A chance to breathe
Experimental implant may give relief to people afflicted with sleep apnea

By JOHN FAUBER

It's about midnight and foggy, not unlike the way Brad Hays will feel when he gets out of bed in a few hours.

Downstairs at the Hays home, Brad's wife, Pam, is watching "Late Night With Conan O'Brien" while the couple's little dog, Moxy, is sleeping on the couch and appears to be dreaming.

Upstairs in bed, Hays, 55, is doing what he has done every night for more than a decade: prodigiously snoring, an activity that occasionally pauses with a momentary interruption of breathing.

Hays dreams, too, and on more than a few occasions it's the same one.

"Often I have dreams of a situation where I'm suffocating," Hays said. "I wake up sometimes gasping for air."

As someone with moderate to severe sleep apnea, Hays' dream is a daily reality. He actually is starved of air more than 100 times a night.

These episodes of snoring, airway closing and interrupted sleep have driven Hays to sign up for an experimental surgery in which a small device would be implanted under his chin.

It's a novel approach that brings elements of rock climbing and fishing into the operating room. The big question: Will it revolutionize treatment of a condition that affects an estimated 12 million Americans, or will it be just another in a long line of apnea therapies that have as many cons as pros?

Last Wednesday, after kissing his wife and being wheeled into day surgery at Froedtert Hospital in Wauwatosa, Hays was about to find out.
In national study

As part of a national study that is headed up by a Milwaukee ear, nose and throat specialist, Hays is one of only a handful of people in the country to be implanted with the device.

"We need surgeries with fewer side effects that can be done under local anesthesia," said B. Tucker Woodson, a professor of otolaryngology at the Medical College of Wisconsin and principal investigator of the U.S. clinical trial of the device.

Although the clinical trial Woodson is leading requires that the device be implanted while the patients are under general anesthesia, Woodson said that once the device is approved, the operation can just as easily be done with local anesthesia.

Woodson is a consultant to Aspire Medical, the company that makes the device and is funding the trial. He also owns stock options in the privately held firm.

Michael Friedman, director of sleep surgery at Rush University Medical Center in Chicago, said a big advantage to the device is that it is adjustable. To get the airway open more, the device can be progressively adjusted in later office visits

He said he doubted that it will be "a magic cure-all."

Still, because so many people with sleep apnea go untreated, partly because of the invasiveness of other surgeries or their inability to tolerate the non-surgical approach of using air pressure masks that fit over the nose, the device could be attractive to many people with untreated apnea.

"I think it's got a future," Friedman said.

Known as the Advance System, the device is implanted through a small incision under the chin. It is designed to open the airway by deploying a tiny barbed implant in the back of the tongue and connecting it by an adjustable tether to an anchor that is screwed into the jaw bone.
Hook and line

"It's about as invasive as a root canal," Woodson says Wednesday morning as he preps for Hays' surgery.

It's also a little like musky fishing.

At 8:52, Woodson injects a local anesthetic at several spots under Hays' chin. Ten minutes later, he makes a small incision, and the surgical part of the procedure begins.

Using a tool with a long, thin shaft and a reel at the other end, Woodson uses his finger to find a spot at the back of Hays' tongue.

He sticks the shaft in Hays' tongue and deploys several tiny metal barbs. The barbs are made out of a "memory metal," a nickel-titanium alloy that later can be straightened out and removed if need be - if the tissue gets infected, for instance.

With the barbs embedded under the tongue, Woodson screws a tiny anchoring device into Hays' jaw.

A polyethylene tether as strong as fishing line connects the two implants.

A special figure-eight knot is tied into the jaw anchor.

"It's a well-used (rock) climbing knot," Jasper Jackson, inventor of the device and an avid rock climber, says while watching Hays' surgery. "You can trust your life with it."

But just in case, Woodson ties a second, overhand knot after tying the figure-eight knot.

"We'll go through the same incision in a few weeks when we (tighten) it," Woodson says.

At 9:40, Woodson closes the incision with five sutures, and the operation is done.

The U.S. clinical trial is expected to be completed in November 2008 after 40 people have been implanted with the device. A similar trial also is going on in Europe. FDA approval of the device is not expected until after the trials are completed.
New treatments needed

Doctors say effective new treatments for apnea are sorely needed.

Most of the people who have the disorder are not getting treated for it and, as a result, are at higher risk for a variety of ailments.

Daily, they are prone to feeling groggy or sleepy during the day with reduced cognitive performance.

Longer term, apnea increases risk of high blood pressure, strokes, heart attacks and dangerous arrhythmias. In May, researchers reported that sleep apnea over five years increased the risk of heart attack 30%.

The pressurized air, non-surgical therapy known as CPAP (continuous positive airway pressure) will continue to be the first-line treatment because it is safe and effective in a large percentage of people with apnea, said Edward Weaver, an associate professor of otolaryngology and chief of sleep surgery at the University of Washington Harborview Medical Center in Seattle.

But because so many people don't like CPAP, the new device may be an attractive alternative, he said.

"It's a compelling device," Weaver said. "It looks like it has great potential."

On Friday, two days after the surgery, Hays, a retired Secret Service and Alcohol, Tobacco and Firearms agent, had a small amount of swelling under his chin. He said his tongue felt like it was in a slightly different position, like it was more against his teeth. But otherwise, he felt good, he said.

Doctors say the full benefit of the device normally is not noticed until it is adjusted in an office visit a couple weeks after the surgery, but the apnea of some patients does improve right away.

Hays' wife said she noticed a change Thursday night.

"It was a different kind of snoring," she said. "It wasn't the constant deeper snore. It was lighter. He wasn't whistling through his nose."

And if his apnea and snoring improve even more after the device is adjusted, it could be enough to return nighttime peace to their Greenfield household.

On a typical night, Pam wears ear plugs, but often his snoring wakes her and Moxy, their 16-pound West Highland terrier, who usually sleeps between them.

First Pam nudges him, and then Moxy joins in by kicking him.

"We have to tag-team him," she said.

original article at: http://www.jsonline.com/story/index.aspx?id=669061