# Valve disease: catheter valve or surgery Guide · id `cardio:guide-valve-disease-options` · Cardiovascular Atlas · release `f4600233112e1c27` (public) > General information only. This guide shows what the sources it cites say. It is not medical advice, it cannot tell you what is right for you, and no clinician has reviewed it. Talk to a qualified health professional about your own care. In an emergency, call your local emergency number. > 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. What heart valve disease is, how MedlinePlus and NHLBI describe treating it, what four trials of a catheter valve (TAVR) found, and questions to ask a care team. ## What heart valve disease is - MedlinePlus says heart valve disease happens when at least one heart valve does not work well. [1] - In regurgitation, the flaps of a valve do not close tightly, so blood leaks backward. [2] - In stenosis, the flaps become thick, stiff or stuck together, so the valve cannot open all the way. [3] - In atresia, a valve did not form properly and has no opening that lets blood through. [4] - Sometimes a valve can have both regurgitation and stenosis. [5] - Aortic valve stenosis is a common type of stenosis, and it affects the valve that lets blood flow from the heart into the large artery that carries it to the body. [6, 7] - Some people are born with heart valve disease, and MedlinePlus says it can also develop over time with age or with certain conditions that affect the heart. [8, 9] - MedlinePlus lists older age as one thing that raises the chance of valve disease, because the valves can become thick and stiff with age. [10] - MedlinePlus says many people live their whole lives with a valve that does not work perfectly and never have any problems. [11] - It also says valve disease may get worse slowly over time. [12] - MedlinePlus lists shortness of breath, fatigue, swelling in the feet, ankles, belly or neck veins, chest pain during physical activity, a problem with heart rate or rhythm, and dizziness or fainting among the signs and symptoms that may develop. [12, 13, 14] - Without treatment, MedlinePlus says, the extra workload on the heart can lead to heart failure, stroke, blood clots, and sudden cardiac arrest or death. [15] ## What MedlinePlus says about treatment - MedlinePlus says most heart valve problems can be treated successfully. [16] - Treatment can involve medicines to control symptoms and keep the heart pumping well, lifestyle changes for related heart conditions, or surgery that repairs or replaces a valve. [17, 18] - It says a person may need surgery even without symptoms, because fixing the valve can help prevent future heart problems. [19] - It says there are many ways to do heart valve surgery, and that the patient and doctor can decide what is best based on the valve problem and general health. [20, 21] - Repair surgery has fewer risks than replacement surgery, MedlinePlus says, so repair is preferred when it is possible. [22] - In some cases replacement is necessary, with either a biologic valve made from pig, cow or human tissue or a human-made mechanical valve. [23, 24, 25] - MedlinePlus says biologic valves tend to wear out after 10 to 15 years, but some may last longer. [26] - It says mechanical valves usually do not wear out, but with one, blood thinners are usually needed for the rest of a person's life to prevent blood clots. [25, 27] - It adds that the risk of endocarditis, a heart infection, is higher with a mechanical valve than with a biologic valve. [28] ## Open-heart surgery and catheter valves, as the sources describe them - MedlinePlus describes open-heart surgery, also called traditional heart surgery, as an operation in which the surgeon cuts the chest open to reach the heart. [29] - For open-heart surgery in general, it says medicines are used to stop the heart. [30] - It also says a heart-lung bypass machine keeps oxygen-rich blood pumping through the body during the operation. [31] - It treats minimally invasive heart surgery as a separate approach, one that uses small cuts between the ribs. [32] - MedlinePlus says heart surgery in general has risks, as all surgery does, even though the results are often excellent. [33] - For heart surgery in general, it lists bleeding, infection, fever and swelling, a problem from anesthesia, arrhythmia (a problem with heart rate or rhythm), damage to the heart, kidneys, liver and lungs, and stroke as risks. [14, 34, 35] - It says these risks tend to be higher if the surgery is an emergency. [36] - It also says the risks tend to be higher with other medical conditions, including diabetes, kidney diseases, lung diseases and peripheral artery disease. [37] - NHLBI says a valve can be replaced in open-heart surgery, or by a less invasive procedure that guides a catheter, which is a thin tube, to the heart through a blood vessel. [38, 39] - NHLBI names transcatheter aortic valve replacement, or TAVR, as a common example of a catheter procedure. [40] - It says TAVR is used to replace the aortic valve in aortic stenosis, and it also uses the name TAVI for the same procedure. [41] - NHLBI lists stroke, blood clots, injury to the heart or kidneys, and bleeding or damage where a catheter went in among the risks of valve replacement. [42, 43] - It adds that the new valve sometimes leaks when it is a poor fit. [44] - NHLBI says the choice between a mechanical and a biological valve is made with the patient's doctors and depends on the person's age, other medical conditions and risk factors. [45, 46] - NHLBI lists inflating a balloon to stretch a valve opening as one way to repair a valve, and says valvuloplasty can use a balloon. [47, 48] - NHLBI says some medicines and regular medical visits remain part of care after a valve is repaired or replaced. [49] ## Four trials of a catheter valve - According to their abstracts, each of the four trials described in this guide was funded by a company, Edwards Lifesciences or Medtronic. [50, 51, 52, 53] - In PARTNER 3, the 2010 trial and EARLY TAVR, the valve was placed through the femoral artery, a route the abstracts call transfemoral. [50, 52, 53] - PARTNER 3 and the Evolut Low Risk trial tested different TAVR valves, and the claim cards say neither result extends to other valves or to people at higher surgical risk. [50, 51] ## PARTNER 3: TAVR against surgery in people at low surgical risk, up to 1 year - In PARTNER 3, 1000 people with severe aortic stenosis and low surgical risk were randomly assigned to TAVR or to surgery. [50] - In PARTNER 3, the average age was 73 and the average surgical risk score was 1.9%. [54] - On that scale, higher scores mean a greater risk of death within 30 days after the procedure. [54, 55] - At 1 year, the estimated rate of death, stroke or being in hospital again was 8.5% with TAVR and 15.1% with surgery. [50] - At 1 year, the authors concluded that this combined rate was significantly lower with TAVR than with surgery in the as-treated population. [50] - MedlinePlus counts atrial fibrillation among the most common arrhythmias, which are problems with the heartbeat's rate or rhythm. [14, 56] - At 30 days in PARTNER 3, TAVR had lower rates of stroke, of death or stroke, and of new atrial fibrillation than surgery. [50] - The abstract also reports a shorter hospital stay for the procedure with TAVR. [50] - The abstract reports no significant differences between TAVR and surgery in major vascular complications, new permanent pacemakers, or moderate or severe leaks around the valve. [50] ## PARTNER 3 at 5 and 7 years - The 5-year and 7-year reports are from the same randomized PARTNER 3 trial, in low-risk people with severe, symptomatic aortic stenosis. [57, 58] - At 5 years, an estimated 22.8% of the TAVR group and 27.2% of the surgery group had a first primary event, which was death, stroke, or rehospitalization related to the valve, the procedure or heart failure. [59, 60] - The authors found no significant difference between the groups in either of the two primary combined outcomes at 5 years. [61] - The 5-year estimates for the parts of the first outcome were death 10.0% with TAVR and 8.2% with surgery, stroke 5.8% and 6.4%, and rehospitalization 13.7% and 17.4%. [62, 63] - At 5 years, bioprosthetic valve failure occurred in 3.3% of the TAVR group and 3.8% of the surgery group. [64] - At 7 years, an estimated 34.6% of the TAVR group and 37.2% of the surgery group had the same kind of combined outcome of death, stroke or rehospitalization. [65, 66] - The 7-year abstract reports no significant differences in either primary combined outcome. [67] - The 7-year estimates for the parts were death 19.5% with TAVR and 16.8% with surgery, stroke 8.5% and 8.1%, and rehospitalization 20.6% and 23.5%. [68, 69] - At 7 years, the percentage of bioprosthetic valves that failed was 6.9% in the TAVR group and 7.5% in the surgery group. [70] ## Evolut Low Risk: TAVR against surgery at 24 months - In the Evolut Low Risk trial, 1468 people with severe aortic stenosis and low surgical risk were randomly assigned to TAVR or to surgery. [51] - The mean age in the Evolut Low Risk trial was 74 years. [71] - At 24 months, a statistical model estimated the rate of death or disabling stroke at 5.3% with TAVR and 6.7% with surgery, from an analysis done when 850 people had been followed for 12 months. [51] - The authors concluded that TAVR was noninferior to surgery on this measure, which tests whether it was no worse and is not a finding that it lowered events. [51] - The abstract reports no test of whether TAVR was better than surgery. [51] - At 30 days in that trial, TAVR had less disabling stroke (0.5% against 1.7%), fewer bleeding complications (2.4% against 7.5%), less sudden (acute) kidney injury (0.9% against 2.8%) and less atrial fibrillation (7.7% against 35.4%) than surgery. [72] - At 30 days it also had more moderate or severe aortic regurgitation, which is blood leaking back through the aortic valve (3.5% against 0.5%), and more pacemaker implants (17.4% against 6.1%). [72] - The abstract gives these 30-day percentages without counts, intervals or tests. [72] ## Evolut Low Risk at 5 years - The 5-year report covers 1,414 people, 730 in the TAVR group and 684 in the surgery group. [73, 74] - At 5 years, an estimated 15.5% of the TAVR group and 16.4% of the surgery group had died from any cause or had a disabling stroke. [75, 76] - The 5-year estimates for the parts were death from any cause 13.5% with TAVR and 14.9% with surgery, and disabling stroke 3.6% and 4.0%. [77, 78] - Over 5 years, the rate of valve reintervention was 3.3% with TAVR and 2.5% with surgery. [79] - The authors described the 5-year rates of death or disabling stroke as comparable, and valve durability and performance as excellent in both groups. [80] ## A 2010 trial in people who could not have surgery - In a 2010 trial, 358 people with severe aortic stenosis whom surgeons judged not suitable for surgery were randomly assigned to TAVI or to standard therapy. [52] - The standard therapy included balloon aortic valvuloplasty. [52] - This trial compared TAVI with standard therapy and not with surgery, because the people in it could not have surgery. [52] - At 1 year, 30.7% of the TAVI group and 50.7% of the standard therapy group had died from any cause. [52] - At 30 days, the abstract reports more major strokes with TAVI than with standard therapy (5.0% against 1.1%) and more major vascular complications (16.2% against 1.1%). [81] - The authors concluded that TAVI lowered deaths, the combined rate of death or repeat hospital stay, and cardiac symptoms despite the higher rate of major strokes and major vascular events. [52, 81] ## A trial of early TAVR in people without symptoms - In EARLY TAVR, 901 people with severe aortic stenosis and no symptoms were randomly assigned to early TAVR or to clinical surveillance. [53] - The abstract says guidelines recommended routine clinical surveillance every 6 to 12 months for people with severe aortic stenosis, no symptoms and a preserved left ventricular ejection fraction. [82] - The abstract reports a median follow-up of 3.8 years but does not tie the event percentages below to a time point. [53] - A primary event, meaning death, stroke or an unplanned hospital stay for heart or blood vessel causes, happened in 26.8% of the TAVR group and 45.3% of the surveillance group. [53] - Death occurred in 8.4% of the TAVR group and 9.2% of the surveillance group, and stroke in 4.2% and 6.7%, and the abstract gives no separate test for these parts. [53] - Unplanned hospital stays for heart or blood vessel causes occurred in 20.9% of the TAVR group and 41.7% of the surveillance group. [53] - During a median follow-up of 3.8 years, 87.0% of the surveillance group had their aortic valve replaced. [53] - The comparison was therefore early TAVR against a strategy after which most people still had their valve replaced. [53] ## What a 2020 guideline summary says about choosing - For people with severe aortic stenosis for whom a biological valve is appropriate, an ACC summary of a 2020 ACC/AHA guideline says the choice between surgery and TAVI should include several factors. [83, 84, 85, 86] - The ACC summary is dated December 17, 2020. [87] ## When the same summary prefers surgery or TAVI - The summary says surgery is preferred for patients younger than 65, or with a life expectancy of more than 20 years. [88] - It says TAVI through the femoral artery is preferred, if feasible, for patients older than 80, or with a life expectancy of less than 10 years. [89] - For symptomatic patients aged 65 to 80 with no reason that rules out TAVI through the femoral artery, it recommends either surgery or TAVI, chosen once the patient and care team have decided together. [90] - It says surgery is preferred if blood vessel anatomy or other factors rule out TAVI through the femoral artery. [91] - It says surgery is preferred for patients without symptoms who have a named reason for the procedure, for example an abnormal result on an exercise test, aortic stenosis that is very severe, fast progression, or a raised BNP blood level. [92, 93, 94] - It says TAVI is preferred, whatever the age, for patients who have symptoms and a surgical risk that is high or prohibitive, if survival of more than 12 months is predicted and the quality of life expected is acceptable. [95, 96] - It recommends palliative care, after shared decision making, for patients with symptoms whose predicted survival after TAVI is under 12 months or who are expected to gain little in quality of life. [97, 98] ## Factors an ACC summary of a 2020 guideline lists for choosing between surgery and TAVI - [ ] The presence of symptoms. [84] - [ ] The patient's age and how long the patient is expected to live. [85] - [ ] The reason for the procedure. [85] - [ ] The predicted risk of surgery. [85] - [ ] Anatomy or other factors that affect whether TAVI can be done through the femoral artery. [86] ## Questions to ask 1. Which of my valves is affected, and is the problem narrowing, leaking or both? 2. Do I have symptoms from the valve, and does that change whether or when a procedure is advised? 3. Is repair possible for my valve, or is replacement needed? 4. If a replacement valve is advised, would it be biologic or mechanical, and what would that mean for how long it lasts and for blood thinners? 5. Would open-heart surgery, a catheter procedure or both be options for my valve and general health? 6. How is my surgical risk estimated, and how does it affect the choice? 7. Is my anatomy suitable for placing a valve through the femoral artery? 8. Do the trial results apply to someone with my age, symptoms and surgical risk? 9. Which of the guideline summary's age and life-expectancy groups applies to me, and what does that mean for choosing between surgery and TAVI? 10. How long do TAVR valves and surgical valves last, and what do the longer trial results mean for someone of my age? 11. What are the chances of a stroke, a pacemaker or a leaking valve with each option? 12. How long would I expect to stay in hospital with each option, and what follow-up and medicines would come after? ## Sources 1. Heart Valve Diseases (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, opening section, para 1. Retrieved 2026-10-14. 2. Heart Valve Diseases (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, types section, regurgitation. Retrieved 2026-10-14. 3. Heart Valve Diseases (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, types section, stenosis. Retrieved 2026-10-14. 4. Heart Valve Diseases (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, types section, atresia. Retrieved 2026-10-14. 5. Heart Valve Diseases (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, types section, closing sentence. 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Claim `cardio:claim-partner-3-primary`: 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: 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. 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. - Supports: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14. - Supports: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentences 4 to 6. Retrieved 2026-10-14. - Supports: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14. - Background: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, METHODS, sentences 1 to 3. Retrieved 2026-10-14. - Background: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentences 1 and 2. Retrieved 2026-10-14. - 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)) . Locator: protocolSection.designModule.designInfo.maskingInfo.masking. Retrieved 2026-10-14. 51. Claim `cardio:claim-evolut-low-risk-primary`: In the Evolut Low Risk trial, 1468 patients with severe aortic stenosis and low surgical risk were randomized to TAVR with a self-expanding valve or to surgery. At 24 months the estimated rate of death or disabling stroke was 5.3% with TAVR and 6.7% with surgery (a difference of -1.4 percentage points; 95% Bayesian credible interval for the difference -4.9 to 2.1; posterior probability of noninferiority above 0.999). The authors conclude TAVR was noninferior to surgery. The abstract reports a noninferiority result only and no test of superiority. - Applies to: Patients with severe aortic stenosis and low surgical risk, 1468 of whom were randomized. The abstract gives a mean age of 74 years. The registry lists no minimum or maximum age. The registry record also covers a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.; Not stated in the abstract. The registry lists sites in the United States, Australia, Canada, France, Japan, the Netherlands and New Zealand.; United States, Australia, Canada, France, Japan, the Netherlands and New Zealand (registry locations); Mean age 74 years (abstract); the registry lists no age limits. Follow-up: The primary end point was at 24 months, analyzed when 850 patients had reached 12-month follow-up (abstract). 30-day outcomes and 12-month valve measurements are also reported. The registry gives an estimated study completion of 2029-06. - Limitations: Funded by Medtronic; the registry lists Medtronic Cardiovascular as lead sponsor and FDA lists Medtronic, Inc. as applicant for the valve. The registry lists no masking. The result is a noninferiority result from a Bayesian analysis done when 850 patients had reached 12-month follow-up; it is not a statement that TAVR lowers events. Results are for one self-expanding valve in selected low-risk patients and do not extend to other valves or to higher-risk patients. Only the abstract was read: the NEJM page was not fetched for this paper, and PubMed lists no open full text. The 30-day harms are in a separate claim and should be read with this one. - Supports: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14. - Supports: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14. - Background: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, METHODS, sentences 1 and 2. Retrieved 2026-10-14. - Background: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentences 1 and 2. Retrieved 2026-10-14. - Background: Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients (Registry, U.S. National Library of Medicine (ClinicalTrials.gov)) . Locator: protocolSection.designModule.designInfo.maskingInfo.masking. Retrieved 2026-10-14. 52. Claim `cardio:claim-tavr-2010-mortality`: 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: 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. 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. - Supports: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentences 2 to 4. Retrieved 2026-10-14. - Supports: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, The New England journal of medicine) . Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14. - Background: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, The New England journal of medicine) . Locator: Abstract, METHODS, sentences 1 and 2. Retrieved 2026-10-14. 53. Claim `cardio:claim-early-tavr-primary`: 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: 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. - 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. - Supports: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 3. Retrieved 2026-10-14. - Supports: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14. - Supports: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14. - Supports: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, The New England journal of medicine) . Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14. - Background: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, The New England journal of medicine) . Locator: Abstract, METHODS, sentences 1 to 3. Retrieved 2026-10-14. - Background: Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentences 1 and 2. Retrieved 2026-10-14. - 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)) . Locator: protocolSection.designModule.designInfo.maskingInfo.masking. Retrieved 2026-10-14. 54. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 2, fragment 1 of 2. Retrieved 2026-10-14. 55. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 2, fragment 2 of 2. Retrieved 2026-10-14. 56. Atrial Fibrillation | AFib (MedlinePlus) (Webpage, MedlinePlus, National Library of Medicine) . Locator: Summary, What is atrial fibrillation (AFib)?, sentence 1. Retrieved 2026-10-14. 57. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years (Publication, The New England journal of medicine) . Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-15. 58. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years (Publication, The New England journal of medicine) . Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-15. 59. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years (Publication, The New England journal of medicine) . Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-15. 60. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 2. Retrieved 2026-10-15. 61. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years (Publication, The New England journal of medicine) . Locator: Abstract, CONCLUSIONS, sentence 1, part. Retrieved 2026-10-15. 62. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 4, lead-in. Retrieved 2026-10-15. 63. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 4, components. Retrieved 2026-10-15. 64. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 6. Retrieved 2026-10-15. 65. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years (Publication, The New England journal of medicine) . Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-15. 66. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 2, part 1. Retrieved 2026-10-15. 67. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years (Publication, The New England journal of medicine) . Locator: Abstract, CONCLUSIONS, sentence 1, part. Retrieved 2026-10-15. 68. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 4, lead-in. Retrieved 2026-10-15. 69. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 4, components. Retrieved 2026-10-15. 70. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 6. Retrieved 2026-10-15. 71. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 2. Retrieved 2026-10-14. 72. Claim `cardio:claim-evolut-low-risk-30-day`: At 30 days in the Evolut Low Risk trial, patients who had TAVR, compared with surgery, had less disabling stroke (0.5% versus 1.7%), fewer bleeding complications (2.4% versus 7.5%), less acute kidney injury (0.9% versus 2.8%) and less atrial fibrillation (7.7% versus 35.4%). They also had more moderate or severe aortic regurgitation (blood leaking back through the aortic valve, 3.5% versus 0.5%) and more pacemaker implantation (17.4% versus 6.1%). At 12 months the valve gradient was lower with TAVR (8.6 versus 11.2 mm Hg) and the effective orifice area larger (2.3 versus 2.0 cm2). - Applies to: Patients with severe aortic stenosis and low surgical risk, 1468 of whom were randomized. The abstract gives a mean age of 74 years. The registry lists no minimum or maximum age. The registry record also covers a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.; Not stated in the abstract. The registry lists sites in the United States, Australia, Canada, France, Japan, the Netherlands and New Zealand.; United States, Australia, Canada, France, Japan, the Netherlands and New Zealand (registry locations); Mean age 74 years (abstract); the registry lists no age limits. Follow-up: The primary end point was at 24 months, analyzed when 850 patients had reached 12-month follow-up (abstract). 30-day outcomes and 12-month valve measurements are also reported. The registry gives an estimated study completion of 2029-06. - Limitations: The abstract gives these percentages without counts, intervals or tests, so no statement of significance is made here. The harms of TAVR (aortic regurgitation and pacemakers) are as important to this claim as the benefits. Funded by Medtronic. The registry lists no masking. Only the abstract was read. The 24-month result is in a separate claim. - Supports: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14. - Supports: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14. 73. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis (Publication, Journal of the American College of Cardiology) . Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-15. 74. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis (Publication, Journal of the American College of Cardiology) . Locator: Abstract, RESULTS, sentence 1. Retrieved 2026-10-15. 75. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis (Publication, Journal of the American College of Cardiology) . Locator: Abstract, RESULTS, sentence 3, part 1. Retrieved 2026-10-15. 76. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis (Publication, Journal of the American College of Cardiology) . Locator: Abstract, RESULTS, sentence 3, part 2. Retrieved 2026-10-15. 77. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis (Publication, Journal of the American College of Cardiology) . Locator: Abstract, RESULTS, sentence 4, parts. Retrieved 2026-10-15. 78. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis (Publication, Journal of the American College of Cardiology) . Locator: Abstract, RESULTS, sentence 4, part 2. Retrieved 2026-10-15. 79. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis (Publication, Journal of the American College of Cardiology) . Locator: Abstract, RESULTS, sentence 9. Retrieved 2026-10-15. 80. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis (Publication, Journal of the American College of Cardiology) . Locator: Abstract, CONCLUSIONS, sentences 1 and 2, parts. Retrieved 2026-10-15. 81. Claim `cardio:claim-tavr-2010-safety`: 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: 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. 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. - Supports: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, The New England journal of medicine) . Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14. - Supports: Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (Publication, The New England journal of medicine) . Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-14. 82. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (Publication, The New England journal of medicine) . Locator: Abstract, BACKGROUND, sentence 1. Retrieved 2026-10-14. 83. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, lead-in, opening words. Retrieved 2026-10-15. Source state: Corrected. 84. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, lead-in, fragment 1 of 3. Retrieved 2026-10-15. Source state: Corrected. 85. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, lead-in, fragment 2 of 3. Retrieved 2026-10-15. Source state: Corrected. 86. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, lead-in, fragment 3 of 3. Retrieved 2026-10-15. Source state: Corrected. 87. 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, Circulation) . Locator: Page date line. Retrieved 2026-10-15. Source state: Corrected. 88. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 1. Retrieved 2026-10-15. Source state: Corrected. 89. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 4. Retrieved 2026-10-15. Source state: Corrected. 90. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 5. Retrieved 2026-10-15. Source state: Corrected. 91. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 2. Retrieved 2026-10-15. Source state: Corrected. 92. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 3, part 1. Retrieved 2026-10-15. Source state: Corrected. 93. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 3, part 2. Retrieved 2026-10-15. Source state: Corrected. 94. 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, Circulation) . Locator: Key perspective on intervention for severe AS, sentence 1, part. Retrieved 2026-10-15. Source state: Corrected. 95. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 6, part 1. Retrieved 2026-10-15. Source state: Corrected. 96. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 6, part 2. Retrieved 2026-10-15. Source state: Corrected. 97. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 7, part 1. Retrieved 2026-10-15. Source state: Corrected. 98. 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, Circulation) . Locator: Key perspective on SAVR versus TAVI, list item 7, part 2. Retrieved 2026-10-15. Source state: Corrected. ## About this guide - Written for: Adults who have a problem with a heart valve, and the people with them - What it covers: Written from two MedlinePlus pages, an NHLBI page, the abstracts of seven trial reports from four trials and one summary of a 2020 guideline. It describes what these sources say and gives no advice for one person. The trial results come from abstracts, not the full papers. - Pages it explains: Heart valve disease (`cardio:heart-valve-disease`); Aortic stenosis (`cardio:aortic-stenosis`); Transcatheter aortic valve replacement (TAVR) (`cardio:tavr`); Surgical aortic valve replacement (`cardio:surgical-aortic-valve-replacement`) - Sources checked: 2026-10-15 - Next check due: 2027-04-15 - Estimated reading grade: 9.9 (target 10) Every sentence cites a source. Words in quotation marks are the source's own; the rest is the atlas's summary. ## Provenance Content hash: f3f20741d4db3eecea71e6755652749cb2347dfe7118e7dde169af63da0f21db Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15