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Updated: Dec 24, 2025
Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
Published on: August 8, 2025
First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement
Azeem Latib1, Antonio Mangieri2, Paolo Vezzulli3
1Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Division of Cardiology, Department of Medicine, University of Cape Town, Cape Town, South Africa; Department of Cardiology, Montefiore Medical Center, New York, New York.
Objectives:
This study sought to evaluate the feasibility of complete cerebral protection during transcatheter aortic valve replacement (TAVR) with a novel embolic protection device.
Background:
Evidences and data about new cerebral embolic protection devices are lacking and scarce.
Methods:
A prospective, nonrandomized, multicenter, first-in-man pilot study designed to evaluate the efficacy and safety of cerebral embolic protection utilizing the Emblok embolic protection system (Innovative Cardiovascular Solutions, Grand Rapids, Michigan) during TAVR. The Emblok is a transfemoral aortic filter that provide full coverage of the epiaortic vessels. Brain diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and 2 to 5 days after TAVR. Primary endpoints were technical success and immediate cerebral embolic burden after TAVR, defined as number and volume of new brain lesions detected with DW-MRI at days 2 to 5 post-TAVR compared with baseline.
Results:
A total of 20 subjects were enrolled. The Emblok system was successfully positioned in all the cases. At 30-day follow-up, no major adverse cardiovascular and cerebrovascular events occurred. Nineteen (95%) patients had new ischemic defects at post-procedural DW-MRI. The median number of new lesions per patient was 10.00 (interquartile range [IQR]: 4.75 to 15.25). The total new lesion volume was 199.9 mm3 (IQR: 83.9 to 447.5 mm3) and the mean lesion volume per lesion was 42.5 mm3 (IQR: 21.5 to 75.6 mm3). Histopathologic analysis showed evidence of significant debris in 18 (90%) filters.
Conclusions:
The Emblok embolic protection system appears to be feasible and safe during TAVR. The device was successfully placed and retrieved in all cases and no neurological events were observed. Cerebral total new lesion volume was similar to other trials on cerebral protection during TAVR, thus warranting a larger study. (European Study Evaluating the Emblok Embolic Protection System During TAVR; NCT03130491).
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