Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism.
Journal of vascular and interventional radiology : JVIR
Adult; Aged; Aged, 80 and over; Belgium; Chile; Computed Tomography Angiography; Female; Humans; Male; Middle Aged; Phlebography; Prosthesis Design; Prosthesis Implantation; Pulmonary Embolism; Risk Factors; Time Factors; Treatment Outcome; United States; Vena Cava Filters; Vena Cava, Inferior; Venous Thrombosis; Young Adult
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.
Dake, Michael D; Murphy, Timothy P; Krämer, Albrecht H; Darcy, Michael D; Sewall, Luke E; Curi, Michael A; Johnson, Matthew S; Arena, Frank; Swischuk, James L; Ansel, Gary M; Silver, Mitchell J; Saddekni, Souheil; Brower, Jayson S; Mendes, Robert; and SENTRY Trial Investigators, "Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism." (2020). Articles, Abstracts, and Reports. 3675.