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Wendt, Daniel, MD; Kleinbongard, Petra, PhD; Knipp, Stephan, MD; Al-Rashid, Fadi, MD; Gedik, Nilgün, PhD; El Chilali, Karim, MD; Schweter, Sebastian, MS; Schlamann, Marc, MD; Kahlert, Philipp, MD; Neuhäuser, Markus, PhD; Forsting, Michael, MD; Erbel, Raimund, MD; Heusch, Gerd, MD; Jakob, Heinz, MD; Thielmann, Matthias, MD
The Annals of thoracic surgery, 08/2015, Letnik: 100, Številka: 2Journal Article
Purpose Transcatheter aortic valve implantation (TAVI) results in the dislodgement of debris with risk of cerebral lesions or stroke. The EMBOL-X protection device (Edwards Lifesciences, Irvine, CA) is positioned within the ascending aorta to capture such debris. Description Between July 2012 and April 2014 we randomly assigned 30 high-risk patients to undergo transaortic TAVI with the SAPIEN XT prosthesis (Edwards Lifesciences) combined with either the EMBOL-X device (group-1, n = 14) or without (group-2, n = 16). Periprocedural cerebral lesions were assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and within 7 days post-procedurally. Evaluation New foci of restricted diffusion on cerebral DW-MRI were found in 69% in group-2 and 50% in group-1. Lesion size was smaller in patients treated with the EMBOL-X device than in those without (88 ± 60 vs 168 ± 217 mm3 , p = 0.27, t = 1.2, degrees of freedom = 10). Transaortic TAVI patients treated with the EMBOL-X device had significantly smaller lesion volumes in the supply region of the middle cerebral artery (33 ± 29 vs 76 ± 67 mm3 , p = 0.04). There were no neurologic events after transaortic TAVI. Conclusions The intraaortic protection device seems to reduce both the incidence and the volume of new cerebral lesions ( ClinicalTrials.gov number, NCT01735513 ).
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Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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