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Clinical trial tests Parachute device for congestive heart failure

SEMINOLE — Rodney Glass didn't worry about heart disease three years ago — even though at 48 he was overweight, had high cholesterol, high blood pressure, a two-pack-a-day smoking habit and a fast food diet.

His doctor said he was a walking heart attack waiting to happen. Glass refused medication, insisting it would never happen to him. Two weeks later, it did.

"I was DOA at the hospital," the Seminole man recalls of the massive heart attack.

That got Glass' attention. He lost 40 pounds and quit smoking. But the damage was done.

Glass was diagnosed with congestive heart failure, in which the heart can't pump blood properly. Heart attacks can cause it, as can untreated high blood pressure.

Congestive heart failure means shortness of breath and crushing fatigue. Even walking to the mailbox becomes a chore. The American Heart Association says nearly 5 million Americans have the condition, which kills about 250,000 annually.

"We spend billions of dollars treating this condition every year," said Dr. Debbie Rinde-Hoffman, medical director of the heart transplant program at Tampa General Hospital. Treatment ranges from lifestyle changes and medication to surgery, implants and even heart transplantation.

Some patients develop a left ventricular aneurysm, or enlargement of the heart's major pumping chamber. The chamber's wall becomes thin, scarred and bulges out like a bubble on a tire. Blood can pool in the bulge, causing clots and strokes. Most patients can be treated with medication for a time, but then doctors may suggest surgery to cut away the damaged tissue.

Glass was nearly to that point. "The doctor said he would split my chest open and cut the bottom of my heart off and I'd have five to six months of recovery," he said. "That was not an option,'' said the business owner and father of three young children.

Dr. Patrick Cambier, an interventional cardiologist with Morton Plant Mease Hospital, offered a less invasive experimental therapy called the Parachute Ventricular Partitioning Device.

The "Parachute," which opens like an upside-down umbrella, is placed in the left ventricle through a thin tube that is threaded through a small puncture in the groin. Opened, the device partitions off the diseased section of the heart.

"If you keep the blood where the pumping is still occurring, you make the heart work more efficiently," Cambier said. "Partitioning or shielding that area deflects blood into the part that still works, so you don't waste energy."

The current clinical trial expands the use of Parachute to 250 heart failure patients at 15 U.S. sites to make sure it is safe and benefits patients. Morton Plant is the only Florida site participating in this phase.

Rinde-Hoffman, who is not involved in the Parachute trial, treats hundreds of heart failure patients each year and refers a handful for left ventricular reconstruction surgery.

"There's absolutely a need for a less invasive therapy that saves patients from having their chests opened," she said. "This is an early, novel approach. If it works and is safe, that's great because right now, surgery is really the only option if medications don't control symptoms."

Glass had the procedure on a recent Friday and was home Sunday afternoon. He's back to work and says he already notices a difference. "I'm walking around and I'm not out of breath, which is amazing to me," he said. "Usually I'd be huffing and puffing."

Irene Maher can be reached at imaher@tampabay.com.

Want to know more?

To find out about the Parachute study, call Morton Plant's Clinical Research Department at (727) 461-8519 or go to cardiokinetix.com/living-with-chf for more details and an animated video of the device.

Clinical trial tests Parachute device for congestive heart failure 08/07/13 [Last modified: Wednesday, August 7, 2013 10:30pm]
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