Transcatheter Aortic Valve Replacement (TAVR)

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A. Decision The Centers for Medicare & Medicaid Services (CMS) has updated the NCD to: 1) cover Transcatheter Aortic Valve Replacement (TAVR) for symptomatic severe aortic valve stenosis (or aortic stenosis (AS)) without the coverage with evidence development (CED) requirement; 2) expand coverage of TAVR to asymptomatic severe AS with CED; 3) revise coverage criteria related to pre-procedural patient assessment, intraoperative requirements, and operator and hospital procedural volume requirements. B. Coverage Criteria TAVR for severe AS is covered when furnished with a complete aortic valve and implantation system that has received Food and Drug Administration (FDA) premarket approval (PMA) for that system’s FDA-approved indication, and the following conditions are met. 1. Patient Criteria TAVR is covered for the treatment of Medicare beneficiaries with: Symptomatic severe AS under § 1862(a)(1)(A) of the Social Security Act (the Act). Asymptomatic severe AS under CED, § 1862(a)(1)(E) of the Act. Provisions in B2 and B3 below apply to all TAVR procedures furnished under the NCD; provision B4 applies only to TAVR procedures furnished under CED. 2. Physician and Heart Team Criteria Heart Team : The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary team of medical professionals with a specialized focus in cardiac care. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Heart teams include the following: At least one cardiac surgeon and one interventional cardiologist experienced in the care and treatment of aortic valve diseases and each with clinical privileges at the hospital where the TAVR will be furnished; and Advanced practice clinicians, nurses, administrators and, as needed, members from other physician specialties and research personnel. Patient Evaluation : Suitability for surgical aortic valve replacement (SAVR), TAVR, close surveillance, and palliative care must be evaluated based on individual clinical, anatomical, and procedural characteristics, and lifetime management considerations that account for patient life expectancy. These evaluations must be documented and made available to other heart team members, the patient, and other clinicians involved in the patient’s care as appropriate, prior to the day of the procedure. Evaluations must include: An initial evaluation by the heart team, which could be asynchronous using medical records to identify patient suitability for TAVR or other treatments, and includes input from both cardiac surgery and interventional cardiology; and An in-person evaluation by a heart team TAVR operator. This cannot be satisfied through a virtual encounter. An additional evaluation by a heart team TAVR operator is not required but is covered if performed. TAVR Operator : A TAVR operator must be an interventional cardiologist or cardiac surgeon member of the heart team and: Perform ≥ 20 total transcatheter cardiac valve (including aortic, mitral, tricuspid, or pulmonic valve) procedures, ≥ 15 of which must be TAVR, every year; or Perform ≥ 40 such procedures, ≥ 30 of which must be TAVR, every two years. Joint participation of two TAVR operators in a TAVR procedure is not required but is covered if determined appropriate by the heart team. If jointly performed, both must be TAVR operators from the heart team and can be from the same specialty or different specialties. 3. Hospital Criteria TAVR procedures must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to: On-site structural heart interventional cardiology and cardiac surgery programs. A post-procedure intensive care unit with personnel experienced in managing patients who have undergone open-heart valve procedures. A continuous quality improvement process that assesses procedural outcomes and makes necessary programmatic adjustments to assure patient safety. 4. CED Study Criteria TAVR items and services must be furnished for the treatment of asymptomatic severe AS with a complete aortic valve and implantation system that has received FDA PMA for that system’s FDA-approved indication, and in the context of a CMS-approved CED study. CED studies must meet requirements of sections B2 (Physician and Heart Team Criteria) and B3 (Hospital Criteria), have an active, contemporaneous comparator and address at least one of the following questions: Does TAVR, SAVR, or close surveillance until symptom onset better improve health outcomes? This is particularly relevant for patients with lower surgical risk, longer life expectancy, preserved left ventricular ejection fraction, and bicuspid aortic valves. What are the long-term valve re-intervention rates of TAVR and does having re-interventions impact health outcomes? Can other measures, for example longer term, risk-standardized, patient-centered health outcomes, replace volume criteria for TAVR operators? CMS-approved CED studies must adhere to the following scientific standards (criteria 1-17 below) that have been identified by the Agency for Healthcare Research and Quality (AHRQ) as set forth in Section VI of CMS’ Coverage with Evidence Development Guidance Document , published August 7, 2024 (the “CED Guidance Document”). Sponsor/Investigator: The study is conducted by sponsors/investigators with the resources and skills to complete it successfully. Milestones: A written plan is in place that describes a detailed schedule for completion of key study milestones, including study initiation, enrollment progress, interim results reporting, and results reporting, to ensure timely completion of the CED process. Study Protocol: The CED study is registered with ClinicalTrials.gov and a complete final protocol, including the statistical analysis plan, is delivered to CMS prior to study initiation. The published protocol includes sufficient detail to allow a judgment of whether the study is fit-for-purpose and whether reasonable efforts will be taken to minimize the risk of bias. Any changes to approved study protocols should be explained and publicly reported. Study Context: The rationale for the study is supported by scientific evidence, and study results are expected to fill the specified CMS-identified evidence deficiency and provide evidence sufficient to assess health outcomes. Study Design: The study design is selected to safely and efficiently generate valid evidence of health outcomes. The sponsors/investigators minimize the impact of confounding and biases on inferences through rigorous design and appropriate statistical techniques. If a contemporaneous comparison group is not included, this choice should be justified, and the sponsors/investigators discuss in detail how the design contributes useful information on issues such as durability or adverse event frequency that are not clearly answered in comparative studies. Study Population: The study population reflects the demographic and clinical diversity among the Medicare beneficiaries who are the intended population of the intervention, particularly when there is good clinical or scientific reason to expect that the results observed in premarket studies might not be observed in older adults or subpopulations identified by other clinical or demographic factors. Subgroup Analyses: The study protocol explicitly discusses beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion requirements effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial. In the protocol, the sponsors/investigators describe plans for analyzing demographic subpopulations as well as clinically relevant subgroups as identified in existing evidence. Description of plans for exploratory analyses, as relevant subgroups emerge, are also included. Care Setting: When feasible and appropriate for answering the CED question, data for the study should come from beneficiaries in their expected sites of care. Health Outcomes: The primary health outcome(s) for the study are those important to patients and their caregivers and that are clinically meaningful. A validated surrogate outcome that reliably predicts these outcomes may be appropriate for some questions. Generally, when study sponsors propose using surrogate endpoints to measure outcomes, they should cite validation studies published in peer-reviewed journals to provide a rationale for assuming these endpoints predict the health outcomes of interest. The cited validation studies should be longitudinal and demonstrate a statistical association between the surrogate endpoint and the health outcomes it is thought to predict. Objective Success Criteria: In consultation with CMS and AHRQ, sponsors/investigators establish an evidentiary threshold for the primary health outcome(s) so as to demonstrate clinically meaningful differences with sufficient precision. Data Quality: The data are generated or selected with attention to provenance, bias, completeness, accuracy, sufficiency of duration of observation to demonstrate durability of health outcomes, and sufficiency of sample size as required by the question. Construct Validity: Sponsors/investigators provide information about the validity of drawing warranted conclusions about the study population, primary exposure(s) (intervention, control), health outcome measures, and core covariates when using either primary data collected for the study about individuals or proxies of the variables of interest, or existing (secondary) data about individuals or proxies of the variables of interest. Sensitivity Analyses: Sponsors/investigators will demonstrate robustness of results by conducting pre-specified sensitivity testing using alternative variable or model specifications as appropriate. Reporting: Final result

Decision Memo: September 10, 2026 Table of Contents Decision Decision Coverage Criteria Patient Criteria Physician and Heart Team Criteria Hospital Criteria CED Study Criteria Other Uses of TAVR Clinical Evidence Review Background Food and Drug Administration Status Review of the Evidence: Methods Evidence Questions Related Work Clinical Literature Search and Selection Quality Assessment Review of Evidence from Primary Studies Study Characteristics Key Findings Quality of Evidence from Primary Studies Applicability to the Medicare Population Supplemental Evidence and Guidance Evidence from Meta-analyses Evidence-based Guidelines / Professional Society Recommendations / Consensus Statements / Other Expert Opinion Appropriate Use Criteria Evidence Summary Public Comment CMS Coverage Analysis CMS Coverage Authority CMS Analysis of Coverage of TAVR for Aortic Stenosis Rationale for Coverage Criteria Evidence Questions - Answered Benefit Category Termination of CED Shared Decision-Making Quality Measures History of Medicare Coverage Previous National Coverage Analysis Current National Coverage Request Timeline of NCA Milestones Appendices Appendix A: Medicare National Coverage Determinations Manual Language Appendix B: Referenced Materials and Supplemental Information Bibliography Abbreviations used throughout the Decision Memorandum for Transcatheter Aortic Valve Replacement (TAVR) ACC – American College of Cardiology AHA – American Heart Association AHRQ – Agency for Healthcare Research and Quality AS – Aortic Stenosis AV – Aortic Valve AVR – Aortic Valve Replacement AATS – American Association for Thoracic Surgery BEV – Balloon-Expandable Valve CABG – Coronary Artery Bypass Grafting CAV – Commercially Available Valves CDC – Centers for Disease Control and Prevention CED – Coverage with Evidence Development CI – Confidence Interval CMS – Centers for Medicare & Medicaid Services COPD – Chronic Obstructive Pulmonary Disease COVID – Coronavirus Disease CS – Clinical Surveillance CV – Cardiovascular DEDICATE-DZHK6 – Decisive Role of Transcatheter Aortic Valve Implantation Compared With Surgical Valve Replacement in Low-to-Intermediate-Risk Patients EACTS – European Association for Cardio-Thoracic Surgery eGFR – Estimated Glomerular Filtration Rate ESC – European Society of Cardiology ESRD – End-Stage Renal Disease EuroSCORE – European System for Cardiac Operative Risk Evaluation FDA – U.S. Food and Drug Administration FU – Follow-up GRADE – Grading of Recommendations Assessment, Development and Evaluation HF – Heart Failure HR – Hazard Ratio ICD – Implantable Cardioverter Defibrillator ITT – Intention-to-treat KCCQ – Kansas City Cardiomyopathy Questionnaire KM – Kaplan–Meier LV – Left Ventricle LRT – Low Risk TAVR MCID – Minimal clinically important differences MEDCAC – Medicare Evidence Development & Coverage Advisory Committee MEV – Mechanically-Expandable Valve MI – Myocardial Infarction N/A – Not Applicable NOTION – Nordic Aortic Valve Intervention NCA – National Coverage Analysis NS – Not Statistically Significant NYHA – New York Heart Association OR – Odds Ratio PARTNER – Placement of Aortic Transcatheter Valves PICOTS – Population, Intervention, Comparator, Outcomes, Timing, Setting RCT – Randomized Controlled Trial RHEIA trial - Randomized researcH in womEn all comers wIth Aortic stenosis RR – Relative Risk SAVR – Surgical Aortic Valve Replacement SCAI – Society for Cardiovascular Angiography and Interventions SD – Standard Deviation SEV – Self-Expanding Valve SHD – Structural Heart Disease SLR – Systematic Literature Review SMART – Small Annuli Randomized to Evolut or SAPIEN Trial SOLVE TAVI - CompariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anaesthesia in Transcatheter Aortic Valve Implantation STS PROM – Society of Thoracic Surgeons Predicted Risk of Mortality SURTAVI – Surgical Replacement and Transcatheter Aortic Valve Implantation TAVR – Transcatheter Aortic Valve Replacement TVT – Transcatheter Valve Therapy USPSTF – U.S. Preventive Services Task Force VARC – Valve Academic Research Consortium VHD – Valvular Heart Disease Throughout this NCD, we use “symptomatic severe aortic stenosis” interchangeably with, but preferentially to, the term “severe symptomatic aortic stenosis” (seen commonly in the medical literature), with the intent of clarifying that it is the stenosis itself that is severe, not necessarily the symptoms. Also, “TAVR” (transcatheter aortic valve replacement) is used interchangeably with “TAVI” (transcatheter aortic valve implantation); the latter may appear in figures, quotations, and citations. I. Decision A. Decision The Centers for Medicare & Medicaid Services (CMS) has updated the NCD to: 1) cover Transcatheter Aortic Valve Replacement (TAVR) for symptomatic severe aortic valve stenosis (or aortic stenosis (AS)) without the coverage with evidence development (CED) requirement; 2) expand coverage of TAVR to asymptomatic severe AS with CED; 3) revise coverage criteria related to pre-procedural patient assessment, intraoperative requirements, and operator and hospital procedural volume requirements. B. Coverage Criteria TAVR for severe AS is covered when furnished with a complete aortic valve and implantation system that has received Food and Drug Administration (FDA) premarket approval (PMA) for that system’s FDA-approved indication, and the following conditions are met. 1. Patient Criteria TAVR is covered for the treatment of Medicare beneficiaries with: Symptomatic severe AS under § 1862(a)(1)(A) of the Social Security Act (the Act). Asymptomatic severe AS under CED, § 1862(a)(1)(E) of the Act. Provisions in B2 and B3 below apply to all TAVR procedures furnished under the NCD; provision B4 applies only to TAVR procedures furnished under CED. 2. Physician and Heart Team Criteria Heart Team : The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary team of medical professionals with a specialized focus in cardiac care. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Heart teams include the following: At least one cardiac surgeon and one interventional cardiologist experienced in the care and treatment of aortic valve diseases and each with clinical privileges at the hospital where the TAVR will be furnished; and Advanced practice clinicians, nurses, administrators and, as needed, members from other physician specialties and research personnel. Patient Evaluation : Suitability for surgical aortic valve replacement (SAVR), TAVR, close surveillance, and palliative care must be evaluated based on individual clinical, anatomical, and procedural characteristics, and lifetime management considerations that account for patient life expectancy. These evaluations must be documented and made available to other heart team members, the patient, and other clinicians involved in the patient’s care as appropriate, prior to the day of the procedure. Evaluations must include: An initial evaluation by the heart team, which could be asynchronous using medical records to identify patient suitability for TAVR or other treatments, and includes input from both cardiac surgery and interventional cardiology; and An in-person evaluation by a heart team TAVR operator. This cannot be satisfied through a virtual encounter. An additional evaluation by a heart team TAVR operator is not required but is covered if performed. TAVR Operator : A TAVR operator must be an interventional cardiologist or cardiac surgeon member of the heart team and: Perform ≥ 20 total transcatheter cardiac valve (including aortic, mitral, tricuspid, or pulmonic valve) procedures, ≥ 15 of which must be TAVR, every year; or Perform ≥ 40 such procedures, ≥ 30 of which must be TAVR, every two years. Joint participation of two TAVR operators in a TAVR procedure is not required but is covered if determined appropriate by the heart team. If jointly performed, both must be TAVR operators from the heart team and can be from the same specialty or different specialties. 3. Hospital Criteria TAVR procedures must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to: On-site structural heart interventional cardiology and cardiac surgery programs. A post-procedure intensive care unit with personnel experienced in managing patients who have undergone open-heart valve procedures. A continuous quality improvement process that assesses procedural outcomes and makes necessary programmatic adjustments to assure patient safety. 4. CED Study Criteria TAVR items and services must be furnished for the treatment of asymptomatic severe AS with a complete aortic valve and implantation system that has received FDA PMA for that system’s FDA-approved indication, and in the context of a CMS-approved CED study. CED studies must meet requirements of sections B2 (Physician and Heart Team Criteria) and B3 (Hospital Criteria), have an active, contemporaneous comparator and address at least one of the following questions: Does TAVR, SAVR, or close surveillance until symptom onset better improve health outcomes? This is particularly relevant for patients with lower surgical risk, longer life expectancy, preserved left ventricular ejection fraction, and bicuspid aortic valves. What are the long-term valve re-intervention rates of TAVR and does having re-interventions impact health outcomes? Can other measures, for example longer term, risk-standardized, patient-centered health outcomes, replace volume criteria for TAVR operators? CMS-approved CED studies must adhere to the following scientific standards (criteria 1-17 below) that have been identified by the Agency for Healthcare Research and Quality (AHRQ) as set forth in Section VI of CMS’ Coverage with Evidence Development Guidance Document , published August 7, 2024 (the “CED Guidance Document”). Sponsor/Investigator: The study is conducted by sponsors/investigators with the resources and skills to complete it successfully. Milestones: A written plan is in place that describes a detailed schedule for completion of key study milestones, including study initiation, enrollment progress, interim results reporting, and results reporting, to ensure timely completion of the CED process. Study Protocol: The CED study is registered with ClinicalTrials.gov and a complete final protocol, including the statistical analysis plan, is delivered to CMS prior to study initiation. The published protocol includes sufficient detail to allow a judgment of whether the study is fit-for-purpose and whether reasonable efforts will be taken to minimize the risk of bias. Any changes to approved study protocols should be explained and publicly reported. Study Context: The rationale for the study is supported by scientific evidence, and study results are expected to fill the specified CMS-identified evidence deficiency and provide evidence sufficient to assess health outcomes. Study Design: The study design is selected to safely and efficiently generate valid evidence of health outcomes. The sponsors/investigators minimize the impact of confounding and biases on inferences through rigorous design and appropriate statistical techniques. If a contemporaneous comparison group is not included, this choice should be justified, and the sponsors/investigators discuss in detail how the design contributes useful information on issues such as durability or adverse event frequency that are not clearly answered in comparative studies. Study Population: The study population reflects the demographic and clinical diversity among the Medicare beneficiaries who are the intended population of the intervention, particularly when there is good clinical or scientific reason to expect that the results observed in premarket studies might not be observed in older adults or subpopulations identified by other clinical or demographic factors. Subgroup Analyses: The study protocol explicitly discusses beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion requirements effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial. In the protocol, the sponsors/investigators describe plans for analyzing demographic subpopulations as well as clinically relevant subgroups as identified in existing evidence. Description of plans for exploratory analyses, as relevant subgroups emerge, are also included. Care Setting: When feasible and appropriate for answering the CED question, data for the study should come from beneficiaries in their expected sites of care. Health Outcomes: The primary health outcome(s) for the study are those important to patients and their caregivers and that are clinically meaningful. A validated surrogate outcome that reliably predicts these outcomes may be appropriate for some questions. Generally, when study sponsors propose using surrogate endpoints to measure outcomes, they should cite validation studies published in peer-reviewed journals to provide a rationale for assuming these endpoints predict the health outcomes of interest. The cited validation studies should be longitudinal and demonstrate a statistical association between the surrogate endpoint and the health outcomes it is thought to predict. Objective Success Criteria: In consultation with CMS and AHRQ, sponsors/investigators establish an evidentiary threshold for the primary health outcome(s) so as to demonstrate clinically meaningful differences with sufficient precision. Data Quality: The data are generated or selected with attention to provenance, bias, completeness, accuracy, sufficiency of duration of observation to demonstrate durability of health outcomes, and sufficiency of sample size as required by the question. Construct Validity: Sponsors/investigators provide information about the validity of drawing warranted conclusions about the study population, primary exposure(s) (intervention, control), health outcome measures, and core covariates when using either primary data collected for the study about individuals or proxies of the variables of interest, or existing (secondary) data about individuals or proxies of the variables of interest. Sensitivity Analyses: Sponsors/investigators will demonstrate robustness of results by conducting pre-specified sensitivity testing using alternative variable or model specifications as appropriate. Reporting: Final results are provided to CMS and submitted for publication or reported in a publicly accessible manner within 12 months of the study’s primary completion date. Wherever possible, the study is submitted for peer review with the goal of publication using a reporting guideline appropriate for the study design and structured to enable replication. If peer-reviewed publication is not possible, results may also be published in an online publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with incomplete results). Sharing: The sponsors/investigators commit to making study data publicly available by sharing data, methods, analytic code, and analytical output with CMS or with a CMS-approved third party. The study should comply with all applicable laws regarding subject privacy, including 45 CFR § 164.514 within the regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and 42 CFR, Part 2: Confidentiality of Substance Use Disorder Patient Records. Governance: The protocol describes the information governance and data security provisions that have been established to satisfy Federal security regulations issued pursuant to HIPAA and codified at 45 CFR Parts 160 and 164 (Subparts A & C), United States Department of Health and Human Services (HHS) regulations at 42 CFR, Part 2: Confidentiality of Substance Use Disorder Patient and HHS regulations at 45 CFR Part 46, regarding informed consent for clinical study involving human subjects. In addition to the requirements under 42 CFR and 45 CFR, studies that are subject to FDA regulation must also comply with regulations at 21 CFR Parts 50 and 56 regarding the protection of human subjects and institutional review boards, respectively. Legal: The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals, although it is acceptable for a study to test a reduction in toxicity of a product relative to standard of care or an appropriate comparator. For studies that involve researching the safety and effectiveness of new drugs and biological products aimed at treating life-threatening or severely-debilitating diseases, refer to additional requirements set forth in 21 CFR § 312.81(a). Consistent with section 1142 of the Act, AHRQ supports clinical research studies that CMS determines meet all the criteria and standards identified above. C. Other Uses of TAVR In addition to the national coverage described above, Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations under section 1862(a)(1)(A) for any other beneficiary seeking coverage for TAVR. This NCD does not apply to use of TAVR in emergency scenarios; coverage for this use is at MAC discretion. Nothing in this NCD precludes coverage of TAVR through NCD 310.1 (Clinical Trial Policy) or through the Investigational Device Exemption (IDE) Policy. Ongoing studies that were previously approved under CED for TAVR have been determined to meet requirements for, and are approved under, either section B4 of this NCD or the Investigational Device Exemption (IDE) regulations (42 CFR § 405 Subpart B). Ongoing studies, as specified on clinicaltrials.gov, will either continue to be posted to the CMS website of approved TAVR CED studies or will be moved to the CMS website of approved IDE studies upon finalization of this NCD. See Appendix A for Medicare National Coverage Determinations Manual language. II. Clinical Evidence Review A. Background Aortic stenosis (AS) is a valvular heart disease in which the aortic valve narrows and does not open fully, restricting blood flow out of the heart. The left ventricle (one of four heart chambers) pumps oxygenated blood through the aortic valve to the aorta (the main artery) and then to the brain and rest of the body (https://www.mayoclinic.org/diseases-conditions/aortic-stenosis/symptoms-causes/syc-20353139). Aortic stenosis is the most common valvular heart disease requiring intervention in the Medicare population. Over 12% of Medicare beneficiaries (age ≥65 years) have AS, with >3% having severe AS (Martin 2024). Severity of stenosis increases with age. AS is usually caused by degenerative, age-related calcification, a congenital bicuspid aortic valve, or rheumatic fever. Symptoms typically occur in late-stage disease, when the stenosis is severe. The “classic” presentation is a triad of heart failure symptoms (dyspnea, or shortness of breath, and fatigue), syncope/presyncope (fainting/dizziness), and angina (chest pain). However, this “classic triad” is less commonly seen in clinical practice today. Increasingly, patients with subtle or no symptoms have their AS diagnosed by an echocardiogram performed for other indications, or when a heart murmur is heard by stethoscope on physical exam. Aortic stenosis is a progressive, fatal disease, with one large, U.S. multi-hospital, real-world database study reporting approximately 45% 4-year mortality for patients with untreated severe AS (Généreux 2023). The definitive treatment for AS is aortic valve replacement (AVR). Transcatheter AVR (TAVR) has emerged as a minimally invasive alternative to surgical AVR (SAVR) for treating AS. A bioprosthetic valve is inserted via a catheter, typically entered through an artery in the groin, into the opening of a native aortic valve or a failed surgical bioprosthetic aortic valve. Since the CMS national coverage determination (NCD) for TAVR in 2012, TAVR has become the predominant method for AVR for patients with symptomatic severe AS in the U.S. (Sherwood 2025). Patients with asymptomatic severe AS have typically been managed with active surveillance, including periodic echocardiography, symptom assessment, and sometimes supervised exercise testing (Otto 2021). This is because the risk of sudden death in asymptomatic severe AS is low (≤1% per year), and there are competing risks associated with the procedure itself (Généreux 2016; Lancellotti 2018). This decision memorandum reconsiders the 2019 TAVR NCD, and was opened after a formal request by Edwards Lifesciences, manufacturer of the Sapien family of TAVR devices, following FDA expanded indications on April 30, 2025 to include asymptomatic as well as symptomatic patients with severe AS. B. Food and Drug Administration Status On November 2, 2011, the FDA approved the first TAVR device for marketing in the United States. The Edwards’ SAPIEN Transcatheter Heart Valve (THV) was approved "for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open AVR and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis" ( https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100041 ). Since this first approval, devices have been approved for: Lower surgical risk groups, including high and intermediate; Alternate access sites, such as transapical and transaortic; Valve-in-valve use for failed surgical bioprosthetic valves; and Asymptomatic AS. Table 1 in Appendix B provides a timeline of TAVR device approvals to date. C. Review of the Evidence: Methods This reconsideration addresses TAVR for AS. It does not address TAVR for the treatment of other conditions such as aortic regurgitation (AR). In the absence of an NCD addressing TAVR for the treatment of other conditions, coverage is at the discretion of the Medicare Administrative Contractors (MACs). Additionally, and since different indications continue to be investigated through clinical trials, coverage of TAVR for other conditions in investigational studies is available through NCD 310.1 (Clinical Trial Policy) or through the Investigational Device Exemption (IDE) Policy. This section describes how evidence from published clinical research regarding TAVR for AS was selected for consideration in this review. A detailed account of the methodological principles used by CMS to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in the CMS National Coverage Analysis Evidence Review Guidance Document , published August 7, 2024, or any successor document. 1. Evidence Questions The following questions guide our review and analysis of the selected evidence on the use of TAVR for AS: Q1: Is the evidence sufficient to conclude that TAVR meaningfully improves health outcomes for Medicare beneficiaries with AS? Q2: Do specific characteristics or comorbidities make patients more or less likely to benefit from TAVR? Q3: Are specific treatment conditions necessary to achieve TAVR health outcomes similar to those demonstrated in the clinical studies reviewed in this analysis? We used contractor support to conduct the literature searches and evidence review and supplemented that review with our own CMS coverage analysis. 2. Related Work i. Key Technology Assessments and Systematic Reviews CMS did not request an external technology assessment (TA) on this topic. ii. Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) A MEDCAC meeting was not convened on this topic. 3. Clinical Literature Search and Selection Using contractor support, the evidence review began with a systematic search of the peer-reviewed literature in PubMed and Embase conducted on Nov 13, 2025, using the following primary search terms: (1) “Asymptomatic;” (2) “Aortic Valve Stenosis;”"[Mesh] (3) “aortic stenosis;” (4) “Transcatheter Aortic Valve Replacement,” [Mesh] or “Transcatheter aortic valve implantation.” The search was restricted to English-language articles published between 2018 and 2025. Primary studies were eligible for detailed analysis if they evaluated TAVR for AS, regardless of clinical or geographic setting, symptom status, or risk factors. They were also eligible for inclusion in this review if they included adults with AS and evaluated the safety or effectiveness of TAVR. Since several eligible randomized controlled trials (RCTs) were available, the analysis focused on major RCTs; registry-based observational studies were considered as supplemental data from real-world data sources, and single-arm or non-randomized trials were excluded. Major RCTs were pivotal trials published in high-impact, peer-reviewed journals with a prespecified statistical analysis plan and had a multicenter design with multinational or multiregional participation to reduce site-specific bias and enhance external validity. The inclusion criteria were broad to include a diverse patient population. Inclusion: Comparison of TAVR with any active comparator, such as surgery or clinical surveillance Assessment of one of the following post-TAVR outcomes: adverse events, durability of the TAVR device, quality of life, stroke, mortality Exclusion: Fewer than 100 patients in the intervention arm Patients followed for less than 30 days after TAVR Due to the paucity of data on asymptomatic AS patients, one publication reporting 138 asymptomatic patients (76 TAVR; 62 SAVR) from the Evolut Low Risk study was included in the analysis (Merhi et al., 2022). Meta-analyses of primary studies investigating TAVR for AS were also eligible for consideration. Because meta-analyses may overlap to some extent with our selected primary studies and may include studies of varying quality, our analysis and evidence quality assessment focused on the selected primary studies. We considered the meta-analytic findings as supplemental evidence. 4. Quality Assessment Our review assessed the quality of individual studies according to the principles outlined in the United States Preventive Services Task Force Procedure Manual, Appendix VI. Criteria for Assessing Internal Validity of Individual Studies . The review used a modified version of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to assess the body of evidence for each outcome or outcome category. The USPSTF tool allows evaluation of the design and conduct of a study with an emphasis on internal validity (minimization of bias). The GRADE system facilitates an assessment of the certainty of the overall evidence for specific outcomes, considering both the quality and findings of individual studies. D. Review of Evidence from Primary Studies 1. Study Characteristics Our selection of primary studies for detailed analysis included 17 RCTs reported in 29 publications. Additionally, three comparative and four registry-based noncomparative observational studies were selected. Collectively, these selections involved approximately 10,686 patients from RCTs and 457,598 patients from the observational studies treated with TAVR. As shown in Table 2 in Appendix B, approximately half the studies were conducted exclusively or partially in the United States. Demographic Characteristics Across the included studies, the mean/median age of participants ranged from 70 to 85 years. The proportion of women participants ranged from 21 to 100 percent. Only four studies provided specific data on ethnicity; the patients in these studies were predominantly White. AS Symptom and Risk Groups Across all 24 included studies, patients were diagnosed with severe AS, defined by elevated transvalvular pressure gradients and reduced aortic valve areas. The surgical risk categories were defined using a combination of standardized scoring systems, specific mortality thresholds, and multidisciplinary clinical assessments. The Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score, often referred to as the “STS score,” was the primary metric used to classify patients into low, intermediate, high, or extreme risk (scores ranging from 0% to 100%, with higher scores indicating greater risk of death within 30 days after the procedure). RCTs Among the 17 studies derived from the RCTs, the study populations comprised asymptomatic severe AS in two studies (Evolut Low Risk Trial [subgroup analyses], EARLY TAVR) and symptomatic severe AS in the remaining studies. One study specifically evaluated patients with symptomatic severe AS and a small aortic annulus (area ≤ 430 mm) (SMART trial). Among studies involving symptomatic AS populations, patients spanned a range of surgical risk profiles, including low risk (N = 4 studies; Evolut Low Risk, NOTION, NOTION-2, and PARTNER 3), low-to-intermediate risk (N = 1 study; DEDICATE-DZHK6), intermediate risk (N = 3; PARTNER 2 cohort A, PARTNER 2 SAPIEN 3, SURTAVI), intermediate-to-high risk (N = 1 study; SOLVE TAVI), high risk (N = 4 studies; Medtronic Core Valve US High-Risk Pivotal Trial, PORTICO IDE, Choice, and REPRISE III ), and studies enrolling patients across all risk categories (N = 3 studies; SMART, RHEIA, GALILEO). Patient Characteristics in Asymptomatic Severe Aortic Stenosis Trials Low surgical risk (generally defined as an STS-PROM score <4%; the mean score was 1.7% and 1.8% in the Evolut Low Risk and EARLY TAVR trials, respectively). Preserved left ventricular ejection fraction (LVEF) (≥ 50% in both Evolut Low Risk and EARLY TAVR trials). A negative exercise treadmill stress test. This was the gold standard for identifying asymptomatic patients in the EARLY TAVR trial. NYHA Functional class I designation, indicating no symptoms during ordinary physical activity; this identified asymptomatic status in the Evolut Low Risk trial. Patient Characteristics in Symptomatic Severe Aortic Stenosis Trials Low risk trials STS score ≤4%. Defined as STS ≤3% in the Evolut Low Risk Trial and ≤4% in the PARTNER 3 and NOTION-2 trials. Mean STS scores ranged from 1.1% to 3.0% among symptomatic low-risk patients of the Evolut Low Risk, NOTION, NOTION-2, and PARTNER 3 trials. NYHA class II–III symptoms. These were the predominant NYHA classes at baseline in most trials (Evolut Low Risk, NOTION, and PARTNER-3). Some trials reported the presence of NYHA class III or IV symptoms in approximately 23.8% to 51.0% of patients at baseline. Low to intermediate risk trials Low risk was defined as a STS score ≤2%, and intermediate risk as a score of 2% to 4% (DEDICATE-DZHK6). Mean STS scores ranged from 1.8% to 1.9% (DEDICATE-DZHK6). NYHA class III or higher (≈46%), indicating moderate functional limitation (DEDICATE-DZHK6). Intermediate risk trials: STS score between 3% and 15% augmented by overall clinical status and comorbidities not captured by the STS risk calculation, including frailty and disability (SURTAVI). The mean STS score of the enrolled population ended up being approximately 4.5%, representing a truly intermediate-risk population with well-balanced frailty indices. STS score between 4% and 8% (PARTNER 2 cohort A) for patient eligibility. Actual STS scores of enrolled patients ranged from 4.4% to 5.8% (PARTNER 2 cohort A, PARTNER 2 SAPIEN 3, SURTAVI). NYHA class III or IV symptoms (74% to 77% of patients in PARTNER 2 and ~55% to 60% in SURTAVI). Intermediate to high risk trials: Median STS scores between 4.7% to 4.9%, with interquartile ranges (IQRs) extending from 3.0% to approximately 9–10% (SOLVE TAVI). NYHA class III or IV symptoms (63% to 66% of patients; only 11.6% were class I) (SOLVE TAVI). Median logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I was 14.8% to 14.9% (IQR 8.7%–23.8%) (SOLVE TAVI). High risk defined as EuroSCORE ≥20% and/or STS risk score ≥10%, or other high-risk criteria by heart team consensus (SOLVE TAVI). High risk trials: Mean STS scores of 5.6% to 7.6% (Medtronic Core Valve US High-Risk Pivotal Trial, CHOICE, and REPRISE III). Defined as STS score of 8% or higher, or for whom two cardiac surgeons concurred that the predicted risk of operative mortality was 15% or higher at 30 days after surgery (PORTICO IDE). Medtronic Core Valve US High-Risk Pivotal Trial defined high risk as subjects with an expected perioperative mortality of 15% or more (based on an investigator-estimated mortality or an STS score >10). Trials such as PORTICO IDE and REPRISE III allowed the local heart team to override or supplement STS scores based on clinical judgment. Extreme risk was defined as a probability of death or serious morbidity exceeding 50% by 30 days after surgery (PORTICO IDE, REPRISE III). Baseline functional limitation with ~60% to 63% of patients classified as NYHA class III (REPRISE III, PORTICO IDE). Patients with lower STS scores could still be categorized as high or extreme risk due to other clinical features, such as a porcelain aorta, hostile chest (due to prior radiation or surgery), severe pulmonary hypertension, or significant frailty (REPRISE III). Observational studies Among the seven observational studies, one (STS/ACC TVT-health status) evaluated minimally symptomatic or asymptomatic patients with AS, one (OCEAN-TAVI) included a mixed population of symptomatic and asymptomatic patients with severe AS, and the remaining five studies focused exclusively on symptomatic patients with severe AS. These studies defined risk categories using a combination of standardized surgical risk scores, clinical symptom status, and multidisciplinary heart team consensus (STS/ACC TVT Registry, OCEAN-TAVI Registry, SWEDEHEART registry). Risk was also categorized by baseline health status using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS), where a score < 75 indicates moderate to severe symptoms and a score of ≥75 indicates minimal or no symptoms (STS/ACC TVT Registry-health status). The median KCCQ-OS ranged from 43 to 85, reflecting wide variability in baseline health status (STS/ACC TVT-health status). Furthermore, the determination of risk frequently relied on heart team consensus, which evaluates patients based on clinical eligibility and serious surgical morbidity risks that scoring algorithms may not fully capture (OCEAN-TAVI, RESPOND). Low surgical risk Defined by an STS-PROM score of 3% or less and the absence of other high-risk comorbidities, such as frailty, porcelain aorta, or advanced liver disease (STS/ACC TVT Registry-health status, LRT). In large real-world registries, patients categorized as low risk or with minimal symptoms had median STS scores ranging from 1.6% to 3.2% (STS/ACC TVT Registry-temporal change analysis and SWEDEHEART). Intermediate surgical risk: Mean STS-PROM scores ranged from 4.4% to 6.0% (RESPOND Study). High surgical risk: Defined as a patient being considered "unsuitable" for SAVR, with high-risk symptomatic cohorts achieving mean STS-PROM values of up to 11.2% (OCEAN-TAVI). The median EuroSCORE II ranged from 2.5% to 9.2% (OCEAN-TAVI). Comparators While the majority of included studies (N = 13) reported comparisons of TAVR with SAVR (including three from observational studies), six studies (all RCTs) reported head-to-head comparisons of different transcatheter heart valve systems. One RCT (EARLY TAVR) compared TAVR with clinical surveillance rather than surgery or a different valve type. Four observational studies (STS/ACC TVT-health status, STS/ACC TVT-temporal change analysis, OCEAN-TAVI, RESPOND study) focused on internal registry comparisons, such as changes in symptom status from baseline or temporal trends, rather than on a primary comparison with surgery or other valve systems. In one study, patients were not randomized to TAVR or SAVR; however, the analysis was adjusted for 25 important covariates in a propensity-matched analysis (PARTNER 2 SAPIEN 3). A variety of valves were used: self-expanding valves (SEV), balloon-expandable valves (BEV), and, to a lesser extent, mechanically expanded valves (MEV). In some studies, different patients received different valves. Overall, observational studies demonstrate greater valve heterogeneity than randomized trials, with substantial overlap between balloon-expandable and self-expanding platforms, and limited representation of mechanically expanded devices, confined to a single registry. Setting and follow-up Across studies, TAVR was delivered in hospital inpatient settings. Follow-up durations typically ranged from one to seven years. A small number of studies fell outside this range: three publications reported short-term outcomes with 30-day follow-up (Evolut Low Risk Trial; SOLVE TAVI; Low Risk TAVR), while one study reported extended long-term outcomes with follow-up of up to 10 years (NOTION). Outcomes A total of 81 outcomes were identified across the included studies: 17 primary and 37 secondary outcomes from RCTs, and an additional 27 outcomes from observational studies. The primary outcomes across RCTs and observational studies evaluated in this report include: composite of all-cause death, all stroke (disabling or non-disabling), or cardiovascular (CV) rehospitalization; composite of all-cause mortality or disabling stroke; composite of all-cause death or stroke; and composite safety outcome of death, stroke, stage 3 acute kidney injury/new dialysis, major, life-threatening, or disabling bleeding, and moderate or severe paravalvular regurgitation/leak. The secondary outcomes evaluated across RCTs and observational studies in this report include: all-cause mortality, CV mortality, stroke, disabling stroke, new permanent pacemaker implantation, myocardial infarction (MI), reintervention, patient-reported outcome using the KCCQ, bleeding, and rehospitalization. Table 1 summarizes the characteristics and key findings of each study while Table 2 provides a summary of the evidence across studies. 2. Key Findings a. Impact on Health Outcomes Health outcomes are summarized first for RCTs and then for observational studies. Within each outcome, results are categorized by patient population (symptomatic, low-, intermediate-, and high-risk). Comparisons are reported in two stages: first, TAVR versus standard comparators such as SAVR or clinical surveillance (CS), and second, comparisons across different valve types where available. All percentages reported below are Kaplan–Meier estimates at the specific time point unless otherwise specified. Studies on asymptomatic patients are discussed separately in this section. The quality of evidence and study limitations are discussed in detail in Appendix B. Randomized Controlled Trials – Symptomatic AS All-cause mortality Among the included studies reporting on all-cause mortality and survival, 11 compared TAVR with either SAVR or CS, while six compared outcomes across different transcatheter valve platforms. Among the 11 studies comparing TAVR with SAVR or CS, eight reported comparable all-cause mortality between the treatment groups, with no statistically significant differences. One study demonstrated a short-term mortality benefit with TAVR at one year in a low–to–intermediate–risk population (DEDICATE-DZHK6). In addition, the PARTNER 2 SAPIEN 3 cohort reported significantly lower mortality with TAVR at one year; however, this early advantage was not sustained over time, and mortality rates were similar between TAVR and SAVR at five years. Across the six studies comparing different valve platforms, no statistically significant differences in all-cause mortality were observed among balloon-expandable, self-expanding, or mechanically expanded valves. Detailed results are described in the sections below. Comparison of TAVR with standard care (Surgery/clinical surveillance) Symptomatic Low-Risk Population In the symptomatic low-risk population, four studies (PARTNER 3, Evolut Low Risk, NOTION, NOTION-2 trial) totaling 1,558 patients treated with TAVR, consistently demonstrated similar outcomes in all-cause mortality between TAVR and SAVR with no statistically significant differences at follow-up times ranging from two to seven years (Leon et al., 2021; Mack et al., 2023; Leon et al., 2025; Forrest et al., 2023; Thyregod et al., 2019; Søndergaard et al., 2019; Jørgensen et al., 2024). Symptomatic Low or Intermediate-Risk Population The DEDICATE-DZHK6 trial results favored TAVR over SAVR at one year in all-cause mortality for a mixed-risk group of 701 patients treated with TAVR. Of note, a substantial proportion of patients were enrolled during the COVID-19 pandemic, a period associated with worse outcomes following cardiac surgery. In addition, the trial included a higher proportion of women, and female sex has been known to increase mortality after SAVR (Blankenberg et al., 2024). Symptomatic Intermediate-Risk Population In the intermediate-risk group, three RCTs reported no statistically significant difference in all-cause mortality after 5-year follow-up (PARTNER 2 cohort, Makkar et al., 2020; SURTAVI, Van Mieghem et al., 2022; PARTNER 2 SAPIEN 3 cohort, Madhavan et al., 2023) although the PARTNER 2 SAPIEN 3 observational study observed a statistically significant difference favoring TAVR in one year mortality. One-year mortality in the PARTNER 2 SAPIEN 3 cohort study favored TAVR (Madhavan et al., 2023). Symptomatic High-Risk Population The Medtronic Core Valve US High-Risk Pivotal Trial reported 5-year survival rates of 44% for TAVR and 39% for SAVR in the iliofemoral cohort, which included 239 patients at high surgical risk (Arnold et al., 2021). Symptomatic Women (Across All Risk) Two analyses involving only female patients yielded no statistically significant differences between TAVR and SAVR in 1-year, all-cause mortality: the RHEIA trial, involving 215 women treated with TAVR (Tchetche et al., 2025) and a post-hoc pooled analysis of the RHEIA trial and the PARTNER 3 trial with 376 women treated with TAVR (Eltchaninoff et al., 2025). Comparisons of different valve types Six RCTs reported no statistically significant differences in all-cause mortality, measured in various comparisons of valve platforms (balloon-expandable, self-expanding, and mechanically expanded) at follow-up intervals ranging from 30 days to five years (SOLVE TAVI, CHOICE, SMART, GALILEO, REPRISE III, PORTICO IDE). Most evidence comes from studies directly comparing self-expanding valves (SEV) with balloon-expandable valves (BEV). Multivariable predictors of mortality In a multivariable Cox regression analysis evaluating 10-year all-cause mortality, advanced age was the strongest independent predictor of long-term outcomes for AS patients. Elderly age greater than 80 years at baseline was significantly associated with increased mortality risk compared to <80 years of age (Thyregod et al., 2024). In contrast, the type of valve intervention was not independently associated with mortality, with no statistical difference observed for TAVR versus SAVR. Pacemaker implantation at 1-month post-TAVR or SAVR demonstrated a trend toward increased mortality, although this did not reach statistical significance. Male sex and preserved LVEF ≥50% at 3-month echocardiographic follow-up were not associated with long-term mortality. Consistent with these findings, a Cox proportional hazards model reported by Abdel-Wahab et al. (2020) showed that the patient risk profile rather than valve type was associated with shorter survival. In that analysis, female patients had a significantly lower risk of mortality than male patients. Higher baseline surgical risk, as measured by the STS score, was independently associated with an 11% increase in mortality per one unit score increase (p<0.001), as was higher systolic pulmonary artery pressure (p=0.001). Notably, valve type was not associated with mortality in this model, reinforcing that long-term mortality after TAVR is primarily driven by baseline patient characteristics rather than the choice of valve platform. Conclusion – All-cause mortality in RCTs All-cause mortality was consistently reported across 11 studies comparing TAVR with standard care (SAVR or CS) and six studies comparing different TAVR valve types. Overall, across the spectrum of surgical risk categories and patient subgroups, TAVR demonstrated comparable all-cause mortality to SAVR, with some early- and mid-term advantages in select subpopulations (e.g., low, low-intermediate, or intermediate risk), but no statistically significant long-term mortality benefit. In symptomatic low-risk populations, mortality results were highly consistent for nine publications across timepoints up to 10 years, reinforcing clinical equipoise for TAVR and SAVR in this group. One trial of mixed low-to-intermediate-risk patients favored TAVR at one year, suggesting a short-term survival advantage. In the intermediate-risk group, studies demonstrated equivalent long-term survival between TAVR and SAVR, with some TAVR benefit at 1-year follow-up in the SAPIEN 3 cohort that was lost at five years. Among high-risk patients in one trial, survival outcomes were again comparable for TAVR and SAVR. Similarly, trials including only female patients, or comparing different transcatheter valve platforms (i.e., BEV, SEV, or MEV), showed no significant difference in early and long-term mortality between interventions. Multivariable analyses consistently indicate that long-term survival after valve replacement is driven predominantly by baseline patient characteristics rather than treatment modality or valve type. Advanced age, female sex, higher surgical risk scores, and elevated pulmonary pressures are the strongest predictors of mortality. Collectively, these findings support the conclusion that TAVR provides durable survival outcomes comparable to surgery across a wide spectrum of patients, with mortality largely determined by underlying patient risk rather than valve selection. Early mortality advantages observed with TAVR likely reflect its less invasive nature, whereas higher early mortality with SAVR may be related to the procedural burden of sternotomy, cardiopulmonary bypass, and cardiac arrest. Over longer follow-up, survival differences attenuate and become non-significant, potentially reflecting later mortality in the TAVR group, which is associated with higher rates of permanent pacemaker implantation and moderate-to-severe paravalvular regurgitation. These patterns may also be influenced by higher loss to follow-up in the SAVR arm of some studies (e.g., 11.9% in PARTNER), higher prevalence of concomitant procedures during SAVR (e.g., coronary artery bypass grafting) that may improve mid-term surgical outcomes, and the favorable hemodynamic performance and durability of BEVs. Cardiovascular (CV) mortality Across the included studies, 13 reported CV mortality outcomes. Of these, 10 studies compared TAVR with SAVR or CS, while three studies focused on comparisons between different valve types. Among the 10 studies comparing TAVR with SAVR or CS, eight reported comparable CV mortality between groups, with no statistically significant differences observed. One trial (DEDICATE-DZHK6) found a statistically significant reduction in 1-year CV mortality with TAVR among low-to-intermediate-risk patients. Another trial (PARTNER 2 SAPIEN 3) showed significantly lower CV mortality with TAVR at one year, though the difference was no longer significant at five years. No RCT reported results showing worse CV mortality with TAVR compared to SAVR. Furthermore, across the three studies comparing valve platforms, no statistically significant differences in CV mortality were observed among BEV, SEV, or MEV used in TAVR procedures. Detailed results are described in the sections that follow. Comparison of TAVR with standard care (Surgery/clinical surveillance) Symptomatic Low-Risk Population In the symptomatic low-risk population, four studies reported CV mortality, all demonstrating comparable outcomes between TAVR and SAVR (Leon et al., 2021; Mack et al., 2023; Leon et al., 2025; Forrest et al., 2022; Thyregod et al., 2019; Sondergaard et al., 2019; Thyregod et al., 2024; Jørgensen et al., 2024). These studies involved 1,558 patients treated with TAVR. In the PARTNER 3 trial, CV mortality was similar between TAVR and SAVR at the 2-year (Leon et al., 2021), 5-year (Mack et al., 2023), and 7-year follow-up (Leon et al., 2025). Consistent shorter-term findings were reported in the Evolut Low Risk trial, with no significant 2-year difference in CV mortality between TAVR and SAVR (Forrest et al., 2022). Longer-term outcomes were also comparable in the NOTION trial, with CV mortality rates of 20.8% for TAVR and 23.0% for SAVR at five years (p = 0.62) (Thyregod et al., 2019) and 49.5% for TAVR and 51.2% for SAVR (p = 0.7) at 10 years (Thyregod et al., 2024). Valve-related deaths also remained low and similar between groups at six years and 10 years (Sondergaard et al., 2019; Thyregod et al., 2024). For low-risk patients aged ≤ 75 years in the NOTION-2 trial, 1-year CV mortality showed no difference between TAVR and SAVR (Jørgensen et al., 2024). Overall, across symptomatic low-risk studies, CV mortality outcomes were comparable between TAVR and SAVR across short-, mid-, and long-term follow-up. Symptomatic Low or Intermediate-Risk Population In this mixed-risk group, the DEDICATE-DZHK6 trial demonstrated significantly lower CV mortality among 701 patients treated with TAVR (2.0%) compared to patients treated with SAVR (4.4%) at one year (Blankenberg et al., 2024). Symptomatic Intermediate-Risk Population In the intermediate-risk population, three stud