@article{63691baf0cce4c3982f507fc3fbfe707,
title = "Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism",
abstract = "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.",
author = "{SENTRY Trial Investigators} and Dake, {Michael D.} and Murphy, {Timothy P.} and Kr{\"a}mer, {Albrecht H.} and Darcy, {Michael D.} and Sewall, {Luke E.} and Curi, {Michael A.} and Johnson, {Matthew S.} and Frank Arena and Swischuk, {James L.} and Ansel, {Gary M.} and Silver, {Mitchell J.} and Souheil Saddekni and Brower, {Jayson S.} and Robert Mendes and Robert Feezor and Sanjeeva Kalva and Darren Kies and Marc Bosiers and Werner Ziegler and Mark Farber and David Paolini and Robert Spillane and Steven Jones and Patrick Peeters",
note = "Funding Information: ClinicalTrials.gov ID NCT01975090 . The study was funded by BTG Vascular (Bothell, Washington). The authors thank Diane Gargus for clinical trial management. Writing support services were provided by Galen Press, Inc (Austerlitz, New York) and paid for by the study sponsor. The following investigators and institutions participated in the SENTRY Clinical Trial (Michael D. Dake, MD, principal investigator) in addition to the authors: Robert Feezor, MD (University of Florida, Gainesville, FL); Sanjeeva Kalva, MD (UT Southwestern Medical Center, Dallas, TX); Darren Kies, MD (Emory University, Atlanta, GA); Marc Bosiers, MD (AZ Sint-Blasius, Dendermonde, Belgium); Werner Ziegler, MD (Memorial Hospital of Colorado Springs, Colorado Springs, CO); Mark Farber, MD (University of North Carolina, Chapel Hill, NC); David Paolini, MD (Jobst Vascular Institute, Toledo, OH); Robert Spillane, MD (Hartford Hospital, Hartford, CT); Steven Jones, MD (Cardiovascular Associates of the Southeast, LLC, Birmingham, AL); and Patrick Peeters, MD (Imelda Hospital, Bonheiden, Belgium). Appendix A Funding Information: ClinicalTrials.gov ID NCT01975090. The study was funded by BTG Vascular (Bothell, Washington). The authors thank Diane Gargus for clinical trial management. Writing support services were provided by Galen Press, Inc (Austerlitz, New York) and paid for by the study sponsor. The following investigators and institutions participated in the SENTRY Clinical Trial (Michael D. Dake, MD, principal investigator) in addition to the authors: Robert Feezor, MD (University of Florida, Gainesville, FL); Sanjeeva Kalva, MD (UT Southwestern Medical Center, Dallas, TX); Darren Kies, MD (Emory University, Atlanta, GA); Marc Bosiers, MD (AZ Sint-Blasius, Dendermonde, Belgium); Werner Ziegler, MD (Memorial Hospital of Colorado Springs, Colorado Springs, CO); Mark Farber, MD (University of North Carolina, Chapel Hill, NC); David Paolini, MD (Jobst Vascular Institute, Toledo, OH); Robert Spillane, MD (Hartford Hospital, Hartford, CT); Steven Jones, MD (Cardiovascular Associates of the Southeast, LLC, Birmingham, AL); and Patrick Peeters, MD (Imelda Hospital, Bonheiden, Belgium). Publisher Copyright: {\textcopyright} 2019 SIR",
year = "2020",
month = feb,
doi = "https://doi.org/10.1016/j.jvir.2019.08.036",
language = "English (US)",
volume = "31",
pages = "221--230.e3",
journal = "Journal of Vascular and Interventional Radiology",
issn = "1051-0443",
publisher = "Elsevier Inc.",
number = "2",
}