# Transcatheter aortic valve replacement (TAVR) Intervention · id `cardio:tavr` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: TAVR; TAVI; Transcatheter aortic valve implantation Browse, organ or system: Heart Browse, condition area: Valve and congenital heart disease ## In plain language 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. ## 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 record of that valve) and EARLY TAVR (no symptoms). Devices: SAPIEN 3 and a self-expanding valve 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. ## Claims, with the population each applies to ## Context: Patients with aortic stenosis who need valve intervention and for whom a bioprosthetic valve is suitable (ACC summary of the 2020 guideline) Recipient: Recipient not specified; Population: Patients for whom a bioprosthetic valve is suitable, which the ACC summary groups under its points on aortic stenosis. Some of its rules name symptomatic patients and a few name an age range (65 to 80 years). The summary does not state an adult-only limit.; Care setting: Not stated in the ACC summary. The decision is described as one for a team and the patient to take together.; Geography: Not stated in the ACC summary (issued by American societies; jurisdiction not verified); Life stage: Not stated; the 65 to 80 year range applies to one rule only; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (guideline context) ### An ACC summary of the 2020 ACC/AHA valvular heart disease guideline says the choice between surgical aortic valve replacement and transcatheter aortic valve implantation should weigh symptoms, age and expected life expectancy, the reason for the procedure, predicted surgical risk and whether the anatomy suits transfemoral TAVI (all class 1). For symptomatic patients aged 65 to 80 with no contraindication to transfemoral TAVI, either option can be chosen once the patient and the care team have decided together. For symptomatic patients whose surgical risk is high or prohibitive, TAVI is the preferred choice at any age, provided survival after the procedure is predicted to be more than 12 months and the expected quality of life is acceptable (see the separate claim on that rule). Surgery is preferred when vascular anatomy or other factors rule out transfemoral TAVI. - Category: Recommendation - Evidence stage: Guidance - Certainty: Certainty not assessed - Applies to: Recipient: Recipient not specified; Population: Patients for whom a bioprosthetic valve is suitable, which the ACC summary groups under its points on aortic stenosis. Some of its rules name symptomatic patients and a few name an age range (65 to 80 years). The summary does not state an adult-only limit.; Care setting: Not stated in the ACC summary. The decision is described as one for a team and the patient to take together.; Geography: Not stated in the ACC summary (issued by American societies; jurisdiction not verified); Life stage: Not stated; the 65 to 80 year range applies to one rule only; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (guideline context) - Limitations: The source is the ACC key-perspectives summary, Part 1 of 3 (ACC content, hash only), not the guideline text. The summary also sets age and life-expectancy rules that favor surgery in younger patients and TAVI in older ones, and a rule for asymptomatic patients; the page text for those rules could not be quoted because its symbols are lost in the page markup, so they are not stated here. Another ACC page says age and life-expectancy rules were added to guide the choice for patients at low or intermediate risk. PubMed lists four corrections to the guideline; their text was not read, so it is not known whether they change anything stated here. The wording is from the 2020 guideline, which later documents may have replaced. No recommendation record is written for this broad statement; the rule for symptomatic patients at high or prohibitive surgical risk has its own claim and record. - Last checked: 2026-10-15 - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: Key perspective on SAVR versus TAVI, lead-in, fragments 1 to 3. Retrieved 2026-10-15T13:52:57Z. Source state: Corrected. Snapshot hash: a22941b13dfac639c9e2466be0f0e80086c8f47a6b195e097915b63e7d1923aa. How it applies: Factors the choice should weigh (all Class 1). 2. Supports: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: Key perspective on SAVR versus TAVI, list item 5. Retrieved 2026-10-15T13:52:57Z. Source state: Corrected. Snapshot hash: a22941b13dfac639c9e2466be0f0e80086c8f47a6b195e097915b63e7d1923aa. How it applies: Either option after shared decision-making, ages 65 to 80. 3. Supports: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: Key perspective on SAVR versus TAVI, list item 6, fragments 1 and 2. Retrieved 2026-10-15T13:52:57Z. Source state: Corrected. Snapshot hash: a22941b13dfac639c9e2466be0f0e80086c8f47a6b195e097915b63e7d1923aa. How it applies: TAVI is preferred when surgical risk is high or prohibitive, at any age. 4. Supports: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: Key perspective on SAVR versus TAVI, list item 2. Retrieved 2026-10-15T13:52:57Z. Source state: Corrected. Snapshot hash: a22941b13dfac639c9e2466be0f0e80086c8f47a6b195e097915b63e7d1923aa. How it applies: Surgery preferred when anatomy precludes transfemoral TAVI. 5. Background: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: What changed, TAVR bullet, sentence 2. Retrieved 2026-10-15T13:53:27Z. Source state: Corrected. Snapshot hash: 6a0f9ccc62a33076623820eb403905d18d4e7dedae331b0764bbd9507af21cc0. How it applies: Age and life-expectancy rules were added to the choice, for patients at low or intermediate risk. 6. Background: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: CommentsCorrectionsList, four ErratumIn entries. Retrieved 2026-10-15T13:48:58Z. Source state: Corrected. Snapshot hash: 2ef5af022a03211aee6564fe6d8b23521016ff4b0d6d4436ae989c0963c13a08. How it applies: Shows that corrections exist. What they change is unknown. ## Context: Symptomatic patients whose surgical risk is high or prohibitive and for whom a bioprosthesis is suitable (ACC summary of the 2020 guideline) Recipient: Recipient not specified; Population: Symptomatic patients, of any age, who need valve intervention for aortic stenosis, for whom a bioprosthetic valve is suitable and whose surgical risk is high or prohibitive, with predicted survival after the intervention beyond 12 months and an acceptable expected quality of life. The summary does not state an adult-only limit.; Care setting: Not stated in the ACC summary. The decision is described as one for a team and the patient to take together.; Geography: Not stated in the ACC summary (issued by American societies; jurisdiction not verified); Life stage: Any age, as the summary words this rule; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (guideline context) ### An ACC summary of the 2020 ACC/AHA valvular heart disease guideline says that, for symptomatic patients whose surgical risk is high or prohibitive and for whom a bioprosthetic valve is suitable, TAVI is the preferred choice at any age, provided predicted survival after the procedure is more than 12 months and the quality of life expected is acceptable. The page labels the rules for choosing between surgery and TAVI, which include this one, as class 1. - Category: Recommendation - Evidence stage: Guidance - Certainty: Certainty not assessed - Applies to: Recipient: Recipient not specified; Population: Symptomatic patients, of any age, who need valve intervention for aortic stenosis, for whom a bioprosthetic valve is suitable and whose surgical risk is high or prohibitive, with predicted survival after the intervention beyond 12 months and an acceptable expected quality of life. The summary does not state an adult-only limit.; Care setting: Not stated in the ACC summary. The decision is described as one for a team and the patient to take together.; Geography: Not stated in the ACC summary (issued by American societies; jurisdiction not verified); Life stage: Any age, as the summary words this rule; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (guideline context) - Limitations: The source is the ACC key-perspectives summary, Part 1 of 3 (ACC content, hash only), not the guideline text. The class 1 label is the one the page prints at the end of the sentence that introduces the list of rules, which includes this one. Other rules in the same list, such as surgery for patients with suitable anatomy and the age and life-expectancy rules, are not part of this claim. PubMed lists four corrections to the guideline; their text was not read, so it is not known whether they change anything stated here. The wording is from the 2020 guideline, which later documents may have replaced. - Last checked: 2026-10-15 - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: Key perspective on SAVR versus TAVI, list item 6, fragments 1 and 2. Retrieved 2026-10-15T13:52:57Z. Source state: Corrected. Snapshot hash: a22941b13dfac639c9e2466be0f0e80086c8f47a6b195e097915b63e7d1923aa. How it applies: Preferred, at any age, when surgical risk is high or prohibitive and survival is predicted beyond 12 months. 2. Background: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: Key perspective on SAVR versus TAVI, lead-in, opening words and fragments 1 to 3. Retrieved 2026-10-15T13:52:57Z. Source state: Corrected. Snapshot hash: a22941b13dfac639c9e2466be0f0e80086c8f47a6b195e097915b63e7d1923aa. How it applies: The list applies to patients for whom a bioprosthesis is appropriate; the lead-in labels the rules class 1. 3. Background: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.) Locator: CommentsCorrectionsList, four ErratumIn entries. Retrieved 2026-10-15T13:48:58Z. Source state: Corrected. Snapshot hash: 2ef5af022a03211aee6564fe6d8b23521016ff4b0d6d4436ae989c0963c13a08. How it applies: Shows that corrections exist. What they change is unknown. ## 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. ### 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. - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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. - 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 - Sources: 1. Supports: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, 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.) Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943. How it applies: Primary event counts and rates, and the hazard ratio. 2. Supports: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, 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.) Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943. How it applies: Death, stroke and hospitalization percentages by group; the abstract gives no test. 3. Supports: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, 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.) Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943. How it applies: Share of the surveillance group who had valve replacement. 4. Supports: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, 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.) Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943. How it applies: The authors' conclusion for the same population. 5. Background: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, 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.) Locator: Abstract, METHODS, sentences 1 to 3. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943. How it applies: Design, centers and end point. 6. Background: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, 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.) Locator: Abstract, RESULTS, sentences 1 and 2. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: 7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943. How it applies: Number randomized, age and risk score. 7. Background: EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis (Registry, edition ClinicalTrials.gov API v2 record, last update posted 2024-05-13.) Locator: protocolSection.designModule.designInfo.maskingInfo.masking. Retrieved 2026-10-14T18:18:27Z. Source state: Current. Snapshot hash: c5b3fac506ff46da7da961337b6ae035819edd44091278e503e871285ae39d4f. How it applies: The registry records no masking. ## 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. ### 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. - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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. - 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 - Sources: 1. Supports: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, 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.) Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8. How it applies: Kaplan-Meier rates of the primary composite at 1 year, the differences and the intervals. 2. Supports: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, 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.) Locator: Abstract, RESULTS, sentences 4 to 6. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8. How it applies: 30-day outcomes, including the outcomes with no significant difference. 3. Supports: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, 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.) Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8. How it applies: The authors' conclusion for the same population. 4. Background: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, 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.) Locator: Abstract, METHODS, sentences 1 to 3. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8. How it applies: Design, population, end point and the noninferiority margin. 5. Background: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, 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.) Locator: Abstract, RESULTS, sentences 1 and 2. Retrieved 2026-10-14T18:18:29Z. Source state: Current. Snapshot hash: d669c4f31ded96722318d6086b5dc4dcf13685a17842763b4131db74624475e8. How it applies: Number randomized, centers, age and risk score. 6. Background: PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (Registry, edition ClinicalTrials.gov API v2 record, last update posted 2026-01-14.) Locator: protocolSection.designModule.designInfo.maskingInfo.masking. Retrieved 2026-10-14T18:18:24Z. Source state: Current. Snapshot hash: c5def3e9e65308c98af817a46ed7a5fb320115038c3897933d93a6fd02a4e606. How it applies: The registry records no masking. ## 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). ### 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. - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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). - 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 - Sources: 1. Supports: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, 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.) Locator: Abstract, RESULTS, sentences 2 to 4. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834. How it applies: One-year death, death or repeat hospitalization, and symptoms among survivors. 2. Supports: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, 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.) Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834. How it applies: The authors' conclusion for the same population. 3. Background: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, 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.) Locator: Abstract, METHODS, sentences 1 and 2. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834. How it applies: Design, population and primary end point. ### 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. - Category: Safety - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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). - 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 - Sources: 1. Supports: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, 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.) Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834. How it applies: 30-day major strokes and major vascular complications. 2. Supports: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, 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.) Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14T18:18:28Z. Source state: Current. Snapshot hash: 63b67fc53f86ce56162aa5e75c7411a5730907adc0988091f704c18127c8d834. How it applies: The authors name the higher incidence of major strokes and major vascular events. ## Guidance, authorization and access ### Recommendation `cardio:rec-acc-aha-2020-tavr-high-prohibitive-risk` - Intervention: Transcatheter aortic valve replacement (TAVR) (`cardio:tavr`) - Direction: Recommended - Issued by: American College of Cardiology (`core:acc`) - Guideline record: 2020 ACC/AHA valvular heart disease guideline (`cardio:guideline-acc-aha-2020-valve`) - Guideline: 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines, edition Published in Circulation 143(5):e72-e227 (issue date 2021-02-02; electronic publication 2020-12-17). PubMed bibliographic record only: PubMed holds no abstract and lists no PMC copy. The guideline text was not read. PubMed lists 4 corrections to the guideline; their text was not read. The same source also holds snapshots of two ACC pages: Part 1 of 3 of the key perspectives (dated Dec 17, 2020) and the ACC article on what changed from the 2017 update. They are ACC summaries, not the guideline text; Parts 2 and 3 were not fetched. In the page markup some less-than symbols hide the text that follows them, so only passages free of such symbols are quoted. The publisher field is the journal title as PubMed gives it.; snapshot `cardio:acc-valve2020-key-perspectives-pt1-2026-10-15` - Jurisdictions: Not stated; note: Issued by American societies; the source read names no jurisdiction. - Strength: Class 1, from the label (all Class 1) that introduces the list of rules, which includes this one (ACC/AHA class of recommendation. The ACC page prints the class for the decision factors; the class definitions were not read here.) - Effective: 2020-12-17 (The date on the ACC summary page, which matches the electronic publication date in PubMed.) - Supersession: Not checked - Applies to: Recipient: Recipient not specified; Population: Symptomatic patients, of any age, who need valve intervention for aortic stenosis, for whom a bioprosthetic valve is suitable and whose surgical risk is high or prohibitive, with predicted survival after the intervention beyond 12 months and an acceptable expected quality of life. The summary does not state an adult-only limit.; Care setting: Not stated in the ACC summary. The decision is described as one for a team and the patient to take together.; Geography: Not stated in the ACC summary (issued by American societies; jurisdiction not verified); Life stage: Any age, as the summary words this rule; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (guideline context) - Basis: claim `cardio:claim-acc-aha-2020-tavr-high-prohibitive-risk` - Source problem: a cited source is corrected. Check the sources before relying on this claim. ## Connected pages - Trial of people unsuitable for surgery (2010): lower one-year death with TAVR than with standard therapy: Aortic stenosis (`cardio:aortic-stenosis`) [a claim, not a settled fact; see claim `cardio:claim-tavr-2010-mortality` and its context] - Same trial: more major strokes and major vascular complications with TAVR at 30 days: Aortic stenosis (`cardio:aortic-stenosis`) [a claim, not a settled fact; see claim `cardio:claim-tavr-2010-safety` and its context] - PARTNER 3, low surgical risk: lower one-year death, stroke or rehospitalization than surgery: Aortic stenosis (`cardio:aortic-stenosis`) [a claim, not a settled fact; see claim `cardio:claim-partner-3-primary` and its context] - EARLY TAVR, no symptoms: a lower rate of death, stroke or unplanned hospital stay than clinical surveillance; death 8.4% versus 9.2%, no test given: Aortic stenosis (`cardio:aortic-stenosis`) [a claim, not a settled fact; see claim `cardio:claim-early-tavr-primary` and its context] - Filed under this front: Procedures and surgery (`cardio:front-procedures-and-surgery`) - ACC summary of the 2020 guideline: TAVI preferred for symptomatic patients at high or prohibitive surgical risk: Aortic stenosis (`cardio:aortic-stenosis`) [a claim, not a settled fact; see claim `cardio:claim-acc-aha-2020-tavr-high-prohibitive-risk` and its context] - Related to: Heart valve disease (`cardio:heart-valve-disease`) - Related to: Surgical aortic valve replacement (`cardio:surgical-aortic-valve-replacement`) - Related to: CoreValve and Evolut transcatheter valves (`cardio:corevalve-evolut`) - Related to: SAPIEN 3 transcatheter heart valve (`cardio:sapien-3`) - Investigated in: EARLY TAVR (`cardio:early-tavr`) - Investigated in: Evolut Low Risk trial (`cardio:evolut-low-risk`) ## Provenance Content hash: 86456f8b26cd470b12485916ac24a4fbde16f3a4822b2177a71637953ecf137d Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-14