Josep Rodés-Cabau1, Philip Kahlert2, Franz-Josef Neumann3, Gerhard Schymik4, John G Webb5, Pierre Amarenco6, Thomas Brott7, Zsolt Garami8, Gino Gerosa9, Thierry Lefèvre10, Bjoern Plicht2, Stuart J Pocock11, Marc Schlamann2, Martyn Thomas12, Beverly Diamond13, Ihsen Merioua13, Friedhelm Beyersdorf14, Alec Vahanian6. 1. Quebec Heart and Lung Institute, Quebec City, Quebec, Canada. Electronic address: josep.rodes@criucpq.ulaval.ca. 2. University Hospital of Essen, Essen, Germany. 3. Universtäts Herzzentrum Bad Krozingen, Krozingen, Germany. 4. Universtäts Klinikum Karslruhe, Karslruhe, Germany. 5. St. Paul's Hospital, Vancouver, British Columbia, Canada. 6. Hôpital Bichat, Paris, France. 7. Mayo Clinic, Rochester, Minnesota. 8. Methodist DeBakey Heart and Vascular Center, Houston, Texas. 9. Division of Cardiac Surgery, University of Padova, Padova, Italy. 10. Hôpital Privé Jacques Cartier, Massy, France. 11. London School of Hygiene and Tropical Medicine, London, United Kingdom. 12. St. Thomas Hospital, London, United Kingdom. 13. Edwards Lifesciences, Irvine, California. 14. Freiburg Universitats Bad Krozingen, Krozingen, Germany.
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.
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.
Authors: Matteo Pagnesi; Luca Baldetti; Paolo Del Sole; Antonio Mangieri; Marco B Ancona; Damiano Regazzoli; Nicola Buzzatti; Francesco Giannini; Antonio Colombo; Azeem Latib Journal: Interv Cardiol Date: 2017-09
Authors: Hector Cubero-Gallego; Isaac Pascual; José Rozado; Ana Ayesta; Daniel Hernandez-Vaquero; Rocio Diaz; Alberto Alperi; Pablo Avanzas; Cesar Moris Journal: Ann Transl Med Date: 2019-10