Rheos System adds heart failure trial to study of its effects on high blood pressure

TAMPA

Charles Cummings underwent triple-bypass surgery and later had two stents placed in his heart. Still, his heart failure was so pronounced he couldn't work in his garden without tiring.

The 65-year-old Lakeland retiree is among a group of heart failure patients who could benefit from a new medical device now being tested. On Wednesday, Cummings became the first person to have the system implanted in a heart failure trial. Researchers hope the device will get his heart to relax so it can better fill with blood. The procedure was performed at Tampa General Hospital.

"It's better than doing nothing, and hopefully it will be helpful," Cummings said. "Even if it doesn't help me, they are learning something."

He suffered from classic heart failure symptoms, including shortness of breath and fatigue. But his problem was not the heart's ability to pump, known as systolic heart failure. Instead, his heart wasn't filling properly.

This condition is called diastolic heart failure. Characterized by a thickening of the heart muscle, doctors say it affects 30 to 50 percent of the more than 5 million Americans living with heart failure.

Diastolic heart failure can be harder to diagnose than systolic heart failure, said Dr. Gregg Schuyler, chief of cardiology at St. Anthony's Hospital in St. Petersburg. Treatment usually involves medications for the accompanying high blood pressure.

"A lot of times you treat the hypertension, you also treat the heart failure," Schuyler said, noting that lifestyle changes such as reducing salt intake can also help.

In the future, as many as 1.5 million heart failure patients could become the target market for the new device, called the Rheos System, according to CVRx, the Minneapolis company that developed it. It is being assessed in clinical trials that will involve more than 500 patients.

Doctors implant a battery-powered box about the size of a small pack of cards beneath the skin under the collar bone. Thin wires connect it to sensors that are positioned around the left and right carotid arteries, which play a critical role in regulating the body's blood pressure.

The device sends electric signals, individualized to each patient, that make the brain think the blood pressure is abnormally high. This should trigger a response to relax the heart and lower the blood pressure.

"We expect to be improving the function of the heart and making the patient feel better," said CVRx founder Robert Kieval, who invented the device and came to Tampa for the heart failure trial's inaugural surgery.

Physicians at TGH are familiar with implanting the Rheos System, which they used in another clinical trial for high blood pressure. That trial is further along, yielding results that researchers thought showed promise for heart failure patients.

(For the October Pulse story on that use of the system, please go to the Times' online Health page: tampabay.com/health.)

CVRx expects to spend tens of millions of dollars on the heart failure trial, including the cost of surgery and medical followup for patients like Cummings. Kieval estimated the device could cost in the "tens of thousands" per patient.

Tampa General and its physicians are not financial partners in the device's development, said Dr. Fadi Matar, medical director of the hospital's cardiac intensive care unit and principal investigator in the trial. But its doctors enjoy such clinical trials.

"It's fun to participate in something new," Matar said. "The innovative thing about this is it's not a pill. It's something that you implant, like a pacemaker."

Letitia Stein can be reached at lstein@sptimes.com or (813) 226-3322. For more health news, visit www.tampabay.com/health.

fast facts

Heart failure and its common symptoms

Heart failure is a chronic condition in which the heart muscle isn't pumping enough blood to meet the body's needs for blood and oxygen. It affects about 5.7-million Americans.

Symptoms include shortness of breath, persistent coughing or wheezing, fluid buildup in body tissues, fatigue, confusion and increased heart rate.

Source: American Heart Association

Rheos System adds heart failure trial to study of its effects on high blood pressure 01/06/10 [Last modified: Wednesday, January 6, 2010 6:57pm]

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