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US FDA approves first artificial iris

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The US Food and Drug Administration on Thursday approved the first stand-alone prosthetic iris, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.
Iris is the coloured part of the eye around the pupil.
Director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, Malvina Eydelman in a statement said patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye.
“Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.” he said.
The FDA granted approval of the “CustomFlex Artificial Iris” to HumanOptics AG a Germany-based firm that produces and distributes intraocular implants of the highest quality.
The CustomFlex Artificial Iris is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual patient.
A surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths out the edges using surgical instruments.
The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures, FDA said.
“The safety and effectiveness of the CustomFlex Artificial Iris was demonstrated primarily in a non-randomised clinical trial of 389 adult and paediatric patients with aniridia or other iris defects.”
The study measured patients’ self-reported decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis.
“More than 70 percent of patients reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure.
In addition, 94 percent of patients were satisfied with the artificial iris’ appearance,” the regulator said with regards to the efficacy of the artificial iris.
The study found low rates of adverse events associated with the device or the surgical procedure, it added.
The FDA also suggested that the CustomFlex Artificial Iris is contraindicated, or should not be used, in eyes under certain conditions such as uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, and cataract caused by rubella virus.

Source: http://www.tribuneindia.com/news/health/us-fda-approves-first-artificial-iris/597985.html

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VR sessions could reduce anxiety, boost chances of IVF success

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Trying for In-vitro Fertilisation (IVF) treatments may make you stressed. Now a new pilot study by the Catholic University of Leuven in Brussels, Belgium, shows that giving women different types of virtual reality (VR) sessions prior to sedation for IVF treatment can reduce their anxiety and improve successful pregnancy rate.

“Virtual reality distraction was shown to be effective to reduce experimental pain as well as the discomfort associated with burn injury care. The technology is being used more and more in medicine, notably in psychiatry to treat phobias,” said Fabienne Roelants, professor at the Catholic University of Leuven.

What the study shows

In the study, 100 women aged between 18 and 42 years and undergoing IVF were randomly assigned one of two types of VR session. In the “distraction group”, women received a VR session — an underwater walk cut off from all ambient noise — and the hypnosis group received a VR session with hypnosis focused on breathing, slowing respiratory rhythm, along with suggestions to repeat the technique later to find well-being and calm as needed.

While there was no statistically significant difference regarding anxiety scores between groups, on the visual anxiety scale of 100 points, the distraction group women’s average anxiety score fell from 34 before the VR session to 23 after. In the hypnosis group, the score fell from 40 to 26 points.

Further, 48 of 55 women in the distraction group, had embryos successfully transferred, but only 10 of these women (22%) were biologically confirmed as pregnant, and only seven of these women (15%) had an ultrasound confirmed successful pregnancy at 12 weeks gestation.

In the hypnosis group, 35 women had embryos successfully transferred, with 16 of these (46%) biologically confirmed as pregnant, and eight of these (23%) went on the have an ultrasound confirmed clinical pregnancy at 12 weeks. The results were presented at 2018 Euroanaesthesia congress in Copenhagen, Denmark.

“The preliminary results show that VR sessions before sedation for fertility treatment significantly reduce women’s anxiety. The type of suggestions used during hypnosis session might show a significant positive impact on the biological pregnancy rate, but not on clinical pregnancy rate at 12 weeks,” Roelants said.

Tips for fertility and IVF treatments

* Acupuncture can boost chances of pregnancy.

A study done by IVF Cube in Prague, Czech Republic, shows that acupuncture therapy can boost your chances of getting pregnant by six per cent. The study found that acupuncture stimulates the sensory nerves under the skin and muscles of the body along with an increased blood flow to the uterus, which makes it more receptive to the embryo implanting when it is transferred during IVF.

* The Mediterranean diet can help.

A study done by the Harokopio University of Athens shows that a diet rich in fresh fruits and vegetables, fish, and olive oil — also called as a Mediterranean diet — would greatly benefit women trying for in-vitro fertilisation (IVF).

* Fertility treatments do not spike divorce risk.

A study done by the University of Porto in Portugal suggests that undergoing fertility treatment does not increase divorce risk. Previous studies have suggested that undergoing assisted reproductive technology (ART) such as in-vitro fertilisation (IVF) greatly increases couples’ stress and anxiety levels.

Source: https://www.hindustantimes.com/health/vr-sessions-could-reduce-anxiety-boost-chances-of-ivf-success/story-dlXuQFo6xnvDucsB8A3RMN.html

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Beware, injectable drug users are at risk of superbug infections

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A type of superbug bacteria is spreading rapidly among people who inject drugs, says a new government report. Due to it, users of heroin and other injectable drugs were 16 times more likely than other people to develop severe illnesses, said the report.

“Drug use has crept up and now accounts for a substantial proportion of these very serious infections,” said Dr William Schaffner of Vanderbilt University, one of the study’s authors.

The US is in the midst of its deadliest drug epidemic ever. While overdose deaths have been the main concern, studies have noted that HIV and hepatitis C infections are spreading among drug users. The authors say the new report is one of the first — and the largest — to highlight how superbug bacterial infections are spreading, too.

MRSA, or methicillin-resistant Staphylococcus aureus bacteria, often live on the skin without causing symptoms. But they can become more dangerous if they enter the bloodstream, destroying heart valves or causing damage. Health officials have tied MRSA to as many as 11,000 US deaths a year.

Public health efforts have focussed on MRSA’s spread in hospitals and nursing homes, and infection-control campaigns have been credited for recent drops in MRSA infections at health care facilities. But as that success story has unfolded, MRSA infections tied to illicit drug use have risen. The opioid epidemic began with abuse of prescription pain pills, but in recent years has shifted to heroin and other injectable drugs.

MRSA is on the skin, and as the needle goes into the skin it brings the bacteria with it, explained Dr Isaac See of the Centers for Disease Control and Prevention, another of the study’s authors. The proportion of invasive, bloodstream-infecting MRSA cases that occurred among injection drug users more than doubled in five years, the study found. In 2011, 4% of those MRSA cases involved injection drug users; in 2016, the proportion was 9%.

The report is based on infections diagnosed at hospitals across Connecticut and in parts of California, Georgia, Minnesota, New York and Tennessee. Data were collected between 2005 and 2016.

Source: https://www.hindustantimes.com/health/beware-injectable-drug-users-are-at-risk-of-superbug-infections/story-t5WJp8XTgDXaGjFM8bHb9N.html

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New Blood Test Could Predict Preterm Labor 2 Months Before It Happens

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Two newly developed blood tests may help moms-to-be accurately answer this ever-popular question: When is your baby due?

One blood test can predict gestational age and delivery date, while the other can flag some women who are at risk for premature delivery, according to a new study.

However, both tests are still in the beginning stages of research and aren’t yet available to the public, according to the study, which was published online today (June 8) in the journal Science.

If these potentially low-cost tests are available for public use someday, they could “hold promise for prenatal care in both the developed and developing worlds,” the researchers wrote in the study. That’s because about 15 million babies are born prematurely every year worldwide, and in the United States, premature birth is the leading cause of death among newborns, as well as complications later in life, the researchers said. [Blossoming Body: 8 Odd Changes That Happen During Pregnancy]

To perform the tests, scientists took blood samples from pregnant women and then analyzed free-floating genetic material known as RNA within each sample. This RNA comes not just from the mother but also the fetus and placenta and can provide insight on fetal development. In fact, these fragments of RNA can reveal which genes are switched on, indicating which stage of maturation the fetus has reached.

In effect, these noninvasive tests provide a way of “eavesdropping on a conversation” between the mother, the fetus and the placenta, without disturbing the pregnancy, study co-researcher Dr. David K. Stevenson, a professor of pediatrics at Stanford University in California, said in a statement.

In the first experiment, scientists examined 31 healthy pregnant women from Denmark who agreed to donate a blood sample from each week of their pregnancy, the researchers said. All of the women delivered their babies at full term, or after 37 weeks of pregnancy. After analyzing the women’s blood samples, the researchers found that RNA fragments corresponding to placental genes, “might provide an accurate estimate of fetal development and gestational age throughout pregnancy,” the researchers wrote in the study.

In fact, the predicted due dates from the RNA biomarkers were comparable with those from a first-trimester ultrasound, the researchers said. Even better, this test could be less expensive and more widely accessible than ultrasounds, the researchers noted.

In the second experiment, the researchers looked at 38 pregnant women — recruited by the University of Pennsylvania and the University of Alabama at Birmingham — who had an increased risk of preterm delivery because they had experienced premature contractions or had given birth prematurely before.

This experiment was small and unblinded (meaning the researchers knew which women’s samples they were looking at) but had encouraging results: When the researchers looked at a subset of the women, they found that the RNA analysis correctly classified six of eight (75 percent) women who delivered prematurely. Moreover, the same test misclassified just one of the 26 women who carried to full term. (In other words, it predicted that one woman wouldn’t carry to full term, but she did.)

When they did the test again on a different group of women within the study, the test accurately predicted 80 percent of preterm births. However, it also misclassified three of the 18 full-term births. These results came from blood samples that were collected two months before the women went into labor, the researchers noted. [9 Uncommon Conditions That Pregnancy May Bring]

“With further study, we might be able to identify specific genes and gene pathways that could reveal some of the underlying causes of preterm birth, and suggest potential targets for interventions to prevent it,” Stevenson said.

However, both tests have several limitations at this point. First and foremost, each test needs to be verified in a larger clinical trial that includes diverse ethnicities and is blinded, meaning the scientists won’t know which women are at risk for preterm birth, the researchers said.

However, if all goes well, the tests could be a useful, potentially inexpensive tool for both pregnant women and their doctors, the researchers said. The study was funded by the March of Dimes, the Bill and Melinda Gates Foundation and the Chan Zuckerberg Biohub — a research collaboration funded by Facebook CEO and founder Mark Zuckerberg and his wife Priscilla Chan.

Original article on Live Science.

Source: https://www.livescience.com/62778-blood-tests-pregnancy-due-date.html

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Gene therapy could restore hand function after spinal cord injury

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Researchers have tested a new gene therapy that has shown potential to help people with spinal cord injuries to re-learn skilled hand movements. People with spinal cord injury often lose the ability to perform everyday actions that require coordinated hand movements such as writing, holding a toothbrush or picking up a drink.

In the study published in the journal Brain, researchers tested the new gene therapy on rats for regenerating damaged tissue in the spinal cord that could be switched on and off using a common antibiotic. “What is exciting about our approach is that we can precisely control how long the therapy is delivered by using a gene ‘switch’. This means we can hone in on the optimal amount of time needed for recovery,” said Elizabeth Bradbury, Professor at King’s College London.

“Gene therapy provides a way of treating large areas of the spinal cord with only one injection, and with the switch we can now turn the gene off when it is no longer needed,” she added.

After a traumatic spinal injury, dense scar tissue forms which prevents new connections being made between nerve cells. The gene therapy causes cells to produce an enzyme called chondroitinase which can break down the scar tissue and allow networks of nerve cells to regenerate.

The researchers gave the gene therapy to rats with spinal injuries that closely mimicked the kind of human spinal injuries that occur after traumatic impacts such as car crashes or falls. “We found that when the gene therapy was switched on for two months the rats were able to accurately reach and grasp sugar pellets,” explained Emily Burnside from King’s College London.

“We also found a dramatic increase in activity in the spinal cord of the rats, suggesting that new connections had been made in the networks of nerve cells,” she noted.

However, the researchers had to overcome a problem with the immune system recognising and removing the gene switch mechanism.

To get around this, they added a “stealth gene” which hides the gene switch from the immune system. The gene therapy is not yet ready for human trials, the researchers said.

Source: https://indianexpress.com/article/lifestyle/health/gene-therapy-could-restore-hand-function-after-spinal-cord-injury-5222196/

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New ‘Smart Stent’ Can Detect Narrowing of Arteries

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Researchers have developed a type of “smart stent” that monitors even subtle changes in the flow of blood through the artery, detecting the narrowing in its earliest stages and making early diagnosis and treatment possible.

‘Smart stent that uses medical-grade stainless steel and looks similar to most commercial stents can help detect narrowing of arteries.’

For every three individuals who have had a stent implanted to keep clogged arteries open and prevent a heart attack, at least one would experience restenosis — the renewed narrowing of the artery due to plaque buildup or scarring — which can lead to additional complications.
The researchers believe that the smart stent could help doctors monitor their patient’s health more easily.

The device prototype was successfully tested in the lab and in a swine model, according to a study published in the journal Advanced Science.

“We modified a stent to function as a miniature antenna and added a special micro-sensor that we developed to continuously track blood flow,” said Kenichi Takahata, Professor at University of British Columbia in Canada.

“The data can then be sent wirelessly to an external reader, providing constantly updated information on the artery’s condition,” Takahata said.

The device uses medical-grade stainless steel and looks similar to most commercial stents.

It can be implanted using current medical procedures without modifications, the researchers said.

“Putting a smart stent in place of a standard one can enable physicians to monitor their patient’s health more easily and offer treatment, if needed, in a timely manner,” said research collaborator York Hsiang, Professor at University of British Columbia.

Source: https://www.medindia.net/news/new-smart-stent-can-detect-narrowing-of-arteries-180394-1.htm

Picture Credit:University of British Columbia 

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Robotic surgery equally effective as traditional open surgery for bladder cancer

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The outcome of robotic-assisted surgery and traditional open surgery are equally effective in treating bladder cancer, say scientists, led by an Indian-origin researcher.

The results, published in the journal The Lancet, may help patients and doctors to make informed decisions on the use of robotic surgery, which is not cheap, the researchers said.

There has been an assumption that patients who receive robotic surgery will perceive a better quality of life than patients who have open surgery. However, the trial showed that both groups had a significant return to their previous quality of life, and there was no advantage of one group over the other at three and six months after surgery.

“We have done more than four million surgeries with the robotic approach since the device came into existence, and on average we do close to a million robotic surgeries a year globally,” said Dipen J. Parekh, Chief Clinical Officer at the University of Miami, Florida in the US.

“There’s a steep cost to robotic technology, and there is a learning curve, so we need to build on this in terms of making rational, data-based decisions,” Parekh added.

A total of 350 patients were involved in the bladder cancer study. Half received the open surgical approach and half received robotic surgery, and they were followed for two to three years so that outcomes could be compared.

“The findings of this study provide high-level evidence to inform a discussion between patients and their physicians regarding the benefits and risks of various approaches for a complex and often morbid surgery, like radical cystectomy,” the researchers said.

But, because robotic surgery is being used in many other organs, including kidney, colorectal, OB/GYN and lung cancer, more studies are needed, Parekh said.

Source: https://www.hindustantimes.com/health/robotic-surgery-equally-effective-as-traditional-open-surgery-for-bladder-cancer/story-NSyTRkWEyrMpV7Cc9QmKRM.html

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Pacemaker for heart, study suggests leadless variant better than transvenous one

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Good news for heart patients. If you want to keep your heart healthy, you should opt for leadless pacemakers over the conventional transvenous variants. While you can you avoid heart attack and stroke risk by following a disciplined exercise and diet routine to keep ensure a healthy heart, you need to be careful with the pacemaker variant you choose after a heart attack. According to a new study, heart patients who opt for leadless pacemakers are likely to have lesser short-term and mid-term complications than those with transvenous pacemakers. Approximately a million pacemakers are annually implanted in patients to provide electrical stimulation to regulate heartbeat. Conventional pacemakers are surgically placed under the skin of patient’s chest stretching from the shoulder vein and attaching to the heart. The wires and surgery lead to complications in the patient.

Leadless pacemakers, on the other hand, don’t have any wires and are ten times smaller than the transvenous ones. They are placed directly into the heart using a catheter passed through the femoral vein in the leg. A study compared short- and mid-term complications between 718 patients receiving the Nanostim leadless pacemaker and 1,436 patients with conventional (transvenous) pacemakers.

It was found that patients receiving one type of leadless pacemaker (Nanostim) overall had fewer complications (5.8% vs. 9.4%). Leadless pacemakers completely eliminated lead and pocket complications, including infection. By comparison, complications among traditional pacemaker recipients included lead complications (3.62%), pocket complications (0.42%) and infection (1.74%). There were no significant differences between the groups in regard to rates of vascular complications, electrode dislodgement and generator complications.

Daniel Cantillon, a researcher said, “The data from this study is encouraging, and we expect complications from leadless pacemakers to continue to decline as the technology improves and physicians gain experience implanting these devices”. The study was published in Heart Rhythm journal.

Source: https://www.hindustantimes.com/health/pacemaker-for-heart-study-suggests-leadless-variant-better-than-transvenous-one/story-kgHsJeC4XRkFAfJqG20pMP.html

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Water: Drinking how much is enough on a daily basis?

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The newest trend sweeping sunny California is people drinking untreated ‘raw’ water from unfiltered sources packed with natural ions, minerals, chemicals and organic matter. The fad will, sooner than later, wreck their health.

Along with ions and minerals, untreated water comes laced with bacteria, viruses, parasites, pesticides and heavy metals that cause nasty diarrhoea,dysentery, hepatitis A, cholera, typhoid and toxicities, among other diseases.

Just as contaminated water sickens and kills, safe water saves lives. Safe and easily available water for drinking, domestic use and food production lowers disease to boost economic growth and lower poverty, according to the World Health Organization.

Water is needed to carry nutrients to cells, moisten tissue, cushion joints, regulate body temperature and flush out toxins. Staying hydrated protects against colorectal and bladder cancers, high blood pressure, heart disease, urinary tract infections and kidney stones.

Most people drink water when they’re thirsty, but in warm and humid weather, thirst is often not the best indicator of dehydration. So how much water should we drink every day?

Water accounts for 55%-60% of the body’s weight, depending on gender. Much like the human body, water is an essential component of all foods and about 20% of our daily fluid requirement comes from food. Butter and oils are the only foods with no water.

The water content is more than 90% in foods like milk and yoghurt, and in some fruits and green vegetables, such as watermelon, cucumber, cabbage, lettuce and spinach. Fruits like apples, grapes, oranges, pears and pineapple are 80% to 90% water, while beans and legumes have a water content ranging from 60% to 70%. Even dried fruits, seeds and nuts are 1% to 9% water.

A normal healthy person needs about eight glasses (two litres) of water a day, which should go up in hot, sweaty weather and during vigorous activities, according to the Indian Council of Medical Research’s Dietary Guidelines for Indians. The tea, coffee, milk, yoghurt and whole foods you have will also help meet your hydration target, but water should be the fluid of choice.

For people in the UK, the National Health Service recommends 1.2 litres (six to eight glasses) of fluid every day to prevent dehydration, while the US National Academies of Sciences, Engineering, and Medicine recommends 3.7 litres (15.5 glasses) of fluids for men and 2.7 litres (11.5 glasses) for women.

Don’t substitute water with juices, even if they’re fresh and unsweetened, because they pack a lot of sugar and calories in each glass. While fresh fruit juices do have vitamins, minerals and other nutrients, they also have very high amounts of fruit sugars, which the World Health Organisation puts in the same category as harmful free sugars, the intake of which should not exceed 25 gm a day.

A glass of fresh orange juice, for example, has 0.4 gm of fibre and 24 gm of sugar, compared to 1.5 gm of fibre and 10 gm of sugar in one whole orange. The sugar in a glass of fresh, unsweetened orange juice (24 gm) is almost the same as in a glass of the colas (26 gm).

Coconut water contains potassium, which helps fight dehydration by increasing the body’s capacity to absorb and retain water and is particularly useful to hydrate people who are ill or very active. But since a 250 ml glass has 50 calories, using it as a substitute for zero-calorie water leads to weight gain.

Dry and scaly skin, frequent muscle cramps and constipation are signs that you’re dehydrated, so watch out for signs now that the hot, wet weather will make seat a part of life in most part of the country.

Source : https://www.hindustantimes.com/health/water-drinking-how-much-is-enough-on-a-daily-basis/story-V2mFxsF9mfg0EBeFMH04AN.html

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Patients with hypertension can now use this new stress free algorithm for treatment

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Hypertensive patients can now receive intensive treatments faster. In a recent study, researchers have devised a machine learning algorithm which combines three variables routinely collected during clinic visits and demonstrates how the emerging field of bioinformatics could transform patient care.

It takes a patient’s age, urinary albumin/creatinine ratio (UACR), and cardiovascular disease history to successfully identify hypertensive patients for whom the benefits of intensive therapy outweigh the risks. “Large randomized trials have provided inconsistent evidence regarding the benefit of intensive blood pressure lowering in hypertensive patients,” said a researcher, Yang Xie.

“To the best of our knowledge, this is the first study to identify a subgroup of patients who derive a higher net benefit from intensive blood pressure treatment,” he added. Researchers used patient data under controlled trials that tested intensive vs. standard blood pressure-lowering treatments — the Systolic Blood Pressure Intervention Trial (SPRINT) and the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

The SPRINT trial included 9,361 non-diabetic hypertensive adults at an elevated risk of a cardiovascular event, while ACCORD enrolled 10,251 patients with Type 2 diabetes. “I think our algorithm can help us identify high-risk patients who will most likely benefit from intensive blood pressure reduction. Long-term intensive HBP drug therapy can reduce the risk of heart failure and death, but it carries an increased risk of side effects,” said another researcher, Wanpen Vongpatanasin.

The researchers’ machine learning method determined three simple criteria to identify adults with high blood pressure who are at the highest risk for early major adverse cardiovascular events — such as cardiovascular death, heart attack, or stroke.

Source : https://www.hindustantimes.com/health/patients-with-hypertension-can-now-use-this-new-stress-free-algorithm-for-treatment/story-fjqoVkieO1rmdKTthfgXZO.html

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