The research team, led by Mohammed Abusharekh and Amir Abbas Mahabadi, compared the original PASCAL repair system with its second-generation iteration, the PASCAL ACE, in a cohort of 366 consecutive patients treated between 2019 and 2024. The PASCAL system, developed by Edwards Lifesciences, introduced a central spacer and independent leaflet capture as structural innovations over the earlier MitraClip platform. The ACE version refined the concept further, featuring a reduced profile, narrower paddles, and increased curvature designed to enhance leaflet approximation, improve deliverability, and distribute mechanical stress more evenly in anatomically challenging valves. Until now, however, head-to-head comparative data in real-world practice have been scarce, leaving device selection largely to operator judgment.

The Essen cohort reflected the realities of contemporary practice. Patients had a mean age of 77.7 years, and nearly 58 percent were men. All had moderate-to-severe or severe mitral regurgitation, categorized by etiology as functional, degenerative, or mixed. Crucially, the two devices were not used interchangeably. Patients receiving the ACE device were older, more frequently had atrial fibrillation, and presented with significantly more complex valve anatomy, including bileaflet or multi-scallop prolapse in 25.8 percent of cases compared with 13.1 percent in the PASCAL group. Moderate-to-severe calcification in the grasping area, leaflet clefts, and restricted leaflet mobility were also more common in the ACE cohort. In other words, clinicians were already intuitively reserving the refined device for the hardest cases.

To move beyond intuition, the investigators deployed comprehensive three-dimensional transesophageal echocardiography before and during every procedure. This imaging approach allowed precise planimetric measurement of the mitral valve orifice area, or MVOA, in late diastole at maximal leaflet opening, along with the vena contracta area, anteroposterior and mediolateral annular diameters, annular area, perimeter, and the annular sphericity index. All 3D datasets were analyzed offline by a senior echocardiographer blinded to device type and outcomes, a methodological safeguard that lends considerable weight to the findings. Procedural endpoints followed the Mitral Valve Academic Research Consortium criteria, and statistical analysis included multivariable regression and propensity score matching to address the inherent selection bias of a non-randomized comparison.

The headline result concerns the fate of the valve orifice. Before the procedure, ACE-treated patients had larger baseline orifice areas, a median of 6.55 square centimeters versus 5.87 square centimeters in the PASCAL group. After the first device was implanted, the ACE group predictably retained a larger residual orifice, 3.81 versus 3.38 square centimeters. But when the researchers calculated the relative reduction, the numbers were almost identical: a decrease of 44.5 percent with ACE versus 45.9 percent with PASCAL, a difference that did not reach statistical significance. This pattern held consistently across functional, degenerative, and mixed etiologies. In essence, both devices squeezed the valve by roughly the same proportion; the final orifice size simply mirrored what the anatomy had provided at the start.

The hemodynamic consequences followed the same logic. The transmitral mean pressure gradient, a key indicator of potential iatrogenic mitral stenosis, rose modestly in both groups, with a slightly smaller increase in the ACE cohort, from one to two millimeters of mercury difference, likely reflecting the larger residual orifice areas in that group. This detail matters clinically, because accumulating evidence suggests that a post-procedural mean gradient of five millimeters of mercury or higher predicts worse outcomes. Whether the modest gradient advantage observed with ACE after the first device translates into long-term clinical benefit remains an open question that the study’s authors flag for future investigation.

Annular remodeling told a similar story of convergence. Both devices shifted the mitral annulus from a circular toward a more elliptical geometry, with comparable relative reductions in the anteroposterior diameter and the annular sphericity index. The slightly larger post-procedural annular dimensions in the ACE group, including a small increase in mediolateral diameter, were best explained by the larger baseline annular size rather than any device-specific geometric effect. Notably, no differences in annular sphericity or transmitral gradients emerged across any of the etiological subgroups, reinforcing the conclusion that the two devices exert fundamentally similar geometric influences on the valve apparatus.

One area where the devices diverged was the need for a second implant. ACE-treated patients more often required two devices, 35.9 versus 23.5 percent, and had a larger residual vena contracta area after the first implant, particularly in degenerative regurgitation where multi-scallop prolapse and bileaflet involvement predominated. Yet after the second device, final vena contracta values and percent reductions were comparable between groups, supporting multi-device strategies as a reliable path to procedural optimization regardless of starting anatomy. Procedural success was uniformly excellent, 100 percent with ACE and 99.6 percent with PASCAL, with no cases of single leaflet device attachment, leaflet injury, or chordal entrapment in either cohort.

The study also documented a clear temporal shift in practice. In the early years, the original PASCAL device accounted for the majority of procedures, but after ACE was introduced at the center in August 2020, its utilization climbed steadily and eventually became the dominant choice. This evolution parallels a rising proportion of patients presenting with complex valve morphology and mixed etiologies, suggesting that the refined device arrived just as the treated population was becoming more challenging. A sensitivity analysis comparing the first fifty PASCAL cases with later ones showed that operator experience improved acute efficacy without compromising safety, partially addressing concerns about a learning curve.

Perhaps the most consequential finding came from the multivariable analysis. After adjusting for age, atrial fibrillation, ejection fraction, etiology, anatomical complexity, baseline dimensions, and temporal trends, the differences in post-procedural orifice and vena contracta areas that appeared in the crude comparison vanished entirely. Device type was not an independent predictor of any geometric or hemodynamic outcome. A stratified analysis by baseline valve size added nuance: device-specific effects on narrowing only emerged in mid-sized valves, where ACE proved more area-sparing in the four-to-five square centimeter range, while at the extremes the underlying leaflet anatomy reigned supreme. The authors’ conclusion is unambiguous: baseline valve anatomy, rather than device selection, is the predominant determinant of post-procedural geometry and hemodynamics. For the growing number of heart teams weighing PASCAL against PASCAL ACE, the message is to choose based on the valve in front of them, favoring the ACE’s narrower paddles for complex, restricted, or calcified anatomies and the original PASCAL’s broader coaptation zone where wide leaflet grasping is needed, always guided by meticulous three-dimensional imaging rather than by any assumption that one device is inherently superior.

Subject of Research: Three-dimensional mitral valve geometry and outcomes after transcatheter edge-to-edge repair comparing PASCAL and PASCAL ACE devices

Article Title: Three-dimensional mitral valve geometry after transcatheter edge-to-edge repair: PASCAL versus PASCAL-ACE—implications for devices selection

Article References: Abusharekh, M., Kampf, J., Schindhelm, F., Jürgens, F., Dykun, I., Al-Rashid, F., Totzeck, M., Rassaf, T., & Mahabadi, A. A. (2026). Three-dimensional mitral valve geometry after transcatheter edge-to-edge repair: PASCAL versus PASCAL-ACE—implications for devices selection. Clinical Research in Cardiology. https://doi.org/10.1007/s00392-026-03031-0

Image Credits: AI Generated

DOI: 10.1007/s00392-026-03031-0

Keywords: mitral regurgitation, transcatheter edge-to-edge repair, PASCAL, PASCAL ACE, 3D echocardiography, mitral valve orifice area, annular remodeling, interventional cardiology, degenerative mitral regurgitation, functional mitral regurgitation, device selection, heart team

Transcatheter aortic valve replacement, widely known as TAVR, has fundamentally redefined the treatment of severe aortic stenosis, a progressive narrowing of the heart’s aortic valve that once carried a dismal prognosis for patients too frail to survive open-heart surgery. Rather than replacing the valve through a sternotomy and cardiopulmonary bypass, TAVR delivers a collapsible bioprosthetic valve through a catheter, typically entered at the femoral artery, and positions it within the diseased native valve. The technique has evolved from a salvage therapy for inoperable patients into a standard option across the entire risk spectrum, supported by an accumulating body of randomized trial evidence demonstrating durability and survival benefit comparable to, and in some populations superior to, surgical valve replacement.

The joint statement opens with explicit appreciation for the federal agency’s willingness to modernize its coverage framework. “The American College of Cardiology, the Society of Thoracic Surgeons, and the Society for Cardiovascular Angiography and Interventions appreciate CMS’s efforts to evolve Medicare coverage for TAVR and enhancing access to more patients as the evidence supporting this therapy continues to grow,” the statement declares. For years, patient advocates and clinicians have argued that earlier national coverage determination requirements, which restricted reimbursement largely to facilities meeting specific volume thresholds, created geographic barriers that left many elderly Americans traveling long distances or forgoing treatment altogether for a disease whose five-year untreated survival rivals many advanced cancers.

Yet the societies were equally emphatic that expanded access must not come at the cost of the disciplined, multidisciplinary model that made TAVR one of the most closely studied and carefully monitored therapies in cardiovascular medicine. “As TAVR expands into new patient populations, it is critical to preserve the quality framework that has contributed to its success,” the statement continues. At the center of that framework sits the Heart Team, the collaborative unit of interventional cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, and advanced practice providers who jointly evaluate every candidate for transcatheter therapy. This team-based approach, embedded in professional society guidelines and prior coverage requirements, ensures that each patient receives an individualized assessment of anatomical suitability, procedural risk, and the relative merits of surgical versus catheter-based valve replacement.

The statement identifies several pillars as non-negotiable as coverage evolves: preservation of the Heart Team, continued collaboration across specialties, collection of real-world evidence, systematic outcomes monitoring, and continuous quality improvement. “The preservation of the Heart Team, continued collaboration across specialties, collection of Real-World Evidence, outcomes monitoring, and continuous quality improvement are the foundation of ensuring and improving outcomes for our patients with severe aortic stenosis,” the societies wrote. From a technical standpoint, this vigilance is well founded. TAVR outcomes are highly sensitive to case selection and procedural expertise, with known complications including paravalvular regurgitation, conduction disturbances requiring permanent pacemaker implantation, vascular access injuries, and, in earlier-generation devices, stroke. Careful imaging with computed tomographic angiography and echocardiography, alongside refined valve designs and delivery systems, has steadily reduced these risks, but only within programs that maintain rigorous procedural volume and data review.

Central to the societies’ position is the role of national registries, which have served as the backbone of TAVR surveillance in the United States since the procedure first received approval. “Participation in national registries, externally benchmarked quality programs and rigorous outcomes reporting remain essential to preserving the high standards of care that have defined TAVR’s success,” the statement affirms. The societies committed explicitly to their continued support of the STS/ACC Transcatheter Valve Therapy Registry, the national data infrastructure that captures procedural details, in-hospital outcomes, and longitudinal follow-up for essentially every TAVR performed in American centers. “The societies will continue to support the STS/ACC TVT Registry and other quality initiatives that promote evidence generation, patient safety, continuous improvement and health care value across the cardiovascular community,” they wrote.

The registry model has proven its scientific worth repeatedly. Data drawn from the TVT Registry have informed valve selection strategies, illuminated sex-specific differences in procedural outcomes, quantified real-world rates of pacemaker dependency and readmission, and provided the pragmatic evidence base that regulators have relied upon at each successive expansion of the coverage determination. Observational registry research complements randomized controlled trials by capturing the full heterogeneity of clinical practice, including elderly patients with frailty, bicuspid anatomy, and multimorbidity who are systematically underrepresented in pivotal trials. For a procedure now performed tens of thousands of times annually in the United States, this continuous feedback loop between bedside practice and aggregate data represents one of the most mature examples of learning health system infrastructure in any field of medicine.

The joint statement carries the signatures of the three organizations’ sitting presidents, underscoring the unified front across specialties that have historically approached valve therapy from different vantage points. Roxana Mehran, MD, FACC, president of the American College of Cardiology; Vinay Badhwar, MD, FACS, FACC, president of The Society of Thoracic Surgeons; and J. Dawn Abbott, MD, MSCAI, president of the Society for Cardiovascular Angiography and Interventions, lent their names to a document that deliberately bridges the surgical and interventional communities. That unity is itself noteworthy. Surgical aortic valve replacement remains a durable and appropriate choice for many patients, and the cardiothoracic surgery community has been an essential partner in TAVR’s development rather than a bystander to its rise, co-owning the registries, co-authoring the guidelines, and staffing the Heart Teams at every established program.

The American College of Cardiology, with a membership exceeding 60,000 cardiovascular professionals across more than 140 countries, brings to the effort its extensive registry and accreditation apparatus, including the NCDR family of quality registries. The Society of Thoracic Surgeons, founded in 1964 and representing more than 8,000 cardiothoracic surgeons, researchers, and allied professionals, has long operated its own national surgical databases that pioneered risk-adjusted outcomes reporting in cardiac surgery. The Society for Cardiovascular Angiography and Interventions, established in 1978 as the primary nonprofit society for invasive and interventional cardiology, contributes the procedural expertise of its more than 5,000 members. Together, these organizations collectively steward the educational standards, credentialing pathways, and data systems that determine how TAVR is practiced nationwide.

As Medicare’s revised national coverage determination takes effect, the practical stakes are considerable for patients, hospitals, and the broader trajectory of structural heart intervention. Expanded eligibility promises that more of the growing population of Americans with severe symptomatic aortic stenosis can receive a minimally invasive valve replacement close to home, while the societies’ insistence on Heart Team evaluation, registry participation, and transparent outcomes reporting aims to ensure that the procedure’s impressive evidence-based track record translates faithfully into everyday community practice. The statement ultimately reads less like celebration and more like stewardship: an acknowledgment that a therapy once confined to a handful of pioneering centers has matured into a population-scale treatment, and that the disciplines of measurement, collaboration, and accountability that carried it from first-in-human trials to standard of care must now scale alongside it.

Beyond the immediate policy debate, the statement arrives at a time when the demographic pressure on valve care continues to intensify. Calcific aortic stenosis is fundamentally a disease of aging, driven by progressive leaflet calcification that shares several mechanistic features with atherosclerosis, including lipid accumulation, inflammation, and active bone-like mineral deposition. As life expectancy rises, the prevalence of severe symptomatic disease is expected to grow steadily, placing sustained demand on both surgical and transcatheter capacity and making coverage policy a genuine population health question rather than a narrow reimbursement matter.

The national coverage determination mechanism itself deserves context. Under Medicare rules, CMS must generally decide whether a service is reasonable and necessary for beneficiaries nationwide, and for novel technologies it has historically used coverage with evidence development, linking payment to registry enrollment or clinical study participation. TAVR became one of the most prominent applications of this model, with successive determinations tracking the expanding randomized evidence and conditioning coverage on facility requirements, Heart Team evaluation, and shared decision-making aids that help patients weigh procedural options against their goals of care.

Shared decision making, though less visible than registries, has been a quiet cornerstone of the TAVR quality framework. Because many candidates are elderly and managing multiple chronic conditions, the choice between transcatheter and surgical replacement, or between intervention and conservative management, depends heavily on individual values, frailty, and life circumstances. Formal decision aids and documented patient-physician conversations were built into prior coverage requirements precisely to ensure that expanded access reflects informed patient preference rather than procedural availability alone.

The societies’ emphasis on health care value also reflects a broader shift in cardiovascular policy toward weighing cost against measurable benefit. With TAVR now among the most common valve interventions performed in the United States, even modest differences in complication rates, length of stay, or device selection carry substantial aggregate economic consequences, reinforcing why continued outcomes reporting remains central to the field’s stewardship.

Subject of Research: Medicare national coverage determination for transcatheter aortic valve replacement and the quality standards supporting its expanded use

Article Title: Joint Statement from the American College of Cardiology, The Society of Thoracic Surgeons, and the Society for Cardiovascular Angiography & Interventions on transcatheter aortic valve replacement national coverage determination

Article References: Joint Statement from the American College of Cardiology, The Society of Thoracic Surgeons, and the Society for Cardiovascular Angiography & Interventions on transcatheter aortic valve replacement national coverage determination. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: TAVR, transcatheter aortic valve replacement, Medicare coverage, CMS, aortic stenosis, Heart Team, TVT Registry, American College of Cardiology, Society of Thoracic Surgeons, SCAI, quality monitoring, structural heart disease