Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients
Open accessAbstract
BACKGROUND: The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. RESULTS: The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. CONCLUSIONS: In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).
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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 [220]
The Methods and Study Device and Procedure sections describe a randomized trial of the balloon-expandable Edwards SAPIEN valve. The References list studies of the self-expanding CoreValve, but this paper neither studies CoreValve nor says that CoreValve and SAPIEN were the most rigorously studied valves. The comparative claim is therefore unsupported by this source. (LLM, conf=0.84)
Experimental — accuracy not yet measuredA sizable subgroup dies soon after TAVR or does not experience improved quality of life, suggesting potential futility of TAVR in some patients.
“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 [220]
The Mortality and Stroke section reports deaths after TAVR: 3.4% by 30 days and 24.2% by one year in the intention-to-treat group. The Other Clinical Outcomes section reports overall improvement in symptoms and walking distance, but does not identify a sizable subgroup without quality-of-life improvement or assess whether TAVR was futile for them. Page numbers are not available in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe prevalence of considerable coronary disease in severe aortic stenosis increases with age and was as high as 75% in recent trials composed mostly of very elderly patients.
“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 [220]
Table 1 (labeled Discussion in our copy; page not supplied) reports coronary artery disease in 74.9% and 76.9% of the two groups, whose mean ages were 83.6 and 84.5 years. It does not show that prevalence increases with age or specify that the recorded coronary disease was “considerable.” (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn general, TAVR is associated with a survival advantage compared with conservative management without aortic valve replacement.
“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 [220]
The Results introduction (page unavailable) reports a 20% improvement in 1-year survival with transfemoral TAVR in a PARTNER subgroup who were not candidates for surgery. That supports a survival advantage in that specific group, but not the claim’s unqualified “in general” comparison with conservative management. This paper’s own trial compared TAVR with surgical replacement, not no replacement. (LLM, conf=0.83)
Experimental — accuracy not yet measuredRandomized 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 [220]
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 [220]
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Self-citationTranscatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis
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Challenges in Infective Endocarditis
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Self-citationEarly Surgery or Conservative Care for Asymptomatic Aortic Stenosis
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Self-citationProtection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement
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Self-citationClinical Outcomes at 1 Year Following Transcatheter Aortic Valve Replacement
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- Authors
- Smith, C. R., Leon, M. B., Mack, M. J., Miller, D. C., Moses, J. W., Svensson, L. G., Tuzcu, E. M., Webb, J. G., Fontana, G. P., Makkar, R. R., Williams, M., Dewey, T., Kapadia, S., Babaliaros, V., Thourani, V. H., Corso, P., Pichard, A. D., Bavaria, J. E., Herrmann, H. C., Akin, J. J., Anderson, W. N., Wang, D., & Pocock, S. J.
- Affiliations
- NewYork–Presbyterian Hospital (US)
- Baylor Scott & White Health (US)
- Stanford Medicine (US)
- Cleveland Clinic (US)
- University of British Columbia (CA)
- Cedars-Sinai Medical Center (US)
- Medical City Dallas Hospital (US)
- Emory University (US)
- MedStar Washington Hospital Center (US)
- Hospital of the University of Pennsylvania (US)
- Edwards Lifesciences (United States) (US)
- London School of Hygiene & Tropical Medicine (GB)
- ORCID
- Smith, Craig R.
- Leon, Martin B.
- Mack, Michael J.
- Miller, D. Craig
- Moses, Jeffrey W.
- Svensson, Lars G.
- Tuzcu, E. Murat
- Webb, John G.
- Fontana, Gregory P.
- Makkar, Raj R.
- Williams, Mathew
- Kapadia, Samir
- Babaliaros, Vasilis
- Thourani, Vinod H.
- Bavaria, Joseph E.
- Herrmann, Howard C.
- Anderson, William N.
- Wang, Duolao
- Pocock, Stuart J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-06-09
- Volume
- 364
- Issue
- 23
- Pages
- 2187-2198
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2165258820
- Cited by
- 6,345
- References
- 44
- Citations by year
- 2026: 194 · 2025: 239 · 2024: 315 · 2023: 331 · 2022: 340 · 2021: 396 · 2020: 457 · 2019: 507 · 2018: 503 · 2017: 545 · 2016: 533 · 2015: 502 · 2014: 455 · 2013: 484 · 2012: 449
- FWCI
- 322.18
- 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 › 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-risk patients, transapical approach, transfemoral access, non-inferiority, mortality, stroke, vascular complications, hemorrhage, atrial fibrillation, periprocedural risk, symptom improvement, randomized trial comparison
- MeSH terms
- Aged, Aged, 80 and over, Aortic Valve, Aortic Valve Stenosis, Cardiovascular Diseases, Catheterization, Female, Cardiac Catheterization, Humans, Male, Postoperative Complications, Risk Factors, Heart Valve Prosthesis Implantation, Stroke, Intention to Treat Analysis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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