Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade
- PMID: 20696949
- DOI: 10.1001/archinternmed.2010.316
Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade
Abstract
Background: Vena cava filters represent an alternative treatment option for patients with contraindications to anticoagulation, or they might serve as adjunctive treatment for continued emboli despite anticoagulation. The fracture of a filter strut with subsequent end-organ embolization is a rarely reported but potentially life-threatening occurrence.
Methods: We sought to determine the prevalence of fracture and embolization of the Bard Recovery (first generation) and the Bard G2 (second generation) vena cava filters. A retrospective, single-center, cross-sectional study was conducted by evaluating all patients who received either a Bard Recovery or Bard G2 filter from April 2004 until January 2009. A total of 189 patients had undergone implantation: 1 pregnant woman and 35 patients who died were excluded from our study. In addition, 10 patients who had the filter removed were also excluded. Ultimately, 80 patients participated in the trial. Subjects underwent fluoroscopy to assess the filter's integrity. Embolized struts were localized by fluoroscopy. Echocardiography and cardiac computed tomography were performed in patients with fragment embolization to the heart.
Results: Thirteen of 80 patients had at least 1 strut fracture (16%). At least 1 strut in 7 of the 28 Bard Recovery filters fractured and embolized (25%). In 5 of these 7 cases, patients had at least 1 fragment embolize to the heart (71%). Three patients experienced life-threatening symptoms of ventricular tachycardia and/or tamponade, including 1 patient who experienced sudden death at home. Six of 52 Bard G2 filters fractured (12%). In 2 of these 6 cases, the patients had asymptomatic end-organ fragment embolization.
Conclusion: The Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae.
Comment in
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Medical devices and the FDA approval process: balancing safety and innovation; comment on "prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade".Arch Intern Med. 2010 Nov 8;170(20):1831-3. doi: 10.1001/archinternmed.2010.323. Epub 2010 Aug 9. Arch Intern Med. 2010. PMID: 20696948 No abstract available.
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Correction to article about prevalence of fracture and fragment embolization of Bard retrievable vena cava filters.Arch Intern Med. 2012 Jun 25;172(12):972. doi: 10.1001/archinternmed.2012.2126. Arch Intern Med. 2012. PMID: 22732763 No abstract available.
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