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 A 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; Victor Novack; Gregory Piazza; Samuel Z Goldhaber

doi:10.1016/j.jvir.2017.05.001

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

J Vasc Interv Radiol. 2017 Sep;28(9):1248-1254. doi: 10.1016/j.jvir.2017.05.001. Epub 2017 Jun 20.

Authors

Victor F Tapson¹, Joshua P Hazelton², John Myers³, Claudia Robertson⁴, Ramyar Gilani⁵, Julie A Dunn⁶, Marko Bukur⁷, Martin A Croce⁸, Ann Peick⁹, Sonlee West¹⁰, Lawrence Lottenberg¹¹, Jay Doucet¹², Preston R Miller¹³, Bruce Crookes¹⁴, Rajesh R Gandhi¹⁵, Chasen A Croft¹⁶, Anthony Manasia¹⁷, Brian A Hoey¹⁸, Howard Lieberman¹⁹, Oscar D Guillamondegui²⁰, Victor Novack²¹, Gregory Piazza²², Samuel Z Goldhaber²³

Affiliations

¹ Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: victor.tapson@cshs.org.
² Division of Trauma and Surgical Critical Care, Cooper University Hospital, Camden, New Jersey.
³ Division of Trauma and Emergency Surgery, Department of Surgery, University of Texas Health Science Center, San Antonio, Texas.
⁴ Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.
⁵ Department of Surgery, Baylor College of Medicine, Houston, Texas.
⁶ Department of Trauma Research and Education, University of Colorado Health North, Loveland, Colorado.
⁷ Department of Surgery, Herbert Wertheim College of Medicine, Florida International University, Delray Beach and Fort Lauderdale, Florida; Division of Trauma, Emergency Surgery, and Surgical Critical Care, Bellevue Hospital Center, New York City, New York; Department of Surgery, New York University School of Medicine, New York City, New York.
⁸ Departments of Surgery and Trauma and Surgical Critical Care, University of Tennessee Health Science Center, Memphis, Tennessee.
⁹ Department of Trauma and Acute Care Surgery, Mercy Hospital, St. Louis, Missouri.
¹⁰ Department of Surgery, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.
¹¹ Department of Surgery, Trauma and Acute Care and Trauma Research and Education, St. Mary's Medical Center, West Palm Beach, Florida; Department of Surgery, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida.
¹² Division of Trauma, Surgical Critical Care and Burns, Department of Clinical Surgery, University of California San Diego Health System, San Diego, California.
¹³ Department of Surgery, Wake Forest Baptist Health, Winston-Salem, North Carolina.
¹⁴ Division of General Surgery, Department of Surgery, Medical University of South Carolina, Charleston, South Carolina.
¹⁵ Department of Surgery, Trauma, John Peter Smith Hospital, Fort Worth, Texas; Department of Surgery, University of North Texas, Fort Worth, Texas.
¹⁶ Division of Trauma and Acute Care Surgery, Department of Surgery, University of Florida Health Science Center, Gainesville, Florida.
¹⁷ Departments of Medicine and Surgery, Mount Sinai School of Medicine, New York City, New York.
¹⁸ Department of General Surgery, St. Luke's University Health Network, Bethlehem, Pennsylvania.
¹⁹ Division of Trauma and Surgical Critical Care, Department of Surgery, Ryder Trauma Center, Miami, Florida.
²⁰ Division of Trauma, Acute Care Surgery and Surgical Critical Care, Department of Surgery, Vanderbilt University, Nashville, Tennessee.
²¹ Clinical Research Center, Soroka University Medical Center and Faculty of Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
²² Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
²³ Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

PMID: 28642012
DOI: 10.1016/j.jvir.2017.05.001

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.

Publication types

Clinical Trial
Multicenter Study

MeSH terms

Adult
Central Venous Catheters* / adverse effects
Critical Illness
Device Removal
Equipment Safety
Female
Fluoroscopy
Humans
Intensive Care Units
Male
Prospective Studies
Pulmonary Embolism / etiology*
Pulmonary Embolism / prevention & control*
Risk Factors
Treatment Outcome
United States
Vena Cava Filters* / adverse effects
Wounds and Injuries / complications*