For decades, people with failing heart valves who nevertheless felt all right would walk out of the cardiologist’s office with the same “wait and see” treatment plan: Come back in six or 12 months. No reason to go under the knife just yet.
A new clinical trial has overturned that thinking, suggesting that those patients would be much better off having their valves replaced right away with a minimally invasive procedure.
The trial, whose results were published this week in The New England Journal of Medicine, could change the way doctors treat severe aortic stenosis, a narrowing of the valve that controls blood flow from the heart. The disease, which has a prognosis worse than that of most cancers, afflicts more than 3 percent of people ages 65 and older. It is expected to become more common as people live longer.
Replacing people’s heart valves, even if they were not yet experiencing any ill effects, appeared to roughly halve their risk of being unexpectedly hospitalized for heart problems over at least two years, the trial found.
Patients who were put on the more conservative treatment plan overwhelmingly ended up needing surgery anyway: Roughly 70 percent of them developed symptoms and needed to have their valves replaced within two years, suggesting that the disease worsens more quickly than previously understood.
“You may be able to at least prevent that progression and perhaps improve patient outcomes by treating earlier,” said Dr. Gregg Stone, a professor of medicine at the Icahn School of Medicine at Mount Sinai, describing the implications of the trial. The findings, he said, “will have a major effect on practice.”
Dr. Stone was not involved in the trial and said he received no support from the replacement valve maker that sponsored it.
Cardiologists have long known that patients like those in the trial — people with failing heart valves but no symptoms — could sometimes deteriorate or even die.
But doctors had only a vague sense of how quickly that might happen. And in the absence of symptoms, they figured that it was better to defer surgery, preferring instead to monitor valves with occasional imaging and symptom checks.
Cardiologists were wary of replacing valves partly because, until recent decades, that would have required open-heart surgery, a risk that hardly seemed worth taking for patients who were able to go about their lives without trouble.
The emergence of a less invasive surgery opened the door to a different approach. In that surgery, called transcatheter aortic valve replacement, or TAVR, cardiologists insert a replacement valve through a patient’s groin and thread it all the way to the heart.
For the new trial, researchers, led by Dr. Philippe Généreux, a director of the structural heart program at Morristown Medical Center in New Jersey, recruited about 900 people with severe aortic stenosis who could nevertheless pass a treadmill stress test. Half of them were randomly chosen to undergo early surgery, and the other half were given the standard wait-and-see plan.
More than two in five of the wait-and-see patients ended up being unexpectedly hospitalized with heart problems, compared with only one in five of the surgical patients. And performing the TAVR procedure right away, rather than after patients developed symptoms, did not seem to carry extra risks.
Doctors said that more studies were needed on the durability of replacement valves and the best approach for younger patients; in the trial, patients had to be 65 or older. But they said the trial was persuasive.
“Cardiologists will be having very different conversations with patients now,” said Dr. Toby Rogers, an interventional cardiologist at MedStar Washington Hospital Center who consults for the valve maker that sponsored the trial but was not involved in running it. “Going earlier avoids bad things happening, especially ending up in the hospital.”
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