Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery
Michael J Reardon, David H Adams, Joseph S Coselli, G Michael Deeb, Neal S Kleiman, Stan Chetcuti, Steven J Yakubov, David Heimansohn, James Hermiller Jr, G Chad Hughes, J Kevin Harrison, Kamal Khabbaz, Peter Tadros, George L Zorn 3rd, 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, CoreValve US Clinical Investigators, Jeffrey Popma, Thomas Armitage, David Adams, John Byrne, Joseph Coselli, Tom Gleason, G Michael Deeb, Michael Reardon, William Anderson, James Hermiller, Steven Yakubov, Maurice Buchbinder, Patrick Serruys, Blasé Carabello, David H Adams, John Byrne, Thomas G Gleason, G Michael Deeb, Michael Reardon, John Conte, Steven Yakubov, Jeffrey J Popma, David Faxon, William Holman, John Orav, Scott E Kasner, John J Lopex, Tom Vassiliades Jr, Ed Gravereaux, Roberto Rodriguez, Sanjay Samy, Cliff Berger, Donald Cutlip, Carey Kimmelstiel, Sergio Waxman, John Dashe, David Thaler, David DeNofrio, Jae K Oh, Peter Zimetbaum, David Cohen, Matthew Reynolds, Raoul Bonan, Stephen Brecker, Haim Danenberg, Eberhard Grube, Anders Jonsson, Iassen Michev, Jean-Claude Laborde, Michael J Reardon, David H Adams, Joseph S Coselli, G Michael Deeb, Neal S Kleiman, Stan Chetcuti, Steven J Yakubov, David Heimansohn, James Hermiller Jr, G Chad Hughes, J Kevin Harrison, Kamal Khabbaz, Peter Tadros, George L Zorn 3rd, 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, CoreValve US Clinical Investigators, Jeffrey Popma, Thomas Armitage, David Adams, John Byrne, Joseph Coselli, Tom Gleason, G Michael Deeb, Michael Reardon, William Anderson, James Hermiller, Steven Yakubov, Maurice Buchbinder, Patrick Serruys, Blasé Carabello, David H Adams, John Byrne, Thomas G Gleason, G Michael Deeb, Michael Reardon, John Conte, Steven Yakubov, Jeffrey J Popma, David Faxon, William Holman, John Orav, Scott E Kasner, John J Lopex, Tom Vassiliades Jr, Ed Gravereaux, Roberto Rodriguez, Sanjay Samy, Cliff Berger, Donald Cutlip, Carey Kimmelstiel, Sergio Waxman, John Dashe, David Thaler, David DeNofrio, Jae K Oh, Peter Zimetbaum, David Cohen, Matthew Reynolds, Raoul Bonan, Stephen Brecker, Haim Danenberg, Eberhard Grube, Anders Jonsson, Iassen Michev, Jean-Claude Laborde
Abstract
Objectives: The 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.
Methods: The 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.
Results: The 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.
Conclusions: These 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.
Trial registration: ClinicalTrials.gov NCT01240902.
Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Source: PubMed