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Article Archive

Same Sex Heart Transplants are better

Drugs for "good" cholesterol fail tests.

Most angioplasties unneeded, study finds.

Study: Garlic won't lower

New Scans may speed chest pain diagnosis

Heart Disease More Common in WV and KY

Heart Transplant Patients Celebrate Life

Diabetics shouldn't nix heart transplant

Doctors ponder fixing heart

Canola Oil Reduces Risk of Heart Disease

Study Correction Shows Early Vioxx Risks

Closed-Heart Surgery

Heart Disease,Stroke Plague Third World

Risk Cited in Replacing Heart Device



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Heart Disease Information
bulletHeart disease is the leading cause of death for both women and men in the United States.*
bulletIn 2002, 696,947 people died of heart disease (51% of them women), accounting for 29% of all U.S. deaths. The age–adjusted death rate was 241 per 100,000 population.
bulletHeart disease is the leading cause of death for American Indians and Alaska Natives, blacks, Hispanics, and whites. Although cancer is the leading cause of death for Asians and Pacific Islanders (accounting for 26.1% of all deaths), heart disease is a close second (26.0%).
bulletHeart disease death rates per 100,000 population for the five largest U.S. racial/ethnic groups are as follows: Hispanics, 72; Asians and Pacific Islanders, 78; American Indians, 80; blacks, 206;  and whites, 259.
bulletIn 2005, heart disease is projected to cost $393 billion, including health care services, medications, and lost productivity.§
bulletStudies among people with heart disease have shown that lowering high blood cholesterol and high blood pressure can reduce the risk of dying of heart disease, having a nonfatal heart attack, and needing heart bypass surgery or angioplasty.
bulletStudies among people without heart disease have shown that lowering high blood cholesterol and high blood pressure can reduce the risk of developing heart disease.


11/13/2008 Turns out men and women really are different at heart: New research finds that heart transplant patients have better odds of survival and a lower risk of rejection if they get organs from donors of the same sex.

Size may be part of the explanation. Men's hearts are bigger than women's and have greater pumping capacity, and men who get men's hearts fare better. But doctors think differences in hormones or immune systems between the sexes may also play a role.

The study was paid for by the federal government and led by Dr. Eric Weiss, a cardiac surgery researcher at Johns Hopkins University in Baltimore. He presented his findings Wednesday at an American Heart Association conference.

Unfortunately for many patients, the findings won't make much of a difference. About 2,700 Americans are waiting for a heart, and only 2,200 heart transplants are done each year _ some of them second operations for people whose first transplant failed, according to UNOS, the United Network for Organ Sharing, which manages the nation's transplant system.

The average wait for a heart is 108 days for women and 119 for men. Three-fourths of heart transplants are done in men, so by necessity, many must receive organs from the opposite sex.

Smaller earlier studies have found hints that gender differences may play a role in other types of transplants, such as lungs or kidneys, but this is the largest by far to find an effect.

Weiss used UNOS records on 18,240 heart transplants between 1998 and 2007. Among the recipients 77 percent of the men and 51 percent of the women were of the same gender as their donors.

The best results were seen in male-to-male transplants. The worst were in men who received hearts from women.

When the donor was bigger than the recipient, the sex difference did not affect survival. But when the donor was smaller, people did not fare as well.

"The organ may not have the strength to supply blood to the body," Weiss explained.

But the donor's gender made a difference even after size was taken into account, he found.

Matching donor and recipient by gender led to:

_ a 13 percent lower risk of organ rejection in the first year;

_ a 14 percent lower risk of rejection throughout the study, which had an average follow-up of more than three years;

_ a 24 percent drop in the risk of dying in the first 30 days after transplant;

_ and a 20 percent lower risk of dying after one year.

Why the difference? Doctors are not certain. But Dr. Maryl Johnson of the University of Wisconsin-Madison said women who have been pregnant generally have slightly worse outcomes from transplants because their immune systems have been "revved up" from carrying foreign genes from their partners through the fetus.

As for the findings, "it's a huge data set _ I don't think we can disregard it," but the issue needs more study, said Johnson, who heads a UNOS panel that sets policies for heart transplants.

In the meantime, few doctors would advise someone who needs a new heart to pass up one from a donor of the opposite sex.

"Organs are in such scarce supply that it's hard to make a blanket statement," Weiss said. "You're still much better off getting a heart transplant" than waiting and risking your own heart will give out before another becomes available.


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03/26/2007 The hot new strategy of trying to prevent heart disease by raising good cholesterol had more setbacks Monday as new studies showed that experimental drugs didn't work and also had safety problems.

The news follows Pfizer Inc.'s abandonment in December of an $800 million investment in torcetrapib, the leading contender in this class of drugs, because it raised the risk of heart attacks and deaths.

Heart specialists have been anxious to know whether the problems extend to all such drugs and doom this approach.

"A lot of people think it's the next big thing, and we'll need to understand what went wrong with torcetrapib to move forward," said Dr. Steven Nissen, a Cleveland Clinic heart specialist who is president of the American College of Cardiology.

The new studies, reported at the group's conference, gave a mixed answer. The Pfizer drug seems uniquely risky, but other drugs have problems, too.

And even though they and the Pfizer drug raised HDL good cholesterol as intended, that made no difference in the odds of heart attacks or deaths, or key measures of cholesterol buildup in arteries.

Doctors long have focused on lowering LDL, or bad cholesterol, to cut heart attack risk. Statins, sold as Lipitor and Zocor and also in generic form, lower LDL, which ferries fats from food into the bloodstream.

But many statin users suffer heart attacks anyway, so doctors have been trying to boost HDL, or good cholesterol _ which transports fat from the blood to the liver to be disposed of _ to further lower risk.

An extended-release niacin drug called Niaspan, sold by Kos Pharmaceuticals Inc., does this. But it can cause a prickly hot sensation called flushing that some people find intolerable. Pfizer, Merck & Co. and Swiss drug maker Roche Holding AG are testing drugs that boost HDL in a novel way.

Pfizer shares rose 7 cents to $25.73 in afternoon trading on the New York Stock Exchange while Merck stock sank 42 cents or nearly 1 percent to $44.03 on the NYSE. Meanwhile, Roche's U.S. traded shares were flat at $90.05 on the Pink Sheets.

On Monday, scientists reported the results of several studies on torcetrapib. In one, the drug boosted HDL by 61 percent, but trends in death, hospitalization and heart attacks "are all going in the wrong direction," Nissen said.

An experimental diabetes drug by Eli Lilly and Co. that is 10,000 times more potent than fibrates, a current cholesterol treatment, also proved disappointing. The new drug raised HDL but also raised the risk of kidney, heart and other serious problems, Nissen reported.

Finally, infusions of a reconstituted form of HDL developed by CSL Ltd., an Australian company, made no big difference in the burden of artery buildups in a study led by Dr. Jean-Claude Tardif of the Montreal Heart Institute.

In several of these studies there were hints of some improvements in less important measures of artery buildup, which provides "a glimmer of hope for future development of this class of drugs," Dr. Alan Tall of Columbia University writes in an editorial in the New England Journal of Medicine.

That journal and the Journal of the American Medical Association published several of the new studies.

"The bar has been raised a lot for this entire class, but I do not think we can abandon this entire approach," Nissen said.

If Baycol had been the first statin tested and research had stopped after safety problems emerged, there wouldn't even be this class of drugs, he noted. Baycol, sold by Bayer AG, was withdrawn from the market in 2001 after reports of a severe and sometimes fatal muscle disorder.

Last update: 03/26/2007


03/26/2007 More than half a million people a year with chest pain are getting an unnecessary or premature procedure to unclog their arteries because drugs are just as effective, suggests a landmark study that challenges one of the most common practices in heart care.

The stunning results found that angioplasty did not save lives or prevent heart attacks in non-emergency heart patients.

An even bigger surprise: Angioplasty gave only slight and temporary relief from chest pain, the main reason it is done.

"By five years, there was really no significant difference" in symptoms, said Dr. William Boden of Buffalo General Hospital in New York. "Few would have expected such results."

He led the study and gave results Monday at a meeting of the American College of Cardiology. They also were published online by the New England Journal of Medicine and will be in the April 12 issue.

Angioplasty remains the top treatment for people having a heart attack or hospitalized with worsening symptoms. But most angioplasties are done on a non-emergency basis, to relieve chest pain caused by clogged arteries crimping the heart's blood supply.

Those patients now should try drugs first, experts say. If that does not help, they can consider angioplasty or bypass surgery, which unlike angioplasty, does save lives, prevent heart attacks and give lasting chest pain relief.

In the study, only one-third of the people treated with drugs ultimately needed angioplasty or a bypass.

"You are not putting yourself at risk of death or heart attack if you defer," and considering the safety worries about heart stents used to keep arteries open after angioplasty, it may be wise to wait, said Dr. Steven Nissen, a Cleveland Clinic heart specialist and president of the College of Cardiology.

Why did angioplasty not help more?

It fixes only one blockage at a time whereas drugs affect all the arteries, experts said. Also, the clogs treated with angioplasty are not the really dangerous kind.

"Even though it goes against intuition, the blockages that are severe that cause chest pain are less likely to be the source of a heart attack than segments in the artery that are not severely blocked," said Dr. David Maron, a Vanderbilt University cardiologist who helped lead the new study.

Drugs are better today than they used to be, and do a surprisingly good job, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.

"It may not be as bad as we thought" to leave the artery alone, she said.

About 1.2 million angioplasties are done in the United States each year. Through a blood vessel in the groin, doctors snake a tube to a blocked heart artery. A tiny balloon is inflated to flatten the clog and a mesh scaffold stent is usually placed.

The procedure already has lost some popularity because of emerging evidence that popular drug-coated stents can raise the risk of blood clots months later. The new study shifts the argument from which type of stent to use to whether to do the procedure at all.

It involved 2,287 patients throughout the U.S. and Canada who had substantial blockages, typically in two arteries, but were medically stable. They had an average of 10 chest pain episodes a week _ moderately severe. About 40 percent had a prior heart attack.

"We deliberately chose to enroll a sicker, more symptomatic group" to give angioplasty a good chance to prove itself, Boden said.

All were treated with medicines that improve chest pain and heart and artery health such as aspirin, cholesterol-lowering statins, nitrates, ACE inhibitors, beta-blockers and calcium channel blockers. All also were counseled on healthy lifestyles _ diet, exercise and smoking cessation.

Half of the participants also were assigned to get angioplasty.

After an average of 4 1/2 years, the groups had similar rates of death and heart attack: 211 in the angioplasty group and 202 in the medication group _ about 19 percent of each.

Heart-related hospitalization rates were similar, too.

Neither treatment proved better for any subgroups like smokers, diabetics, or older or sicker people.

At the start of the study, 80 percent had chest pain. Three years into it, 72 percent of the angioplasty group was free of this symptom as was 67 percent of the drug group.

That means you would have to give angioplasties to 20 people for every one whose chest pain was better after three years _ an unacceptably high ratio, Nissen said.

After five years, 74 percent of the angioplasty group and 72 percent of the medication group were free of chest pain - "no significant difference," Boden said.

The study was funded by the U.S. Department of Veterans Affairs, the Medical Research Council of Canada and a host of drug companies. Stent makers refused to help pay for the research, said scientists who led the study.

The study renewed a heated animosity between doctors who perform angioplasty and other heart specialists.

In fact, one who does the procedures and who spoke at a meeting in New Orleans sponsored by stent maker Boston Scientific Corp. was responsible for the early release of the study's results, which were not due out until Tuesday.

The study "was rigged to fail, and it did," the Wall Street Journal quoted Dr. Martin B. Leon of Columbia University telling several hundred of his colleagues Sunday night.

"A lot of people have been taking shots at us, and we need to go on the offense for awhile," the Journal reported Leon said.

He claimed to have inside knowledge of the results because he reviewed the study for the New England Journal. The journal would not comment, saying the identity of its reviewers is confidential.

The cardiology college issued a statement saying it was "extremely disappointed" results were released prematurely, "betraying the confidentiality of the scholarly process and the professional integrity of the scientific community."

The college "will be considering strong sanctions against the individual or individuals involved," the statement said.

Boston Scientific shares fell $1.05, or 6.6 percent, to close at $14.22 on the New York Stock Exchange at double their average volume.

Dr. Spencer King of Piedmont Hospital in Atlanta, a leading cardiologist who does many angioplasties, said he was disappointed in the study results.

"How many patients have interventions in which the only expectation is to reduce the use of nitroglycerin or to walk a bit faster? Most patients anticipate a better prognosis and might opt for an extended course of medical therapy if they believe they are not putting their life at excess risk," he wrote in a recent editorial in an American Heart Association journal.

In an interview at the cardiology meeting, King said he recently had surgery for back pain and did not expect permanent relief but added, "If it only held up for five years, I wouldn't be happy about it."

The new study "should lead to changes in the treatment of patients with stable coronary artery disease, with expected substantial health care savings," Dr. Judith Hochman of New York University wrote in an editorial in the journal.

An angioplasty costs roughly $40,000. The drugs used in the study are almost all available in generic form.

Maron, the Vanderbilt doctor who helped lead the study, said people should give the drugs a chance.

"Often I think that patients are under the impression that unless they have that procedure done, they're not getting the best of care and are at increased risk of having a heart attack and die," he said.

Dr. Raymond Gibbons, a Mayo Clinic cardiologist and American Heart Association president, agreed: "This trial shows convincingly that that assumption is incorrect."


02/26/2007 Garlic doesn't do much for the breath and it stinks for lowering cholesterol. That's the conclusion of the most rigorous, head-to-head study of raw garlic and popular garlic supplements, despite promoters' claims to the contrary.

Whether it was eaten raw in heart-healthy sandwiches, or in pills made of powdered or aged garlic, the strong-smelling herb had no effect on cholesterol in people whose levels were already elevated, the government-funded study found.

"If garlic was going to have a chance to work, it would have worked in this study," said researcher Christopher Gardner. But it didn't.

Garlic is a longtime folk remedy for a variety of ills, including heart disease, cancer, infections and even mosquito bites. Scientific research on its purported benefits has had conflicting results. Some previous studies suggested garlic might help lower risks for digestive and prostate cancers, or might reduce blood pressure and cholesterol levels; others found no benefit.

Health benefits have been thought to come from a sulfur-containing substance called allicin that is released when raw garlic is chopped or crushed. In lab tests, it can be applied directly to cells and has been shown to prevent cholesterol production.

But any direct benefits to the body from allicin may be diluted when garlic is eaten, said Gardner, an assistant professor of medicine at Stanford University.

Still, Gardner, a garlic lover, was optimistic when he and colleagues began their study. He called the results disappointing but said it's still possible garlic might improve cholesterol when eaten in bigger doses or by people with more severe cholesterol problems. Also, garlic could have characteristics other than influencing cholesterol that might benefit the heart, he said.

The study appears in Monday's Archives of Internal Medicine.

An Archives editorial agreed and said "the jury is still out" on whether garlic might prevent cardiovascular disease.

The study involved 192 adults aged about 50 on average with moderately elevated levels of LDL cholesterol, the bad kind that contributes to heart disease. The average LDL level was 140 milligrams per deciliter of blood, or in the borderline-high range. Below 100 is considered ideal.

Participants were randomly assigned to eat the equivalent of an average clove of garlic in either raw form or garlic pills, or dummy pills, six days weekly for six months.

Raw garlic was mixed into salsa, fat-free mayonnaise or other condiments spread on portobello mushroom sandwiches, chicken quesadillas and other specialty sandwiches. Participants in the garlic pill and dummy pill groups also got sandwiches, but without garlic.

Bad breath and body odor were reported by more than half the raw garlic eaters, and a handful of people in the supplement groups reported flatulence, but there were no major side effects. There also was virtually no effect on cholesterol levels in any of the groups.

Blood samples were taken monthly to detect any changes in cholesterol readings but found none that were statistically significant. Diet and exercise levels also were monitored to detect any changes that could affect cholesterol levels.

Robert Borris, a scientist with the Council for Responsible Nutrition, a trade group for nutritional supplement makers, said the study doesn't answer whether garlic might help regulate cholesterol levels in healthy people.

The results also don't refute scientific evidence suggesting that garlic can reduce the tendency of blood platelets to build up and form clots that could block arteries, Borris said.

"I certainly would not give up on garlic," he said.


02/27/2007 Millions of people with chest pain enter emergency room limbo, spending up to 24 hours waiting for tests to tell if a heart attack really is brewing or if it's something less dire. A computerized heart scan may start easing the wait, giving doctors a faster picture of clogged arteries to help determine who can go home _ within just four hours _ and who needs more care. If these souped-up CT scans pan out _ and major studies of several thousand chest-pain sufferers are to begin soon _ they may do more than send the worried well home faster.

"To be able to show the patient what's going on in their arteries is very powerful," says Dr. James Goldstein of William Beaumont Hospital in Royal Oak, Mich.

He's finding that the 3-D pictures of gunk-filled arteries can motivate patients to change their heart-risky behaviors better than lecturing them about high blood pressure or cholesterol.

On the other side, when arteries look clean, "you can say the chance that this patient would have any cardiac event in the next five years will be very, very low," adds Dr. Udo Hoffmann of Massachusetts General Hospital. "If they come back a week later with chest pain, you know it's not the heart."

Sudden chest pain sends about 6 million people to U.S. emergency rooms every year. It's the most common symptom of a heart attack, but a maddening symptom, too _ because half the time it signals something other than heart disease, and telling the difference can be tough.

The dilemma starts with describing the pain. The classic "elephant on my chest" sensation isn't what everyone experiences. Some feel not pain but a tightening of the chest. Others feel pain in the arm, neck or jaw. Some people say it felt like they had a toothache before their heart attack; others felt nausea.

"Trying to sort out whether there's a life-threatening heart problem based on symptoms alone is difficult," explains Goldstein. "Sometimes it seems obvious, and you're wrong. Sometimes the symptoms are unimpressive, and you're wrong. The implications of missing the diagnosis are disastrous."

An electrocardiogram, or EKG, sometimes catches a heart attack in progress, or an artery so unstable that one's imminent.

But at least half the time, early tests are inconclusive and patients are admitted to the hospital for repeat EKGs, blood tests and other checks that can last 24 hours _ and eventually rule out a heart attack two-thirds of the time. Patient anxiety aside, the tab for all that testing surpasses $10 billion annually.

Worse are those whose heart attacks are missed, between 2 percent and 8 percent of patients who are sent home too soon.

Cardiac catheterization _ threading a probe up into the heart to view the inside of arteries _ or stressing the heart with exercise can provide a faster answer, but both are risky so doctors until now have stuck with the wait-and-see approach.

Enter CT angiography. Doctors inject patients with a dye to illuminate artery walls. Then newer machines called 64-slice CT scanners use computerized X-rays to measure both rock-like calcium and soft fatty blockages inside arteries. Within 30 minutes, the 3-D images can show if arteries are narrowed, and how much.

Beaumont researchers studied 197 chest pain sufferers considered at low risk of a heart attack, giving half the souped-up CT scan. The noninvasive test either ruled in or ruled out heart disease in 75 percent, helping to decide who really needed to be hospitalized 11 hours faster than with routine testing, researchers report in this week's Journal of the American College of Cardiology.

Don't reserve the souped-up CTs for low-risk patients, says Mass General's Hoffmann. He tested the scans in 103 patients, 14 of whom had either a full heart attack or a dangerous condition called unstable angina. The CT scans correctly spotted blocked arteries in those patients, and correctly cleared others who had no or minimal clogs, he reported last fall in the journal Circulation.

So who should get the scans? Hoffmann and the Beaumont group both are preparing larger studies to try to settle that, and to tell if CT angiography improves patients' outcomes or just speeds the diagnosis.

Finding clean arteries or very blocked ones makes for an easy diagnosis. But if the clog is medium-sized, is it causing the chest pain and does it need immediate treatment? A CT alone won't be enough to tell, notes Hoffmann.

Nor is even this noninvasive test risk-free. CT scans do involve radiation, and the injectible dye isn't for people with kidney disease.

While some hospitals already are using the CTs to diagnose chest pain, "most physicians at this time are not familiar with a cardiac CT and what it means," Hoffmann cautions.

For now, just insisting on a thorough check may be the best consumer advice. A disturbing new study of more than 7,000 emergency room visits found blacks and women were less likely to get even that first-step EKG than other chest-pain sufferers. The study couldn't explain the disparity, but lead researcher Liliana Pezzin of the Medical College of Wisconsin suspects harried workers in overcrowded ERs were too quick to assume another cause.

"Be your own advocate," Pezzin says. "Say, 'I need to be tested.'"


02/15/2007 West Virginia and Kentucky _ states known for high levels of obesity, diabetes and smoking _ have the highest proportion of people with heart disease in the nation, U.S. health officials said Thursday.

The findings, from the first study ever to look at heart disease prevalence state by state, showed that states in the Southeast and Southwest were heart disease leaders. Colorado and the District of Columbia had the lowest percentages.

The results line up well with previous, state-specific reports about heart disease death rates, obesity and other risk factors, said Wayne Rosamond, an epidemiology professor at the University of North Carolina who chairs a statistics committee for the American Heart Association.

He called the report by the U.S. Centers for Disease Control and Prevention "very important. It confirms what we know about regional differences in the burden of disease."

For the nation as a whole, roughly 4 percent of those surveyed had had a heart attack. A slightly higher percentage reported angina or coronary heart disease, and 6.5 reported any of those conditions.

But in West Virginia, more than 10 percent had at least one of the conditions. The prevalence in Kentucky was nearly 9 percent, and Mississippi was No. 3, with 8 percent.

CDC researchers drew their data from a 2005 telephone survey of 356,112 U.S. adults in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands.

Participants were asked if a doctor or health care professional had told them they had experienced a heart attack, angina, or coronary heart disease. The researchers then statistically adjusted the results to correct demographic differences in state samples to better mirror the U.S. census.

The prevalence in both Colorado and the District of Columbia was a little under 5 percent, tying them for the nation's lowest rate. Hawaii was close behind.

The regional differences are believed to stem from rates of obesity, high blood pressure, high cholesterol, diabetes, smoking and other known risk factors for heart disease, said the study's lead author, Jonathan Neyer, a CDC epidemiologist.

That means the explanation would come from differences in cultural norms, poverty rates and other social factors, and not environmental causes, he said. "There's not something in the water," Neyer said.

Other findings:

_ Among those who didn't finish high school, 1 in 10 had at least one of the conditions. Among college graduates, only 1 in 20 did.

_ More than 8 percent of men had one of the conditions, but only 5 percent of women did.

_ Nearly 1 in 5 people 65 and older had at least one of the conditions. The percentages were much smaller among younger age groups.

_ The results were the same for blacks and whites, with just over 6 percent having one of the conditions. Fewer than 5 percent of Asian-Americans had any of the health problems, making them the healthiest ethnic group. American Indians and Alaska Natives had the highest prevalence, at about 11 percent.

02/14/2007 Eddie Knipp's two heart transplants have given him the wisdom to savor the small wonders of life and the strength to endure one of its largest losses _ the death of a child. On Tuesday, Knipp and nine other heart transplant recipients celebrated more than 20 years of survival after surgery at the place that made it possible: the Texas Heart Institute at St. Luke's Episcopal Hospital.

"It has given me a new perspective on life, a new dimension," said Knipp, 61, an El Paso resident who had transplants in 1987 and 1999.

In 1995, Knipp's 17-year-old son was killed in a car accident. His organs were donated and went to at least 70 other people, Knipp said. Despite the tragedy, Knipp says he is grateful for his second _ and third _ chance at life.

"Every day I wake up and I thank God for every breath I take," Knipp said. "It's the little things in life that we really take for granted that I now realize are so wonderful, so big."

Besides celebrating the longevity of some of its patients, the renowned cardiac center marked the 25th anniversary of a program dedicated to repairing failing hearts.

The first successful heart transplant in the United States was performed at the hospital in 1968 by founder Dr. Denton Cooley, who is now surgeon-in-chief. Since then, more than 1,000 transplants have been performed there, according to hospital officials.

By the end of the year, the Texas Heart Institute could have 23 patients who have reached the 20-year survival milestone. The average heart transplant patient survives eight to 10 years. According to the American Heart Association, the five-year survival rate is 71 percent for men and 67 percent for women.

The risks were even greater when the field of transplant surgery was still evolving two decades ago.

"The real brave ones were the patients," said Dr. Branislav Radovancevic, director of the Center of Cardiac Support and associate director of Cardiovascular Surgery and Transplant Research.

Charles Washington of Oak Ridge, Tenn., was one of those patients.

In 1982, he suffered a massive heart attack, leaving his heart functioning at less than 30 percent of capacity.

"I was literally gasping for air," Washington said. After seven bypasses, Washington's health continued to deteriorate and his prognosis was bleak. Then, on March 27, 1983, Washington received a new heart, and a new appreciation for life.

Now 70, the longest-surviving Texas Heart Institute transplant recipient at nearly 24 years had the chance to watch his children and grandchildren become adults.

"It makes you really enjoy all of life, not just a special occasion," said Washington, who is four years shy of the longest-surviving heart transplant recipient in the U.S., according to the United Network for Organ Sharing in Richmond, Va.

Shortly after the surgery, Washington was attending the annual Oak Ridge dogwood blossom celebration and was taken aback by the sight of the trees in full bloom.

"I looked up, grabbed a leaf and tears came to my eye," Washington said. "I thought about the beauty and tragedy of nature. It reminded me that there was tragedy about the beauty of life. The trees blooms, they die, they come back the next year in full bloom."

2006-11-06   Diabetics who don't have other health problems survive heart transplants about as well as nondiabetics, according to a new study, which suggests diabetes shouldn't disqualify patients from a transplant waiting list.

"It actually reinforces the approach that we've taken for 20 years, that diabetes without major complications ... does not exclude transplantation," said Dr. W. Steves Ring, chairman of cardiovascular and thoracic surgery at the University of Texas Southwestern in Dallas. Ring, who heads up heart transplant programs at three Dallas area hospitals, was not involved in the study.

While national rules do not prevent diabetics from getting heart transplants, each transplant center has its own rules.

A spokeswoman with the United Network for Organ Sharing, which helps coordinate organ distribution, said the network doesn't know what criteria individual transplant centers use. She said 135 U.S. hospitals offer heart transplants.

Dr. John Buse, president-elect of the American Diabetes Association, said he believes that rules automatically denying heart transplants to diabetics was something that may have been more common in the past.

For the study, published online Monday in the American Heart Association journal Circulation, researchers analyzed UNOS records for survival rates of more than 20,000 people who had heart transplants between 1995 and 2005. That included 3,687 people who were diabetic.

The researchers found that nondiabetics had a median survival rate of 10.1 years, while diabetics had a survival rate of 9.3 years, a difference the study authors said was not statistically significant.

About 21 million Americans suffer from diabetes, mostly Type 2, which is linked to obesity. The disease, which significantly increases the risk for heart disease and stroke, is often associated with other cardiovascular risk factors, including high blood pressure, cholesterol problems and insulin resistance.

And more people are developing heart failure, said one of the study authors, Dr. Mark Russo, a researcher at Columbia University. A transplant is often the only solution for heart failure, when the weakened heart gradually loses its pumping power.

Russo said the study confirms doctors' intuition. While showing that many diabetics do well with a heart transplant, the research also showed that median survival for those with one complicating condition of diabetes fell to under 7 years and for those with two complications, transplant survival was under 4 years.

"Prior to this it was unclear whether diabetes mattered and what it meant if they had complications related to their diabetes," Russo said.


2006-10-30   One in five adults has a little hole in the heart. Most will never know it. But the defect may play a role in certain strokes and severe migraines, leading thousands to get devices implanted to seal it shut.

The problem: Doctors haven't yet proved when the hole is harmful, and whether fixing the heart in turn helps the head.

It's a controversy dividing cardiologists, even as use of the umbrella-shaped implants steadily rises. Now the Food and Drug Administration has taken an unusual step to push manufacturers to settle the issue, stopping promotion of the expensive implants.

"What's really incumbent upon us now is proving these relationships and proving that closing the hole is beneficial," says Dr. Robert Sommer of Columbia University Medical Center, who implants the devices and is helping to study them.

Everyone is born with a tiny flap-like opening between the heart's two upper chambers. Usually, it grows shut during infancy. But in at least 20 percent of the population, the opening doesn't heal over, a defect called "patent foramen ovale" or PFO.

When blood returns to the heart, it's supposed to go to the lungs to pick up more oxygen and be filtered clean. A PFO can allow some blood to seep back into circulation without that filtering step. The theory: That could allow small blood clots or other substances into the bloodstream, traveling straight to the brain.

What's the evidence? It's mostly circumstantial. Among people who have strokes at a young age _ 55 or under _ with no apparent risk factors, up to 60 percent also have a hole in the heart. By some estimates, that could equal 30,000 to 60,000 strokes a year.

In the late 1990s, cardiologists started aggressively sealing PFOs in stroke survivors, in hopes of lowering their risk for further strokes. They threaded tiny implants into the heart through a hole in the groin, pulling them against the PFO's flap to seal it shut.

Then some implant recipients started reporting an odd side effect: Their migraine headaches went away. Subsequent research suggested at least 40 percent of people who suffer a severe type of migraine _ the kind that comes with an "aura" or visual disturbance _ have fairly large PFOs.

None of that research proves a PFO actually causes the ailments, cautioned Dr. Joseph Carrozza of Boston's Beth Israel Deaconness Hospital, in a debate about whether to close the holes at an international cardiology meeting last week.

"Association is not causation," Carrozza said, noting that the vast majority of people with PFOs will never report symptoms, and that PFO closure occasionally causes such serious side effects as blood clots and irregular heartbeats.

"I would argue passionately ... we need the data."

Studies comparing the $23,000 implants to stroke-fighting drugs are going on now. Yet PFO closure already is widespread in Europe. And until this week, the FDA had allowed two manufacturers to market implants here for repeat-stroke sufferers, under a special rule that lets promising devices for rare conditions sell before there's final proof that they work.

But with PFO closure no longer rare, the FDA has withdrawn that special approval, urging makers NMT Medical and AGA Medical to finish their studies and tightening, slightly, how stroke patients get the devices in the meantime. Both makers have pledged to push forward, although Sommer notes that repeat-stroke sufferers often want their PFOs closed despite the controversy, and thus won't enter a study.

Proponents say migraines may settle the questions faster _ because the only way a migraine sufferer can receive a PFO-closing implant today is through a clinical trial. Three major U.S. studies have begun recruiting hundreds of patients whose aura-inducing migraines overwhelm medications. Those patients would test competing implants.

Among them is the first dissolvable implant, NMT's BioStar, made of collagen that's designed to hold the PFO closed until the heart's own cells seal it over, and then to degrade. "It's designed to repair this defect in a very natural way," said Dr. Michael Mullen of London's Royal Brompton Hospital, who reported promising results from BioStar's first human safety test in the journal Circulation last week.

Next up: trying to weld PFOs shut with heat, beaming radiofrequency energy into the heart, instead of using an implant. Studies have begun in Europe.EDITOR'S NOTE _ Lauran Neergaard covers health and medical issues for The Associated Press in Washington.__

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2006-10-07   Canola oil may now be sold to consumers as a product that can reduce the risk of coronary heart disease.

The disease is the leading cause of death in the United States, killing half a million people every year.

Canola oil and certain foods made with canola oil are allowed to start making the claim, the Food and Drug Administration said Friday.

Labels can say that limited evidence suggests eating 19 grams _ about 1 1/2 tablespoons _ of canola oil daily may reduce the risk of coronary heart disease due to its unsaturated fat content, the FDA said. Canola oil should replace a similar amount of saturated fat and not increase the total number of calories a person eats each day, FDA said.

The U.S. Canola Association, which petitioned FDA for permission to make the claim, said studies show that unsaturated fat from canola oil lowers cholesterol, including LDL or "bad" cholesterol, as part of a diet low in saturated fat.


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2006-06-26   A correction published Monday by a medical journal to a key study on withdrawn painkiller Vioxx reveals the risk of heart problems was elevated throughout the time people took the drug and did not develop only after 18 months of use as the drug's maker, Merck & Co., has contended.

The correction in the New England Journal of Medicine supports many doctors' contention that risks showed up with as little as four months of use.

Heart attacks and strokes occurred more frequently after people had been on the drug for at least 18 months, but the actual harm might have occurred much earlier, said Dr. Jeffrey Drazen, editor-in-chief of the journal, who worked with the authors to correct their original findings of the APPROVe trial, published in March 2005.

"It's a subtle but very critical point," Drazen said, comparing the situation to health problems being detected months after exposure to excessive radiation.

Cleveland Clinic cardiologist Dr. Steven Nissen, who has challenged the study's conclusions in the past and did so again in a separate letter also published by the medical journal on Monday, agreed.

"A key legal defense in the liability cases has been the suggestion that there was no risk until patients had taken the drug for 18 months," he said. Now, with the correction, "the authors have removed any claim that there was a delay in risk."

The main authors, Dr. Robert Bresalier of the University of Texas' M.D. Anderson Cancer Center and Dr. John A. Baron of Dartmouth Medical School, could not be reached for comment but acknowledge in a letter released by the journal that their statistical analysis had been flawed.

Merck, which paid for the study and helped conduct it, acknowledged the flawed analysis last month but claimed it did not change the results.

On Monday, the company posted on its Web site what it called "an open letter to the scientific community," saying it stands behind the original results of the study.

"This correction did not change the data in the APPROVe study or its results," said a statement from Peter S. Kim, president of Merck Research Laboratories. "It is important to understand that the correction centered on the description of a single statistical method."

"The scientific debate surrounding the APPROVe study in no way changes our commitment to defending the VIOXX litigation on a case-by-case basis," says a statement from Kenneth C. Frazier, senior vice president and general counsel of the company.

Merck faces more than 13,000 lawsuits over Vioxx, a blockbuster arthritis drug until it was pulled from the market in September 2004.

An ongoing trial in Atlantic City, N.J., is the seventh case to reach trial. Merck has won half of the previous six.

Legal experts think there could be a spurt of additional suits filed against Merck soon, as a two-year statute of limitations affecting patients in most states ends at the end of September.

Shares of Whitehouse Station, N.J.-based Merck rose 8 cents to close at $35.02 on the New York Stock Exchange.

Associated Press Business Writer Linda A. Johnson in Trenton, N.J., contributed to this report.

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'Closed-Heart Surgery' Is Newest Frontier

2006-04-01   Dr. Samuel Lichtenstein cut a 2-inch hole between an elderly man's ribs. Peering inside, he poked a pencil-sized wire up into the chest, piercing the bottom of the man's heart.

Within minutes, Bud Boyer would have a new heart valve _ without having his chest cracked open.

Call it closed-heart surgery.

"I consider it some kind of magic," said Boyer, who left the Vancouver, British Columbia, hospital a day later and was almost fully recovered in just two weeks.

In Michigan, Dr. William O'Neill slipped an artificial valve through an even tinier opening. He pushed the valve up a patient's leg artery until it lodged in just the right spot in the still-beating heart.

The dramatic experiments, in a few hospitals in the U.S., Canada and Europe, are designed to find easier ways to replace diseased heart valves that threaten the lives of tens of thousands of people every year. The experiments are starting with the aortic valve that is the heart's key doorway to the body.

The need for a less invasive alternative is great and growing. Already, about 50,000 people in the U.S. have open-heart surgery every year to replace the aortic valve. Surgeons saw the breastbone in half, stop the heart, cut out the old valve and sew in a new one. Even the best patients spend a week in the hospital and require two months or three months to recuperate.

Thousands more are turned away, deemed too ill to survive that operation and out of options. Demand is poised to skyrocket as the baby boomers gray; the aortic valve is particularly vulnerable to rusting shut with age.

The new experiments are a radical departure from that proven, if arduous, surgery.

The artificial valves do not even look like valves, squished inside metal cages until they are wedged into place. Barely 150 of any type have been implanted worldwide, most in the last year. It is unclear if they will work as well as traditional valve replacements, which last decades.

For now, the only patients who qualify for these valves are too sick to be good candidates for regular valve replacement.

Some deaths during the earliest attempts at implanting the devices forced doctors to come up with safer techniques. Clinical trials apparently are back on track, and even the most skeptical cardiologists and heart surgeons are watching how these pioneers fare.

The hope is that one day, replacing a heart valve could become almost an overnight procedure.

"There's lots of technical challenges that need to be overcome," said Dr. Robert Bonow, a valve specialist at Northwestern University, who is monitoring the research for the American Heart Association. "Most of us do think this is the future," he said.

O'Neill's first successful patient in March celebrated the one-year anniversary of his through-the-leg implant.

"I call it a new birthday," chuckled Fred Grande, 78, a Richmond, Mich., car collector who took one of his beloved models for a fast spin less than a week after the procedure.

"That's the home run we want to hit with all the patients," said O'Neill, cardiology chief at William Beaumont Hospital in Royal Oak, Mich.

"It's gratifying" to watch people once deemed beyond help bounce back, added Dr. Jeffrey Moses of New York-Presbyterian Hospital/Columbia University, who with O'Neill is leading the U.S. study. One of Moses' first patients is playing golf at age 92.

The heart has four valves, one-way swinging doors that open and close with each heartbeat to ensure blood flows in the right direction. More than 5 million Americans have moderate to severe valve disease, where at least one valve does not work properly, usually the aortic or mitral valves. Worldwide, roughly 225,000 valves are surgically replaced every year.

Topping that list is the aortic valve. It can become so narrowed and stiff that patients' hearts wear out trying harder and harder to push oxygen-rich blood out to the rest of the body.

Calcium deposits accumulate on its tender leaflets. Touch one chipped out of a patient and it feels almost like a rock.

With minimally invasive valve replacement, doctors do not remove that diseased valve. Instead, they prop it open and wedge an artificial one into that rigid doorway.

"It's ironic. You use the disease process to actually help hold your valve in place," said Lichtenstein, of St. Paul's Hospital in Vancouver, who helped create the between-the-ribs method.

Irvine, Calif.-based Edwards LifeSciences, the biggest maker of artificial heart valves, and Paris-based CoreValve are testing versions of a collapsible valve made of animal tissue that is folded inside a stent, a mesh-like scaffolding similar to those used to help unclog heart arteries.

The difference is how doctors get the new valve to the right spot, pop open its metal casing and make it stick.

The U.S. studies thread the Edwards valve through a leg artery up to the heart, known as "percutaneous valve replacement."

Unlike with open-heart surgery, doctors do not stop the patient's heart. So the trickiest part is keeping regular blood flow from washing away the new valve before it is implanted.

Once the device is almost in place, doctors speed the heartbeat until normal pumping pauses for mere seconds _ and quickly push the new valve inside the old one. Inflating a balloon widens the metal stent to the size of a quarter, lodging it into place and unfolding the new valve inside, which immediately funnels the resuming blood flow.

So far, 19 Americans have been implanted this way, plus more than 80 other people worldwide, most of them in France by the procedure's inventor, Dr. Alain Cribier, and in Vancouver by Lichtenstein's colleague, Dr. John Webb.

Some 14 people in Canada, Germany and Austria have received the Edwards valve through the ribs. That is a more direct route to the heart for patients whose leg arteries are too clogged to try the other experiment. Doctors make a tiny hole in the bottom of the heart muscle so the new valve can enter. Then they use the same balloon technique to wedge it inside the old valve.

Talks have begun with the Food and Drug Administration about opening a similar U.S. study later this year.

CoreValve's slightly different valve is being tested in Europe and Canada. It, too, is threaded up the leg artery. But it is made of pig tissue instead of horse tissue and has a self-expanding stent that requires no balloon. Doctors remove a sheath covering it and the stent's metal alloy, warmed by the body, widens until it lodges tight against the old, rocky valve.

More than 45 have been implanted; CoreValve hopes to begin a U.S. study next year. Lead researcher Dr. Eberhard Grube of The Heart Center in Siegburg, Germany, expects within months to begin testing a newer version small enough to thread through an artery at the collarbone, another more direct route to the heart.

The experiments come with some significant risks.

Edwards temporarily halted the U.S. study last year after four of the first seven U.S. patients died. Initially, doctors threaded the valve up a leg vein, not an artery, a route that required tortuous turns inside the heart and sometimes damaged a second valve, O'Neill said.

Twelve people have been implanted since the study restarted in December using the artery route considered easier and safer. All but one have survived and are faring well, researchers say.

O'Neill and Moses _ plus doctors at a third hospital, the Cleveland Clinic _ have government permission to implant eight additional patients in the U.S. pilot study, which will be expanded if it goes well.

CoreValve's first four patients died as doctors struggled to develop and learn the through-the-artery technique, Grube said.

For doctors, pushing the large valve through tiny, twisting arteries _ against regular blood flow and guided by X-rays _ is laborious. Occasionally, they are not able to wedge it into position.

Because they are squeezing a round valve into an irregular-shaped opening, there is a risk that the new valve will leak blood backward into the heart, also problematic.

But once researchers master how to get the valve into place safely, the question becomes how much recipients benefit. Do these very ill patients live longer than expected? If not, does quality of life improve enough to warrant the procedure anyway?

Three of French inventor Cribier's original patients have lived 2 1/2 years so far, with a "return to normal life and no sign of heart failure," he said. Eleven others have lived a year and counting.

CoreValve reports five patients faring well a year later.

Aside from those who did not survive the implantation, others have died from their advanced illnesses even though their new valve was working.

It is the cases of astounding successes _ Grande and Boyer, for example _ that have other heart specialists taking note, Northwestern's Bonow said.

"Patients have to know what they're getting into," he said. Many of the seriously ill are willing to chance the experimental procedure because "they're so debilitated and ... there have been some good examples of patients who have gotten better."

The bigger challenge, Bonow added, is whether to expand the studies to include less sick patients who could survive open-heart valve replacement but want to avoid its rigors. Already, there are such patients clamoring to be included.

That is a difficult decision because even 80- and 90-year-olds successfully can have regular valve replacement. When performed by the most skilled surgeons, risk of death from the operation is about 2 percent _ but in less experienced hands, it can reach 15 percent, Bonow said.

Just as using a balloon to unclog heart arteries is sometimes done on patients who would fare better with bypass surgery, researchers eventually will have to ask if patients would accept a less-than-perfect aortic valve if they got to skip surgery's pain and risks, said Dr. Michael Mack of Medical City Hospital in Dallas.

"There is a trade-off, and how you make that trade-off is a totally gray area," he said.

But Vancouver's Boyer, who had two previous open-heart surgeries for clogged arteries, said avoiding that kind of pain is not a trivial issue for patients.

"They're doing something to the field of medicine that's going to make life a hell of a lot easier to people who've got that problem," said a grateful Boyer, describing how he could finally breathe easy after the through-the-ribs valve implant. "I think I'll have a bunch of other parts go bad before I have a problem with this."


Last update: 2006-04-01


Heart Disease, Stroke Plague Third World
2006-04-05   Each year cardiovascular disease kills 13 million people in developing countries, almost triple the number who die from AIDS, tuberculosis and malaria combined, researchers said Wednesday.

Cardiovascular disease _ including heart disease, heart failure and stroke _ is the world's biggest killer, and it often strikes people in their prime working years of 35 to 64, experts said during a four-day health conference.

In China, deaths from cardiovascular disease have skyrocketed alongside the country's rapid economic development, making it the No. 1 killer _ fueled by smoking, high blood pressure, diabetes and obesity, said Dr. Runlin Gao, a cardiologist at Fu Wai Hospital.

"The total disease burden of cardiovascular disease in China is higher than in the United States and most other Western countries," he said. "Cardiovascular disease has been the leading cause of deaths in China since the 1990s."

In many developing countries, growing prosperity has led to vast changes in diet and lifestyle. Easy access to cheap, fatty foods along with migration from rural farming areas into cities has altered the way many people live.

The conference launched the Disease Control Priorities Project, which includes three books compiled by nearly 500 international experts focusing on cost-effective strategies for improving global health.

Senior editor Dean Jamison, a health economics professor at the University of California, San Francisco, said taxing tobacco and reducing trans fat in foods, as the Dutch have done, are effective government interventions to help lower cardiovascular disease risk factors.

"You don't have to change people's hearts and minds, you change behavior through changing prices people face or changing specific aspects of their environment like putting in speed bumps or simply taking things off the shelves. They don't have any choice," he said.

But he said persuading people to make lifestyle changes can be much more difficult _ especially with fast, processed foods available globally.

"It's right there at your fingertips, anytime you want it," Jamison said. "We have our genes being given this feast. How do you stop that?"

Creating areas in cities where people can exercise or adding bicycle lanes are simple ways to promote healthier living along with ensuring that children are served healthy meals in schools, he said.

Using drugs to lower cholesterol and high blood pressure are cost-effective ways to help lower the risk of cardiovascular disease, while aspirin and beta-blockers can help prevent costly heart bypass surgeries, the researchers reported.

While the number of male smokers has dropped in China from 61 percent to 54 percent over the past two decades, Gao said cigarette-smoking continues to rank as the country's highest contributor to cardiovascular disease.

Taxing cigarettes 70 percent globally could save 46 million to 114 million smoking-related deaths over the next 50 years, the researchers said.

Last update: 2006-04-05


Risk Cited in Replacing Heart Device

2006-04-25   A new study suggests that for some patients with implanted heart defibrillators that have been recalled by the manufacturer, replacing the device might be riskier than leaving it in.

Canadian researchers found a much higher than expected rate of surgical complications in people who had their potentially faulty defibrillators replaced.

As a result, some patients "might want to hang out and wait and see what happens," said study co-author Dr. Andrew Krahn of the London Health Sciences Center in Ontario.

Six percent of the 533 patients who decided to have their recalled defibrillators replaced over a 12-month period suffered major complications, including two deaths, the study found.

In contrast, the risk of failure among recently recalled defibrillators has been estimated by the manufacturers at just 0.009 percent to 2.6 percent. And not every failure is deadly.

The study, published in Wednesday's Journal of the American Medical Association, provides the first estimate of the risk of major complications from replacement surgery. That is important information for patients and doctors faced with the decision of whether to leave a possibly defective device in the body or replace it.

Implantable defibrillators can be as small as a half dollar and are placed surgically under the skin of the upper chest. Vice President Dick Cheney is among the thousands of Americans who have one.

When the device senses a dangerous and potentially deadly irregular heartbeat, it sends electrical impulses to jolt the heart back to normal. It can correct a heart that beats too fast, as in ventricular tachycardia, or quivers chaotically, a condition known as ventricular fibrillation.

A total of 270,000 defibrillators have been recalled since January 2005, though it is unclear how many were inside patients and how many were on the shelf, according to the Food and Drug Administration. About 80,000 patients received the implantable devices in 2004.

Krahn said the rate of complications from surgical removal will surprise doctors, because replacing a defibrillator is considered a minor procedure.

"It's typically performed with a local anesthetic and sedation. It takes an hour or less," he said. "Most patients return home the same day."

The researchers studied 2,915 patients who were tracked by 17 Canadian hospitals in 2004-05. All the patients had devices that were recalled by manufacturers, Canada's national health system or the FDA.

Only 18 percent decided to undergo replacement surgery. Infection, bruising or bleeding required a follow-up operation in 31 of those patients. Two patients died.

"That risk is much higher than we initially thought," Krahn said.

The researchers did not follow the people who decided against replacement to see whether anything actually went wrong with their defibrillators.

The findings are applicable to the U.S. because American medical practices are similar to those in Canada, Krahn said.

"We probably should leave more of these alone if they appear to be functioning normally," said Dr. Anne Curtis, president of the Heart Rhythm Society, a nonprofit group of heart specialists, and chief of cardiology at the University of South Florida. Curtis was not involved in the study.

The Heart Rhythm Society plans to release draft recommendations Wednesday on pacemakers and implantable defibrillators. The draft will include guidelines to help doctors respond to recalls, Curtis said.

Implantable defibrillators, which cost between $30,000 and $40,000, contain batteries, insulated wires, memory chips, magnetic switches and other parts that can go awry. But some flaws are worse than others.

While some people might die because the device doesn't deliver the necessary shock, other devices might have a flaw that merely causes the battery to run down early, something that can be caught during routine monitoring.

And some people who have defibrillators don't need them as much as other patients do. Some patients are implanted with the devices as a preventive measure and have never actually suffered from fibrillation.

Doctors and patients often decide to leave a potentially faulty device in place after weighing the details of the recall and the patient's health. Krahn said some patients may decide they cannot risk a device failure, and may go ahead with replacement surgery.

Dr. Dan Schultz, director of the FDA's Center for Devices and Radiological Health, praised the study.

"This will allow the agency, as well as manufacturers and professional societies, to develop guidelines based on actual evidence, and to provide better advice to patients and doctors in the future," Schultz said.

After a recall, manufacturers provide free replacements. But insurance companies must pay for the surgery, which can cost thousands of dollars.

Krahn reported that he has financial ties to two device makers, Medtronic and Guidant. But he said that the study was conducted without funding or influence from industry, and that his consulting work does not involve the defibrillators.


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