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

JACC Cardiovasc Interv. 2020 Apr 13;13(7):860-868. doi: 10.1016/j.jcin.2019.11.017.

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).

Keywords: embolic protection device; neuroprotection; stroke; transcatheter aortic valve replacement.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / surgery*
  • Diffusion Magnetic Resonance Imaging
  • Embolic Protection Devices*
  • Feasibility Studies
  • Female
  • Heart Valve Prosthesis*
  • Humans
  • Intracranial Embolism / diagnostic imaging
  • Intracranial Embolism / etiology
  • Intracranial Embolism / prevention & control*
  • Italy
  • Male
  • Non-Randomized Controlled Trials as Topic
  • Pilot Projects
  • Prospective Studies
  • Prosthesis Design
  • Severity of Illness Index
  • Time Factors
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / instrumentation*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT03130491