Cited by 2,902Cardiac Valve Diseases and TreatmentsAortic Disease and Treatment ApproachesInfective Endocarditis Diagnosis and Management

Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis

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Adams, David H., Popma, Jeffrey J., Reardon, Michael J., Yakubov, Steven J., Coselli, Joseph S., Deeb, G. Michael, Gleason, Thomas G., Buchbinder, Maurice +16 more·2014·New England Journal of Medicine

Abstract

BACKGROUND: We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS: We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS: A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. CONCLUSIONS: In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).

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Crossref · 10.1056/nejmoa1400590

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  • Balloon-expandable and self-expanding transcatheter valves, specifically CoreValve and SAPIEN, have been the most rigorously studied to date.

    “Balloon-expandable and self-expanding transcatheter valves have been the most rigorously studied to date, specifically the CoreValve (Medtronic, Dublin, Ireland) and SAPIEN (Edwards, Irvine CA, USA) valves”

    From Calcific aortic stenosis (2016) · cites this paper as [221]

    The Study Procedures section identifies CoreValve as the self-expanding prosthesis tested in this trial, and the Conclusions passage discusses prior studies of balloon-expandable valves. The copy does not name SAPIEN or say that CoreValve and SAPIEN were the most rigorously studied valves. Page numbers are not provided in the indexed passages. (LLM, conf=0.85)

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  • In older patients at high or extreme surgical risk undergoing TAVR, disease-specific and generic health status are often extremely poor.

    “In older patients at high or extreme surgical risk undergoing TAVR, disease-specific and generic health status are often extremely poor221;224;244;245.”

    From Calcific aortic stenosis (2016) · cites this paper as [221]

    Table 1 shows that the TAVR patients were older and that most had NYHA class III or IV symptoms; Study End Points says the paper assessed disease-specific and generic quality of life. But the passages do not establish that both health-status measures were often extremely poor, and Patient Selection describes increased surgical risk rather than an extreme-risk group. (LLM, conf=0.84)

    Experimental — accuracy not yet measured
  • For patients at high or prohibitive risk of operative mortality with surgical aortic valve replacement, TAVR has been a transformative and life-saving treatment for those previously not candidates.

    “For patients at high or prohibitive risk of operative mortality, with surgical AVR, TAVR has been a transformative innovation, providing a life-saving treatment for patients who were previously not candidates for AVR”

    From Calcific aortic stenosis (2016) · cites this paper as [221]

  • Randomized trials of balloon-expandable and self-expanding valves have shown that TAVR is a viable alternative to surgery in patients at high risk for aortic valve replacement.

    “Randomized trials of balloon-expandable and self-expanding valves have also demonstrated that TAVR is a viable alternative to surgery in patients at high risk for AVR (Table 4)220;221.”

    From Calcific aortic stenosis (2016) · cites this paper as [221]

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Cites

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Research works printed but not linked: 2

  1. [1]1. Carabello BA, Paulus WJ. Aortic ste- nosis. Lancet 2009;373:956-66.
  2. [11]11. Holmes DR Jr, Mack MJ. Transcathe- ter valve therapy: a professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. J Am Coll Cardiol 2011;58:445-55.

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Authors
Adams, D. H., Popma, J. J., Reardon, M. J., Yakubov, S. J., Coselli, J. S., Deeb, G. M., Gleason, T. G., Buchbinder, M., Hermiller, J., Kleiman, N. S., Chetcuti, S., Heiser, J., Merhi, W., Zorn, G., Tadros, P., Robinson, N., Petrossian, G., Hughes, G. C., Harrison, J. K., Conte, J., Maini, B., Mumtaz, M., Chenoweth, S., & Oh, J. K.
Affiliations
  • Houston Methodist (US)
  • Beth Israel Deaconess Medical Center (US)
  • Riverside Methodist Hospital (US)
  • University of Michigan (US)
  • University of Pittsburgh Medical Center (US)
  • VA Palo Alto Health Care System (US)
  • St. Francis Hospital (US)
  • Spectrum Health (US)
  • The University of Kansas Health System (US)
  • Duke Medical Center (US)
  • Johns Hopkins Hospital (US)
  • Harrisburg Hospital (US)
  • Medtronic (United States) (US)
  • Mayo Clinic (US)
Venue
New England Journal of Medicine
Published
2014-05-08
Volume
370
Issue
19
Pages
1790-1798
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2132585880
Cited by
2,902
References
43
Citations by year
2026: 83 · 2025: 125 · 2024: 140 · 2023: 176 · 2022: 174 · 2021: 226 · 2020: 264 · 2019: 303 · 2018: 289 · 2017: 346 · 2016: 348 · 2015: 309 · 2014: 104 · 2013: 5 · 2012: 1
FWCI
251.17
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Aortic Disease and Treatment Approaches
  • Health Sciences › Medicine › Epidemiology › Infective Endocarditis Diagnosis and Management
Keywords
transcatheter aortic valve implantation, surgical aortic valve replacement, severe aortic stenosis, high surgical risk, mortality, non-inferiority, major adverse cardiovascular events, stroke, quality of life, heart team
MeSH terms
Aged, Aged, 80 and over, Aortic Valve, Aortic Valve Stenosis, Bioprosthesis, Female, Cardiac Catheterization, Heart Valve Prosthesis, Humans, Male, Postoperative Complications, Prosthesis Design, Risk Factors, Survival Rate, Kaplan-Meier Estimate

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