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

**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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