Clinical UM Guideline

This document addresses transcatheter (percutaneous or catheter-based) aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI).

Note: For additional information on transcatheter mitral, pulmonary, or tricuspid valve procedures please see the following related document:

• SURG.00121 Transcatheter Mitral, Pulmonary, and Tricuspid Heart Valve Procedures

Note: For a high-level overview of this document, please see “Summary for Members and Families” below. 

Medically Necessary:

Transcatheter Aortic Valve Replacement (TAVR):

TAVR using a U.S. Food and Drug Administration (FDA) approved device* is considered medically necessary when the following criteria have been met:

1. The individual has severe degenerative, native valve aortic stenosis demonstrated by one of the following:
   1. The aortic valve area (AVA) is equal to or less than 1.0 cm²; or
   2. The AVA index is equal to or less than 0.6 cm²/m²; or
   3. A mean aortic valve gradient equal to or more than 40 mm Hg; or
   4. A peak aortic-jet velocity equal to or more than 4.0 m/sec;
      and
2. Heart failure symptoms of New York Heart Association (NYHA) class II or greater; and
3. The individual is in one of the following categories:
   1. Age 65 years or older with any open surgical risk; or
   2. Age younger than 65 with intermediate or greater open surgical risk (predicted risk of surgical mortality at 30 days greater than or equal to 3%) as determined by at least two physicians.

Note:

When echocardiographic parameters are discordant (for example, low-flow/low-gradient severe aortic stenosis), confirmation of severe disease should be based on comprehensive clinical and imaging assessment consistent with guideline-directed evaluation.

Valve-in-valve TAVR implantation using an FDA approved device* is considered medically necessary for treatment when the following criteria are met:

1. The individual has failure (that is, stenosed, insufficient, or both) of previous open surgical bioprosthetic aortic valve; and
2. The individual is at high or greater risk for open surgical therapy (that is, Society of Thoracic Surgeons operative risk score greater than or equal to 8% or at a 15% or greater risk of operative mortality at 30 days) as determined by at least two physicians.

*Note: Please refer to background section below for a list of FDA approved transcatheter heart valve (THV) devices used for TAVR.

Not Medically Necessary:

Transcatheter aortic valve replacement is considered not medically necessary when the criteria above are not met.

Valve-in-valve TAVR implantation within a previously implanted transcatheter aortic valve (“Redo TAVR”) is considered not medically necessary for all indications.

TAVR cerebral protection devices (for example, Sentinel^™ Cerebral Protection System) are considered not medically necessary for all indications.

This document describes clinical studies and expert recommendations, and explains when replacing the aortic valve using thin tubes through the blood vessels instead of open surgery through the chest (open-heart surgery) is appropriate. The aortic valve is the main valve between the heart and the rest of the body. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Transcatheter Aortic Valve Replacement (commonly referred to by its abbreviation, TAVR) is a procedure that replaces a damaged aortic heart valve without open-heart surgery. It is used to treat aortic stenosis, a condition where the valve becomes narrow and restricts blood flow. TAVR can also be used to replace worn-out artificial valves (called valve-in-valve TAVR). TAVR is most often done through a thin tube inserted into a blood vessel the leg (transfemoral approach), which is less invasive than traditional open-heart surgery and usually has a shorter recovery time. Each option has possible risks and benefits. Some procedures in this document are still being studied and have not been proven to improve health.

What the Studies Show

TAVR is a good treatment for some people with severe aortic stenosis who cannot safely undergo open-heart surgery. It can also be a good option for people at lower risk for problems due to surgery if they are older. Good studies show that TAVR can improve how long a person can live and lessen symptoms like shortness of breath and chest pain. Compared to open-heart surgery, TAVR may lead to faster recovery, fewer bleeding problems, and lower risk of irregular heartbeat (atrial fibrillation). However, it can increase the chance of needing a pacemaker or having some leakage around the new valve. TAVR and surgery have similar results in many cases, especially for people over 65 years of age. For people under 65, the long-term effects of TAVR are still being studied.

Valve-in-valve TAVR has been shown to work well for some people who have already had a valve replaced with human or animal donor tissue (bioprosthetic valve) that is wearing out when open-heart surgery is too risky. Studies show that this approach has lower short-term risk and faster recovery than redoing open heart surgery, but may not last as long, especially in people with smaller valves. This approach is considered appropriate for people who have been carefully chosen based on their health status, age and other factors.

Redo TAVR (a second TAVR after a previous one fails) has been done successfully in people with high risks for problems due to open surgery. Some studies have shown good short-term results, but they cannot prove how well the treatment really works compared to other options. Better studies are needed to know if redo TAVR improves health, how long the valves last, and how it compares to replacing the old valve through open-heart surgery.

Cerebral (brain) protection devices are temporary filters placed in the arteries leading to the brain to try to prevent strokes during TAVR procedures. They have not been shown to reduce the risk of stroke. In a large study where people were randomly put into groups, those who got this device had about the same chances of dying or having a stroke as those who did not get it. Other studies also did not show a clear benefit. Better studies are needed to know if these devices improve health.

When is TAVR Clinically Appropriate?

TAVR using an FDA-approved device may be appropriate in these situations:

• The person has severe narrowing of the aortic valve (aortic stenosis) with one of the following:
  • Aortic valve area (AVA) ≤ 1.0 cm²; or
  • AVA index ≤ 0.6 cm²/m²; or
  • Mean gradient ≥ 40 mm Hg; or
  • Peak aortic-jet velocity ≥ 4.0 m/sec; and
• Has severe symptoms of heart failure (New York Heart Association (NYHA) class II or higher); and
• Is either:
  • Age 65 or older with any level of surgical risk; or
  • Under age 65 and at intermediate or higher surgical risk (≥3% predicted risk of death at 30 days), confirmed by two doctors.

Valve-in-valve TAVR may be appropriate in these situations:

• The person has a failing surgical bioprosthetic aortic valve (due to narrowing, leaking, or both); and
• Is at high or higher risk for open surgery (Society of Thoracic Surgeons [STS] score ≥8% or ≥15% chance of death at 30 days), confirmed by two doctors.

When is this not Clinically Appropriate?

TAVR is not appropriate when the medical situations described above are not met. Valve-in-valve TAVR inside a previously placed TAVR valve (called redo TAVR) has not been proven to improve health. Although it may work for some high-risk people, the evidence comes mostly from studies that are not high-quality. Redo TAVR is uncommon, and better studies are needed to understand its safety, effectiveness, and long-term results. TAVR cerebral protection devices are also not appropriate because they have not been shown to reduce stroke risk or improve health.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the codes listed above when criteria are not met.

When services are also Not Medically Necessary:
When the code describes a procedure indicated in the Clinical Indications section as not medically necessary (such as redo TAVR), or for the following procedure codes:

Summary

This document outlines evidence-based coverage criteria for aortic transcatheter heart valve (TAVR) procedures. The medical necessity criteria are aligned with U.S. Food and Drug Administration (FDA)-approved indications and a critical appraisal of clinical evidence, with emphasis on randomized controlled trials, long-term outcomes, and comparative effectiveness data. Additionally, they are aligned with the recommendations of respected expert organizations, including the American College of Cardiology (ACC), the American Heart Association (AHA), and the European Society of Cardiology (ESC).

Discussion

Transcatheter heart valve replacement is a less invasive alternative to conventional open-heart surgery that does not require cardiopulmonary bypass. A catheter-based approach allows delivery of an expandable prosthetic heart valve to the diseased native valve. The transfemoral (TF) vascular access approach has been associated with reduced vascular complications (Carrol, 2020). The 2020 ACC/AHA guideline (Otto, 2020) recommendations for TAVR in moderate or lower Society of Thoracic Surgeons (STS) risk individuals specify that the TF vascular access is the preferred approach. Registry data shows that more than 90% of TAVR in the U.S. is now performed with the TF approach. When TF access is not feasible, contemporary alternatives such as transcarotid, transaxillary/subclavian, or transcaval access are commonly used; transapical and direct transaortic approaches have become uncommon and are generally reserved for select situations.

Techniques and technologies for TAVR have evolved significantly since the original proof of concept reported by Cribner in 2002. TAVR was initially considered an option only for individuals considered inoperable for conventional surgical aortic valve replacement (SAVR). Proposed indications for transcatheter aortic valve replacement have expanded for selected individuals with lower surgical risk as more experience has been gained with this procedure. TAVR is sometimes labeled as transcatheter aortic valve implantation (TAVI). In this document we consider TAVR and TAVI to be equivalent terms and will refer to the procedure as TAVR.

The design and major outcomes of major clinical trials investigating TAVR are summarized below:

Outcomes are reported as TAVR vs. SAVR, respectively; RCT = Randomized Clinical Trial

A multicenter case series evaluated the outcomes of 345 TAVR procedures in 339 participants who presented with severe symptomatic aortic stenosis (AS) at very high or prohibitive surgical risk (Rodés-Cabau, 2010). The transfemoral [TF] approach was used in 168 and a transapical [TA] approach was used for 177. Outcome results were reported in 332 cases. These results showed a 30-day procedural success rate of 93.3% and 10.4% mortality (TF: 9.5%, TA: 11.3%). A survival rate of 76% was reported at 1-year follow-up, with most deaths resulting from non-cardiac conditions. This study demonstrated the feasibility of transcatheter valve replacement for individuals with extremely high risk of death from an open surgical replacement. It did not, however, compare TAVR to optimal medical management.

Leon and colleagues reported results of the PARTNER clinical trial in 2010. Cohort B of this study evaluated the safety and effectiveness of Edwards SAPIEN THV in a population of inoperable participants. Participants in Cohort B were randomized to treatment with TF TAVR or to standard therapy. There were 179 participants in each group. Individuals who did not have suitable femoral access were not enrolled. All enrolled participants had severe symptomatic AS with a functional NYHA class II or greater. Severe AS was defined by aortic-valve area of less than 0.8 cm², a mean aortic-valve gradient of 40 mm Hg or more, or a peak aortic-jet velocity of 4.0 m per second or more. At least two cardiovascular surgeon investigators had to agree that the individual was not a suitable candidate for surgery due to a predicted probability of 50% or more of either death within 30 days after surgery or a serious irreversible complication. Researchers categorized most participants as high risk based on Society of Thoracic Surgeons (STS) score (average 11 ± 6%). Some participants had lower Society of Thoracic Surgery (STS) scores but had pre-existing conditions that contributed to the surgeon’s rationale for deeming a participant ineligible for surgery.

There were 9 deaths (5.0%) in the TAVR group within 30 days of their procedure. In the standard care cohort, there were 5 deaths (2.8%) in the first 30 days after randomization. After 12 months, there were 55 deaths (30.7%) in the TAVR group compared to 89 deaths (49.7%) in the standard care group. After 1 year, participants treated with TAVR were more likely than those in standard care to have experienced a stroke (10.6% TAVR vs. 4.5% standard care), vascular complication (32.4% vs. 7.3%), or major bleeding episode (22.3% vs. 11.2%). Participants receiving standard care were more likely than those who received TAVR to have required repeat hospitalization (70.4% in standard care vs. 42.5% in TAVR), balloon aortic valvuloplasty (36.9 % vs. 0.6%), or open aortic valve replacement (9.5% vs. 1.1%).

The PARTNER trial provided more evidence of the feasibility of TAVR for severe symptomatic aortic stenosis. While showing significantly lower 12-month rates of death or need for rehospitalization, TAVR resulted in a markedly higher rate of stroke. The authors proposed that this could be due to the large diameter devices then in use and with the fact that TAVR was a new procedure with which many of the investigators needed to gain experience. An important limitation of the trial was its exclusion of individuals with significant coronary or peripheral vascular disease (PAD). Many individuals with severe symptomatic AS also have those conditions; estimates indicate 20-30% of the TAVR population have comorbid PAD (Mazzolai, 2024). In 2024, the ESC published guidelines for the management of peripheral arterial and aortic disease which endorse a Class 1 Level B recommendation for screening of ilio-femoral PAD prior to TAVR.

In 2011, based in part on the results of PARTNER, the FDA approved use of the Edwards Sapien Valve for individuals with severe calcific AS who were considered to be non-operable for conventional SAVR.

Smith and colleagues (2011) reported results from cohort A of the PARTNER trial in 2011. Cohort A included 699 individuals considered to be at high risk for mortality or a severe event following SAVR. Participants were randomized to receive TAVR or SAVR. The mortality rate (24.2% for TAVR vs. 26.8% for SAVR) and the rate of rehospitalization (18.2% TAVR vs. 15.5% SAVR) were comparable 1 year after the procedure. As observed for cohort B, the TAVR arm had higher rates of stroke (8.3% TAVR vs. 4.3% SAVR) and vascular complications (18.0% TAVR vs. 4.8% SAVR).

The FDA expanded its indications for TAVR in 2012 to include individuals with operative risk of greater than or equal to 8% or a risk of mortality greater than or equal to 15% with surgical valve replacement.

In 2016, the FDA expanded indications for the SAPIEN XT and SAPIEN 3 transcatheter heart valves to treatment of individuals with symptomatic severe calcific AS at intermediate or greater risk for open surgical therapy. This level of risk was defined as predicted risk of surgical mortality greater than or equal to 3% at 30 days as determined by at least two physicians.

The FDA approval for the SAPIEN XT and SAPIEN 3 devices was based on results from the PARTNER 2 trials (Leon, 2016). These were two parallel, prospective, multicenter, randomized trials that enrolled 2032 individuals with severe AS at intermediate surgical risk. Participants that met enrollment criteria were stratified in cohorts according to access route (transfemoral or transthoracic) then randomized at a 1:1 ratio to undergo TAVR or SAVR. In contrast to the PARTNER trials, PARTNER 2 allowed enrolment of individuals with noncomplex coronary artery disease requiring revascularization. In the SAVR arm, 77 of 1021 participants (7.5%) declined to undergo their assigned procedure. This compares to 17 of 1011 participants (1.7%) declining their procedure in the TAVR arm.

PARTNER 2 found comparable outcomes for TAVR and SAVR. After 2 years, the composite outcome of death from any cause or disabling stroke was 19.3% for TAVR and 21.1% for SAVR. TAVR resulted in larger aortic-valve areas and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation. SAVR resulted in fewer major vascular complications and less paravalvular aortic regurgitation. Major vascular complications occurred in 8.6% of those receiving TAVR as compared to 5.5% of those receiving SAVR. SAVR was more likely to result in life-threatening or disabling bleeding (47.0% vs. 17.3%). The SAVR group also had a higher rate of new atrial fibrillation (27.3% vs. 11.3%).

The authors of the PARTNER 2 trial concluded that TAVR, when performed by experienced centers using newer valve systems, was shown to be non-inferior to SAVR with regard to mortality or stroke. They also remarked that longer-term study was needed to evaluate the durability of outcomes for this procedure.

In 2020, Makkar and colleagues reported longer-term clinical outcomes after TAVR versus SAVR in the intermediate-risk population (PARTNER 2). At 5-year follow-up, at least mild paravalvular aortic regurgitation was more common in the TAVR group than the SAVR group (33.3% vs. 6.3%), as were repeat hospitalizations (33.3% vs. 25.2%) and aortic-valve interventions (3.2% vs. 0.8%). At 5 years, the improvement in health status was similar for the TAVR and SAVR groups. The authors concluded, “Among patients with aortic stenosis who were at intermediate surgical risk, there was no difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement.” A post-hoc study of registry data determined that 12.5% of participants in the trial required a permanent pacemaker implanted within 30 days of TAVR. The 5-year clinical outcomes data suggests that pacemaker implantation was not associated with worse clinical outcomes including mortality. Modifiable risk factors for pacemaker implantation included bioprosthetic valve oversizing, prostheses size and implantation depth (Chen, 2024).

Mack and colleagues reported preliminary results from the PARTNER 3 trial in 2019. This was a prospective, randomized, controlled, multicenter study evaluating the safety and effectiveness of the SAPIEN 3 transcatheter valve. The study compared TAVR to SAVR in individuals with severe symptomatic AS who were at low risk (STS < 4%) for surgery. There was no minimum age for inclusion. The mean age of participants was 73. The mean STS score was 1.9. Investigators randomized 1000 participants into two groups: 496 received TAVR and 465 received SAVR. After 1 year, the composite rate of death, stroke, or hospitalization was 8.5% for the TAVR group and 15.1% in the SAVR group (p<0.0001 for non-inferiority). As in PARTNER 2, a much larger number of participants in the SAVR arm declined their procedure (43 of 497 [8.7%] in the SAVR group compared to 7 of 503 [1.4%] in the TAVR group).

Popma and colleagues (2019) reported results from a pre-market, multicenter, international, prospective study evaluating TAVR with the Medtronic CoreValve Evolut THV systems to SAVR in individuals with severe AS (AVA of 1.0 cm² or less; AVA index of ≤ 0.6 cm² per square meter; mean gradient of 40 mm Hg or more; or maximal aortic-valve velocity of 4.0 m or more per second) and who were at low surgical risk (STS score ≤ 3%). The as-treated cohort included 1403 assigned participants, 725 in the TAVR group and 678 in the surgery group. At 24 months, the estimated incidence of death from any cause and disabling stroke were 4.5% and 1.1% in the TAVR group versus 4.5% and 3.5% in the surgery group. The authors concluded that TAVR was noninferior to SAVR with respect to death from any cause or disabling stroke at 2 years for participants in this trial. The 5-year results from this trial were published in 2025 and are discussed below (Forrest, 2025).

In September 2020, the ACC and AHA published an updated guideline for the management of valvular heart disease in adults (Otto, 2020). The panel offered recommendations for the choice between SAVR or TAVR for individuals for whom a bioprosthetic AVR is appropriate and for whom estimated risk is not high or prohibitive. In the guidelines, individuals with severe AS were defined by any of the following, (1) an AVA of equal to or less than 1.0 cm², or (2) an AVA index equal to or less than 0.6 cm²/m², or (3) a mean aortic valve gradient of at least 40 mm Hg, or (4) a peak aortic-jet velocity of more than 4.0 m/second.  The guidelines were based on the enrollment criteria in the PARTNER 3 (low risk), SURTAVI (intermediate risk) and EVOLUT (low risk) clinical trials. The authors new recommendations include treatment:

• For symptomatic patients with severe AS who are 65 to 80 years of age and have no anatomic contraindication to transfemoral TAVR, either SAVR or transfemoral TAVR is recommended after shared decision making about the balance between patient longevity and valve durability (Category 1A)
• For symptomatic patients with severe AS who are > 80 years of age or for younger patients with a life expectancy < 10 years and no anatomic contraindication to transfemoral TAVR, transfemoral TAVR is recommended in preference to SAVR (Category 1A)

The ACC/AHA recommendations are based on results from the PARTNER 3 study and the Medtronic Evolut Transcatheter Aortic Valve Replacement trials in low-risk individuals discussed above (Mack, 2019; Popma, 2019).

In 2021, Leon and colleagues reported follow-up results from the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-risk Patients with Aortic Stenosis) in individuals with symptomatic AS, comparing TAVR to SAVR. At 2 years, the primary composite endpoint was reached in 11.5% of participants in the TAVR group compared to 17.4% in the SAVR group. Mortality, strokes, TIAs, and rehospitalizations each occurred less frequently in the TAVR group than in the SAVR group. In 2023, 5-year data from the PARTNER 3 trial showed a TAVR compared to SAVR mortality rate of 10.0 compared to 9.0 and a rehospitalization rate 13.7 compared to 17.4 (Mack, 2023). In 2025, 7-year results from the same trial demonstrated no significant difference in long-term outcomes between TAVR and SAVR, with all-cause mortality of 19.5 % for TAVR versus 16.8 % for SAVR and stroke/TIA rates of 8.5 % and 8.1 %, respectively. Repeat cardiovascular hospitalization occurred in 20.6 % of the TAVR group and 23.5 % of the SAVR group. Hemodynamic performance and valve durability remained comparable through 7 years, with low rates of valve reintervention or structural deterioration (Leon, 2025).

The PARTNER 3 trial provides reassuring evidence that TAVR results in health outcomes comparable to SAVR 2 years after the procedure. The 2020 ACC/AHA guideline (Otto, 2020) notes that TAVR:

has a slightly lower mortality risk and is associated with a shorter hospital length of stay, more rapid return to normal activities, lower risk of transient or permanent atrial fibrillation, less bleeding, and less pain than SAVR. On the other hand, SAVR is associated with a lower risk of paravalvular leak, less need for valve reintervention, and less need for a permanent pacemaker.

These considerations form the basis for the 2020 ACC/AHA guideline 1A recommendation for either SAVR or transfemoral TAVR for individuals at low open surgical risk between the ages of 65-80 based on shared decision making about the balance between longevity and valve durability.

A prospective multicenter registry trial (NCT02628899) was conducted to assess the safety and feasibility of TAVR in individuals with symptomatic, severe AS who are at low risk (STS score ≤ 3%) for SAVR with either bicuspid or tricuspid native aortic valves (Rogers, 2017). This study was designed to have an estimated enrollment of 300 participants, 200 low-risk participants (up to 100 TAVR in bicuspid AS). While 30-day and 1-year outcome data are published, as of January, 2026, the ClinicalTrials.gov site for the study indicated that it was completed in January, 2023, but long-term, peer-reviewed published results are not yet available (Waksman, 2018 & 2019). The mean age of individuals enrolled in this clinical trial was 74 and the final study was planned to include outcomes at 2, 3, 4 and 5 year follow-up.

In 2024, Kowalowka and colleagues published 2-year data from a registry study, Aortic Valve Multicenter Registry (AVALON) which compared elective transfemoral TAVR to SAVR in low-risk individuals. A total of 922 individuals (SAVR n=593; TAVR n=329) were enrolled and included in the final analysis. A total of 88% of the participants were over 70 years of age. The 30-days post-procedure mortality was 3.32% (n=11 of 329) in the TAVR group and 3.03% (18 of 593) in the SAVR group (p=0.801). At 2-years, the mortality rates began to diverge in favor of the SAVR group with a 30% lower mortality (Hazard Ratio [HR], 0.70; 95% confidence interval [CI], 0.496-0.777; p=0.048).

In 2024, Thyregod and colleagues published 10-year results from the NordicAortic Valve Intervention (NOTION) clinical trial. This was the first trial to randomize low surgical risk participants to TAVR or SAVR. A total of 280 study participants were randomized to TAVR (n=145) with CoreValve bioprosthesis or SAVR (n=135) with a bioprosthesis. Eligible participants were all 70 years old or older. Individuals could participate if they had suitable anatomy regardless of their estimated surgical risk. The mean STS risk score, 3.0 ± 1.7 %, showed the cohort to be at low surgical risk. The baseline characteristics of the study arms were well balanced, with a mean age of 79 and 53-54% male. After 10-years of follow-up, the composite outcome of all-cause mortality, stroke, myocardial infarction, bioprosthetic valve failure, and endocarditis were not significantly different between the two groups. Both structural (HR, 0.2, 95% CI, 0.04-0.7; p=0.02) and nonstructural valve dysfunction (p<0.001) significantly favored the TAVR arm. The SAVR arm experienced an increased risk of new-onset atrial fibrillation relative to the TAVR arm (74.1% vs. 52.0%; p<0.01, respectively) and a significantly reduced risk of new permanent pacemaker placement (14.0 vs. 44.7; p<0.01, respectively).

In 2024, Blankenberg published 1-year results from a randomized noninferiority trial conducted across 38 sites in Germany. This study enrolled low and intermediate risk individuals aged 65 or older and randomized them to receive either TAVR (n=701) or SAVR (n=713). Enrolled participants had a mean age of 74 years and 57% identified as male. The median STS risk score was 1.8% (low surgical risk). Of note, 13.4% of the participants assigned to this study’s SAVR group either crossed over to the TAVR group (9.8%) or withdrew from the trial (3.6%) after randomization, a proportion that may have been driven by the participant’s desire to avoid open surgery. These numbers compare with only 2.3% of participants in the TAVR group who either crossed over to the SAVR group (1.7%) or withdrew from the trial (0.6%) The primary outcome was a composite of death from any cause or stroke at 1 year. This was reported for 5.4% in the TAVR group and 10.0% in the SAVR group (HR, 0.53; 95% CI, 0.35 to 0.79; p<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVR group and 6.2% in the SAVR group (HR, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (HR, 0.61; 95% CI, 0.35 to 1.06). Peri-procedural complications occurred in 1.5% and 1.0% of participants in the TAVR and SAVR groups, respectively and were not significantly different. The study authors noted that the incidence of primary and secondary outcomes were higher than expected and exceeded rates reported in other trials. They proposed that this could be a potential confounding effect from the COVID-19 pandemic occurring during the clinical trial period. In summary, this trial met its primary endpoint demonstrating noninferiority of TAVR compared to SAVR at 1 year for low surgical risk individuals who are 65 years or older.

In 2024, Généreux and colleagues published initial results from the EARLY TAVR trial, a prospective, multicenter, open-label RCT enrolling 901 individuals aged 65 or older with asymptomatic severe aortic stenosis. The majority (84%) of participants had low surgical risk. Participants were randomized to undergo early TAVR with medical therapy or to receive clinical surveillance with medical therapy alone. Asymptomatic status was confirmed in approximately 90% of enrolled individuals; however, around 10% may have had unrecognized symptoms, and no data were reported on whether this was balanced between study arms. The primary endpoint was a time-to-event composite of death from any cause, stroke, or unplanned cardiovascular hospitalization. At 2 years, 26.8% of the TAVR group and 45.3% of the surveillance group had reached the primary endpoint (HR, 0.50; 95% CI, 0.40-0.63; p<0.001), with the difference driven largely by a reduction in cardiovascular hospitalizations (20.9% vs. 41.7%). Rates of death (8.4 vs. 9.2) and stroke (4.2 vs. 6.7) were not significantly different between the TAVR and surveillance arms. During the median follow-up of 3.8 years, 87% of the surveillance cohort crossed over and received TAVR. Almost all (97%) of the 388 participants crossing over from clinical surveillance to TAVR did so because of symptomatic heart failure. Five-year follow-up is ongoing (NCT03042104). This study highlights the need for continued evaluation of long-term benefits and risks of TAVR as a treatment for asymptomatic severe aortic stenosis.

On April 30, 2025, the FDA approved an expanded indication for the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems to include treatment of individuals with asymptomatic severe native calcific aortic stenosis. This approval was intended to reduce the risk of progression from asymptomatic to symptomatic severe aortic stenosis in individuals deemed suitable candidates for TAVR by a multidisciplinary heart team, as current guidelines recommend routine clinical surveillance every 6 to 12 months. This decision was based on the EARLY TAVR trial discussed above (Généreux, 2024).

In 2025, Mehaffey and colleagues analyzed Medicare data comparing TAVR to SAVR in low-risk Medicare beneficiaries from 2018 to 2020. The study included 77,885 TAVR and 33,210 SAVR procedures. After risk adjustment, TAVR was associated with lower in-hospital mortality (0.62% vs. 1.06%), stroke (0.45% vs. 0.68%), and major bleeding (2.6% vs. 6.6%) but higher rates of pacemaker implantation (14.2% vs. 6.3%) and readmission (17.9% vs. 14.9%). Long-term outcomes favored SAVR with better survival at 3 years. Subgroup analysis in individuals aged 75 years or older showed that TAVR had lower in-hospital mortality and stroke, but higher readmission and pacemaker rates. The study suggests that TAVR has a favorable short-term safety profile in low-risk Medicare beneficiaries. The finding of a potential survival advantage with SAVR after 3 years of follow up underscores the need for longer follow-up and randomized studies in low-risk individuals.

In 2025, Forrest and colleagues reported 5-year outcomes from the Evolut Low Risk trial comparing self-expanding TAVR to SAVR in low surgical risk individuals with severe aortic stenosis. Two-year results of this are discussed above (Popma, 2019). Among 1414 individuals assessed 5 years after treatment, the composite endpoint of all-cause mortality or disabling stroke was similar between those who had TAVR (15.5%) and those who had open surgery (16.4%; p=0.47). Mortality rates, disabling stroke, cardiovascular and noncardiovascular deaths did not differ significantly. Valve performance remained durable with lower mean gradients and larger effective orifice area observed in the TAVR cohort. Quality of life improvements were sustained and comparable between groups. Pacemaker implantation rates were higher following TAVR (27.0% vs. 11.3%), whereas atrial fibrillation incidence was more frequent after surgery (41.2% vs. 16.3%). Rates of reintervention, valve thrombosis, myocardial infarction, and major bleeding were similar. This trial demonstrated that TAVR and SAVR had comparable safety and efficacy 5 years after the procedure. The average age of participants at the time of surgery was 73 and the findings of this trial may not be applicable to younger individuals.

Requirement for Multidisciplinary Evaluation:

All of the major trials assessing the effects of TAVR required multi-physician confirmation of eligibility for the procedure. An informed decision to pursue an intervention may be optimized when a multidisciplinary team with primary care physicians, cardiologists, interventional cardiologists, cardiac surgeons, individuals, and family members communicate and proceed in a coordinated, interdisciplinary manner. Depending on the individual's unique circumstance, additional multidisciplinary team members may include other subspecialty consultants (e.g., hematology, oncology, pulmonology). Care may be optimized by leveraging the expertise and experience of subspecialists, each of whom can weigh in on the nuances of an individual’s disease state relevant to their presenting illness.

TAVR Valve-in-Valve:

In a study published by Dvir and colleagues in 2014, the authors noted that increasing use of bioprosthetic rather than mechanical aortic valves was leading to an increasing prevalence of issues with degeneration of these bioprostheses. They reported results from a multinational (55 centers) valve-in-valve (ViV) registry that included 459 participants (mean age 77.6 years) with a degenerated aortic valve bioprosthesis who underwent ViV implantation using balloon or self-expandable THV. At 30 days post procedure, 35 (7.6%) deaths were reported. A higher mortality rate was reported for the stenosis group (10.5%) when compared to the regurgitation group (4.3%) and to the combined group (7.2%) (p=0.04). There was no difference between the self-expandable and balloon expandable ViV device groups in terms of mortality or stroke rates. Participants who received balloon-expandable valves experienced more major or life-threatening bleeding and acute kidney injury, while those in the self-expanding valve group had more permanent pacemaker implantations. The authors concluded, “In this registry of patients who underwent transcatheter ViV implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprosthetic valves and in those with predominant surgical valve stenosis.” Since this study did not compare ViV to open treatment of bioprosthetic valve degeneration, it does not permit conclusions to be drawn about the relative effectiveness of transcatheter and open procedures.

In March 2015, the FDA expanded approval of the CoreValve System TAVR as a ViV treatment for individuals with failure (either stenosed, insufficient, or combined) of a bioprosthetic aortic valve identified as having a high or greater risk for open surgical therapy by a heart team including an interventional cardiologist. FDA specified high or greater surgical risk as STS operative risk score greater than or equal to 8% or at a 15% or greater risk of operative mortality at 30 days. The FDA indication is based on preliminary data collected from 143 participants in registry 6 of the “TAV-in-SAV” observational study (NCT01675440).

In October 2015, Edwards Lifesciences received expanded approval for use of the SAPIEN XT THV for ViV implantation in individuals with failure (either stenosed, insufficient, or combined) of a bioprosthetic aortic valve who had been identified as having a high or greater risk for open surgical therapy by a heart team including a cardiac surgeon . FDA specified high or greater surgical risk as STS operative risk score greater than or equal to 8% or at a 15% or greater risk of operative mortality at 30 days. The FDA approval was based on cohort B of the PARTNER II trial (NCT01314313) with 197 ViV participants treated and the SOURCE XT registry including 57 participants who had a SAPIEN XT valve inserted into a failing bioprosthetic valve.

Several systematic reviews and meta-analyses compare ViV TAVR to redo SAVR for degenerated bioprosthetic valves. These analyses consistently show that ViV TAVR is associated with significantly lower 30-day mortality and major bleeding rates, as well as shorter hospital stays, despite the fact that individuals undergoing ViV TAVR generally have higher baseline surgical risk and more comorbidities. In contrast, redo SAVR is associated with lower rates of paravalvular leak, severe prosthesis-patient mismatch (PPM), and postoperative mean aortic valve gradients. Mid- to long-term mortality and cardiovascular outcomes appear comparable between ViV TAVR and redo SAVR; however, limited follow-up duration and study heterogeneity limit definitive conclusions. The higher incidence of PPM and elevated gradients after ViV TAVR may impact long-term valve durability. Prospective randomized trials are needed to clarify optimal treatment strategies, particularly for younger or lower-risk individuals (Ahmed 2021; Nasir, 2024; Saleem; 2021; SaMBPO 2021; Thandra, 2021).

In 2024, Tran and colleagues published data from a retrospective registry cohort study that identified 375 matched pairs of individuals who underwent ViV TAVR or redo SAVR after a previous SAVR performed between 1995 and 2014. Records for review were obtained from registries maintained by state health officials in California, New York, and New Jersey. In order to focus more on individuals whose indication for reintervention was structural valve degeneration or failure, the authors excluded individuals who had their reintervention within 5 years of their initial SAVR procedure. The matched pairs were identified through propensity matching based on available demographic information. The authors did not have access to STS risk scores, so they computed frailty index scores using claims information. This study’s primary outcome was all-cause mortality that was confirmed using public vital records sources. The study reported the following outcomes:

There were no significant differences in the 5-year incidence of stroke, reoperation, major bleeding, or infective endocarditis. This retrospective registry study found similar mortality rates for ViV TAVR and redo SAVR through approximately 2 years post-procedure; however, long-term follow-up showed significantly greater mortality in the ViV TAVR group beginning 2 years after the procedure and increasing through 5 years after the procedure. The authors note significant limitations related to this study’s reliance on administrative data that may not have reported potential confounding factors. A prospective randomized trial comparing ViV TAVR to redo SAVR is needed to better understand the relative effectiveness of these two treatments.

Redo TAVR

Several multicenter registry and case series investigations have evaluated clinical outcomes following redo TAVR performed for transcatheter valve dysfunction or significant paravalvular regurgitation (Barbanti 2016; Landes 2020; Makkar; 2023; Percy 2021; Tang 2023).

These large, multicenter registries, including the Redo-TAVR, EXPLANTORREDO-TAVR, FRANCE 2/FRANCE TAVI, STS/ACC TVT, and international multicenter collaborations, show that redo TAVR accounted for less than 1% of all TAVR procedures performed during the study periods (2009 to 2022), indicating that repeat intervention remains uncommon. The index transcatheter valves were typically first- or second-generation CoreValve, Evolut, or Sapien devices, and the most frequent valves used for redo procedures were next-generation self-expanding (Evolut R/PRO) or balloon-expandable (Sapien 3) systems. Median time from initial implantation to reintervention ranged from approximately 2 to 5 years, depending on the study population and underlying mechanism of valve failure. Data derived from these studies reflect retrospective or registry-based cohort analyses rather than randomized comparisons.

Barbanti and colleagues (2016) pooled data from 14 centers in Europe and North America, with all included individuals treated prior to 2015. The international Redo-TAVR Registry (Landes, 2020) was a multicenter observational registry that reported outcomes after 212 redo-TAVR procedures using self-expanding Evolut valves with procedures performed at 37 centers across Europe, North America, and the Middle East. Percy and colleagues (2021) analyzed U.S. Medicare data from 2012 to 2017 to provide the first nationally representative cohort. The EXPLANTORREDO-TAVR Registry (Tang, 2023) prospectively enrolled 396 reinterventions from 2009 through 2022 across 29 international sites. The STS/ACC TVT Registry analysis (Makkar, 2023) evaluated 365, 188 TAVR procedures using balloon-expandable Sapien3 valves between 2011 and 2022, identifying 1320 redo cases with balloon-expandable valves. The FRANCE 2/FRANCE TAVI Registries (Durand, 2025) captured 72,850 TAVR procedures performed between 2010 and 2022, using national linked datasets.

Across these registries, redo TAVR demonstrated high procedural success (85-95%) and low periprocedural complication rates. In the pooled experiences reported by Barbanti and Landes, rates for hospital mortality were 0-2.9%, stroke ≤ 2%, and major vascular complications < 5%. Mean post-redo transvalvular gradients ranged between 12-15 mm Hg, with mild or no regurgitation in over 90% of cases. Survival at 1 year after redo TAVR ranged between 85-90%.

In national cohorts (Durand, 2025; Makkar, 2023; Percy, 2021), short-term mortality after redo TAVR ranged between 5-7% at 30 days and approximately 20% at 1 year. Short term mortality for redo TAVR was lower than seen for surgical explantation and comparable to primary TAVR in similarly aged populations. Durand (2025) reported an 8-year cumulative reintervention rate of 1.7% (0.9% redo-TAVR, 0.8% explant), with median interval of about 0.5 years after redo TAVR and 0.6 years after explant, with 6-year mortality between 65-75%. Makkar (2023) found no difference in 30-day or 1-year death or stroke between redo TAVR and matched primary TAVR, and similar quality-of-life gains.

The earlier multicenter studies primarily assessed first-generation self-expanding CoreValve and balloon-expandable Sapien prostheses. Later national and international registries incorporated Evolut R/PRO and Sapien 3 devices. Durand (2025) and Makkar (2023) reflect outcomes in contemporary practice dominated by these newer valves.

These registry studies have the following strengths and limitations:

Strengths

• Inclusion of large, multicenter or national registries capturing real-world practice across multiple valve generations.
• Consistent use of standardized endpoint definitions (VARC-2/3).
• Comparative analyses between redo TAVR, surgical explantation, and native-valve TAVR cohorts.
• Longitudinal follow-up (up to 8 years in Durand 2025).

Limitations

• Observational and retrospective designs subject to selection bias and incomplete follow-up.
• Small absolute numbers of redo procedures (< 1% of TAVR population).
• Heterogeneity in valve type, procedural technique, and timing of reintervention.
• Earlier registries primarily evaluated first- and second-generation transcatheter valves, which differ from contemporary devices in design and performance characteristics, limiting the applicability of their findings to current valve technology.
• Limited long-term data on structural valve durability beyond 5 years after redo TAVR.

The studies reported by Percy, Tang, Makkar, and Tang included direct or matched comparisons between redo TAVR and surgical explantation for failed transcatheter valves. In these studies, individuals selected for redo TAVR differed substantially from those who underwent surgical explantation, limiting direct comparison of outcomes. As noted by Percy and colleagues,

…comparison of repeat TAVR versus TAVR explantation is limited by the potential for unmeasured confounders related to patient selection. Repeat TAVR is likely offered to patients who are not surgical candidates, and surgery is offered only to those patients deemed to be of acceptable risk for surgery. Thus, this comparison should be viewed as an exploratory analysis.

These clinical differences reflect selection bias inherent in observational datasets and preclude meaningful head-to-head comparison of procedural risk or long-term outcomes between redo TAVR and explant cohorts.

In 2022, Gallo and colleagues conducted systematic review without meta-analysis for data reported in 13 studies (1 multicenter registry, 3 case series, and 9 case reports). These studies analyzed outcomes of redo-TAVR after failed balloon-expandable or self-expanding devices in 163 individuals across 13 Italian centers. More than 85% of the reported results came from a single source, the registry reported by Landes as described above. The data were derived primarily from uncontrolled case reports that had no comparator arm, randomization, or adjustment for confounding. Procedural success was reported as being 91%, with a 30-day mortality of 4.3% and stroke rate of 1.8%. At 2 years, survival was 69%, with higher mortality in those presenting with baseline regurgitation. The study was limited by observational design and modest cohort size.

In 2023, Gilbert and colleagues examined single-center outcomes of 68 redo-TAVR procedures. Procedural success was 93%, with no in-hospital deaths. At 1 year, survival was 85%, though higher risk of coronary obstruction and challenges with coronary access were highlighted. The authors emphasized the importance of procedural planning and anatomy-specific risks. Study limitations included single-center design and short follow-up.

On August 28, 2025, the FDA approved an expanded indication for the Medtronic Evolut TAVR system to permit implantation of a new Evolut valve within a previously implanted transcatheter aortic valve for individuals with failure of a prior transcatheter aortic valve who are at high or greater risk for open surgical therapy. Approval was based on the RESTORE trial, an ongoing prospective, multicenter, observational study (n=225) to evaluate short- and long-term outcomes following Redo-TAVR, including mortality, stroke, procedural success, and health status through 5 years of follow-up. The study commenced in 2025 with estimated completion in 2033 (NLM Identifier: NCT06777368). At the time of FDA approval, no pivotal trial data were available in the published, peer-reviewed literature. The updated FDA label expansion is forthcoming.

Overall, the registry and case series evidence portrays redo TAVR as a technically feasible and relatively safe management option for failed transcatheter valves; , however, the current evidence base consists of predominantly observational registry and case-series data, without randomized or long-term comparative outcomes. The consistently high procedural success and acceptable short-term outcomes across diverse registries suggest that redo TAVR can be performed with risk similar to initial TAVR in appropriately selected individuals. However, the rarity of redo TAVR underscores the limited clinical experience available to define optimal selection criteria. Differences in outcomes between redo TAVR and surgical explantation largely reflect selection bias rather than intrinsic procedural efficacy, as those referred for redo TAVR are often older and less suitable for surgery. Earlier registry experience, based on obsolete valve designs, provides reassurance regarding procedural feasibility but limited insight into current practice, while newer datasets incorporating Evolut R/PRO and Sapien 3 devices better represent present outcomes. Overall, redo TAVR appears to offer a practical means of managing transcatheter valve failure in high-risk individuals, but the field still lacks randomized evidence or long-term durability data sufficient to establish it as an equivalent alternative to surgical replacement.

TAVR Embolic Protection Device

In 2020, the FDA provided 510(k) premarket clearance for the Sentinel™ Cerebral Protection System (Boston Scientific Corporation) for use in individuals with aortic stenosis undergoing TAVR. The device consists of two filters placed percutaneously from the right radial or brachial artery in the brachiocephalic artery (proximal filter) and the left common carotid artery (distal filter) before TAVR. The device is removed once TAVR is complete.

In 2022, Kapadia and colleagues conducted a RCT to assess the safety and efficacy of the Sentinel Cerebral Protection device during TAVR procedures. The study’s primary outcome was stroke within 72 hours of TAVR or prior to discharge. Secondary outcomes included disabling stroke, all-cause mortality, TIA, delirium, and acute kidney injury. In total, 3000 participants were randomized 1:1 to receive the embolic protection device (n=1406, successfully implanted [94% of those attempted]) and 1499 to the control group. The incidence of stroke during the follow-up period did not differ significantly between the intervention and control arms (2.3% vs. 2.9%; p=0.30). The study did not demonstrate a significant difference between the intervention arm and the control arm in mortality, stroke, TIA, delirium, or acute kidney injury. One vascular complication was reported at the cerebral embolic protection device access site. This RCT did not demonstrate added clinical benefit from implantation of a cerebral embolic protection device in the first 72 hours following TAVR.

In 2023, Wolfrum and colleagues published results of a prospective real-world registry of individuals undergoing TAVR with the Sentinel Cerebral Protection System. Participants with severe aortic stenosis undergoing TAVR were enrolled. The Sentinel Cerebral Protection System was successfully deployed in 330 participants (85%, Group 1) and was either not attempted, unsuccessful or only partially successful in 59 participants (15%, Group 2). Debris was captured in 98% of Group 1. The amount of debris was graded moderate or extensive for 40% of this group. The risk of stroke was numerically lower in participants who underwent TAVR with the Sentinel Cerebral Protection System but this reduction did not meet statistical significance (2.1 vs. 5.1%, respectively, p=0.15). No strokes occurred during Cerebral Protection System indwelling, but one participant experienced a stroke immediately after device retrieval. This registry study did not demonstrate an added clinical benefit from implantation of a cerebral embolic protection device.

Large registry studies (n=416) and meta-analyses continue to demonstrate little effect on stroke distribution, severity, and outcomes with the use of cerebral protection devices during TAVR (Balata, 2025; Levi, 2024; Warraich, 2025). On October 24, 2024 the BHF-PROECT-TAVI trial (target sample, n=7730) was halted early after the data monitoring committee determined that “there is little prospect of demonstrating a benefit in the primary endpoint” and furthermore that they “could not rule out the potential for harm” (Kharbanda, 2023). Other cerebral protection devices are being evaluated in on-going clinical trials, such as the TriGUARD 3 cerebral embolic protection device CEPD (Daal, 2023; Heuts, 2024). FDA clearance for cerebral embolic protection devices was based on device performance and substantial equivalence rather than demonstration of improved clinical outcomes such as stroke reduction.

*The FDA has approved marketing of the following aortic THV devices:

Aortic valve stenosis: Also known as aortic stenosis, this form of valvular heart disease is characterized by narrowing of the aortic valve opening.

Congenital heart disease (CHD): Heart problems present at birth.

Premarket Approval (PMA): The most stringent type of device marketing application required by the FDA. A PMA is an application submitted to the FDA to request clearance to market or to continue marketing of a Class III medical device. Class III medical devices are those devices that present significant risk to the individual and/or require significant scientific review of the safety and effectiveness of the medical device prior to commercial introduction. Frequently the FDA requires follow-up studies for these devices.

Prosthesis-patient mismatch (PPM): Occurs when the effective orifice area of the implanted valve is insufficient relative to the individual’s body size, resulting in elevated transvalvular gradients.

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62. Rodés-Cabau J, Webb JG, Cheung A, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010; 55(11):1080-1090.
63. Rogers T, Torguson R, Bastian R, et al. Feasibility of transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis: rationale and design of the Low Risk TAVR (LRT) study. Am Heart J. 2017; 189:103-109.
64. Saleem S, Ullah W, Syed MA, et al. Meta-analysis comparing valve-in-valve TAVR and redo-SAVR in patients with degenerated bioprosthetic aortic valve. Catheter Cardiovasc Interv. 2021; 98(5):940-947
65. Sá MPBO, Van den Eynde J, Simonato M, et al. Valve-in-valve transcatheter aortic valve replacement versus redo surgical aortic valve replacement: an updated meta-analysis. JACC Cardiovasc Interv. 2021; 14(2):211-220.
66. Shimamura J, Kuno T, Malik A, et al. Safety and efficacy of cerebral embolic protection devices in patients undergoing transcatheter aortic valve replacement: a meta-analysis of in-hospital outcomes. Cardiovasc Interv Ther. 2022; 37(3):549-557.
67. Silva I, Alperi A, Hecht S, et al. Echocardiographic results of transcatheter versus surgical aortic valve replacement in women with severe aortic stenosis: The RHEIA Trial. J Am Heart Assoc. 2026; 15(1):e047196.
68. Siontis GCM, Overtchouk P, Cahill TJ, et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis. Eur Heart J. 2019; 40:3143-3153.
69. Smith CR, Leon MB, Mack MJ, et al.; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23):2187-2198.
70. Tang GHL, Zaid S, Kleiman NS, et al. Explant vs redo-TAVR after transcatheter valve failure: mid-term outcomes from the EXPLANTORREDO-TAVR International Registry. JACC Cardiovasc Interv. 2023; 16(8):927-941.
71. Tchetche D, Pibarot P, Bax JJ, Bonaros N, et al. Transcatheter vs. surgical aortic valve replacement in women: the RHEIA trial. Eur Heart J. 2025; 46(22):2079-2088.
72. Thourani VH, Forcillo J, Beohar N, et al. Impact of preoperative chronic kidney disease in 2,531 high-risk and inoperable patients undergoing transcatheter aortic valve replacement in the PARTNER trial. Ann Thorac Surg. 2016; 102(4):1172-1180.
73. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016; 387(10034):2218-2225.
74. Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010; 122(1):62-69.
75. van Bergeijk KH, van Ginkel DJ, Brouwer J, et al. Sex differences in outcomes after transcatheter aortic valve replacement: a POPular TAVI Subanalysis. JACC Cardiovasc Interv. 2023; 16(9):1095-1102.
76. Van Mieghem NM, Deeb GM, Søndergaard L, et al. Self-expanding transcatheter vs surgical aortic valve replacement in intermediate-risk patients: 5-year outcomes of the SURTAVI randomized clinical trial. JAMA Cardiol. 2022; 7(10):1000-1008.
77. Waksman R, Corso PJ, Torguson R, et al. TAVR in low-risk patients: 1-year results from the LRT Trial. JACC Cardiovasc Interv. 2019; 12(10):901-907.
78. Waksman R, Rogers T, Torguson R, et al. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol. 2018; 72(18):2095-2105.
79. Warraich N, Sá MP, Jacquemyn X, et al. Cerebral embolic protection devices in transcatheter aortic valve implantation: meta-analysis with trial sequential analysis. J Am Heart Assoc. 2025; 14(7):e038869.
80. Wolfrum M, Moccetti F, Loretz L, et al. Cerebral embolic protection during transcatheter aortic valve replacement: insights from a consecutive series with the Sentinel cerebral protection device. Catheter Cardiovasc Interv. 2023; 102(2):339-347.
81. Zahr F, Ramlawi B, Reardon MJ, et al. 3-Year Outcomes from the Evolut low risk TAVR bicuspid study. JACC Cardiovasc Interv. 2024; 17(14):1667-1675.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Arbelo E, Protonotarios A, Gimeno JR, et al. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023; 44(37):3503-3626.
2. Baumgartner H, Backer J, Babu-Narayan SV, et al. 2020 ESC Guidelines for the management of adult congenital heart disease: the Task Force for the management of adult congenital heart disease of the European Society of Cardiology (ESC). Eur Heart J. 2020; 42(6):563-645.
3. Baumgartner H, Bonhoeffer P, De Groot NM, et al. European Society of Cardiology (ESC). ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). The task force on the management of grown-up congenital heart disease of the European Society of Cardiology (ESC). Eur Heart J. 2010; 31(23):2915-57.
4. Bonow RO, Carabello BA, Kanu C, et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of patients with valvular heart disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation. 2008; 118:e523-e661.
5. Centers for Disease Control and Prevention (CDC). About valvular heart disease. Updated September 5, 2024. Available at: https://www.cdc.gov/heart-disease/about/heart-valve-disease.html?CDC_AAref_Val=https://www.cdc.gov/heart-disease/about/valvular-heart-disease.html?CDC_AAref_Val=https://www.cdc.gov/heartdisease/valvular_disease.htm. Accessed on December 05, 2025. 
6. Durko AP, Pibarot P, Atluri P, et al. Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force. Ann Thorac Surg. 2021; 111(1):314-326.
7. Edwards Lifesciences. EARLY TAVR: Evaluation of TAVR compared to surveillance for patients with asymptomatic severe aortic stenosis (EARLY TAVR). NLM Identifier: NCT03042104. Last updated May 13, 2024. https://clinicaltrials.gov/study/NCT03042104. Accessed on December 05, .
8. Edwards Lifesciences. The PARTNER 3 - Trial - the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in low risk patients with aortic stenosis (P3). NLM Identifier: NCT02675114. Last updated November 29, 2024. Available at: https://clinicaltrials.gov/ct2/show/NCT02675114. Accessed on December 05, 2025.
9. Holmes DR, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement, Journal of the American College of Cardiology. 2012; 59(13):1200-54. d.
10. Jneid H, Chikwe J, Arnold SV, et al. 2024 ACC/AHA clinical performance and quality measures for adults with valvular and structural heart disease: a report of the American Heart Association/American College of Cardiology Joint Committee on Performance Measures. Circ Cardiovasc Qual Outcomes. 2024; 17(4):e000129.
11. Kolkailah AA, Doukky R, Pelletier MK, et al. Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis in people with low surgical risk. Cochrane Database Syst Rev. 2019;(12):CD013319.
12. Mazzolai L, Teixido-Tura G, Lanzi S, et al. 2024 ESC guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J. 2024: ehae179.
13. Medtronic Cardiovascular. Medtronic Evolut transcatheter aortic valve replacement in low risk patients. NLM Identifier: NCT02701283. Last updated May 01, 2025. Available at: https://clinicaltrials.gov/ct2/show/NCT02701283. Accessed on December 05, 2025.
14. Medtronic Cardiovascular. REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE (RESTORE). NLM Identifier: NCT06777368. Last updated on December 22, 2025. Available at: https://www.clinicaltrials.gov/study/NCT06777368?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(aortic%20valve%20stenosis)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING))&rank=5. Accessed on December 05, 2025.
15. Medtronic Cardiovascular. Safety and efficacy study of the Medtronic CoreValve System in the treatment of severe, symptomatic aortic stenosis in intermediate risk subjects who need aortic valve replacement (SURTAVI). (SURTAVI). NLM Identifier: NCT01586910. Last updated on October 28, 2025. Available at: https://clinicaltrials.gov/ct2/show/NCT01586910. Accessed on December 05, 2025.
16. Nishimura R, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2017; 70(2):252-289.
17. Ommen SR, Ho CY, Asif IM, et al. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR guideline for the management of hypertrophic cardiomyopathy: a report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2024; 149(23):e1239-e1311.
18. Otto CM, Nishimura RA, Bonow RO, et al. 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. Circulation. 2020; available at: https://www.ahajournals.org/doi/10.1161/CIR.0000000000000923?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub  0pubmed. Accessed on December 05, 2025.
19. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling. Abbott PORTICO with FLEXNAV Transcatheter Aortic Valve Implantation System. Premarket approval application No. P190023. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190023. Accessed on December 05, 2025.
20. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling. Abbott PORTICO Navitor™ Transcatheter Aortic Valve Implantation (TAVI) System. Premarket approval application No. P190023/S002. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190023S012. Accessed on December 05, 2025.
21. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Boston Scientific Corporation, Sentinel Cerebral Protection System. 501(k) No. K192460. Maple Grove, MN: January 21, 2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192460.pdf. Accessed on December 05, 2025.
22. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling. Medtronic CoreValve Evolute Pro System. Premarket approval application No. P130021/S029. March 20, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S029. Accessed on December 05, 2025.
23. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System. Premarket Approval application No. P13022/S058. Rockville, MD: August 16, 2019. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S058. Accessed on December 05, 2025.
24. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Medtronic CoreValve System. Premarket approval application No. P130021/S033. Rockville, MD: July 10, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S033. Accessed on December 05, 2025.
25. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3 Transcatheter Heart Valve. Premarket approval No. P140031/S028. Rockville, MD. June 5, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140031S028. Accessed on December 05, 2025.
26. U.S. Food and Drug Administration (FDA). Centers for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve. Premarket approval No.P140031/S074. Rockville, MD. December 27, 2018. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140031S074. Accessed on December 05, 2025.
27. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN XT Transcatheter Heart Valve (THV) with the NovaFlex+ Delivery System. Premarket approval application No. P130009/S037. Rockville, MD: February 29, 2016. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130009S037. Accessed on December 05, 2025.
28. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN XT Transcatheter Heart Valve (THV) Model 9300TFX, 23, 26, and 29mm and accessories. Premarket approval application No. P130009/S057. Rockville, MD: August 18, 2016. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S057d.pdf. Accessed on December 05, 2025.
29. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System Premarket approval application No. P200015. Rockville, MD: August 31, 2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200015B.pdf. Accessed on December 05, 2025.
30. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System. Summary of Safety and Effectiveness. No. P140031/S162. Rockville, MD: May 23, 2024. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031S162B.pdf. Accessed on December 05, 2025.
31. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and Labeling: Edwards SAPIEN 3 Transcatheter Heart Valve System. Premarket approval application No. P140031/S182. Rockville, MD: April 30, 2025. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140031S182. Accessed on June 23, 2025.
32. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Medtronic CoreValve System. Premarket approval application No. P130021/S002. June 12, 2014. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S002. Accessed on December 28, 2025.
33. Vahanian A, Alfieri O, Al-Attar N, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European association of cardio-thoracic surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). EuroIntervention. 2008; 4(2):193-199.
34. Vahanian, A, Baumgartner H, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Available at https://scc.org.co/wp-content/uploads/2018/10/2021-ESCEACTS-Guidelines-for-the-management-of-valvular-heart-disease-1.pdf. Accessed on December 05, 2025.
35. Vahanian A, Beyersdorf F, Praz F, et al. 2024 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J. 2024; 45(15):1255-1356.

1. American Heart Association. Available at: https://www.heart.org/. Accessed on December 05, 2025.
2. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Humanitarian Use Devices. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm. Accessed on December 05, 2025.

Aortic valve replacement (AVR)
Edwards SAPIEN XT transcatheter heart valve
Edward SAPIEN 3 transcatheter heart valve
Edward SAPIEN 3 Ultra transcatheter heart valve
Medtronic CoreValve Evolut PRO System
Medtronic CoreValve Evolut R System
Medtronic CoreValve Systems
Medtronic Evolut PRO+ System
PORTICO Transcatheter Aortic Valve Implantation System
Prosthetic heart valve
Transcatheter aortic valve implantation (TAVI)
Transcatheter aortic valve replacement (TAVR)
Transcatheter heart valve (THV)
Valvular heart disease

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