TYRONE - About a year ago, Brenda Werner started having trouble breathing.
The 57-year-old Tyrone resident chalked it up to working long hours, she said recently while sitting on a couch in her mom's Tyrone home with her dog, Bandit, at her side.
But on a planned trip to Las Vegas, the breathing problems persisted despite hot showers Werner took in an attempt to ease her discomfort.
Article Photos
Brenda Werner of Tyrone sits on a couch at the home of her mother, Vergie Werner, with her dog, Bandit. She is one of the first people to get a nerve-stimulation device to help with her chronic heart failure as part of a clinical trial.
"By the time I got back from Vegas, I literally thought I was dying," she said.
After a chest X-ray and an echocardiogram, doctors found Werner had the chronic progressive condition known as heart failure. Her heart was not pumping how it should, she said.
Her primary care doctor, Dr. Jerome Dejulia of Tyrone Medical Associates, ended up sending her to Allegheny General Hospital in Pitts-burgh. She was put under the care of heart failure cardiologist Dr. George Sokos.
Fact Box
Symptoms of heart failure and changes that can help
The top three symptoms of heart failure are shortness of breath, fatigue and swelling in the legs and abdomen.
Below are some of the lifestyle changes that can alleviate heart failure symptoms, slow the progression of the disease and improve every day life:
Quit smoking
Maintain a healthy weight through a heart-healthy diet and doctor-monitored exercise plan
Track fluid intake
Avoid alcohol; avoid or limit caffeine
Get adequate sleep
Manage stress and find support through social services
Source: Dr. George Sokos, Allegheny General Hospital heart failure cardiologist, and the American Heart Association website at www.heart.org.
Eligibility requirements
Eligible patients must be at least 18 years old, diagnosed with congestive heart failure and suffering from heart failure symptoms such as shortness of breath or fatigue despite treatment with a combination of medicines.
Anyone interested in seeing if they qualify for the INOVATE-HF clinical trial, can call Allegheny General Hospital research coordinator Sarah Sherry at 412-359-3253.
The move ended up making her the first person to receive an innovative nerve-stimulation device known as the CardioFit system, which was developed by BioControl Medical, a medical technology company based in Yehud, Israel, and New Hope, Minn.
Sokos, the principal investigator for the new clinical trial called INOVATE-HF, suggested Werner was a candidate.
He had told Werner, who was not responding to her medication, a heart transplant could be in her future.
"It was frustrating for me," she said. "That's not a course I wanted to take."
The best case scenario is the device will help eliminate the need for a heart transplant, Werner said.
The trial will enroll up to 650 patients at 80 centers in the United States and Europe.
"Congestive heart failure, when the heart becomes weakened and cannot pump as much blood as it should, is the most rapidly growing cardiovascular disorder in the United States," Sokos said. "We treat most of our patients with medications that can help relieve their symptoms but do not always stop the heart's deterioration. We are very eager to learn through this study whether the CardioFit system offers patients with heart failure a new therapeutic option that will improve and extend their lives."
The CardioFit system stimulates the vagus nerve, which runs up into the neck along the carotid artery and plays a critical role in managing the heart's response to stress. Vagus nerve stimulation has long been used to treat epilepsy.
The study will determine whether the combination of the implanted device and medical therapy is more effective than medical therapy alone in treating congestive heart failure.
Heart failure is one of the leading causes of death and disability in the United States, affecting more than five million Americans and killing approximately 250,000 people each year. The disease is the leading cause of hospital admissions in adults over age 65.
When someone has heart failure, the human body tries to compensate and goes into the fight or flight-mode, Sokos said. Initially, that reaction will help someone get through the beginning throes of heart failure, but then it starts to create problems, weakening the heart over time.
After the study coordinator talked to Werner, her medical records were reviewed and she went through two days worth of tests, before she was randomly selected to receive the device, she said.
The study has a control group which will not receive the device. She was relieved when she was picked to get it, she said.
The study will follow her progress for more than five years, she said. She returns every three months to Pittsburgh for a checkup.
"I didn't see where there was any downside," Werner said of participating in the study. "It looks to me like this device has a lot of potential."
Recent results from the pilot study out of Europe are promising, according to a press release.
The surgery leaves two scars - one in the neck and one in the chest, he said.
The battery-operated device sits under the skin on the right side of the chest, Werner said.
Werner had the surgery July 5. She returned weekly for adjustments to get the device functioning at the appropriate level, she said. It is done that way because it can be painful if it is turned up all at once.
The device sends six to seven pulses, stops briefly and then sends the pulses again. Werner said she could feel a tingle in the back of her throat when the device was adjusted, but it goes away after awhile.
Werner's last adjustment was on Sept. 11.
"Her heart function has improved dramatically," Sokos said of his patient. It has almost gotten back to normal, he said.
Werner, who works for the Blair County Children, Youth and Family Services, said the goal was to get her back to work. After being off work for nine months, she is back on the job.
While she still gets tired - a day of work wipes her out - she is breathing better these days, Werner said. Since she is headed through uncharted territory she isn't sure if the fatigue she still feels will ease, she said.
She hopes the publicity from her experience brings about awareness of the study and possibly helps someone else like her, she said.
She is pleased with the care she has received at Allegheny General.
"Their care is just completely comprehensive," Werner said.
Through the hospital she met with a pharmacist who suggested taking her off anti-inflammatory medication because it causes users to retain fluid, which she couldn't afford to do at the time, she said. She met with a dietitian who helped her tackle weight loss and sodium control.
Werner was placed on a low-sodium diet, which she said is not easy. She has lost about 45 pounds, she said.
"I'm thrilled," said her mom, Virgie, who had many friends praying for her daughter. "When I thought of heart transplant, I sunk pretty far."
Brenda Werner feels fortunate to have ended up at Allegheny General, which has a heart failure clinic and some of the best doctors in the field, she said.
"I'm just grateful. I really lucked out," she said. "I feel like I've been lucky and blessed, and I'm very thankful."
Mirror Staff Writer Amanda Gabeletto is at 949-7030.
