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Fluids & Electrolytes
TUESDAY, Aug. 10 (HealthDay News) -- There is a high rate of fracture and embolization with potentially devastating sequelae associated with two types of Bard filters, according to research published online Aug. 9 in the Archives of Internal Medicine. In addition, the U.S. Food and Drug Administration is recommending that physicians in care of patients with retrievable inferior vena cava filters consider removing the filters as soon as protection from pulmonary embolism is no longer necessary.
William Nicholson, M.D., of York Hospital in Pennsylvania, and colleagues evaluated 80 eligible subjects who had received either a Bard Recovery or Bard G2 (first and second generation, respectively) to assess the prevalence of fracture and embolization associated with implantation of these devices.
The researchers found that 13 (16 percent) of the patients experienced one or more strut fractures, with at least one strut out of seven in the Bard Recovery filters having fractured and embolized. Patients experienced at least one fragment embolization to the heart in five of seven of these cases (71 percent). In addition, three patients experienced ventricular tachycardia and/or tamponade at a life-threatening level; one of these patients died suddenly at home. In the 52 Bard G2 filters, six fractures occurred (12 percent), resulting in asymptomatic end-organ fragment embolization in two of the six cases.
"In conclusion, the prevalence of fragmentation and embolization was found to be high in both the Bard Recovery (25 percent, seven of 28) and the Bard G2 (12 percent, six of 52) vena cava filters," the authors write. "It is essential that other medical centers evaluate patients who have received a Bard retrievable filter or any other inferior vena cava filter, both for patient safety and to corroborate our single-center findings."
More Information - FDA Initial Communication
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