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

Azeem Latib, Antonio Mangieri, Paolo Vezzulli, Pietro Spagnolo, Francesco Sardanelli, Giovanni Fellegara, Matteo Pagnesi, Francesco Giannini, Andrea Falini, Riccardo Gorla, Matteo Montorfano, Francesco Bedogni, Antonio Colombo, Jeffrey Popma, William M. Merhi, Federico De Marco

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

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)

Original languageEnglish (US)
Pages (from-to)860-868
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume13
Issue number7
DOIs
StatePublished - Apr 13 2020

Keywords

  • embolic protection device
  • neuroprotection
  • stroke
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint

Dive into the research topics of 'First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement'. Together they form a unique fingerprint.

Cite this