Transcatheter Aortic Valve Replacement (TAVR)

A cardiologist (or two cardiologists) should not be able to perform TAVR without an involved surgeon as they cannot perform necessary life-saving procedures in the event of a complication. Only surgeons should be able to perform this procedure as a single operator as that is the only type of training that allows for comprehesive management of TAVR complications.

Needs to include continue Coverage with Evidence Development (CED) for the areas where clinical science is lacking to include asymptomatic aortic stenosis (AS), moderate AS, bicuspid AS, pure aortic regurgitation (AR), valve-in-valve repeat interventions, and low surgical risk.

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I write to express strong support for the proposed revisions to TAVR NCD 20.32. CMS should be commended for undertaking this thoughtful reconsideration. The proposed changes reflect the substantial maturation of TAVR over the past decade and will meaningfully improve access to this lifesaving therapy for Medicare beneficiaries. As a structural heart specialist who performs these procedures and cares for patients with aortic stenosis, I am encouraged that the proposed NCD addresses several critical barriers that have limited timely patient access.

The most impactful proposed change is clarifying that joint participation of two TAVR operators is not required. This revision will have immediate, tangible benefits for patient access and program capacity. In my experience, the prior requirement for both a cardiac surgeon and interventional cardiologist to be present created scheduling bottlenecks that delayed procedures, particularly at centers with limited staffing or in rural and suburban settings where TAVR-trained physicians may cover multiple hospitals. Contemporary TAVR has an excellent safety profile, with conversion to open surgery occurring in fewer than 0.5% of cases, which is comparable to PCI, which has never required dual-operator presence. The COVID-19 pandemic demonstrated that excellent outcomes could be achieved without the strict two-operator requirement. By allowing experienced operators to perform TAVR independently while still permitting centers to maintain two-operator systems if they choose, this proposal strikes the right balance between safety and access. I anticipate this change alone will reduce patient wait times, improve procedural throughput, and help centers meet the ACC/AHA quality target of treatment within 90 days of diagnosis.

I strongly support removing CED requirements for symptomatic severe AS. The evidence base for TAVR in this population is now definitive, with long-term durability demonstrated through 10 years, real-world outcomes from the TVT Registry matching pivotal trial results, and a validated 30-day composite quality metric endorsed by the National Quality Forum. The original CED questions have been thoroughly answered. Sunsetting CED for symptomatic AS appropriately recognizes TAVR as an established, evidence-based therapy and will reduce administrative burden on programs while maintaining quality through direct outcome measurement.

I also support expanding coverage to asymptomatic severe AS. The EARLY TAVR trial, published in the New England Journal of Medicine, demonstrated significant reductions in death, stroke, and cardiovascular hospitalization with early intervention compared to watchful waiting. These findings are consistent with earlier randomized trials, including RECOVERY and AVATAR. Clinically, disease progression in AS is unpredictable, where patients can convert rapidly from asymptomatic to acutely decompensated, carrying higher procedural risk. While I understand the rationale for CED in this newer indication, I would note that the existing randomized trial evidence is robust and may already satisfy many of the proposed CED questions. I encourage CMS to establish a clear pathway for transitioning asymptomatic coverage from CED to standard coverage as additional data accrue, and to ensure CED requirements do not create undue barriers to enrollment or delays in treatment for appropriate patients.

The revised volume requirements allowing operators to count all transcatheter valve procedures toward their threshold is reasonable and reflects the reality that skills developed across structural heart interventions are transferable. The continued emphasis on heart team evaluation and hospital infrastructure requirements appropriately maintains quality standards while removing outdated process barriers. In summary, I urge CMS to finalize this proposed NCD. These changes will improve patient access, reduce delays in care, address geographic disparities, and better align coverage policy with the current evidence and safety profile of TAVR while maintaining appropriate quality oversight through outcome-based measurement

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Thank you for the opportunity to comment on the proposed National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR).

As cardiac surgeons practicing within a large, integrated academic cardiovascular system, we appreciate CMS's thoughtful review of this important policy and recognize several positive aspects of the proposed determination. We are particularly encouraged by CMS's decision to preserve the Heart Team model, maintain the requirement for participation of a cardiac surgeon in patient evaluation, and continue to require on-site cardiac surgical programs. These elements have been foundational to the outstanding clinical outcomes achieved in the United States since the introduction of TAVR and remain critical safeguards for patient safety and quality.

We also acknowledge CMS's efforts to expand patient access to TAVR and to modernize the coverage framework in response to the maturation of the technology and the growing body of clinical evidence.

At the same time, we respectfully request reconsideration of several aspects of the proposed determination.

First, we remain concerned by language that permits TAVR to be performed as a single-operator procedure. While we recognize that not every case requires active participation by two operators, the ability of the Heart Team to determine when dual-operator participation is appropriate should be preserved and encouraged. The success of TAVR in the United States has been built upon a collaborative model involving both interventional cardiologists and cardiac surgeons. This partnership enhances procedural planning, patient selection, management of complications, and overall quality of care.

Importantly, catastrophic complications requiring immediate surgical intervention, although uncommon, continue to occur. In these situations, the immediate availability and active participation of an experienced cardiac surgeon can be lifesaving. We believe CMS should preserve language that recognizes the value of dual-operator participation in appropriate cases.

Second, we encourage CMS to reconsider the removal of Coverage with Evidence Development (CED) requirements for evolving clinical indications, including moderate aortic stenosis, bicuspid aortic valve disease, pure aortic regurgitation, valve-in-valve procedures, and low-surgical-risk patients. These patient populations continue to represent areas of active investigation where important questions remain regarding long-term durability, optimal patient selection, lifetime management strategies, and comparative effectiveness. Continued evidence generation through registries and structured data collection will help ensure that future expansion of TAVR indications remains grounded in high-quality clinical science.

Third, we encourage CMS to continue supporting robust operator competency standards. As TAVR expands into increasingly complex patient populations, operator experience, procedural volume, and multidisciplinary expertise remain essential determinants of quality and patient outcomes. Any future coverage framework should continue to emphasize training, competency, and ongoing outcomes assessment for all operators regardless of specialty.

The Heart Team model has transformed the care of patients with aortic valve disease. Its success stems not from the interests of any individual specialty, but from the shared commitment of cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, nurses, and allied professionals working together to provide the safest and most effective care possible.

We respectfully urge CMS to preserve and strengthen those collaborative principles in the final National Coverage Determination. Doing so will continue to promote patient safety, evidence-based innovation, and optimal long-term outcomes for Medicare beneficiaries.

Thank you for your consideration.

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Chief, Cardiac Surgery, Jefferson Einstein Montgomery Hospital
Vice Chair, Quality, Department of Cardiac Surgery
Bruce and Robbi Toll Heart & Vascular Institute, Jefferson Health
Clinical Professor of Surgery
Sidney Kimmel College of Medicine
Thomas Jefferson University

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TAVR is an additional option for patients with defined types of aortic valve disease. It is not a substitute for SAVR but rather a valuable addition to current options and for patients formerly not amenable for open surgery.
So much more is it of utmost importance, that decision making must happen in a functioning heart team between cardiologists, cardiac surgeons and also cardiac critical care specialists for the benefit of our patients, based on a critical individual evaluation.
We don't need a gatekeeper decision but rather a common table discussion.

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It would be a serious mistake to remove the requirement for cardiac surgeon participation during TAVR procedures. While TAVR has become a mature and highly successful therapy, catastrophic complications—including annular rupture, coronary obstruction, aortic dissection, ventricular perforation, and valve embolization—remain possible and can require immediate surgical intervention.

The Heart Team model has been a cornerstone of the excellent outcomes achieved with TAVR in the United States. Requiring the presence and participation of a cardiac surgeon ensures that patients have access to the full spectrum of expertise and treatment options, including emergent conversion to open surgery when necessary.

The argument that complications are infrequent is not a justification for eliminating surgical involvement. The rarity of these events does not diminish their severity. Medicare beneficiaries deserve the highest standard of care, and that includes maintaining a multidisciplinary approach with active cardiac surgeon participation during TAVR deployment.

CMS should preserve the current requirement for cardiac surgeon involvement in TAVR procedures and continue to support the Heart Team model that has contributed substantially to patient safety and procedural success.

The consequence of not having a surgeon immediately available is not a minor inconvenience—it is potentially a preventable death.

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I disagree with the plan to change coverage decision for TAVR. Specifically, the complication rate for bicuspid Aortic valves should make the procedure limited to very high risk patients. The data on intermediate and longterm survival of TAVR vs SAVR in young patients should prohibit these young low risk patients from having TAVR. These survival curves diverge at about 3 years. I also believe that having a cardiac surgeon and interventional cardiololgist on these cases has resulted in great outcomes

Modifying the coverage decision will dilute the commitment to the heart team

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am writing to express my strong opposition to any policy changes that would transition the Transcatheter Aortic Valve Replacement (TAVR) procedure into a single-operator model led solely by interventional cardiologists. Eliminating the mandatory involvement of cardiothoracic surgeons poses a severe threat to patient safety and clinical outcomes.The current heart team model—requiring active, dual-operator collaboration between a surgeon and a cardiologist—is vital for several critical reasons:Life-Saving Bailout: TAVR procedures carry inherent risks of acute, catastrophic complications, such as aortic dissection, annular rupture, or severe coronary occlusion. Having a surgeon actively scrubbed in ensures immediate, on-site surgical conversion when seconds matter most.Unbiased Patient Selection: Joint evaluation prevents specialty bias, ensuring patients receive the safest option for their specific anatomy, whether that is TAVR or surgical aortic valve replacement (SAVR).Comprehensive Care: True collaboration merges the unique spatial and structural expertise of surgery with the wire-and-catheter skills of interventional cardiology.Moving away from this multidisciplinary standard removes a critical safety net, erodes the collaborative check-and-balance system, and ultimately compromises patient care. I urge CMS to maintain the current dual-operator Heart Team requirement to protect Medicare beneficiaries.Sincerely,

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It is of utmost and critical importance for patient safety, optimal patient outcomes and lifetime patient disease management that cardiac valvular disease be treated with a heart team approach, irrespective of whether it involves the aortic, mitral, tricuspid or pulmonic valve.

Moreover, it is important that continuing evidence development be an important and integral part of future national coverage decisions as therapies continue to develop and emerge for valvular heart disease.

White the composition of the heart team may vary, surgical input should remain a necessary and key part of therapy development for this patient subset.

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Public Comment Regarding the Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement

I appreciate the opportunity to comment on the proposed National Coverage Determination for transcatheter aortic valve replacement (TAVR).

Over the past decade, TAVR has transformed the treatment of aortic valve disease and has become one of the great successes of contemporary cardiovascular medicine. That success did not occur by chance. It was built upon rigorous clinical investigation, careful patient selection, transparent outcomes reporting, and the collaborative heart team model that brought together interventional cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, and multidisciplinary support teams. These principles have contributed to excellent patient outcomes and should remain foundational as indications continue to evolve.

I support several aspects of the proposed determination, including preservation of the surgeon’s role in patient evaluation and the requirement for onsite cardiac surgical capability. These provisions recognize that aortic valve disease management is not simply a procedure, but rather a comprehensive process of patient-centered decision-making and lifelong valve management.

However, I am concerned that the proposed determination retreats from the principle of Coverage with Evidence Development (CED) in several important areas where the science remains incomplete. Expanding routine coverage for asymptomatic severe aortic stenosis, moderate aortic stenosis, bicuspid valve disease, pure aortic regurgitation, valve-in-valve interventions, and low surgical risk populations without continued evidence generation risks outpacing the clinical data necessary to guide optimal patient care.

Innovation and evidence generation are not competing goals. Continued CED provides an important mechanism to ensure that expansion of indications is accompanied by robust collection of outcomes data, allowing clinicians and patients to understand durability, reintervention rates, and long-term consequences of therapy. This is particularly important given the younger age and longer life expectancy of many patients now being considered for transcatheter therapies.

I am also concerned by language permitting single-operator procedures. While local heart teams should retain flexibility, the success of TAVR in the United States has been inseparable from the collaborative heart team model. The involvement of multiple disciplines has enhanced patient selection, procedural safety, and management of complications. Policies should reinforce—not inadvertently weaken—the culture of collaboration that has distinguished structural heart care.

As indications broaden and technologies evolve, it is essential that national coverage policy maintain the appropriate balance between expanding access, encouraging innovation, and preserving evidence-based safeguards. The quality standards incorporated into prior coverage determinations have served patients well and should not be abandoned without compelling evidence that doing so will improve outcomes.

The history of TAVR demonstrates that disciplined adoption and rigorous evidence have accelerated, rather than impeded, innovation. We should be cautious about abandoning the very principles that made this success possible.

The remarkable progress achieved in structural heart disease has been a triumph of multidisciplinary care and scientific rigor. Future policy should preserve both.

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TAVR has been an incredible innovation that has helped 100,000s of patients. It definitely has a role in offering a less stressful way to correct diseases of the aortic valve, and also other heart valves. Removing the requirement for a second operator (this would be the cardiac surgeon) maybe the natural evolution of the procedure. What is concerning the changes in the coverage with evidence development (CED) at the same time. This is definitely not in the patients best interest. Changing a requirement and then removing the way to track how it affects patients outcomes. It is contradictory to the scientific method and medical research in general. These changes also come at a time where the surgical valve (SAVR) outcomes and TAVR valve outcomes have trended from short term advantages to intermediate term equipoise and possibly a further change within a patients expected lifetime.

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I submit these comments as a board-certified cardiothoracic surgeon and former leader of multidisciplinary structural heart programs with extensive experience in both surgical and transcatheter therapies. My practice has included minimally invasive valve surgery, complex mitral valve repair, surgical aortic valve replacement, aortic root enlargement procedures, coronary artery bypass grafting, and the treatment of complex aortic pathology. I have also been actively involved in the development and performance of structural heart interventions, including transcatheter aortic valve replacement (TAVR), transcatheter edge-to-edge repair (TEER), and other transcatheter valve therapies. Having participated in the evaluation and treatment of a large number of patients with valvular heart disease, I have witnessed firsthand how the Heart Team model improves patient selection, promotes balanced counseling regarding available treatment options, and enhances procedural safety and outcomes. The concerns expressed in this comment arise not from opposition to TAVR, but from a commitment to preserving the patient-centered principles that have contributed substantially to the success of TAVR in the United States.

I am writing to express my concerns regarding the proposed modifications to the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR), specifically those changes that may diminish the role of the multidisciplinary Heart Team and reduce the involvement of cardiac surgeons in the evaluation and management of these patients.

The extraordinary success of TAVR over the past decade has not been attributable solely to technological advances. Rather, it has been the direct result of the Heart Team approach, which brought together interventional cardiologists, cardiac surgeons, cardiac imaging specialists, anesthesiologists, advanced practice providers, and nursing teams to provide comprehensive evaluation and individualized treatment recommendations. This collaborative model has improved patient selection, procedural planning, complication management, and overall outcomes. It has become one of the defining strengths of structural heart programs in the United States.

The Heart Team was established because patients with severe aortic stenosis often have multiple treatment options, each with distinct short- and long-term implications. A balanced evaluation is critical to ensure that patients receive the therapy most appropriate for their anatomy, age, comorbidities, life expectancy, and personal goals. Without meaningful surgeon involvement, there is concern that some patients who may derive greater long-term benefit from surgical intervention could instead be directed toward transcatheter therapies without a comprehensive discussion of all available options.

Examples include younger patients who may be better served with surgical aortic valve replacement, patients who may benefit from mechanical prostheses because of durability considerations, individuals requiring aortic root enlargement to prevent prosthesis-patient mismatch, patients with bicuspid aortic valve anatomy, and those with concomitant cardiac conditions such as coronary artery disease or ascending aortic pathology that can be addressed at the time of surgery. While transcatheter approaches have transformed the treatment of aortic stenosis, they are not universally the optimal strategy for every patient.

There is also increasing recognition that TAVR explantation represents a complex and high-risk operation associated with substantial morbidity and mortality. As TAVR expands into younger populations with longer life expectancy, the downstream implications of lifetime valve management become increasingly important. Decisions made today may significantly affect the safety and feasibility of future interventions. Therefore, careful patient selection remains essential. Consideration should be given to establishing guardrails regarding age, anticipated life expectancy, valve durability, anatomic suitability, and conditions such as small annular dimensions relative to body size, bicuspid valve anatomy, and the presence of other surgical indications.

The concern is not primarily with experienced, high-volume centers where multidisciplinary evaluation is deeply embedded in clinical practice and adherence to guidelines is routine. Rather, the concern is that removing the requirement for Heart Team participation may inadvertently weaken these safeguards in smaller or less experienced programs. In such settings, the absence of structured multidisciplinary review could increase the risk of inappropriate utilization, incomplete counseling regarding treatment alternatives, and variability in patient selection.

Maintaining the Heart Team should not be viewed as an administrative requirement but rather as an essential patient safety measure. Patients deserve an unbiased evaluation that incorporates the expertise of both interventional cardiologists and cardiac surgeons. Shared decision-making is strongest when all reasonable therapeutic options are presented transparently and without specialty-specific bias.

In addition, the presence and active involvement of cardiac surgeons during TAVR procedures continues to provide an important safety net. Although procedural complications have become less frequent, they can still occur unexpectedly and may require immediate surgical judgment or intervention. The collaborative procedural environment has contributed significantly to the excellent outcomes observed in contemporary TAVR practice.

As CMS considers modifications to the NCD, I strongly encourage the preservation of the multidisciplinary Heart Team framework and meaningful cardiac surgeon participation in both the evaluation and management of patients undergoing TAVR. The success of TAVR in the United States has been built upon collaboration rather than convenience. Any changes to coverage policy should reinforce, rather than weaken, the safeguards that have contributed to improved outcomes, enhanced patient safety, and more appropriate use of these transformative technologies.

Respectfully submitted,

Roberto Rodriguez, MD, MS, FACC, FACS

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I disagree with the proposed NCD's determination to do away with the requirement for a surgeon's role in the TAVR procedure. Our heart team functions best when we work together, and removing surgeons from the actual procedure compromises both the Heart Team process itself as well as patient safety. This is not merely about emergency situations in which a surgeon might be needed - though we do bring valuable skills to the table like vascular access techniques as well as the ability to rapidly perform an emergent open heart surgery if needed. Discounting the surgeon's role in the procedure violates the Heart Team principle which has guided cardiovascular treatments for some time now. Many of us have become quite close with our interventional cardiology colleagues through collaborating on TAVR procedures, and our patients are better for it. This proposed NCD virtually ensures that many institutions will have surgeons "rubber-stamp" patients for TAVR in the pre-procedure evaluation process and I suspect lead to a worrying tendency (already worsening) to simply perform TAVR in patients who would would benefit from surgical treatments.

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To the Centers for Medicare & Medicaid Services Coverage and Analysis Group:
I am writing as a practicing Chief of Cardiothoracic Surgery and as a member of an active two operator structural heart program, a model in which every TAVR case is performed jointly by a cardiothoracic surgeon and a structural cardiologist. I support the Society of Thoracic Surgeons’ formal comments and want to add a frontline clinical perspective on the provisions most likely to affect patient safety in practice.
1. The single operator allowance should be reconsidered
The proposed NCD permits a single operator model, leaving the decision to perform TAVR with one or two operators to the discretion of the local heart team. In my experience, the value of a true dual operator case is not symbolic. It is functional. Annular rupture, coronary obstruction, need for emergent conversion to open repair, and complex vascular access complications are managed in real time by having a surgeon scrubbed and engaged in the procedure itself, not merely “available” elsewhere in the building. Making this a local option rather than a baseline standard risks normalizing single operator practice at lower volume centers where the second set of hands matters most. I urge CMS to require, rather than merely permit, a collaborative two physician procedural model (surgeon and interventional cardiologist, at minimum) for TAVR cases performed under this NCD.
2. Coverage with Evidence Development should be retained for the indications CMS proposes to exclude
The current proposal limits CED to asymptomatic severe aortic stenosis, while removing it for moderate AS, bicuspid AS, pure aortic regurgitation, valve in valve reintervention, and low surgical risk patients. These are precisely the populations where long term durability and comparative outcomes data remain immature:
Bicuspid anatomy carries known anatomic variability, including asymmetric calcification and annular ellipticity, that affects device sizing and paravalvular leak risk, and is underrepresented in pivotal trials. Valve in valve cases involve durability and coronary obstruction questions that differ substantially from native valve TAVR and deserve continued data capture. Low surgical risk patients have the longest life expectancy after the procedure, making long term valve durability data, out to ten or fifteen years, essential before this becomes unrestricted standard of care. Pure AR and moderate AS both lack the volume of randomized outcomes data that supported approval in severe, symptomatic AS.
Removing CED for these groups before adequate registry or trial data exists shifts the evidentiary burden away from CMS and onto patients and treating physicians after the fact.
3. Hospital level and procedural safeguards should remain linked
I support CMS’s decision to retain onsite cardiac surgery as a hospital level requirement. However, an onsite surgical program is only protective if surgeons remain integrated into the actual procedure and case selection, not simply present in the institution. I encourage CMS to make the connection between facility level criteria and procedural team composition explicit in the final determination.
Summary of requested changes
1. Require a two operator (surgeon plus cardiologist) procedural model rather than leaving it to local discretion.
2. Restore CED for moderate AS, bicuspid AS, pure AR, valve in valve, and low surgical risk TAVR.
3. Tie onsite surgical program requirements to actual surgeon involvement in procedure and patient selection, not facility presence alone.
Thank you for the opportunity to comment. I appreciate CMS’s continued engagement with the heart team community throughout this process and would welcome the opportunity to provide additional clinical detail if useful.
Respectfully,
Robert Strange MD

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Memorandum

To: Centers for Medicare & Medicaid Services, Coverage and Analysis Group

Date: June 16, 2026

Submitted by:
Michael E. Bowdish, MD, MS
Division Director, Adult Cardiac Surgery
Vice Chair, Department of Cardiac Surgery
Smidt Heart Institute
Cedars-Sinai Medical Center

Re: Public Comment on Proposed Decision Memorandum: Transcatheter Aortic Valve Replacement (TAVR) for Aortic Stenosis (CAG-00430R2)

I write to comment on the Proposed Decision Memorandum for Transcatheter Aortic Valve Replacement (CAG-00430R2), published June 15, 2026. I write as a cardiac surgeon caring for patients with valvular heart disease. I have no financial relationship with any manufacturer of transcatheter or surgical valve devices. I support the determination that the evidence now supports coverage of symptomatic severe aortic stenosis without Coverage with Evidence Development, and I support the expansion of coverage to asymptomatic severe aortic stenosis under Coverage with Evidence Development. I recognize the careful deliberation CMS has brought to this complex determination.

My central concern is one element of the proposed revision: the effective elimination of participation in national clinical data registries as a condition of coverage for symptomatic TAVR. I address that concern in Part One. In Part Two, I offer several related recommendations regarding the asymptomatic study comparator, the operator-volume threshold, and retention of procedural safeguards.
Part One. Preserve National Registry Participation as a Condition of Coverage

I. The Proposed Decision Removes the Registry Mandate for Symptomatic TAVR
Under the current NCD (20.32), all TAVR procedures are furnished under Coverage with Evidence Development, which requires participation in the STS/ACC Transcatheter Valve Therapy (TVT) Registry. The proposed revision terminates CED for symptomatic severe AS, covering it under standard reasonable-and-necessary authority (§1862(a)(1)(A)). While the proposed Hospital Criteria (Section B3) require “a continuous quality improvement process that assesses procedural outcomes and makes necessary programmatic adjustments to assure patient safety,” this language does not specify participation in a national clinical data registry. An institutional quality improvement committee, an internal morbidity and mortality conference, or a local database would satisfy this criterion.
The practical consequence is that for the approximately 100,000 symptomatic TAVR procedures performed annually in the United States, there will no longer be a national coverage requirement mandating data capture in a standardized, auditable, multi-institutional registry. This represents a fundamental change in the infrastructure that has supported TAVR’s evidence base since its inception.

II. The TVT Registry Is the Foundation on Which TAVR Coverage Has Been Built
The STS/ACC TVT Registry is not merely a regulatory compliance tool. It is the single most important real-world evidence engine in structural heart disease. Since its inception, the TVT Registry has enrolled over 583,000 TAVR patients across 726 U.S. hospitals and has directly generated the evidence that CMS cites throughout the proposed decision memorandum to justify coverage expansion:

Volume-outcomes relationships: Vemulapalli et al. (NEJM 2019) used TVT Registry data to demonstrate a significant inverse association between hospital TAVR volume and risk-adjusted 30-day mortality. This analysis directly informed the volume requirements in the 2019 NCD and remains relevant to the operator volume thresholds proposed in the current revision.

Demographic shifts and indication patterns: Alabbadi et al. (JACC 2026) used TVT Registry data to document the shift from high-risk elderly patients to low-risk younger patients, with low-risk cases growing from 2.7% to 35.7% of all cases over the registry’s history. This analysis identified off-guideline use patterns that have raised concerns across the surgical community, medical societies, and CMS’s own evidence review.

Temporal trends and safety signals: The TVT Registry has enabled continuous monitoring of pacemaker implantation rates, paravalvular leak incidence, stroke rates, and reintervention trends across device generations and patient populations. These data have informed device iteration, guideline development, and post-market surveillance.

Health status outcomes: The STS/ACC TVT Registry health-status analyses cited in the proposed decision memorandum (Section II.D) used KCCQ data systematically collected through the registry to characterize real-world patient-reported outcomes.

None of these analyses would have been possible without a national coverage mandate requiring universal data capture. The TVT Registry’s near-complete capture of U.S. TAVR procedures is what distinguishes it from voluntary registries, which are subject to selection bias and incomplete enrollment.

III. Removing the Registry Mandate Undermines CMS’s Own Stated Evidence Needs
The proposed decision memorandum itself identifies critical unanswered questions that can only be addressed through continued comprehensive data collection. The three CED research questions mandated for asymptomatic coverage (Section B4) are illustrative:

CED Question 1: “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.”

CED Question 3: “Can longer term, risk-standardized, patient-centered health outcomes replace volume criteria for TAVR operators?”

Both of these questions require population-level, risk-adjusted outcomes data that can only be generated by a comprehensive national registry. Randomized controlled trials, however well-designed, enroll highly selected patients at experienced centers and cannot capture the heterogeneity of real-world practice. The paradox is that CMS is asking questions that require registry-level data while simultaneously removing the mechanism that generates that data for the majority of TAVR procedures.

The proposed decision memorandum also acknowledges throughout its evidence review that the durability question remains unresolved. The longest randomized follow-up available comes from the NOTION trial, which reports 10 years of follow-up, a small study of 280 elderly patients using first-generation devices. The pivotal low-risk trials (PARTNER 3 and Evolut Low Risk) will not have 10-year data until approximately 2029-2030. During this interval, continued comprehensive registry data collection is essential for detecting early signals of structural valve deterioration, characterizing reintervention patterns, and monitoring the expanding use of TAVR in populations not represented in the pivotal trials.

IV. Voluntary Registry Participation Declines Without Coverage Mandates
The history of medical device registries in the United States demonstrates that voluntary participation rates decline when coverage mandates are removed. Compliance-driven registries achieve near-universal capture precisely because participation is a condition of payment. When that linkage is severed, participation becomes discretionary, administrative burden calculations dominate, and data completeness erodes. The resulting selection bias undermines the registry’s value for the very analyses that CMS and the clinical community depend upon.

The TVT Registry’s current near-complete capture rate is a direct consequence of the CED mandate. It would be imprudent to assume that this capture rate would persist in its absence, particularly as TAVR expands to new, lower-volume centers where the administrative infrastructure for registry participation may be less robust.

V. A Registry Requirement Is Distinct from CED and Can Be Maintained Independently
CMS has historically linked registry participation to Coverage with Evidence Development. These are, however, conceptually and legally distinct mechanisms. CED is a framework for generating evidence to resolve specific coverage questions. Registry participation is a quality assurance and post-market surveillance mechanism that serves as an ongoing monitoring function independent of any specific evidence question.

CMS has the authority under §1862(a)(1)(A) to define conditions that are reasonable and necessary for the safe and effective furnishing of TAVR. Participation in a CMS-recognized national clinical data registry is a reasonable condition of coverage that serves patient safety, quality assurance, and population health surveillance. This is not a novel concept: Medicare conditions of participation for hospitals already include quality reporting requirements, and CMS has established quality measurement programs across numerous clinical domains.

I respectfully propose that CMS add the following language to the Hospital Criteria (Section B3):

“TAVR procedures must be reported to a CMS-recognized national clinical data registry that captures standardized demographic, procedural, and outcomes data, including but not limited to 30-day mortality, stroke, new permanent pacemaker implantation, paravalvular regurgitation, reintervention, and patient-reported health status outcomes.”

This language is device- and registry-agnostic (it does not mandate the TVT Registry specifically, though it is the only registry that currently meets these criteria) and is independent of CED. It preserves the quality assurance infrastructure that has served TAVR patients, clinicians, and CMS itself for over a decade.

VI. The Registry Is Especially Critical as TAVR Expands to New Populations and Settings
The proposed decision memorandum expands TAVR coverage in two dimensions simultaneously: to asymptomatic patients (under CED) and to potentially new institutional settings (through restructured volume requirements that shift from hospital-level to operator-level thresholds). Both expansions increase the urgency of comprehensive data collection:

New patient populations: Asymptomatic patients are, by definition, patients who feel well. The risk-benefit calculus for intervening in an asymptomatic patient is fundamentally different from that for treating a symptomatic patient, and the long-term consequences of that decision (valve durability, pacemaker dependence, coronary access, need for reintervention) require decades of follow-up to characterize. Registry data capture across the full spectrum of treated patients, not only those enrolled in CED-approved studies, is essential for detecting safety signals and characterizing real-world outcomes.

New institutional settings: The shift from hospital-level to operator-level volume requirements may facilitate TAVR at centers with less institutional experience. The volume-outcomes literature demonstrates that outcomes vary across institutions. Registry participation provides the monitoring infrastructure needed to ensure that quality standards are maintained as the procedure diffuses to new settings.

Off-guideline use: TVT Registry data show that TAVR is increasingly used in patients younger than guideline-recommended age thresholds, including, in some reports, nearly 50% of patients under 65 years in some U.S. states. Without registry-level data capture, there is no mechanism to monitor these trends, assess their outcomes, or inform future guideline and coverage revisions. Part Two. Related Recommendations

VII. The Asymptomatic CED Studies Should Require a Contemporaneous Surgical Comparator

I support covering asymptomatic severe aortic stenosis only under Coverage with Evidence Development, and I write to strengthen the comparator requirement. The expansion rests on a single contemporary randomized trial, EARLY TAVR (Genéreux et al., New England Journal of Medicine, 2025). Its statistically significant primary result, a composite of death, stroke, or unplanned cardiovascular hospitalization of 26.8% with early TAVR versus 45.3% with surveillance at a median of 3.8 years, is driven almost entirely by unplanned cardiovascular hospitalization (20.9% versus 41.7%). All-cause death (8.4% versus 9.2%) and stroke (4.2% versus 6.7%) did not differ significantly, and 87% of patients assigned to surveillance underwent valve replacement within five years. The trial therefore establishes that close surveillance with prompt intervention at symptom onset is safe; it does not establish that pre-emptive replacement improves survival or reduces stroke, and it never compared early TAVR with early surgical replacement. Because the durability and life-expectancy questions CMS itself raises in CED Question 1 cannot be answered without a surgical arm, I recommend that approved CED studies for asymptomatic disease include a contemporaneous surgical comparator wherever anatomy and risk permit, rather than relying on a surveillance comparator alone.

VIII. The Operator-Volume Threshold Should Be Reconciled with the Evidence CMS Cites
The proposal replaces hospital-level volume requirements with an individual operator threshold of fifteen TAVR procedures per year and removes the hospital open-heart surgical volume minimum. That operator threshold falls within the intermediate-volume band described in the analysis CMS cites (Kumbhani et al., 2026), which found a significant difference in outcomes between high- and low-volume operators but not between high- and intermediate-volume operators. The earlier volume-outcomes work from the TVT Registry (Vemulapalli et al., NEJM 2019) likewise demonstrated an inverse relationship between volume and risk-adjusted mortality. Permitting a single operator at intermediate volume, with no hospital volume floor, changes two variables at once. I recommend that CMS either retain a hospital-level volume or quality floor during a defined transition period, or, at a minimum, condition coverage at new and lower-volume programs on registry-based outcome reporting, so that the effect of this change can be monitored rather than assumed. This recommendation reinforces the central point of this letter: the registry is the instrument through which the safety of these structural changes can be verified.

IX. The Heart-Team and Procedural Safeguards Should Be Retained
I support retention of the multidisciplinary heart team, including a cardiac surgeon; the requirement for on-site cardiac surgery; and the requirement for at least one in-person evaluation by a heart-team operator that cannot be satisfied virtually. For asymptomatic and low-risk patients with long life expectancy, where five- to seven-year reintervention curves are still separating and bioprosthetic durability is not yet established relative to the long record of surgical valves, an independent surgical evaluation is the patient’s principal protection against a treatment decision made before the durability data mature. These safeguards should remain in place.

Conclusion and Specific Recommendations
The TVT Registry is not a burden to be retired; it is an asset to be preserved. It has been the single most productive source of real-world evidence in structural heart disease, directly enabling the coverage expansions that CMS now proposes. Removing the registry mandate at the very moment TAVR is expanding into new populations and new settings would deprive CMS, clinicians, patients, and the broader scientific community of the data infrastructure needed to ensure that this expansion occurs safely and with appropriate ongoing evaluation.

I respectfully recommend that CMS:

1. Add a national clinical data registry participation requirement to the Hospital Criteria (Section B3), independent of CED, applicable to all TAVR procedures covered under the NCD.
2. Specify that the registry capture standardized demographic, procedural, and outcomes data, including 30-day and 1-year mortality, stroke, new permanent pacemaker implantation, paravalvular regurgitation, reintervention, and patient-reported health status outcomes.
3. Require that registry data be made available for CMS-approved quality measurement, post-market surveillance, and research purposes, consistent with the data-sharing standards articulated in the CED Guidance Document.
4. Require that approved CED studies for asymptomatic disease include a contemporaneous surgical comparator wherever anatomy and risk permit.
5. Retain a hospital-level volume or quality floor, or condition coverage at new and lower-volume programs on registry-based outcome reporting, during any transition to operator-level volume criteria.
6. Retain the multidisciplinary heart team with a cardiac surgeon, on-site cardiac surgery, and the in-person operator evaluation that cannot be satisfied virtually.

Thank you for the opportunity to comment on this important determination. I am available to discuss these recommendations in further detail.

Respectfully submitted,

Michael E. Bowdish, MD, MS
Division Director, Adult Cardiac Surgery
Vice Chair, Department of Cardiac Surgery
Smidt Heart Institute
Cedars-Sinai Medical Center

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I write in strong support of the proposed NCD for Transcatheter Aortic Valve Replacement (TAVR).

The removal of the CED requirement for symptomatic severe aortic stenosis appropriately reflects the extensive randomized trial data now supporting TAVR across all surgical risk categories. Simultaneously, extending coverage to asymptomatic severe aortic stenosis under CED is well-justified by the EARLY TAVR trial, which demonstrated a 50% reduction in the composite of death, stroke, or unplanned cardiovascular hospitalization compared to surveillance.

The continued emphasis on the multidisciplinary heart team is essential. This collaborative model has been a cornerstone of TAVR's success, and its preservation ensures individualized, patient-centered care.

Finally, the decision to no longer mandate dual-operator participation in every case is a sensible acknowledgment of the decreasing procedural complexity of contemporary transfemoral TAVR. Preserving the heart team's authority to deploy additional operators when clinically warranted strikes the right balance between safety and access.

I urge CMS to finalize this proposal.

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I believe the proposed documentation would benefit from more explicit language regarding physician location and participation requirements during the procedure. Specifically, CMS should clearly define the expectations for both the primary procedural operator and the required surgical backup team.

The policy should unequivocally state that the procedure may be performed by a single qualified operator, including an appropriately credentialed interventional cardiologist, when all applicable training and competency requirements have been met. However, it should also provide detailed guidance regarding the required involvement of the on-site surgical team.

In particular, CMS should specify whether the surgical team must be physically present in the procedure room, immediately adjacent to the laboratory, elsewhere within the hospital, or simply available on standby. The policy should also clarify whether the surgeon is expected to be actively participating in the procedure, immediately available for emergency intervention, or merely on call within the facility.

Providing this level of specificity would promote consistent implementation across institutions, reduce variability in interpretation of the requirements, and ensure that all programs maintain an appropriate level of preparedness to respond to procedural complications. Most importantly, clearly defining these expectations would strengthen patient safety by establishing uniform operational standards for facilities performing these procedures.

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