New procedure could
relieve some pressure

By Jon Campisi
Times Staff Writer

Joanne DeVuono was in tremendous spirits although, just two days earlier, she’d gone under the knife.
Her demeanor could have been linked perhaps to finally receiving hope in her long battle with elevated blood pressure. DeVuono, who is in her mid-50s, underwent a two-and-a-half-hour surgical procedure on March 31 to try to control her high blood pressure, something she has grappled with for many years.
The procedure is part of the Rheos Pivotal Trial, and it was performed at Jeanes Hospital in Fox Chase by the nationally recognized Dr. John Blebea, chief of vascular surgery at Temple University Hospital.
At the heart of the procedure is a device about the size of an iPod that is implanted under the skin near the collarbone. The stimulator, as it is referred to, is attached to two wires that are wrapped around the carotid artery on each side of the patient’s neck.
The idea, Blebea said, is to use the body’s own natural mechanisms to return a person’s blood pressure to a more acceptable level.
The technology — the Rheos Baroreflex Hypertension Therapy System — was developed by CVRx Inc., a private company in Minneapolis, Minn.
In 2006, the company received approval of a conditional investigational device exemption, or IDE, from the U.S. Food and Drug Administration to use the Rheos system in a pivotal trial. The data gathered during the trial is intended to support pre-market approval of the technology by the FDA.
Blebea, the Temple doctor, already is a believer. And so, for that matter, is DeVuono.
"It was amazing. I saw it go from 180 to 120," she said of her blood pressure during an April 2 interview from her hospital bed. "I can’t remember the last time I had 120 blood pressure."
DeVuono was referring to the test run performed after she was awakened from surgery, and able to literally watch a screen depicting her blood pressure dropping as Blebea worked his magic using an external remote-control device.
As Blebea explained, the Baroreflex system works by using a person’s own body to recognize changes in blood pressure, and subsequently corrects the problem by manipulating the pressure through electronic voltage stimulation.
"That’s the beauty of this," Blebea said. "We’re using the body’s own mechanisms to lower the blood pressure."
Baroreflex is short for baroreceptor reflex, the term relating to the body’s rapid response system for dealing with changes in blood pressure.
In short, the system works by tapping into the pressure sensors, or baroreceptors, which are located on the carotid arteries and in the carotid sinus, to lower the body’s blood pressure at times of reduced activity, or when it should be lowered.
"Effectively, what we’re doing with this is fooling the brain to think the blood pressure is much higher than it is," Blebea said.
Using a remote electrical stimulator, doctors are able to lower a patient’s blood pressure at will, simply by stimulating the carotid sinus nerve on which the wires are attached.
Blebea said he believes the technology will change the face of blood-pressure management.
"This could very much revolutionize how we treat patients with high blood pressure," Blebea said.
Currently, the procedure is being performed only on those who suffer from drug-resistant hypertension, or a type of high blood pressure that affects an estimated 12 million adults in the U.S. To be approved for the pivotal trial, a patient must be resistant to at least three anti-hypertension medications.
For DeVuono, the decision to be part of the clinical trial was a no-brainer. On her father’s side of the family, "everybody suffered a stroke," said DeVuono, who traveled from Cape May, N.J., to have the surgery performed at Jeanes, the first time the procedure has been done at the hospital.
Strokes are common for people with hypertension, as are heart attacks, heart failure and kidney disease.
According to Blebea, this is the fourth time the Baroreflex procedure has been performed in Philadelphia, the only location throughout Pennsylvania approved as a testing ground.
The first person to have the procedure done in Pennsylvania was Hazelene Jackson, a Northeast Philadelphia resident. Blebea implanted the device in his 53-year-old patient during surgery at Temple University Hospital in December.
Meanwhile, DeVuono believes she made the right decision by opting for the surgery. She recently had been on five medications intended to quell her elevated blood pressure, "and it still hasn’t been controlled," she said, explaining that her journey to Jeanes Hospital and Baroreflex had been 15 years in the making.
"I walk, I go to the gym, I eat well, and I can’t control my blood pressure," she said.
Now, even though she has what most likely will form into a 2-inch scar on the right side of her chest, and incisions on side of her neck, she feels great, a testament to her faith in the procedure, DeVuono explained.
"You have to believe in it," she said. "I was very calm because I felt like I was doing the right thing."
DeVuono also said the mild-mannered doctor who performed her surgery put her at ease.
"Dr. Blebea and his entire staff made me feel comfortable," she said.
Patients who undergo the procedure can expect to spend an average of two days in the hospital, the doctor said, and resume normal everyday activities on the third day.
DeVuono was preparing to return to work soon after her release.
While there are virtually no physical restrictions, Blebea did say doctors are required to wait until 30 days after surgery to turn on the Baroreflex system, so that the patient has ample time to heal.
Once the device is implanted, there is minimal upkeep. Just like a pacemaker, however, the system must have its battery replaced on average every three years, although the duration depends upon the voltage level of the device, which varies from patient to patient, Blebea said. Replacement involves a relatively easy, 30-minute outpatient procedure where doctors enter through the scar tissue on the chest to access the stimulator.
None of this, however, seems to bother DeVuono. The upbeat Jersey Shore resident is just happy to have the opportunity to try something that might finally work for her. And if it works for her, she’ll most likely recommend it to her children and grandchildren, if it is discovered that they also possess the high-blood-pressure gene.
"I don’t want to have to see my children be limited with things," she said.
While understanding there were risks involved in participating in the clinical trial, DeVuono was in part inspired to sign on because of her grandmother, who was diagnosed with breast cancer at a very young age. Having no medical insurance, her grandmother opted to take part in a clinical study.
DeVuono has two grandchildren of her own, ages 4 and 2, and another on the way sometime in August. She wants to make sure she’s around and feels good enough to play with the youngsters, DeVuono said.
So, the question remains, would she recommend the procedure to others? It seems as though that’s a no-brainer as well.
"It feels like nothing," she said with a smile, slightly pulling on her hospital gown to reveal a slight bulge under her collarbone, the location of the stimulator.
As for adjusting the device, Blebea said the voltage level can be tweaked as often as needed, and will undoubtedly vary from patient to patient, but in terms of research protocol, the device is scheduled to be adjusted at one, two, three, six, nine and 12 months. The adjustment, he said, can be done during a simple doctor’s office visit.
Blebea also said the stimulator is currently set to be turned on 24 hours a day, although it can be set up to give different voltages during different times of the day, such as when people are sleeping.
The hope for future designs of the system, Blebea said, is to have a built-in sensor in the stimulator to give a minute-by-minute blood-pressure reading, and subsequently have the voltage automatically adjusted as needed.
According to information from CVRx Inc., the company that developed the technology, the Food and Drug Administration has approved the Rheos Pivotal Trial to be conducted with 300 patients in up to 50 clinical sites around the world. The first patient to have the device implanted, Blebea said, was a citizen of Germany
Anyone interested in learning more about this clinical procedure can visit www.bloodpressuretrial.com. ••
Reporter Jon Campisi can be reached at 215-354-3038 or jcampisi@phillynews.com