Τίτλος:
New distal embolic protection device the fibernet (R) - 3 dimensional
filter: First carotid human study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Objective: Evaluate the performance and safety of the FiberNet (R)
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 (R) (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 mu m 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 Rm. The
feasibility of the FiberNet has been demonstrated. Additional patients
will demonstrate the overall safety and efficacy of this new EPD device.
(C) 2007 Wiley-Liss, Inc.
Συγγραφείς:
Henry, Michel
Polydorou, Antonios
Henry, Isabelle
Liasis,
Nikos
Polydorou, Adamantia
Polydorou, Victoria
Demesticha,
Theano
Skandalakis, Panayiotis
Kotsiomitis, Evaggelos
Hugel,
Michel
Sedgewick, Jerry
Ruth, George
Περιοδικό:
Catheterization and Cardiovascular Interventions (Formerly Catheterization and Cardiovascular Diagnosis)
Λέξεις-κλειδιά:
angioplasty; CAS; carotid stenting; interventional
