Doctors pursue pill to postpone heart valve replacement

WASHINGTON -- Tens of thousands of Americans face the heart valve replacement that Sen. Bob Graham underwent last week, open-heart surgery that is likely to increase dramatically as the population ages.

But what if a simple pill could slow the rusting of the aortic heart valve and let patients postpone, maybe even avoid, the surgery that is today's only fix?

Scientists have uncovered tantalizing evidence that statins, those pills so popular to lower cholesterol, might do just that -- and not through any cholesterol effect, but by a completely different action that suggests even patients with low cholesterol might benefit.

"It's very exciting," says Dr. Ann Bolger of the American Heart Association, who is monitoring early research that suggests bad valves are half as likely to worsen if patients take statins. "No one expected this."

The aortic valve shunts oxygen-rich blood from the heart's main pumping chamber to the rest of the body. It looks something like a rounded tulip, with three leaflets that open and close with each heartbeat.

But it can essentially start to rust shut and cause the heart to pump harder and harder to force blood through the narrowed opening. Eventually, patients with this "aortic stenosis" require open-heart surgery to replace the faulty valve or face life-threatening heart damage.

Aging is the biggest culprit, as with Graham, the 66-year-old Florida senator and possible Democratic presidential candidate whose aortic valve was replaced last week. Just as older people's arteries harden, something sometimes scars the aortic valve's tender leaflets. Calcium deposits build amid the leaflets, further narrowing and stiffening the opening.

Another significant cause is a birth defect, a two-leaflet, or bicuspid, aortic valve. Those naturally narrower valves can accumulate calcium sooner, which can lead to valve replacements for patients in their 30s and 40s.

Five in 10,000 Americans have significant aortic stenosis, Bolger says, and more than 20,000 aortic valves are replaced each year.

It's highly successful surgery; even 90-year-olds can experience huge relief. But it's a painful operation, with a 4 percent risk of death, one that will show dramatic increases as the baby boom generation ages. And while some patients qualify for biological replacements like pig or cow valves, many receive a mechanical heart valve that requires taking blood-thinners for the rest of their lives.

Hence excitement about a possible pill.

Scientists at the Mayo Clinic tracked 156 people with aortic stenosis, including 38 who took statins, cholesterol-lowering drugs sold under such brand names as Lipitor and Pravachol.

Initially, the researchers were disappointed: Patients' cholesterol levels had no bearing on how quickly their aortic stenosis worsened.

Yet in almost four years, the statin users were half as likely to see their valves worsen. Other small studies have suggested a similar effect.

If cholesterol didn't matter, why would statins help heart valves? They're thought to fight inflammation, one key to stiffening heart tissues, and to increase bones' calcium absorption. That leaves less calcium floating in the blood to deposit in the wrong spot, explains Mayo lead researcher Dr. Maurice Sarano.

Within a year, Mayo hopes to begin a 1,000-patient experiment giving either statins or dummy pills to people whose aortic valves are going bad, in hopes of proving if the pills truly help. European scientists are pursuing similar experiments.

Some 8 million Americans already take statins to lower cholesterol, and while the drugs do have some side effects, serious problems are rare. So, with surgery at some point inevitable, should patients with bad aortic valves try the pills now?

If they also have high cholesterol, definitely, says Dr. Robert Bonow, president of the American Heart Association. Many doctors also prescribe statins for atherosclerosis, a type of hardening of the arteries.

Sarano has a few patients with normal cholesterol trying statins just for their valves. But other cardiologists advise awaiting more proof.

"You do have to be very careful" with such early research, says Bolger, of the University of California, San Francisco. But hunt another reason to prescribe statins, she adds: "Atherosclerosis and coronary plaques are the American disease. You'd have to look pretty hard to find somebody who doesn't have some."