Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients

Victor F. Tapson, Joshua P. Hazelton, John Myers, Claudia Robertson, Ramyar Gilani, Julie A. Dunn, Marko Bukur, Martin Croce, Ann Peick, Sonlee West, Lawrence Lottenberg, Jay Doucet, Preston R. Miller, Bruce Crookes, Rajesh R. Gandhi, Chasen A. Croft, Anthony Manasia, Brian A. Hoey, Howard Lieberman, Oscar D. Guillamondegui & 3 others Victor Novack, Gregory Piazza, Samuel Z. Goldhaber

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Purpose To evaluate efficacy and safety of a novel device that combines an inferior vena cava (IVC) filter and central venous catheter (CVC) for prevention of pulmonary embolism (PE) in critically ill patients. Materials and Methods In a multicenter, prospective, single-arm clinical trial, the device was inserted at the bedside without fluoroscopy and subsequently retrieved before transfer from the intensive care unit (ICU). The primary efficacy endpoint was freedom from clinically significant PE or fatal PE 72 hours after device removal or discharge, whichever occurred first. Secondary endpoints were incidence of acute proximal deep venous thrombosis (DVT), catheter-related thrombosis, catheter-related bloodstream infections, major bleeding events, and clinically significant thrombus (occupying > 25% of volume of filter) detected by cavography before retrieval. Results The device was placed in 163 critically ill patients with contraindications to anticoagulation; 151 (93%) were critically ill trauma patients, 129 (85%) had head or spine trauma, and 102 (79%) had intracranial bleeding. The primary efficacy endpoint was achieved for all 163 (100%) patients (95% confidence interval [CI], 97.8%–100%, P <.01). Diagnosis of new or worsening acute proximal DVT was time dependent with 11 (7%) occurring during the first 7 days. There were no (0%) catheter-related bloodstream infections. There were 5 (3.1%) major bleeding events. Significant thrombus in the IVC filter occurred in 14 (8.6%) patients. Prophylactic anticoagulation was not initiated for a mean of 5.5 days ± 4.3 after ICU admission. Conclusions This novel device prevented clinically significant and fatal PE among critically ill trauma patients with low risk of complications.

Original languageEnglish (US)
Pages (from-to)1248-1254
Number of pages7
JournalJournal of Vascular and Interventional Radiology
Volume28
Issue number9
DOIs
StatePublished - Sep 1 2017

Fingerprint

Pulmonary Embolism
Critical Illness
Equipment and Supplies
Wounds and Injuries
Vena Cava Filters
Catheter-Related Infections
Thrombosis
Hemorrhage
Venous Thrombosis
Intensive Care Units
Device Removal
Central Venous Catheters
Fluoroscopy
Spine
Catheters
Head
Clinical Trials
Confidence Intervals
Safety
Incidence

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients. / Tapson, Victor F.; Hazelton, Joshua P.; Myers, John; Robertson, Claudia; Gilani, Ramyar; Dunn, Julie A.; Bukur, Marko; Croce, Martin; Peick, Ann; West, Sonlee; Lottenberg, Lawrence; Doucet, Jay; Miller, Preston R.; Crookes, Bruce; Gandhi, Rajesh R.; Croft, Chasen A.; Manasia, Anthony; Hoey, Brian A.; Lieberman, Howard; Guillamondegui, Oscar D.; Novack, Victor; Piazza, Gregory; Goldhaber, Samuel Z.

In: Journal of Vascular and Interventional Radiology, Vol. 28, No. 9, 01.09.2017, p. 1248-1254.

Research output: Contribution to journalArticle

Tapson, VF, Hazelton, JP, Myers, J, Robertson, C, Gilani, R, Dunn, JA, Bukur, M, Croce, M, Peick, A, West, S, Lottenberg, L, Doucet, J, Miller, PR, Crookes, B, Gandhi, RR, Croft, CA, Manasia, A, Hoey, BA, Lieberman, H, Guillamondegui, OD, Novack, V, Piazza, G & Goldhaber, SZ 2017, 'Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients', Journal of Vascular and Interventional Radiology, vol. 28, no. 9, pp. 1248-1254. https://doi.org/10.1016/j.jvir.2017.05.001
Tapson, Victor F. ; Hazelton, Joshua P. ; Myers, John ; Robertson, Claudia ; Gilani, Ramyar ; Dunn, Julie A. ; Bukur, Marko ; Croce, Martin ; Peick, Ann ; West, Sonlee ; Lottenberg, Lawrence ; Doucet, Jay ; Miller, Preston R. ; Crookes, Bruce ; Gandhi, Rajesh R. ; Croft, Chasen A. ; Manasia, Anthony ; Hoey, Brian A. ; Lieberman, Howard ; Guillamondegui, Oscar D. ; Novack, Victor ; Piazza, Gregory ; Goldhaber, Samuel Z. / Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients. In: Journal of Vascular and Interventional Radiology. 2017 ; Vol. 28, No. 9. pp. 1248-1254.
@article{a9612aa2b84347048a994dad5142f0e3,
title = "Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients",
abstract = "Purpose To evaluate efficacy and safety of a novel device that combines an inferior vena cava (IVC) filter and central venous catheter (CVC) for prevention of pulmonary embolism (PE) in critically ill patients. Materials and Methods In a multicenter, prospective, single-arm clinical trial, the device was inserted at the bedside without fluoroscopy and subsequently retrieved before transfer from the intensive care unit (ICU). The primary efficacy endpoint was freedom from clinically significant PE or fatal PE 72 hours after device removal or discharge, whichever occurred first. Secondary endpoints were incidence of acute proximal deep venous thrombosis (DVT), catheter-related thrombosis, catheter-related bloodstream infections, major bleeding events, and clinically significant thrombus (occupying > 25{\%} of volume of filter) detected by cavography before retrieval. Results The device was placed in 163 critically ill patients with contraindications to anticoagulation; 151 (93{\%}) were critically ill trauma patients, 129 (85{\%}) had head or spine trauma, and 102 (79{\%}) had intracranial bleeding. The primary efficacy endpoint was achieved for all 163 (100{\%}) patients (95{\%} confidence interval [CI], 97.8{\%}–100{\%}, P <.01). Diagnosis of new or worsening acute proximal DVT was time dependent with 11 (7{\%}) occurring during the first 7 days. There were no (0{\%}) catheter-related bloodstream infections. There were 5 (3.1{\%}) major bleeding events. Significant thrombus in the IVC filter occurred in 14 (8.6{\%}) patients. Prophylactic anticoagulation was not initiated for a mean of 5.5 days ± 4.3 after ICU admission. Conclusions This novel device prevented clinically significant and fatal PE among critically ill trauma patients with low risk of complications.",
author = "Tapson, {Victor F.} and Hazelton, {Joshua P.} and John Myers and Claudia Robertson and Ramyar Gilani and Dunn, {Julie A.} and Marko Bukur and Martin Croce and Ann Peick and Sonlee West and Lawrence Lottenberg and Jay Doucet and Miller, {Preston R.} and Bruce Crookes and Gandhi, {Rajesh R.} and Croft, {Chasen A.} and Anthony Manasia and Hoey, {Brian A.} and Howard Lieberman and Guillamondegui, {Oscar D.} and Victor Novack and Gregory Piazza and Goldhaber, {Samuel Z.}",
year = "2017",
month = "9",
day = "1",
doi = "10.1016/j.jvir.2017.05.001",
language = "English (US)",
volume = "28",
pages = "1248--1254",
journal = "Journal of Vascular and Interventional Radiology",
issn = "1051-0443",
publisher = "Elsevier Inc.",
number = "9",

}

TY - JOUR

T1 - Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients

AU - Tapson, Victor F.

AU - Hazelton, Joshua P.

AU - Myers, John

AU - Robertson, Claudia

AU - Gilani, Ramyar

AU - Dunn, Julie A.

AU - Bukur, Marko

AU - Croce, Martin

AU - Peick, Ann

AU - West, Sonlee

AU - Lottenberg, Lawrence

AU - Doucet, Jay

AU - Miller, Preston R.

AU - Crookes, Bruce

AU - Gandhi, Rajesh R.

AU - Croft, Chasen A.

AU - Manasia, Anthony

AU - Hoey, Brian A.

AU - Lieberman, Howard

AU - Guillamondegui, Oscar D.

AU - Novack, Victor

AU - Piazza, Gregory

AU - Goldhaber, Samuel Z.

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Purpose To evaluate efficacy and safety of a novel device that combines an inferior vena cava (IVC) filter and central venous catheter (CVC) for prevention of pulmonary embolism (PE) in critically ill patients. Materials and Methods In a multicenter, prospective, single-arm clinical trial, the device was inserted at the bedside without fluoroscopy and subsequently retrieved before transfer from the intensive care unit (ICU). The primary efficacy endpoint was freedom from clinically significant PE or fatal PE 72 hours after device removal or discharge, whichever occurred first. Secondary endpoints were incidence of acute proximal deep venous thrombosis (DVT), catheter-related thrombosis, catheter-related bloodstream infections, major bleeding events, and clinically significant thrombus (occupying > 25% of volume of filter) detected by cavography before retrieval. Results The device was placed in 163 critically ill patients with contraindications to anticoagulation; 151 (93%) were critically ill trauma patients, 129 (85%) had head or spine trauma, and 102 (79%) had intracranial bleeding. The primary efficacy endpoint was achieved for all 163 (100%) patients (95% confidence interval [CI], 97.8%–100%, P <.01). Diagnosis of new or worsening acute proximal DVT was time dependent with 11 (7%) occurring during the first 7 days. There were no (0%) catheter-related bloodstream infections. There were 5 (3.1%) major bleeding events. Significant thrombus in the IVC filter occurred in 14 (8.6%) patients. Prophylactic anticoagulation was not initiated for a mean of 5.5 days ± 4.3 after ICU admission. Conclusions This novel device prevented clinically significant and fatal PE among critically ill trauma patients with low risk of complications.

AB - Purpose To evaluate efficacy and safety of a novel device that combines an inferior vena cava (IVC) filter and central venous catheter (CVC) for prevention of pulmonary embolism (PE) in critically ill patients. Materials and Methods In a multicenter, prospective, single-arm clinical trial, the device was inserted at the bedside without fluoroscopy and subsequently retrieved before transfer from the intensive care unit (ICU). The primary efficacy endpoint was freedom from clinically significant PE or fatal PE 72 hours after device removal or discharge, whichever occurred first. Secondary endpoints were incidence of acute proximal deep venous thrombosis (DVT), catheter-related thrombosis, catheter-related bloodstream infections, major bleeding events, and clinically significant thrombus (occupying > 25% of volume of filter) detected by cavography before retrieval. Results The device was placed in 163 critically ill patients with contraindications to anticoagulation; 151 (93%) were critically ill trauma patients, 129 (85%) had head or spine trauma, and 102 (79%) had intracranial bleeding. The primary efficacy endpoint was achieved for all 163 (100%) patients (95% confidence interval [CI], 97.8%–100%, P <.01). Diagnosis of new or worsening acute proximal DVT was time dependent with 11 (7%) occurring during the first 7 days. There were no (0%) catheter-related bloodstream infections. There were 5 (3.1%) major bleeding events. Significant thrombus in the IVC filter occurred in 14 (8.6%) patients. Prophylactic anticoagulation was not initiated for a mean of 5.5 days ± 4.3 after ICU admission. Conclusions This novel device prevented clinically significant and fatal PE among critically ill trauma patients with low risk of complications.

UR - http://www.scopus.com/inward/record.url?scp=85020911354&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85020911354&partnerID=8YFLogxK

U2 - 10.1016/j.jvir.2017.05.001

DO - 10.1016/j.jvir.2017.05.001

M3 - Article

VL - 28

SP - 1248

EP - 1254

JO - Journal of Vascular and Interventional Radiology

JF - Journal of Vascular and Interventional Radiology

SN - 1051-0443

IS - 9

ER -