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Transcatheter aortic valve replacement (TAVR)

TAVR replaces a narrowed aortic valve with a minimally invasive procedure. A doctor threads a thin tube (a catheter) through a blood vessel to the heart and places a new valve. The other main way is open-heart surgery. Trials have tested TAVR in people who could not have surgery, in people at low surgical risk and in people with a severely narrowed valve but no symptoms. The results differ by group. In a 2010 trial of people judged unsuitable for surgery, TAVR cut deaths over one year compared with standard care, but major strokes and major vascular complications were more frequent.

Also called TAVR · TAVI · Transcatheter aortic valve implantation

  • Intervention
  • In this atlas

Overview

Technical summary

Also called transcatheter aortic valve implantation (TAVI); MeSH D065467. Evidence in this atlas: a 2010 randomized trial of people unsuitable for surgery (PMID 20961243; its abstract prints NCT00530894; no study record for it), PARTNER 3 (balloon-expandable valve, low risk), the Evolut Low Risk trial (self-expanding valve, low risk; filed on the CoreValve and Evolut product record) and EARLY TAVR (no symptoms). Devices: SAPIEN 3 and the CoreValve and Evolut family. PARTNER 3, Evolut Low Risk and EARLY TAVR were each funded by the company that is the FDA applicant for the valve it tested; the 2010 trial was funded by Edwards Lifesciences (its abstract). Recommendations for who should have TAVR are guideline matters that this record does not state.

About this intervention

Type
Procedure
Mechanism
A replacement valve is carried to the heart on a catheter, a thin tube passed through a blood vessel (NHLBI).

Claims and evidence

Context Adults 65 or older with severe aortic stenosis and no symptoms, randomized in EARLY TAVR

Recipient
Adult
Population
Patients 65 years or older (registry minimum age) with asymptomatic severe aortic stenosis, 901 of whom were randomized at 75 centers in the United States and Canada. The abstract gives a mean age of 75.8 years, a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 1.8% and 83.6% of patients at low surgical risk. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
Care setting
75 centers in the United States and Canada (abstract)
Geography
United States and Canada
Life stage
Registry minimum age 65 years; mean age 75.8 years (abstract)
Follow-up
Median follow-up 3.8 years (abstract). The registry gives the primary completion as 2024-03-31 and an estimated study completion of 2032-03.
Eligibility: 2 inclusion criteria; exclusion criteria not stated
Included
  • Asymptomatic severe aortic stenosis
  • Age 65 years or older (registry)
Excluded
None stated

  • Effect Interventional Certainty not assessed

    In EARLY TAVR, 901 patients with severe aortic stenosis and no symptoms were randomized to early TAVR with a balloon-expandable valve (455 patients) or to clinical surveillance (446 patients). A primary event (death, stroke or unplanned hospitalization for cardiovascular causes) occurred in 122 patients (26.8%) in the TAVR group and 202 (45.3%) in the surveillance group (hazard ratio 0.50, 95% confidence interval 0.40 to 0.63). Death occurred in 8.4% versus 9.2%. Strokes were 4.2% versus 6.7% and unplanned hospitalizations 20.9% versus 41.7%, in the TAVR and surveillance groups respectively. During a median follow-up of 3.8 years, 87.0% of the surveillance group had their aortic valve replaced.

    Applies to Adult
    • Patients 65 years or older (registry minimum age) with asymptomatic severe aortic stenosis, 901 of whom were randomized at 75 centers in the United States and Canada. The abstract gives a mean age of 75.8 years, a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 1.8% and 83.6% of patients at low surgical risk. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
    • 75 centers in the United States and Canada (abstract)
    • United States and Canada
    • Registry minimum age 65 years; mean age 75.8 years (abstract)
    Follow-up Median follow-up 3.8 years (abstract). The registry gives the primary completion as 2024-03-31 and an estimated study completion of 2032-03.
    Certainty method
    Not assessed
    Limitations
    Funded by Edwards Lifesciences, which the registry lists as lead sponsor. The registry lists no masking. Death occurred in 8.4% and 9.2% of the two groups, and the abstract gives no test for the individual components, so this record does not say whether the differences in death or stroke are meaningful. Most patients in the surveillance group (87.0%) later had their valve replaced, so the comparison is early replacement with a strategy after which most patients still had replacement. The percentages are not tied to a time point in the abstract. Only the abstract was read. The registry has no posted results yet.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (7)

    1. Supports Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

      Locator
      Abstract, RESULTS, sentence 3
      How it applies
      Primary event counts and rates, and the hazard ratio.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    2. Supports Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

      Locator
      Abstract, RESULTS, sentence 4
      How it applies
      Death, stroke and hospitalization percentages by group; the abstract gives no test.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    3. Supports Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

      Locator
      Abstract, RESULTS, sentence 5
      How it applies
      Share of the surveillance group who had valve replacement.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    4. Supports Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      The authors' conclusion for the same population.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    5. Background Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

      Locator
      Abstract, METHODS, sentences 1 to 3
      How it applies
      Design, centers and end point.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    6. Background Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

      Locator
      Abstract, RESULTS, sentences 1 and 2
      How it applies
      Number randomized, age and risk score.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    7. Background EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-05-13. · NCT: NCT03042104

      Locator
      protocolSection.designModule.designInfo.maskingInfo.masking
      How it applies
      The registry records no masking.
      Retrieved
      Source effective date
      2024-05-13
      Source state
      Current
      Snapshot hash
      c5b3fac506ff46da7da961337b6ae035819edd44091278e503e871285ae39d4f
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT03042104.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

Context Patients with severe aortic stenosis at low surgical risk, randomized in PARTNER 3

Recipient
Recipient not specified
Population
Patients with severe aortic stenosis and low surgical risk, 1000 of whom were randomized at 71 centers. The abstract gives a mean age of 73 years and a mean Society of Thoracic Surgeons risk score of 1.9%. The registry lists no minimum or maximum age. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
Care setting
71 centers (abstract). The registry lists sites in the United States, Australia, Canada, Japan and New Zealand.
Geography
United States, Australia, Canada, Japan and New Zealand (registry locations)
Life stage
Mean age 73 years (abstract); the registry lists no age limits
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
The primary end point was at 1 year; 30-day outcomes are also reported (abstract). The registry gives an estimated study completion of 2029-12.
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • Severe aortic stenosis
  • Low surgical risk
  • Randomized to TAVR by transfemoral placement of a balloon-expandable valve or to surgery (abstract methods)
Excluded
None stated

  • Effect Interventional Certainty not assessed

    In PARTNER 3, 1000 patients with severe aortic stenosis and low surgical risk were randomized at 71 centers to TAVR with a balloon-expandable valve placed through the femoral artery, or to surgery. At 1 year, 8.5% of the TAVR group and 15.1% of the surgery group had died, had a stroke or had been hospitalized again (an absolute difference of -6.6 percentage points, 95% confidence interval -10.8 to -2.5; hazard ratio 0.54, 95% confidence interval 0.37 to 0.79). The authors tested both whether TAVR was no worse than surgery (margin 6 percentage points) and whether it was better, and report P<0.001 for noninferiority and P = 0.001 for superiority in the as-treated population. At 30 days TAVR had lower rates of stroke, of death or stroke, and of new atrial fibrillation. The abstract also reports a shorter index hospitalization with TAVR, without tying it to a time point. It reports no significant differences in major vascular complications, new permanent pacemaker insertions or moderate or severe paravalvular regurgitation.

    Applies to Recipient not specified
    • Patients with severe aortic stenosis and low surgical risk, 1000 of whom were randomized at 71 centers. The abstract gives a mean age of 73 years and a mean Society of Thoracic Surgeons risk score of 1.9%. The registry lists no minimum or maximum age. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
    • 71 centers (abstract). The registry lists sites in the United States, Australia, Canada, Japan and New Zealand.
    • United States, Australia, Canada, Japan and New Zealand (registry locations)
    • Mean age 73 years (abstract); the registry lists no age limits
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up The primary end point was at 1 year; 30-day outcomes are also reported (abstract). The registry gives an estimated study completion of 2029-12.
    Certainty method
    Not assessed
    Limitations
    Funded by Edwards Lifesciences; the registry lists Edwards Lifesciences as lead sponsor and FDA lists Edwards Lifesciences, LLC as applicant for the valve. The registry lists no masking. The abstract gives the 1-year result of the composite only and no separate counts for death, stroke and rehospitalization, so this record cannot say which part drove the difference. Results are for one valve (SAPIEN 3) placed through the femoral artery in selected low-risk patients. They do not extend to patients at higher risk, to other valves or to other ways of placing the valve. Longer follow-up is not read here. Only the abstract was read: the NEJM page returned HTTP 403, and PubMed lists no open full text.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (6)

    1. Supports Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1814052 · PMID: 30883058

      Locator
      Abstract, RESULTS, sentence 3
      How it applies
      Kaplan-Meier rates of the primary composite at 1 year, the differences and the intervals.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    2. Supports Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1814052 · PMID: 30883058

      Locator
      Abstract, RESULTS, sentences 4 to 6
      How it applies
      30-day outcomes, including the outcomes with no significant difference.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    3. Supports Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1814052 · PMID: 30883058

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      The authors' conclusion for the same population.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    4. Background Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1814052 · PMID: 30883058

      Locator
      Abstract, METHODS, sentences 1 to 3
      How it applies
      Design, population, end point and the noninferiority margin.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    5. Background Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1814052 · PMID: 30883058

      Locator
      Abstract, RESULTS, sentences 1 and 2
      How it applies
      Number randomized, centers, age and risk score.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    6. Background PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2026-01-14. · NCT: NCT02675114

      Locator
      protocolSection.designModule.designInfo.maskingInfo.masking
      How it applies
      The registry records no masking.
      Retrieved
      Source effective date
      2026-01-14
      Source state
      Current
      Snapshot hash
      c5def3e9e65308c98af817a46ed7a5fb320115038c3897933d93a6fd02a4e606
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT02675114.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

Context Patients with severe aortic stenosis judged not suitable for surgery, randomized in a 2010 trial of TAVI

Recipient
Recipient not specified
Population
Patients with severe aortic stenosis whom surgeons considered not to be suitable candidates for surgery; 358 were randomized at 21 centers, 17 of them in the United States. The abstract gives no age range. No registry record was fetched for this trial (the abstract prints NCT00530894).
Care setting
21 centers, 17 of them in the United States (abstract)
Geography
United States and other countries (the abstract gives 17 of 21 centers in the United States)
Life stage
Not stated in the abstract
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Outcomes at 30 days and at 1 year (abstract).
Eligibility: 2 inclusion criteria; exclusion criteria not stated
Included
  • Severe aortic stenosis
  • Not considered by surgeons to be suitable candidates for surgery
Excluded
None stated

  • Effect Interventional Certainty not assessed

    In a 2010 trial, 358 patients with severe aortic stenosis whom surgeons considered not suitable for surgery were randomized at 21 centers to standard therapy (including balloon aortic valvuloplasty) or to transfemoral implantation of a balloon-expandable valve (TAVI). At 1 year the rate of death from any cause was 30.7% with TAVI and 50.7% with standard therapy (hazard ratio 0.55, 95% confidence interval 0.40 to 0.74). The rate of death or repeat hospitalization was 42.5% with TAVI and 71.6% with standard therapy (hazard ratio 0.46, 95% confidence interval 0.35 to 0.59). Among survivors at 1 year, 25.2% of the TAVI group and 58.0% of the standard therapy group had cardiac symptoms of New York Heart Association class III or IV.

    Applies to Recipient not specified
    • Patients with severe aortic stenosis whom surgeons considered not to be suitable candidates for surgery; 358 were randomized at 21 centers, 17 of them in the United States. The abstract gives no age range. No registry record was fetched for this trial (the abstract prints NCT00530894).
    • 21 centers, 17 of them in the United States (abstract)
    • United States and other countries (the abstract gives 17 of 21 centers in the United States)
    • Not stated in the abstract
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Outcomes at 30 days and at 1 year (abstract).
    Certainty method
    Not assessed
    Limitations
    Funded by Edwards Lifesciences. The group studied could not have surgery, so the result does not compare TAVR with surgery. The paper is from 2010, and this record does not say how its valve and delivery system compare with those in the later trials. The harms in the same trial are in a separate claim and should be read with this one. Only the abstract was read; no registry record for this trial was fetched.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (3)

    1. Supports Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2010-10-21 · DOI: 10.1056/NEJMoa1008232 · PMID: 20961243

      Locator
      Abstract, RESULTS, sentences 2 to 4
      How it applies
      One-year death, death or repeat hospitalization, and symptoms among survivors.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    2. Supports Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2010-10-21 · DOI: 10.1056/NEJMoa1008232 · PMID: 20961243

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      The authors' conclusion for the same population.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    3. Background Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2010-10-21 · DOI: 10.1056/NEJMoa1008232 · PMID: 20961243

      Locator
      Abstract, METHODS, sentences 1 and 2
      How it applies
      Design, population and primary end point.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  • Safety Interventional Certainty not assessed

    In the same 2010 trial, at 30 days TAVI was associated with a higher incidence of major strokes (5.0% versus 1.1% with standard therapy, P = 0.06) and major vascular complications (16.2% versus 1.1%, P < 0.001). The authors conclude that TAVI reduced death and symptoms despite the higher incidence of major strokes and major vascular events.

    Applies to Recipient not specified
    • Patients with severe aortic stenosis whom surgeons considered not to be suitable candidates for surgery; 358 were randomized at 21 centers, 17 of them in the United States. The abstract gives no age range. No registry record was fetched for this trial (the abstract prints NCT00530894).
    • 21 centers, 17 of them in the United States (abstract)
    • United States and other countries (the abstract gives 17 of 21 centers in the United States)
    • Not stated in the abstract
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Outcomes at 30 days and at 1 year (abstract).
    Certainty method
    Not assessed
    Limitations
    The stroke difference has P = 0.06 in the abstract. These harms are as important to the TAVR decision in this group as the lower death rate. This record does not say how the valve and delivery system compare with those in the later trials. Only the abstract was read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (2)

    1. Supports Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2010-10-21 · DOI: 10.1056/NEJMoa1008232 · PMID: 20961243

      Locator
      Abstract, RESULTS, sentence 5
      How it applies
      30-day major strokes and major vascular complications.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    2. Supports Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2010-10-21 · DOI: 10.1056/NEJMoa1008232 · PMID: 20961243

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      The authors name the higher incidence of major strokes and major vascular events.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Record details

Record id
cardio:tavr
Content hash
c1c544727e66181c00e9270c93d513363875ffcf3ca104e6f2b395b0f894eb31