Year in Review: EARLY TAVR, Tricuspid Nuance, Mitral Gains, and More

Structural heart news arrived in a steady stream throughout 2025—from pivotal trials to approvals, reimbursement decisions, and real-world rollouts of novel technologies. The growth was seen in aortic, mitral, and tricuspid valve disease, with a few notes of caution aimed at left atrial appendage occlusion (LAAO).

Perhaps the biggest development was in the transcatheter treatment of asymptomatic aortic stenosis (AS). Positive results from the EARLY TAVR randomized trial, released last year, led the US Food and Drug Administration to approve use of the balloon-expandable Sapien 3 device (Edwards Lifesciences) in asymptomatic patients in 2025. Other data from the trial suggested that early intervention improved prognosis for this subgroup no matter the extent of their cardiac damage, guideline indication, or age.

Michael Borger, MD, PhD (Leipzig Heart Center, Germany), speaking with TCTMD, highlighted the 2025 European guidelines for valvular heart disease, which did not change the strength of the recommendation for TAVI in asymptomatic patients with low procedural risk. Instead, the wording was altered slightly to lower the LVEF cutoff to ≥ 50% and say it should be considered “as an alternative to close active surveillance.”

“There was hope among some members of the community that we would come up with a level I recommendation for asymptomatic aortic stenosis, and we just didn’t feel that the evidence was clear enough to make that step,” Borger explained when the guidelines first came out. That said, heart teams and referring physicians should consider taking action earlier in the disease course, particularly for individuals with smaller body size, he advised.

Looking back on 2025, “I like to think it was one of the biggest stories to come out, especially since valvular heart disease is such a rapidly evolving area,” said Borger, the European Association of Cardio-Thoracic Surgery chairperson for that document. The US guidelines are currently in development and expected to come out next year, he noted.

He said the European recommendations have been received, “for the most part, very positively,” though some weren’t happy the advice lowered the age cutoff for recommending transcatheter over surgical aortic valve replacement from 75 to 70 years.

“We tried to come up with a very pragmatic and patient-oriented document,” said Borger.

Treatment of asymptomatic primary mitral regurgitation, thanks to data from the MIDA study group, also got the nod in the guidelines when affected patients meet certain criteria, specifically three or four of the following: pulmonary hypertension, atrial fibrillation, left atrial dilatation, and concomitant tricuspid regurgitation.

Michael Young, MD (Darthmouth Health, Lebanon, NH), a member of the American College of Cardiology’s Vascular Disease Council, agreed that the expanded indication to asymptomatic patients with severe AS was exciting.

“In a lot of ways, that opens up our armamentarium and our ability to guide and treat our patients who are increasingly being referred earlier in their disease process,” Young told TCTMD. Many clinicians may still take a wait-and-see approach, he predicted, but “it’s been nice to at least have the option available to us. It doesn’t necessarily mean that we have to treat everybody who’s asymptomatic. I think the thing to remember is that we use these trials [for guiding] practice, but we also have to be careful that the patients we treat more or less align with the patients that were studied in the trials.”

Major Trials and More

Key results continued to accrue from ongoing follow-up in pivotal trials, among them 5-year data from Evolut Low Risk and 7-year data from PARTNER 3 on low-risk AS patients, plus 2-year data on tricuspid transcatheter edge-to-edge (T-TEER) repair from TRILUMINATE.

For Young, the PARTNER 3 follow-up stands out as the top news in the aortic arena.

“That was highly anticipated, because there are still a number of folks out in the structural and cardiac surgery communities who, as we advise our patients who could go either way, . . . are interested to see if there are any notable differences in terms of the outcomes for each therapy,” he said. This is especially pertinent to patients on the younger side who are at low surgical risk and “arguably could do well with either open-heart AVR or TAVR.”

Most clinicians, added Young, “try to do the best that we can with the evidence that we have.”

In his own practice, he tells patients that surgical AVR is a “long-standing, tried-and-true therapy” that’s backed by a body of evidence showing durability through, on average, 10-15 years. “So, we’ve used that as the benchmark that TAVR has been held to,” Young said.

Based on the 7-year PARTNER 3 data, offering low-risk patients TAVI isn’t “doing them a disservice,” he added, noting that forthcoming follow-up on self-expanding transcatheter aortic valves may well show a class effect.

Yet structural heart disease saw numerous fresh reports, too. For the mitral valve, this year the FDA approved the Tendyne (Abbott) and Sapien M3 (Edwards Lifesciences) for transcatheter mitral valve replacement (TMVR). For the aortic valve, promising results were released for Myval and Myval Octacor (Meril Life Sciences)

And finally, for the tricuspid valve, the TRAVEL trial showed the potential of the Lux-Valve (Jenscare Scientific) for transcatheter tricuspid valve replacement (TTVR).

Financial concerns, in turn, also were addressed. Based on TRILUMINATE and other trials, T-TEER is now reimbursed by the Centers for Medicare & Medicaid Services, with TTVR following on its heels thanks to TRISCEND II and a single-arm registry.

[We] try to do the best that we can with the evidence that we have. Michael Young

Indeed, the tricuspid space was the focus of much excitement—and some reluctance—this year. Early on in 2025, speakers at the Society of Thoracic Surgeons annual meeting urged surgeons to be active in tricuspid procedures, lest they be “left behind.” A few months after, the ACC published a consensus document to help clinicians navigate issues around tricuspid regurgitation (TR), with patients also seeking to be better informed about the disease. One study bolstered the case for lowering TR with transcatheter interventions as a means to improve quality of life, while a meta-analysis drew attention to the risk of valve thrombosis with TTVR.

For tricuspid interventions, there’s “a bit of a learning curve that people have to acclimate to,” both at the operator and institutional level, said Young. “We want to see, as more sites adopt these therapies beyond the large centers that were part of the pivotal studies, from the real-world data . . . that our outcomes are good, that they are safe, and that they are effective.”

A positive, he added, is that the tricuspid experience has highlighted the value of having expert imaging specialists as part of the multidisciplinary heart team.

In 2025, the field also moved towards optimizing the stalwarts.

For mitral valves, the EXPANDed registry showed MitraClip (Abbott) to be safe and effective in patients who don’t meet COAPT inclusion criteria, while a study conducted by the BATMAN Collaboratory suggested a balloon-assisted technique may serve as a way to prevent left ventricular outflow tract obstruction in high-risk TMVR patients. Other research cautioned about the risk posed by atrial fibrillation in M-TEER and the potential for infective endocarditis after mitral valve replacement surgery, but offered a potential remedy for failed M-TEER. Also in the surgical space, investigators found the polymer-based Tria valve (Foldax) had an “acceptable safety” profile and stable hemodynamics at 1-year follow-up.

Aortic valve interventions also continued to be fine-tuned through practices like minimalist anesthesia, though the news wasn’t good for embolic protection and prophylactic pacemakers. Data from the TVT Registry for 2017-2022, published this year, raised the perplexing possibility that 1-year mortality is nudging higher with TAVI. Studies also explored the best way to couple TAVI with complex, high-risk PCI, novel approaches to imaging in AS, and how to handle failed TAVI. Not every device was a winner, however—thanks to issues with underexpansion, Boston Scientific pulled its Acurate neo2 off the market midyear.

Creative applications of drug therapies, including SGLT2 inhibitors and ataciguat, a soluble guanylate cyclase activator, were harnessed to possibly curb AS progression. Additional research delved into the treatment of frail patients, calcified aortic and mitral valves, small aortic annuli, valve-in-valve TAVI, and bicuspid aortic valves.

LAAO Ups and Downs

Closure of the left atrial appendage has seen a bit of a rocky year.

On the upside, this August the Society for Cardiovascular Angiography and Interventions paired with the Heart Rhythm Society to release their first practice guideline for LAAO in patients with nonvalvular atrial fibrillation. Real-world results from the National Cardiovascular Data Registry published that same month confirmed LAAO offers long-term stroke protection, while the OCEAN-LAAC registry suggested that LAAO may be an option for anticoagulated patients who experience breakthrough stroke.

Also in August, however, the FDA warned of an air embolism risk seen with some access systems used to perform Watchman Flex LAAO, an issue that led Boston Scientific to recommend updates to the products’ instructions for use.

Additionally, CLOSURE-AF sparked debate when presented at the American Heart Association 2025 Scientific Sessions—findings from the randomized study, as yet unpublished, suggest LAAO isn’t noninferior to standard medical care including anticoagulants. At the time, CLOSURE-AF investigator Ulf Landmesser, MD (Deutsches Herzzentrum Charité, Berlin, Germany), said this result was “indeed somewhat unexpected for us, because this is exactly the patient population where we are now doing left atrial appendage closure,” and predicted the trial will change his own practice.

LAAO proponents, on the other hand, asserted that the trial doesn’t reflect current practice—enrollment started in 2018 at a time when operators were less experienced and over the next 6 years used a mix of devices, including some that are no longer on the market.

Young said CHAMPION-AF, comparing LAAO with Watchman FLEX (Boston Scientific) against direct oral anticoagulation, will hopefully clarify whether the intervention can be an alternative to modern-day medical therapy. The pivotal trials of Watchman had compared the device-based approach to warfarin, which has “been a been a little bit of a sticking point” for some, he noted.

The Big Picture

Amid these shifts, TCTMD covered not only the data but also the nuances that drive practice. Key discussions continue to revolve around whether valve therapies are in fact reaching the patients who need them and whether patient-centered outcomes are prioritized. Researchers are attempting to find solutions: DETECT-AS showed that automated alerts sent to physicians about severe AS can increase eligibility for replacement and narrow the gender gap, while PREVUE-VALVE leveraged retail pharmacies to capture the prevalence of valve disease in the United States.

An in-depth feature released in March explored whether, fully two decades into the experience of fixing AS with catheter-delivered devices, it was time to pin down the therapy’s name: TAVR or TAVI. Another feature sifted through the evidence base for tricuspid valve interventions as they move into real-world use. Cardiologists, too, dug into the gray areas, leading to news stories on topics like the carbon footprint of surgical versus transcatheter aortic valve replacement and the financial fallout from emerging therapies.