Greg Vigna, MD, JD, an academic rehabilitation physician serving a Level 1 Trauma Center in Indianapolis states, “Removable Inferior Vena Cava Filters (IVC) that are placed in traumatic brain injury, spinal cord injury and complex pelvic fracture patients are rarely removed within the FDA recommended time frame. The FDA states these filters should be removed between 29 to 54 days after placement; however, because of the very nature of the at risk population for which they are indicated, this doesn’t happen.”
According to Dr. Vigna, the rationale behind leaving the filters in longer can make sense to a treating physician for the newly injured. “If you are caring for a traumatic brain injured patient with an intracranial bleed who may have undergone emergent neurosurgical procedures, there are often multiple reasons not to use Coumadin or other anti-coagulants. The time frame to avoid anticoagulant therapy may last well after the 54 day period recommended by the FDA to remove the IVC, and therefore it is quite reasonable for a physician to leave the filter in longer.”
Dr. Vigna, also an Academic Physician Life Care Planner, states, “There is a significant design defect with IVCs. These devices can fracture, migrate, puncture, and tilt, especially when they are used longer than two months. Filters remain in place longer than 54 days in over 90% of patients for a variety of reasons. Seeing patients on a daily basic with traumatic brain injury, spinal cord injury, and multiple fractures it is exceptionally rare that there is consideration to remove the device prior to 54 days. They remain at risk of falls that is a relative contraindication to anticoagulation, they have impaired mobility putting them at risk for blood clots, and often have future planned surgeries ahead that would prevent anticoagulation. Also, filters have been within the standard of care for over 25 years and severe complications related to the device are exceptionally rare so there is rarely a compelling reason to remove the device early”.
In terms of marketing these products despite the documented defects, Dr. Vigna adds: “The manufacturers aggressively marketed these devices to trauma surgeons, and failed to provide mechanisms to follow these patients forward to ensure removal. These manufacturers understand that a vast majority of catastrophically injured patients move to 2 or 3 rehabilitation facilities prior to going home, or are often requiring long-term facilities where the subsequent providers don’t even know they had the device placed. These companies should have provided safeguards to following these patients forward for timely removal when medically advisable”.
Dr. Greg Vigna clarifies his stance related to filters, “The utility of filters have been questioned by studies that examined the risk versus benefits of these devices. These studies from a clinical standpoint add information for the physician to include in the consent for the device but doubt it will have much effect on the frequency of use. When families are faced with the potential for a fatal pulmonary embolism versus the exceptionally rare situation where a filter complication causes significant morbidity or mortality they will sign the informed consent and the device will be placed. Families and physicians, however, will be on notice that the device is not meant to be permanent and should be removed when feasible”.
Case Managers for the catastrophically injured patient must be aware that these devises should be removed when medically feasible and must stay current with the American College of Chest Physicians guidelines for the prevention and management of deep venous thrombosis. Academic Physician Life Care Planners are in the best position to individualize the life care plan with all the medically necessary care for those with chronic venous thrombosis including physician follow up, laboratory testing, and diagnostic testing to the injured person’s life expectancy.
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