Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism.

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism.

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

Journal of Vascular and Interventional Radiology

2020

2020-02

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.

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

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journalArticle

221-230.e3

2

31

1535-7732 1051-0443

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