Emboli capture using the Embol-X intraaortic filter in cardiac surgery: a multicentered randomized trial of 1,289 patients.
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.
Banbury
Michael K
MK
The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. banburm@ccf.org
Kouchoukos
Nicholas T
NT
Allen
Keith B
KB
Slaughter
Mark S
MS
Weissman
Neil J
NJ
Berry
Gerald J
GJ
Horvath
Keith A
KA
D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D016001:Confidence Intervals; D001026:Coronary Artery Bypass / Q000295:instrumentation / Q000379:methods; D003327:Coronary Disease / Q000601:surgery; D004617:Embolism / Q000517:prevention & control*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000601:surgery; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D006801:Humans; D007431:Intraoperative Complications / Q000517:prevention & control*; D008297:Male; D008851:Micropore Filters; D008875:Middle Aged; D016017:Odds Ratio; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D015996:Survival Rate; D016896:Treatment Outcome