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Stenting through the wrist reduces risk of death in heart disease patients

13 Jul 2016

Inserting stents by radial access for percutaneous coronary intervention (PCI) reduced bleeding and risk of death in patients with coronary artery disease (CAD) as opposed to femoral access, according to a recent meta-analysis of 24 randomized trials.

“These findings support the use of radial access as the default approach for coronary angiography followed by PCI in the whole spectrum of patients with CAD undergoing invasive management, and strongly support a change in the ‘femoral first’ paradigm to a ‘radial first’ approach,” said lead author Dr. Giuseppe Ferrante of the Department of Cardiovascular Medicine at Humanitas Research Hospital in Milan, Italy.

In the meta-analysis which pooled data from 22,843 patients in 24 randomized studies, patients who underwent radial access had a 29 percent lower risk of death from any cause compared with those who had intervention through femoral access (odds ratio [OR], 0.71, 95 percent confidence interval [CI], 0.59-0.87; p=0.001). [JACC Cardiovasc Interv 2016;doi:10.1016/j.jcin.2016.04.014]

Risk of major adverse cardiovascular events (MACE) also decreased by 16 percent with radial access in comparison to femoral access (OR, 0.84, 95 percent CI, 0.75-0.94; p=0.002).

Additionally, there was a significant reduction of risks for major bleeding by 47 percent (OR, 0.53, 95 percent CI, 0.42-0.65; p<0.001) and major vascular complications by 77 percent (OR, 0.23, 95 percent CI, 0.16-0.35; p<0.001) with radial access in contrast to femoral access.

Risks of stroke and myocardial infarction were similar using both methods.

Importantly, the researchers found that radial access improved clinical outcomes mentioned above across a broad spectrum of stable and unstable CAD, including ST segment elevation myocardial infarction (STEMI), non-ST segment elevation (NSTE) acute coronary syndromes (ACS), and unstable angina.

“As much as possible, all eligible patients with a good radial pulse and positive Allen’s test [could be considered for transradial PCI],” said Dr. Jack Tan Wei Chieh, a senior consultant cardiologist and director of the Coronary Care Unit at the National Heart Centre Singapore in Singapore who was unaffiliated with the study.

At least 70 percent of all his pre-scheduled cases for coronary intervention in Singapore were performed through radial access, he added.

“Several anatomic features give the wrist an advantage over the groin,” said Dr. John Bittl, a cardiologist at Munroe Regional Medical Center in Ocala, Florida, US, in a separate commentary. “With the redundant vascular supply of the hand… loss of a radial pulse has fewer consequences than loss of the common femoral artery pulse.” [JACC Cardiovasc Interv 2016;doi:10.1016/j.jcin.2016.05.026]

However, patients with small radial arteries, upper-extremity haemodialysis access, and abnormal Allen’s test results are not favourable candidates for PCI through radial access, he said.

Tan agreed, adding that, “[Transradial PCI is] not for renal failure patients and post-bypass cases. Patients who require larger French guide catheters, or who have poor radial pulses with failure to demonstrate good collateral filling of the hand from the Ulnar artery [are also not recommended].”

Certain anatomical features of Asians could also limit radial access for the procedure, said Tan.

“The radial accesses for elderly ladies are smaller, more tortuous and tend to have spasms with minimal manipulation.”

The main challenge in performing transradial PCI lies in overcoming the learning curve to attain mastery of technical skills, said Tan. Previous studies have reported that high procedure volumes were often required by cardiologists to achieve proficiency. [Int J Cardiol 1998;64:231–239]

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New Guidelines Issued on Breast, Genital Plastic Surgery for Teen Girls

hd60993A growing interest among teenaged girls in plastic surgery on their breasts or genitals has prompted a leading ob/gyn group to recommend that doctors first talk to these young women about “normal” sexual development.

“Our membership has been telling us this is coming up more and more frequently with their adolescent patients,” said Dr. Julie Strickland. She is chair of the Adolescent Health Care Committee of the American College of Obstetricians and Gynecologists (ACOG).

The new recommendations also suggest that physicians screen these patients for body dysmorphic disorder, which is an obsession with an imagined or slight defect in appearance.

There are already guidelines from the American Society of Plastic Surgeons (ASPS) on breast augmentation and reduction among teenagers. If it’s strictly for cosmetic reasons, the society recommends surgery should generally be delayed until age 18.

But, Strickland said, there’s no guidance for cases where teenagers want labiaplasty — where surgery is used to reduce the inner labia, the folds of skin that surround the vaginal opening.

Normal labia come in all sizes and shapes, Strickland said, and there’s no widely accepted definition of labial “hypertrophy,” or enlargement. Nor are there clear guidelines on when surgery might be appropriate for teenagers.

The new guidelines appear in the May issue of Obstetrics & Gynecology.

When girls are worried about the appearance of their breasts or genitals, Strickland said, the anxiety can often be “diffused” by letting them know there is a wide variation in “normal” development.

Even in this day and age, she noted, many girls do not know what their genitals are “supposed” to look like. “Despite all of the anatomy books that have been published over the years, we’re lacking in descriptions of normative female genital development,” Strickland said.

Nationwide, about 8,000 13- to 19-year-olds underwent breast augmentation in 2014, according to the ASPS. Statistics on breast reduction are harder to come by, but in 2010 about 4,600 were performed on 13- to 19-year-olds.

The ASPS does not track labiaplasty figures, and it’s not clear how many teenagers have the procedure each year, according to ACOG.

No one knows exactly why teenagers are voicing more concerns about their labial development, either, Strickland said.

“One theory is that girls these days are seeing images of ‘idealized’ bodies,” Strickland said. “There have also been cultural changes, with more girls grooming their pubic hair. That may make them more self-conscious about the appearance of their genitals.”

Then there are the yoga pants and other form-fitting clothes that can either make girls scrutinize their appearance, or be physically uncomfortable, she added.

And it is actually physical discomfort that seems to be the main issue for teenage girls who want labiaplasty, said Dr. David Song, president of the ASPS. Song is also chief of plastic and reconstructive surgery at the University of Chicago.

“It’s pretty rare to have a teenager coming in for cosmetic reasons,” Song said.

When the inner labia protrude from the outer labia, he explained, it can be “very uncomfortable” to wear tighter clothing, or to exercise at all. In those cases, surgery to reduce the inner labia may help a girl feel better physically and emotionally, Song said.

He agreed that it’s important to be sure teenagers are mature enough, and fully informed of the risks, before any plastic surgery. With labiaplasty, ACOG says, the potential risks include infection, scarring, and pain during sex.

According to Song, board-certified plastic surgeons are also trained to screen for body dysmorphic disorder and other mental health issues, like depression.

“They understand when they should be referring patients to a mental health professional,” Song said.

That’s why it’s key, he added, for parents and young women to make sure they’re seeing a surgeon who is board-certified.

When it comes to breast surgery, the ASPS does recommend that it generally be delayed to age 18. But, Song said, the issue is “not black-and-white,” and there are cases where earlier may be better.

An example, he said, would be a younger teen whose breast growth is far out of proportion to the rest of her body — to the point that it’s causing her physical discomfort.

According to Strickland, the bottom line for parents is this: Listen to your daughter’s concerns about her development, and be able to reassure her that she’s going through normal changes. If you’re not sure of what’s “normal,” talk to your pediatrician or family doctor, Strickland said.

“It’s typical for teenagers to question whether they’re ‘normal’ or not,” she noted. “So we shouldn’t be ‘horrified’ if they come to us with these questions. We need to respond sensitively and honestly.”

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Researchers say blood test can predict risk up to five years before damage begins

Levels of the protein suPAR (soluble urokinase-type plasminogen activator receptor) can predict risk of developing chronic kidney disease up to five years before it begins causing damage, according to research published online Nov. 5 in the New England Journal of Medicine. The research was published to coincide with the American Society of Nephrology’s Kidney Week 2015, held from Nov. 3 to 8 in San Diego.

The researchers assessed suPAR levels and kidney function in 2,292 people, and followed them for five years.

Over that time, the researchers found that 40 percent of participants with high suPAR levels but no known kidney disease developed chronic kidney disease, compared with 10 percent of those with low suPAR levels. The researchers also found that suPAR levels predicted kidney function decline in people with known early-stage kidney disease.

“SuPAR promises to do for kidney disease what cholesterol has done for cardiovascular disease,” senior author Jochen Reiser, M.D., Ph.D., said in a Rush University Medical Center news release. Reiser, a nephrologist, is chairman of internal medicine at the Chicago medical center.

Several authors disclosed patents related to soluble urokinase-type plasminogen activator receptor research.

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FDA Approves Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) for HIV

The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

The CDC estimates that 1.2 million persons ages 13 years and older are living with HIV infection, and that more than another 150,000 persons in this age range have HIV but are unaware of their infection. Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable.

“Today’s approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Genvoya is approved for use in HIV-infected adults and children ages 12 years and older weighing at least 35 kilograms (77 pounds) who have never taken HIV therapy (treatment-naïve) and HIV-infected adults whose HIV-1 virus is currently suppressed. While Genvoya is not recommended for patients with severe renal impairment, those with moderate renal impairment can take Genvoya.

Genvoya’s safety and efficacy in adults were evaluated in 3,171 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA approved HIV treatment. Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens.

Genvoya contains a new form of tenofovir that has not been previously approved. This new form of tenofovir provides lower levels of drug in the bloodstream, but higher levels within the cells where HIV-1 replicates. It was developed to help reduce some drug side effects. Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir containing regimens based on laboratory measures. Patients receiving Genvoya experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies.

Genvoya carries a Boxed Warning alerting patients and health care providers that the drug can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal. The Boxed Warning also states that Genvoya is not approved to treat chronic hepatitis B virus infection. The most common side effect associated with Genvoya is nausea. Serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system (immune reconstitution syndrome). Health care providers are advised to monitor patients for kidney and bone side effects. Genvoya should not be given with other antiretroviral products and may have drug interactions with a number of other commonly used medications.

Genvoya is marketed by Gilead Sciences Inc. based in Foster City, California.

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First-of-its-kind corneal implant to improve near vision in certain patients

April 17, 2015
The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery.

Presbyopia is the loss of the ability to change the focusing power of the eye. It occurs with normal aging and results in difficulty with near vision, generally in adults 40 to 50 years of age. The KAMRA inlay is an opaque, ring-shaped device intended for use in patients 45 to 60 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.00 to +2.50 diopters of power—but do not need glasses or contacts for clear distance vision.

“Presbyopia is a natural part of aging and can make reading and performing close-up work difficult,” said William Maisel, M.D., deputy center director for science in the FDA’s Center for Devices and Radiological Health. “The KAMRA inlay provides a new option for correcting near vision in certain patients.”

The device works by blocking unfocused light rays entering the eye in order to improve near vision. It blocks peripheral light rays while allowing central light rays to pass through a small opening in the center of the device, making near objects and small print less blurry.

To insert the device, an eye surgeon uses a laser to create a pocket in the cornea of one eye of the patient and implants the device in that pocket. This is intended to allow the patient to have improved near vision in the eye containing the implant, while not affecting the distance vision of the two eyes working together.

To evaluate the safety and efficacy of the KAMRA inlay, the FDA reviewed the results of three clinical studies. The results of the main study showed that 83.5 percent of the evaluable 478 participants achieved uncorrected near visual acuity of 20/40 or better at 12 months. This is the level of vision needed to read most text in magazines and newspapers.

The device is not intended for patients who have had cataract surgery or patients with severe dry eye; an active eye infection or inflammation; corneal abnormalities related to thinning and irregular shape of the surface of their eyes; insufficient corneal thickness to withstand the procedure; a recent or recurring herpes eye infection or problems resulting from past infection; uncontrolled glaucoma; uncontrolled diabetes; or active autoimmune or connective tissue disease.

The labeling warns that the device’s safety and effectiveness in patients who have had LASIK or other refractive procedures is unknown.

The KAMRA inlay may cause or worsen dry eye and various vision-related problems, such as glare, halos, night vision problems, and blurry vision. It also can cause corneal complications such as swelling, clouding, thinning and potential perforation, and challenges evaluating and managing eye problems. For patients experiencing vision problems after the surgery, removal of the device may improve vision in some cases. In other cases, decreased vision could become permanent. There is also a potential risk for the focusing power of the eye to change, causing blurry vision and requiring glasses.

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Researchers create antimicrobial biofilm to protect medical implants from infection

24 September 2015
Countless lives have been prolonged and improved with medical implants like pacemakers and replacement hips. But such operations also carry the risk that infection-causing microbes may grow on the implant and the immune system may reject the foreign object.

Despite having several layers, the new biofilm is only a few hundred nanometers thick and invisible to the naked eye.

Now, an Inserm team from Strasbourg University in France has succeeded in creating a biofilm that protects against such infection.

The biomaterials and bioengineering researchers describe their work in the journal Advanced Healthcare Materials.

Inserm (Institut national de la santé et de la recherche médicale) is a national biomedical and public health research institution that is mostly based in French hospitals and universities.

The extremely thin, silver-coated biofilm has antimicrobial, antifungal and anti-inflammatory properties and can be used to cover titanium implants – including new hips, prostheses and pacemakers, and other medical devices that can cause infection, such as catheters.

The team has performed various tests on the new film and found it reduces inflammation and prevents the most common bacterial and fungal infections.

They showed that when an implant coated with the film comes into contact with human blood, the film prevents immune cells from triggering inflammatory markers.

Senior author Dr. Philippe Lavalle, research director at Inserm, says they also found that “the film inhibits the growth and long-term proliferation of staphylococcal bacteria (Staphylococcus aureus), yeast strains (Candida albicans) or fungi (Aspegillus fumigatus) that frequently cause implant-related infection.”

The team expects the film will be available for use in a few years.
An effective alternative to antibiotics

Implantable medical devices provide an ideal surface for microbial colonies. This can lead to infection and inflammation and rejection of the implant.

Currently, antibiotics are used to reduce the risk of such infections, but the growth of drug-resistant microbes is making them less effective.

Despite having several layers, the new biofilm is only a few hundred nanometers thick and invisible to the naked eye. It comprises two substances: polyarginine and hyaluronic acid.

The polyarginine causes the immune system to suppress its anti-inflammatory response, and the hyaluronic acid, which occurs naturally in the body and is compatible with it, inhibits bacterial growth.

The film is also embedded with natural antimicrobial peptides, including catestatin. These are not only very effective against microbes – they kill them by punching holes in their cell walls and blocking any counter-moves – they are nontoxic to the body.

Another important feature of the biofilm is its silver lining. This prolongs its antimicrobial activity, as Dr. Lavalle explains:

“Silver is an anti-infectious material currently used on catheters and dressings. This strategy allows us to extend antimicrobial activity in the long term.”

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New device to help the blind process visual signals via their tongues

June 18, 2015
The Food and Drug Administration today allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.

The BrainPort V100 is a battery-powered device that includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue. Software converts the image captured by the video camera in to electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user’s tongue. With training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.

“Medical device innovations like this have the potential to help millions of people,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “It is important we continue advancing device technology to help blind Americans live better, more independent lives.”

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Non-surgical temporary balloon device to treat obesity

July 28, 2015
The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach.

The device does not change or alter the stomach’s natural anatomy. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

The ReShape Dual Balloon is indicated for weight reduction in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2. The device is limited to patients with one or more obesity-related conditions such as high blood pressure, high cholesterol, and diabetes. It is intended for patients who have failed previous attempts at weight loss through diet and exercise alone.

There are currently three other FDA-approved devices to treat morbid obesity: the Allergan LAP-Band the Ethicon Endo-Surgery Realize Adjustable Gastric Band and the Maestro Rechargeable System.