One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter

SENTRY Trial Investigators

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8 Citations (Scopus)

Abstract

Purpose: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods: At 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. Results: Clinical 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. 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 12 months of imaging-intense follow-up.

Original languageEnglish (US)
Pages (from-to)1350-1361.e4
JournalJournal of Vascular and Interventional Radiology
Volume29
Issue number10
DOIs
StatePublished - Oct 1 2018

Fingerprint

Vena Cava Filters
Pulmonary Embolism
Clinical Trials
Safety
Venae Cavae
Venous Thrombosis
Tomography
Confidence Intervals
Phlebography
Radiography
Thrombosis
Recurrence
Equipment and Supplies
Incidence

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

@article{a120f6d256c048fda59b7c5b1f544381,
title = "One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter",
abstract = "Purpose: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods: At 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. Results: Clinical 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. 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 12 months of imaging-intense 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 Dake, {Michael D.} 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",
year = "2018",
month = "10",
day = "1",
doi = "10.1016/j.jvir.2018.05.009",
language = "English (US)",
volume = "29",
pages = "1350--1361.e4",
journal = "Journal of Vascular and Interventional Radiology",
issn = "1051-0443",
publisher = "Elsevier Inc.",
number = "10",

}

TY - JOUR

T1 - One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial

T2 - Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter

AU - SENTRY Trial Investigators

AU - Dake, Michael D.

AU - Murphy, Timothy P.

AU - Krämer, Albrecht H.

AU - Darcy, Michael D.

AU - Sewall, Luke E.

AU - Curi, Michael A.

AU - Johnson, Matthew S.

AU - Arena, Frank

AU - Swischuk, James L.

AU - Ansel, Gary M.

AU - Silver, Mitchell J.

AU - Saddekni, Souheil

AU - Brower, Jayson S.

AU - Mendes, Robert

AU - Dake, Michael D.

AU - Feezor, Robert

AU - Kalva, Sanjeeva

AU - Kies, Darren

AU - Bosiers, Marc

AU - Ziegler, Werner

AU - Farber, Mark

AU - Paolini, David

AU - Spillane, Robert

AU - Jones, Steven

AU - Peeters, Patrick

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Purpose: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods: At 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. Results: Clinical 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. 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 12 months of imaging-intense follow-up.

AB - Purpose: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods: At 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. Results: Clinical 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. 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 12 months of imaging-intense follow-up.

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U2 - 10.1016/j.jvir.2018.05.009

DO - 10.1016/j.jvir.2018.05.009

M3 - Article

C2 - 30177423

AN - SCOPUS:85052750247

VL - 29

SP - 1350-1361.e4

JO - Journal of Vascular and Interventional Radiology

JF - Journal of Vascular and Interventional Radiology

SN - 1051-0443

IS - 10

ER -