Emboli capture using the Embol-X intraaortic filter in cardiac surgery: A multicentered randomized trial of 1,289 patients

Michael K. Banbury, Nicholas T. Kouchoukos, Keith B. Allen, Mark S. Slaughter, Neil J. Weissman, Gerald J. Berry, Keith A. Horvath, Sara J. Shumway

Research output: Contribution to journalArticle

Abstract

Background. Particulate emboli are thought to play a significant role in the development of cardiac surgical complications. Intraaortic filtration of particulate emboli may reduce the burden of this morbidity in cardiac patients. Methods. A multiinstitutional randomized trial was designed and enrolled 1,289 patients at 22 centers. Six hundred forty-five patients were assigned to the treatment arm and received the Embol-X intraaortic filter, whereas 644 patients were assigned to the control arm. The endpoints examined were mortality, stroke, transient ischemic attack, renal insufficiency/failure, myocardial infarction, gastrointestinal complications, and limb-threatening ischemia. All filters were examined for histologic evidence of particulate emboli. Results. Particulate emboli were identified in 598 (96.8%) of 618 filters successfully deployed. Composite event rates for the clinical endpoints were similar in both the filtered and nonfiltered arm (110/645 = 17% vs 122/644 = 19%, respectively). Individual event rates were also similar in both arms. A post hoc comparison of patients with moderate or greater preoperative risk scores demonstrated event reduction favoring the filtered group for renal complications (17/124 = 14% vs 28/117 = 24%, p = 0.04) and for the composite endpoint (30/124 = 24% vs 42/117 = 36%, p = 0.047). No clinically evident complications attributed to the use of the filter were identified. Conclusions. The use of the Embol-X intraaortic filter is both safe and effective, as demonstrated by the emboli capture rate of 97%. In addition, post hoc analysis indicates a reduction in postoperative renal complications for patients with moderate or greater preoperative risk. Further study of high-risk patients is warranted.

Original languageEnglish (US)
Pages (from-to)508-515
Number of pages8
JournalAnnals of Thoracic Surgery
Volume76
Issue number2
DOIs
StatePublished - Aug 1 2003

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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    Banbury, M. K., Kouchoukos, N. T., Allen, K. B., Slaughter, M. S., Weissman, N. J., Berry, G. J., Horvath, K. A., & Shumway, S. J. (2003). Emboli capture using the Embol-X intraaortic filter in cardiac surgery: A multicentered randomized trial of 1,289 patients. Annals of Thoracic Surgery, 76(2), 508-515. https://doi.org/10.1016/S0003-4975(03)00530-7