Objective We report our first-in-human clinical experience in the use of the new version of the EMBOL-X intra-aortic filter (Edwards Lifesciences Corporation, Irvine, Calif) to capture embolic material during transaortic transcatheter aortic valve implantation and cardiac surgery. Method Five patients were enrolled into the first-in-human clinical assessment of the new version of the EMBOL-X intra-aortic filter. Three patients underwent coronary artery bypass grafting, and 2 patients underwent transaortic transcatheter aortic valve implantation. During coronary artery bypass grafting, the filter was deployed before clamping of the aorta and removal of the aortic clamp. In contrast, the filter was deployed before aortic puncture for transaortic transcatheter aortic valve implantation and kept in the aorta throughout the entire procedure. Results The filter introducer sheath and filter were easily placed and removed without difficulty. There were no complications related to the use of the filter. Postoperative examination of the retrieved filters revealed the presence of multiple microemboli in the filters from all 5 cases. Histologic study revealed various kinds of tissue and thrombus. Conclusions This first-in-human clinical experience has demonstrated the safety and feasibility of using the new version of the EMBOL-X intra-aortic filter during either cardiac surgery or transaortic transcatheter aortic valve implantation. We believe that the combination of the transaortic approach without aortic arch manipulation and the use of the EMBOL-X filter with a high capture rate is a promising strategy to reduce the incidence of embolic complications during transcatheter aortic valve implantation.
Ye, J., & Webb, J. G. (2014). Embolic capture with updated intra-aortic filter during coronary artery bypass grafting and transaortic transcatheter aortic valve implantation: First-in-human experience. Journal of Thoracic and Cardiovascular Surgery, 148(6), 2905–2910. https://doi.org/10.1016/j.jtcvs.2013.12.050