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Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery
Open accessAbstract
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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“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 [201]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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 [201]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Although, in general, TAVR is associated with a survival advantage compared to conservative (no AVR) management”
From Calcific aortic stenosis (2016) · cites this paper as [201]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“among inoperable patients treated with TAVR in the PARTNER I Cohort B trial (Table 4), at 1 year after the procedure approximately 31% were dead and 18 % had less than a moderate improvement in their quality of life or New York Heart Association functional class201;244”
From Calcific aortic stenosis (2016) · cites this paper as [201]
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In the citing paper
“there is a sizable sub-group that dies soon after TAVR or does not experience an improvement in quality of life, suggesting potential futility of TAVR in some patients201;202;220;244;245.”
From Calcific aortic stenosis (2016) · cites this paper as [201]
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“The prevalence of considerable coronary disease in the setting of severe AS increases with age and was as high as 75% in recent trials comprised mostly of very elderly patients201;220.”
From Calcific aortic stenosis (2016) · cites this paper as [201]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“For patients who are at high-risk for surgical interventions were previously not treated with AVR, TAVR has been a transformative innovation that has improved survival and quality of life200;201.”
From Calcific aortic stenosis (2016) · cites this paper as [201]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Compared with inoperable patients treated with conservative management, patients treated with TAVR had less severe heart failure symptoms and better disease-specific and generic health status over the year after randomization201;244.”
From Calcific aortic stenosis (2016) · cites this paper as [201]
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“In addition, older (> 80 years) and sicker patients who previously were not candidates for definitive therapy are being treated200;201.”
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“In the PARTNER Trial, there was a 20% absolute reduction in 1-year mortality (HR 0.55; 95% CI 0.40 to 0.74) with TAVR compared to standard therapy (30.7% versus 50.7%)201.”
From Calcific aortic stenosis (2016) · cites this paper as [201]
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“This survival benefit was accompanied by relief of symptoms and improvement in functional capacity in many patients201;225.”
From Calcific aortic stenosis (2016) · cites this paper as [201]
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Metadata
- Authors
- Leon, M. B., Smith, C. R., Mack, M., Miller, D. C., Moses, J. W., Svensson, L. G., Tuzcu, E. M., Webb, J. G., Fontana, G. P., Makkar, R. R., Brown, D. L., Block, P. C., Guyton, R. A., Pichard, A. D., Bavaria, J. E., Herrmann, H. C., Douglas, P. S., Petersen, J. L., Akin, J. J., Anderson, W. N., Wang, D., & Pocock, S.
- Affiliations
- NewYork–Presbyterian Hospital (US)
- Medical City Dallas Hospital (US)
- Stanford Medicine (US)
- Cleveland Clinic (US)
- University of British Columbia (CA)
- Cedars-Sinai Medical Center (US)
- Emory University (US)
- MedStar Washington Hospital Center (US)
- Hospital of the University of Pennsylvania (US)
- Duke Medical Center (US)
- Edwards Lifesciences (United States) (US)
- London School of Hygiene & Tropical Medicine (GB)
- ORCID
- Leon, Martin B.
- Smith, Craig R.
- Mack, Michael
- Miller, D. Craig
- Moses, Jeffrey W.
- Svensson, Lars G.
- Tuzcu, E. Murat
- Webb, John G.
- Fontana, Gregory P.
- Makkar, Raj R.
- Brown, David L.
- Block, Peter C.
- Guyton, Robert A.
- Bavaria, Joseph E.
- Herrmann, Howard C.
- Douglas, Pamela S.
- Anderson, William N.
- Wang, Duolao
- Pocock, Stuart
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-10-21
- Volume
- 363
- Issue
- 17
- Pages
- 1597-1607
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2149609916
- Cited by
- 7,205
- References
- 43
- Citations by year
- 2026: 226 · 2025: 309 · 2024: 312 · 2023: 349 · 2022: 374 · 2021: 410 · 2020: 462 · 2019: 521 · 2018: 503 · 2017: 565 · 2016: 555 · 2015: 570 · 2014: 511 · 2013: 580 · 2012: 569
- FWCI
- 335.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Aortic Disease and Treatment Approaches
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Infective Endocarditis Diagnosis and Management
- Keywords
- transcatheter aortic valve implantation, severe aortic stenosis, inoperable patients, bovine pericardial valve, transfemoral access, balloon aortic valvuloplasty, all-cause mortality, stroke, vascular complications, cardiac symptoms, high-risk surgical patients, bioprosthetic valve durability, recurrent hospitalization
- MeSH terms
- Aged, Aged, 80 and over, Aortic Valve Stenosis, Cardiovascular Diseases, Catheterization, Echocardiography, Female, Cardiac Catheterization, Hospitalization, Humans, Male, Prospective Studies, Treatment Outcome, Heart Valve Prosthesis Implantation, Kaplan-Meier Estimate
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