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Until now no guidelines existed for one of the more difficult questions in medicine — what to do with a heart-assisting device, such as an implanted defibrillator, in a patient’s final days of life?

An implanted defibrillator delivers a potentially life-saving electric shock to restart a heart that stops beating. However, the shock can cause acute discomfort in the last days of life, when the goal is to minimize pain, and in this case continued use of the devices may conflict with a patient’s wishes.

Now, expert guidelines announced Friday at the meeting of the Heart Rhythm Society in Denver suggest that, whenever possible, terminally ill patients should be free to make their own decisions as to whether they’d like the devices removed.

“This is a situation we face more and more often,” noted Dr. Rachel Lampert, associate professor of cardiology at Yale University School of Medicine. “As the population in hospices grows, the issue of how to manage defibrillators becomes more important.”

Lampert is co-chair of a committee scheduled to present a consensus statement on the management of pacemakers, defibrillators and other cardiovascular implantable electronic devices. The statement will also be published in the July issue of HeartRhythm.

Few medical institutions have policies about deactivating electronic heart devices. A recent study of more than 400 hospices found that just 10 percent had guidelines about disconnecting implanted defibrillators.

“At Yale, we looked at our own population and found that up to 20 percent of patients with defibrillators got shocked in the weeks before death,” Lampert said.

She worked with Dr. David Hayes of the Mayo Clinic, Rochester, Minn., in assembling a committee to consider guidelines for the issue. “We put together a group of individuals with expertise in different areas,” Lampert said. “It included an ethicist, a lawyer, a nurse and a psychiatrist.”

The purpose of the statement “is to carry out a patient’s wish to provide or withdraw therapy as the patient desires,” said Dr. Richard Page, professor and chair of medicine at the University of Wisconsin and president of the Heart Rhythm Society.

Removing an implanted defibrillator near the end of life, “is not physician-assisted suicide or euthanasia,” he stressed.

The statement, developed in cooperation with other organizations, including the American College of Cardiology and the American Heart Association, recommends above all that all patients with implanted electronic devices be encouraged to make advance directives.

“Ideally, you have the conversation and make the patient aware of his or her empowerment and what decision should be made before you get to this point,” Page said.

Other provisions of the consensus statement:
All adult patients are assumed to be competent to make decisions on continuing or stopping treatment. When a patient lacks capacity, the decision can be made by a designated health care proxy.
Physicians or other caregivers cannot be compelled to carry out a procedure that conflicts with their ethical values. In such a case, the issue can be passed to a colleague who is willing to carry out the task.
The recommendations will give physicians and institutions a frame of reference, experts said. “At least now you have a consensus statement based on a number of perspectives and a literature review to provide guidance,” Page said.

SOURCES: Rachel Lampert, M.D., F.H.R.S., associate professor, cardiology, Yale University, New Haven, Conn.; Richard Page, M.D., professor and chair, medicine, University of Wisconsin, Madison, and President, Heart Rhythm Society; May 14, 2010, Heart Rhythm Society annual meeting, Denver;

Patients who get the clot-busting drug alteplase (tPA) within 4.5 hours of having a stroke fare better than patients who are given the drug later, Scottish doctors report.

It has been known that treating a stroke earlier is better than later, but this study shows for the first time that there is significant harm done with starting tPA after 4.5 hours, the researchers noted.

“The benefit of giving this treatment for stroke continues if we start it as late as 4.5 hours,” said lead researcher Dr. Kennedy R. Lees, from the University Department of Medicine and Therapeutics of the Gardiner Institute at the Western Infirmary in Glasgow.

“There is no net benefit to patients if you start the treatment after 4.5 hours. But if you start treatment after 4.5 hours, you will have more patients who die,” he added.

“Starting at an hour is much better than starting at two hours, and that’s better than three hours, and that’s better than 4.5 hours,” Lees explained.

The benefit derived from early tPA treatment is a long-term benefit, Lees pointed out.

“It’s a benefit that we can measure three months later,” he said. “So, what we are getting is long-term improved function. They are more likely to have no symptoms and more likely, if they do have symptoms, to be able to do things for themselves, or need less help. A whole range of disability is reduced, by just starting tPA a few minutes earlier.”

The report is published in the May 15 issue of The Lancet.

For the study, the research team collected data on 3,670 patients in eight trials that investigated how the benefits and risks of tPA changed based on the time the drug was given after the onset of a stroke.

The investigators found that when tPA was given within 4.5 hours, the chances of a positive outcome were good. However, when the drug was given later, the chances of a strong recovery rapidly declined.

In fact, patients given tPA within 90 minutes after suffering a stroke were more than 2.5 times more likely to have a good recovery, compared with similar patients who did not get the drug. Moreover, patients who got tPA 4.5 hours after their stroke had only a 22 percent chance of a good recovery, compared with patients who never got tPA, the researchers found.

Lees and colleagues also found that patients given the drug after 4.5 hours of the onset of a stroke were more likely to die.

These findings mean that patients have more time to get to the hospital, Lees said. “The message for the doctors is we can’t waste a moment once the patient has arrived in starting treatment, so there is more time for the patients and less time for the doctors.”

Dr. Steven R. Levine, a professor of neurology at Mount Sinai School of Medicine in New York City and co-author of an accompanying journal editorial, agreed that “the sooner you get treatment for your stroke, the more likely you are to have minimal or no disability from it.”

For every 90 minutes you wait to get treated, you reduce your chances of a good recovery by a factor of two, he noted. “For every 10 minutes you wait, that’s about 20 million brain cells that are dying,” Levine said.

Everybody needs to know about stroke and what to do, Levine said. The first thing is to call 911, he said.

“Time is brain. That’s really the message,” he said.

Another expert, Dr. Larry B. Goldstein, director of the Duke Stroke Center at Duke University, said that “this combined analysis is consistent with the prior analysis based on a smaller number of trials and reinforces the benefit of treatment with tPA on carefully selected patients with acute ischemic stroke.”

It also reinforces the need to begin treatment as soon as possible after symptom onset, Goldstein added.

“Even though selected patients may derive benefit up to 4.5 hours after symptom onset, the likelihood of benefit is much greater if treatment can begin sooner. Primary stroke centers are organized to evaluate and treat stroke patients in an expedited fashion. Time saved is brain saved,” he said.

SOURCES: Kennedy R. Lees, M.D., University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary, Glasgow, U.K.; Steven R. Levine, M.D., professor, neurology, Mount Sinai School of Medicine, New York City; Larry B. Goldstein, M.D., professor and director, Duke Stroke Center, Duke University, Durham, N.C.

After hip replacement surgery, a compression device works as well as medication — and is safer — for preventing blood clots, a new study suggests.

“This device is as useful as blood thinners for the reduction of blood clots after hip replacement, and it’s superior in safety,” said study co-author Dr. Douglas E. Padgett, chief of adult reconstruction and joint replacement at the Hospital for Special Surgery in New York City, in a statement. “This has the potential to change the paradigm as to how we prevent blood clots after hip replacement. The efficacy is the same, the safety is markedly better and the cost is comparable.”

An estimated 30 percent to 50 percent of hip or knee replacement surgery patients will develop blood clots if preventive measures, such as taking blood thinning medication, aren’t taken.

In the study, researchers looked at a compression device that wraps around the leg and pumps it, helping to prevent clots. Typically, these devices are only used in hospitals because they’re big and restrict movement, but a new, smaller device can be used outside the hospital.

Researchers randomly assigned 410 hip replacement patients to get a blood thinner or use the compression device. Ultrasound examinations 10 to 12 days after surgery found major bleeding in 6 percent of those who took the blood thinner, but in none who used the device.

The study is published in the March issue of Journal of Bone & Joint Surgery.

A new drug called mipomersen reduced low-density lipoprotein (LDL) “bad” cholesterol by nearly 25 percent when added to current therapy in people with a rare genetic condition that causes extremely high cholesterol, a new study finds.

Mipomersen is designed to decrease the formation of apolipoprotein B (the main structural protein in LDL cholesterol) and its release from the liver or intestine. This reduces circulating LDL cholesterol concentrations.

Inherited high cholesterol (homozygous familial hypercholesterolemia) affects one in every one million people. Patients with the disorder have severely elevated LDL cholesterol and a high risk of early cardiovascular disease. If untreated, these patients rarely live past the age of 30.

This phase 3 clinical trial included 51 patients with homozygous FH who were already taking lipid-lowering drugs, including high-dose statins. The patients were randomly selected to receive either 200 milligrams of mipomersen or placebo per week for 26 weeks.

At the end of the treatment period, LDL cholesterol levels had decreased 24.7 percent in the mipomersen group, compared with 3.3 percent in the placebo group.

“Mipomersen could be a valuable addition to the drugs used in the management of homozygous FH and should prove useful in the management of other forms of severe refractory hypercholesterolemia,” wrote an international team of researchers led by Frederick Raal of the University of Witwatersrand, Johannesburg, South Africa.

The study was published online March 13 in advance of print publication this week in The Lancet, and was slated to be presented Saturday at the annual meeting of the American College of Cardiology in Atlanta.

SOURCE: The Lancet, news release.

Better health translates into better sex lives, with healthy people more likely to engage in sex (and good sex at that) and to express an interest in sex, new research finds.

This association held firm into middle-age and later life as well, according to the study by University of Chicago researchers.

The authors of the study, published in the March 10 issue of BMJ, also created a novel measure called “sexually active life expectancy.” According to this new measure, men aged 55 could expect another 15 years of sex while women of the same age could expect 10.6 more active years.

Overall, however, more men reported a satisfying sex life than women, a chasm that widened as people aged.

The findings shine light on a little discussed topic.

“The really important thing about this study is just that it was done,” said Dr. Eva Ritvo, vice chair of psychiatry at the University of Miami Miller School of Medicine. “People don’t look at sexual activity in a scientific way very often but it’s so very fundamental to our existence. The focus has always been on illness, but health is about well-being, looking at sexual functioning as an important part of well-being.”

Dr. Margaret E. Wierman, professor of medicine at the University of Colorado Denver, said the new study “points out that, over time, as a society women and men are becoming more comfortable talking about sex. Having a good sex life is critical to their overall quality of life.”

But the fact that men are doing better than women is something that needs attention, Ritvo stated. “Why should men be having better sex than women? Viagra came out for men. Where’s the female equivalent? For whatever reason women are not as satisfied as men and that needs to be addressed,” she said.

The study authors looked at two different samples of people, one involving over 3,000 adults aged 25 to 74, and another with more than 3,000 adults aged 57 to 85. An equal number of men and women were in each group.

Men were more likely to report positive experiences with sex than women. This gender gap was most noticeable among 75-to-85-year olds, with 38.9 percent of men, compared to 16.8 percent of women, reporting being sexually active. Almost 71 percent of men in this age group reported a good sex life, versus only half of the women.

And more men today are reporting an interest in sex than in 2000.

“This probably is related to new medications in therapy, so now men who before never could even think about having sex can have sex,” Weirman said.

Also, she added, “as people age, the unhealthy men die off so these are the healthiest men in that cohort.”

Study lead author Dr. Stacy Tessler Lindau, director of the University of Chicago’s Program in Integrative Sexual Medicine, said the “major reason why the picture looks better for men than women is that women tend to outlive their marriages and relationships, so there are more women in the adult population without partners. But if you look at women who have partners, the proportion who say they’re sexually active is about the same as men who have a partner.”

On the other hand, men’s sex lives do seem to suffer more from poorer health.

“At age 55, men have, on average, 15 years of sexually active life expectancy and women about 11 years,” Lindau explained. “Men who are in excellent or good health gain an additional five to seven years. What this says is that men benefit more from good health. Men in poor health lose more years of sexually active life expectancy than do women.”

People with partners were more likely to be having sex and more men than women reported having partners, especially in later life, the study found.

SOURCES: Stacy Tessler Lindau, M.D., director, Program in Integrative Sexual Medicine, University of Chicago; Eva Ritvo, M.D., vice chair of psychiatry, University of Miami Miller School of Medicine, and co-author, The Beauty Prescription; Margaret E. Wierman, M.D., professor of medicine, University of Colorado Denver; BMJ