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

Josep Rodés-Cabau, Philip Kahlert, Franz Josef Neumann, Gerhard Schymik, John G. Webb, Pierre Amarenco, Thomas Brott, Zsolt Garami, Gino Gerosa, Thierry Lefèvre, Bjoern Plicht, Stuart J. Pocock, Marc Schlamann, Martyn Thomas, Beverly Diamond, Ihsen Merioua, Friedhelm Beyersdorf, Alec Vahanian

Research output: Contribution to journalArticle

93 Scopus citations

Abstract

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.

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.

Original languageEnglish (US)
Pages (from-to)1146-1155
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume7
Issue number10
DOIs
StatePublished - Oct 1 2014

Keywords

  • Embrella Embolic Deflector
  • embolic protection
  • magnetic resonance imaging
  • transcatheter aortic valve implantation
  • transcranial Doppler

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Rodés-Cabau, J., Kahlert, P., Neumann, F. J., Schymik, G., Webb, J. G., Amarenco, P., Brott, T., Garami, Z., Gerosa, G., Lefèvre, T., Plicht, B., Pocock, S. J., Schlamann, M., Thomas, M., Diamond, B., Merioua, I., Beyersdorf, F., & Vahanian, A. (2014). 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: Cardiovascular Interventions, 7(10), 1146-1155. https://doi.org/10.1016/j.jcin.2014.04.019