Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2007
New distal embolic protection device the FiberNet 3 dimensional filter: first carotid human study.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Henry Michel, Polydorou Antonios, Henry Isabelle, Liasis Nikos, Polydorou Adamantia, Polydorou Victoria, Demesticha Theano, Skandalakis Panayiotis, Kotsiomitis Evaggelos, Hugel Michel, Sedgewick Jerry, Ruth George
Аннотация
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.
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.
Предметные рубрики MeSH
AgedAged, 80 and overAngioplasty, BalloonCarotid StenosisCerebrovascular CirculationDevice RemovalFeasibility StudiesFemaleFiltrationHumansIntracranial EmbolismMagnetic Resonance ImagingMaleMiddle AgedProspective StudiesProsthesis DesignSeverity of Illness IndexStentsTime FactorsTomography, X-Ray ComputedTreatment Outcome