First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement

Area of Science:

• Cardiovascular Surgery
• Neurology
• Medical Devices

Background:

• Limited evidence exists for cerebral embolic protection devices during TAVR.
• Stroke risk remains a concern in TAVR procedures.

Purpose of the Study:

• To evaluate the feasibility, safety, and efficacy of the Emblok embolic protection system during TAVR.
• To assess the cerebral embolic burden using diffusion-weighted MRI post-TAVR.

Main Methods:

• A prospective, nonrandomized, multicenter pilot study involving 20 patients undergoing TAVR.
• The Emblok system, a transfemoral aortic filter, was used for epiaortic vessel coverage.
• Brain diffusion-weighted MRI was performed at baseline and 2-5 days post-TAVR.

Main Results:

• The Emblok system was successfully deployed and retrieved in all cases.
• No major adverse cardiovascular or cerebrovascular events occurred within 30 days.
• Ninety-five percent of patients showed new ischemic lesions on MRI, with a median of 10 lesions and a total volume of 199.9 mm³; 90% of filters contained significant debris.

Conclusions:

• The Emblok system demonstrates feasibility and safety for cerebral protection during TAVR.
• The observed cerebral lesion volume is comparable to other cerebral protection trials.
• A larger study is warranted to further validate the Emblok system's efficacy.