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

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86 Scopus citations


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
Issue number2
StatePublished - Aug 1 2003

Bibliographical note

Funding Information:
This study was funded by Embol-X, Inc, Mountain View, CA, under a US FDA Investigational Device Exemption. The seven principal authors served as consultants to the company during the FDA review process.


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