Earlier heart valve fix cut heart failure events in some older adults

Older adults whose main heart valve had narrowed to a moderate degree, and who already showed signs of strain, had fewer deaths or heart failure events over two years when the valve was replaced early instead of watched, according to a large trial called PROGRESS.¹ The results were published in The New England Journal of Medicine and presented on November 2 at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 meeting in San Diego.¹

The condition is aortic stenosis: a narrowing of the aortic valve, which lets blood flow out of the heart to the rest of the body.¹ It affects more than 3% of adults aged 65 and older.¹ The treatment tested was TAVR (transcatheter aortic valve replacement), where a new valve is placed through a thin tube in a blood vessel instead of through open-heart surgery.¹

What happened

Today, people with moderate narrowing are usually monitored. Current guidelines recommend a heart ultrasound (an echocardiogram) every one to two years, and valve replacement only once the narrowing becomes severe or another reason for surgery appears.¹ PROGRESS asked whether acting sooner helps some of these patients.

The trial enrolled 744 people aged 65 or older at 74 centers in six countries.¹ All had moderate aortic stenosis plus at least one feature pointing to higher risk, such as symptoms or changes in the structure or function of the heart.¹ By chance, like a coin toss, 373 were assigned to early TAVR and 371 to “clinical surveillance”: regular check-ups, with a valve replacement available when needed.¹

After two years:

• 16.7% of the early-TAVR group had died or had a heart failure event, compared with 23.9% of the surveillance group.¹
• 7.4% of the early-TAVR group were hospitalized for heart failure, compared with 14.9% of the surveillance group, about half the rate.¹

Raj Makkar of the Smidt Heart Institute at Cedars-Sinai, the trial’s national principal investigator, said the difference came mainly from fewer heart failure events, including hospital stays.¹

“Patients with moderate aortic stenosis can already have symptoms and signs that their heart is under strain. These results show that for selected patients with at-risk features, treating the valve earlier can reduce the risk of heart-failure events before the narrowing becomes severe.”

That quote was given by Makkar in the Cedars-Sinai announcement.¹

The evidence so far

This is a randomized controlled trial, the kind of study where people are assigned to treatments by chance so the groups can be fairly compared. The main measure combined two outcomes over two years: death or a heart failure event.¹ The trial’s registry record lists that two-year effectiveness measure as its main goal, along with a 30-day safety measure.²

One finding stands out about the “wait and watch” group. More than half of the patients first assigned to surveillance had their valve replaced within two years.¹ Study co-author Aakriti Gupta of the Smidt Heart Institute said this suggests the disease can move quickly from moderate to severe in some patients.¹ It also means the trial compared early replacement with replacement a little later for many people, rather than with no replacement at all.

What it does not show yet

The researchers said directly that the findings do not mean every patient with moderate aortic stenosis should undergo TAVR.¹ Several questions remain open:

• Longer life. Two years is short. The team plans to follow participants for 10 years to see whether fewer early heart failure events lead to longer survival.¹
• How long the new valves last. They will also study valve durability and whether people need more procedures later.¹
• Who benefits most. Finding which patients are most likely to gain is another stated goal.¹
• Younger or lower-risk people. Participants averaged 78 years old, and all had at least one warning sign. Whether the results apply to younger people or to those without these risk features is still unknown.¹

The available announcement does not break down the two parts of the main measure separately for death, so this article does not report a survival difference.

Who is behind it

The trial was funded by Edwards Lifesciences.¹ Edwards is listed as the sponsor in the public trial registry, which shows the valves tested were its SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA devices.² In other words, the company that makes the valves paid for the study.

Makkar reported consulting for and receiving research grants from Edwards Lifesciences, Medtronic, Abbott, Jena Valve and Boston Scientific, and serving on scientific advisory boards with equity in iCardio.ai, AllHeart and PiCardia.¹ Cedars-Sinai, which co-led the trial, enrolled more patients than any other center.¹

The registry record, first posted in May 2021, shows the study started in October 2021 and still lists its status as recruiting, with an estimated enrollment of 2,250 and a primary completion date of June 2029.² It notes that after enrollment is completed, participants can join a “continued access” phase of the trial.² The registry figures differ from the 744 people described in the published results, and the sources given here do not explain the difference in detail.

How it fits the field

PROGRESS is part of a wider push to test whether valve replacement should happen earlier than guidelines now advise. Results have not all pointed the same way.

An earlier trial called TAVR UNLOAD looked at people with moderate aortic stenosis who also had a weak heart pump (heart failure with reduced ejection fraction).³ It found no significant difference between TAVR and surveillance in its main measure, which combined death, stroke and hospital stays, though people who had TAVR reported a clearly better quality of life at one year.³ Discussing that trial, its author Nicolas Van Mieghem and Aakriti Gupta pointed to the need to choose patients carefully, and noted limits such as slow enrollment and the study’s size.³ Both are also listed as authors on PROGRESS.¹

A separate trial, EARLY TAVR, has tested the same idea one step further along the disease: people 65 or older with severe narrowing but no symptoms, randomly assigned to TAVR with an Edwards SAPIEN 3 valve or to surveillance.⁴ Its eligibility rules required a normally pumping heart and excluded people with symptoms.⁴

Taken together, these studies frame a practical question for heart doctors: whether “wait until severe” should remain the rule for everyone, or whether some people with earlier disease and warning signs should be treated sooner.

What to watch next

• Longer follow-up from PROGRESS, planned to run 10 years, on survival, valve durability and repeat procedures.¹
• Analyses of which patients gained the most, including any work on younger or lower-risk people.¹
• The continued access phase and the larger enrollment target listed in the trial registry.²
• Whether guideline groups, which now advise check-ups every one to two years for moderate disease, revisit that advice.¹

This article reports research findings. It is not medical advice.