• Michael J Reardon, David H Adams, Joseph S Coselli, G Michael Deeb, Neal S Kleiman, Stan Chetcuti, Steven J Yakubov, David Heimansohn, James Hermiller, G Chad Hughes, J Kevin Harrison, Kamal Khabbaz, Peter Tadros, George L Zorn, William Merhi, John Heiser, George Petrossian, Newell Robinson, Brijeshwar Maini, Mubashir Mumtaz, Joon Sup Lee, Thomas G Gleason, Jon Resar, John Conte, Daniel Watson, Sharla Chenoweth, Jeffrey J Popma, and CoreValve US Clinical Investigators.
• Houston-Methodist-Debakey Heart and Vascular Center, Houston, Tex. Electronic address: mreardon@houstonmethodist.org.
• J. Thorac. Cardiovasc. Surg.. 2014 Dec 1;148(6):2869-76.e1-7.

ObjectivesThe CoreValve Extreme Risk US Pivotal Trial enrolled patients with symptomatic severe aortic stenosis deemed unsuitable for surgical aortic valve replacement. Implants were attempted using transfemoral access (n = 489) or an alternative access (n = 150). In present analysis, we sought to examine the safety and efficacy of CoreValve transcatheter aortic valve replacement using alternative access.MethodsThe present study included 150 patients with prohibitive iliofemoral anatomy who were treated with the CoreValve transcatheter heart valve delivered by way of the subclavian artery (n = 70) or a direct aortic approach (n = 80). The echocardiograms were read by an independent core laboratory. The primary endpoint was all-cause mortality or major stroke at 12 months.ResultsThe preoperative aortic valve area was 0.72 ± 0.27 cm(2) and mean aortic valve gradient was 49.5 ± 17.0 mm Hg. After the transcatheter aortic valve replacement, the effective aortic valve area was 1.82 ± 0.64 cm(2) at 1 month and 1.85 ± 0.51 cm(2) at 12 months. The mean aortic valve gradient was 9.7 ± 5.8 mm Hg at 30 days and 9.5 ± 5.7 mm Hg at 12 months. The death or major stroke rate was 15.3% at 30 days and 39.4% at 12 months. The individual rate of all-cause mortality and major stroke was 11.3% and 7.5% at 30 days and 36.0% and 9.1% at 12 months.ConclusionsThese data demonstrate that the CoreValve transcatheter heart valve delivered by an alternative access provides a suitable alternative for treatment of extreme risk patients with symptomatic severe aortic stenosis, who have prohibitive iliofemoral anatomy and no surgical options.Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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