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Cited by 1,040Cardiac Valve Diseases and TreatmentsAortic Disease and Treatment ApproachesInfective Endocarditis Diagnosis and Management

Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery

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Popma, Jeffrey J., Adams, David H., Reardon, Michael J., Yakubov, Steven J., Kleiman, Neal S., Heimansohn, David, Hermiller, James, Hughes, G. Chad +13 more·2014·Journal of the American College of Cardiology
DOI 10.1016/j.jacc.2014.02.556
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Abstract

Objectives This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery.Background Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy.Methods We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG).Results A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis).Conclusions TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

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Crossref · 10.1016/j.jacc.2014.02.556

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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 [224]

    The Study device and Study design sections identify CoreValve as a self-expanding valve evaluated in a multicenter trial. The Discussion also compares its results with studies of SAPIEN. The paper does not establish that CoreValve and SAPIEN were the most rigorously studied transcatheter valves; pages are not specified in our copy. (LLM, conf=0.82)

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  • 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 [224]

    The Abstract says that some patients are not candidates for surgical valve replacement and reports that TAVR reduced 12-month mortality versus medical therapy in patients unsuitable for surgery. The Discussion reports favorable outcomes for this study’s extreme-risk patients. The paper does not establish the life-saving claim for the broader group of high-risk patients included in the citing sentence. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • 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 [224]

    Table 1 reports a mean age of 83.2 years, and the Patient enrollment results say 91.3% of these extreme-risk TAVR patients were in NYHA class III or IV at baseline, supporting poor baseline symptom status. The paper does not report disease-specific and generic health-status measures, so it does not establish that both were extremely poor; its cohort also does not establish the claim for high-risk patients generally. (LLM, conf=0.82)

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Research works printed but not linked: 1

  1. [21]21. Roques F, Michel P, Goldstone AR, Nashef SA. The logistic Euro- SCORE. Eur Heart J 2003;24:881-2.

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Authors
Popma, J. J., Adams, D. H., Reardon, M. J., Yakubov, S. J., Kleiman, N. S., Heimansohn, D., Hermiller, J., Hughes, G. C., Harrison, J. K., Coselli, J., Diez, J., Kafi, A., Schreiber, T., Gleason, T. G., Conte, J., Buchbinder, M., Deeb, G. M., Carabello, B., Serruys, P. W., Chenoweth, S., & Oh, J. K.
Affiliations
  • Beth Israel Deaconess Medical Center (US)
  • Icahn School of Medicine at Mount Sinai (US)
  • Houston Methodist (US)
  • Riverside Methodist Hospital (US)
  • St Vincent Hospital (US)
  • Duke University (US)
  • Baylor St. Luke's Medical Center (US)
  • Detroit Medical Center (US)
  • University of Pittsburgh (US)
  • Johns Hopkins University (US)
  • United States Department of Veterans Affairs (US)
  • University of Michigan (US)
  • Erasmus University Rotterdam (NL)
  • Medtronic (United States) (US)
  • Mayo Clinic (US)
Corresponding author
Popma, Jeffrey J.
ORCID
Venue
Journal of the American College of Cardiology
Publisher
Elsevier BV
Published
2014-05
Volume
63
Issue
19
Pages
1972-1981
ISSN
0735-1097 (ISSN-L)
DOI
10.1016/j.jacc.2014.02.556
OpenAlex
W2037507673
Cited by
1,040
References
43
Citations by year
2026: 34 · 2025: 28 · 2024: 57 · 2023: 59 · 2022: 52 · 2021: 76 · 2020: 85 · 2019: 125 · 2018: 108 · 2017: 130 · 2016: 128 · 2015: 113 · 2014: 39
FWCI
94.35
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of the American College of Cardiology (publishedVersion)
  • PubMed (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
Funders
  • Medtronic, Inc
  • Abbott Vascular
  • Abiomed
  • Boston Scientific
  • Cordis
  • Covidien
  • eV3
  • Medtronic
  • CoreValve
  • Edwards Lifesciences
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, self-expanding bioprosthesis, CoreValve, severe aortic stenosis, high-risk patients, all-cause mortality, major stroke, paravalvular aortic regurgitation, bleeding complications, permanent pacemaker
MeSH terms
Aged, Aged, 80 and over, Aortic Valve Stenosis, Bioprosthesis, Female, Follow-Up Studies, Cardiac Catheterization, Heart Valve Prosthesis, Humans, Male, Prospective Studies, Prosthesis Design, Risk Factors, Severity of Illness Index, Treatment Outcome, Heart Valve Prosthesis Implantation

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