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International Council of Emboli Management (ICEM) Study Group results: risk adjusted outcomes in intraaortic
1Klinik und Poliklinik für Herzchirurgie, Sigmund-Freud-Strasse 25, 53105, Bonn, Germany. christoph.schmitz@ukb.uni-bonn.de
Insights
Intra-aortic filtration significantly reduced major neurologic events after coronary artery bypass grafting, with observed events being half of those predicted by the Stroke Risk Index. This suggests filtration is effective in preventing adverse outcomes.
Area of Science:
- Cardiovascular Surgery
- Neurology
- Medical Technology
Background:
- The Multicenter Study of Perioperative Ischemia (McSPI) developed a Stroke Risk Index for major perioperative neurologic events in coronary artery bypass grafting (CABG).
- The International Council of Emboli Management (ICEM) Study Group proposed intra-aortic filtration to reduce neurologic events.
Purpose of the Study:
- To compare predicted versus observed neurologic outcomes in patients undergoing CABG with intra-aortic filtration.
Main Methods:
- A prospective registry of 402 patients undergoing isolated CABG with intra-aortic filtration across 15 European centers (February 1999-August 2000).
- Calculation of the McSPI Stroke Risk Index for each patient to determine expected neurologic events.
- Comparison of expected versus observed neurologic events using confidence limits and goodness of fit.
Main Results:
- Six neurologic events were observed (1.5%), significantly lower than the 13.7 predicted by the McSPI Stroke Risk Index (3.4%) (P=0.03).
- Observed event rate was approximately half of the predicted rate.
Conclusions:
- Intra-aortic filtration use in CABG was associated with rare adverse neurologic events, fewer than predicted by the McSPI Stroke Risk Index.
- The low event rate makes them unsuitable as primary endpoints for randomized trials, but the Stroke Risk Index remains a valuable benchmark.
Background:
The Multicenter Study of Perioperative Ischemia (McSPI) developed and validated a Stroke Risk Index for estimating the likelihood that patients undergoing isolated coronary artery bypass grafting will experience major perioperative neurologic events. The International Council of Emboli Management (ICEM) Study Group has suggested that use of intraaortic filtration reduces adverse neurologic events.
Objective:
The objective of the present study was to compare predicted and observed neurologic outcomes in patients receiving intraaortic filtration.
Patients And Methods:
From February 1999 to August 2000, 962 patients were enrolled consecutively in a prospective, nonvoluntary registry of intraaortic filtration in 15 European centers. Of these, 447 underwent isolated coronary artery bypass grafting, the target population for applying the McSPI Stroke Risk Index. Forty-five had incomplete data, yielding a study group of 402 patients. The Stroke Risk Index was calculated for each patient, and the sum across patients yielded an expected number of neurologic events. These were compared to observed events by confidence limits and goodness of fit.
Results:
Six neurologic events were observed (1.5%; 95% confidence limits 0.6-3.4%), roughly half the 13.7 predicted by the Stroke Risk Index (3.4%; 95% confidence limits 2.0-5.8%), P=0.03.
Conclusions:
Adverse neurologic events associated with coronary artery bypass grafting in which intraaortic filtration was used were rare and fewer than expected on the basis of the Stroke Risk Index. Rare occurrence of clinically relevant events precludes their use as primary endpoints for randomized clinical studies; however, the Stroke Risk Index provides a valuable benchmark in the absence of such studies.