Allegheny General Hospital involved in heart tool trial
Device stimulates nerve extending from the brain
September 12, 2012 4:00 AM
Brenda Warner, of Tyrone, Pa., participates in a walk test Tuesday as part of the CardioFit system clinical trial at Allegheny General Hospital. Warner is the first person in to receive the CardioFit implant as part of the trial.
Brenda Werner, of Tyrone, Pa., is part of the CardioFit system clinical trial at Allegheny General Hospital. Ms. Werner is the first person to participate in the program.
By David Templeton Pittsburgh Post-Gazette
Last November, Brenda Werner was in Las Vegas when she began losing her breath while walking, climbing steps, or doing any physical activity including sleeping.
The Blair County woman was startled to learn she had heart failure, also called congestive heart failure -- the most rapidly growing form of heart disease and leading cause of hospital admissions in adults older than 65.
Ms. Werner, 56, of Tyrone, Pa., proceeded to lose 45 pounds but showed insufficient improvement with medications.
So how did it happen that Ms. Werner was walking sprightly for six minutes Tuesday up and down an Allegheny General Hospital hallway while announcing to nurses she was feeling little fatigue, with her six-minute walk distance improving by longer than a football field in just six weeks?
Her secret? She's the first person chosen to participate in a clinical trial to test an implantable electrical device that stimulates the vagus nerve -- the nerve extending from the brain to the heart among other organs. The stimulation slows heart function so it can beat more efficiency, allowing the weakened heart to send more blood with each beat to oxygen-depleted organs and muscles.
The CardioFit device, already used to treat epilepsy, showed early success in a European study of 32 patients, with anticipation that the device can slow disease progression and even repair the heart.
AGH in the West Penn Allegheny Health System, one of 32 centers in the United States and Europe and the only one in Pittsburgh, will enroll 19 more patients to participate in the INOVATE-HF clinical trial to test whether the CardioFit device can improve heart function in patients who continue having symptoms of heart failure despite maximum medical therapy.
The international trial will involve 650 patients, with two of every three having the device implanted and the remainder to serve as the control group that will take only medications. The 51/2-year trial will determine whether the combination of the implanted device and medical therapy is more effective in treating heart failure than medical therapy alone, said George Sokos, the AGH heart-failure cardiologist who is the local study's principal investigator.
Eligible patients must be 18 or older, diagnosed with heart failure and suffering from heart failure symptoms such as shortness of breath and continued fatigue. Participants will be required to visit a physician or a research nurse regularly, complete questionnaires and undergo tests similar to those taken during the evaluation stage after diagnosis.
Those willing to participate should call 412-359-3253.
"We treat most of our patients with medications that can help relieve their symptoms but do not always stop the heart's deterioration," Dr. Sokos said. "We are very eager to learn through the INOVATE-HF study whether the CardioFit system offers patients with this disease a new therapeutic option that will improve and extend their lives."
Heart failure affects 5.8 million Americans, with as many as 700,000 new diagnoses and 250,000 deaths each year, the Heart Failure Society of America reports. Half of the patients fail to survive five years after diagnosis, with 1 in 5 dying within a year.
Ms. Werner -- a child protective-services caseworker before her heart condition forced her to go on leave last December -- has lost 45 pounds and lowered sodium intake. She had the CardioFit device implanted on July 5 in the upper right side of her chest, with lead wires extending to the vagus nerve in the neck and the heart's right ventricle.
With heart failure, the fast, inefficient heartbeat can enlarge the heart or cause scarring, further hindering its efficiency. When drugs don't adequately control the disease, the patient can face the last resort: a heart transplant.
"I'm feeling very good, but whether it is due to that [device] or not I don't know," Ms. Werner said. "But I can go up a flight of steps without having to rest or catch my breath, and I'm walking at a more normal pace. I just know how I feel, and what I'm able to do that I couldn't do before.
"Whatever it's doing, I hope it continues doing it. I want to go back to work."
She soon may get her wish.
On Tuesday, Dr. Sokos said the device appears to be playing a role in Ms. Werner's improvements and said he anticipates giving her the go-ahead to return to work.
"She's been OK after adjusting her medications, but she's significantly better ever since we turned on the device," he said. "I want her to get back to a normal life, and she's pretty close to that.
"The ultimate success is the normalization of the heart, getting back to work and living a normal life."