Device restores taste, smell, some freedom to paralyzed patients

BY FRED TASKER
ftasker@MiamiHerald.com

CHARLES TRAINOR JR / MIAMI HERALD STAFF
Ashley Hicks is thrilled that she can smell again after trading a bulky ventilator for the much smaller pacing system, cradled in her arm.

The day after her new breathing device was implanted, Ashley Hicks did something astounding: she smelled the sweet scent of flowers in a hospital bouquet.

“I was speechless,” she says now. “I couldn’t believe how much I missed that.”
Hicks, 21, had been unable to smell — or taste — anything for the nine years since she was shot in the neck during a drive-by attack at her Pompano Beach home.

Paralyzed and unable to breathe, she had been kept alive by a mechanical ventilator. But it pumped air into her lungs through a tracheostomy — a hole in her neck — bypassing her mouth and nose. And that meant she had no sense of taste or smell.

The new device she got in April, a “diaphragm pacing system,” changed that. Using tiny steel electrodes implanted in her chest, it electronically stimulates her diaphragm to contract, pulling air into her lungs through her nose and mouth. It lets her breathe the way everybody else does. And it returned her senses of taste and smell.

And more. When successful, the new device — FDA-approved in 2008 but just arriving in South Florida — can wean patients paralyzed by spinal-cord injury or disease off their bulky, noisy, expensive mechanical ventilators. It can help them speak better, avoid infections and sometimes get them out of expensive hospitals and skilled nursing homes and back to work, study and home.

Even Superman praised the system. Actor Christopher Reeve, paralyzed in a fall from a horse in 1995, told Barbara Walters in his final interview before his 2004 death that the pacing system, then experimental, had helped his morale.

It can save thousands of dollars a year in the cost of care, doctors say. But to the frustration of Hicks’ caregivers at Broward Children’s Center, Medicaid won’t directly pay for it. The center tried to persuade Medicaid, then gave up and paid the $33,000 cost of the device itself.

THE SPORTS FAN
Another patient using the pacing system at the center is Philip Starling, 23, who had been on a ventilator since 15, when nerves were severed accidentally during an operation to ease pressure on his spine.

Starling is a big sports fan. He played baseball at Pinellas Park Middle School, pre-injury, and his room at the center is plastered with posters of the Miami Dolphins, NASCAR race driver Jeff Gordon and others.

Starling has some control of his arms and legs and, with the help of the pacing system, he hopes one day to leave his power chair and walk.

His goal: “I want to be a crew chief for a NASCAR team.”
It’s not impossible — even the walking part — says Denise Wronowski, the center’s community liaison. One advantage of the pacing system is that it helps tone the diaphragm and the phrenic nerves that connect it to the brain after years of atrophy on the ventilator, possibly strengthening them enough so Starling could breathe on his own.

Starling hopes soon to live with his mother in Ocala. To live at home on a ventilator, Starling might need as much as $3,000 a month in skilled nursing help. On the pacing system, though, he might get by with only the help of his mother, who is a nurse, Wronowski says.

“That would save $36,000 a year,” she says.
When Tom DeLilla, head of the spinal cord injury program at the Florida Department of Health, learned what the devices could do for paralyzed patients, he launched a crusade to get Medicaid to pay for them.

DeLilla asked the Florida Agency for Health Care Administration (AHCA), which operates Medicaid in Florida, to make sure hospitals could get upfront reimbursement for the $33,000 cost.

“Medicaid would save money in the long run,” he says.
But Medicaid took a different tack, he says. Rather than reimbursing hospitals directly for the devices, it required them to absorb the upfront cost and then include it in quarterly cost reports they send to Medicaid.

The hospitals knew what that would mean, he said: “They would never fully recover all costs. So they don’t want to do it.”

AHCA spokeswoman Shelisha Durden said her agency agrees the pacing system “shows considerable promise” for reducing costs, and affirmed that Medicaid pays for the device through quarterly cost reports rather than upfront.

In the cases of Hicks and Starling, the Broward center raised money to pay for the machines. Shands University of Florida Hospital in Gainesville implanted them, billing Medicaid for the hospital costs.

IRON LUNG
Breathing assistance for paralyzed patients goes back at least to 1929, when Harvard professor Philip Drinker invented the “iron lung.”

In a healthy person, breathing takes place when a signal from the brain travels down the phrenic nerve to the diaphragm, which contracts and draws air through the mouth and nose into the lungs.

The early iron lung was a huge tank that allowed only the patient’s head to be exposed. An air pump would decrease the pressure inside the tank, drawing in air through the patient’s mouth and nose to the lungs.

Mechanical ventilators have come a long way. Today, a 15-pound ventilator mounted on the back of a wheelchair blows air through a flexible plastic tube into a tracheostomy low in the patient’s neck, forcing air into the lungs.

Because of that, some patients can’t speak unless an attendant temporarily closes a valve in the neck to allow exhaled air to pass over the voice box above the tracheostomy. The always-open hole must be constantly medicated to fight diseases such as pneumonia.

And the ventilator issues a constant “pssst . . . click” sound.
“It makes the patients self-conscious,” says Wronowski. “On a vent, it’s hard to get them out into the community for movies or shopping.”

The new diaphragm pacing system is attached in a 90-minute laparoscopic operation. Surgeons connect four tiny steel electrodes to the phrenic nerves in the chest. The wires run out the patient’s side and connect to an “external pulse generator” that is six inches long and three inches wide.

The generator sends a signal to the phrenic nerve, causing the diaphragm to contract and pull in air. The air passes through the nose and mouth, restoring smell and taste. And it is exhaled past the voice box, so the patient can speak.

The pulse generator is small enough to hide under a shirt. It has a 500-hour lithium battery, making it easier for the patient to travel or go to work.

The new device, called NeuRx Diaphragm Pacing System (DPS), was developed over 20 years at Case Western Reserve University and the University Hospitals of Cleveland. In 2002, Synapse Biomedical was founded to manufacture and sell it. Crucial to its development was Dr. Raymond Onders, director of minimally invasive surgery at University Hospitals, Cleveland and a founder of Synapse Biomedical.

Onders’ most famous patient was actor Reeve. In 2003, he was the third patient in the device’s clinical trial that led to the FDA approval in 2008.

In Reeve’s interview with Walters, he praised the system: “The more you can get some systems back — like the ability to breathe as normal — it just makes you feel you’re moving forward.”

In a clinical trial of the pacing system with 50 patients, half were able to wean themselves off a ventilator altogether and another 17 percent were able to do without it for 12 hours at a time.

So far, Synapse has sold about 150 devices nationwide, including eight in Florida.
Another company, Avery Biomedical Devices of Commack, N.Y., makes a different diaphragm pacing system. It sells “a couple of dozen” implants a year in the United States, a spokesman said.

ALS PATIENTS
At Synapse, another clinical trial is under way in patients with Amyotrophic Lateral Sclerosis (ALS) — Lou Gehrig’s disease. It’s a neuromuscular disease with progressive muscle weakness that eventually affects the patient’s ability to breathe.

Today, about 300,000 people in the United States live with spinal-cord injury, with 12,000 or so new cases a year, according to the National Spinal Cord Injury Database. About 500 new cases a year need ventilators.

Another 30,000 people in the United States live with ALS, with about 5,600 new cases diagnosed each year. Of them, about 2,400 might quality for diaphragm pacing.

Even taken together, it’s a small number of patients who might benefit from the device.
But for those who do, the device can be life-changing.
Hicks, an aspiring writer who graduated from Blanche Ely High School in Pompano Beach after her injury, is among them. She hopes to attend Florida Atlantic University and has written a 112-page book about her injury and her life using a laptop and a “jouse” — a mouth-operated combination joy stick and mouse.

With the help of her pacing device, she’ll be more mobile, less dependent and maybe a bit more able to live the life she wants.

And, she noted with a laugh, there’s another plus: “It’s completely silent. Now I can sneak up on people.”

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