Originally created 03/27/04

Reshaping heart is new treatment for congestive heart failure



DALLAS -- After Charles Neal suffered five heart attacks and a stroke, his heart was so worn out that he couldn't walk across a room without feeling exhausted and short of breath.

Constant fatigue caused by congestive heart failure eventually forced the 72-year-old business owner into early retirement.

"I used to go to work every day, go on trips, but that quit two years ago, I couldn't stand up to it," said Neal, who owns an underground fuel tank storage company.

That all changed a few months ago when doctors used a new device to help reshape Neal's sickly left ventricle - the lower heart chamber - allowing the heart to pump more efficiently.

The operation was done along with six bypass procedures, which also contributed to his improved health.

Restoring the heart with the help of a plastic shaper is a new approach to a procedure that's been around for more than 20 years.

Although Italian doctors have been physically reshaping weakened hearts for years, few American doctors are trained to perform surgical ventricular restoration.

"This is the only device to do this operation," said Dr. John Conte, the director of heart and lung transplants at Johns Hopkins University in Baltimore. "It allows a doctor anywhere in the world to do it in the same fashion."

More than 5 million Americans suffer from congestive heart failure, and about 1,000 people die each day from the condition, typically seen in older people.

The disease develops when the heart is not pumping the way it should, causing the organ to work harder. This happens when the heart has been damaged or weakened by a prior heart attack, clogged arteries or high blood pressure, which can cause the left ventricle to become enlarged.

Patients usually are short of breath, exhausted and suffer from persistent coughing or wheezing and increased or irregular heartbeat.

Doctors usually treat the problem with medicine, but that doesn't always relieve the symptoms. Heart transplants also are an option but many heart patients are too old or too sick to withstand the surgery - even if they are among the 20 percent who succeed at getting a donor heart.

Ventricular restoration can be a better option because it treats the cause of the symptoms and can improve quality of life, doctors said.

"It's a far safer and economical treatment than a heart transplant or putting in a mechanical device," said Conte. But he cautioned that it is not for all heart patients, who should be carefully screened to see if they would benefit from the surgery.

During a two-hour operation, the shaper is inserted into the ventricle and the heart wall is stretched around the device. Once the heart is molded to the right shape and inflated to the right volume, a patch is sewn onto the heart to maintain the shape and the device is deflated and removed.

So far, more than 700 patients in the United States have had the procedure since the FDA approved the new device two years ago.

The procedure costs about $22,000 to $35,000 and is covered by Medicaid, Medicare and private insurance, said Bert Davis, president and chief executive of Chase Medical, the suburban Dallas company that manufactures the Mannequin shaping device.

Johns Hopkins is the only training institution in the United States for surgical ventricular restoration, but some American doctors are also getting training in Italy.

"Before the Mannequin, doctors had to do it by eyeball," Davis said. That meant some ventricles were made too small, too large or too spherical. He said the device was designed with the help of the Italian doctors who perform restoration surgery.

Dr. Paul Grayburn, Neal's cardiologist at Baylor University Medical Center, said his hospital has done the procedure more than 25 times with good results.

Grayburn said it's uncertain whether Neal will live longer because of the procedure. But Neal is one of the patients in a national study to determine if ventricular restoration is more beneficial than medicine and heart bypasses.

Dr. Eric Eichhorn, a cardiologist at Medical City Dallas and one of the study investigators, said it's the first effort to evaluate the outcomes of the procedure.

"Right now, we don't know what to do with patients - whether to send them to surgery or not," Eichhorn said. "This may help to identify what patients benefit and why, and whether they live longer."

Neal, who had severely depressed heart function, is now walking 25 minutes on a treadmill without feeling exhausted and looks great, Grayburn said.

"I think it also holds out promise for other patients," he said.

Even though the surgery was risky for Neal because of his age and severe heart condition, he said it has allowed him to return to his once active lifestyle.

"The worst thing was I could die on the operating table, but I had reached a point in my life that I was so miserable, I would take any chance for quality of life," said Neal, who has three grown children.

He had the surgery on his birthday, Nov. 6. It was the best present ever, he said.

"I can't tell you how great I feel."



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