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 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 [201]
The Results (p. 1) show that TAVI reduced one-year mortality compared with standard therapy among patients who were not suitable candidates for surgery, supporting the life-saving characterization for that group. The Discussion (p. 10) explicitly says these results cannot be extrapolated to other patients and calls for trials in high-risk patients for whom surgery remains a viable option; this paper therefore does not establish the claim for that broader group. (LLM, conf=0.88)
Experimental — accuracy not yet measuredBalloon-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 [201]
The Study Device and Procedure section (p. 3) identifies SAPIEN as balloon-expandable, and the paper reports a randomized trial using it. The References (p. 11) identify CoreValve as self-expanding, but the paper does not establish that CoreValve and SAPIEN were the most rigorously studied valves. (LLM, conf=0.84)
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 [201]
The Rates of Death section (p. 6) reports lower one-year mortality with TAVI than with standard therapy in patients unsuitable for surgery (30.7% versus 50.7%). The Discussion (p. 10) explicitly says these results cannot be extrapolated to other patients with aortic stenosis, so the source does not support the claim's unqualified “in general” framing. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAmong inoperable patients treated with TAVR in PARTNER I Cohort B, at 1 year approximately 31% were dead and 18% had less than moderate improvement in quality of life or NYHA functional class.
“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]
The Results (p. 1) report 30.7% mortality at one year in the TAVI group, supporting the approximately 31% figure. Other Clinical Outcomes (p. 6) report that 74.8% of surviving TAVI patients were in NYHA class I or II, but do not report that 18% had less than moderate improvement in quality of life or NYHA class. (LLM, conf=0.89)
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 [201]
Procedural Outcomes (p. 4) reports that 11 of 173 patients who underwent TAVI (6.4%) died within 30 days; Results (p. 1) reports 30.7% mortality at one year. Other Clinical Outcomes (p. 6) reports improved symptoms overall, but does not establish a subgroup whose quality of life failed to improve. The paper does not assess futility in such a subgroup. (LLM, conf=0.84)
Experimental — accuracy not yet measured
The 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 [201]
The baseline-characteristics table (p. 5) reports coronary artery disease in 74.3% of standard-therapy patients, whose mean age was 83.2 years, supporting the approximately 75% figure in a very elderly trial group. It does not show that coronary disease prevalence increases with age, and it does not define the reported disease as “considerable.” (LLM, conf=0.88)
Experimental — accuracy not yet measuredFor high-risk patients who were previously not treated with aortic valve replacement, TAVR has improved survival and quality of life.
“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]
The Results (p. 1) show better one-year survival with TAVI than with standard therapy in patients unsuitable for surgery. Other Clinical Outcomes (p. 6) report fewer symptoms and improved six-minute walk performance, but the paper does not directly report a quality-of-life measure; that part of the claim goes beyond its findings. (LLM, conf=0.84)
Experimental — accuracy not yet measuredCompared with inoperable patients treated conservatively, patients treated with TAVR had less severe heart failure symptoms and better disease-specific and generic health status over the year after randomization.
“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]
Other Clinical Outcomes (p. 6) reports significantly less severe NYHA symptoms with TAVI than with standard therapy at 30 days, 6 months, and 1 year. The paper does not report the claimed improvements in disease-specific or generic health status; Study End Points (p. 3) lists NYHA class and the 6-minute walk test, but not those health-status measures. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOlder patients over 80 years and sicker patients who were previously not candidates for definitive therapy are now being treated.
“In addition, older (> 80 years) and sicker patients who previously were not candidates for definitive therapy are being treated200;201.”
From Calcific aortic stenosis (2016) · cites this paper as [201]
In the PARTNER Trial, TAVR compared with standard therapy produced a 20% absolute reduction in 1-year mortality, with an HR of 0.55 and 95% CI 0.40-0.74, and mortality rates of 30.7% versus 50.7%.
“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]
The survival benefit of TAVR was accompanied by symptom relief and improved functional capacity in many patients.
“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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Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients
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Self-citationTranscatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis
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The Role of Stress Echocardiography in Valvular Heart Disease: A Current Appraisal
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Self-citation2020 ESC Guidelines for the management of adult congenital heart disease
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Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement
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Self-citation2021 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure
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Guidelines on the management of valvular heart disease (version 2012)
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Self-citationAortic Stenosis in the Elderly
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Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis
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Transcatheter Aortic Valve Implantation in Failed Bioprosthetic Surgical Valves
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Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement
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Self-citation
- 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 › Pulmonary and Respiratory Medicine › Aortic Disease and Treatment Approaches
- Health Sciences › Medicine › Epidemiology › 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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