Original Title: A Patient Level Pooled Analysis of NeuroProtection with the TriGuard Embolic DEFLECTion Device Compared to Unprotected Transcatheter Aortic Valve Replacement.
Presenter: Alexandra Lansky
This work was designed to assess the safety and efficacy of the TriGuard device as a complement during transcatheter aortic valve implantation (TAVI) compared to no protection in a pooled analysis of 3 prospective clinical trials.
With a total of 142 patients (TriGuard n=59 and control n=83) from the trials DEFLECT I (23 TriGuard patient registry), DEFLECT III (randomized study of 36 TriGuard patients and 44 control patients) and NeuroTAVR (44 control patient registry).
Combined events rate was similar in both groups but the average lesion volume assessed by MRI was smaller in patients using the device.
Conclusion
Neuroprotection with the new TriGuard device is associated to a 40% reduction of brain lesion volume and 28% reduction of any new brain lesion assessed by MRI. Clinical neurological deficit reduction was also significant (0% vs 19%, p = 0,001). The study REFLECT RCT was designed to confirm these results.
