Tag: iab-heart and cardiovascular diseases

Common kinds of air pollution led to changes in teens’ blood pressure, study says | CNN

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CNN
 — 

Scientists know that air pollution can make it difficult to breathe and may ultimately cause serious health problems like cancer, but a new study shows that it might also have a negative impact on teens’ blood pressure.

Exposure to higher levels of nitrogen dioxide was associated with lower blood pressure in teens, according to the study, published Wednesday in the journal PLOS One. Exposure to particulate matter 2.5, also known as particle pollution, was associated with higher blood pressure.

The researchers say the impact is “considerable.”

Other studies have found a connection between blood pressure changes and pollution, but much of that work focuses on adults. Some research has also found negative associations with pollution exposure and younger children, but little has focused on teens.

Generally, low blood pressure can cause immediate problems like confusion, tiredness, blurred vision and dizziness. High blood pressure in adolescence can lead to a lifetime of health problems including a higher risk of stroke or heart attack. It’s a leading risk factor for premature death worldwide.

The study did not look at whether the teens had symptoms or health effects from the change in blood pressure.

The scientists saw this association between pollution and blood pressure in data from the Determinants of Adolescent Social Well-Being and Health study, which tracks the health of a large and ethnically diverse group of children in London over time.

The researchers took data from more than 3,200 teens and compared their records to their exposures to pollution based on annual pollution levels where they lived.

Nitrogen dioxide pollution is most commonly associated with traffic-related combustion byproducts. Nitrogen may help plants grow, but it can impair a person’s ability to breathe and may cause damage to the human respiratory tract. In this study, the nitrogen was thought to be coming predominantly from diesel traffic.

The particle pollution in the study is so tiny – 1/20th of a width of a human hair – that it can travel past the body’s usual defenses. Instead of being carried out when a person exhales, it can get stuck in the lungs or go into the bloodstream. The particles cause irritation and inflammation and may lead to a whole host of health problems.

Particle pollution can come from forest fires, wood stoves, power plants and coal fires. It can also come from traffic and construction sites.

In this study, the link between pollution exposure and changes in blood pressure was stronger in girls than in boys. The researchers can’t determine why there is a gender difference, but they found that 30% of the female participants got the least amount of exercise among the group and noted that that can have an effect on blood pressure.

“It is thus imperative that air pollution is improved in London to maximise the health benefits of physical exercise in young people,” the study says.

Although the study also can’t pinpoint why teens’ blood pressure changed with pollution exposure, others have found that exposure to air pollution may affect the central nervous system, causing inflammation and damage to the body’s cells. Additionally, exposure to particle pollution can disrupt a person’s circadian rhythms, which could affect blood pressure. Particle pollution exposure may also reduce the kidneys’ ability to excrete sodium during the day, leading to a higher nighttime blood pressure level, the study says.

When it came to nitrogen dioxide pollution, the researchers had previously done a crossover study that involved the blood pressure of 12 healthy teen participants who were exposed to nitrogen oxide from a domestic gas cooker with lit burners. Their blood pressure fell compared with participants exposed to only room air.

In the new study, the associations between pollution and blood pressure were consistent. Body size, socieoecomonic status and ethnicity didn’t change the results.

However, it looks only at teens in London, and only 8% of them were people of color. Those children were exposed to higher levels of pollution than White children, the study found.

Levels of pollution in London are also well above what World Health Organization guidelines suggest is safe for humans. However, the same could be said for most any area in the world. In 2019, 99% of the world’s population lived in places that did not meet WHO’s recommended air quality levels.

Earlier work has shown that pollution can damage a young person’s health and may put them at a higher risk for chronic diseases like heart problems later in life. Studies in adults found that exposure to air pollution can affect blood pressure even within hours of exposure.

Pollution caused 1 in 6 deaths worldwide in 2019 alone, another study found.

Some experts suggest that one way to reduce a teen’s risk of pollution-related health problems is to invest in portable air cleaners with HEPA filters that are highly effective at reducing indoor air pollution. However, the filters can’t remove all of the problem, and experts say communitywide solutions through public policy are what’s needed.

Dr. Panagis Galiatsatos, an assistant professor in pulmonary and critical care medicine at Johns Hopkins Medicine, said research like this is important to generate a hypothesis about what these pollutants are doing to people. Galiatsatos, a volunteer medical spokesperson with the American Lung Association, was not involved with the new study.

“A lot of these air pollutions tend to cluster in economically disadvantaged neighborhoods, so it’s one of the big reasons we want to always keep a close eye on this, as it disproportionately impacts certain populations more than others,” he said.

Blood pressure is an important marker to track for health because it is a surrogate to understand the more complex processes that might be happening in the body.

“My big takeaway is that these toxins clearly seem to have some physiological impact on the cardiovascular system, and any manipulation should be taken into the context of a concern,” Galiatsatos said.

Study co-author Dr. Seeromanie Harding, a professor of social epidemiology at King’s College London, said she hopes it will lead to more research on the topic.

“Given that more than 1 million under 18s live in [London] neighborhoods where air pollution is higher than the recommended health standards,” she said in a news release, “there is an urgent need for more of these studies to gain an in-depth understanding of the threats and opportunities to young people’s development.”

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For the first time, US task force proposes expanding high blood pressure screening recommendations during pregnancy | CNN

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CNN
 — 

The US Preventive Services Task Force has released a draft recommendation to screen everyone who is pregnant for hypertensive disorders of pregnancy, by monitoring their blood pressure throughout the pregnancy, and the group is calling attention to racial inequities.

This is the first time the task force has proposed expanding these screening recommendations to include all hypertensive disorders of pregnancy, which are on the rise in the United States.

It means the average person might notice their doctor paying closer attention to their blood pressure measurements during pregnancy, as well as doctors screening not just for preeclampsia but for all disorders related to high blood pressure.

The draft recommendation statement and evidence review were posted online Tuesday for public comment. The statement is consistent with a 2017 statement that recommends screening with blood pressure measurements throughout pregnancy.

It was already recommended for blood pressure measurements to be taken during every prenatal visit, but “the difference is now really highlighting the importance of that – that this is a single approach that is very effective,” said Dr. Esa Davis, a member of the task force and associate professor of medicine at the University of Pittsburgh.

The draft recommendation urges doctors to monitor blood pressure during pregnancy as a “screening tool” for hypertensive disorders, she said, and this may reduce the risk of some hypertensive disorders among moms-to-be going undiagnosed or untreated.

“Since the process of screening and the clinical management is similar for all the hypertensive disorders of pregnancy, we’re broadening looking at screening for all of the hypertensive disorders, so gestational hypertension, preeclampsia, eclampsia,” Davis said.

The US Preventive Services Task Force, created in 1984, is a group of independent volunteer medical experts whose recommendations help guide doctors’ decisions. All recommendations are published on the task force’s website or in a peer-reviewed journal.

To make this most recent draft recommendation, the task force reviewed data on different approaches to screening for hypertensive disorders during pregnancy from studies published between January 2014 and January 2022, and it re-examined earlier research that had been reviewed for former recommendations.

“Screening using blood pressure during pregnancy at every prenatal encounter is a long-standing standard clinical practice that identifies hypertensive disorders of pregnancy; however, morbidity and mortality related to these conditions persists,” the separate Evidence-Based Practice Center, which informed the task force’s draft recommendation, wrote in the evidence review.

“Most pregnant people have their blood pressure taken at some point during pregnancy, and for many, a hypertensive disorder of pregnancy is first diagnosed at the time of delivery,” it wrote. “Diagnoses made late offer less time for evaluation and stabilization and may limit intervention options. Future implementation research is needed to improve access to regular blood pressure measurement earlier in pregnancy and possibly continuing in the weeks following delivery.”

The draft recommendation is a “B recommendation,” meaning the task force recommends that clinicians offer or provide the service, as there is either a high certainty that it’s moderately beneficial or moderate certainty that it’s highly beneficial.

For this particular recommendation, the task force concluded with moderate certainty that screening for hypertensive disorders in pregnancy, with blood pressure measurements, has a substantial net benefit.

Hypertensive disorders in pregnancy appear to be on the rise in the United States.

Data published last year by the US Centers for Disease Control and Prevention shows that, between 2017 and 2019, the prevalence of hypertensive disorders among hospital deliveries increased from 13.3% to 15.9%, affecting at least 1 in 7 deliveries in the hospital during that time period.

Among deaths during delivery in the hospital, 31.6% – about 1 in 3 – had a documented diagnosis code for hypertensive disorder during pregnancy.

Older women, Black women and American Indian and Alaska Native women were at higher risk of hypertensive disorders, according to the data. The disorders were documented in approximately 1 in 3 delivery hospitalizations among women ages 45 to 55.

The prevalence of hypertensive disorders in pregnancy was 20.9% among Black women, 16.4% among American Indian and Alaska Native women, 14.7% among White women, 12.5% among Hispanic women and 9.3% among Asian or Pacific Islander women.

The task force’s new draft recommendation could help raise awareness around those racial disparities and how Black and Native American women are at higher risk, Davis said.

“If this helps to increase awareness to make sure these high-risk groups are screened, that is something that is very, very important about this new recommendation,” she said. “It helps to get more women screened. It puts it more on the radar that they will then not just be screened but have the surveillance and the treatment that is offered based off of that screening.”

Communities of color are at the highest risk for hypertensive disorders during pregnancy, and “it’s very related to social determinants of health and access to care,” said Dr. Ilan Shapiro, chief health correspondent and medical affairs officer for the federally qualified community health center AltaMed Health Services in California. He was not involved with the task force or its draft recommendation.

Social determinants of health refer to the conditions and environments in which people live that can have a significant effect on their access to care, such as their income, housing, safety, and not living near sources for healthy food or easy transportation.

These social determinants of health, Shapiro said, “make a huge difference for the mother and baby.”

Hypertensive disorders during pregnancy can be controlled with regular monitoring during prenatal visits, he said, and the expectant mother would need access to care.

Eating healthy foods and getting regular exercise also can help get high blood pressure under control, and some blood pressure medications are considered safe to use during pregnancy, but patients should consult with their doctor.

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Weight loss surgery extends lives, study finds | CNN

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CNN
 — 

Weight loss surgery reduces the risk of premature death, especially from such obesity-related conditions as cancer, diabetes and heart disease, according to a new 40-year study of nearly 22,000 people who had bariatric surgery in Utah.

Compared with those of similar weight, people who underwent one of four types of weight loss surgery were 16% less likely to die from any cause, the study found. The drop in deaths from diseases triggered by obesity, such as heart disease, cancer and diabetes, was even more dramatic.

“Deaths from cardiovascular disease decreased by 29%, while deaths from various cancers decreased by 43%, which is pretty impressive,” said lead author Ted Adams, an adjunct associate professor in nutrition and integrative physiology at the University of Utah’s School of Medicine.

“There was also a huge percentage drop — a 72% decline — in deaths related to diabetes in people who had surgery compared to those who did not,” he said. One significant downside: The study also found younger people who had the surgery were at higher risk for suicide.

The study, published Wednesday in the journal Obesity, reinforces similar findings from earlier research, including a 10-year study in Sweden that found significant reductions in premature deaths, said Dr. Eduardo Grunvald, a professor of medicine and medical director of the weight management program at the University of California San Diego Health.

The Swedish study also found a significant number of people were in remission from diabetes at both two years and 10 years after surgery.

“This new research from Utah is more evidence that people who undergo these procedures have positive, beneficial long-term outcomes,” said Grunvald, who coauthored the American Gastroenterological Association’s new guidelines on obesity treatment.

The association strongly recommends patients with obesity use recently approved weight loss medications or surgery paired with lifestyle changes.

“And the key for patients is to know that changing your diet becomes more natural, more easy to do after you have bariatric surgery or take the new weight loss medications,” said Grunvald, who was not involved in the Utah study.

“While we don’t yet fully understand why, these interventions actually change the chemistry in your brain, making it much easier to change your diet afterwards.”

Despite the benefits though, only 2% of patients who are eligible for bariatric surgery ever get it, often due to the stigma about obesity, said Dr. Caroline Apovian, a professor of medicine at Harvard Medical School and codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston. Apovian was the lead author for the Endocrine Society’s clinical practice guidelines for the pharmacological management of obesity.

Insurance carriers typically cover the cost of surgery for people over 18 with a body mass index of 40 or higher, or a BMI of 35 if the patient also has a related condition such as diabetes or high blood pressure, she said.

“I see patients with a BMI of 50, and invariably I will say, ‘You’re a candidate for everything — medication, diet, exercise and surgery.’ And many tell me, ‘Don’t talk to me about surgery. I don’t want it.’ They don’t want a surgical solution to what society has told them is a failure of willpower,” she said.

“We don’t torture people who have heart disease: ‘Oh, it’s because you ate all that fast food.’ We don’t torture people with diabetes: ‘Oh, it’s because you ate all that cake.’ We tell them they have a disease, and we treat it. Obesity is a disease, too, yet we torture people with obesity by telling them it’s their fault.”

Most of the people who choose bariatric surgery — around 80% — are women, Adams said. One of the strengths of the new study, he said, was the inclusion of men who had undergone the procedure.

“For all-causes of death, the mortality was reduced by 14% for females and by 21% for males,” Adams said. In addition, deaths from related causes, such as heart attack, cancer and diabetes, was 24% lower for females and 22% lower for males who underwent surgery compared with those who did not, he said.

Four types of surgery performed between 1982 and 2018 were examined in the study: gastric bypass, gastric banding, gastric sleeve and duodenal switch.

Gastric bypass, developed in the late 1960s, creates a small pouch near the top of the stomach. A part of the small intestine is brought up and attached to that point, bypassing most of the stomach and the duodenum, the first part of the small intestine.

In gastric banding, an elastic band that can be tightened or loosened is placed around the top portion of the stomach, thus restricting the volume of food entering the stomach cavity. Because gastric banding is not as successful in creating long-term weight loss, the procedure “is not as popular today,” Adams said.

“The gastric sleeve is a procedure where essentially about two-thirds of the stomach is removed laparoscopically,” he said. “It takes less time to perform, and food still passes through the much-smaller stomach. It’s become a very popular option.”

The duodenal switch is typically reserved for patients who have a high BMI, Adams added. It’s a complicated procedure that combines a sleeve gastrectomy with an intestinal bypass, and is effective for type 2 diabetes, according to the Cleveland Clinic.

One alarming finding of the new study was a 2.4% increase in deaths by suicide, primarily among people who had bariatric surgery between the ages of 18 and 34.

“That’s because they are told that life is going to be great after surgery or medication,” said Joann Hendelman, clinical director of the National Alliance for Eating Disorders, a nonprofit advocacy group.

“All you have to do is lose weight, and people are going to want to hang out with you, people will want to be your friend, and your anxiety and depression are going to be gone,” she said. “But that’s not reality.”

In addition, there are postoperative risks and side effects associated with bariatric surgery, such as nausea, vomiting, alcoholism, a potential failure to lose weight or even weight gain, said Susan Vibbert, an advocate at Project HEAL, which provides help for people struggling with eating disorders.

“How are we defining health in these scenarios? And is there another intervention — a weight neutral intervention?” Vibbert asked.

Past research has also shown an association between suicide risk and bariatric surgery, Grunvald said, but studies on the topic are not always able to determine a patient’s mental history.

“Did the person opt for surgery because they had some unrealistic expectations or underlying psychological disorders that were not resolved after the surgery? Or is this a direct effect somehow of bariatric surgery? We can’t answer that for sure,” he said.

Intensive presurgery counseling is typically required for all who undergo the procedure, but it may not be enough, Apovian said. She lost her first bariatric surgery patient to suicide.

“She was older, in her 40s. She had surgery and lost 150 pounds. And then she put herself in front of a bus and died because she had underlying bipolar disorder she had been self-medicating with food,” Apovian said. “We as a society use a lot of food to hide trauma. What we need in this country is more psychological counseling for everybody, not just for people who undergo bariatric surgery.”

Managing weight is a unique process for each person, a mixture of genetics, culture, environment, social stigma and personal health, experts say. There is no one solution for all.

“First, we as a society must consider obesity as a disease, as a biological problem, not as a moral failing,” Grunvald said. “That’s my first piece of advice.

“And if you believe your life is going to benefit from treatment, then consider evidence-based treatment, which studies show are surgery or medications, if you haven’t been able to successfully do it with lifestyle changes alone.”

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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States | CNN

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CNN
 — 

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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ER on the field: An inside look at how NFL medical teams prepare for a game day emergency | CNN

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CNN
 — 

When Buffalo Bills safety Damar Hamlin dropped to the ground from a cardiac arrest earlier this month, help was by his side in under 10 seconds to administer CPR.

It wasn’t coincidence or luck. Rather, it’s the result of careful planning and practice – the execution of detailed choreography performed by the medical personnel present at every National Football League game.

Saving Hamlin’s life was the ultimate test.

“What we want is that the players are getting the same care here that they would if they were in a hospital or health care facility and that’s what the system has been set up to do,” NFL Chief Medical Officer Dr. Allen Sills told CNN Chief Medical Correspondent Dr. Sanjay Gupta on Saturday.

About 30 medical personnel are at every game, including orthopedic and trauma specialists, athletic trainers, paramedics and dentists. Sills gave CNN a rare behind-the-scenes look at the league’s medical personnel during Saturday’s playoff game between the Jacksonville Jaguars and the Los Angeles Chargers. The goal, Sills said, is to deliver hospital-quality care on the gridiron.

When Hamlin collapsed on January 2, speed was of the essence. Studies find that for every minute someone who experiences cardiac arrest and doesn’t receive CPR, their chances of survival decrease 7 to 10%.

Hamlin’s heart was restarted on the field. The 24-year-old spent more than a week in the hospital in Cincinnati, then transferred to a hospital in Buffalo before he was released home last week.

Sills said that being on the field was likely a factor for Hamlin: Survival is more likely for someone who experiences cardiac arrest in the hospital. One study found that 10 to 12% those who have cardiac arrest outside of the hospital survive to discharge, but that survival rate more than doubled for those who experienced cardiac arrest in the hospital.

“I think he was being resuscitated as he would have been in an emergency room at that moment,” Sills said.

Hear audio of medical personnel treating Damar Hamlin after he collapsed

The NFL requires all teams to have an emergency action plan, or EAP, for all player facilities, including practice fields.

The plans are filed by the teams every year and are approved by the League as well as the NFL Players Association, the players’ union, Sills said. They run drills on the plan, so when an event like Hamlin’s cardiac arrest occurs, the medical team’s choreography is close to automatic.

“The EAP was followed to a letter that night,” Sills said. “In that moment everyone knew what they needed to do, how they needed to do it and had the equipment to do it and felt comfortable.”

These plans include details about where ambulances are located, the quickest route to the hospital, where medical equipment is stored, and even what radio and hand signals will be used in case of a medical event.

While the teams are all connected by radio, the sound from the game and the crowd can be overwhelming.

“It gets loud and so having those nonverbal signs is a way for us to communicate,” explained Dr. Kevin Kaplan, Jacksonville Jaguars’ head physician. For example, using two hands as if driving a steering wheel indicates needing the medical cart, while crossing arms to make an “X” is an all-call for medical personnel.

The home team sends the plan to the visiting team a week before the game. Then, an hour before kickoff, medical teams from both teams gather to review and confirm the details in what’s known as a “60-minute meeting.”

Medical teams from the Los Angeles Chargers and Jacksonville Jaguars gathered for the 60-minute meeting ahead of kickoff on Saturday.

It’s like the NFL’s version of what happens in a hospital: Before doctors perform a procedure, the medical team gathers for a “timeout” to review who is responsible for what.

Before the football game, they identify the team physicians, athletic trainers and key trauma personnel, including an airway specialist who can place a breathing tube in moments, if needed.

In the excitement of game day, there needs to be a simple, clear way to identify who can help in case of an emergency. At any NFL game, you’ll see it: a red hat.

Dr. Justin Deaton, NFL airway management physician, wears a red hat on the sideline of the Jacksonville Jaguars-Los Angeles Chargers game on Saturday.

“That signifies me as the emergency physician, the airway physician, so that even the other team knows when I come out what my role is,” Dr. Justin Deaton told Gupta. “Once I come out onto the field, I kind of take over, I identify if the patient is either unconscious or has an airway obstruction.”

At every game, Deaton stands along the 30 yard line, just like his counterparts at other games.

“We standardize the location so that everybody knows where our airway physician is going to be located,” said Sills.

If the player isn’t breathing, it’s up to Deaton to identify who will administer CPR. If the player’s breathing is blocked and he can’t breathe on his own, Deaton may have to intubate the player on the field. In order to do so, he carries a videoscope to look down someone’s throat and an ultrasound machine.

In the event Deaton can’t get the patient to breathe through their mouth, he’s prepared to essentially do surgery on the field.

“If someone has an obstruction or significant trauma to the face and we can’t secure an airway by the mouth, we’re able to make an incision and insert that way,” he told Gupta. “I really have all the resources available here that I would have in an emergency room.”

The challenge is that they’re surrounded by chaos – not the more controlled environment of the emergency department or operation room.

“When you have a larger-than-average-sized person that’s laying flat on the ground and not able to be elevated to a certain level with extra equipment, plus cameras and other people around, those are really the confounders and things that make it more difficult to manage,” Deaton said.

In football, it’s not just about executing in the moment – it’s about anticipating. The same is true for medical personnel.

The NFL includes certified athletic trainers on its medical team to serve as spotters. They’re positioned throughout the stadium, including a booth that oversees the entire stadium, to watch the game in real time and again in replay – sometimes over and over – to immediately catch any injuries or assess those that might have been overlooked. They have around 30 different angles of the field at their fingertips.

“We watch every play probably minimally four times and then we’ll go back and watch it again,” said Sue Stanley-Green, one of the athletic trainer spotters assigned to Saturday’s game. “We just want to make sure we don’t miss anything.”

Spotters around the field at every game have different views of plays -- and potential injuries.

The spotters who sit in a stadium booth above the field are able to communicate directly with the medical team on the sidelines and direct them to concerning plays and possible injuries. They also have a unique line of communication to the referees, and the ability to stop the game for a medical timeout.

Sills acknowledges that there is always room for improvement and need to evolve.

In September, Miami Dolphins quarterback Tua Tagovailoa experienced an apparent head injury while playing against the Bills. He stumbled after being hit, but was allowed to return to the game. The incident put new scrutiny of the NFL and its policies.

Afterward, the league changed its concussion policy. Now, Sills says, “if we see something that looks like ataxia on video, (players) are done.”

Sills said he believes the NFL’s network of practices is working to keep players safe, and the league is currently reviewing the moments around Hamlin’s cardiac arrest. One aspect of emergencies that Sills wants to see more work on is privacy.

In the moments after Hamlin fell, his teammates formed “kind of a shield,” Sills said, which limited the view of Hamlin.

“I think there’s some things there that we may look at,” Sill said. “Obviously any of us would want some privacy in a moment like that.”

But when facing a test like saving a life on the field, “everything went really as well as you could have asked to have gone in the moment,” Sills said. “It’s always about the right people, the right plan and the right equipment.”

Bob Costas Damar Hamlin split for video

Bob Costas: Hamlin collapsing is not an indictment of NFL safety

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Damar Hamlin could be released from a Buffalo hospital in the next day or two | CNN

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CNN
 — 

A week after suffering a cardiac arrest while playing the Cincinnati Bengals, doctors are hoping Buffalo Bills safety Damar Hamlin is healthy enough to be released from a Buffalo hospital within 24 to 48 hours, Michael Hughes, senior vice president and chief administrative officer at Kaleida Health, told CNN on Tuesday.

Doctors are finishing tests and are identifying possible causes of the event, including whether there were any pre-existing conditions that played a role in Hamlin’s January 2 cardiac arrest.

“Hamlin is going through a series of testing and evaluation today,” Kaleida Health said in a statement Tuesday. The Buffalo General Medical Center team will also “potentially treat any pathology that may be found, as well as plan for his recovery, discharge and rehabilitation.”

Hamlin himself updated his fans Tuesday afternoon.

“Not home quite just yet,” Hamlin tweeted. “Still doing & passing a bunch of test. Special thank-you to Buffalo General it’s been nothing but love since arrival! Keep me in y’all prayers please!”

Hamlin was transferred from a Cincinnati hospital to the Buffalo hospital on Monday after doctors determined his critical condition had improved to good or fair – surpassing expectations.

“We felt that it was safe and proper to help get him back to the greater Buffalo area,” Dr. Timothy Pritts, chief of surgery at the University of Cincinnati Medical Center, said Monday.

Hamlin’s parents flew from Cincinnati back home to Pittsburgh but then flew to Buffalo. They were en route Tuesday from the Buffalo Bills’ practice facility and were expected to arrive at the hospital to see Hamlin soon.

Hamlin, a second-year NFL player, has been regaining strength over the past several days after his sudden collapse after a tackle against the Bengals in Cincinnati.

“He’s certainly on what we consider a very normal to even accelerated trajectory from the life-threatening event that he underwent,” Pritts said, “but he’s making great progress.”

Normal recovery from a cardiac arrest can be measured in weeks to months, Pritts explained. But Hamlin has been beating that timeline at each stage and is neurologically intact.

Still, Pritts said it’s too early to say when Hamlin could get back to normal life or what caused his heart to stop, saying more testing is needed.

Hamlin was sedated and on a ventilator for days after his cardiac arrest. On Friday morning, the breathing tube was removed, and Hamlin began walking with some help by that afternoon, his doctors said Monday.

The safety’s condition was upgraded Monday because his organ systems were stable and he no longer needed intensive nursing or respiratory therapy, doctors said.

“He walks normally,” said Dr. William Knight, a neurovascular critical care expert who treated Hamlin at UC Health. “He is admittedly a little weak. I don’t think that’s of any real surprise after what he went through, just regaining his strength. And that’s part of his recovery process.”

Hamlin’s release Monday meant he could return to Buffalo, which prompted even more encouragement and eagerness for some of his teammates to see him again.

“Super excited that he’s back in Buffalo and what a job that the team of docs and the medical team did out in Cincinnati, and now he’s in great care here in Buffalo. We’re happy to have him back,” Buffalo Bills head coach Sean McDermott told reporters Monday.

After seeing him Monday, McDermott said Hamlin was “tired” but seemed happy. “Happy to be back in Buffalo and around a familiar area to him. I know he’s taking it just one step at a time.”

The coach also said his team has grown since Hamlin was injured, saying such experiences nurture growth.

“We will all have grown as people, and as men in this case,” McDermott said, noting there’s a plan in place for the players and staff to visit Hamlin “at the proper time.”

“Having him nearby will give us more comfort” and inspire the team as it prepares for the postseason, McDermott said.

Although Hamlin was not with the team when they played Sunday against the New England Patriots, his support was definitely felt.

When his team scored a touchdown, Hamlin set off alarms in the ICU, Pritts said.

“When the opening kickoff was run back, he jumped up and down and got out of his chair and set – I think – every alarm off in the ICU in the process, but he was fine, it was just an appropriate reaction to a very exciting play. He very much enjoyed it,” Pritts said.

Hamlin was “beyond excited” Sunday and felt “very supported by the outpouring of love from across the league, especially from the Buffalo area. We’ve learned this week that the Bills mafia is a very real thing,” Pritts added.

The immediate medical response to Hamlin’s collapse helped save his life, and the Buffalo Bills are now encouraging people to learn how to administer CPR.

Assistant athletic trainer Denny Kellington is credited with performing CPR when Hamlin lost his pulse on the field and needed to be revived through resuscitation and defibrillation.

The medical response was part of an emergency action plan that “involves team, independent medical and athletic training staff, equipment and security personnel, and is reviewed prior to every game,” a Monday statement from the Bills read.

The team pledged support for resources including CPR certifications, automated external defibrillator units and guidance developing cardiac emergency response plans within the Buffalo community, according to the statement.

“We encourage all our fans to continue showing your support and take the next step by obtaining CPR certification,” the Bills said.

Clarification: This story has been updated to clarify Hughes’ remarks about Hamlin’s injury and recovery.



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