Percutaneous aortic valve replacement (TAVI) is a new treatment option for patients that are inoperable or present a high surgical risk. Some studies have shown that the stroke rate may be higher with TAVI than with medical treatment or surgical replacement. Embolic protection has been used successfully for the carotids, but there is not much data available in the context of TAVI. The Embrella Embolic Deflector System is designed to reduce the amount of embolic material that may reach the carotids during TAVI. It requires a right radial or brachial access of 6 Fr to introduce the oval device, which is made of nitinol and polyurethane. It is positioned along the arch covering the ostium of the brachiocephalic artery and the left carotid artery.
We included 54 patients (42 received the device and 12 were controls) and evaluated the clinical outcomes (stroke and TIA), the neurological images (transcranial doppler and MRI) and the clinical criteria for cognitive status. Both the device and the valve were implanted successfully in all patients. Atfter 7 days, there was a death, a minor stroke, and two major bleedings. The magnetic resonance showed new ischemic lesions in 100% of patients; however, the results of the cognitive tests were unchanged after the procedure compared to the baseline results.
Conclusion: It is feasible to use the Embrella device during TAVI. The only minor stroke occurred 2 days after the procedure. However, all patients showed new ischemic defects in different and multiple territories during the resonance.
J. Rodes Cabau
2013-05-22
Original title: Procedural and early neurological outcomes in the PROTAVI-C pilot study
