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Ann Thorac Surg. 2015 Aug;100(2):686-91. doi: 10.1016/j.athoracsur.2015.03.119.

Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation.

Author information

1
Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany. Electronic address: daniel.wendt@uk-essen.de.
2
Institute for Pathophysiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
3
Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
4
Department of Cardiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
5
Institute of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany.
6
Department of Mathematics and Technology, Koblenz University of Applied Science, Remagen, Germany.

Abstract

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 mm(3), 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 mm(3), 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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