TAVI has seen a steady increase in use, though stroke continues to be one of its unwanted complications, mostly ischemic and, less frequently, hemorrhagic.
The use of cerebral embolic protection (CEP) devices continues under debate, seeing as the several analyses conducted so far have failed to show conclusive or significant results as regards effectiveness.
The BHF PROTECT-TAVI included 7,601 patients undergoing TAVI: 3,798 were treated with the SENTINEL device, while the rest formed the control group.
The primary endpoint was stroke within 72 hours after procedure or before hospital discharge.
Population mean age was 81, and 39% were women. Mean EUROSCORE was 2.4%. Regarding comorbidities: 68% had hypertension, 20% diabetes, 8% TIA, 6% previous stroke, 33% coronary artery disease, 13% heart failure, 33% atrial fibrillation, 33.5% peripheral vascular disease, 13% aortic arch abnormalities (including bovine arch), and 8% bicuspid aorta.
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Ejection fraction was <30% in 5.5% of patients and 30% to 49% in 18%. Mean gradient was 43 mmHg. Nearly half of patients showed aortic annulus severe calcification, and 4% showed outflow tract calcification.
No significant differences were observed in primary end point, with 2.1% stroke incidence among CEP patients and 2.2% among control group patients (difference: –0.02 percentage points; 95% CI: –0.68 to 0.63; p=0.94). Also, there were no differences in severe stroke incidence (0.5% vs. 0.5%; difference: 0.0 percentage points; 95% CI: –0.3 to 0.3), and most strokes occurred within the first 24 hours after procedure.
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Likewise, no differences were observed in disabling stroke between weeks 6 and 8 after TAVI (1.2% vs. 1.4%; difference: –0.2 percentage points; 95% CI: –0.7 to 0.4), or mortality within 72 hours, during hospitalization, or at 8 weeks.
Conclusion
Among patients undergoing TAVI, the routine use of cerebral protection devices did not reduce stroke incidence within the first 72 hours.
Original Title: Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation.
Reference: Rajesh K. Kharbanda, et al. NEJM DOI: 10.1056/NEJMoa2415120.
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