Strokes after TAVI occur in between 3.8 and 6.7% of the cases, with new MRI lesions being almost the rule. The TriGuard EDD device is a nitinol filter covering the origin of the vessels of the neck and held in place with stabilizers. It has a diameter of 9 Fr and is implanted by femoral access. There was one in-hospital death observed and, after 30 days, mortality from all causes reached 3.6%. The rate of major stroke with disability after 30 days was 7.1%.
Conclusion: The TriGuard device decreased the size of the new brain lesions after TAVI, but not their number compared to historical controls.
m_mulen_europcr
M. Mulen
2013-05-22
Original title: First report of the DEFLECT I trial: a prospective, single arm feasibility study to evaluate the safety and performance of the Keystone Heart TriGard embolic deflection device in patients undergoing TAVI