Feasibility and exploratory efficacy evaluation of the Embrella Embolic Deflector system for the prevention of cerebral emboli in patients undergoing transcatheter aortic valve replacement: the PROTAVI-C pilot study

JACC Cardiovasc Interv. 2014 Oct;7(10):1146-55. doi: 10.1016/j.jcin.2014.04.019.

Abstract

Objectives: This study sought to determine the feasibility, safety, and exploratory efficacy of the Embrella Embolic Deflector (EED) system (Edwards Lifesciences, Irvine, California) in patients undergoing transcatheter aortic valve replacement (TAVR).

Background: Few data exist on the value of using embolic protection devices during TAVR.

Methods: This pilot study included 52 patients who underwent transfemoral TAVR. The EED system was used in 41 patients, whereas 11 patients underwent TAVR without embolic protection (control group). Cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and within 7 days and 30 days after TAVR.

Results: The EED system was successfully deployed at the level of the aortic arch in all patients with no complications. The deployment of the EED system was associated with high-intensity transient signals (HITS) as evaluated by transcranial Doppler (median: 48 [interquartile range: 17 to 198] HITS), and a higher total number of HITS was observed in the EED group (p < 0.001 vs. control group). DW-MRI performed within 7 days after TAVR showed the presence of new ischemic lesions in all patients in both groups, with a median number of 7 (interquartile range: 3 to 13) lesions per patient. The use of the EED system was associated with a lower lesion volume compared with the control group (p = 0.003). All new cerebral lesions had disappeared on the DW-MRI performed at 30 days after TAVR. Two strokes unrelated to the EED system occurred 2 and 29 days after TAVR.

Conclusions: This study showed the feasibility and safety of using the EED system in TAVR procedures. The EED system did not prevent the occurrence of cerebral microemboli during TAVR or new transient ischemic lesions as evaluated by DW-MRI, but it was associated with a reduction in lesion volume. Further studies are warranted to determine the efficacy of using the EED system during TAVR procedures.

Keywords: Embrella Embolic Deflector; embolic protection; magnetic resonance imaging; transcatheter aortic valve implantation; transcranial Doppler.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis / complications
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / therapy*
  • Canada
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / methods
  • Diffusion Magnetic Resonance Imaging
  • Embolic Protection Devices*
  • Europe
  • Feasibility Studies
  • Female
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / methods
  • Humans
  • Intracranial Embolism / diagnosis
  • Intracranial Embolism / etiology
  • Intracranial Embolism / prevention & control*
  • Ischemic Attack, Transient / etiology
  • Ischemic Attack, Transient / prevention & control
  • Male
  • Pilot Projects
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Severity of Illness Index
  • Stroke / etiology
  • Stroke / prevention & control
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Transcranial