Background: Particulate emboli are thought to play a significant role in the development of cardiac surgical complications. Intraaortic filtration of particulate emboli may reduce the burden of this morbidity in cardiac patients.
Methods: A multiinstitutional randomized trial was designed and enrolled 1,289 patients at 22 centers. Six hundred forty-five patients were assigned to the treatment arm and received the Embol-X intraaortic filter, whereas 644 patients were assigned to the control arm. The endpoints examined were mortality, stroke, transient ischemic attack, renal insufficiency/failure, myocardial infarction, gastrointestinal complications, and limb-threatening ischemia. All filters were examined for histologic evidence of particulate emboli.
Results: Particulate emboli were identified in 598 (96.8%) of 618 filters successfully deployed. Composite event rates for the clinical endpoints were similar in both the filtered and nonfiltered arm (110/645 = 17% vs 122/644 = 19%, respectively). Individual event rates were also similar in both arms. A post hoc comparison of patients with moderate or greater preoperative risk scores demonstrated event reduction favoring the filtered group for renal complications (17/124 = 14% vs 28/117 = 24%, p = 0.04) and for the composite endpoint (30/124 = 24% vs 42/117 = 36%, p = 0.047). No clinically evident complications attributed to the use of the filter were identified.
Conclusions: The use of the Embol-X intraaortic filter is both safe and effective, as demonstrated by the emboli capture rate of 97%. In addition, post hoc analysis indicates a reduction in postoperative renal complications for patients with moderate or greater preoperative risk. Further study of high-risk patients is warranted.
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http://dx.doi.org/10.1016/s0003-4975(03)00530-7 | DOI Listing |
Ann Thorac Surg
August 2015
Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
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).
J Thorac Cardiovasc Surg
June 2015
St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
J Thorac Cardiovasc Surg
December 2014
Division of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
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.
Ann Thorac Surg
November 2011
Department of Cardiac Surgery, Clinique St. Luc, Bouge, Belgium.
Techniques for transcatheter aortic valve implantation involve manipulation of the native aortic valve and the aortic arch. As a result, excellent technical outcomes of this technique remain counterbalanced by a level of neurologic complications that remain unacceptably high. We present here a report of a new potential combined approach to reduce periprocedural neurologic events.
View Article and Find Full Text PDFEur Heart J
February 2010
Department of Neurology, Justus-Liebig University Giessen, Giessen, Germany.
Aims: The purpose of the study was to investigate whether intra-operative filter devices protect the brain during coronary artery bypass grafting (CABG) and to determine the impact of solid and gaseous micro-emboli on neuropsychological functioning.
Methods And Results: Patients undergoing CABG received either an intra-aortic filter (Embol-X) (n = 43), designed to reduce solid micro-emboli, a dynamic bubble trap (DBT) (n = 50), designed to reduce gaseous micro-emboli, or no additional device (control group) (n = 50). Cognitive functioning was assessed before and 3 months after CABG.
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