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, G. Chad Hughes, J. Kevin Harrison, Kamal Khabbaz, Peter Tadros, George L. Zorn, William Merhi, John Heiser, George Petrossian, Newell Robinson, Brijeshwar Maini, Mubashir MumtazJoon Sup Lee, Thomas G. Gleason, Jon Resar, John Conte, Daniel Watson, Sharla Chenoweth, Jeffrey J. Popma

Research output: Contribution to journalArticle

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.

Results The preoperative aortic valve area was 0.72 ± 0.27 cm2 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 cm2 at 1 month and 1.85 ± 0.51 cm2 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.

Original languageEnglish (US)
Pages (from-to)2869-2876.e7
JournalJournal of Thoracic and Cardiovascular Surgery
Volume148
Issue number6
DOIs
StatePublished - Dec 1 2014

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ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Reardon, M. J., Adams, D. H., Coselli, J. S., Deeb, G. M., Kleiman, N. S., Chetcuti, S., Yakubov, S. J., Heimansohn, D., Hermiller, J., Hughes, G. C., Harrison, J. K., Khabbaz, K., Tadros, P., Zorn, G. L., Merhi, W., Heiser, J., Petrossian, G., Robinson, N., Maini, B., ... Popma, J. J. (2014). Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery. Journal of Thoracic and Cardiovascular Surgery, 148(6), 2869-2876.e7. https://doi.org/10.1016/j.jtcvs.2014.07.020