A new treatment for chronic obstructive pulmonary disease (COPD) in the United States is proving life-changing for some patients.
BACK IN THE SADDLE: Randy Ayers' goal was to ride her horse without supplemental oxygen. That goal became a reality when she received her endobronchial valve.
Four years ago, Randy Ayers of rural Goodview, Virginia, did something many lifelong smokers find impossible: She quit. Yet that victory gave her scant comfort. By then she was already suffering from emphysema, a condition that falls under the umbrella of chronic obstructive pulmonary disease (COPD).
Although only in her 60s, Ayers had trouble walking distances, and even taking a shower had become a terrifying ordeal.
“You lose your breath, and it’s very scary,” she says. But the worst part for Ayers, an avid equestrienne, was no longer being able to ride her beloved gelding, Waylon, whom she’s owned for 25 of his 30 years.
Even with oxygen at her side, Ayers says, “I would go to the barn to brush him for a few minutes and then I’d get winded. That’s all I could do. It was too hard to ride.”
She adds, simply: “I quit smoking too late.”
Then, in 2019, Ayers made an appointment with Maria del Mar Cirino-Marcano, M.D., a pulmonary specialist at Carilion Clinic. Dr. Cirino-Marcano told Ayers about an endobronchial valve, a device that can help some people with COPD, and she wondered whether her patient might be a candidate for it.
“When I interview patients to see whether they qualify for the valve, I ask them what their plans are,” says Dr. Cirino-Marcano. “And Randy was clear about what she wanted. ‘I want to ride my horse,’ she told me, ‘and if I can do it without supplemental oxygen, even better.’”
A Better Quality of Life
Endobronchial valves are small, specialized devices that are implanted in the lungs to close off airways leading to diseased areas and to allow greater airflow to healthier areas. With the lungs not working as hard to deliver oxygen, patients often find they can breathe easier and resume routine activities with less shortness of breath, says Edmundo R. Rubio, M.D., chief of Pulmonary and Critical Care Medicine at Carilion.
The valves don’t cure COPD; so far, cures for the chronic condition are elusive. What they do offer, says Dr. Rubio, is the potential for a better quality of life.
“If you can breathe easier, you have more stamina,” Dr. Rubio says. “As activity increases, patients may feel more energetic. They’re better able to eat, and they sometimes feel less depressed. One thing leads to another.”
After months of delay because of the COVID-19 pandemic, Carilion launched an endobronchial valve program in the summer of 2020, with Ayers among the first of a handful of recipients. Nationally, studies are still underway to determine more precisely their long-term effectiveness. Yet the results so far are encouraging—and for people like Ayers, relief can’t come fast enough.
The region Carilion serves has an unfortunate abundance of patients with COPD. This is tobacco country, and southwestern Virginia has the state’s highest rate of smoking—18.1 percent of residents, compared with just 7.7 percent in Northern Virginia.
“It’s a prevalent condition” says Dr. Cirino-Marcano, “and in any pulmonary clinic, people with COPD make up the bulk of the patient population.”
The Perfect Candidate
Endobronchial valves aren’t right for every patient with COPD, according to Dr. Rubio. “Candidates include those with some mobility who have had a significant impact on their daily activities,” he says. “You want someone who can walk in the range of 100 to 500 meters. Those unable to walk 100 meters may not be able to tolerate the procedure, while someone who can walk, say, 1,000 meters or more without severe discomfort may not need it.”
Although Ayers could still walk short distances, decades of smoking had damaged her lungs. Over the years, smoking can destroy the lung’s alveoli, which are responsible for exchanging oxygen and carbon dioxide. Smoking can also cause the narrowing and scarring of airways, known as remodeling, and it can enlarge the lungs, a condition known as hyperinflation.
“With hyperinflation, some parts of the lung get destroyed,” says Dr. Cirino-Marcano. “The lungs become like stretched-out balloons. They get really, really big.”
When inhalations introduce a large volume of air into the lungs, the recoil of that “balloon” is insufficient to expel all of the air. “That’s part of the reason for shortness of breath,” says Dr. Cirino-Marcano. “The lungs are so big they’ve stretched the muscles that help us breathe, and those respiratory muscles don’t work well anymore.”
For more than a century, physicians have been searching for a safe, effective way to reduce the size of the hyperinflated lungs of COPD patients. In some cases, surgery is the answer. “With the perfect candidate, surgery can be very beneficial,” Dr. Cirino-Marcano says. But surgery can have significant complications, she adds, and it’s helpful if only the upper parts of the lungs are affected. For a much greater number of patients, endobronchial valves inserted into the lungs can be an effective alternative.
During an evaluation before the procedure, a CT scan is used to assess damage to the lungs. Then, with the patient under anesthesia, pulmonologists advance a balloon that allows them to block an airway, essentially simulating what would happen if they were to put the valve there. They need to make sure the damaged part of the lung will deflate.
If that test succeeds, the balloon is removed and an endobronchial valve is inserted in its place in a minimally invasive, nonsurgical procedure using a flexible bronchoscope. The valve is designed to let air escape from the damaged area, but not enter. If the airway is too large, doctors may instead place multiple valves on smaller airways feeding that section. The procedure typically takes 20 minutes to an hour.
Recovery time for most patients is minimal; they awaken within two hours and are quickly able to eat, get out of bed, and walk. Most remain in the hospital several days for observation, however, to ensure no new air leaks have developed.
After the procedure, improvement comes gradually. Immediately afterward, patients may even see their symptoms worsen.
“By around the third day, most people are back to where they were, and after about a few weeks, they’ll tell me they’re able to take a deeper breath than before,” says Dr. Cirino-Marcano. “Then, every time I talk to them, there will be something else they can do. They may say, ‘Now I’m able to talk longer without getting out of breath.’ And the next time, that shower that used to take an hour may take 20 minutes. One patient was excited because she could get into her neighbor’s pool for the first time in years. Another, who works in a supermarket, was thrilled to be able to walk up and down the aisles without feeling short of breath.”
Ayers experienced steady improvement following her procedure in September 2020. Although she still gets winded with exertion and keeps her oxygen nearby, she has been able to resume activities that once seemed impossible. “Taking a shower is a lot easier,” she says. She can slowly climb stairs, and she even bought a treadmill and a stationary bicycle.
A moment of truth came when she went to lead Waylon around the arena for the first time in ages, wondering whether he would still “follow me around like a puppy,” with no lead line, as he had always done in the past. To her immense gratification, he stayed behind her step for step. And that made everything worthwhile.
Well-Tested in Europe
The first endobronchial valve—the Zephyr Valve, now manufactured by Pulmonx—was approved by the U.S. Food and Drug Administration in 2018. But it has been around for much longer.
Dr. Cirino-Marcano was involved in the first U.S. trial when she was a fellow at the Tulane University School of Medicine in 2005, and the valve has been available in Europe for almost 20 years. In the United States, doctors have used the valve to alleviate other conditions—such as bronchopleural fistulas, a serious condition often associated with lung cancer surgery—for years.
That long experience, involving thousands of patients, has been reassuring. “They have good safety data,” says Dr. Cirino-Marcano.
For the COPD treatment to succeed, patients will typically receive three to five valves. Although the valves can be quickly and easily removed if a problem arises, most patients do well with them. As long as the valves are helping, they can stay in place for the rest of the patient’s life.
A Range of Possible Solutions
Dr. Cirino-Marcano says that most patients with COPD tend to end up with a variation on the same treatment. Typically they’re given an inhaler with either a bronchodilator or a steroid, and they may also be given oxygen.
“One thing the endobronchial valve procedure has taught us is that not all patients with COPD are the same,” she says. “Although the valves can help a large swath of patients, they aren’t for everyone.”
Other patients need other solutions. “In the workup for this procedure, we look at other factors associated with COPD,” Dr. Cirino-Marcano says. Carilion runs a pulmonary hypertension clinic that identifies the causes of the disease and the best therapies for each patient. Some patients may be referred for possible surgery or even a lung transplant.
At Carilion and across the United States, endobronchial valves are still in their infancy as a treatment for COPD. As Dr. Rubio notes, more time and more procedures will be needed to get firmer numbers on the percentage of patients who experience improved breathing, and whether the valves truly enable better oxygenation in the lungs, thus freeing more people from oxygen machines.
Yet for Ayers, who recently turned 70, the evidence is already in. Although she knows her condition has no cure, she’s enjoying rides with Waylon. She felt confident enough to enter a local horse show recently—and together they took first prize.
Written by Marcia Lerner