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Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.

Publication ,  Journal Article
Leon, MB; Smith, CR; Mack, M; Miller, DC; Moses, JW; Svensson, LG; Tuzcu, EM; Webb, JG; Fontana, GP; Makkar, RR; Brown, DL; Block, PC ...
Published in: N Engl J Med
October 21, 2010

BACKGROUND: Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. METHODS: We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. RESULTS: A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. CONCLUSIONS: In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

October 21, 2010

Volume

363

Issue

17

Start / End Page

1597 / 1607

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prospective Studies
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • Hospitalization
  • Heart Valve Prosthesis Implantation
  • General & Internal Medicine
  • Female
  • Echocardiography
 

Citation

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Leon, M. B., Smith, C. R., Mack, M., Miller, D. C., Moses, J. W., Svensson, L. G., … PARTNER Trial Investigators, . (2010). Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med, 363(17), 1597–1607. https://doi.org/10.1056/NEJMoa1008232
Leon, Martin B., Craig R. Smith, Michael Mack, D Craig Miller, Jeffrey W. Moses, Lars G. Svensson, E Murat Tuzcu, et al. “Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med 363, no. 17 (October 21, 2010): 1597–1607. https://doi.org/10.1056/NEJMoa1008232.
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597–607.
Leon, Martin B., et al. “Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med, vol. 363, no. 17, Oct. 2010, pp. 1597–607. Pubmed, doi:10.1056/NEJMoa1008232.
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S, PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597–1607.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

October 21, 2010

Volume

363

Issue

17

Start / End Page

1597 / 1607

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prospective Studies
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • Hospitalization
  • Heart Valve Prosthesis Implantation
  • General & Internal Medicine
  • Female
  • Echocardiography