New asthma treatment offered in Charlotte region

Nov. 25--Wendy Myers breathes easier today, without all the powerful medicines and inhalers she has used to treat her asthma for 50 years.

The change occurred in recent weeks after the 53-year-old Morganton woman came to Carolinas Medical Center-University for a relatively new procedure -- bronchial thermoplasty -- that uses heat to shrink soft muscle tissue and open the airways of the lungs.

It's 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 Myers, 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 University Medical Center, 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 reduction in asthma flare-ups and visits to the emergency room.

"This procedure does not cure asthma," said Dr. Michael Zgoda, a pulmonologist at CMC-University, part of Carolinas HealthCare System. "But it really makes a positive impact on people's lives."

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. Zgoda and other doctors 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."

Losing her son

Myers first learned about bronchial thermoplasty two years ago from her Hickory doctor, who suggested she sign up for one of the clinical trials in Colorado.

She declined because she didn't want to travel that far. But then something happened that caused her to reconsider. Her 35-year-old son died from asthma complications.

On May 17, Jamey Myers was found dead at his home in Hickory. He had recently been diagnosed with bronchitis, a common complication, for which his doctor had prescribed antibiotics.

"He probably took his medicine, sat down and fell asleep," Wendy Myers said. "He was on the couch, probably watching TV."

Although her son had had asthma since he was 2, Wendy Myers said his symptoms were never as bad as hers. She couldn't walk up the stairs in their three-story house without stopping to get her breath. She kept a nebulizer, a device to deliver medicine, in her car because she'd sometimes have an attack while driving. Earlier this year, when she wound up in the emergency room, her lips were turning blue.

"I wasn't sure if she was going to get another breath or not," said her husband, Mark Myers, senior pastor of Marketplace Church in Hickory.

He got serious about finding a better treatment. And when he researched bronchial thermoplasty on the Internet, he found it was offered at several North Carolina hospitals. Although his wife wasn't crazy about "somebody going inside her lungs and burning some of it off," Mark Myers said online patient reviews "kept coming back positive."

Despite her reluctance, Wendy Myers was growing tired of taking so much medicine. For three years, she 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.

"People don't realize how serious asthma is," she said. "It can be a life-threatening condition."

She also wanted to stay healthy for her family. The Myerses have a married daughter and a 3-month-old granddaughter. They also have an adopted daughter who is 6. "I need to be able to breathe," she said.

Still 'investigational'

In May, Wendy Myers met with Zgoda, who treats patients at CMC-University. He is one of six North Carolina pulmonologists trained to perform bronchial thermoplasty and has treated six patients since July.

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.

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

Myers said it could save money over the long term if she can stop taking some of her medicines. She and her husband spend about $200 a month on prescriptions, which means insurance pays about $1,000. That doesn't count supplies, including three nebulizers that must be replaced every year, and tubing to go with them.

"My deductible always gets met in January because of my illness," she said.

Breathing easier

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.

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.

"I can actually go up and down my stairs without stopping to catch my breath," she 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."

___

(c)2013 The Charlotte Observer (Charlotte, N.C.)

Visit The Charlotte Observer (Charlotte, N.C.) at www.charlotteobserver.com

Distributed by MCT Information Services