Transcatheter Aortic Valve Replacement (TAVR) for Aortic Regurgitation (AR)

Favor :

Patients are getting exceptional care with the joint interventional cardiology and cardiac surgery care model. Encouraging physicians to compete for patients has value, but a collaborative approach seems to have added value.

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October 9, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00430R3 National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR) for Aortic Regurgitation

Dear Ms. Baldwin:

The Society for Cardiovascular Angiography and Interventions (SCAI) has dedicated its work to advancing the profession and is the designated society for guidance, representation, professional recognition, education, and research opportunities for invasive and interventional cardiology professionals. For more than 40 years, SCAI has personified professional excellence and innovation globally, fostering a trusted community of more than 5000 members dedicated to medical advancement and lifesaving care for adults and children with cardiovascular disease.

SCAI appreciates the opportunity to comment on this national coverage determination (NCD) proposal.

SCAI strongly supports Medicare coverage of FDA-approved transcatheter aortic valve replacement (TAVR) therapies for native aortic regurgitation (AR). This treatment provides an essential pathway for patients who previously had limited therapeutic options. Please see the joint letter from SCAI, the American College of Cardiology (ACC), and the Society of Thoracic Surgeons (STS) for our detailed comments on the heart team, coverage with evidence development, real world evidence generation, and quality improvement. These comments are meant to fill in the gaps not addressed by the joint letter.

Operator Requirements
As stated in the joint letter, SCAI supports a two-operator approach for TAVR for AR given the technical complexity of the procedure. However, SCAI strongly believes that the operator requirements should permit any combination of qualified interventional cardiologists and cardiac surgeons. The local Heart Team should determine the appropriate composition of the operative team based on patient needs, operator expertise, and institutional capabilities. Two qualified operators, regardless of specialty combination, help ensure appropriate procedural planning, device deployment, real-time clinical decision-making, and management of complications as TAVR expands into this distinct and technically challenging patient population.

SCAI appreciates the opportunity to comment on this NCD proposal and looks forward to continuing to work with CMS on these important issues. If SCAI can provide additional information or assistance, please contact Monica Wright, Director of Regulatory Affairs, at 202-327-5451 or mlwright@scai.org.

Sincerely,

J. Dawn Abbott, MD, MSCAI
President

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October 9, 2026
Joanna Baldwin
Director, Coverage and Analysis Group (CAG)
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis for Transcatheter Aortic Valve Replacement for Aortic Regurgitation - CAG-00430R3

Dear Ms. Baldwin,

On behalf of The Society of Thoracic Surgeons (STS), I write to provide comments on the Transcatheter Aortic Valve Replacement (TAVR) for Aortic Regurgitation (AR) National Coverage Analysis (NCA). Founded in 1964, STS is an 8,000 member not-for-profit organization dedicated to ensuring the best possible outcomes for therapy of the heart, lungs, and esophagus.

STS supports the multisociety comments being submitted by the American College of Cardiology (ACC), Society for Cardiovascular Angiography & Interventions (SCAI), and STS in response to this NCA. We submit these additional comments to further emphasize that surgical involvement should be required, not optional, both in the in-person evaluation of patients with isolated native AR and in the TAVR procedure for patients with AR.

These recommendations are founded solely to ensure the clarity of evaluation and the safety of TAVR for native AR as a novel and clinically distinct application to TAVR for aortic stenosis, one with substantially less clinical trial data and and real-world evidence. The difference in experience is substantial: the STS/ACC TVT Registry recorded nearly one million patients undergoing TAVR across 850 sites in the United States since 2011, while the expanded ALIGN-AR study enrolled just 700 patients with native AR across 30 U.S. centers through July 2025. , Native AR also presents distinct anatomical and procedural challenges, including limited or absent valvular calcification, larger annular dimensions, and dilation of the aortic root, which can complicate device anchoring, positioning, and sealing and increase the risk of valve migration, embolization, and paravalvular regurgitation. , These considerations make appropriate patient selection, multidisciplinary decision-making, and procedural expertise particularly important as this therapy enters broader clinical practice. Maintaining appropriate safeguards during this early period of adoption is essential to protecting patient safety and achieving optimal outcomes.

Importantly, the pivotal ALIGN-AR trial incorporated a multidisciplinary Heart Team that included both an interventional cardiologist and a cardiac surgeon to determine surgical risk and treatment eligibility, as well as to perform the procedure.4 STS believes Medicare coverage should reflect the framework under which the evidence supporting this indication was generated.

Accordingly, TAVR for native AR should be performed jointly by two qualified operators—an interventional cardiologist and a cardiac surgeon. Requiring both specialties preserves the multidisciplinary model reflected in ALIGN-AR while experience and real-world evidence continues to accumulate. The limited evidence supporting TAVR for native AR does not yet warrant the same degree of flexibility outlined in the recent TAVR NCD for symptomatic aortic stenosis and therefore data for this procedure should be captured under the provisions of Coverage for Evidence Development.

We appreciate CMS’s consideration and remain committed to collaborating on policies that guarantee safe, effective, and accessible aortic valve therapies for all patients. For additional information or clarification, please contact Molly Peltzman, Director of Health Policy and Regulatory Affairs, at mpeltzman@sts.org.

Sincerely,

Vinay Badhwar, MD
STS President

References:
1. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020;76(21):2492-2516. doi:10.1016/j.jacc.2020.09.595.
2. Vahl TP, Thourani VH, Makkar RR, et al. Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study. Lancet. 2025;406(10521):2757-2771. doi:10.1016/S0140-6736(25)02215-9.
3. Poletti E, De Backer O, Scotti A, et al. Transcatheter aortic valve replacement for pure native aortic valve regurgitation: the PANTHEON international project. JACC Cardiovasc Interv. 2023;16(16):1974-1985. doi:10.1016/j.jcin.2023.07.026.
4. Yoon SH, Schmidt T, Bleiziffer S, et al. Transcatheter aortic valve replacement in pure native aortic valve regurgitation. J Am Coll Cardiol. 2017;70(22):2752-2763. doi:10.1016/j.jacc.2017.10.006.

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October 9, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00430R3 National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR) for Aortic Regurgitation

The American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and The Society of Thoracic Surgeons are the professional medical societies representing the physicians and health care professionals who care for patients who undergo transcatheter (TAVR) or surgical (SAVR) aortic valve replacement procedures for the treatment of aortic valve disease including aortic stenosis (AS) and aortic regurgitation (AR). We appreciate the opportunity to respond to the Centers for Medicare & Medicaid Services’ (CMS) request for comment on the National Coverage Analysis (NCA) for TAVR in patients with AR.

The Societies strongly support timely Medicare coverage for FDA-approved TAVR therapies, including for symptomatic severe native aortic regurgitation (Grade 3+ or 4+ confirmed by echocardiography or cardiac magnetic resonance imaging) that meet guideline indications for treatment (Otto et al., 2021; Praz et al., 2025). This patient population has historically faced limited treatment options, among patients who are at high to prohibitive surgical risk. The recent FDA approval of a dedicated transcatheter therapy for native AR represents an important advancement that has the potential to expand access to life-improving and life-saving care for appropriately selected Medicare beneficiaries. At the same time, given the novelty of this indication, the limited clinical experience to date, and the need for continued evidence generation, the Societies believe coverage should be implemented through a Coverage with Evidence Development (CED) framework that both facilitates patient access and supports ongoing evaluation of clinical outcomes.

Background and Evolution of TAVR
For more than a decade, TAVR has transformed the treatment of patients with AS through a deliberate and evidence-based process involving close collaboration among clinicians, regulators, manufacturers, and professional societies. This approach has enabled the responsible expansion of patient access while maintaining a strong commitment to evidence generation and quality improvement, providing a valuable model for the evaluation of emerging TAVR indications, including native AR.

The Societies have long supported patient access to transcatheter valve therapies when supported by evidence and delivered within a framework that promotes quality, safety, and ongoing evidence generation. Since the initial national coverage determination (NCD) (20.32), CMS has evolved coverage for TAVR to reflect an expanding evidence base, broadening coverage from patients with symptomatic severe AS at extreme surgical risk to those at high, intermediate, and low surgical risk and, most recently, to select patients with asymptomatic severe AS. Throughout these updates, CMS has maintained a consistent commitment to patient selection, Heart Team evaluation, quality oversight, and evidence generation. While specific coverage requirements have evolved over time, these core principles remain highly relevant as CMS considers coverage for new TAVR indications, including AR.

During CMS's recent reconsideration of the TAVR NCD, the ACC encouraged CMS to establish a durable and flexible coverage framework capable of accommodating evolving indications as the evidence base matures, including potential future applications for native aortic regurgitation. While CMS ultimately finalized the TAVR NCD without expanding coverage to include native AR, the Societies appreciate the agency’s subsequent decision to initiate this National Coverage Analysis (NCA) to evaluate TAVR for the treatment of native AR.

As CMS considers coverage for this new indication, the ACC encourages the agency to establish a clear and predictable coverage pathway that leverages existing TAVR program infrastructure while recognizing the unique clinical considerations associated with AR. Doing so would help minimize unnecessary administrative burden, promote operational clarity for providers, and ensure timely beneficiary access to appropriate transcatheter treatment options as evidence and clinical experience continue to grow.

Aortic Regurgitation vs. Aortic Stenosis
Native AR differs from AS in several important aspects, including pathophysiology, anatomic considerations, and medical management. For instance, unlike AS, where calcified valve leaflets often provide anchoring for transcatheter valves, patients with native AR frequently lack sufficient valvular calcification and may present with annular dilation, aortic root enlargement, or associated aortopathy. Native AR may also involve more complex valve deployment, larger access requirements, increased risk of paravalvular leak, and higher rates of conduction disturbances requiring permanent pacemaker implantation. Additionally, the rate of complications such as valve embolization and need for valve-in-valve procedures is significantly higher in this setting compared with TAVR for AS. These differences can influence patient eligibility, procedural planning, device performance, and long-term outcomes, making careful patient selection and comprehensive anatomical assessment critical.

Native AR presents unique clinical, anatomical, and procedural elements that distinguish it from established AS-TAVR practice. Whereas multiple platforms are available for AS-TAVR and more than a decade of clinical experience has informed patient selection and procedural practice, AR-TAVR is a newly approved indication with a more limited evidence base and substantially less collective clinical experience. Currently, only one FDA-approved transcatheter valve system is available for the treatment of native AR for use in patients at high or prohibitive surgical risk, and its use presents distinct clinical and operational considerations, including higher observed pacemaker implantation rates. Moreover, only a small fraction of U.S. TAVR programs currently has experience with commercially available AR-TAVR systems compared with the hundreds of centers routinely performing TAVR-AS. Collectively, available evidence and real-world experience reflect approximately 1,500 native AR procedures performed to date across roughly 30 U.S. TAVR centers, including patients enrolled in the ALIGN-AR pivotal study, ARTIST, and commercial and compassionate-use experience (Vahl et al., 2024; ClinicalTrials.gov NCT06608823; Gouda et al., 2026). In contrast, nearly one million TAVR procedures have been performed for AS across 850 active U.S. TAVR centers, highlighting the substantial smaller volume of experience. Furthermore, long-term outcomes and device durability remain areas of ongoing study. Collectively, these factors underscore the importance of a thoughtful approach to coverage implementation and continued evidence development to refine patient selection, ensure patient safety, and better understand long-term outcomes.

Despite these important distinctions, several principles that have guided the successful adoption of TAVR for AS remain directly applicable to native AR. Similar to AS, patients with severe symptomatic native AR face substantial morbidity and mortality without appropriate intervention. While surgical intervention remains the mainstay of treatment and frequently requires consideration of concomitant aortic root and ascending aortic intervention in addition to valve replacement or repair, treatment options for patients at high or extreme surgical risk have been limited. The availability of an FDA-approved AR-TAVR device represents an important advancement in this underserved population. Moreover, the fundamental principles that have guided prior CMS coverage decisions remain highly relevant, including multidisciplinary Heart Team evaluations, appropriate facility infrastructure, operator experience, continued evidence development, and ongoing quality improvement.

Patient Population and Evidence Base
The patient population evaluated in ALIGN-AR (Makkar R, et al. The Lancet, 2025) provides an important reference point as CMS considers coverage parameters for this emerging indication. Key inclusion criteria included patients with predominant native AR with a trileaflet valve requiring aortic valve replacement (AVR). This was defined as a Class I or Class II indication for AVR under ACC/AHA or ESC/EACTS guideline recommendations; moderate-to-severe or severe AR (Grade 3+ or 4+) confirmed by echocardiography or cardiac magnetic resonance imaging; ascending aorta or aortic root dimension less than 5 cm; and symptomatic disease with New York Heart Association (NYHA) Class II or greater symptoms (Otto et al., 2021; Praz et al., 2025). Patients were also required to be candidates for TAVR using the Trilogy transcatheter heart valve (THV) system (adequate iliofemoral access, favorable ascending aortic anatomy, appropriate aortic valve morphology and annular dimensions), high or extreme risk for SAVR, capable of providing informed consent, and willing to comply with longitudinal follow-up requirements. These considerations are reflected in the FDA-approved indication for the Trilogy Transcatheter Heart Valve System (FDA PMA P250024, approved March 17, 2026), which states: "This device is indicated for the treatment of symptomatic, severe native tricuspid aortic valve regurgitation (not due to acute endocarditis, rheumatic heart disease, or acute aortic dissection) in patients who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for surgical aortic valve replacement (i.e., predicted risk of surgical mortality =8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).”

The importance of careful patient selection is further reflected in international guideline recommendations. The 2025 ESC/EACTS Valvular Heart Disease Guidelines include a Class IIb recommendation supporting consideration of TAVR in selected patients with native aortic regurgitation who are ineligible for surgery (Praz F et al. 2025). Taken together, the ALIGN-AR study population, FDA-approved indication, and guideline recommendations emphasize careful patient selection through multidisciplinary Heart Team evaluation and individualized clinical assessment.

Heart Team
As CMS considers coverage for this indication, the Societies strongly emphasize the importance of a multidisciplinary Heart Team. As outlined above, patients with severe native AR frequently present with complex clinical and anatomical considerations that require individualized assessment. Unlike AS, treatment decisions may be influenced not only by valve pathology, but also by factors such as aortic root dilation, ascending aortic disease, ventricular remodeling, and other concomitant structural abnormalities. For patients not of extreme surgical risk, the current standard of care is surgery. While transcatheter treatment of native AR is currently limited to patients at high or greater surgical risk consistent with the FDA-approved indication, the field continues to evolve. As additional evidence emerges and indications potentially expand, patients with native AR, particularly those who are younger or at intermediate or lower surgical risk, may have a broader range of treatment options. Unlike AS for which valve replacement is the only available option, isolated AR may be treated with reconstructive options for the aortic valve including aortic valve repair, valve-sparing root replacement, and the Ross procedure that avoid several of the complications of prosthetic valves and are associated with better long-term clinical outcomes (Girdauskas et al., 2024; Tastet et al., 2024; El-Hamamsy et al., 2022; Mazine et al.,). Furthermore, approximately 30-40% of patients undergoing surgery for significant native AR have concomitant significant aortic pathology requiring consideration of concomitant aortic root or ascending surgery at a threshold of 4.5 cm (Anand et al., 2023; Chang et al., 2022; Praz et al., 2025). A multidisciplinary evaluation is therefore important to ensure patients understand the full range of available treatment options and engage in informed shared decision-making regarding the risks and benefits that are individualized based on patient anatomy, clinical characteristics, and long-term considerations.

Accordingly, the Societies believe that an in-person evaluation by both an interventional cardiologist and a cardiac surgeon from the Heart Team must remain an essential component of patient assessment and treatment planning. This approach provides an important safeguard for appropriate patient selection and consideration of all available treatment options without relying on potentially burdensome numerical eligibility criteria that may not fully capture the complexity of individual patients. The complementary expertise of these specialists is critical to evaluating the full range of therapeutic options, including transcatheter intervention, surgical valve replacement, reconstructive options for the aortic valve, and management of associated aortic pathology.

Equally important is comprehensive multimodality imaging assessment, which plays a central role in evaluating aortic valve morphology, annular dimensions, aortic root and ascending aortic anatomy, procedural feasibility, and suitability for alternative treatment strategies. Input from these specialties helps ensure comprehensive evaluation of patient-specific anatomy, procedural considerations, and long-term treatment needs.

A collaborative Heart Team approach, including interventional cardiologists, cardiac surgeons, imaging specialists, advanced practice providers, nurses, administrators, and other clinically appropriate specialists, remains essential to determining the most appropriate treatment strategy for each patient. This framework has been a cornerstone of the successful adoption of TAVR and is particularly important for a newly approved indication where careful patient selection will be critical to achieving optimal outcomes.

Operator Requirements
It is pivotal that this NCD maintain a two-operator requirement when performing TAVR procedures for AR. Unlike calcific aortic stenosis, native AR frequently occurs in the absence of significant annular or leaflet calcification, eliminating an important mechanism for anchoring and stabilizing a transcatheter valve during deployment (Yoon et al., 2017). AR is also commonly associated with larger or dilated annuli and aortic roots, while increased stroke volume and the regurgitant “suction effect” can further complicate precise valve positioning (Franzone et al., 2016). Together, these characteristics increase the technical complexity of the procedure and the potential for valve malposition, migration, embolization, paravalvular regurgitation, or the need for conversion to surgery.

These risks are demonstrated in the available clinical evidence. The PANTHEON international registry of TAVR for pure native AR reported transcatheter valve embolization or migration in 12.4 percent of patients, with these events associated with worse short- and longer-term outcomes. Although newer dedicated devices have substantially improved procedural outcomes, the ALIGN-AR trial itself recognizes the unique challenges associated with anchoring and positioning a transcatheter valve in the noncalcified anatomy characteristic of AR (Poletti et al., 2023). Given these procedural complexities, the evolving evidence base, and the potential need to rapidly identify and manage complications, including circumstances requiring surgical intervention, we believe the complementary expertise of two qualified operators remains an important patient safety safeguard. Maintaining a two-operator requirement helps ensure appropriate procedural planning, device deployment, real-time clinical decision-making, and management of complications as TAVR expands into this distinct and technically challenging patient population.

Coverage with Evidence Development
As experience with TAVR for native AR continues to evolve, continued evidence development will be essential to better understand long-term outcomes, identify patient populations most likely to benefit, and inform future refinements to clinical practice. The Societies believe coverage for severe symptomatic native AR is well-suited for CED. Given the limited long-term evidence currently available for TAVR in native aortic regurgitation, we believe a CED framework should be a requirement and should be structured in a manner consistent with CMS's recently finalized coverage approach for asymptomatic severe AS. While the specific clinical questions should reflect the unique characteristics and remaining evidence gaps associated with native AR, CMS should leverage existing operational infrastructure, study expectations, and data collection processes whenever feasible. Aligning study requirements, evidence development expectations, and data collection processes across newer TAVR indications would promote consistency, reduce unnecessary administrative burden, and support continued evidence generation while ensuring timely beneficiary access.

The ALIGN-AR pivotal trial (Vahl et al., 2024) demonstrated favorable safety and effectiveness outcomes and formed the basis for FDA approval. Given the absence of an approved transcatheter treatment option for this population at the time of study design and the poor prognosis associated with untreated symptomatic severe AR, a traditional randomized trial was neither practical nor ethical. Nevertheless, ALIGN-AR successfully met its prespecified safety and effectiveness endpoints, and additional evidence will continue to emerge through ongoing studies, including ARTIST (ClinicalTrials.gov NCT06608823), as well as real-world clinical experience.

The primary objective of CED should be to address remaining areas of clinical uncertainty and generate evidence that can inform future coverage decisions. Accordingly, CMS should establish clear, clinically meaningful research questions that can be prospectively evaluated and ultimately answered over time. Particular areas of interest include procedural outcomes, such as permanent pacemaker implantation, device embolization or conversion to SAVR, vascular access complications, and valve performance, as well as longer-term outcomes including durability, reintervention on the aortic valve or aorta, aortic endpoints (rupture or dissection), and survival. Defining targeted evidence gaps at the outset will help ensure that CED remains focused on generating information that is both clinically relevant and actionable for future policy considerations.

Real-World Evidence Generation and Quality Improvement
The cardiovascular community has an already established infrastructure capable of supporting both real-world evidence generation and quality assessment for TAVR in native AR. The STS/ACC Transcatheter Valve Therapy (TVT) Registry has played a central role in advancing understanding of transcatheter valve therapies, informing clinical practice, supporting regulatory and coverage decision-making, and generating high-quality real-world evidence. Registry-derived data have informed evaluations of procedural outcomes, patient selection, operator and institutional experience, and longitudinal clinical performance, while also identifying opportunities for quality improvement across TAVR programs. The TVT Registry is particularly well-suited to support CED for native AR because it enables standardized data collection at scale, facilitates longitudinal follow-up, and provides a mechanism for evaluating outcomes in a real-world Medicare population.

While administrative claims databases and linked data sources can provide valuable information regarding longitudinal outcomes, utilization patterns, and survival, these sources cannot fully replicate the detailed clinical, procedural, imaging, and device-specific information captured within the TVT Registry. Such data sources should therefore be viewed as complementary to, rather than substitutes for, robust clinical registry participation. Particularly for a newly approved indication such as native AR, high-quality real-world evidence requires the integration of detailed clinical information with longitudinal outcomes data and remains essential to understanding patient selection, procedural performance, and device durability. As experience with this new indication grows, collection of consistent national data will be critical for addressing evidence gaps that cannot be fully answered through premarket studies alone and to informing future clinical practice and coverage decisions.

Beyond evidence development, the TVT Registry has demonstrated the value of nationally standardized quality assessment and benchmarking. Participation in a national registry enables programs to evaluate performance against standardized measures and national benchmarks, identify opportunities for improvement, and monitor outcomes over time in a manner that extends beyond traditional internal quality review activities. These capabilities help support accountability, transparency, and continuous learning across TAVR programs. The Societies are committed to ensuring that data collection remains focused, efficient, and clinically meaningful and are actively working to reduce administrative burden, including efforts to streamline registry participation and make one-year follow-up data collection optional, while preserving the Registry's essential roles in generating high-quality, real-world evidence and supporting quality improvement.

The Societies support inclusion of a quality improvement requirement for TAVR in native AR, consistent with the approach adopted in the final 2026 TAVR NCD. We appreciate CMS's continued emphasis on quality improvement and patient safety and agree that programs performing TAVR for native AR must maintain a continuous quality improvement process that assesses procedural outcomes and makes necessary programmatic adjustments to assure patient safety. We also recognize CMS's desire to provide hospitals with flexibility in how these activities are implemented rather than prescribing a single mechanism for quality oversight. While this approach reduces administrative burden and allows institutions to leverage existing quality programs, it may also result in substantial variation in how quality improvement expectations are interpreted and operationalized across programs.

As currently written, the requirement establishes an important expectation but does not specify how programs should assess performance against external standards or demonstrate compliance. Internal activities such as morbidity and mortality conferences, departmental reviews, and quality committee meetings are important components of a comprehensive quality program, but they do not necessarily provide the same degree of objective benchmarking and external performance assessment as nationally standardized quality measurement programs. Consequently, one institution may rely solely on internal review processes, while another may participate in robust benchmarking initiatives, despite both technically satisfying the same requirement.

The Societies respectfully encourage CMS to provide additional guidance regarding appropriate approaches to quality assessment and benchmarking. Rather than prescribing a single pathway, CMS could recognize participation in national registries, quality improvement programs, third-party accreditation or certification programs, state quality programs, public reporting initiatives, or other structured benchmarking processes capable of providing objective performance assessment, external benchmarking, and accountability. Such an approach would preserve institutional flexibility while promoting greater consistency, transparency, and accountability across TAVR programs.

As CMS seeks to expand access while reducing administrative burden, we believe it remains important to maintain mechanisms that support standardized performance assessment and continuous quality improvement. The success of TAVR in the U.S. has been driven not only by expanded access, but also by a longstanding commitment to evidence generation, quality oversight, and accountability. Clarifying how programs may demonstrate adherence to quality improvement expectations would help preserve these principles as experience with TAVR for native AR continues to evolve.

Conclusion
This NCD will play an important role in the implementation of TAVR for AR, particularly given the early stage of experience with this newly approved indication. The field is expected to evolve rapidly, with additional dedicated AR technologies under development and ongoing clinical studies further informing patient selection, procedural approaches, and long-term outcomes. As CMS develops a coverage framework for this indication, it will be important to maintain an approach that supports continued innovation while allowing emerging evidence to inform clinical practice. The ACC/AHA is currently developing updated valvular heart disease guidelines in conjunction with the surgical societies that will incorporate new evidence and provide recommendations regarding the appropriate use of transcatheter therapies in aortic valve disease. Together with ongoing clinical studies, real-world evidence generation, and continued quality assessment, these efforts will help refine patient selection and optimize outcomes for Medicare beneficiaries with native AR.

The Societies appreciate CMS's thoughtful consideration of this important coverage issue and its ongoing commitment to ensuring that Medicare beneficiaries have timely access to safe, effective, and innovative cardiovascular therapies. We look forward to continued collaboration as experience with TAVR for AR grows. We believe a coverage framework that promotes patient access, supports evidence development, encourages quality assessment, and preserves multidisciplinary Heart Team decision-making will help ensure the safe, effective, and evidence-based adoption of this promising therapy for Medicare beneficiaries. Please direct any questions or concerns to Amanda Stirling, Regulatory Affairs Associate, at 202-375-6553 or astirling@acc.org.

Sincerely,

Roxana Mehran, MD, FACC
President, American College of Cardiology

J. Dawn Abbott, MD, MSCAI
President, Society for Cardiovascular Angiography & Interventions

Vinay Badhwar, MD
President, The Society of Thoracic Surgeons

References
Otto CM, Nishimura RA, Bonow RO. 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. J Am Coll Cardiol. 2021 Feb 2;77(4):e25-e197.

Praz F, Borger MA, Lanz J, et al. 2025 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J. 2025;46(44):4635-4736.

Makkar R, Thourani V, Vahl T et al. Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study. Lancet, 2025; 406, 2757-2771.

Vahl TP, Thourani VH, Makkar RR, et al. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet. 2024;403(10435):1451-1459.

ClinicalTrials.gov. Study of Transcatheter Aortic Valve Replacement for Aortic Regurgitation. ClinicalTrials.gov Identifier: NCT06608823. Available at: https://clinicaltrials.gov/study/NCT06608823. Accessed September 2026.

Gouda P, Koerner J, Stebbins A, et al. Outcomes of transcatheter aortic valve replacement for primary aortic regurgitation. Structural Heart, 2026; Published online September 25, 2026.

U.S. Food and Drug Administration. Premarket Approval (PMA): Trilogy Transcatheter Heart Valve System (P250024). Approved March 17, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250024 Girdauskas E, Balaban Ü, Herrmann E, et al. Aortic valve repair results in better 1-Year survival than replacement: results from German Aortic Valve Registry. Ann Thorac Surg. 2024 Mar;117(3):517-525.

Tastet L, Salaun E, de Heer F, et al. Mid-term clinical and hemodynamic outcomes in patients treated for aortic regurgitation and/or ascending aorta aneurysm: the 3-year flight of the AVIATOR Registry. Journal of the Heart Valve Society. 2024;1(1).

El-Hamamsy I, Toyoda N, Itagaki S, et al. Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults. J Am Coll Cardiol. 2022 Mar 1;79(8):805-815.

Mazine A, David TE, Stoklosa K, et al. Improved Outcomes Following the Ross Procedure Compared With Bioprosthetic Aortic Valve Replacement. J Am Coll Cardiol. 2022 Mar 15;79(10):993-1005.

Vidhu Anand, Hanwen Hu, Alexander D Weston, et al. Machine learning-based risk stratification for mortality in patients with severe aortic regurgitation, European Heart Journal - Digital Health, Volume 4, Issue 3, May 2023, Pages 188–195. Chang, H, Lo, H, Chen, W. et al. Comparison between bicuspid and tricuspid aortic regurgitation: presentation, survival, and aorta complications. JACC. 2022 Mar, 79 (9_Supplement) 1737.

Yoon SH, Schmidt T, Bleiziffer S, et al. Transcatheter aortic valve replacement in pure native aortic valve regurgitation. J Am Coll Cardiol. 2017;70(22):2752-2763.

Franzone A, Piccolo R, Siontis GCM, et al. Transcatheter aortic valve replacement for the treatment of pure native aortic valve regurgitation: a systematic review. JACC Cardiovasc Interv. 2016;9(22):2308-2317.

Poletti E, De Backer O, Scotti A, et al. Transcatheter aortic valve replacement for pure native aortic valve regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv. 2023;16(16):1974-1985.

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I am writing to express my support for FDA-approved transcatheter aortic valve replacement (TAVR) technologies for carefully selected patients with severe symptomatic native aortic regurgitation (AR) who are at high or prohibitive surgical risk. However, as these devices enter broader clinical use, it is important that regulatory oversight continue to reflect the unique characteristics of native AR and the current limitations of available evidence.

Native AR differs substantially from calcific aortic stenosis. Many patients have noncalcified valves, annular dilation, bicuspid valve anatomy, aortic root enlargement, or associated ascending aortic disease. These anatomic features influence both procedural outcomes and treatment selection. Unlike patients with aortic stenosis, patients with AR often have surgical options beyond prosthetic valve replacement, including aortic valve repair, valve-sparing root replacement, and the Ross procedure. These alternatives may offer important long-term benefits and should remain part of a comprehensive treatment discussion. Associated aortic pathology is particularly important. A substantial proportion of patients with significant AR have concomitant aortic root or ascending aortic enlargement that may warrant surgical intervention. While TAVR can address valvular insufficiency, it does not treat associated aortopathy. Therefore, treatment decisions should be based on a full assessment of the valve, aortic root, ascending aorta, and the patient’s long-term management strategy, rather than procedural feasibility alone.

Although recent studies supporting device approval have demonstrated encouraging early outcomes, clinical experience with dedicated TAVR devices for native AR remains very limited compared with the extensive experience accumulated in aortic stenosis. Important questions remain regarding patient selection, procedural complications, valve durability, reintervention, and long-term outcomes. Continued post-market surveillance and evidence development are therefore essential.

I encourage the FDA to maintain a strong emphasis on multidisciplinary Heart Team evaluation and ongoing registry-based follow-up. Involvement of both cardiac surgeons and interventional cardiologists helps ensure that all therapeutic options are considered and that patient selection remains appropriate. Robust post-market data collection will be critical to defining long-term safety and effectiveness and to guiding future expansion of this therapy. TAVR for native AR represents an important advance for patients with limited treatment options. Its continued success, however, will depend on careful patient selection, multidisciplinary decision-making, and rigorous long-term evaluation.

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As members of the investigator team for the Align AR trial we have personally seen the benefits of treating high risk patients with severe symptomatic aortic regurgitation with the Trilogy System. The improvement in the quality of life, symptoms and mortality have been clearly demonstrated over an intermediate duration of follow up. Our team firmly endorses the expansion of the National Coverage Decision to include the treatment of high-risk patients with severe symptomatic aortic regurgitation, who have been evaluated by a multidisciplinary team, with a device that is specifically designed for this pathology to ensure appropriate outcomes and maintenance of patient safety.
Alan Zajarias
Tsuyoshi Kaneko

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Subject: Public Comment on National Coverage Analysis for TAVR for Aortic Regurgitation (AR)

Dear CMS Coverage and Analysis Group,

I am writing to strongly support and advocate for a favorable National Coverage Determination (NCD) resulting from the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) for Aortic Regurgitation (AR). Specifically, I want to highlight the urgent, unmet clinical need for dedicated transcatheter technologies—such as the JenaValve Trilogy system—for Medicare beneficiaries suffering from severe AR who are unable to undergo alternative high-risk open-heart surgery.

Severe aortic regurgitation is a debilitating, progressive condition. A significant population of patients with native AR are deemed high-risk, frail, or entirely ineligible for traditional surgical aortic valve replacement. For these vulnerable individuals, open-heart surgery carries prohibitive mortality and morbidity risks, leaving them with a critical lack of safe, minimally invasive therapeutic alternatives.

The availability of purpose-built transcatheter systems, like the Trilogy system, represents a vital breakthrough in patient care. These technologies are specifically engineered to address the distinct anatomical challenges of aortic regurgitation, providing a reliable and precise solution for patients who otherwise have no viable surgical pathway.

To ensure that hospitals can successfully adopt and provide patient access to these newly approved therapies, it is equally vital that coverage decisions align with robust reimbursement mechanisms, such as the proposed New Technology Add-on Payment (NTAP) for Trilogy. Aligning national coverage with appropriate hospital payment frameworks is essential to removing institutional barriers to care.

Establishing Medicare coverage for TAVR in the treatment of AR—and ensuring access to advanced devices designed explicitly for this pathology—is a medical necessity. It will directly improve clinical outcomes, reduce the burden of recurrent heart failure hospitalizations, and, most importantly, save the lives of high-risk patients who cannot tolerate conventional open-heart surgery.

Thank you for your time, leadership, and ongoing commitment to evaluating innovative cardiovascular technologies that expand access to life-saving care for Medicare beneficiaries. We strongly urge CMS to establish broad and timely national coverage for this critical indication.

Ramzi Khalil, M.D
Director of Cardiac Catheterization Lab
Allegheny General Hospital
Pittsburgh Pennsylvania

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**Re: National Coverage Analysis – Transcatheter Aortic Valve Replacement for Aortic Regurgitation (JenaValve Trilogy)**

As an interventional cardiologist and Director of the Structural Heart Program at Deborah Heart and Lung Center, I strongly support national coverage for dedicated transcatheter devices to treat patients with pure native aortic regurgitation.

Surgical aortic valve replacement is currently the only approved option for these patients. Yet many are elderly, frail, or carry significant comorbidities that make them high-risk or suboptimal surgical candidates. As a result, a substantial number go untreated, facing progressive heart failure, recurrent hospitalizations, and increased mortality.

Off-label use of conventional TAVR platforms is not an adequate alternative in this population. The absence of annular calcification makes anchoring unreliable and increases the risk of valve embolization and paravalvular leak. Devices designed specifically for aortic regurgitation address this anatomic challenge directly, and the ALIGN-AR trial has demonstrated their safety and efficacy in high-risk patients.

To reduce hospitalizations and mortality in this underserved population, dedicated devices for aortic regurgitation must be approved and covered. I urge CMS to provide national coverage so that these patients have access to a safe, effective, less invasive treatment option.

Respectfully,
Muhammad Raza, MD, FACC
Director, Structural Heart Program
Deborah Heart and Lung Center

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AMERICAN ASSOCIATION FOR THORACIC SURGERY
Comments on CAG-00430R3: National Coverage Analysis for TAVR for Aortic Regurgitation

October 6, 2026

The American Association for Thoracic Surgery (AATS) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) National Coverage Analysis for transcatheter aortic valve replacement (TAVR) in patients with native aortic regurgitation (AR). AATS supports access to FDA-approved transcatheter therapy for appropriately selected patients with symptomatic severe native AR who are at high or prohibitive surgical risk. At the same time, native AR is a distinct disease from calcific aortic stenosis (AS), and its coverage framework should preserve the clinical safeguards required to ensure that patients receive the most appropriate treatment in the safest way.

Why Native AR Requires a Distinct Approach
Unlike calcific AS, native AR frequently occurs in noncalcified valves and is often associated with annular dilation, bicuspid aortic valves, aortic root enlargement, ascending aortic disease, and other structural abnormalities. These features influence both the technical performance of TAVR and, importantly, the choice of treatment. Unlike severe AS, surgical therapy for AR is not limited to prosthetic valve replacement. For patients with isolated AR, reconstructive options that avoid some of the long-term complications of prosthetic valves may be feasible including aortic valve repair, valve-sparing root replacement, and the Ross procedure. These approaches are associated with improved long-term survival and quality of life in carefully selected patients and must be considered as part of informed lifetime management for patients with AR.

Associated aortopathy is particularly important in patients with native AR. Approximately 30-40% of patients undergoing surgery for significant native AR have concomitant aortic pathology that may warrant consideration of aortic root or ascending aortic intervention at a threshold of 4.5 cm. TAVR treats the valve but does not address associated aortic disease. A decision to proceed with TAVR therefore cannot be based solely on whether a transcatheter valve can technically be implanted or on an estimate of operative mortality. It requires an assessment of valve reparability, root and ascending aortic pathology, consideration of all surgical and transcatheter options, and the implications of each strategy for the patient's long-term care.

The current evidence base also remains early. The FDA-approved indication is limited to symptomatic severe native tricuspid AR in patients judged by a Heart Team, including a cardiac surgeon, to be at high or greater risk for surgical AVR. Clinical experience with dedicated AR-TAVR remains far more limited than experience with TAVR for AS. To date, approximately 1,500 TAVR procedures for native AR have been performed across roughly 30 U.S. centers, compared with nearly one million TAVR procedures for AS across approximately 850 active U.S. TAVR centers. This marked difference in collective experience reinforces the need for continued clinical safeguards and evidence development, particularly given important uncertainties regarding patient selection, procedural complications, durability, reintervention, and long-term aortic and valvular outcomes.

AATS Recommendations to CMS
1. Require an in-person Heart Team evaluation by a cardiac surgeon.
For native AR, surgical evaluation is not simply a determination of whether a patient can tolerate an operation. The cardiac surgeon must assess the mechanism of AR; the feasibility and expected durability of valve repair or other reconstructive procedures; the presence and significance of aortic root or ascending aortic disease; the role of concomitant procedures; and the patient’s lifetime treatment options. AATS therefore recommends that CMS require an in-person evaluation by a cardiac surgeon as an essential component of Heart Team assessment before TAVR for native AR. This provides an important safeguard against selecting a transcatheter procedure without fully considering surgical replacement options including mechanical valves, valve-preserving reconstruction, or treatment of associated aortopathy.

2. Require both and interventional cardiologist and cardiac surgeon as operators.
AATS recommends that TAVR for native AR be performed with both an interventional cardiologist and a cardiac surgeon serving as operators, as was mandated in the ALIGN-AR trial. Native AR presents procedural challenges distinct from calcific AS, including the absence of calcification for valve anchoring, larger or dilated annuli and roots, and increased potential for malposition, migration, embolization, paravalvular regurgitation, or conversion to surgery. Although dedicated devices have improved outcomes, experience remains limited and complications may require rapid multidisciplinary decision-making or surgical intervention. The complementary expertise of both specialties should therefore remain a mandatory patient-safety requirement during this early phase of adoption.

3. Continue Coverage with Evidence Development for TAVR in native AR.
AATS supports Medicare coverage for appropriately selected patients but recommends that coverage remain linked to prospective evidence development. ALIGN-AR demonstrated relatively favorable early safety and effectiveness and supported FDA approval, but real-world procedural outcomes and long-term experience remains limited. CED should focus on clinically meaningful unanswered questions, including procedural success and complications, permanent pacemaker implantation, device embolization, conversion to surgery, valve durability, reintervention on the valve or aorta, aortic rupture or dissection, and long-term survival. Existing national registry infrastructure can support efficient real-world evidence generation while avoiding unnecessary administrative burden.

Conclusion
TAVR for native AR represents an important new treatment option for patients who are at high or prohibitive surgical risk. Its responsible introduction, however, should reflect the unique nature of AR and the broader range of surgical and reconstructive treatments available to these patients. AATS urges CMS to preserve three core safeguards in the national coverage framework: mandatory in-person cardiac surgical Heart Team evaluation, dual-specialty procedural participation by an interventional cardiologist and cardiac surgeon, and continued Coverage with Evidence Development. Together, these requirements will support appropriate patient selection, informed shared decision-making, procedural safety, and responsible evidence-based expansion of this promising therapy.

The AATS appreciates CMS’s consideration of these recommendations and looks forward to continued collaboration on the care of Medicare beneficiaries with native aortic regurgitation.

Sincerely,

Joseph Woo
President, American Association for Thoracic Surgery

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Dear CMS Coverage and Analysis Group,

I am an interventional cardiologist specializing in structural heart disease with substantial experience treating patients with severe native aortic regurgitation, including a decade of experience using the JenaValve transcatheter heart valve system.

I strongly support national Medicare coverage for transcatheter aortic valve replacement for appropriately selected patients with severe aortic regurgitation when performed using an FDA-approved device in accordance with its approved indication.

Severe native aortic regurgitation remains an important unmet clinical need. Many affected patients are elderly, symptomatic, and have left ventricular dysfunction, prior cardiac procedures, or other comorbidities that make surgical aortic valve replacement high risk or unattractive.

My clinical experience with the JenaValve system has been excellent. I have been impressed by both its procedural performance and the clinical response of appropriately selected patients. A dedicated transcatheter device for native aortic regurgitation addresses important limitations of conventional TAVR devices in the non-calcified or minimally calcified annulus.

This experience is consistent with the prospective evidence from the ALIGN-AR program supporting the safety and effectiveness of dedicated transcatheter treatment in symptomatic patients with severe native aortic regurgitation at elevated surgical risk, and with the subsequent FDA approval of the Trilogy Transcatheter Heart Valve System.

I encourage CMS to establish straightforward national coverage without imposing unnecessary barriers. In particular, coverage requirements developed for TAVR in calcific aortic stenosis, such as specific heart-team processes, institutional criteria, or other legacy restrictions, should not automatically be applied to aortic regurgitation unless they are supported by evidence or necessary for patient safety.

Importantly, coverage should be manufacturer-neutral and adaptable to future developments. The NCD should cover TAVR for aortic regurgitation when performed using an FDA-approved transcatheter heart valve in accordance with its FDA-approved indication. This would allow Medicare coverage to remain aligned with future FDA approvals and label expansions without repeated reconsideration of the NCD.

The availability of dedicated transcatheter therapy represents a meaningful advance for patients with severe aortic regurgitation who previously had few satisfactory treatment options. I respectfully urge CMS to provide national coverage for FDA-approved transcatheter heart valves for the treatment of aortic regurgitation.

Respectfully submitted,

Toby Rogers, MD, PhD

Interventional Cardiologist
MedStar Washington Hospital Center

Professor of Medicine
Georgetown University

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For this NCD I would ask CMS to be aware and careful with the specific language used. It seems like CMS has been inserting vague language into the NCD's as a nod to political pressure. For example, the new TAVR NCD included a statement that patients don't need a surgical consult yet every patient needs "input" from cardiac surgery. This type of language is not helpful, creates confusion and allows people to play political games for their own self interest. This type of language is not involved in NCD's for other procedures. It's time to get all of these politics out of structural. Just say the hospital needs cardiac surgery on site and let the hospital decide who needs a consult, who scrubs into the procedure and who needs "input". Coronary disease has no such rules and yet in 40 years of PCI patients with left main disease and diabetics with triple vessel disease almost uniformly get surgical consults. Cardiologists and cardiac surgeons naturally work in a "team" for everything they do. This whole "heart team" nonsense is nothing more than veiled turf protection. Just focus on the patients and who it will help, leave doctor politics out of it.

The other thing I would request is CMS leave out risk criteria in the decision. If the initial NCD only includes high risk patients, it will be outdated almost immediately as trials are already in progress for low and intermediate risk patients. I would request making it available for all FDA approved indications as FDA approval seem much easier to obtain than NCD changes. Let doctors treat their patients with the most up to date data without having to wait for prolonged government approval processes.

Lastly, please do not put forced co-operator language into the NCD. This has created so many issues for TAVR programs over the years with negligible to no value for patients. Forcing two people to do a one man procedure for political purposes is not helpful, unnecessary and many times unsafe (like trying to drive a care with two people's hands on the wheel).

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I urge CMS not to limit Medicare coverage for aortic regurgitation strictly to a single device platform. While the approval of JenaValve Trilogy is a vital advance, commercial onboarding takes time and the device is not yet universally available or anatomically suitable for every prohibitive-risk patient. In our practice, selected severe AR patients have been treated successfully using balloon-expandable valves —an approach validated in published multicenter literature including the international PANTHEON Project (JACC Cardiovasc Interv. 2023). To avoid creating care gaps, I recommend CMS maintain a Coverage with Evidence Development (CED) pathway under the STS/ACC TVT Registry to preserve access to established balloon-expandable systems for carefully screened, inoperable patients.

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CMS should include coverage for patients with Aortic Insufficiency who can receive valves specifically designed for this purpose, apporved by the FDA, and recommended by the Heart Team.. In addition, in high risk or inoperable patients, the Heart Team should be able to decide on a case by case basis on treating other high risk patients with other approved transcatheter heart valves. This includes patients with LVAD's and severe AI and patients who cannot receive valves approved specifically for AI.

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