Cerebral embolic protection does not decrease stroke incidence in TAVI patients

1. In this randomized trial, the use of cerebral embolic protection (CEP) did not decrease the 72-hour incidence of stroke in patients undergoing transcatheter aortic-valve implantation (TAVI).

2. The occurrence of serious adverse events was similar between the CEP group and the placebo group.

Evidence Rating Level: 1 (Excellent)

Study Rundown: In patients with severe aortic stenosis, TAVI is an effective and commonly used treatment. Strokes are an unpredictable post-operative TAVI complication caused by embolism, hemorrhage, or cerebrovascular collapse. These complications are associated with high morbidity and mortality. Cerebral embolic protection devices prevent debris released during the TAVI procedure from reaching the brain. The Sentinel CEP device is the only CEP device that is currently approved for clinical use in the United States and Europe. It is delivered percutaneously from the right radial artery and deploys filters in the left common carotid and right innominate arteries. This randomized controlled trial evaluated whether the routine use of CEP in TAVI procedures reduced the risk of incidence of clinical stroke. Patients who met inclusion criteria were randomly assigned in a 1:1 ratio to undergo TAVI with a CEP device (CEP group) or TAVI without a CEP device (control group). The primary outcome for this trial was stroke within 72 hours after TAVI or before discharge from the hospital. The results from this study showed that the use of CEP did not decrease the incidence of stroke within 72 hours in patients undergoing a TAVI procedure. Moreover, the occurrence of serious adverse events was similar between the CEP and the control group.  Limitations of this trial included the lack of minority racial or ethnic group participants.

Click here to read the study in NEJM

In-Depth [randomized controlled trial]: This randomized controlled trial investigated whether the routine use of CEP in TAVI procedures would reduce the incidence of clinical stroke. Adult patients who were 18 years or older with aortic stenosis and scheduled to have a TAVI procedure, who were clinically stable, and who were anatomically suitable for treatment with the Sentinel CEP device were enrolled in the study. The Sentinel CEP device is usually delivered percutaneously from the right radial artery and deploys a filter in the left common carotid artery and right innominate artery. The primary outcome of this study was stroke within 72 hours after TAVI or before discharge from the hospital if discharge occurred sooner. A participant’s stroke-free survival after TAVI was determined with the Questionnaire for Verifying Stroke Free Status, which was administered daily for the first 72 hours or until discharge. A total of 7635 patients with aortic stenosis were randomly assigned in a 1:1 ratio to undergo TAVI with a CEP device (CEP group; n = 3815) or TAVI without a CEP device (control group; n = 3820). A primary outcome event occurred in 81 of 3795 participants (2.1%) in the CEP group and 82 of 3,799 participants (2.2%) in the control group (difference, −0.02 percentage points; 95% confidence interval, –0.68 to 0.63; P=0.94). Disabling stroke occurred in 1.2% of participants in the CEP group and 1.4% in the control group. Death occurred in 0.8% of participants in the CEP group and 0.7% in the control group. Access site complications and adverse events were similar between groups. Overall, this study found that among participants undergoing TAVI procedures, routine use of CEP did not decrease the incidence of stroke within 72 hours.

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