Noticias

Noticias

  • Título: Multicenter iRetrieve Study Evaluates Methods to Improve IVC Filter Retrieval Rates
  • Fecha: 09-07-2014

  • MULTI-CENTER STUDY EVALUATES METHOD TO IMPROVE RETRIEVAL RATE OF

    INFERIOR VENA CAVA FILTERS

    iRetrieve study uses a novel algorithm to track patients, engage physicians and improve

    outcomes.

    BEVERLY, MA (July 9, 2014)—The Heart and Vascular Outcomes Research Institute (HVORI)

    is collaborating with a number of medical centers to launch the iRetrieve Study aimed to

    improve the retrieval rate of Inferior Vena Cava (IVC) Filters. John E. Rectenwald, M.D., M.S.,

    Associate Professor of Surgery, Univeristy of Michigan is the Principal Investigator for iRetrieve

    study, and the clinical trial is currently underway.

    IVC filters are placed in patients who have a history of, or who are at risk of, developing blood

    clots in the legs. The purpose of the filter is to trap large clot fragments and prevent them from

    traveling through the vena cava vein to the lungs, where they could cause severe complications

    or even death.

    The filter is placed in the inferior vena cava, the large vein in the abdomen that returns blood

    from the lower body to the heart. Until recently, IVC filters were available only as permanently

    implanted devices. Now, there are newer filters, that may be left in place permanently or have

    the option to be removed from the blood vessel later. Unlike permanent filters, retrievable filters

    have hooks or other structures that allow physicians to recapture and remove them from

    patients.

    The iRetrieve Study employs the IVC Filter Module, which combines a novel retrieval algorithm

    with a pathway incorporated in the Venous Patient Outcome Registry, that catalogs clinical

    outcomes for various treatments of deep and superficial venous diseases .

    The IVC Filter Module will enable physicians to enter and track patients who receive a filter, the

    types of filters they are using, how frequently they are retrieving filters and any affiliated

    complications within the registry. Using the retrieval algorithm, each patient is assessed based

    on a multi-factorial analysis and a score will trigger a secure email and text message sent to

    both the physician and patient as a reminder to schedule a follow-up appointment or a

    procedure to retrieve the filter. Physicians will also be able to compare their patients’ outcome

    with the national aggregate.

    “Retrievable IVC filters, although FDA-approved for permanent placement, are intended to be

    removed to limit potential long-term complications. They are designed specifically with the

    intention of being re-constrained and removed,” says Dr. Rectenwald. “Unfortunately, these

    designs and the materials used so that the filter can be retrieved, may predispose these filters to

    their own long-term complications, such as migration, and fracture if they are not removed.”

    Improving retrieval rates and patient outcomes

    In 2003, the first retrievable IVC filter was introduced in the U.S, but it was taken off the market

    two years later due to complications with filter fracture and migration. Since then, improvements

    in the filter design have resolved problems of structural integrity and increased the ability to

    remove the filter after longer periods of time.

    Retrievable filters are frequently made from a material called nitinol, which can fracture and

    cause potential complications. In August 2010, the U.S. Food and Drug Administration (FDA)

    issued a communication advising physicians to remove retrievable filters whenever possible and

    updated that letter again in May 2014, due to concerns that these retrievable IVC filters,

    intended for short-term placement, are not always removed once a patient’s risk for PE

    subsides. Known long-term risks associated with IVC filters include lower limb deep vein

    thrombosis, filter fracture, filter migration, filter embolization and IVC perforation.

    Several studies have shown that approximately 80 to 85 percent of retrievable IVC filters are

    never retrieved. The successful removal of retrievable filters requires diligent patient follow-up

    and interdepartmental cooperation and even then, successful removal is not always

    accomplished.

    The American College of Chest Physicians guidelines for IVC filter placement advocate for a

    close, structured follow-up of retrievable IVCFs to improve filter retrieval rates. Though some

    progress has been made, in order to achieve high retrieval rates hospitals and clinics may need

    a dedicated program that closely monitors patients with retreivable IVC Filters. Not every

    hospital or clinic has the resources available to implement a dedicated IVC Filter Clinic.

    The predicted results from the iRetrieve Study could alleviate that burden on hospitals and

    clinics, while improving patient outcomes.

    “Physicians in the U.S. place an estimated 250,000 retrievable filters in patients annually. Using

    the algorithm we’re testing in the iRetrieve Study, we anticipate a retrieval rate of more than 90

    percent, as the system will ensure a robust follow up for patients and also a reminder for

    physicians,” says Uchenna Onyeachom, Director of Endovascular Research at HVORI and

    Study Director for iRetrieve. “The model also can eliminate the huge overhead cost incurred in

    the implementation of a dedicated IVC Filter Clinic.”

    'I would like to commend Dr. John Rectenwald, Uchenna Onyeachom, the HVORI Institute, and

    the iRetrieve investigators for initiating this important study,” says William Kuo, M.D., FSIR,

    FCCP, FCIRSE, Director, Stanford IVC Filter Clinic. “Hopefully, their new module will help

    automate the process of tracking indwelling IVC filters so that more patients may benefit from

    prompt filter retrieval.'

    To learn more about the iRetrieve Study email hvori@administrare.com or call 978-927-7800.


    About the Heart and Vascular Outcomes Research Institute

    The Heart and Vascular Outcomes Research Institute is a nonprofit research organization

    dedicated to the study of heart, vascular and related disorders. HVORI's mission is to provide

    excellence in outcome research that is patient focused and thereby improve quality of care,

    advance clinical outcomes, reduce healthcare costs and drive innovation. Learn more at

    www.hvori.org.

    Heart and Vascular Outcomes Research Institute

    100 Cummings Center, Suite 124A

    Beverly, MA 01915.

    Tel: 978-927-7800

    Fax:978-927-7872



  • Fuente: endovascular.es