Milestone Pig-to-Human Heart Transplant May Pave the Way for Broader Trial

Milestone Pig-to-Human Heart Transplant May Pave the Way for Broader Trial

Post By Science And Technology heart disease

Editor’s Note (11/1/23): Pig heart transplant recipient Lawrence Faucette died on October 30, according to the University of Maryland Medical Center, where Faucette received the surgery and posttransplant care. The medical team reported that Faucette showed signs of organ rejection. He had lived for nearly six weeks after receiving a genetically modified pig heart.

Late last month a team of researchers at the University of Maryland School of Medicine transplanted a genetically modified pig heart into a person—the second such surgery ever attempted—and it has kept him alive for the past few weeks. The patient, 58-year-old Lawrence Faucette, underwent the highly experimental procedure under a “compassionate use” pathway, in which the U.S. Food and Drug Administration permits an unapproved therapy when a person is seriously ill or dying and has no other options available. Faucette was not eligible for a conventional human heart transplant because he had peripheral vascular disease and other complications, which narrowed the outlook for success.

By mid-October, Faucette was continuing to recover and doing physical therapy. “He’s had a rough time,” however, Bartley Griffith, a surgeon at the University of Maryland, who performed Faucette’s procedure as well as the previous one, said at that time. According to Griffith, Faucette was living at home when the FDA first approved the surgery, but he was subsequently hospitalized with fluid in his lungs. Then he suffered a cardiac arrest the night before the surgery. Still, he had so far responded well to the transplant—and was sitting up in a chair two days afterward.

More than 100,000 people are waiting for an organ transplant—most of them for kidneys—so researchers have long been exploring xenotransplantation: transplanting other species’ organs into humans. To prevent the human immune system from attacking these alien organs, scientists have begun to breed genetically modified donor pigs that lack certain genes or have other genes added.

In the past couple of years, pig xenotransplants have been tested in both nonhuman primates and deceased humans—but the ultimate goal is to conduct human clinical trials on a bigger scale. The results of the recent compassionate use transplant will likely influence the FDA’s consideration of whether and when to allow such trials to take place. Many researchers hope this could happen in the next year or two.

“I would love to see heart [xenotransplantation in] a clinical trial next year and kidney [xenotransplantation trials] shortly thereafter,” says Jayme Locke, director of the division of transplantation at the University of Alabama at Birmingham, who was not involved in the latest experimental surgery. Locke and her colleagues have performed several kidney xenotransplants in humans who had suffered brain death. “The FDA holds those cards, and I think it’s going to really depend on what their risk tolerance threshold is,” she says. “But I’m hopeful. I think the FDA wants to see this happen.”

In January 2022 Griffith and his team at the University of Maryland transplanted a genetically modified pig heart from the company Revivicor into a patient, David Bennett, Sr., who lived for two months before the heart failed, and he passed away. The heart was later found to be infected with a pig virus that had escaped screening, although other factors may have also played a role in the transplant’s failure and Bennett’s death.

“We took a pretty good swing at the ball the first time, and we got very close to a prolonged success, we think,” Griffith says. There were some unforeseen circumstances in that first xenotransplant that may have affected its result, such as the pig virus that was later found in the heart, Griffith adds. Since then his team and others have developed better methods to test for these viruses.

Bennett’s family is glad he was able to take part. “He lived for two months, and we got to spend more time with him. So I was grateful for that,” says his son, David Bennett, Jr., who hopes Faucette’s surgery will be successful. “I’m thankful for every dream and hope and every person that is involved in this and the ability that it has to move forward.”

One major difference between the first and second surgeries is that although Faucette was considered terminally ill, he was much healthier than Bennett was at the time of his procedure. Unlike Bennett, Faucette had been living at home until shortly before the transplant and was much more mobile, according to Muhammad Mohiuddin, director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, who is managing Faucette’s anti-transplant-rejection regimen.

Other researchers agree that Faucette was a more appropriate candidate for such a novel procedure. “My overall feeling is that this patient was in much better shape than the previous patient,” says Nader Moazami, a cardiothoracic transplant surgeon at NYU Langone Health, who was not involved in Faucette’s transplant. “Part of the problem when we have a patient who is very, very sick—and you go into doing experimental xenotransplantation, where we still don’t necessarily know exactly what combination of immunosuppressive agents is good—is that those patients are very prone to developing a variety of complications.” Last year Moazami and his colleagues transplanted genetically modified pig hearts into two people who had suffered brain death, and the organs functioned well for several days.

Both Bennett’s and Faucette’s procedures used standard immunosuppressive drugs in addition to an experimental one. With Bennett, the team employed an experimental antibody drug called KPL-404, which blocks a receptor called CD40 that activates the host’s B cell and T cell immune responses, which can lead to the rejection of a foreign organ. With Faucette, the team used a drug called tegoprubart, which was developed by Eledon Pharmaceuticals and blocks the molecule, or ligand, which binds to CD40. Tegoprubart has been tested in phase 2 clinical trials for human kidney transplants but is not yet FDA-approved.

The team is also working with international laboratories that are using artificial intelligence to evaluate biopsies of Faucette’s heart tissue, an assessment that Griffith says could detect early signs of tissue rejection.

The FDA has been closely watching Faucette’s case, which could inform the agency’s decision to approve clinical trials of xenotransplantation. Locke thinks the first trials will likely involve hearts, not kidneys, because dialysis can keep people with kidney disease alive for several years. There is no comparable substitute for heart function. Dialysis is still an imperfect option, however, and Locke hopes kidney xenotransplants will be next. “I think there is a common misperception that dialysis is an appropriate alternative, and it is not,” Locke says. “People may live a bit longer on dialysis” than on life-extending heart therapies, she says, but dialysis can’t replace kidney function in the long term. Only transplants can do that. “We now have an alternative organ source that I genuinely believe is better than dialysis,” she says. “And it’s time to be able to test that.”

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How to Protect Yourself from Smoky Wildfire Air

Skies have been stained a sickly brown in the U.S. Northeast this week. Smoke from numerous wildfires in Canada has circulated hundreds of miles down the East Coast, as far south as South Carolina. The dense plumes triggered unhealthy air quality alerts in 18 states as of 6 P.M. Eastern Daylight Time on Wednesday.

“Fires see no boundaries. There’s actually no safe distance from wildfire smoke,” says Kari Nadeau, chair of the department of environmental health at the Harvard T. H. Chan School of Public Health and a member of the U.S. Wildland Fire Mitigation and Management Commission. Nadeau, who is currently working with wildfire firefighters, has seen firsthand what constant wildfire smoke exposure can do to health. But as climate change makes fires more frequent and intense, “no one is immune to the effects of wildfire smoke,” she says. “Everyone is going to be vulnerable at some point, but some people are more vulnerable.”

People—especially those with preexisting conditions such as lung disease or asthma—are advised to stay indoors if possible. “Breathe the air with caution,” says Ilona Jaspers, a toxicologist and professor at the University of North Carolina at Chapel Hill. North Carolina is in code orange on the Air Quality Index.

Scientific American spoke to Nadeau and Jaspers about the health impacts of wildfire smoke exposure, who is most vulnerable to health risks, and measures you can take to protect yourself.

[An edited transcript of the interview follows.]

How does the wildfire smoke differ regionally?

JASPERS: Wildfire smoke is sort of a moving target because it always depends on where the emissions are coming from—where the fire is burning. It’s very different depending on whether it’s on the East Coast or the West Coast because different regions have different vegetation. That will change the mixture. Now, increasingly, wildfires are also encroaching on residential property and human-made anthropogenic sources. That’s when you start burning plastics, household items, installations, things like that. You increase your mixture to include a lot more toxic chemicals.

NADEAU: What people in Boston, New York City or New Jersey are breathing in [right now] is basically smoke from wildfires in Canada. Even hundreds of miles away, you can still inhale that. The fires in Canada most likely are covering a lot of organic material in forests. But wildfire smoke often is not wild anymore. The wildfires in the U.S., for example, burn mostly forests but also a lot of times burn materials in residential communities.

What’s in wildfire smoke?

NADEAU: Oftentimes wildfire smoke is very similar to what’s in air pollution. When you’re burning petroleum, you’re basically burning trees that are millions of years old that were just compacted into oil. There are almost 200 different toxins in air pollution, and it’s the same thing with wildfire smoke. But in addition to burning trees and burning organic material, you’re burning paint thinners, you’re burning paint, you’re burning detergents, you’re burning shampoo, you’re burning the upholstery of your sofa, you’re burning your car. And so add that onto typical air pollution, and you get a lot of trouble in terms of toxins that can affect your health.

What we look at in air pollution is something called particulate matter 2.5 [PM_2.5, particulate matter with a diameter of 2.5 microns or smaller]. Those are particles that you can’t even see, but they go into your lungs. A lot of times when there’s smoke or there’s pollution, we can smell it. But what we’re smelling is not just the particulate matter; we’re smelling what we call volatile organic compounds, which are also not safe. Those are compounds that escape even masks, and they go into our lungs, and they’re also toxic.

What are potential health effects of wildfire smoke?

NADEAU: Typically, even within eight hours of being exposed to a minimum amount of wildfire smoke even hundreds of miles away, you can start feeling an itchy throat, you can start coughing, your eyes start watering, your skin starts itching. Any one person can have any of those symptoms or maybe none, but the wildfire smoke is still affecting you.

Within days to weeks, you can start seeing changes in asthma, heart attack, stroke, especially in children and elderly communities. [There are] more chronic effects. Women who are pregnant really should be careful because they can either have premature or still birth, or they themselves can be affected because their metabolism is different from nonpregnant women. Children also have increased metabolism, so they can take up these toxins. Chronic conditions such as mental stress disorders are also part of what we need to look into. Finally, cancers: there was a paper published last year that showed that brain cancer and lung cancer are increased not only in wildfire fighters but also communities that have been exposed for many years from smoke exposure because of wildfires. They don’t have to be close to wildfire to have those cancer effects; they can be hundreds of miles away.

Who is most at risk of health issues from wildfire smoke?

JASPERS: Definitely people with preexisting conditions, such as cardiopulmonary disease, asthma, chronic obstructive pulmonary disease (COPD), and certainly children with preexisting conditions, should remain indoors if possible. If you need to go outside and work, do so with caution. Don’t go exercise outside. Wildfire smoke exposure can exacerbate the disease or worsen the disease. A lot of people with asthma have controlled asthma, and this would basically exacerbate their ability to control the disease—so increased use of medication, wheezing, shortness of breath, difficulty breathing.

NADEAU: There are certain populations that are at higher risk of having wildfire-smoke-related health issues. It’s especially dangerous for children, for the elderly and for people who are already at high risk for being exposed to other environmental toxic chemicals. Kids younger than five years of age can have an increase in asthma by about twofold. Wildfire smoke can even induce asthma in a child that otherwise doesn’t have asthma—so it doesn’t just make your asthma worse; it can actually induce it.

Another population that we need to be careful about is the elderly. If you’re older than 65 years of age, and you’ve been exposed to, let’s say, zero to five days of wildfire smoke even hundreds of miles away, you can start to see an increase in heart attacks, as well as stroke. Some people report that the increased risk of stroke goes up by 40 percent, compared with baseline before the wildfire smoke exposure. We’re only as good as our data, but that’s the approximation. It’s real, and it’s very serious.

Unfortunately, people of color and underserved communities are most affected by these extreme weather events. Those people are already at risk because of red zoning, because of all the unfortunate colonization and discrimination that’s occurring. More than half of people of color and discriminated communities in the U.S. will live near a toxic waste dump or a pollutant industry. So wildfire will not only affect their body, but they already have had sensitization to other toxicants.

What can people do to protect themselves?

JASPERS: COVID may be under control, but you can use the masks for the smoke. You won’t get protection from the gas components or volatile organic compounds, but masks may protect from the particulate matter. So they could be protective in the context of wildfires. If you’re going outdoors, put your mask back on. It’s simple and very doable. It’s not an intervention but a management.

You can also look up if your air is safe to breathe. There are some Environmental Protection Agency–supported websites where you can look in your zip code and find if the air is a code red or a code orange and what that means. One called AirNow.gov allows you to put in your zip code, and it tells you what the air is like in your area. There’s an app called Smoke Sense, a crowdsourcing project that was developed by my colleagues from the EPA. It’s another resource to empower citizens about what the wildfire smoke exposure could do to their health and what steps to take.

NADEAU: The first thing is to wear protective gear such as N95 masks and stay indoors if you can. There are some occupations where people have to work outdoors. So I would say to their employers, and for themselves, to please wear an N95 mask, try to minimize your exposure and check the air quality indices. Then the second, if you can, is to evacuate and go to a place that is not as smoky. But not everyone can do that and it’s hard when you can’t really predict if the winds [will] change. The third is to get an air filter for your home, if you can. Getting air filters for your home can be expensive, however.

Typically, when there’s wildfire smoke, it’s often hot outside, so you’re also dealing with heat stress. If people can go to a cool, air-filtered room, that would be great. So to be able to provide cooling centers in cities is important. I think the other thing people can do is contact their local governments and make sure that there are protections that are given, that there are evacuation plans for communities already set in place before a wildfire or wildfire smoke exposure happens.

The next thing people can do on an individual basis is to go to their doctors. If they’re feeling sick or they’re having headaches or they know there’s wildfire smoke in the air, and they’re not feeling well, [they should] go to [their] health care professional.

Importantly, this is stressful. If people start to get stressed and feel anxious, [they should] go and talk to others and go to a counselor. A lot of people can get post-traumatic stress disorder after seeing an orange sky for 14 days because they don’t know what’s going to happen. That anxiety and that dealing with the unknown is something that we all need to be compassionate about and acknowledge and give people agency to talk about to others.

It’s a wake-up call for all of us to think about solutions facing research and think about if we can mitigate and do prescribed burns. If we can do better forest management, if we can reduce greenhouse gasses, we could protect our firefighters and communities better. There’s already data to show that better forest management results in decreased wildfire smoke exposure to communities. There’s a lot of hope and promise here that we can start being that solution.

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Elite athletes with genetic heart disease can safely return to play with diagnosis and treatment, early study suggests | CNN

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In a new study, most elite athletes with a diagnosed genetic heart disease did not experience serious or fatal symptoms of their condition, such as sudden cardiac death. The research suggests it can be “feasible” and “safe” for athletes to continue to participate in their sport.

Among a sample of 76 elite athletes with a genetic heart disease who had competed or are still competing in either Division I university or professional sports, 73 out of the 76 did not experience a cardiac event triggered by their disease during the study period, according to researchers behind a late-breaking clinical trial presented Monday at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology.

Among those elite athletes with a genetic heart disease, 40 of them – 52% – were asymptomatic, the study abstract finds.

Over the years, researchers have become more aware of alarming reports about elite athletes experiencing heart problems, or even suddenly collapsing during games.

“For athletes with genetic heart conditions, and I would add non-athletes, the tragedies occur when we don’t know of their condition,” said Dr. Michael Ackerman, a genetic cardiologist at Mayo Clinic in Rochester, Minnesota, who was a senior author of the new research. “When we know of their condition, and we assess the risk carefully and we treat it well, these athletes and non-athletes, they can expect to live and thrive despite their condition.”

The new research has not yet been published in a peer-reviewed journal, but the findings suggest that many athletes with a genetic heart disease can decide with their health care professionals on whether to continue competing in their sport and how to do so safely, instead of being automatically disqualified due to their health conditions.

“In sports, historically, we’ve been paternalistic and de-emphasize patient preference and risk tolerance, but we know that athletes come from all walks of life. They are intelligent and when there’s scientific uncertainty, their values should be incorporated in medical decision-making,” Dr. J. Sawalla Guseh, cardiologist at Massachusetts General Hospital, who was not involved in the new study, said during Monday’s scientific session.

“Shared decision-making when done well can have very favorable outcomes,” he said.

Elite basketball, hockey, soccer and football players, were among the 76 athletes included in the new study, conducted by researchers at Mayo Clinic and other institutions in the United States. They wrote in their study abstract that this is the first study to their knowledge describing the experience of athletes competing at the NCAA Division I level or in professional sports with a known genetic heart disease that puts them at risk of sudden cardiac death.

The athletes in the study were cleared for return-to-play at either a NCAA Division I school or at the professional level. They were studied over an average of seven years, and all had been diagnosed with a genetic heart disease in the past 20 years, being treated at either Mayo Clinic, Morristown Medical Center, Massachusetts General Hospital or Atrium Health Sports Cardiology Center.

“Only three of them had a breakthrough cardiac event, which means after they were diagnosed and treated, they were still having an event,” said Katherine Martinez, an undergraduate student at Loyola University in Baltimore, who helped conduct the research as an intern in the Mayo Clinic’s Windland Smith Rice Sudden Death Genomics Laboratory.

Fainting was the most common event, and one athlete received a shock with an implantable cardioverter defibrillator, or ICD. None of the athletes died.

“The majority of these athletes went on to continue their career with no events at all,” Martinez said. But most of the athletes in the study – 55 of them, or 72% – were initially disqualified from competing by their primary provider or institution after their diagnosis. Most ultimately opted to return to play with no restrictions after undergoing comprehensive clinical evaluations and talking with their doctors.

While each sports league has its own set of rules, historically, some people diagnosed with a genetic heart disease that puts them at an increased risk for sudden cardiac death have been restricted from competitive sports, the researchers wrote in their study abstract.

“Just because you were given this diagnosis, doesn’t mean that your life, your career, the future that you see for yourself is over, but taking a second opinion from an expert who knows what they’re doing and is comfortable with shared decision-making is the next step,” said Martinez, who worked on the new research alongside her father, Dr. Matthew Martinez, director of Atlantic Health System Sports Cardiology at Morristown Medical Center and an author of the new research.

Regarding the new study, “the take-home message is, if you have one of these findings, seek out an expert who’s going to help you identify a safe exercise plan for you and determine what level you can continue to safely participate in,” he said. “This is the next best step – the next evolution – of how we manage athletes with genetic heart disease.”

Leaving their sport due to a genetic heart disease can be “very destructive” for athletes who have devoted their lives to excelling in competitions, said Dr. Lior Jankelson, director of the Inherited Arrhythmia Program at NYU Langone Heart in New York, who was not involved in the new research.

Yet he added that these athletes still need to consult with their doctors and be watched closely because some genetic diseases could be more likely to cause a serious cardiac event than others.

The new study highlights that “the majority of athletes with genetic heart disease could probably – after careful, meticulous expert risk-stratification and care strategy – participate in sports,” Jankelson said. “But at the same time, this is exactly the reason why these patients should be cared only in high-expertise genetic cardiology clinics, because there are other conditions that are genetic, that could respond very adversely to sports, and have a much higher risk profile of developing an arrhythmia during intense activity.”

Separately, the NCAA Sports Science Institute notes on its website, “Though many student-athletes with heart conditions can live active lives and not experience health-related problems, sudden fatality from a heart condition remains the leading medical cause of death in college athletes.”

For athletes with a genetic heart disease, their symptoms and their family history of cardiac events should be considered when determining their risks, said Dr. Jayne Morgan, a cardiologist with Piedmont Healthcare in Atlanta, who was not involved in the new research.

“Certainly, there is concern with elite athletes competing and whether or not they are being screened appropriately,” Morgan said. But she added that the new research offers “some understanding” to the mental health implications for athletes with a genetic heart disease who may be required to step away from a competitive sport that they love.

“This study, I think, begins to go a long way in identifying that we may not need to pull the trigger so quickly and have athletes step away from something that they love,” Morgan said.

The new study is “timely” given the recent national attention on athletes and their risk of sudden cardiac death, Dr. Deepak Bhatt, director of Mount Sinai Heart in New York City, who was not involved in the research, said in an email.

“These are some of the best data showing that the risk of return to play may not be as high as we fear,” Bhatt said about the new research.

“Some caveats include that the majority of these athletes were not symptomatic and about a third had an implantable defibrillator,” he added. “Any decision to return to the athletic field should be made after a careful discussion of the potential risks, including ones that are hard to quantify. Input from experts in genetic cardiology and sports cardiology can be very helpful in these cases.”

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Bempedoic acid improved heart health in patients who can’t tolerate statins, study finds | CNN

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Bempedoic acid may be an alternative for people who need to lower their cholesterol but can’t or won’t take statins, according to a large study published Saturday in the New England Journal of Medicine.

Statins are the most commonly prescribed cholesterol-lowering drugs that help lower what’s known as the “bad” cholesterol, or low-density lipoprotein (LDL) cholesterol in the blood; more than 90% of adults who take a cholesterol-lowering medicine use a statin, according to the US Centers for Disease Control and Prevention.

Statins are considered safe and effective, but there are millions of people who cannot or will not take them. For some people it causes intense muscle pain. Past research has shown anywhere between 7% and 29% of patients who need to lower cholesterol do not tolerate statins, according Dr. Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and co-author of the new study.

“I see heart patients that come in with terrible histories, multiple myocardial infarction, sometimes bypass surgery, many stents and they say, ‘Doctor, I’ve tried multiple statins, but whenever I take a statin, my muscles hurt, or they’re weak. I can’t walk upstairs. I just can’t tolerate these drugs,’ ” Nissen said. “We do need alternatives for these patients.”

Doctors have a few options, including ezetimibe and a monoclonal antibody called a proprotein convertase subtilisin/kexin type 9, or PCSK9 inhibitors for short.

Bempedoic acid, sold under the name Nexletol, was designed specifically to treat statin-intolerant patients. The FDA approved it for this purpose in 2020, but the effects of the drug on heart health had not been fully assessed until this large trial. The new study was funded in part by Esperion Therapeutics, the maker of Nexletol.

For the study, which was presented Saturday at the American College of Cardiology’s Annual Scientific Session with the World Congress of Cardiology, Nissen and his colleagues enrolled 13,970 patients from 32 countries.

All of the patients were statin intolerant, typically due to musculoskeletal adverse effects. Patients had to sign an agreement that they couldn’t tolerate statins “even though I know they would reduce my risk of a heart attack or stroke or death,” and providers signed a similar statement.

The patients were then randomized into two groups. One was treated with bempedoic acid, the other was given a placebo, which does nothing. Researchers then followed up with those patients for up to nearly five years. The number of men and women in the trial were mostly evenly divided, and most participants, some 91%, were White, and 17% were Hispanic or Latino.

The drug works in a similar way that statins do, by drawing cholesterol out of a waxy substance called plaque that can build up in the walls of the arteries and interfere with the blood flow to the heart. If there is too much plaque buildup, it can lead to a heart attack or stroke.

But bempedoic acid is only activated in the liver, unlike a statin, so it is unlikely to cause muscle aches, Nissen said.

In the trial, investigators found that bempedoic acid was well-tolerated and the percent reduction in the “bad” cholesterol was greater with bempedoic acid than placebo by 21.7%.

The risk of cardiovascular events – including death, stroke, heart attack and coronary revascularization, a procedure or surgery to improve blood flow to the heart – was 13% lower with bempedoic acid than with placebo over a median of 3.4 years.

“The drug worked in primary and secondary prevention patients – that is, patients that had had event and patients who were very high risk for a first event. There were a lot of diabetics. These were very high risk people,” Nissen said. “So the drug met its expectations and probably did a lot better than a lot of people thought it would do.”

In the group that took bempedoic acid, there were a few more cases of gout and gallstones, compared with people who took a placebo.

“The number is small, and weighing that against a heart attack, I think most people would say, ‘OK I’d rather have a little gout attack,’ ” Nissen said.

Bempedoic acid had no observed effect on mortality, but that may be because the observation period was too short to tell if it had that kind of impact. Earlier trials on statins showed the same; it was only after there were multiple studies on statins that scientists were able to show an impact on mortality.

Dr. Howard Weintraub, a cardiologist at NYU Langone Health who did not work on this study, said that while he knows some people will not consider a medication successful unless it reduces mortality, he thinks that is short-sighted.

“I think there’s more to doing medicine then counting body bags,” Weintraub said.”Preventing things that can be life changing, crippling, and certainly change your quality of life forever going forward, and your cost of doing things going forward, I think is a good thing.”

He was pleased to see the results of this trial, especially since the people in this study are often what he called “forgotten individuals” – the millions who could benefit from lowering their cholesterol, but can’t take statins.

“It’s not like their LDL was 180 or 190 or 230, their LDL was 139. This is about average in our country,” Weintraub said. He said often doctors will just tell those patients to watch their diet, but he thinks this suggests they would benefit from medication.

“Both groups primary and secondary prevention got benefit, which I think is impressive with the modest amount of LDL reduction,” Weintraub said.

There are some limitations to this trial. It was narrowly focused on patients with a known statin intolerance. Nissen said the trial was not designed to determine whether bempedoic acid could be an alternative to statins.

“Statins are the gold standard. They are the cornerstone. The purpose of this study was not to replace statins, but to allow an alternative therapy for people who simply cannot take them,” Nissen said.

Bempedoic acid is a much more expensive drug than a statin. There are generic versions of statins and some cost only a few dollars. Bempedoic acid, on the other hand, has no generic alternative and a 30-day supply can cost more than $400, according to GoodRx.

“I think what insurance companies need to recognize that even though this drug is going to cost more than statins, having a heart attack or a stroke or needing a stent is expensive. A 23% reduction in (myocardial infarctions) is a considerable reduction,” Weintraub said.

In an editorial in the New England Journal of Medicine that accompanied the study, Dr. John H. Alexander, who works in the division of cardiology at Duke Clinical Research Institute, Duke Health, Durham said that doctors should take these results into consideration when treating patients with high cholesterol who can’t take statins.

“The benefits of bempedoic acid are now clearer, and it is now our responsibility to translate this information into better primary and secondary prevention for more at-risk patients, who will, as a result, benefit from fewer cardiovascular events,” Alexander wrote.

Dr. Manesh Patel, a cardiologist and volunteer with the American Heart Association who was not a part of the study, said that providers are already prescribing bempedoic acid for some patients, but with this new research, he thinks they will quickly be used with more statin-intolerant patients.

“We continue to see that if we can lower your LDL significantly, we improve people’s cardiovascular health. And so we need as many different arrows in our quiver to try to get that done,” Patel said.

Heart disease is the No. 1 killer for men and women in the world. One person dies every 34 seconds in the US from cardiovascular disease, according to the CDC. About 697,000 people in the US died from heart disease in 2020 alone – about the same number as the population of Oklahoma City.

“Given the number of people that are eligible for statins, which are tens of millions of patients already, the number of people who cannot tolerate statins is in the millions,” Nissen said. “This is a big public health problem and I think we’ve come up with something that directly addresses this.”

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Stem cell therapy may reduce risk of heart attack and stroke in certain heart failure patients, study shows | CNN

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Cell therapy, involving adult stem cells from bone marrow, has been shown to reduce the risk of heart attack and stroke in severe heart failure patients, according to a new study.

A single administration of adult stem cells directly into an inflamed heart, through a catheter, could result in a long-term 58% reduced risk of heart attack or stroke among heart failure patients with reduced ejection fraction, meaning they have a weakened heart muscle, suggests the study, published Monday in the Journal of the American College of Cardiology.

The study is being called the largest clinical trial of cell therapy to date in patients with heart failure, a serious condition that occurs when the heart can’t pump enough blood to meet the body’s needs.

“We followed these patients during several years – three years – and what we found was that their hearts got stronger. We found a very significant reduction in heart attack and stroke, especially in the patient that we measured in their blood that they had more inflammation going on,” said the study’s lead author Dr. Emerson Perin, a practicing cardiologist and medical director at The Texas Heart Institute in Houston.

“That effect, it was there across everyone, but for the patient that had inflammation, it was even more significant,” Perin said. “And there also is evidence that we had a reduction in cardiovascular deaths.”

The therapy involves injecting mesenchymal precursor cells into the heart. These particular stem cells have anti-inflammatory properties, which could improve outcomes in heart failure patients since elevated inflammation is a hallmark feature of chronic heart failure.

More than 6 million adults in the United States have chronic heart failure, and most are treated with drugs that address the symptoms of the condition. The patients included in the new study were all taking medications for heart failure, and the new research suggests that cell therapy can be beneficial when used in conjunction with heart failure drugs.

“You can imagine, we keep everybody going and doing better with the medicine. And now we have a treatment that actually addresses the cause and quiets everything down. So, this line of investigation really has a great future and I can see that, with a confirmatory trial, we can bring this kind of treatment into the mainstream,” Perin said.

“We can treat heart failure differently,” he said. “We have a new weapon against heart failure and this study really opens the door and leads the way for us to be able to get there.”

The new study – sponsored by Australian biotechnology company Mesoblast – included 565 heart failure patients with a weakened heart muscle, ages 18 to 80. The patients were screened between 2014 and 2019 and randomly assigned to either receive the cell therapy or a placebo procedure at 51 study sites across North America.

The patients who received the cell therapy were delivered about 150 million stem cells to the heart through a catheter. The cells came from the bone marrow of three healthy young adult donors.

The researchers, from The Texas Heart Institute and other various institutions in the United States, Canada and Australia, then monitored each patient for heart-related events or life-threatening arrhythmias.

Compared with the patients who received a sham procedure, those treated with the stem cell therapy showed a small but statistically significant strengthening of the muscle of the heart’s left pumping chamber within a year.

The researchers also found that the cell therapy decreased the risk of heart attack or stroke by 58% overall.

“This is a long-term effect, lasting an average of 30 months. So that’s why we’re so excited about it,” Perin said.

Among patients with high inflammation in their bodies, the combined reduced risk of heart attack or stroke was even greater, at 75%, the researchers found.

“These cells directly address inflammation,” Perin said.

“They have little receptors for these inflammatory substances – some of them are called interleukins, and there’s other kinds,” he said. “When you put them into an inflamed heart, it activates the cells and the cells go, ‘Wow, we need to respond. This house is on fire. We need to put out the fire.’ And so they then secrete various anti-inflammatories.”

The researchers wrote in their study that their findings should be considered as “hypothesis generating,” in that they show this cell therapy concept could work, but clinical trials would be needed to specifically confirm the effects of these stem cells on heart attack, stroke and other events. It is still unclear for how long the effects of the stem cell therapy last beyond 30 months and whether patients will need more stem cell injections in the future.

Overall, there were no major differences between the adverse events reported among the patients who received the cell therapy compared with those in the control group, and the researchers reported no major safety concerns.

“We’ve made an enormous step to be able to harness the real power of adult stem cells to treating the heart,” Perin said. “This trial really is a signal of a new era.”

For more than a decade, scientists have been studying potential stem cell therapies for heart failure patients – but more research is needed to determine whether this treatment approach could reduce the amount of hospitalizations, urgent care events or complications among patients with heart failure.

The new study didn’t find that, said cardiologist Dr. Nieca Goldberg, medical director of Atria New York City and clinical associate professor of medicine at NYU Grossman School of Medicine, who was not involved in the latest study.

What the new study did find is that “there may be a population of people that could benefit from the stem cell therapy, particularly people who have inflammation,” Goldberg said.

“It’s actually an interesting therapy, an interesting thing to consider, once more research substantiates its benefit. Because in heart failure, there’s multiple things going on and, particularly for the inflammatory component, this could be an interesting treatment,” she said. “It might have some role in heart failure patients with inflammation.”

The therapy’s effects on heart attack or stroke risks “were positive,” Dr. Brett Victor, a cardiologist at the Cardiology Consultants of Philadelphia, who was not involved in the study, said in an email.

“Specifically, patients who received the stem cell therapy were less likely to have a heart attack or stroke over the next 2.5 years, especially among those who were found to have a high degree of systemic inflammation as measured by a laboratory test,” Victor said in the email, adding that this represents how heart failure has a significant inflammatory component.

Those “positive signals” likely will be evaluated more in subsequent studies, Victor said.

“Current therapies for heart failure including lifestyle modifications, a growing list of excellent medications, and device therapies will continue to be the standard of care for treatment in the near-term,” he said. “I suspect that this trial will continue to move the field forward in studying cardiac cell therapy as we continue to look for ways to not just treat, but actually find a cure for this disease.”

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Zero-calorie sweetener linked to heart attack and stroke, study finds | CNN

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CNN
—

A sugar replacement called erythritol – used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products – has been linked to blood clotting, stroke, heart attack and death, according to a new study.

“The degree of risk was not modest,” said lead study author Dr. Stanley Hazen, director of the Center for Cardiovascular Diagnostics and Prevention at the Cleveland Clinic Lerner Research Institute.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, according to the study, published Monday in the journal Nature Medicine.

“If your blood level of erythritol was in the top 25% compared to the bottom 25%, there was about a two-fold higher risk for heart attack and stroke. It’s on par with the strongest of cardiac risk factors, like diabetes,” Hazen said.

Additional lab and animal research presented in the paper revealed that erythritol appeared to be causing blood platelets to clot more readily. Clots can break off and travel to the heart, triggering a heart attack, or to the brain, triggering a stroke.

“This certainly sounds an alarm,” said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health, a hospital in Denver, who was not involved in the research.

“There appears to be a clotting risk from using erythritol,” Freeman said. “Obviously, more research is needed, but in an abundance of caution, it might make sense to limit erythritol in your diet for now.”

In response to the study, the Calorie Control Council, an industry association, told CNN that “the results of this study are contrary to decades of scientific research showing reduced-calorie sweeteners like erythritol are safe, as evidenced by global regulatory permissions for their use in foods and beverages,” said Robert Rankin, the council’s executive director, in an email.

The results “should not be extrapolated to the general population, as the participants in the intervention were already at increased risk for cardiovascular events,” Rankin said.

The European Association of Polyol Producers declined to comment, saying it had not reviewed the study.

Like sorbitol and xylitol, erythritol is a sugar alcohol, a carb found naturally in many fruits and vegetables. It has about 70% of the sweetness of sugar and is considered zero-calorie, according to experts.

Artificially manufactured in massive quantities, erythritol has no lingering aftertaste, doesn’t spike blood sugar and has less of a laxative effect than some other sugar alcohols.

“Erythritol looks like sugar, it tastes like sugar, and you can bake with it,” said Hazen, who also directs the Cleveland Clinic’s Center for Microbiome and Human Health.

“It’s become the sweetheart of the food industry, an extremely popular additive to keto and other low-carb products and foods marketed to people with diabetes,” he added. “Some of the diabetes-labeled foods we looked at had more erythritol than any other item by weight.”

Erythritol is also the largest ingredient by weight in many “natural” stevia and monkfruit products, Hazen said. Because stevia and monkfruit are about 200 to 400 times sweeter than sugar, just a small amount is needed in any product. The bulk of the product is erythritol, which adds the sugar-like crystalline appearance and texture consumers expect.

The discovery of the connection between erythritol and cardiovascular issues was purely accidental, Hazen said: “We never expected this. We weren’t even looking for it.”

Hazen’s research had a simple goal: find unknown chemicals or compounds in a person’s blood that might predict their risk for a heart attack, stroke or death in the next three years. To do so, the team began analyzing 1,157 blood samples in people at risk for heart disease collected between 2004 and 2011.

“We found this substance that seemed to play a big role, but we didn’t know what it was,” Hazen said. “Then we discovered it was erythritol, a sweetener.”

The human body naturally creates erythritol but in very low amounts that would not account for the levels they measured, he said.

To confirm the findings, Hazen’s team tested another batch of blood samples from over 2,100 people in the United States and an additional 833 samples gathered by colleagues in Europe through 2018. About three-quarters of the participants in all three populations had coronary disease or high blood pressure, and about a fifth had diabetes, Hazen said. Over half were male and in their 60s and 70s.

In all three populations, researchers found that higher levels of erythritol were connected to a greater risk of heart attack, stroke or death within three years.

But why? To find out, researchers did further animal and lab tests and discovered that erythritol was “provoking enhanced thrombosis,” or clotting in the blood, Hazen said.

Clotting is necessary in the human body, or we would bleed to death from cuts and injuries. The same process is constantly happening internally, as well.

“Our blood vessels are always under pressure, and we spring leaks, and blood platelets are constantly plugging these holes all the time,” Hazen said.

However, the size of the clot made by platelets depends on the size of the trigger that stimulates the cells, he explained. For example, if the trigger is only 10%, then you only get 10% of a clot.

“But what we’re seeing with erythritol is the platelets become super responsive: A mere 10% stimulant produces 90% to 100% of a clot formation,” Hazen said.

“For people who are at risk for clotting, heart attack and stroke – like people with existing cardiac disease or people with diabetes – I think that there’s sufficient data here to say stay away from erythritol until more studies are done,” Hazen said.

Oliver Jones, a professor of chemistry at RMIT University in Victoria, Australia, noted that the study had revealed only a correlation, not causation.

“As the authors themselves note, they found an association between erythritol and clotting risk, not definitive proof such a link exists,” Jones, who was not involved in the research, said in a statement.

“Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” Jones said.

In a final part of the study, eight healthy volunteers drank a beverage that contained 30 grams of erythritol, the amount many people in the US consume, Hazen said, according to the National Health and Nutrition Examination Survey, which examines American nutrition each year.

Blood tests over the next three days tracked erythritol levels and clotting risk.

“Thirty grams was enough to make blood levels of erythritol go up a thousandfold,” Hazen said. “It remained elevated above the threshold necessary to trigger and heighten clotting risk for the following two to three days.”

Just how much is 30 grams of erythritol? The equivalent of eating a pint of keto ice cream, Hazen said.

“If you look at nutrition labels on many keto ice creams, you’ll see ‘reducing sugar’ or ‘sugar alcohol,’ which are terms for erythritol. You’ll find a typical pint has somewhere between 26 and 45 grams in it,” he said.

“My co-author and I have been going to grocery stores and looking at labels,” Hazen said. “He found a ‘confectionery’ marketed to people with diabetes that had about 75 grams of erythritol.”

There is no firm “accepted daily intake,” or ADI, set by the European Food Safety Authority or the US Food and Drug Administration, which considers erythritol generally recognized as safe (GRAS).

“Science needs to take a deeper dive into erythritol and in a hurry, because this substance is widely available right now. If it’s harmful, we should know about it,” National Jewish Health’s Freeman said.

Hazen agreed: “I normally don’t get up on a pedestal and sound the alarm,” he said. “But this is something that I think we need to be looking at carefully.”

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Is your school equipped to save a life? Here’s how you’ll know | CNN

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CNN
—

When 24-year-old Buffalo Bills safety Damar Hamlin collapsed on the field from cardiac arrest during the January 2 game against the Cincinnati Bengals, millions of people witnessed a remarkable resuscitation in real time on live television.

As a trauma neurosurgeon myself, I was in awe of the dozens of medical professionals – athletic trainers, doctors and EMTs – who put their years of training into action within seconds. The immediate recognition that this wasn’t a routine injury and the speedy administration of CPR and defibrillation saved his heart, his brain and his life. Six weeks later, we now hear Dr. Thomas Mayer, the medical director of the NFL Players Association, say “I guarantee you that Damar Hamlin will play professional football again.”

The rescue response was awesome to watch and reflected the remarkable resources and planning that go into every game played in the NFL. As a parent, though, I couldn’t help but wonder what would’ve happened if Hamlin faced this when he was still in high school. What if it would’ve happened to any of my three teenage kids at their school? Would they have been saved as well?

Sudden cardiac deaths are rare in young people, but you may be surprised to know that the US Centers for Disease Control and Prevention estimates that there are about 2,000 such deaths in people under the age of 25 every year.

While the overall number of cardiac arrests has stayed largely consistent, there is no question that school safety efforts – and cardiac arrest survival rates – have improved over the years. Florida was the first state to enact laws requiring automated external defibrillators, or AEDs, in schools in 1999, and there are now 20 states, along with the District of Columbia, with similar mandates, according to the American College of Cardiology. Even in most of the states with no requirement on the books, AEDs are available in the majority of schools.

Most venues with more than 200 people – large businesses, stadiums, casinos and concert halls – are required to have AEDs as well, but there has been a major focus on schools in recent decades, considering that about 20% of the US population is on school grounds at any one time. In the past quarter-century, we went from hardly any AEDs being present in schools to a remarkable awareness of the lifesaving potential they hold. That increased awareness and attention to defibrillators and CPR has directly resulted in more athletes surviving, says Dr. Jonathan Drezner, director of the University of Washington Medicine Center for Sports Cardiology and team physician for the Seattle Seahawks.

He points out that when he began investigating sudden cardiac arrest in young athletes in the early 2000s, survival rates hovered around 11%. A more recent study of young athletes from 2014 to 2018 found that survival rates have climbed to an average of 68%. That’s an improvement of more than 500% in less than two decades.

Still, we can and must do better, especially at the high school level. While there is increased awareness and availability of AEDs, none of that matters if the lifesaving device can’t be accessed within two to three minutes.

As part of a CNN investigation, we wanted a detailed understanding not just of AED availability in schools but of real-life accessibility. Speed matters when someone has suddenly dropped due to cardiac arrest. The best estimates are that every minute without defibrillation reduces survival by up to 10%.

That’s why Dr. Victoria Vetter, a cardiologist with the Cardiac Center at Children’s Hospital of Philadelphia, told us that “just having an AED is not sufficient.”

“You need to make sure that there is an accessible AED that is not locked in the nurse’s office or in some back office,” Vetter said.

The American Heart Association recommends that defibrillators be placed within a two- to three-minute walk. Unfortunately, even in schools that have diligently purchased devices – typically at a cost of $1,000 to $2,000 – too many of them are not readily accessible.

One small study of secondary public schools in Ohio and southeast Michigan found that in more than 70% of the 24 public schools surveyed, the devices simply couldn’t be reached in time. Another study of schools in Oregon found that people in just half of the schools surveyed could access the devices within four minutes of a field or arena. In Vermont, 81% of the state’s 74 schools had defibrillators near athletic fields or arenas; half of the time, the AEDs were kept in the main office, with the nurse or in the lobby.

As part of our investigation, we defined AED access as knowing where the AEDs are in case of emergency. But it is essential to make sure they are always fully charged and that drills are regularly run to ensure people know how to use them.

“We have fire drills in schools generally, every month. We have active shooter drills. But we do not in most schools have sudden cardiac arrest drills,” Vetter said.

Nationally, she said, just a handful of states require schools to practice cardiac emergency plans.

Many people have held up the NFL’s cardiac response as the gold standard: quick action and accessibility. Watching the remarkable 30-person team of professionals who saved Hamlin, many would argue that most high schools don’t have the resources to employ dozens of medical professionals.

But it doesn’t take an army to save a life.

“A single person can save a young athlete’s life if they promptly recognize cardiac arrest, call for help, start CPR and someone gets the AED,” said the Seahawks’ Drezner. “The treatment algorithm really is that simple.”

For many schools, that person would be an athletic trainer, the medical professional on the field.

And yet, in about a third of the nation’s high schools, there is no access to athletic trainers at all.

“You have to ask yourself: When those athletes get injured, who’s addressing those injuries? Who’s there to provide the emergency action plan in case something like this happens?” asked Kathy Dieringer, president of the National Athletic Trainers’ Association.

Drezner’s work has found that the survival rate from cardiac arrest for young athletes nearly doubled to over 80% when an athletic trainer was present or an AED was used. Part of the reason is that schools with athletic trainers were also the ones most likely to have emergency plans and AEDs. As things stand now, schools least likely to have athletic trainers are in urban or rural areas, and the schools most likely to have them are in the suburbs, areas that tend to have higher incomes.

“If I were a parent, I would ask those questions,” Dieringer said. “Where are the AEDs in my school? Are they accessible, and does someone know how to use them if they’re needed?”

Sudden cardiac arrest is a leading cause of death in young competitive athletes, with one study finding as many as one death every three days in youth sports.

One of those deaths was 16-year-old Matthew Mangine Jr., a soccer player at St. Henry District High School in Erlanger, Kentucky. In 2020, Matthew collapsed on the soccer field.

“There were five AEDs at the school that night, and one wasn’t brought to him,” his father, Matthew Mangine Sr., told the local news. “That night, his initial shock came from EMS. They arrived roughly 12 minutes after he was down.” Matthew died an hour later at the hospital.

John and Luann Ellsessar also know that pain well. They lost their 16-year-old son, Michael, on the football field when he went into cardiac arrest during a game in 2010. “There was no ambulance or AED on the field, and it took 15 minutes for the squad to arrive,” John told CNN. “If that ambulance is arriving 15 minutes later, he’s already 150% gone.” John recalls that the doctors at the hospital worked on Michael for 45 minutes before pronouncing him dead.

Many schools have AEDs on campus, but often, they're hard to find quickly.

Fortunately, this wasn’t the story for Peter Laake. In 2021, the star lacrosse player was already on the varsity team as a freshman at Loyola Blakefield in Towson, Maryland. Peter was hit on the left side in what was apparently a normal play, but what followed wasn’t normal at all. Peter told me he blacked out and collapsed on the field.

Jeremy Parr, the school’s athletic trainer, said he immediately went to Peter’s side and checked for a pulse.

“With no pulse, no breathing, we needed to get the AED and EMS activated as soon as possible,” Parr told me when I spoke with him recently.

CPR was started, and in Peter’s case, the AED data showed that his heart was beating again within two to three minutes.

Within three weeks, Peter was back on the field.

It’s an example of how things should work and could work in all schools.

Training in CPR for all staff, athletic and educational. Availability and accessibility of AEDs with regular drills to make sure execution is flawless. An emergency action plan that is posted and reviewed.

As a parent, you can and should ask about all of this yourself. After witnessing what happened to Hamlin, I did just that with the athletic department at my own children’s school.

In a world where we have many complicated problems, saving someone’s life is possible with the knowledge and resources we have right now. With a plan, it is easy. We often prioritize buses, fields and athletic equipment, but cardiac safety must also be at the top of the list.

As Parr told me, when the unthinkable happens, “every athlete deserves the chance to survive.”

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

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CNN
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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: 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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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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