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40
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Text
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<a href="http://doi.org/10.1016/j.jvir.2019.08.036" target="_blank" rel="noreferrer noopener">http://doi.org/10.1016/j.jvir.2019.08.036</a>
Pages
221-230.e3
Issue
2
Volume
31
ISSN
1535-7732 1051-0443
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Update Year & Number
Hospital List
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Title
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Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism.
Publisher
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Journal of Vascular and Interventional Radiology
Date
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2020
2020-02
Subject
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Aged; Humans; Male; Adult; Female; Aged 80 and over; United States; Risk Factors; Middle Aged; Treatment Outcome; Time Factors; Young Adult; Prosthesis Design; Vena Cava Filters; Phlebography; Computed Tomography Angiography; Belgium; Chile; Vena Cava Inferior/diagnostic imaging; Prosthesis Implantation/adverse effects/instrumentation; Pulmonary Embolism/diagnostic imaging/prevention & control; Venous Thrombosis/diagnostic imaging/prevention & control
Creator
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Dake MD; Murphy TP; Krämer AH; Darcy MD; Sewall LE; Curi MA; Johnson MS; Arena F; Swischuk JL; Ansel GM; Silver MJ; Saddekni S; Brower JS; Mendes R
Description
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PURPOSE: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years. RESULTS: The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n = 126) through 1 year and 2.4% (n = 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filter-related deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.
Identifier
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<a href="http://doi.org/10.1016/j.jvir.2019.08.036" target="_blank" rel="noreferrer noopener">10.1016/j.jvir.2019.08.036</a>
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journalArticle
2020
Adult
Aged
Aged 80 and over
Ansel GM
Arena F
Belgium
Brower JS
Chile
Computed Tomography Angiography
Curi MA
Dake MD
Darcy MD
Female
Hospital List
Humans
Johnson MS
Journal of Vascular and Interventional Radiology
journalArticle
Krämer AH
Male
Mendes R
Middle Aged
Murphy TP
Phlebography
Prosthesis Design
Prosthesis Implantation/adverse effects/instrumentation
Pulmonary Embolism/diagnostic imaging/prevention & control
Risk Factors
Saddekni S
Sewall LE
Silver MJ
Swischuk JL
Time Factors
Treatment Outcome
United States
Vena Cava Filters
Vena Cava Inferior/diagnostic imaging
Venous Thrombosis/diagnostic imaging/prevention & control
Young Adult