Journal article
Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically III Trauma Patients
Journal of vascular and interventional radiology, v 28(9), pp 1248-1254
01 Sep 2017
PMID: 28642012
Featured in Collection : UN Sustainable Development Goals @ Drexel
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 froth the intensive care unit (ICU). The primary efficacy endpoint was freedom from clinically Sigthficant 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 volurne 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 prithary, 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.
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Details
- Title
- Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically III Trauma Patients
- Creators
- Victor F. Tapson - Cedars-Sinai Medical CenterJoshua P. Hazelton - Cooper University HospitalJohn Myers - The University of Texas Health Science Center at San AntonioClaudia Robertson - Baylor College of MedicineRamyar Gilani - Baylor College of MedicineJulie A. Dunn - University of Northern ColoradoMarko Bukur - New York UniversityMartin A. Croce - University of Tennessee Health Science CenterAnn Peick - Mercy HospitalSonlee West - University of New MexicoLawrence Lottenberg - Florida Atlantic UniversityJay Doucet - University of California, San DiegoPreston R. Miller - Atrium Health Wake Forest BaptistBruce Crookes - Medical University of South CarolinaRajesh R. Gandhi - University of North Texas Health Science CenterChasen A. Croft - University of Florida Health Science CenterAnthony Manasia - Icahn School of Medicine at Mount SinaiBrian A. Hoey - St. Luke's University Health NetworkHoward Lieberman - Ryder Trauma Ctr, Dept Surg, Div Trauma & Surg Crit Care, Miami, FL USAOscar D. Guillamondegui - Vanderbilt UniversityVictor Novack - Ben-Gurion University of the NegevGregory Piazza - Brigham and Women's HospitalSamuel Z. Goldhaber - Brigham and Women's Hospital
- Publication Details
- Journal of vascular and interventional radiology, v 28(9), pp 1248-1254
- Publisher
- Elsevier
- Number of pages
- 7
- Grant note
- Bristol-Myers Squibb Thrombosis Research Institute (Boston, Massachusetts) Inert Janssen EKOS/BTG Bio2 Medical Boehringer-lngelheim; Boehringer Ingelheim Daiichi; Daiichi Sankyo Company Limited Boehringer-Ingelheim; Boehringer Ingelheim Bayer; Bayer AG Daiichi-Sankyo; Daiichi Sankyo Company Limited
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:000409397400007
- Scopus ID
- 2-s2.0-85020911354
- Other Identifier
- 991022057017504721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Peripheral Vascular Disease
- Radiology, Nuclear Medicine & Medical Imaging