Medtronic, HeartWare data shows heart-failure success

A device that synchronizes heart rhythm and a tiny pump that takes over when the beat falters are giving doctors fresh tools to fight heart failure, a disorder reaching epidemic levels among the elderly in the U.S.

Heart failure, a progressive disease, strikes 1 in 5 Americans older than 40. It occurs when a damaged organ can't supply enough oxygen-rich blood to keep other organs, such as the lungs, working. There are few treatments, and no cure. The data reported yesterday at the American Heart Association meeting in Chicago is part of a research push to find new ways to shoulder a failing heart's workload.

The synchronization unit, from Medtronic Inc. in Fridley, slowed the disease in a study that may boost use of the device in the disorder's early stages.

The 5-ounce implantable pump from HeartWare International Inc., of Framingham, Massachusetts, extended the lives of patients in a study showing it could help those with few options beyond a transplant.

"Heart failure has seen a new day," said Clyde Yancy, medical director of the Baylor Heart & Vascular Institute, in Dallas, at a news conference yesterday. "After this meeting is said and done, we'll be armed with new strategies we didn't have before, and current strategies with expanded indications."

Medtronic increased 3 cents to $34.66 in New York Stock Exchange composite trading. Those shares have declined 12 percent in the past 12 months.

New ideas are needed as an aging population combines with medical care that extends the lives of heart-attack victims to boost the number of Americans affected. About 550,000 new cases are expected a year, according to the National Heart Lung and Blood Institute. About 22 million people worldwide have the condition.

Breakthroughs are expected to be reported this week at the annual heart meeting for patients at every stage of the disease, including medications to ease debilitating symptoms and reduce complications in people with mild disease.

For patients with mild to moderate disease, Medtronic Inc.'s device to synchronize the heart's pumping action helped slow physical decline, according to research reported at the heart meeting Sunday. The device adds cardiac resynchronization, or CRT, to a defibrillator, a device that shocks the heart to restore normal heartbeat.

The system, called CRT-D, reduced by 25 percent the risk of death or hospitalization from mild-to-moderate heart failure, compared with use of a standard defibrillator, the study found.

The device, costing about $35,000, is approved for use in people with severe heart failure. Medtronic, the world's biggest maker of heart devices, plans to seek U.S. approval to expand use of its CRT-D devices in those with milder symptoms in the coming months, said Catherine Peloquin, a spokeswoman, in a Nov. 13 telephone interview.

Pfizer Inc.'s Inspra, for instance, slashed by one-third deaths from cardiovascular causes and hospitalizations in patients with mild disease, easing concerns about the drug's safety that have limited its use. The drug, also sold in generic form, helps prevent salt retention that can cause the body to retain fluids. Reducing fluid build-up eases shortness of breath, reduces fatigue and lessens swelling.

HeartWare's 5-ounce pump aims to help patients with more advanced disease while causing less surgical trauma during implantation than similar devices that are larger. Smaller pumps may use less power once in place, said Mark Slaughter, a University of Louisville surgeon and one of the researchers who studied the use of the pump.

Ninety-two percent of patients given the HeartWare pump, called the HVAD, were alive, had undergone a heart transplant or were improved enough to have the pump removed, researchers said today at the medical meeting in Chicago. The device, sold in Europe, isn't yet approved in the U.S.

"We are facing an increasing number of people with heart failure and there's nothing we can do medically," said Soon Park, a cardiovascular surgeon at the Mayo Clinic in Rochester, Minnesota, in a telephone interview. "This new technology is exciting."

Rising heart failure rates and the spurt in innovation to treat the illness may come together to make it an increasingly expensive disease to treat. The disorder cost $39.3 billion to treat this year.

HeartWare's pump costs $86,000, according to Christopher Taylor, a company spokesman. It would compete with a heart pump from Pleasanton, California-based Thoratec Corp., the Heartmate II, which weighs twice as much. Thoratec's product had $230 million in 2009 sales. The HeartWare pump has been sold in Europe since early 2009, and generated $24 million in revenue last year.

The company said it plans to file by year's end for U.S. approval to use its HVAD pump in heart failure patients who are awaiting transplants.

"It's one of the few conditions in medicine where everything is going in the wrong direction: more patients, more hospitalizations, more expense, more deaths," said Robert Bonow, professor of cardiology at Northwestern University Medical School in Chicago.

Still, doctors are embracing implantable pumps, which churn out 5 liters of blood a minute, matching a healthy heart, the Mayo Clinic's Park said.

Four years ago, the clinic implanted about one pump a quarter, Park said. Last year, surgeons at the Rochester, Minnesota medical center put in three a month, and they are close to doubling that number this year, he said.

Ron Lekavich, a 72-year-old music teacher from Orland Park, Illinois, was diagnosed with heart failure in 2004. Lekavich's health had declined to the point where he could no longer drive, walk up and down stairs or even dress himself.

Told he had six months to live, he took the advice of doctors at the University of Chicago to be implanted with a HeartMate II device in 2009.

"My neighbors thought I wouldn't be coming home from the surgery," he said in an interview.

After more than a year on the device, Lekavich has resumed teaching music students, helped a friend fix a flat tire and recently played nine holes of golf. "I was hitting the ball straight and even got a hole in one," he said.

It may be years until doctors know how well the devices hold up, Park said. Blood clots may form that could impede their function or they could eventually damage the red blood cells flowing through them, he said. In the meantime, they are the only option for many patients, he said.

Robert Califf, a cardiologist and vice chancellor for clinical research at Duke University Medical Center in Durham, North Carolina, said that despite the recent success with some devices, a cure is still needed.

"We are delaying the inevitable here," Califf said.