoshikazu Okada
- Department of Neurosurgery, St. Luke's International Hospital, Tokyo, Japan
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Kumar GP, Kabinejadian F, Liu J, Ho P, Leo HL, Cui F. Simulated Bench Testing to Evaluate the Mechanical Performance of New Carotid Stents. Artif Organs 2016; 41:267-272. [PMID: 27357068 DOI: 10.1111/aor.12745] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2015] [Revised: 02/02/2016] [Accepted: 03/01/2016] [Indexed: 11/27/2022]
Abstract
Our group recently developed a novel covered carotid stent that can prevent emboli while preserving the external carotid artery (ECA) branch blood flow. However, our recent in vitro side-branch ECA flow preservation tests on the covered stents revealed the need for further stent frame design improvements, including the consideration to crimp the stent to a low profile for the delivery of the stent system and having bigger cells. Hence, the current work aims to design new bare metal stents with bigger cell size to improve the crimpability and to accommodate more slits so that the side-branch flow could be further increased. Three new stent designs were analyzed using finite element analysis and benchmarked against two commercially available carotid stents in terms of their mechanical performances such as crimpability, radial strength, and flexibility. Results indicated that the new bare metal stent designs matched well against the commercial stents. Hence our new generation covered stents based on these designs can be expected to perform better in side-branch flow preservation without compromising on their mechanical performances.
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Affiliation(s)
| | - Foad Kabinejadian
- Department of Bioengineering, National University of Singapore.,Department of Surgery, National University of Singapore
| | - Jianfei Liu
- Institute of High Performance Computing, A*STAR
| | - Pei Ho
- Department of Surgery, National University of Singapore.,Department of Cardiac, Thoracic & Vascular Surgery, National University Health System, Singapore
| | - Hwa Liang Leo
- Department of Bioengineering, National University of Singapore
| | - Fangsen Cui
- Institute of High Performance Computing, A*STAR
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Kabinejadian F, Kaabi Nezhadian M, Cui F, Ho P, Leo HL. Covered Stent Membrane Design for Treatment of Atheroembolic Disease at Carotid Artery Bifurcation and Prevention of Thromboembolic Stroke: An In Vitro Experimental Study. Artif Organs 2015; 40:159-68. [DOI: 10.1111/aor.12520] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Affiliation(s)
- Foad Kabinejadian
- Department of Biomedical Engineering; National University of Singapore; Singapore Singapore
- Department of Surgery; National University of Singapore; Singapore Singapore
| | | | - Fangsen Cui
- Institute of High Performance Computing (IHPC); Agency for Science, Technology and Research (A*STAR); Singapore Singapore
| | - Pei Ho
- Department of Surgery; National University of Singapore; Singapore Singapore
- Department of Cardiac, Thoracic & Vascular Surgery; National University Health System; Singapore Singapore
| | - Hwa Liang Leo
- Department of Biomedical Engineering; National University of Singapore; Singapore Singapore
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16
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Comparison of dual protection and distal filter protection as a distal embolic protection method during carotid artery stenting: a single-center carotid artery stenting experience. Neurosurg Rev 2015; 38:671-6. [DOI: 10.1007/s10143-015-0639-x] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2014] [Revised: 11/28/2014] [Accepted: 01/19/2015] [Indexed: 11/30/2022]
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17
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Chueh JY, Puri AS, Wakhloo AK, Gounis MJ. Risk of distal embolization with stent retriever thrombectomy and ADAPT. J Neurointerv Surg 2014; 8:197-202. [PMID: 25540180 PMCID: PMC4752657 DOI: 10.1136/neurintsurg-2014-011491] [Citation(s) in RCA: 179] [Impact Index Per Article: 16.3] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2014] [Accepted: 12/01/2014] [Indexed: 11/21/2022]
Abstract
Background There is a discrepancy in clinical outcomes and the achieved recanalization rates with stent retrievers in the endovascular treatment of ischemic stroke. It is our hypothesis that procedural release of embolic particulate may be one contributor to poor outcomes and is a modifiable risk. The goal of this study is to assess various treatment strategies that reduce the risk of distal emboli. Methods Mechanical thrombectomy was simulated in a vascular phantom with collateral circulation. Hard fragment-prone clots (HFC) and soft elastic clots (SECs) were used to generate middle cerebral artery (MCA) occlusions that were retrieved by the Solitaire FR devices through (1) an 8 Fr balloon guide catheter (BGC), (2) a 5 Fr distal access catheter at the proximal aspect of the clot in the MCA (Solumbra), or (3) a 6 Fr guide catheter with the tip at the cervical internal carotid artery (guide catheter, GC). Results from mechanical thrombectomy were compared with those from direct aspiration using the Penumbra 5MAX catheter. The primary endpoint was the size distribution of emboli to the distribution of the middle and anterior cerebral arteries. Results Solumbra was the most efficient method for reducing HFC fragments (p<0.05) while BGC was the best method for preventing SEC fragmentation (p<0.05). The risk of forming HFC distal emboli (>1000 µm) was significantly increased using GC. A non-statistically significant benefit of direct aspiration was observed in several subgroups of emboli with size 50–1000 µm. However, compared with the stent-retriever mechanical thrombectomy techniques, direct aspiration significantly increased the risk of SEC fragmentation (<50 µm) by at least twofold. Conclusions The risk of distal embolization is affected by the catheterization technique and clot mechanics.
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Affiliation(s)
- Ju-Yu Chueh
- Department of Radiology, New England Center for Stroke Research, University of Massachusetts Medical School, Worcester, Massachusetts, USA
| | - Ajit S Puri
- Department of Radiology, New England Center for Stroke Research, University of Massachusetts Medical School, Worcester, Massachusetts, USA
| | - Ajay K Wakhloo
- Department of Radiology, New England Center for Stroke Research, University of Massachusetts Medical School, Worcester, Massachusetts, USA
| | - Matthew J Gounis
- Department of Radiology, New England Center for Stroke Research, University of Massachusetts Medical School, Worcester, Massachusetts, USA
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18
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Akkaya E, Vuruskan E, Gul ZB, Yildirim A, Pusuroglu H, Surgit O, Kalkan AK, Akgul O, Akgul GP, Gul M. Cerebral microemboli and neurocognitive change after carotid artery stenting with different embolic protection devices. Int J Cardiol 2014; 176:478-483. [PMID: 25125014 DOI: 10.1016/j.ijcard.2014.07.241] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/26/2014] [Accepted: 07/28/2014] [Indexed: 11/30/2022]
Abstract
OBJECTIVES Proximal cerebral protection devices have been developed as an alternative to filter protection devices for reducing neurological complications during carotid artery stenting (CAS). The aim of the present study was to evaluate the frequency of silent cerebral embolism after CAS using different cerebral embolic protection devices and the impact of silent cerebral embolism on neurocognitive function. METHODS One hundred consecutive patients who underwent CAS were enrolled. The patients were randomized to either proximal balloon occlusion or filter protection. Neurocognitive tests were performed before and six months after CAS. Cerebral embolisms were evaluated with diffusion-weighted magnetic resonance imaging (DW-MRI). RESULTS The number and volume of new ischemic lesions found with DW-MRI were higher in the filter protection group than in the proximal balloon occlusion group. According to our definition, nine (21%) patients in the balloon occlusion group and 16 (36%) patients in the filter protection group showed neurocognitive decline, and ten (23%) patients in the balloon occlusion group and four (9%) patients in the filter protection group showed neurocognitive improvement (NS). Regarding the group of patients with new cerebral ischemic lesions on DW-MRI, neurocognitive decline occurred in 14 (31%) of 45 patients with DW-MRI lesions and 11 (26%) of 43 patients without DW-MRI lesions (NS). CONCLUSION Neurocognitive outcome after CAS is unpredictable; both neurocognitive decline and improvement can occur. In this study, the proximal balloon occlusion system significantly decreased cerebral microemboli during CAS compared to filter protection. Cerebral microembolism was not found to be associated with neurocognitive decline.
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Affiliation(s)
- Emre Akkaya
- Department of Cardiology, Mehmet Akif Ersoy Thorasic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.
| | - Ertan Vuruskan
- Department of Cardiology, Gaziantep State Hospital, Gaziantep, Turkey
| | - Zeynep Bastug Gul
- Department of Neurology, Dr. Mazhar Osman Teaching and Research Hospital for Mental Health and Neurological Disorders, Istanbul, Turkey
| | - Aydın Yildirim
- Department of Cardiology, Mehmet Akif Ersoy Thorasic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Hamdi Pusuroglu
- Department of Cardiology, Mehmet Akif Ersoy Thorasic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Ozgur Surgit
- Department of Cardiology, Mehmet Akif Ersoy Thorasic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Ali Kemal Kalkan
- Department of Cardiology, Mehmet Akif Ersoy Thorasic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Ozgur Akgul
- Department of Cardiology, Mehmet Akif Ersoy Thorasic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
| | - Gamze Pinar Akgul
- Department of Neurology, Gaziantep State Hospital, Gaziantep, Turkey
| | - Mehmet Gul
- Department of Cardiology, Mehmet Akif Ersoy Thorasic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
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Asai K, Imamura H, Mineharu Y, Tani S, Adachi H, Narumi O, Todo K, Hoshi T, Sato S, Kono T, Sakai C, Sakai N. Triple Balloon Protection Technique Using the Mo.Ma Ultra with the Carotid GuardWire for Carotid Stenting: Technical Note. J Stroke Cerebrovasc Dis 2014; 23:1871-6. [DOI: 10.1016/j.jstrokecerebrovasdis.2014.02.021] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/16/2013] [Revised: 02/07/2014] [Accepted: 02/14/2014] [Indexed: 11/26/2022] Open
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Giri J, Yeh RW, Kennedy KF, Hawkins BM, Weinberg I, Weinberg MD, Parikh SA, Garasic J, Jaff MR, White CJ, Rosenfield K. Unprotected carotid artery stenting in modern practice. Catheter Cardiovasc Interv 2013; 83:595-602. [DOI: 10.1002/ccd.25090] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2013] [Revised: 06/04/2013] [Accepted: 06/16/2013] [Indexed: 11/05/2022]
Affiliation(s)
- Jay Giri
- Cardiovascular Medicine Division; Hospital of the University of Pennsylvania; Philadelphia Pennsylvania
| | - Robert W. Yeh
- Division of Cardiology; Massachusetts General Hospital, Harvard Medical School; Boston Massachusetts
| | - Kevin F. Kennedy
- St. Luke's Mid-America Heart Institute; University of Missouri - Kansas City; Kansas City Missouri
| | - Beau M. Hawkins
- Division of Cardiology; Massachusetts General Hospital, Harvard Medical School; Boston Massachusetts
| | - Ido Weinberg
- Division of Cardiology; Massachusetts General Hospital, Harvard Medical School; Boston Massachusetts
| | - Mitchell D. Weinberg
- Division of Cardiology; Massachusetts General Hospital, Harvard Medical School; Boston Massachusetts
| | - Sahil A. Parikh
- University Hospitals Harrington Heart and Vascular Institute and Case Western Reserve University School of Medicine; Cleveland Ohio
| | - Joseph Garasic
- Division of Cardiology; Massachusetts General Hospital, Harvard Medical School; Boston Massachusetts
| | - Michael R. Jaff
- Division of Cardiology; Massachusetts General Hospital, Harvard Medical School; Boston Massachusetts
| | - Christopher J. White
- John Ochsner Heart and Vascular Institute; Ochsner Medical Center; New Orleans Louisiana
| | - Kenneth Rosenfield
- Division of Cardiology; Massachusetts General Hospital, Harvard Medical School; Boston Massachusetts
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21
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Bauer C, Franke J, Bertog S, Woerner V, Ghasemzadeh-Asl S, Sievert H. FiberNet-A new embolic protection device for carotid artery stenting. Catheter Cardiovasc Interv 2013; 83:1014-20. [DOI: 10.1002/ccd.25138] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/14/2013] [Accepted: 07/21/2013] [Indexed: 11/12/2022]
Affiliation(s)
- C. Bauer
- CardioVascular Center Frankfurt; Frankfurt Germany
| | - J. Franke
- CardioVascular Center Frankfurt; Frankfurt Germany
| | - S.C. Bertog
- CardioVascular Center Frankfurt; Frankfurt Germany
| | - V. Woerner
- CardioVascular Center Frankfurt; Frankfurt Germany
| | | | - H. Sievert
- CardioVascular Center Frankfurt; Frankfurt Germany
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22
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Stetler W, Gemmete JJ, Pandey AS, Chaudhary N. Endovascular treatment of carotid occlusive disease. Neuroimaging Clin N Am 2013; 23:637-52. [PMID: 24156855 DOI: 10.1016/j.nic.2013.03.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/26/2022]
Abstract
Carotid occlusive disease is one of several etiologic factors for stroke. Of all strokes, an estimated 88% are ischemic in nature. Less than 20% of these are caused by atheroma in the carotid bifurcation. Traditionally, carotid artery stenosis has been treated with carotid endarterectomy (CEA); however, carotid artery balloon angioplasty and stent placement has enjoyed significant technological advances over the last decade and can now offer a comparable treatment alternative to CEA. In this review, the authors concentrate their discussion on the treatment of carotid atherosclerotic disease with particular attention on the endovascular treatment.
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Affiliation(s)
- William Stetler
- Department of Neurosurgery, University of Michigan Hospitals, 1500 East Medical Center Drive, Ann Arbor, MI 48109, USA
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23
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González A, Piñero P, Martínez E, González-Marcos JR, Rafel E, Mayol A, Gil-Peralta A. Silent cerebral ischemic lesions after carotid artery stenting with distal cerebral protection. Neurol Res 2013; 27 Suppl 1:S79-83. [PMID: 16197830 DOI: 10.1179/016164105x35431] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/31/2022]
Abstract
OBJECTIVE To evaluate by MR diffusion weighted image (DWI-MR) the presence of new ischemic cerebral lesions after carotid artery stenting (CAS) and distal cerebral protection, in patients with internal carotid artery (ICA) stenosis >70. METHODS Sixty-seven CAS were performed under cerebral protection with a distal filter. Mean age of the patients was 68.3 years (range 37-86) and 42 patients (62.7%) were symptomatic. An EZ filter device was used in all cases. The mean length of the procedure was 22.2 minutes (range 8-110). All patients had a cerebral MRI done in the 3 days before CAS and a DW-MR (eco planar single shot, b=1000 mm2/seconds) was done the day after. RESULTS As a consequence of the CAS, three transient ischemic attacks were observed. There was one minor stroke (1.5%) on day 21, but no major stroke, death or myocardial infarction in a 30-day period. DW-MRI after CAS showed 26 new silent ischemic lesions in 11 asymptomatic patients (16.4%). In six, they were multiple (range 2-5). Lesions were mainly seen in the ipsilateral medial cerebral artery (21); four in the posterior fossa, and one in the contralateral medial cerebral artery. DISCUSSION Although the use of distal cerebral protection was safe, new cerebral ischemic lesions, supposedly embolic, were observed in 16.4% of the patients. Although without clinical consequences in our series, their moderate high incidence should promote the investigation of safer techniques and devices.
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Affiliation(s)
- Alejandro González
- Interventional Neuroradiology, Radiology Department, Hospitales Universitarios Virgen del Rocío, Avda, Manuel Siurot s/n, 41013 Sevilla, Spain.
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24
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Montorsi P, Caputi L, Galli S, Ciceri E, Ballerini G, Agrifoglio M, Ravagnani P, Trabattoni D, Pontone G, Fabbiocchi F, Loaldi A, Parati E, Andreini D, Veglia F, Bartorelli AL. Microembolization during carotid artery stenting in patients with high-risk, lipid-rich plaque. A randomized trial of proximal versus distal cerebral protection. J Am Coll Cardiol 2013; 58:1656-63. [PMID: 21982309 DOI: 10.1016/j.jacc.2011.07.015] [Citation(s) in RCA: 160] [Impact Index Per Article: 13.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/04/2011] [Revised: 07/13/2011] [Accepted: 07/19/2011] [Indexed: 12/20/2022]
Abstract
OBJECTIVES The goal of this study was to compare the rate of cerebral microembolization during carotid artery stenting (CAS) with proximal versus distal cerebral protection in patients with high-risk, lipid-rich plaque. BACKGROUND Cerebral protection with filters partially reduces the cerebral embolization rate during CAS. Proximal protection has been introduced to further decrease embolization risk. METHODS Fifty-three consecutive patients with carotid artery stenosis and lipid-rich plaque were randomized to undergo CAS with proximal protection (MO.MA system, n = 26) or distal protection with a filter (FilterWire EZ, n = 27). Microembolic signals (MES) were assessed by using transcranial Doppler during: 1) lesion wiring; 2) pre-dilation; 3) stent crossing; 4) stent deployment; 5) stent dilation; and 6) device retrieval/deflation. Diffusion-weighted magnetic resonance imaging was conducted before CAS, after 48 h, and after 30 days. RESULTS Patients in the MO.MA group had higher percentage diameter stenosis (89 ± 6% vs. 86 ± 5%, p = 0.027) and rate of ulcerated plaque (35% vs. 7.4%; p = 0.019). Compared with use of the FilterWire EZ, MO.MA significantly reduced mean MES counts (p < 0.0001) during lesion crossing (mean 18 [interquartile range (IQR): 11 to 30] vs. 2 [IQR: 0 to 4]), stent crossing (23 [IQR: 11 to 34] vs. 0 [IQR: 0 to 1]), stent deployment (30 [IQR: 9 to 35] vs. 0 [IQR: 0 to 1]), stent dilation (16 [IQR: 8 to 30] vs. 0 [IQR: 0 to 1]), and total MES (93 [IQR: 59 to 136] vs. 16 [IQR: 7 to 36]). The number of patients with MES was higher with the FilterWire EZ versus MO.MA in phases 3 to 5 (100% vs. 27%; p < 0.0001). By multivariate analysis, the type of brain protection was the only independent predictor of total MES number. No significant difference was found in the number of patients with new post-CAS embolic lesion in the MO.MA group (2 of 14, 14%) as compared with the FilterWire EZ group (9 of 21, 42.8%). CONCLUSIONS In patients with high-risk, lipid-rich plaque undergoing CAS, MO.MA led to significantly lower microembolization as assessed by using MES counts.
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Affiliation(s)
- Piero Montorsi
- Department of Cardiovascular Sciences, University of Milan, Centro Cardiologico Monzino, IRCCS, Via Parea 4, Milan, Italy.
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Galego SJ, Colli Junior DF, Donatelli R, Cardoso MAP, Bueno AN, Lobato ACD, Corrêa JA, Goldman S. Initial experience with a reversal-of-flow cerebral protection device in carotid angioplasty. J Vasc Bras 2013. [DOI: 10.1590/s1677-54492013000100005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
PURPOSE: To report initial findings with the GORE Flow Reversal System®, with a focus on major/minor adverse events in the 30 first postoperative days. METHODS: The first 24 patients submitted to carotid angioplasty using the GORE system, from June 2010 to May 2012, were retrospectively assessed with regard to indications, anatomic details, technical difficulties, and early clinical outcomes, including major (stroke, death, acute myocardial infarction) and minor (hematoma) adverse events. RESULTS: Systemic hypertension was present in 100% of the patients, diabetes mellitus in 58.3%, and coronary disease in 37.5%. Type II aortic arch was encountered in 62.5% of the patients and atherosclerotic lesion predominantly at the carotid bifurcation affecting the internal and common carotid arteries in 79.2%. Angiographic data revealed contralateral carotid arteries with <50% stenosis in 95.8% of cases and preservation of cerebral blood flow in 95.8%. All procedures but one were technically successful. Mean cerebral flow reversal time was 14.9 minutes, with a statistically significant difference between the first 12 (17.9 minutes) and the last 12 patients treated (11.6 minutes) (p<0.001). Intolerance to flow reversal was observed in 17.4% of the cases. Technical difficulties were experienced in 1 patient (4.2%). Clinical outcomes included 4.2% of stroke and 12.5% of hematomas at arterial puncture sites. CONCLUSION: The system was technically effective. A significant reduction in cerebral flow reversal time was observed, and the rates of early major/minor adverse events were within acceptable limits, suggesting that the device is safe and effective.
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Affiliation(s)
- Sidnei José Galego
- Faculdade de Medicina do ABC, Brazil; Instituto de Cirurgia Vascular e Endovascular de São Paulo, Brazil; Hospital São Luíz, Brazil
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Mousa AY, Campbell JE, AbuRahma AF, Bates MC. Current update of cerebral embolic protection devices. J Vasc Surg 2012; 56:1429-37. [DOI: 10.1016/j.jvs.2012.05.077] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2012] [Revised: 03/19/2012] [Accepted: 05/16/2012] [Indexed: 11/30/2022]
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Leal I, Orgaz A, Flores Á, Gil J, Rodríguez R, Peinado J, Criado E, Doblas M. A diffusion-weighted magnetic resonance imaging-based study of transcervical carotid stenting with flow reversal versus transfemoral filter protection. J Vasc Surg 2012; 56:1585-90. [PMID: 22960021 DOI: 10.1016/j.jvs.2012.05.107] [Citation(s) in RCA: 80] [Impact Index Per Article: 6.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2012] [Revised: 05/30/2012] [Accepted: 05/31/2012] [Indexed: 02/08/2023]
Abstract
BACKGROUND Transfemoral carotid artery stenting (CAS) has been associated with a high incidence of embolic phenomena and silent brain infarction. The goal of this study was to compare the incidence of new ischemic cerebral lesions on diffusion-perfusion magnetic resonance imaging (MRI) sequences after transcervical CAS performed with carotid flow reversal vs stenting via transfemoral approach with distal filter protection. METHODS During a 26-month period, 64 consecutive patients diagnosed with significant carotid stenosis by ultrasound imaging were assigned to transcervical CAS with carotid flow reversal or a transfemoral approach with a distal filter. The Rankin stroke scale was administered by an independent neurologist, and diffusion-weighted MRI (DW-MRI) studies were performed ≤24 hours before and ≤24 to 48 hours after the procedure. DW-MRI studies were compared by two neuroradiologists not involved in the study and blinded for time, clinical status, and treatment option. Hyperintense DW-MRI signals found after the procedure were interpreted as postoperative ischemic infarcts. All patients were assessed at 1, 6, and 12 months after the intervention. RESULTS The distribution of demographic and pathologic variables was similar in both groups. All procedures were technically successful, with a mean carotid flow reversal time of 22 minutes. Twenty-one (70%) and 23 patients (69.69%) were symptomatic in the transcervical and transfemoral groups, respectively (P=.869). After intervention, new postprocedural DW-MRI ischemic infarcts were found in four transcervical (12.9%) and in 11 transfemoral (33.3%) patients (P=.03), without new neurologic symptoms. No major adverse events occurred at 30 days after the intervention. All patients remained neurologically intact, without an increase in stroke scale scoring. All stents remained patent, and all patients remained stroke-free during follow-up. In multivariate analysis, age (relative risk [RR], 1.022; P<.001), symptomatic status (RR, 4.109; P<.001), and open-cell vs closed-cell stent design (RR, 2.01; P<.001) were associated with a higher risk of embolization in the transfemoral group but not in the transcervical group. CONCLUSIONS These data suggest that transcervical carotid stenting with carotid flow reversal carries a significantly lower incidence of new ischemic brain infarcts than that resulting from transfemoral CAS with a distal filter. The transcervical approach with carotid flow reversal may improve the safety of CAS and has the potential to improve results in especially vulnerable patients such as the elderly and symptomatic.
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Affiliation(s)
- Ignacio Leal
- Vascular Surgery Section, Complejo Hospitalario de Toledo, Toledo, Spain.
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Bismuth J, Garami Z, Anaya-Ayala JE, Naoum JJ, El Sayed HF, Peden EK, Lumsden AB, Davies MG. Transcranial Doppler findings during thoracic endovascular aortic repair. J Vasc Surg 2011; 54:364-9. [DOI: 10.1016/j.jvs.2010.12.063] [Citation(s) in RCA: 53] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2010] [Revised: 12/14/2010] [Accepted: 12/18/2010] [Indexed: 11/25/2022]
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Riga CV, Bicknell CD, Hamady MS, Cheshire NJW. Evaluation of robotic endovascular catheters for arch vessel cannulation. J Vasc Surg 2011; 54:799-809. [PMID: 21620623 DOI: 10.1016/j.jvs.2011.03.218] [Citation(s) in RCA: 55] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/03/2010] [Revised: 03/02/2011] [Accepted: 03/04/2011] [Indexed: 10/18/2022]
Abstract
OBJECTIVE Conventional catheter instability and embolization risk limits the adoption of endovascular therapy in patients with challenging arch anatomy. This study investigated whether arch vessel cannulation can be enhanced by a remotely steerable robotic catheter system. METHODS Seventeen clinicians with varying endovascular experience cannulated all arch vessels within two computed tomography-reconstructed pulsatile flow phantoms (bovine type I and type III aortic arches), under fluoroscopic guidance, using conventional and robotic techniques. Quantitative (catheterization times, catheter tip movements, vessel wall hits, catheter deflection) and qualitative metrics (Imperial College Complex Endovascular Cannulation Scoring Tool [IC3ST]) performance scores were compared. RESULTS Robotic catheterization techniques resulted in a significant reduction in median carotid artery cannulation times and the median number of catheter tip movements for all vessels. Vessel wall contact with the aortic arch wall was reduced to a median of zero with robotic catheters. During stiff guidewire exchanges, robotic catheters maintained stability with zero deflection, independent of the distance the catheter was introduced into the carotid vessels. Overall IC3ST performance scores (interquartile range) were significantly improved using the robotic system: Type I arch score was 26/35 (20-30.8) vs 33/35 (31-34; P = .001), and type III arch score was 20.5/35 (16.5-28.5) vs 26.5/35 (23.5-28.8; P = .001). Low- and medium-volume interventionalists demonstrated an improvement in performance with robotic cannulation techniques. The high-volume intervention group did not show statistically significant improvement, but cannulation times, movements, and vessel wall hits were significantly reduced. CONCLUSION Robotic technology has the potential to reduce the time, risk of embolization and catheter dislodgement, radiation exposure, and the manual skill required for carotid and arch vessel cannulation, while improving overall performance scores.
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Affiliation(s)
- Celia V Riga
- Imperial Vascular Unit, St. Mary's Hospital, Imperial College London, London, UK.
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30
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Tallarita T, Rabinstein AA, Cloft H, Kallmes D, Oderich GS, Brown RD, Lanzino G. Are distal protection devices 'protective' during carotid angioplasty and stenting? Stroke 2011; 42:1962-6. [PMID: 21566230 DOI: 10.1161/strokeaha.110.607820] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND AND PURPOSE To evaluate the periprocedural outcome after carotid artery stenting with embolic brain protection (EBP+) versus without embolic brain protection (EBP-). METHODS We retrospectively reviewed data from a prospective nonrandomized database of 357 patients who underwent carotid artery stenting in the neuroradiology division of our institution from 1999 to 2009. One hundred five patients underwent angioplasty and stenting without distal protection, whereas 252 were treated with distal protection. Patients were analyzed according to their EBP status (+ or -) for the primary end points of perioperative stroke, death, or myocardial infarction. RESULTS Unprotected stenting was mostly performed in the early years of this study and this is reflected in significant baseline differences between the two groups. In our earlier experience, carotid artery stenting was used in patients with more significant comorbidities. Diabetes mellitus (P=0.04), previous coronary artery disease (P=0.02) and myocardial infarction (P=0.04), and symptomatic lesion (P=0.01) were significantly more common in the EBP- cohort. Despite these baseline differences, there were no significant differences in the primary end points (2% in the EBP+ group and 4.8% in the EBP-, P=0.15). The incidence of ipsilateral stroke in the EBP- and in the EBP+ group was 3.8% versus 0.8%, respectively (P=0.6). There were 2 perioperative deaths (1 in each group) and 4 myocardial infarctions (3 in the EBP+ arm and 1 in the EBP- arm, all non-Q infarcts; P=nonsignificant). CONCLUSIONS In accordance with recent literature, this series cast doubts as to the real effectiveness of distal embolic protection devices in reducing periprocedural complications.
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Affiliation(s)
- Tiziano Tallarita
- Mayo Clinic, Department of Neurosurgery, 200 First Street SW, Rochester, MN 55905, USA.
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The incidence of microemboli to the brain is less with endarterectomy than with percutaneous revascularization with distal filters or flow reversal. J Vasc Surg 2011; 53:316-22. [DOI: 10.1016/j.jvs.2010.08.063] [Citation(s) in RCA: 46] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2010] [Revised: 08/10/2010] [Accepted: 08/24/2010] [Indexed: 11/24/2022]
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Micari A, Stabile E, Cremonesi A, Vadalà G, Castriota F, Pernice V, Sorropago G, Rubino P, Biamino G. Carotid artery stenting in octogenarians using a proximal endovascular occlusion cerebral protection device: a multicenter registry. Catheter Cardiovasc Interv 2010; 76:9-15. [PMID: 20578188 DOI: 10.1002/ccd.22503] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/10/2022]
Abstract
BACKGROUND Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians. PURPOSE The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high-volume centers by experienced operators. METHODS From July 2005 to May 2009, a total of 198 octogenarians patients, in three different institutions, were included in this registry. All patients underwent CAS using proximal endovascular occlusion device (Mo.Ma. device Invatec, Roncadelle, Italy). An independent neurologist evaluated all patients. The primary endpoint was death and stroke rate at 30 days. RESULTS 198 octogenarians (135 men; mean age: 83.2 years) were included in the registry. 39.4% of the patients were symptomatic. Procedural success was 100%. In-hospital complications: Two minor and two major strokes (2.02%) occurred. No device-related complications and no serious access site complication were noted. Between discharge and 30-day follow-up, one patient died due to a cardiac arrest. The overall 30-day combined stroke/death rate was 2.52%, resulting in 1.61% event incidence in asymptomatic and 3.9% in symptomatic patients (P = ns). Logistic regression did not identify independent predictor of neurological events, except in the female gender. CONCLUSION This multicenter prospective registry shows that CAS performed with proximal flow blockage is safe and feasible also in octogenarians. Thirty days death/stroke rates are similar to those of the overall population and within the International guidelines.
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Affiliation(s)
- Antonio Micari
- Cardiology Unit, GVM Care and Research, Villa Maria Eleonora Hospital, Viale Regione Siciliana 1572, Palermo, Italy.
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Chaer RA, Shen J, Rao A, Cho JS, Abu Hamad G, Makaroun MS. Cerebral reserve is decreased in elderly patients with carotid stenosis. J Vasc Surg 2010; 52:569-74; discussion 574-5. [PMID: 20620003 DOI: 10.1016/j.jvs.2010.04.021] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2009] [Revised: 04/05/2010] [Accepted: 04/06/2010] [Indexed: 10/19/2022]
Abstract
OBJECTIVES Octogenarians and even patients over 70 years old have unexplained poor outcomes with carotid angioplasty and stenting (CAS). We sought to evaluate whether older patients may have compromised intracranial collaterals and cerebral reserve and be intolerant to otherwise clinically silent emboli generated during CAS. METHODS One thousand twenty-four cerebral blood flow (CBF) studies performed between 1991 and 2001 with stable xenon computed tomography scans (Xe/CT) were reviewed. CBF was measured before and after 1 gm intravenous acetazolamide (ACZ), a cerebral vasodilator. The normal response to ACZ is an increase in CBF. In areas of significant compromise of cerebral reserve (CR), CBF drops, representing a "steal" phenomenon. CBF changes were categorized as normal or abnormal and correlated with age, gender, cerebral symptoms, and with intracranial, carotid, or vertebral artery disease. Logistic regression was used to determine the effect of age on CR in the entire group and a subgroup of 179 patients with significant carotid stenosis of >50%. RESULTS Nine hundred sixteen studies were suitable for analysis. Carotid occlusion was predictive of decreased reserve (OR, 3.9; P = .03) regardless of age. There was also a trend toward lower reserve with severe carotid stenosis >70% (OR, 3) and in women (OR, 1.8; P = .08). Age >or=70 had no effect on reserve in the overall heterogeneous population with and without carotid disease and neither did a history of stroke, carotid, or intracranial stenosis. However, in 179 patients with significant carotid stenosis, age >or=70 was predictive of poor reserve (OR, 2.7; P = .03) and so was the presence of peripheral vascular disease (OR, 3.7; P = .03). A trend toward decreased reserve was also seen in women (OR, 2.3; P = .08). CONCLUSIONS Age >or=70 is associated with poor cerebral reserve in patients with significant carotid stenosis as measured by CBF response to an ACZ challenge. Thus, patients >or=70 may be more sensitive to minor cerebral emboli, which may be one factor explaining their higher risk of stroke during CAS.
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Affiliation(s)
- Rabih A Chaer
- University of Pittsburgh Medical Center, Division of Vascular Surgery, Pittsburgh, PA 15213, USA.
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Taha MM, Maeda M, Sakaida H, Kawaguchi K, Toma N, Yamamoto A, Hirose T, Miura Y, Fujimoto M, Matsushima S, Taki W. Cerebral ischemic lesions detected with diffusion-weighted magnetic resonance imaging after carotid artery stenting: Comparison of several anti-embolic protection devices. Neurol Med Chir (Tokyo) 2009; 49:386-93. [PMID: 19779282 DOI: 10.2176/nmc.49.386] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
Distal embolism is an important periprocedural technical complication with carotid angioplasty and carotid artery stenting (CAS). We evaluated the safety and efficacy of protection devices used during CAS by detecting new cerebral ischemic lesions using diffusion-weighted magnetic resonance imaging in 95 patients who underwent 98 CAS procedures: 34 using single PercuSurge GuardWire, 31 using double balloon protection, 15 using proximal flow reverse protection devices, 14 using Naviballoon, and 4 using filter anti-embolic devices. Diffusion-weighted imaging was performed preoperatively and postoperatively to evaluate the presence of any new embolic cerebral lesions. Postoperative diffusion-weighted imaging revealed 117 new ischemic lesions. Three patients had new ischemic stroke, two minor and one major, all ipsilateral to the treated carotid artery. The remaining patients had clinically silent ischemia. The incidence of new embolic lesions was lower using the proximal flow reverse protection device than with the double balloon protection (33% vs. 48.4%), but the volume of ipsilateral new ischemic lesions per patient was 136.6 mm(3) vs. 86.9 mm(3), respectively. Neuroprotection with Naviballoon yielded ipsilateral lesions of large volume (86.6 mm(3)) and higher number (5.7 lesions per patient) than using the filter anti-embolic device (34.8 mm(3) and 1 lesion per patient). New cerebral ischemic lesions after neuroprotected CAS are usually silent. The lower incidence of distal ischemia using proximal flow reverse and double balloon protection devices is limited by the larger volume and higher number of ischemic lesions.
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Affiliation(s)
- Mahmoud M Taha
- Department of Neurosurgery, Mie University School of Medicine, Tsu, Mie
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Macdonald S. Role of filter design in embolic protection during carotid artery stenting. Interv Cardiol 2009. [DOI: 10.2217/ica.09.24] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
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Wellons ED, Kochupura PV, Burkett AB, McDevitt DT, Rosenthal D. Use of the Angiojet catheter to remove plaque outside a neuroprotection filter during carotid artery stenting. Vascular 2009; 17:300-2. [PMID: 19769814 DOI: 10.2310/6670.2009.00029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Abstract
Carotid protection devices (CPD) during carotid artery stenting reduce the risk of cerebral embolization. The presence of debris outside the filter presents a problem as the material may be plaque or thrombus. We report a case that required the use of the Angiojet catheter to remove debris outside the CPD.
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Affiliation(s)
- Eric D Wellons
- Department of Vascular Surgery, Atlanta Medical Center, Atlanta, GA, USA.
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37
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Distal filtration versus flow reversal: An ex vivo assessment of the choices for carotid embolic protection. J Vasc Surg 2009; 49:1181-8. [DOI: 10.1016/j.jvs.2008.12.028] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2008] [Revised: 12/11/2008] [Accepted: 12/12/2008] [Indexed: 11/22/2022]
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Wyers MC, Powell RJ, Fillinger MF, Nolan BW, Cronenwett JL. The value of 3D-CT angiographic assessment prior to carotid stenting. J Vasc Surg 2009; 49:614-22. [DOI: 10.1016/j.jvs.2008.10.015] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/01/2007] [Revised: 09/20/2008] [Accepted: 10/05/2008] [Indexed: 10/21/2022]
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Garami ZF, Bismuth J, Charlton-Ouw KM, Davies MG, Peden EK, Lumsden AB. Feasibility of simultaneous pre- and postfilter transcranial Doppler monitoring during carotid artery stenting. J Vasc Surg 2009; 49:340-4, 345.e1-2; discussion 345. [DOI: 10.1016/j.jvs.2008.08.102] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2008] [Revised: 07/29/2008] [Accepted: 08/30/2008] [Indexed: 10/21/2022]
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40
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Barbato JE, Dillavou E, Horowitz MB, Jovin TG, Kanal E, David S, Makaroun MS. A randomized trial of carotid artery stenting with and without cerebral protection. J Vasc Surg 2008; 47:760-5. [DOI: 10.1016/j.jvs.2007.11.058] [Citation(s) in RCA: 94] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2007] [Revised: 11/14/2007] [Accepted: 11/24/2007] [Indexed: 10/22/2022]
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El-Koussy M, Schroth G, Do DD, Gralla J, Nedeltchev K, von Bredow F, Remonda L, Brekenfeld C. Periprocedural Embolic Events Related to Carotid Artery Stenting Detected by Diffusion-Weighted MRI: Comparison Between Proximal and Distal Embolus Protection Devices. J Endovasc Ther 2007; 14:293-303. [PMID: 17723007 DOI: 10.1583/06-1990.1] [Citation(s) in RCA: 34] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
Abstract
PURPOSE To evaluate and compare the efficacy of proximal versus distal embolus protection devices (EPD) during carotid artery angioplasty/stenting (CAS) based on diffusion-weighted magnetic resonance imaging (DW-MRI). METHODS Forty-four patients (31 men; mean age 68 years, range 48-85) underwent protected CAS and had DW-MRI before and after the intervention. The cohort was analyzed according to the type of EPD used: a proximal EPD was deployed in 25 (56.8%) patients (17 men; mean age 66 years, range 48-85) and a distal filter in 19 (14 men; mean age 70 years, range 58-79). Fifteen (60.0%) patients with proximal protection were symptomatic of the target lesion; in the distal protection group, 10 (52.6%) were symptomatic. RESULTS New lesions were seen on the postinterventional DW-MRI in 28.0% (7/25) of the proximal EPD group versus 32.6% (6/19) of those with a distal filter (p = NS). The majority were clinically silent. The new lesions in the vascular territory of the stented carotid artery in the group as a whole and per patient were fewer in the proximal EPD group (p = NS). No significant differences were noted in the T(2) appearance of the new lesions or the number of new lesions observed away from the vascular territory of the stented artery. CONCLUSION Proximal embolus protection devices show a nonsignificant trend toward fewer embolic events, which warrants large-scale studies. Furthermore, proximal protection devices can be useful to control and treat acute in-stent thrombosis.
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Affiliation(s)
- Marwan El-Koussy
- Institute for Diagnostic and Interventional Neuroradiology, University of Bern, Inselspital, Bern, Switzerland.
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Subclinical embolization after carotid artery stenting: New lesions on diffusion-weighted magnetic resonance imaging occur postprocedure. J Vasc Surg 2007; 45:867-72; discussion 872-4. [DOI: 10.1016/j.jvs.2006.12.058] [Citation(s) in RCA: 81] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2006] [Accepted: 12/20/2006] [Indexed: 11/18/2022]
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Henry M, Polydorou A, Henry I, Liasis N, Polydorou A, Polydorou V, Demesticha T, Skandalakis P, Kotsiomitis E, Hugel M, Sedgewick J, Ruth G. New distal embolic protection device the FiberNet® 3 dimensional filter: First carotid human study. Catheter Cardiovasc Interv 2007; 69:1026-35. [PMID: 17530701 DOI: 10.1002/ccd.21129] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
OBJECTIVE Evaluate the performance and safety of the FiberNet Embolic Protection System during carotid artery intervention. BACKGROUND Carotid Angioplasty and Stenting (CAS) can be proposed to treat the majority of carotid stenoses. Brain embolization takes place and routine use of Embolic Protection Devices (EPD) is warranted. Many EPDs have significant limitations, which may be addressed by a new EPD, the FiberNet (Lumen Biomedical, Plymouth, MN). METHODS The system consists of a 3-dimensional expandable filter made of fibers, which expand radially, mounted onto a 0.014'' wire and retrieval catheter. FiberNet can capture particles as small as 40 microm without compromising flow. RESULTS 35 lesions treated in 34 patients. Male 67.6%. Age: 71.4 +/- 8.8 (50-85). Average stenosis 84.5% +/- 7.9 (70-99). 29.4% were symptomatic. Technical success: 34/35 (97%). No stroke or death within 30 days. Neurological events: two permanent amaurosis, one amaurosis fugax. All samples visually contained significant amounts of emboli. The mean surface area of debris caught was 63.8 mm(2) (37.7-107.5). Comparisons were made with other EPDs. The mean surface area of debris caught was 12.2 mm(2) (2.7-34.3). No changes were noted in CT/MRI at 30-day post procedure. CONCLUSION The first human use of this new novel EPD in carotid artery stenting is encouraging. The FiberNet was easy to use and confirmed the ability to capture particles less than 100 microm. The feasibility of the FiberNet has been demonstrated. Additional patients will demonstrate the overall safety and efficacy of this new EPD device.
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Iihara K, Murao K, Sakai N, Yamada N, Nagata I, Miyamoto S. Outcome of carotid endarterectomy and stent insertion based on grading of carotid endarterectomy risk: a 7-year prospective study. J Neurosurg 2006; 105:546-54. [PMID: 17044557 DOI: 10.3171/jns.2006.105.4.546] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
Object
The authors of this study prospectively compared periprocedural neurological morbidity and the appearance of lesions on diffusion-weighted (DW) magnetic resonance (MR) imaging in patients who had undergone carotid endarterectomy (CEA) or carotid artery stent placement (CASP) with distal balloon protection, based on a CEA risk grading scale.
Methods
Patients undergoing CEA (139 patients) and CASP (92 patients) were classified into Grades I to IV, based on the presence of angiographic (Grade II), medical (Grade III), and neurological (Grade IV) risks. Although not randomized, the CEA and CASP groups were well matched in terms of the graded risk factors except for a greater proportion of neurologically unstable patients in the CEA group (11 compared with 3%, p = 0.037). There were greater proportions of asymptomatic (64 compared with 34%, p = 0.006) and North American Symptomatic Carotid Endarterectomy Trial–ineligible patients (29 compared with 14%, p < 0.0001) in the CASP group. The overall rates of neurological morbidity with ischemic origin and the appearance of lesions on DW MR imaging after CEA were 2.2 and 9.3%, and those after CASP were 7.6 and 35.9% (nondisabling stroke only), respectively. The only disabling stroke was caused by an intracerebral hemorrhage attributable to hyperperfusion in one case (0.7%) of CEA. There were no deaths. There was no significant association between neurological morbidity and the risk grade in patients who had undergone CEA, although the incidence of lesions on DW imaging was significantly greater in the Grade IV risk group compared with that in the other risk groups combined (42.1 compared with 4.2%, p < 0.0001). After CASP, a higher incidence of neurological morbidity and lesions on DW imaging was noted for the Grade II and III risk groups combined as compared with that in the Grade I risk group, regardless of a symptomatic or an asymptomatic presentation (neurological morbidity: 10.5 compared with 3.1%, respectively, p = 0.41; and DW imaging lesions: 47.4 compared with 19.4%, p = 0.01). The incidence of lesions on DW imaging after CEA was significantly lower than that after CASP except for the Grade IV risk groups.
Conclusions
Despite a higher incidence of DW imaging–demonstrated lesions in the Grade IV risk group, there was no significant association between the risk group and neurological morbidity rates after CEA. The presence of vascular and medical risk profiles conferred higher rates of neurological morbidity and an increased incidence of lesions on DW imaging after CASP. Considering that no serious nonneurological complications were noted, CEA and CASP appear to be complementary methods of revascularization for carotid artery stenosis with various risk profiles.
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Affiliation(s)
- Koji Iihara
- Department of Neurosurgery, National Cardiovascular Center, Suita, Osaka, Japan.
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Müller-Hülsbeck S, Gühne A, Tsokos M, Hüsler EJ, Schaffner SR, Paulsen F, Hedderich J, Heller M, Jahnke T. Stent-Protected Carotid Angioplasty Using a Membrane Stent: A Comparative Cadaver Study. Cardiovasc Intervent Radiol 2006; 29:630-6. [PMID: 16729234 DOI: 10.1007/s00270-005-0219-5] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
PURPOSE To evaluate the performance of a prototype membrane stent, MembraX, in the prevention of acute and late embolization and to quantify particle embolization during carotid stent placement in human carotid explants in a proof of concept study. METHODS Thirty human carotid cadaveric explants (mild stenoses 0-29%, n = 23; moderate stenoses 30-69%, n = 3; severe stenoses 70-99%, n = 2) that included the common, internal and external carotid arteries were integrated into a pulsatile-flow model. Three groups were formed according to the age of the donors (mean 58.8 years; sample SD 15.99 years) and randomized to three test groups: (I) MembraX, n = 9; (II) Xpert bare stent, n = 10; (III) Xpert bare stent with Emboshield protection device, n = 9. Emboli liberated during stent deployment (step A), post-dilatation (step B), and late embolization (step C) were measured in 100 microm effluent filters. When the Emboshield was used, embolus penetration was measured during placement (step D) and retrieval (step E). Late embolization was simulated by compressing the area of the stented vessel five times. RESULTS Absolute numbers of particles (median; >100 microm) caught in the effluent filter were: (I) MembraX: A = 7, B = 9, C = 3; (II) bare stent: A = 6.5, B = 6, C = 4.5; (III) bare stent and Emboshield: A = 7, B = 7, C.=.5, D = 8, E = 10. The data showed no statistical differences according to whether embolic load was analyzed by weight or mean particle size. When summing all procedural steps, the Emboshield caused the greatest load by weight (p = 0.011) and the largest number (p = 0.054) of particles. CONCLUSIONS On the basis of these limited data neither a membrane stent nor a protection device showed significant advantages during ex vivo carotid angioplasty. However, the membrane stent seems to have the potential for reducing the emboli responsible for supposed late embolization, whereas more emboli were observed when using a protection device. Further studies are necessary and warranted.
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Affiliation(s)
- Stefan Müller-Hülsbeck
- Department of Radiology, University Hospital, Schleswig-Holstein-Campuskiel, Arnold-Heller-Strasse 9, 24105, Kiel, Germany.
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Gorog DA, Foale RA, Malik I. Distal Myocardial Protection During Percutaneous Coronary Intervention. J Am Coll Cardiol 2005; 46:1434-45. [PMID: 16226166 DOI: 10.1016/j.jacc.2005.04.061] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2005] [Revised: 04/12/2005] [Accepted: 04/15/2005] [Indexed: 11/22/2022]
Abstract
The discrepancy between angiographic success and microvascular perfusion has been recognized for some time. In the face of an open artery, the degree of microvascular perfusion determines post-infarct prognosis. Despite successful epicardial recanalization, tissue perfusion may be absent in up to 25% patients with acute myocardial infarction. Historically associated with saphenous vein graft intervention, embolization is increasingly recognized in native coronary arteries, particularly in patients undergoing primary percutaneous coronary intervention (PCI). With more than two million PCI procedures performed worldwide each year, there is enormous interest in protecting the left ventricular myocardium from embolization during PCI. This article reviews the evidence for distal myocardial protection and discusses the relative merits of the different available techniques.
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Affiliation(s)
- Diana A Gorog
- Waller Cardiac Department, St. Mary's Hospital, London, United Kingdom.
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47
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Green DW, Sanchez LA, Parodi JC, Geraghty PJ, Ferreira LM, Sicard GA. Acute thromboembolic events during carotid artery angioplasty and stenting: etiology and a technique of neurorescue. J Endovasc Ther 2005; 12:360-5. [PMID: 15943512 DOI: 10.1583/05-1526.1] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
PURPOSE To review the protected carotid stenting experience at two major referral centers to evaluate the frequency of clinically significant intraprocedural thromboembolic events, use of neurorescue techniques, and ultimate clinical outcomes. METHODS A retrospective review was conducted of 254 cases of protected transfemoral carotid stenting performed at the Washington University-Barnes Hospital and The Fleni Institute of Buenos Aires in a 6-year period. Medical records of patients with periprocedural thromboembolic events were reviewed to determine the type of complication, method of treatment, and outcome. RESULTS Among the 254 cases in which a carotid protection device was used, 2 (0.79%) episodes of witnessed, symptomatic thromboembolism occurred. Both patients suffered thromboembolic occlusion of the M1 branch of the middle cerebral artery (MCA) immediately following crossing of the internal carotid lesion with the protection device. Neurological symptoms consisted of agitation, aphasia, and hemiplegia in both patients. After rapid stent deployment across the carotid lesion, the MCA was cannulated and the occlusion treated with balloon angioplasty. This was followed by selective intra-arterial delivery of urokinase and intravenous abciximab. These maneuvers resulted in excellent restoration of blood flow in the MCA and its branches. With the exception of minor word-finding difficulties in one, both patients demonstrated full neurological recovery within the perioperative period. CONCLUSIONS In our experience, intraprocedural thromboembolic events occur despite the use of cerebral protection devices, but are rare. Notably these complications appeared to occur at the time of lesion crossing by distal cerebral protection devices. These thromboembolic events can be successfully treated if the complication is rapidly identified and the physician is adequately prepared and proficient in neurorescue techniques.
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MESH Headings
- Abciximab
- Acute Disease
- Aged
- Angiography, Digital Subtraction
- Angioplasty, Balloon/adverse effects
- Antibodies, Monoclonal/administration & dosage
- Antibodies, Monoclonal/therapeutic use
- Anticoagulants/administration & dosage
- Anticoagulants/therapeutic use
- Blood Vessel Prosthesis Implantation/adverse effects
- Blood Vessel Prosthesis Implantation/instrumentation
- Carotid Artery, Internal
- Carotid Stenosis/diagnostic imaging
- Carotid Stenosis/therapy
- Drug Therapy, Combination
- Follow-Up Studies
- Humans
- Immunoglobulin Fab Fragments/administration & dosage
- Immunoglobulin Fab Fragments/therapeutic use
- Injections, Intra-Arterial
- Injections, Intravenous
- International Cooperation
- Intracranial Thrombosis/diagnosis
- Intracranial Thrombosis/etiology
- Intracranial Thrombosis/therapy
- Intraoperative Complications
- Male
- Middle Aged
- Middle Cerebral Artery
- Plasminogen Activators/administration & dosage
- Plasminogen Activators/therapeutic use
- Retrospective Studies
- Treatment Outcome
- Ultrasonography, Doppler, Transcranial
- Urokinase-Type Plasminogen Activator/administration & dosage
- Urokinase-Type Plasminogen Activator/therapeutic use
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Affiliation(s)
- Douglas W Green
- Section of Vascular Surgery, Washington University School of Medicine, St. Louis, Missouri 63110, USA
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Kashyap VS, Franklin KS, Fitzpatrick CM. Bilateral brachial artery occlusion decreases internal carotid artery volume flow: a simple adjunct for cerebral protection? J Endovasc Ther 2005; 12:454-60. [PMID: 16048377 DOI: 10.1583/05-1518mr.1] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
PURPOSE To investigate if a decrease in internal carotid artery (ICA) blood flow occurs with bilateral brachial artery occlusion (BBO), which may improve the effectiveness of cerebral protection devices during carotid interventions. METHODS Thirty-two asymptomatic patients (21 men; mean age 67 years) with carotid atherosclerosis between 15% and 79% were enrolled in the study. Carotid duplex ultrasound was followed by volume flow rate (VF) determination in the right ICA, external carotid (ECA), and vertebral arteries. After baseline values were obtained, BBO was induced by bilateral arm pressure cuff inflation to 30 mmHg over the systolic pressure for no more than 3 minutes. VF measurements were repeated. RESULTS Seventeen patients (responders) had an ICA VF decrease from 406+/-109 mL/min (+/-SD) to 303+/-90 mL/min (p=0.005), while 15 patients (nonresponders) had no significant change in their ICA VF (340+/-192 versus 447+/-267 mL/min, p=0.22). In responders, ECA VF increased (190+/-65 to 232+/-125 mL/min), as did vertebral VF (77+/-53 to 95+/-60 mL/min; p>0.05). The ratio of ICA/ECA VF dropped from 2.13 to 1.31 in responders, but did not change in nonresponders. No patient exhibited any neurological symptoms during the study. Post cuff volume flows approximated baseline values. Cerebral magnetic resonance angiograms obtained in 10 responders revealed a complete circle of Willis in 8 (80%), while only 1 (16%) of 6 nonresponders had a complete pathway. CONCLUSIONS A transient decrease in ICA VF, with concomitant elevations of the ECA and vertebral VFs, occurs with occlusion of the brachial arteries in the setting of a complete circle of Willis. Since no flow reversal occurs, this maneuver is insufficient to provide complete cerebral protection, but it may improve the effectiveness of cerebral protection devices and serve as an adjunctive maneuver in selected cases. Furthermore, changes in ICA VF may prove to be a noninvasive test for evaluating the integrity of the circle of Willis.
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Affiliation(s)
- Vikram S Kashyap
- Department of Vascular Surgery, Cleveland Clinic, Cleveland, Ohio 44195, USA.
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Parodi JC, Ferreira LM, Sicard G, La Mura R, Fernandez S. Cerebral protection during carotid stenting using flow reversal. J Vasc Surg 2005; 41:416-22. [PMID: 15838474 DOI: 10.1016/j.jvs.2005.01.003] [Citation(s) in RCA: 77] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Abstract
BACKGROUND Carotid angioplasty and stenting can be used in stroke prevention in high-risk patients. As embolic complications can occur during carotid angioplasty and stenting, a device was developed to protect from cerebral embolization. METHODS Between September 1999 and May 2002, carotid angioplasty and stenting was performed in 100 patients (84 men; mean age, 69.2 years) with symptomatic (26%) or asymptomatic (74%) severe carotid artery stenosis. Wallstents were used in all cases with selective pre-dilatation. Cerebral protection devices (Parodi Anti-Emboli System [PAES], ArteriA, San Francisco, Calif) were used in all patients. All patients were evaluated by a neurologist, both before and after the procedure. According to the criteria set forth by the large trials, the occurrence of minor, major or fatal stroke and myocardial infarction (end points) within 30 days and follow-up were determined as end points. Data were collected prospectively. RESULTS The overall perioperative stroke and death rate was 3% (1 noncorresponding minor stroke, 1 hemorrhagic stroke, and 1 cardiac event). Four patients developed postoperative transient neurologic events (three related to hemodynamic instability and the fourth due to postoperative embolization). The overall technical success rate for carotid angioplasty (protection device placed in position percutaneously) was 99%. CONCLUSION The efficacy and safety of carotid angioplasty and stenting with PAES are confirmed. This innovative protection device may prevent the debris released by angioplasty from entering the cerebral circulation. Further investigation is warranted.
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Affiliation(s)
- Juan C Parodi
- Vascular Surgery Division, Fundación de Lucha Contra las Enfermedades Neurológicas, Montaneses 2325, Ciudad de Buenos Aires C1428AQK, Argentina
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Müller-Hülsbeck S, Stolzmann P, Liess C, Hedderich J, Paulsen F, Jahnke T, Heller M. Vessel Wall Damage Caused by Cerebral Protection Devices: Ex Vivo Evaluation in Porcine Carotid Arteries. Radiology 2005; 235:454-60. [PMID: 15858088 DOI: 10.1148/radiol.2352031968] [Citation(s) in RCA: 42] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
PURPOSE To determine the extent of vessel wall damage caused by cerebral protection devices designed for carotid angioplasty by using ex vivo porcine carotid arteries. MATERIALS AND METHODS The local animal experimentation committee did not require its approval for this study. With a benchtop vascular model (flow rate, 470 mL/min; dicrotic pulsatile flow, 76 pulses per minute; pressure, 115/67 mm Hg [mean pressure, 91 mm Hg]) into which 85 porcine internal carotid arteries (ICAs) were inserted, five different protection devices (Angioguard [Cordis/Johnson & Johnson, Miami, Fla], Filterwire EX [Boston Scientific, Natick, Mass], Trap [Microvena, White Bear Lake, Minn], Neuroshield [Abbott Laboratories, Redwood City, Calif], and Percusurge [Abbott Laboratories]) were evaluated. Adverse movement (1 cm up, 2 cm down, and 1 cm up again) of the activated devices (deployed filters or inflated balloons [Percusurge only]) was simulated, and the device was retrieved. For each of these steps (deployment, movement, retrieval) the amount of debris from the vessel wall in the effluent of the ICA was determined by using a 100-microm filter. The Mann-Whitney test was used to test for differences, and a correction for multiple comparisons was made. P < .05 was considered to indicate a significant difference. The authors attempted to determine whether there was a notable association between the total amount of debris captured and the classification of damage at microscopy. Carotid arteries were analyzed histologically with light and scanning electron microscopy. RESULTS All examined protection devices caused dislodged debris, which was captured in the effluent filter. There were significant differences among the devices in terms of the total amount of debris captured in the filters (lowest amounts of debris, 4.75 mg [Angioguard] and 5.02 mg [Filterwire EX]; highest amount, 7.51 mg [Trap]; P < or = .001 for all). All devices caused histologically visible wall damage, with the degree of intimal denudation correlating with the mass of the debris. The Trap device caused the most severe intimal and subintimal wall damage. Adverse movement resulted in no increased debris dislodgment as compared with the debris dislodged during deployment and retrieval of the devices. CONCLUSION On the basis of the data obtained, cerebral protection devices themselves have a potential influence on embolization rates by causing debris to be dislodged during carotid stent placement.
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MESH Headings
- Angioplasty, Balloon/adverse effects
- Angioplasty, Balloon/instrumentation
- Animals
- Carotid Artery Injuries/pathology
- Carotid Artery, Internal/pathology
- Carotid Stenosis/pathology
- Endothelium, Vascular/injuries
- Endothelium, Vascular/pathology
- Equipment Design
- Filtration/instrumentation
- Intracranial Embolism/pathology
- Intracranial Embolism/prevention & control
- Microscopy, Electron, Scanning
- Models, Cardiovascular
- Muscle, Smooth, Vascular/injuries
- Muscle, Smooth, Vascular/pathology
- Stents/adverse effects
- Swine
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Affiliation(s)
- Stefan Müller-Hülsbeck
- Department of Radiology, University Hospital Schleswig-Holstein-Campus Kiel, Arnold-Heller-Strasse 9, 24105 Kiel, Germany.
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