November 25, 2013

New asthma treatment offered at Duke Medical Center, other NC hospitals

Dr. Momen Wahidi at Duke University Medical Center is treating patients who have severe asthma with bronchial thermoplasty, a recently approved treatment for severe asthma. The procedure uses heat to reduce thickness in the airways of the lungs, allowing patients to breathe more easily and take less medicine.

DURHAM Sarah Owen of Raleigh was just out of college, and life should have been just starting. Instead it felt like the end.

Her asthma, already severe, was worsening. Attacks hit so hard and quick that she would collapse to the floor and be unable to get to the phone or medicine for help. She had been using a host of powerful medicines and inhalers to treat her asthma since she was 2 years old, but they weren’t enough. It was only only a matter of time, Owen was sure, until she had a stroke and perhaps brain damage, or even death.

Then she heard about a long-term research study at Duke University Medical Center of a new procedure called bronchial thermoplasty, which uses heat to shrink soft muscle tissue and open the airways of the lungs.

Owen felt she was out of options, so she decided to sign up. Since May 2012, when the multistep procedure was finished, Owen has been able to sharply reduce her expensive drug regimen and do things she never could before, including hiking long distances in the mountains without worrying about what season it was, and even running short distances with her dog.

“I am now able to do moderate exercise, make long-term plans without having to plan around my bad asthma seasons, am able to participate more with friends and activities which frequently got canceled because of symptomatic days, and have more of a ‘traditional future,’” Owen said. “I may now be able to have children, participate in their futures and not have to worry as much about missing out on the important things.”

Bronchial thermoplasty

Bronchial thermoplasty is the first nondrug therapy approved by the Food and Drug Administration for treatment of patients with severe asthma.

Across the country, about 25 million people, or one in 12, suffer from asthma. For most of them, avoiding allergens and using inhaled medications keeps symptoms under control. But for a minority of patients, like Owen, medication isn’t enough.

With normal breathing, the bronchial passages are fully open. But people with asthma have more smooth muscle in those airways, and that constricts airflow and causes difficulty breathing. Those are the patients for whom some pulmonologists are now recommending bronchial thermoplasty.

In clinical trials, including one at Duke, patients who had the three-part treatment were found to have significant improvement in symptoms, such as breathlessness, coughing and wheezing. They also experienced a significant reduction in asthma flare-ups and visits to the emergency room.

“This procedure is not the ultimate cure for asthma, but it is a valuable addition to the therapies we have for a sub-group, severe asthma patients who are still symptomatic despite maximal medical treatment,” said Dr. Momen Wahidi, director of Interventional Pulmonology and Bronchoscopy at Duke. Those whose condition is considered severe are estimated at less than 10 percent of all asthma patients, he said.

Wahidi performed the procedure on Owen and, along with Dr. Monica Kraft, ran Duke’s part of the national clinical trial that led to its FDA approval. And they’re still recruiting new patients for an ongoing long-term follow-up study to generate more data for the FDA.

Not for everyone

Bronchial thermoplasty isn’t for everyone with asthma. It’s recommended for patients over 18 whose asthma is uncontrolled despite taking recommended medicines and who need to use “rescue inhalers” two or three times a week because of asthma attacks.

The procedure is covered by Medicare but not yet routinely covered by private insurance. Doctors who perform the procedure in North Carolina say they spend a lot of time trying to get their patients covered by insurers that perceive the procedure as experimental.

Dr. Kimberly McCrea, a pulmonologist at Novant Health Presbyterian Medical Center in Charlotte, has several patients who hope to undergo the procedure, but they’re waiting for the OK from insurers.

“They’re not quite ready to sign off on this,” McCrea said. “One lady has been in the approval process for six months. We’re trying to make sure that it is approved up front so the patient is not burdened with unexpected cost.”

The outpatient procedure is expensive – about $30,000, not counting anesthesia, and even more if an overnight stay is required. But McCrea said it could save money in the long run by keeping people out of the ER and reducing their medicines.

“I think it will help a subset of patients,” McCrea said, “and will get more accepted as time goes on.”

Still ‘investigational’

In May, Wendy Myers, 53, of Morganton, met with Dr. Michael Zgoda, who treats patients at Carolinas Medical Center-University in Charlotte. He and Wahidi are among six North Carolina pulmonologists trained to perform bronchial thermoplasty, and Zgoda has treated six patients since July.

For three years, Myers, a serious asthma sufferer, had been taking 60 milligrams of prednisone a day, a very high dose of a steroid that caused her to gain weight and also put her at risk for long-term side effects, such as diabetes and osteoporosis. She developed bronchitis and other complications so often that she had become resistant to all but two antibiotics.

Before Myers scheduled the procedure, Zgoda sent letters to her insurance company, Blue Cross and Blue Shield of North Carolina, to make sure the company would cover her treatment. He said his staff spends hours advocating for patients by writing multiple letters or making phone calls to insurers.

Although approved by the FDA in 2010, bronchial thermoplasty is still characterized by Blue Cross as “investigational.” Although several studies have shown that patients benefit from the procedure, a company statement says some of the response “suggests a large placebo effect with novel asthma treatments.”

The Blue Cross statement also says that “long term safety data are not yet available,” and clinical trials are underway to evaluate both degree of benefit and potential adverse effects.

Costs and benefits

Despite that, Blue Cross agreed to cover its part of Myers’ procedures.

Owen was lucky: her procedure was free because she was accepted for the study. What’s more, it has become clear that she will have to spend substantially less on medication. In 2010 she was taking 11 different medications and needing 12 to 20 puffs from her rescue inhaler. Now she is using two medications, and some days doesn’t need the inhaler at all.

At times, her insurance co-payments for medications were as much as $875 a month. Now, Owen said, they are under $100. “I also don’t have to feel tied down to a clock to make sure one medicine is taken 5 times per day, another 3, etc.,” she said.

Also, before the bronchial thermoplasty, Owen needed to be hospitalized two or more times a year. Since the procedure, she has only gone once.

The procedure

With insurance approval, Myers’ three procedures were scheduled about three weeks apart in September and October. During the first two, Zgoda treated each lower lobe of the lungs. The third treatment was for both upper lobes.

Myers was deeply sedated, and Zgoda guided a bronchoscope, a long flexible tube, through her mouth and into her lungs. An attached camera and light allowed him to view the inside of her airways on a monitor. Zgoda then inserted a catheter with an array of electrodes through the bronchoscope. Then, with the electrodes warmed by radio-frequency energy, Zgoda delivered repeated zaps of mild heat to the smooth muscle.

Each blast lasted a few seconds, accompanied by beeping sounds from the machine. Over and over, he moved the catheter and activated it from 80 to 100 times, until the entire airway was treated.

Breathing easier

The difference was visible on the monitor. Before treatment, the tissue was reddish and swollen, with extra mucus hanging like a hammock from the sides of her airways. Afterward, the tissue was red and splotchy. But a few days later, the heat damage had healed, and the tissue looked healthy, a whitish pink, smooth and clear.

After the first treatment, Myers was able to reduce her daily dose of prednisone from 60 milligrams to 10. A month after her final treatment, she is down to 5 milligrams and feeling better than she has in years. And she’s seeing some of the other life-changing improvements that Owen is enjoying, too.

“I can actually go up and down my stairs without stopping to catch my breath,” Myers said. “That sounds small to a lot of people. But believe me, that’s huge for me. I called my husband.

“My whole reason for doing this was to get off steroids, but I think it’s going to be so much better,” she said. “I would have never believed it would (be) this good.”

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