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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 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]
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“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.”
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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.”
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“Although, in general, TAVR is associated with a survival advantage compared to conservative (no AVR) management”
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“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]
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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 [220]
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McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O. D., et al. (2021) · PubMed · doi:10.1093/eurheartj/ehab670 · Cited by 19,890
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Metadata
- 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 › 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, 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
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