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Heart Disease Newsletter
September 15, 2008


In This Issue
• 2 Techniques Found Effective in Carotid Artery Narrowing
• Defibrillators Don't Diminish Quality of Life
• Fish Oil Supplements Help With Heart Failure
• Antipsychotic Drugs Boost Stroke Risk
 

2 Techniques Found Effective in Carotid Artery Narrowing


SATURDAY, Sept. 6 (HealthDay News) -- In the treatment of patients with symptomatic narrowing (stenosis) of the carotid artery, angioplasty with stenting and endarterectomy (surgical removal of the obstruction) are similarly effective in preventing ipsilateral stroke at two and four years after the procedure, according to two studies.

Ipsilateral stroke is a stroke that occurs on the same side as the carotid artery that has the blockage. The carotid arteries carry blood to the brain.

Currently, endarterectomy is the standard treatment for narrowing of the carotid artery. Stenting is an alternative treatment is which a rigid mesh tube is used to widen and reinforce the artery. Stenting is less invasive, but the long-term effectiveness of stenting hadn't been investigated.

In one study, researchers compared endarterectomy and stenting in 1,214 patients in Austria, Germany, and Switzerland by measuring rates of ipsilateral stroke and restenosis (recurrence of blockage) up to two years after the procedures.

Re-blockage to at least 70 percent of the artery occurred in 10.7 percent of the patients who had stenting and in 4.6 percent of those who had surgery. Ipsilateral stroke occurred in 9.5 percent of patients who had stenting and in 8.8 percent of those who had surgery.

In the second study, researchers in France assessed 265 patients who had stenting and 262 patients who had endarterectomy. The patients were checked for a composite outcome of any stroke or death at 30 days after the procedures, and for ipsilateral stroke up to four years after the procedures.

"Although, overall, the patients who underwent stenting were twice as likely to have this composite outcome, stroke mostly occurred soon after the procedure (within 30 days), and there was no difference in the risk of ipsilateral stroke among patients who did not have a stroke within this postoperative period; therefore, stenting seems to be as effective as endarterectomy in the medium term," said a news release about the study.

Both studies were published online and in the October issue of The Lancet Neurology.

"The results of both trials seem to recommend stenting as an alternative treatment to endarterectomy in the medium term, but the risks of stroke and death need to be reduced in the crucial 30-day period after surgery, possibly through defining better criteria to select patients," the journal news release said.

More information

The Society for Vascular Surgery has more about carotid endarterectomy  External Links Disclaimer Logo and carotid stenting  External Links Disclaimer Logo.


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Defibrillators Don't Diminish Quality of Life


WEDNESDAY, Sept. 3 (HealthDay News) -- Getting an implanted defibrillator that can deliver a shock to restart a failing heart not only prolongs life but also doesn't appear to detract from the quality of life, a new study finds.

The study was done "not only to see whether or not lives would be saved but also the quality of those lives," said lead author Dr. Daniel B. Mark, a professor of medicine at Duke University Medical Center. "We wanted to know whether patients who will have these devices for many years would be satisfied with them."

Mark and his colleagues reviewed results of a 30-month study whose primary purpose was to measure whether implanted defibrillators reduced deaths among 2,521 people with heart failure, a life-threatening condition in which the heart progressively loses the ability to pump blood. All the participants got standard drug treatment for the condition. And one-third of them had defibrillators implanted, one-third were also given the rhythm-restoring drug amiodarone, and one-third got a placebo.

All the participants had about the same scores on tests of psychological well-being at the start of the study. Subsequent interviews found that those with the defibrillators had somewhat higher scores at three and 12 months, and there were no differences in psychological outlook at 30 months.

"Keeping in mind that they all have chronic heart failure, there is no evidence that defibrillators make anything worse," Mark said.

But caution is needed in interpreting the study, he said, because it couldn't achieve the desired goal of being "double-blind" -- with neither patient nor doctor knowing who was getting which treatment. The early positive reports by those with defibrillators "could have been due to the fact that they got some positive feedback from having been selected for the defibrillator arm of the trial," he said.

Something else to consider was the patients' sobering introduction to the study, Mark said. "They were told they faced sudden death. That is a conversation they probably had not had before, being told there is a good chance you could just keel over one day with no significant warning," he noted.

Actually getting a heart-restarting shock made people feel worse, Mark noted. "We don't know if it was the shock itself or the condition that created the need for the shock," he said.

The findings are published in the Sept. 4 issue of the New England Journal of Medicine.

There were serious worries about the effect of implanted defibrillators on recipients' feelings of well-being when the devices were first introduced about two decades ago, said Dr. Marie-Noelle Langan, an electrophysiologist at Lenox Hill Hospital in New York City.

"There were definite reasons for worry," Langan said. "First, a defibrillator is a physical reality. It cannot be ignored as a medication can be. Second, the shocks delivered by early models could be very bothersome."

Worries have eased as the technology has advanced, she said. "Defibrillators have become much more sophisticated," Langan said.

Another paper in the same issue of the journal showed vividly that getting a defibrillator shock is grounds for worry. In a study of 829 heart-failure patients with implanted defibrillators, researchers found that 269 received at least one shock over a period of 45.5 months. Of these, 128 got shocks that were medically warranted, 87 got "inappropriate" shocks, and 54 received both kinds.

Getting an appropriate shock was a serious sign of trouble, increasing the risk of subsequent death more than fivefold, compared to not getting a shock. But even an inappropriate shock nearly doubled the risk of death. For those who lived longer than 24 hours after an appropriate shock, the risk of death during the study was nearly tripled, the researchers found.

The study shows that "we can now define a group of patients at higher risk of dying of heart failure," said study author Dr. Jeanne E. Poole, a professor of medicine and director of electrophysiology at the University of Washington.

Special measures are needed for anyone getting an appropriate shock, because it shows a potentially fatal heart rhythm abnormality, Poole said. The steps to be taken depend on an analysis of each patient's needs, she said.

More information

Learn more about implanted defibrillators from the U.S. National Heart, Lung, and Blood Institute.


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Fish Oil Supplements Help With Heart Failure


SUNDAY, Aug. 31 (HealthDay News) -- Daily supplements of omega-3 polyunsaturated fatty acids -- the kind found in fish oil -- reduced deaths and hospitalizations of people with heart failure, an Italian study found.

But a cholesterol-lowering statin drug had no beneficial effect in a parallel heart failure trial.

"This confirms what we've been seeing for a couple of decades in observational studies," Dr. Dariush Mozaffarian, an associate professor of medicine and epidemiology at Harvard Medical School and the Harvard School of Public Health, said of the fish oil trial. "There is a benefit of omega-3 polyunsaturated fatty acids for heart failure patients."

Both findings were published online Aug. 31 in the journal The Lancet and presented at a meeting of the European Society of Cardiology, in Munich, Germany.

The omega-3 polyunsaturated fatty acid (PUFA) study, done by a consortium of 357 Italian cardiology centers, enlisted more than 7,000 people diagnosed with heart failure, which is the progressive loss of the heart's ability to pump blood. Half took a daily capsule containing omega-3 PUFA, the other half took a capsule with a placebo. The death rate in the PUFA group was 27 percent, compared to 29 percent in the placebo group.

That reduction might not seem like much, but it impressed Mozaffarian, who has done his own PUFA studies.

"There are few treatments we have in medicine that affect total mortality in patients," he said. "Just a handful of treatments affect total mortality. Even a small move percentage-wise is a very important effect."

In absolute terms, the Italian researchers reported that 56 people with heart failure would have to take PUFA supplements for about four years to avoid one death. The supplements also reduced hospitalizations, with one less hospitalization or death for every 44 people taking the supplements for four years.

Similar results have been reported in two earlier trials, Mozaffarian said. But they did not have the strict conditions of the Italian study, which were placebo-controlled and "double-blind," meaning that neither the physicians nor the participants knew who was getting the active substance rather than the placebo.

"You always like to have a placebo-controlled trial," he said.

But the positive trial results don't mean that anyone with heart failure can start taking fish oil supplements on their own, said Dr. Gregg Fonarow, professor of cardiovascular medicine at the University of California, Los Angeles, who wrote an editorial accompanying the journal report.

"They used a specific formulation, a prescription formulation," Fonarow said. "Heart failure is a very high-risk condition. It is absolutely critical for patients, whether it is a prescription medicine or modification of diet or a supplement, that they consult their physician."

The negative results of the statin trial were a surprise, Fonarow said. It included more than 4,500 people with heart failure, half of whom took the statin rosuvastatin (Crestor), while the other half took a placebo. The death rate was 29 percent in the statin group, 28 percent in the placebo group.

The result doesn't mean that a statin should not be prescribed for someone with heart failure and high cholesterol, Fonarow said. "There were no safety concerns," he said. "The drug was well tolerated. It indicates that heart failure, in and of itself, should not be reason to start a patient on a statin."

The study "doesn't shut the door" on the use of statins for heart failure, Mozaffarian said, "but it closes it partly. Maybe another statin would have a benefit. It definitely makes us question the benefit of statins in heart failure, but it doesn't close the door completely."

Another report in the same issue of the journal that was led by British cardiologists described a trial of the drug ivabradine, which reduces the heart rate, in people with coronary artery disease and an unusually fast heart rate. The drug reduced deaths and hospitalizations significantly, the researchers said.

More information

Learn more about heart failure and its treatment from the American Heart Association  External Links Disclaimer Logo.


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Antipsychotic Drugs Boost Stroke Risk


THURSDAY, Aug. 28 (HealthDay News) -- All antipsychotic drugs can increase the risk of stroke, but the risk is greatest among older patients with dementia, British researchers report.

Concerns about the risk of stroke and antipsychotics were first raised in 2002, especially in people with dementia. In 2004, Britain's Committee on Safety of Medicines recommended that antipsychotics not be used in people with dementia. And, in 2005, the U.S. Food and Drug Administration ordered manufacturers of atypical antipsychotics to add a black box warning to their products about the increased risk for stroke.

"Antipsychotics are effective in treating potentially very distressing psychiatric symptoms, but as with all drugs, their use can be associated with a range of benefits and possible side effects," said study author Dr. Ian Douglas, a research fellow at the London School of Hygiene and Tropical Medicine. "This study has further clarified the potential for antipsychotics to increase the risk of stroke."

Both typical (first generation) and atypical (second generation) antipsychotics are associated with an increased risk of stroke, Douglas said. "This risk is substantially higher in patients with dementia than those without. These findings need to be factored into prescribing decisions made by doctors caring for patients with often-distressing and difficult-to-treat psychiatric symptoms."

For the study, Douglas and his colleague Liam Smeeth, a professor of clinical epidemiology, collected data on 6,790 patients who had suffered a stroke and were taking antipsychotic drugs. Patients taking antipsychotic drugs were 1.7 times more likely to have a stroke, and patients with dementia taking antipsychotics were 3.5 times more likely to have a stroke.

The risk for stroke was slightly higher for people taking the newer atypical antipsychotics, compared with people taking the older typical antipsychotics. Atypical antipsychotics include drugs such as Abilify, Clozaril and Zyprexa. Typical antipsychotics include Thorazine, Haldol and Clopixol.

The study authors did not look at the potential mechanisms associated with antipsychotics that cause stroke, or why the risk appears higher with atypical antipsychotics.

"We believe that the risks associated with antipsychotic use in patients with dementia generally outweigh the potential benefits, and, in this patient group, use of antipsychotic drugs should be avoided wherever possible," Douglas said. "For other patients, careful consideration must be given to the likely individual risks and benefits of any prescribing decision."

The findings were published online Aug. 29 in the British Medical Journal.

Dr. Sam Gandy is associate director of the Alzheimer's Disease Research Center at Mount Sinai Medical Center in New York City, and chairman of the Alzheimer's Association's national medical and scientific advisory council. He said the new study addresses an "important topic and elevates the concern about risks of antipsychotics to a whole new level. The FDA [U.S. Food and Drug Administration] might investigate whether availability limitations or warning labeling should be imposed.

More information

To learn more about antipsychotics, visit the National Institute of Mental Health.


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