• 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@stanford.edu.
• J Vasc Interv Radiol. 2018 Oct 1; 29 (10): 1350-1361.e4.

PurposeTo prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE).Materials And MethodsAt 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months.ResultsClinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%-99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%-100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months.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 12 months of imaging-intense follow-up.Copyright © 2018 SIR. Published by Elsevier Inc. All rights reserved.

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