A breath of hope
A small device that can stimulate diaphragm muscles holds the promise of freeing patients of ventilators
By GAYLE WHITEThe Atlanta Journal-Constitution Published on: 04/01/07
Don Pollard's eyes widened. He was breathing. His diaphragm was going up and down, pulling air into his lungs and forcing it out.
The sensation felt strange to the 28-year-old, who has depended on a ventilator since he was injured in a car crash before his second birthday.
"My diaphragm hasn't moved — at least not like that — in 27 years," said Pollard, who is paralyzed from the neck down except for limited movement in his right arm. "I've never had that kind of feeling."
On Monday, he took his first breaths as part of a clinical trial of a new mechanism called a diaphragm pacing stimulation system. It electrically stimulates the muscle sheet across the rib cage much as a pacemaker regulates the heart.
The new device, being tested at Atlanta's Shepherd Center, could permanently free Pollard and others who can't breathe on their own from trachea hoses and bulky machines. It's smaller, less expensive and more portable than the ventilator, and the breath it produces is much more natural.
To Pollard, who expects to be in a wheelchair for the rest of his life, the stimulator offers hope of independence. He dreams of doing something most people take for granted: Pollard, who does not drive, wants to get in a van alone and go, not worrying about having someone else nearby in case his ventilator hose comes loose or the machine malfunctions.
He had surgery at Piedmont Hospital on March 12 to implant the device, which was developed by Case Western Reserve University and University Hospitals of Cleveland. Shepherd Center and a Cleveland hospital are the only U.S. sites where the device is being tested. A patient in Vancouver, British Columbia, also has received one.
The late "Superman" actor Christopher Reeve, who was paralyzed by a fall from a horse, was the third of about 50 patients who have tried the experimental device. He underwent surgery in Cleveland in 2003.
Easier to talk
Unlike the ventilator, which forces air into the lungs like blowing up a balloon, the new breathing device operates by stimulating the diaphragm using electrodes implanted by laparoscopic surgery. The electrodes cause the muscle to contract as it normally would, drawing air in.
"When you and I breathe, the brain sends a signal through the phrenic nerve to the diaphragm," said Dr. Saeid Khansarinia, the Piedmont Hospital surgeon who operates on the Shepherd Center patients. A severe spinal cord injury severs the connection from the brain, but the nerve frequently remains intact, he said.
"If you can use that phrenic nerve and pace the diaphragm, you can make the patient breathe."
The device — a little larger than a video iPod — is much less intrusive and much less constraining than the 25-pound ventilator, which is bigger than a car battery and works by pumping air through a hose inserted into the trachea.
Because the breathing is more normal, patients can talk without the gasps and interruptions caused by ventilators.
The new device even improves the sensations of taste and smell in some patients, said Michelle Nemeth, a Shepherd Center physical therapist who is leading research on the device in Atlanta.
"Because no air is going through the nose and mouth, patients on a ventilator may lose their sense of taste and smell," she said. "This allows them to actually regain the ability to taste and smell. That's huge for quality of life."
May extend life
Researchers hope patients will actually live longer. One of the leading causes of death for ventilator patients is pneumonia. Because the new device gets more air into the lower portion of the lungs than the ventilator does, it may cut down on that risk, said Moustapha Diop, the chief operating officer of Synapse Biomedical Inc., the Ohio-based start-up that plans to market the device if clinical trials are successful and the federal Food and Drug Administration approves it for widespread use. That approval could come later this year, Diop said.
About one-tenth of the 11,000 people whose spinal cords are injured each year require mechanical ventilation, according to scientists at Case Western. About 300 of those patients will need lifelong breathing support.
The ventilator, based on technology developed in the 1960s, can cost more than $15,000 a month for rental, backup equipment, maintenance and nursing care.
The implanted breathing device, although not yet priced, could cost up to $20,000 including surgical installation, said Dr. Raymond Onders, the University Hospitals of Cleveland surgeon who developed the device along with biomedical engineers at Case Western Reserve University, where Onders also is a professor.
Replacement batteries and cables probably will cost less than $100 a month, Onders said.
The device should free patients from the need for round-the-clock care.
A cost analysis on a Cleveland patient found that the device saved Ohio Medicaid $13,000 a month.
Researchers believe the diaphragm pacer could be especially effective if implanted soon after injury, before the diaphragm has had time to atrophy from lack of use.
The Cleveland researchers are testing the device separately in people with amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease. They hope also to work with post-polio and muscular dystrophy patients.
Recipients of the device have ranged in age from 18 into their 70s, and include both men and women.
One Cleveland recipient was able to move from a nursing facility into a home and was married last year. Another patient whose device was implanted by Cleveland doctors lived through Hurricane Katrina without fear of dying because of loss of electrical power to a ventilator. The Canadian man whose surgery was performed two months ago now operates a sailboat by blowing through a steering device.
Pollard is the fourth patient to be implanted through Shepherd.
Twenty-year-old Adam Booker of Jackson, Miss., who had surgery at Piedmont in June 2006, was the first. Booker was 19, living in Lenoir, N.C., and driving home from work at a country club when a car came over a hill and crashed into him as he made a left turn.
He's paralyzed from the shoulders down and was on a ventilator for several months.
"Having that big vent on the back of my chair was hard," he said. "Before I got my pacer, I didn't get out much. I didn't want to go anywhere. I was self-conscious about that big blue tube hanging out of my neck."
Now, he said, "things have turned around. I get out more. I'm feeling a little better about myself."
Booker is a success story for Shepherd.
Eight days after first taking a breath with the new device, he was completely weaned from the ventilator.
Now, he thinks he can get back into college and get on with his life.
Like Pollard, he found the new device strange at first. His first breath, he said, felt as if he were going over the hill on a roller coaster.
Now, he said, he breathes without thinking about it — as he did before the accident.
Lure of independence
Pollard doesn't expect to progress as quickly as Booker. After all, his diaphragm hasn't worked since he was a toddler.
He carefully considered Shepherd doctors' proposal that he participate in the clinical trial. He thought he was faring pretty well on the ventilator. He'd avoided many of the health problems associated with its long-term use.
He was busy playing wheelchair soccer, volunteering for a prison ministry through his church and studying to become a real estate agent. Why not leave well enough alone?
But the lure of independence was strong.
So there he was with his mother at Shepherd Center last week, feeling new sensations as Dr. Brock Bowman, a rehabilitation physician at Shepherd, stimulated one electrode, then another.
His abdomen kind of jumped with the first deep breath.
Because every patient is different, Bowman tried different settings.
Pollard, it turns out, has more natural strength on the right side of his diaphragm than his left, so the electrodes needed to produce different degrees of stimulation.
When Bowman and his study team were convinced that Pollard was getting a good volume of air, his blood was being adequately saturated with oxygen, and he was as comfortable as he could be, they declared success.
Pollard, who lives with his mother and stepfather outside Conyers, is trying life without the ventilator several times a day.
His mother, Sharon Tyroff, said if he attains his goal of driving by himself it would be life-altering.
"That would be a huge step," she said, "but he might be able to do it someday."
~Best viewed with a positive attitude~