• Michael D Dake, Timothy P Murphy, Albrecht H Krämer, Michael D Darcy, Luke E Sewall, Michael A Curi, Matthew S Johnson, Frank Arena, James L Swischuk, Gary M Ansel, Mitchell J Silver, Souheil Saddekni, Jayson S Brower, Robert Mendes, and SENTRY Trial Investigators.
• Department of Cardiothoracic Surgery, Stanford University School of Medicine, Falk Cardiovascular Research Center, 300 Pasteur Drive, Stanford, CA 94305. Electronic address: mddake@email.arizona.edu.
• J Vasc Interv Radiol. 2020 Feb 1; 31 (2): 221-230.e3.

PurposeTo 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 MethodsIn 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.ResultsThe 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.ConclusionsThe 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.Copyright © 2019 SIR. Published by Elsevier Inc. All rights reserved.

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