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The report finds that percutaneous heart valve replacement, a procedure in which a replacement valve is implanted through a catheter rather than by open heart surgery, is a realistic option for some patients with heart valve disease, especially older or sicker patients. The report found that percutaneous heart valve replacement may be a safe and effective alternative to open heart surgery, especially in the short term, for those patients. However, information is lacking on the potential long-term benefits and risks of this procedure, particularly compared with open heart valve replacement surgery. The report did not conclude that any of the seven valves studied is safer or more effective than another.

The report was produced by the Duke Evidence-based Practice Center for AHRQ, a leading Federal agency conducting comparative effectiveness research. Results of the report were published online today in Annals of Internal Medicine. Heart valve disease—a narrowing of the heart valve—is blamed for approximately 20,000 deaths a year.

“As the U.S. population ages, the number of patients with heart valve disease will increase, so more Americans will need options for safe, effective heart valve replacement,” said AHRQ Director Carolyn M. Clancy, M.D. “This report identifies what is known about this emerging procedure and where the research is lacking to give patients more options about their treatment.”

Conventional heart valve replacement is a well-established procedure, with approximately 95,000 open heart surgeries performed per year for patients with severe narrowing of the heart valve. However, as many as one-third of patients with severe heart valve disease are considered too high risk for open heart surgery, in which patients typically are under general anesthesia for three to six hours, are hospitalized for 5 to 6 days, and require recovery time of 12 weeks. These patients would likely benefit from a less invasive option.

The report found that percutaneous heart valve replacement is a good option for patients at high risk for traditional surgery because of advanced age or illness. Approximately 92 percent of patients who received a percutaneous valve survived the procedure; of those, 86 percent survived for at least 30 days, the report found.

Catheter-based valve implantation was first reported in 2002. Just one device, the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, currently has approval from the U.S. Food and Drug Administration. This device was approved in January 2010 under the Humanitarian Device Exemption program. Percutaneous heart valve replacement surgery has been available in Europe for nearly 2 years.

The report identified 62 published studies representing a total of 856 patients, as well as additional studies not yet published. However, researchers were unable to make direct comparisons between percutaneous valves and traditional surgical replacement because of differences between patient groups receiving the treatments. Clinical trials that may allow direct comparisons are currently underway in the United States.

Percutaneous Heart Valve Replacement is the newest technical brief from AHRQ’s Effective Health Care Program. Technical briefs are rapid-turnaround reports that summarize key issues regarding emerging treatments, highlighting where more research is needed, and where research may be sufficient to warrant a full systematic comparative effectiveness review. The Effective Health Care Program represents a leading federal effort to compare alternative treatments for health conditions and make the findings public to help doctors, nurses, pharmacists and others work together with patients to choose the most effective treatments.

In conjunction with the new report, AHRQ will soon publish plain-language summary guides about heart surgery for patients, clinicians and policymakers. Summary guides on numerous clinical topics and other information and background on the Effective Health Care Program can be found at http://www.effectivehealthcare.ahrq.gov.

For more information, please contact AHRQ Public Affairs: (301) 427-1998 or (301) 427-1855.

The highly sensitive assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the ARCHITECT HIV Ag/Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies. Most tests used today in the diagnostic setting detect HIV antibodies only. Although direct detection of the virus itself by nucleic acid testing is available, it is not widely used in diagnostic settings.

HIV is the virus that can lead to acquired immune deficiency syndrome, or AIDS. HIV damages a person’s body by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified: HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.

The Centers for Disease Control and Prevention report that approximately 18 million people in the United States are tested for HIV each year. Most recent CDC estimates are that there are about 56,000 new HIV infections in the United States each year. In addition, there are more than 1 million people living with HIV in the United States, according to CDC.

“The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “It provides for more sensitive detection of recent HIV infections compared with antibody tests alone.”

The ARCHITECT HIV Ag/Ab Combo assay is not intended to be used for routine screening of blood donors. However, it is approved as a donor screening assay for HIV-1/HIV-2 infection in urgent situations where licensed blood donor screening tests are unavailable or their use is impractical.

The ARCHITECT HIV Ag/Ab Combo assay will be used in clinical laboratories and in public health laboratories, and is the first assay approved in the United States to detect HIV antigen and antibodies simultaneously.

The ARCHITECT HIV Ag/Ab Combo assay is manufactured by Abbott Laboratories, Abbott Park, Illinois.

Nearly 8 percent of patients referred to a sleep disorders clinic reported they had initiated or taken part in sexual behavior while sleeping. Men accounted for three-quarters of the self-reported sexsomniacs.

“We were surprised at how common it was,” said study author Sharon A. Chung, a staff scientist in the Sleep Research Laboratory at the University Health Network in Toronto. “We thought we’d get just a handful of people, yet it was almost one in twelve.”

The research was to be presented Monday at SLEEP 2010, the annual meeting of the Associated Professional Sleep Societies, in San Antonio.

In the study, researchers asked 832 patients about sexual behavior while sleeping, which can range from masturbation to intercourse. About 11 percent of men and 4 percent of women said they had engaged in “sleep sex.”

Researchers said the prevalence is probably lower in the general population.

Sexsomnia is a form of a sleep disorder called parasomnia, or unwanted behavior that occurs during sleep. “An act of parasomnia can be as small as opening your eyes while fast asleep or grinding your teeth, to getting up and vacuuming, speaking, eating or having sex,” Chung said.

Generally, people have no awareness of what they are doing and no recollection of it, Chung said.

Sexsomnia is more than a medical curiosity. It has been used as a criminal defense in sexual assault cases. In 2008, a Toronto man was found not guilty of sexually assaulting a woman after the court heard evidence that the man had engaged in “sleep sex” with several former girlfriends, according to news reports.

Colin Shapiro, the senior author of the paper, was an expert witness in that case, Chung noted, which got the team wondering just how common sexsomnia really was.

What brings on sexsomnia isn’t really understood, but about twice as many patients who reported sexsomnia had used illegal drugs (15.9 percent vs. 7.7 percent) and were more likely to have consumed alcohol (41 percent vs. 27 percent). People who had experienced sexsomnia reported problems with insomnia (falling or staying asleep), fatigue and depression, although no more so than other patients at the sleep clinic. Rates of caffeine consumption and smoking were also similar, according to the study.

People experiencing a parasomnia are not often violent; they usually pose more of a threat to themselves, said Dr. Lisa Shives, medical director of Northshore Sleep Medicine in Evanston, Ill. But there are rare cases in which people have killed someone and claimed they were sleeping and unaware of their actions.

The good news is that parasomnia, sexsomnia included, is treatable with medications including benzodiazepines, such as clonazepam, which is also used to treat epilepsy and anxiety disorders, Shives said.

Yet few patients bring the issue up with the doctors. In the study, only four said they had previously told a medical professional about sexsomnia.

“Of the thousands of patients I’ve seen, I’ve never had someone come in complaining of sexsomnia, but I have always believed it’s a bona fide disorder,” Shives said. “It’s a form of sleep walking. When people are sleep walking, they may do any rote or instinctual behavior. That can include walking, eating, driving and sexual activity.”

The reason patients don’t bring it up could be embarrassment, the fact that doctors rarely ask about it, or that patients aren’t particularly bothered by it, Chung said.

“Is it a problem? As long as you don’t get into legal problems and as long as your partner doesn’t mind, it’s not a problem,” Chung said. “Although it can leave you tired the next day.”

SOURCES: Sharon A. Chung, Ph.D., staff scientist, Sleep Research Laboratory, Department of Psychiatry, University Health Network, Toronto; Lisa Shives, M.D., medical director, Northshore Sleep Medicine, Evanston, Ill.

A defibrillator delivers an electric shock to restart a heart that has stopped beating. About 100,000 of them are implanted in Americans each year. Current models require careful surgery to run wires from the device through a vein into the heart — a procedure that can damage the heart, a lung or a blood vessel, even when done by the most skilled practitioner.

The new device, developed by Cameron Health, a small California company, does away with those wires and has worked as well as the more complicated existing implanted defibrillators in several studies, according to a report to be released Wednesday at the Heart Rhythm Society annual meeting in Denver.

Another report on two successful trials conducted in 61 patients is also being released early in the May 12 issue of the New England Journal of Medicine.

“It’s an exciting new technology,” said Dr. Richard Page, chair of medicine at the University of Wisconsin and president of the Heart Rhythm Society. “What we see is a truly innovative approach to the problem of sudden cardiac arrest and the problems associated with current technology.”

Still, it’s too early to give a full assessment, said Page, who noted that this is the first report on the use of the device.

“It is a relatively small study, and there is much to learn about the effectiveness and reliability of this system over time,” he said.

The new defibrillator “is a small device with enough power to restart the heart while away from it and also sense the heart’s electrical activity while away from it,” said Dr. Gust H. Bardy, a clinical professor of medicine at the University of Washington and founding president of the Seattle Institute for Cardiac Research.

Heart activity — or the lack of it — is detected by electronics that give “three different angles of looking at the heart,” Bardy explained. The device is capable of telling the difference between electronic abnormalities that originate in the heart vs. those that occur outside the heart.

In the two trials reported in the journal, the implanted defibrillator successfully detected all 137 instances of the potentially fatal abnormal heartbeat called ventricular fibrillation. A larger trial that will implant 340 of the devices is now enrolling participants, Bardy said.

“The results will be given to the [U.S.] Food and Drug Administration in the summer of 2011,” he said. “Then it is up to the regulatory authorities.”

The defibrillator already is in use in several European countries, added Dr. Martin Burke, director of the Heart Rhythm Center at the University of Chicago. He took part in the trials that led to European approval and is participating in the new trial.

“There is no question that the entire system, from implanting to programming to postoperative care for patients, is simpler,” Burke said.

The new device might even reduce the cost of implanted defibrillators, both Bardy and Burke said.

Implantation of existing defibrillators now requires expensive fluoroscopy screening, Bardy said. “The new one doesn’t need fluoroscopy and can be installed in 30 minutes,” he said. “That will whittle away at the cost dramatically, and because complications now occur in 10 percent of cases, it can cut costs by eliminating those complications.”

The new defibrillator is implanted alongside the sternum, the chest bone, in a much simpler surgical procedure than is now needed, Bardy said. And if something should go wrong, “removing it is relatively minor surgery compared to removing of one that breaks while an electrode is in a vein,” he said.

“The spectrum of complications goes down and then the overall cost of the implant, both acutely and chronically, improves,” Burke said.

SOURCES: Richard Page, M.D, professor and chair, medicine, University of Wisconsin, Madison, and president, Heart Rhythm Society; Gust H. Bardy, M.D., clinical professor, medicine, University of Washington, and founding president, Seattle Institute for Cardiovascular Research; Martin Burke, M.D., associate professor, medicine, and director, Heart Rhythm Center, University of Chicago; May 12, 2010, New England Journal of Medicine,;

American and Mexican researchers interviewed more than 900 female sex workers in the Mexican border towns of Tijuana and Ciudad Juarez, which are adjacent to San Diego and El Paso, Texas, respectively. The sex workers, who were also tested for HIV and sexually transmitted diseases (STDs), operate legally in the two Mexican towns, which are located on major drug trafficking routes.

The researchers found that female sex workers who didn’t have HIV, but tested positive for active syphilis infection, were more likely than those without active syphilis infection to inject drugs, to use illegal drugs before or during sex in the past month, and to have U.S. clients who had higher rates of drug use, including the use of injection drugs.

“As more than two-thirds of these women have clients from the U.S., our data suggest that U.S. men seeking paid sex across the border in Mexico are at considerable risk of acquiring and transmitting syphilis and other STDs,” study co-author Steffanie A. Strathdee, associate dean for Global Health Sciences and chief of the Division of Global Public Health at the University of California, San Diego, said in a news release.

STD clinics in Tijuana and Ciudad Juarez should provide users with access to sterile syringes, and needle exchange programs should offer rapid, on-site testing for syphilis, Strathdee said.

Failure to control the spread of syphilis among injection drug users could also increase the spread of HIV, the virus that causes AIDS.

“Because syphilis is a co-factor for HIV, when an HIV epidemic occurs among drug users, high rates of syphilis could be a contributing factor that promotes the HIV epidemic,” Strathdee said. “Men who have unprotected sex with female sex workers who have syphilitic sores are much more likely to acquire HIV because the two organisms exacerbate each other.”

The study was published online recently in the journal Addiction.

SOURCE: University of California, San Diego.

Active rTMS treatment accounted for remissions in 14 percent of antidepressant-resistant patients actively treated, compared to about 5 percent for a simulated treatment.

“Although rTMS treatment has not yet lived up to early hopes that it might replace more invasive therapies, this study suggests that the treatment may be effective in at least some treatment-resistant patients,” said Thomas R. Insel, M.D., director of the National Institute of Mental Health (NIMH), part of the National Institutes of Health, which funded the study.

Mark George, M.D., of the Medical University of South Carolina, Charleston; Harold Sackeim, Ph.D., and Sarah Lisanby, M.D., of Columbia University, New York City; David Avery, M.D., of the University of Washington, Seattle; William McDonald, M.D., of Emory University, Atlanta; and colleagues, report on their findings in the May 2009 issue of the Archives of General Psychiatry.

“This study should help settle the debate about whether rTMS works for depression,” said George, who led the research team. “We can now follow up clues suggesting ways to improve its effectiveness, and hopefully further develop a potential new class of stimulation treatments for other brain disorders.”

The treatment aims to jump-start underactive mood-regulating circuitry by targeting the top left front part of the brain with an electromagnetic coil that emits 3,000 pulses over a 37-minute session. It can be safely administered in a doctor’s office with few side effects – unlike more invasive brain stimulation treatments, such as electroconvulsive therapy (ECT) (http://www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies.shtml) (See Background below).

Following a decade and a half of studies yielding mixed results, the FDA cleared an rTMS device for treatment of mildly treatment resistant depression in 2008, based on data submitted by the manufacturer. The field has been awaiting the results of the NIMH-funded multi-site trial to provide more definitive evidence of efficacy.

Lack of a convincing simulation control treatment that mimics transient tapping and twitching sensations produced by the magnet weakened confidence in findings of some previous rTMS studies. To address these concerns, the new study sought to blind patients, treaters and raters with a simulation control treatment that produced the same head-tapping sensation and scalp twitching as the active treatment. A metal insert below the magnet blocked the magnetic field from entering the brain, while electrodes touching the scalp delivered the tapping sensation. This simulation was so convincing that even the treaters could not confidently guess the randomization above chance level, according to the researchers.

A sample of 190 patients who had previously failed to respond to antidepressant medications received at least three weeks of randomized, controlled magnetic stimulations on weekdays for three weeks, with the rTMS magnet aimed at their brain’s left prefrontal cortex. Those who showed improvement received up to an additional three weeks of such blinded treatment.

Thirteen (14 percent) of 92 patients who received the active treatment achieved remission, compared to 5 (about 5 percent) of 98 patients who received the simulation treatment. Patients who received active rTMS were significantly more likely to reach remission, particularly if they had been moderately, rather than severely, treatment resistant. The remission rate climbed to nearly 30 percent in an open-label phase of this study in which there was no simulation control. George said this is comparable to rates seen in the STAR*D (http://www.nimh.nih.gov/trials/practical/stard/index.shtml) medication studies. However, the researchers note that “the overall number of remitters and responders was less than one would like with a treatment that requires daily intervention for three weeks or more, even with a benign side effect profile.”

Patients who responded to active treatment received up to three weeks of additional blinded, controlled rTMS until they achieved remission or stopped showing a meaningful response – so the number of responders did not differ significantly from the number of remitters. These patients who remitted then received a combination of medications intended to help maintain the treatment effect. Despite failing to respond to medications in the past, most remained in remission for several months.

Study participants who failed to improve during the blinded phase entered a course of open-label rTMS. Among those who had been in the active rTMS group, 30 percent achieved remission during this second phase. This suggests that some patients might require as many as 5-6 weeks of daily rTMS treatment, according to George. Most patients who remitted required 3-5 weeks of treatment.

“For treatment resistant-patients, we found that rTMS is at least as good as current medications or anything else we have available, except ECT,” said George. “Our current antidepressants do not work for many people.”

Since the rTMS treatment did not trigger any seizures or notable side effects, the researchers propose that higher levels of magnetic stimulation be used in future studies, as evidence suggests antidepressant effects of such stimulation are dose-dependent. Higher remission rates might also be attainable if rTMS were combined with medications, they suggest.

Using magnetic resonance imaging (MRI) scans of patients’ brains showing exactly where the magnetic coil was positioned, the researchers hope to confirm earlier findings suggesting that a more forward and to-the-side placement produces a larger therapeutic effect. They plan to report the results of the MRI analysis at the American Psychiatric Association meeting in late May.

The survey was conducted online among 164 subscribers to the journal Drug and Therapeutics Bulletin, which published the results online April 8. More than 80 percent of the respondents were doctors, mostly family physicians, and most of the other respondents were pharmacists.

More than 85 percent of the survey participants indicated that they believe the public is poorly informed about herbal medicines. None considered the public to be well informed. However, 75 percent said that doctors also are poorly informed on the subject, with 22 percent indicating that doctors are “moderately well informed.”

Nearly half (48 percent) of the respondents said their own knowledge and understanding of herbal medicines was either “quite poor” or “very poor,” and 90 percent said their knowledge of herbal medicines was much poorer than their knowledge of prescription drugs.

About 70 percent said that if they knew a patient was taking an herbal remedy about which they had little knowledge, they would get further information before starting or adjusting prescription drugs. Uncertainty about how to use such information was among the reasons they cited for not seeking further information about herbal medicines.

Among the other findings:
More than 70 percent of the respondents said the public has misplaced faith in the effectiveness of herbal remedies.
About 77 percent said they worried that their patients would take herbal medicines and not tell them. Nonetheless, just 13 percent said they always ask whether a patient is taking herbal medicines when reviewing or planning prescription drug treatment, and 55 percent said they never ask or do so only occasionally.
Only 3 percent of respondents said they know a great deal about herbal medicine regulatory rules, and 85 percent said they believe that herbal medicines are not well regulated.

“It’s obviously worrying that doctors in general seem to know so little about herbal medicines, given the widespread use of such products,” Dr. Ike Iheanacho, editor of the Drug and Therapeutics Bulletin, said in a news release from the journal. “The fact that few doctors make a point of asking patients whether they are taking herbal medicines raises further safety concerns. Similarly unsettling is that even when doctors don’t know the effects of a herbal medicine a patient is taking, many won’t try and look these up.”

SOURCE: BMJ Journals, news release

Genomic testing — which analyzes 21 genes in breast tumors removed during surgery in order to predict the risk of cancer recurrence — can help guide decisions about the use of chemotherapy in patients with early-stage breast cancer. Patients at high risk may decide on more aggressive treatment, while those at low risk may opt to forego chemotherapy and its potential side effects.

For this study, researchers surveyed 77 patients with early-stage, estrogen receptor-positive breast cancer who underwent genomic testing between 2004 and 2009.

About one-third of the women said they felt they did not fully understand their discussions with doctors about their genomic test results and their risk of cancer recurrence, and about one-quarter suffered distress.

“Almost all women agreed that having the test gave them a better understanding of their treatment options chance of success,” Noel Brewer, an assistant professor of health behavior and health education at the University of North Carolina’s Gillings School of Public Health, said in a news release. “Most women said that they would have the test if they had to decide again today, and that they would recommend the test to other women in their same situation.”

The researchers also found that most women accurately remembered the risk results from their genomic test.

While most patients in the study had a positive attitude about genomic testing and felt that it helped them better understand their treatment options, there is room for improvement in how doctors discuss cancer recurrence risk and treatment decisions with patients, Brewer and colleagues concluded.

The study is published online in the journal Cancer.

The study looked at the first one million stroke patients treated at hospitals enrolled in the “Get With The Guidelines” stroke program, launched in 2003 by the American Heart Association and the American Stroke Association.

The guidelines require that hospitals follow seven specific steps for treating stroke patients, including administering clot-dissolving medications within three hours of the start of symptoms and anti-platelet medications (such as aspirin) in the first 48 hours.

Between 2003 and 2009, hospitals that followed the protocols lowered the risk of death by 10 percent for patients who had an ischemic stroke, the most common type, or a transient ischemic attack (TIA), considered a precursor to a full-blown stroke.

“There have been remarkable improvements in quality of care delivered and outcomes,” said study author Dr. Gregg Fonarow, a professor of cardiovascular medicine at University of California, Los Angeles. “For individuals having a stroke, coming to one of the ‘Get With The Guidelines’-participating hospitals means there is a far greater likelihood they will receive evidence-based therapies that can reduce the risk of long-term disability, deaths and recurrent events.”

The study is published in the Feb. 22 online issue of Circulation: Cardiovascular Quality and Outcomes.

Each year, more than 795,000 Americans suffer a stroke and another 200,000 to 500,000 have a TIA, the study authors noted. But across the nation, stroke treatment was inconsistent among hospitals and physicians, and not everyone was getting optimal care based on what research showed worked best.

“Early in the program, there were gaps in the use of evidence-based therapies, large variations between different hospitals and different physicians, and disparities in the use of recognized therapies,” Fonarow explained. “There were certain patients — including older patients, women and minorities — who were less likely to receive recommended therapy.”

The recommended steps include:
Giving clot-dissolving medication, or intravenous recombinant tissue plasminogen activator (tPA) three hours from the onset of symptoms for those with ischemic stroke.
Giving anti-platelet or anticoagulant medication within 48 hours of admission and at discharge.
Providing treatments to prevent deep vein thrombosis by the end of day two.
Giving patients with atrial fibrillation anticoagulation medications such as Coumadin (warfarin) at discharge.
Providing cholesterol-lowering medications such as statins to help prevent additional strokes or heart attacks.
Provide smokers with information on smoking cessation.

Additional measures include making sure CT scans get done quickly; offering stroke education to patients and caregivers, including information about prevention and warning signs of stroke; referrals for stroke rehabilitation and screening for swallowing problems.

Since 2003, nearly 1,400 hospitals of the nation’s approximately 5,000 community hospitals have pledged to follow the protocols and enter their data into a national registry. Between 2003 and 2009, the percentage of stroke or TIA patients who received all of the recommended treatments increased from 44 percent to 84 percent, while those who received nearly all increased from 72 percent to 93 percent, the researchers reported.

Patients average age was about 72. About 60 percent had an ischemic stroke, which occurs when a blood clot blocks a blood vessel in the brain; nearly 23 percent had a TIA; nearly 11 percent had an intracerebral hemorrhage; 3.5 percent had a subarachnoid hemorrhage; and 2.7 percent of strokes were unclassified.

Hospital mortality was highest among patients suffering hemorrhagic strokes, caused by blood leaking into the brain tissue.

Dr. Brian Silver, a stroke neurologist at Henry Ford Hospital in Detroit, said the study provides powerful evidence that the protocols can save lives and urged all hospitals that treat stroke patients to implement the guidelines.

“A lot of physicians advocate for stroke patients being directed to centers that apply these measures, with the implication that if you go to a center that applies these evidence-based guidelines, your outcomes will be improved,” Silver said. “We didn’t have data to show that before, but now that we have the data it can be a powerful argument that will motivate hospitals to improve their practice in order to improve outcomes.”

Already, several states have legislation pending that would require stroke patients to be taken to hospitals best equipped to treat them, while Medicare now requires hospitals submitting claims to report if they participate in a database registry for stroke care. Medicare will require more detailed reporting on stroke performance measures in upcoming years, Fonarow said.

SOURCES: Gregg Fonarow, M.D., professor, cardiovascular medicine, University of California, Los Angeles; Brian Silver, M.D., spokesman, American Stroke Association, and stroke neurologist, Henry Ford Hospital, Detroit;