Indian-origin doctor in US implants first leadless pacemaker inside patient's heart

February 9, 2014

Pacemaker_inside_patients_heartNew York, Feb 9: An Indian-origin doctor in the US has implanted the first miniature-sized, leadless cardiac pacemaker directly inside a patient's heart without surgery.

The leads-free pacemaker is implanted directly inside the heart during a catheter-guided procedure through the groin via the femoral artery.

The device implanted by Vivek Reddy from The Mount Sinai Hospital, resembles a small metal silver tube, and is only a few centimetres in length, making it less than ten per cent the size of a traditional pacemaker.

The Nanostim device, made by St Jude Medical, is being tested for safety and efficacy in an international, multicentre clinical trial called LEADLESS II, which is planning to enroll 670 patients at 50 centres across the US, Canada, and Europe.

"This clinical research trial will be testing the latest innovative, non-surgical pacemaker option for patients experiencing a slowed heart beat," said Reddy, the study's co-investigator.

"This new-age, tiny pacemaker may ultimately be safer for patients because it doesn't have leads or have to be inserted under the skin of a patient's chest, like a traditional cardiac pacemaker," Reddy said.

Similar to other cardiac pacemakers, the Nanostim device treats a heart rate that is too slow called bradycardia.

It works by closely monitoring the heart's electrical rhythms and if the heart beat is too slow it provides electrical stimulation therapy to regulate it.

More than 4 million patients globally have a pacemaker, and 700,000 new patients receive one each year, researchers said.

The possible advantages of the leadless pacemaker include the elimination of a surgical pocket and no visible pacemaker device under a patient's chest skin, no incision scar on the chest, no connector wires or leads, and no restrictions on a patient's activities.

The device's benefits may also allow for less patient discomfort, infections, and device complications and dysfunction.

In addition, the free-standing, battery-operated pacemaker device is designed to be fully retrievable from the heart.

"The same cardiac pacing results for patients may be available with this smaller leads-free device with the added benefits of a non-surgical procedure and less complication risks," said Srinivas Dukkipati, who is the study's principal investigator.

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Agencies
July 15,2020

The first COVID-19 vaccine tested in the US revved up people's immune systems just the way scientists had hoped, researchers reported Tuesday -- as the shots are poised to begin key final testing.

No matter how you slice this, this is good news, Dr. Anthony Fauci, the U.S. government's top infectious disease expert, told The Associated Press.

The experimental vaccine, developed by Fauci's colleagues at the National Institutes of Health and Moderna Inc., will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus.

But Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost.

Those early volunteers developed what are called neutralizing antibodies in their bloodstream -- molecules key to blocking infection -- at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.

This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection, said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.

There's no guarantee but the government hopes to have results around the end of the year -- record-setting speed for developing a vaccine.

The vaccine requires two doses, a month apart.

There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren't uncommon with other vaccines -- fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn't being pursued.

Some of those reactions are similar to coronavirus symptoms but they're temporary, lasting about a day and occur right after vaccination, researchers noted.

Small price to pay for protection against COVID, said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who wasn't involved with the study.

He called the early results a good first step, and is optimistic that final testing could deliver answers about whether it's really safe and effective by the beginning of next year.

It would be wonderful. But that assumes everything's working right on schedule, Schaffner cautioned.

Moderna's share price jumped nearly 15 percent in trading after US markets closed. Shares of the company, based in Cambridge, Massachusetts, have nearly quadrupled this year.

Tuesday's results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19.

Those results aren't public yet but regulators are evaluating them. Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus and Black and Latino populations likewise affected.

Nearly two dozen possible COVID-19 vaccines are in various stages of testing around the world. Candidates from China and Britain's Oxford University also are entering final testing stages.

The 30,000-person study will mark the world's largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn't the only one set for such massive U.S. testing, crucial to spot rare side effects. The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study.

Already, people can start signing up to volunteer for the different studies.

People think this is a race for one winner. Me, I'm cheering every one of them on, said Fauci, who directs NIH's National Institute of Allergy and Infectious Diseases.

We need multiple vaccines. We need vaccines for the world, not only for our own country. Around the world, governments are investing in stockpiles of hundreds of millions of doses of the different candidates, in hopes of speedily starting inoculations if any are proven to work.

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Agencies
May 17,2020

Geneva, May 17: Spraying disinfectant on the streets, as practised in some countries, does not eliminate the new coronavirus and even poses a health risk, the World Health Organization (WHO) warned on Saturday.

In a document on cleaning and disinfecting surfaces as part of the response to the virus, the WHO says spraying can be ineffective. "Spraying or fumigation of outdoor spaces, such as streets or marketplaces, is... not recommended to kill the Covid-19 virus or other pathogens because disinfectant is inactivated by dirt and debris," explains the WHO.

"Even in the absence of organic matter, chemical spraying is unlikely to adequately cover all surfaces for the duration of the required contact time needed to inactivate pathogens." The WHO said that streets and pavements are not considered as "reservoirs of infection" of Covid-19, adding that spraying disinfectants, even outside, can be "dangerous for human health".

The document also stresses that spraying individuals with disinfectants is "not recommended under any circumstances".

"This could be physically and psychologically harmful and would not reduce an infected person's ability to spread the virus through droplets or contact," said the document.

Spraying chlorine or other toxic chemicals on people can cause eye and skin irritation, bronchospasm and gastrointestinal effects, it adds.

The organisation is also warning against the systematic spraying and fumigating of disinfectants on to surfaces in indoor spaces, citing a study that has shown it to be ineffective outside direct spraying areas.

"If disinfectants are to be applied, this should be done with a cloth or wipe that has been soaked in disinfectant," it says.

The SARS-CoV-2 virus, the cause of the pandemic that has killed more than 300,000 people worldwide since its appearance in late December in China, can attach itself to surfaces and objects.

However, no precise information is currently available for the period during which the viruses remain infectious on the various surfaces.

Studies have shown that the virus can stay on several types of surfaces for several days. However, these maximum durations are only theoretical because they are recorded under laboratory conditions and should be "interpreted with caution" in the real-world environment.

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April 4,2020

Washington D.C., Apr 4: While consuming a high-diet salt can result in high blood pressure, a recent study has revealed a link between salt-rich diet and weaker immune system.

The study was conducted under the leadership of the University Hospital Bonn, and the results were published in the journal Science Translational Medicine.

The research was conducted on mice that were fed a high-salt diet. Later, they were found to suffer from much more severe bacterial infections.

Human volunteers who consumed an additional six grams of salt per day also showed pronounced immune deficiencies.

The World Health Organization (WHO) has recommended a maximum amount of five grams of salt a day.

It corresponds approximately to one level teaspoon. In reality, however, many Germans exceed this limit considerably. 

Figures from the Robert Koch Institute suggest that on average men consume ten, and women more than eight grams a day.

This means that we reach for the salt shaker much more than is good for us. After all, sodium chloride, which is its chemical name, raises blood pressure and thereby increases the risk of heart attack or stroke.

"We have now been able to prove for the first time that excessive salt intake also significantly weakens an important arm of the immune system," said Prof. Dr. Christian Kurts from the Institute of Experimental Immunology at the University of Bonn.

This finding is unexpected, as some studies point in the opposite direction. For example, infections with certain skin parasites in laboratory animals heal significantly faster if these consume a high-salt diet.

The study also sheds light on the fact that the skin serves as a salt reservoir.

"Our results show that this generalization is not accurate," emphasized Katarzyna Jobin, lead author of the study.

The body keeps the salt concentration in the blood and in the various organs largely constant. Otherwise important biological processes would be impaired. The only major exception is the skin which functions as a salt reservoir of the body. This is why the additional intake of sodium chloride works so well for some skin diseases.

However, other parts of the body are not exposed to the additional salt consumed with food. Instead, it is filtered out by the kidneys and excreted in the urine.

"We examined volunteers who consumed six grams of salt in addition to their daily intake," said Prof. Kurts. This is roughly the amount contained in two fast-food meals, i.e. two burgers and two portions of French fries.

After one week, from the results, it showed that the immune cells coped much worse with bacteria after the test subjects had started to eat a high-salt diet.

In human volunteers, excessive salt intake also resulted in increased glucocorticoid levels.

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