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Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients
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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.”
From Calcific aortic stenosis (2016) · cites this paper as [220]
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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.”
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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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Self-citationTranscatheter Aortic Heart Valves
Sellers, S., Turner, C. T., Sathananthan, J., Cartlidge, T. R. G., Sin, F., Bouchareb, R., Mooney, J. F., Nørgaard, B. L., Bax, J. J., Bernatchez, P. N., et al. (2018) · JACC. Cardiovascular imaging · doi:10.1016/j.jcmg.2018.06.028 · Cited by 167
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General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation
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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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