Condensed from New Mobility magazine,
Sep 2006 Ventilator-FREE OPTION
By Sam Maddox
Kathleen DeSilva has been told she's the longest-living C1-2 spinal cord injury survivor in history. This may be true, she doesn't know for sure, but DeSilva hasn't heard of anyone who can top her 38 years and counting. She was 16 in 1968 when she got hurt in a gymnastics mishap. Back then, life expectancy for a person who couldn't move anything below the head and who couldn't breathe on her own was about 2 or 3 years. Respiratory issues, most likely pneumonia, hastened the typical early exit. Bu DeSilva didn't get pneumonia then and says she never has. Her respiratory hygiene has been impeccable, in large part, DeSilva suggests, because of her breathing system. In 1971 she had an operation to put electrodes on the phrenic nerves in her neck. A battery-operated radio frequency signal actuates her diaphragm muscle, which causes air to enter her lungs several times a minute and frees her from a ventilator and all that comes with it.
The pacing system allows her to breathe more normally. Besides improved health, DeSilva says phrenic pacing has dramatically improved her quality of life.
"One of the most important things for me is being able to be by myself," she says. "When I'm on a vent, somebody has to be there in case something happens. There's great peace of mind with phrenic pacers. With a vent there's always something—hoses get disconnected, the machine can come unplugged or go off if the power goes out. Not to mention there's no tube coming out of your neck."
DeSilva, who recently retired as house attorney for The Institute for Rehabilitation and Research in Houston, used phrenic pacers around the clock for 17 years or so. She uses a vent part-time now because she doesn't breathe as well as she used to, especially in her left lung. "They don't know why. I think it's related to aging," she says.
DeSilva's pacer is called the Avery System, after the New York company that makes the parts. Avery has been in use since before the FDA even approved medical devices, with research going back to Dr. William Glenn's pioneering work at Yale in the mid-1960s. The Avery has been implanted in over 2000 people, with about 600 currently on the system, according to marketing manager Ken Aron.
Despite the compelling testimony of a long-time user, implanted respiratory pacing has not been able to shake its reputation as a high-risk option. Aron says this is not based on medical literature or the actual clinical history of the device. There may have been failures in the early days, he admits, and poor recipient selection. But nothing that would prompt the degree of high-profile put-down that occurred: In his 1998 book Still Me, Christopher Reeve, speaking of his urgent desire to get off his ventilator, wrote, "One option was phrenic pacing, a drastic and dangerous procedure...you have to stay in intensive care for months of constant monitoring...the risks are enormous...The procedure frees you from a ventilator but the outcome can be fatal."
"Who fed him this misinformation, I have no idea," says Aron. "He didn't get it from us." For its part, Avery didn't do much to nurture its reputation or its market. The company was purchased in the 1970s by William Dobelle, a biomedical inventor whose core mission was developing artificial vision. Dobelle died two years ago and his estate has given Aron and a team of managers the green light to market the Avery phrenic-nerve pacing system in the modern era. Just in time—there's another system moving its way through the FDA process. This one, from Cleveland, has gotten a much warmer celebrity glow. Reeve was the third to use it in the trial. Ironically, at first they didn't want him—he was too high profile. But eventually he showed it off on national television to Barbara Walters.
Dr. Raymond Onders and his group have performed their FDA-approved experimental implant on 27 people. The pacers reside not on the phrenic nerve per se, but on the diaphragm muscle itself. The stated health and quality of life benefits for the Cleveland System, now known as the Synapse Biomedical by the company Onders helped create to bring it to market., are the same as for the Avery method. But there are significant differences in how the devices are implanted.
The Avery involves surgery through the body or neck to locate branches of the phrenic nerve on both sides of the body and expose and suture electrodes around them. A small radio receiver is also implanted in the chest cavity, which is activated by an external antennae taped to the body. A technician from Avery is in the operating room to make sure it's hooked up correctly. "People always make it seem like we're using sharp sticks and hot rocks in a cave somewhere," says Aron. "The surgeon does not open large chest incisions; the incisions are an inch to an inch and a quarter—that's as invasive as it gets."
