Predicting the Safety and Effectiveness of Inferior Vena Cava Filters Study: Design of a unique safety and effectiveness study of inferior vena cava filters in clinical practice

David L. Gillespie, James B. Spies, F. Sandra Siami, John E. Rectenwald, Rodney A. White, Matthew S. Johnson

Research output: Contribution to journalArticle

Abstract

Background: Death from venous thromboembolism remains a significant cause of death worldwide. Although anticoagulation is the cornerstone of treatment in patients at risk for venous thromboembolism, inferior vena cava (IVC) filter use has increased exponentially over the last decade driven predominantly by the prophylactic use in patients at risk for venous thromboembolism despite limited evidence supporting this practice. The Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Study is being implemented by the Society for Vascular Surgery, Society of Interventional Radiology, U.S. Food and Drug Administration, and several IVC filter manufactures to better understand the safety, effectiveness, and current patterns of real-world use of IVC filters. Methods: The PRESERVE Study includes IVC filters from seven manufacturers: ALN (ALN ± hook), Argon (Option Elite), B. Braun (LP, Vena Tech Convertible), CR Bard (Denali), Cook (Gunther Tulip), Cordis (OptEase, TrapEase), and Philips Volcano (Crux). The indications for filter placement, filter brand, complications, stability, frequency and success of retrieval, and clinical effectiveness of each filter will be recorded. Approximately 2100 patients (300 for each filter brand included in the study) are intended to be enrolled at 60 U.S. centers. Results: Men and women age 18 years or older requiring IVC filters for prevention of venous thromboembolism will be included in the study if no contrast allergy is present and they are willing to commit to the prescribed study follow-up. Participants will be evaluated at discharge, 3, 6, 12, 18, and 24 months after filter placement and/or 1 month after retrieval, which ever occurs first. Intravascular ultrasound examination or venography will be done before and after IVC filter placement, with abdominal plain film at 3 months, and contrast enhanced computed tomography scans at 12 and 24 months to evaluate filter stability. The primary safety end point is a composite of clinical end points, including freedom from perforation, embolization, thrombosis, recurrent DVT, and defined serious adverse events. Secondary end points include mechanical stability and procedure related complications at 3 months, major adverse events at 6, 12, 18, and 24 months, and filter tilt of more than 15° at any point. Conclusions: The PRESERVE Study represents the largest prospective study ever undertaken to investigate real-world outcomes with contemporary use of IVC filters. The investigators await results with the hope that it can improve patient care.

Original languageEnglish (US)
JournalJournal of Vascular Surgery: Venous and Lymphatic Disorders
DOIs
StateAccepted/In press - Jan 1 2019

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Vena Cava Filters
Safety
Venous Thromboembolism
Tulipa
Phlebography
Argon
United States Food and Drug Administration
Motion Pictures
Cause of Death
Patient Care
Hypersensitivity
Thrombosis
Tomography
Research Personnel
Prospective Studies

Keywords

  • Filter
  • Inferior vena cava
  • Pulmonary embolism
  • Venous thromboembolism

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters Study : Design of a unique safety and effectiveness study of inferior vena cava filters in clinical practice. / Gillespie, David L.; Spies, James B.; Siami, F. Sandra; Rectenwald, John E.; White, Rodney A.; Johnson, Matthew S.

In: Journal of Vascular Surgery: Venous and Lymphatic Disorders, 01.01.2019.

Research output: Contribution to journalArticle

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abstract = "Background: Death from venous thromboembolism remains a significant cause of death worldwide. Although anticoagulation is the cornerstone of treatment in patients at risk for venous thromboembolism, inferior vena cava (IVC) filter use has increased exponentially over the last decade driven predominantly by the prophylactic use in patients at risk for venous thromboembolism despite limited evidence supporting this practice. The Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Study is being implemented by the Society for Vascular Surgery, Society of Interventional Radiology, U.S. Food and Drug Administration, and several IVC filter manufactures to better understand the safety, effectiveness, and current patterns of real-world use of IVC filters. Methods: The PRESERVE Study includes IVC filters from seven manufacturers: ALN (ALN ± hook), Argon (Option Elite), B. Braun (LP, Vena Tech Convertible), CR Bard (Denali), Cook (Gunther Tulip), Cordis (OptEase, TrapEase), and Philips Volcano (Crux). The indications for filter placement, filter brand, complications, stability, frequency and success of retrieval, and clinical effectiveness of each filter will be recorded. Approximately 2100 patients (300 for each filter brand included in the study) are intended to be enrolled at 60 U.S. centers. Results: Men and women age 18 years or older requiring IVC filters for prevention of venous thromboembolism will be included in the study if no contrast allergy is present and they are willing to commit to the prescribed study follow-up. Participants will be evaluated at discharge, 3, 6, 12, 18, and 24 months after filter placement and/or 1 month after retrieval, which ever occurs first. Intravascular ultrasound examination or venography will be done before and after IVC filter placement, with abdominal plain film at 3 months, and contrast enhanced computed tomography scans at 12 and 24 months to evaluate filter stability. The primary safety end point is a composite of clinical end points, including freedom from perforation, embolization, thrombosis, recurrent DVT, and defined serious adverse events. Secondary end points include mechanical stability and procedure related complications at 3 months, major adverse events at 6, 12, 18, and 24 months, and filter tilt of more than 15° at any point. Conclusions: The PRESERVE Study represents the largest prospective study ever undertaken to investigate real-world outcomes with contemporary use of IVC filters. The investigators await results with the hope that it can improve patient care.",
keywords = "Filter, Inferior vena cava, Pulmonary embolism, Venous thromboembolism",
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T2 - Design of a unique safety and effectiveness study of inferior vena cava filters in clinical practice

AU - Gillespie, David L.

AU - Spies, James B.

AU - Siami, F. Sandra

AU - Rectenwald, John E.

AU - White, Rodney A.

AU - Johnson, Matthew S.

PY - 2019/1/1

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N2 - Background: Death from venous thromboembolism remains a significant cause of death worldwide. Although anticoagulation is the cornerstone of treatment in patients at risk for venous thromboembolism, inferior vena cava (IVC) filter use has increased exponentially over the last decade driven predominantly by the prophylactic use in patients at risk for venous thromboembolism despite limited evidence supporting this practice. The Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Study is being implemented by the Society for Vascular Surgery, Society of Interventional Radiology, U.S. Food and Drug Administration, and several IVC filter manufactures to better understand the safety, effectiveness, and current patterns of real-world use of IVC filters. Methods: The PRESERVE Study includes IVC filters from seven manufacturers: ALN (ALN ± hook), Argon (Option Elite), B. Braun (LP, Vena Tech Convertible), CR Bard (Denali), Cook (Gunther Tulip), Cordis (OptEase, TrapEase), and Philips Volcano (Crux). The indications for filter placement, filter brand, complications, stability, frequency and success of retrieval, and clinical effectiveness of each filter will be recorded. Approximately 2100 patients (300 for each filter brand included in the study) are intended to be enrolled at 60 U.S. centers. Results: Men and women age 18 years or older requiring IVC filters for prevention of venous thromboembolism will be included in the study if no contrast allergy is present and they are willing to commit to the prescribed study follow-up. Participants will be evaluated at discharge, 3, 6, 12, 18, and 24 months after filter placement and/or 1 month after retrieval, which ever occurs first. Intravascular ultrasound examination or venography will be done before and after IVC filter placement, with abdominal plain film at 3 months, and contrast enhanced computed tomography scans at 12 and 24 months to evaluate filter stability. The primary safety end point is a composite of clinical end points, including freedom from perforation, embolization, thrombosis, recurrent DVT, and defined serious adverse events. Secondary end points include mechanical stability and procedure related complications at 3 months, major adverse events at 6, 12, 18, and 24 months, and filter tilt of more than 15° at any point. Conclusions: The PRESERVE Study represents the largest prospective study ever undertaken to investigate real-world outcomes with contemporary use of IVC filters. The investigators await results with the hope that it can improve patient care.

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KW - Venous thromboembolism

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