What Menopause Does To The Heart

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World Menopause Day: Menopause & Cardiovascular Disease Risk

Today, the 18th of October, is World Menopause Day.

The theme for this year is cardiovascular disease (CVD), and if your first reaction is to wonder what that has to do with the menopause, then this is the reason why it’s being featured. Much of the menopause and its effects are shrouded in mystery; not because of a lack of science (though sometimes a bit of that too), but rather, because it is popularly considered an unimportant, semi-taboo topic.

So, let’s be the change we want to see, and try to fix that!

What does CVD have to do with the menopause?

To quote Dr. Anjana Nair:

❝The metabolic and clinical factors secondary to menopause, such as dyslipidemia, insulin resistance, fat redistribution and systemic hypertension, contribute to the accelerated risk for cardiovascular aging and disease.

Atherosclerosis appears to be the end result of the interaction between cardiovascular risk factors and their accentuation during the perimenopausal period.

The increased cardiovascular risk in menopause stems from the exaggerated effects of changing physiology on the cardiovascular system.❞

Source: Cardiovascular Changes in Menopause

See also: Menopause-associated risk of cardiovascular disease

Can we do anything about it?

Yes, we can! Here be science:

This (in few words: get your hormone levels checked, and consider HRT if appropriate) is consistent with the advice from gynecologist Dr. Jen Gunter, whom we featured back in August:

What You Should Have Been Told About The Menopause Beforehand

What about lifestyle changes?

We definitely can do some good things; here’s what the science has to say:

For a full low-down on all of these:

Revealing the evidence-based lifestyle solutions to managing your menopause symptoms

Want to know more?

You can get the International Menopause Society’s free downloadable booklet here:

Menopause & Cardiovascular Disease: What Women Need To Know

You may also like our previous main feature:

What Does “Balance Your Hormones” Even Mean?

Take care!

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  • An RSV vaccine has been approved for people over 60. But what about young children?

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    The Therapeutic Goods Administration (TGA) has approved a vaccine against respiratory syncytial virus (RSV) in Australia for the first time. The shot, called Arexvy and manufactured by GSK, will be available by prescription to adults over 60.

    RSV is a contagious respiratory virus which causes an illness similar to influenza, most notably in babies and older adults.

    So while it will be good to have an RSV vaccine available for older people, where is protection up to for the youngest children?

    A bit about RSV

    RSV was discovered in chimpanzees with respiratory illness in 1956, and was soon found to be a common cause of illness in humans.

    There are two key groups of people we would like to protect from RSV: babies (up to about one year old) and people older than 60.

    Babies tend to fill up hospitals during the RSV season in late spring and winter in large numbers, but severe infection requiring admission to intensive care is less common.

    In babies and younger children, RSV generally causes a wheezing asthma-like illness (bronchiolitis), but can also cause pneumonia and croup.

    Although there are far fewer hospital admissions among older people, they can develop severe disease and die from an infection.

    A baby sitting on a bed.
    Babies account for the majority of hospitalisations with RSV.
    Prostock-studio/Shutterstock

    RSV vaccines for older people

    For older adults, there are actually several RSV vaccines in the pipeline. The recent Australian TGA approval of Arexvy is likely to be the first of several, with other vaccines from Pfizer and Moderna currently in development.

    The GSK and Pfizer RSV vaccines are similar. They both contain a small component of the virus, called the pre-fusion protein, that the immune system can recognise.

    Both vaccines have been shown to reduce illness from RSV by more than 80% in the first season after vaccination.

    In older adults, side effects following Arexvy appear to be similar to other vaccines, with a sore arm and generalised aches and fatigue frequently reported.

    Unlike influenza vaccines which are given each year, it is anticipated the RSV vaccine would be a one-off dose, at least at this stage.

    Protecting young children from RSV

    Younger babies don’t tend to respond well to some vaccines due to their immature immune system. To prevent other diseases, this can be overcome by giving multiple vaccine doses over time. But the highest risk group for RSV are those in the first few months of life.

    To protect this youngest age group from the virus, there are two potential strategies available instead of vaccinating the child directly.

    The first is to give a vaccine to the mother and rely on the protective antibodies passing to the infant through the placenta. This is similar to how we protect babies by vaccinating pregnant women against influenza and pertussis (whooping cough).

    The second is to give antibodies directly to the baby as an injection. With both these strategies, the protection provided is only temporary as antibodies wane over time, but this is sufficient to protect infants through their highest risk period.

    A pregnant woman receives a vaccination.
    Women could be vaccinated during pregnancy to protect their baby in its first months of life.
    Image Point Fr/Shutterstock

    Abrysvo, the Pfizer RSV vaccine, has been trialled in pregnant women. In clinical trials, this vaccine has been shown to reduce illness in infants for up to six months. It has been approved in pregnant women in the United States, but is not yet approved in Australia.

    An antibody product called palivizumab has been available for many years, but is only partially effective and extremely expensive, so has only been given to a small number of children at very high risk.

    A newer antibody product, nirsevimab, has been shown to be effective in reducing infections and hospitalisations in infants. It was approved by the TGA in November, but it isn’t yet clear how this would be accessed in Australia.

    What now?

    RSV, like influenza, is a major cause of respiratory illness, and the development of effective vaccines represents a major advance.

    While the approval of the first vaccine for older people is an important step, many details are yet to be made available, including the cost and the timing of availability. GSK has indicated its vaccine should be available soon. While the vaccine will initially only be available on private prescription (with the costs paid by the consumer), GSK has applied for it to be made free under the National Immunisation Program.

    In the near future, we expect to hear further news about the other vaccines and antibodies to protect those at higher risk from RSV disease, including young children.The Conversation

    Allen Cheng, Professor of Infectious Diseases, Monash University

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • Blood-Brain Barrier Breach Blamed For Brain-Fog

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    Move Over, Leaky Gut. Now It’s A Leaky Brain.

    …which is not a headline that promises good news, and indeed, the only good news about this currently is “now we know another thing that’s happening, and thus can work towards a treatment for it”.

    Back in February (most popular media outlets did not rush to publish this, as it rather goes against the narrative of “remember when COVID was a thing?” as though the numbers haven’t risen since the state of emergency was declared over), a team of Irish researchers made a discovery:

    ❝For the first time, we have been able to show that leaky blood vessels in the human brain, in tandem with a hyperactive immune system may be the key drivers of brain fog associated with long covid❞

    ~ Dr. Matthew Campbell (one of the researchers)

    Let’s break that down a little, borrowing some context from the paper itself:

    • the leaky blood vessels are breaching the blood-brain-barrier
      • that’s a big deal, because that barrier is our only filter between our brain and Things That Definitely Should Not Go In The Brain™
    • a hyperactive immune system can also be described as chronic inflammation
      • in this case, that includes chronic neuroinflammation which, yes, is also a major driver of dementia

    You may be wondering what COVID has to do with this, and well:

    • these blood-brain-barrier breaches were very significantly associated (in lay terms: correlated, but correlated is only really used as an absolute in write-ups) with either acute COVID infection, or Long Covid.
    • checking this in vitro, exposure of brain endothelial cells to serum from patients with Long Covid induced the same expression of inflammatory markers.

    How important is this?

    As another researcher (not to mention: professor of neurology and head of the school of medicine at Trinity) put it:

    ❝The findings will now likely change the landscape of how we understand and treat post-viral neurological conditions.

    It also confirms that the neurological symptoms of long covid are measurable with real and demonstrable metabolic and vascular changes in the brain.❞

    ~ Dr. Colin Doherty (see mini-bio above)

    You can read a pop-science article about this here:

    Irish researchers discover underlying cause of “brain fog” linked with long covid

    …and you can read the paper in full here:

    Blood–brain barrier disruption and sustained systemic inflammation in individuals with long COVID-associated cognitive impairment

    Want to stay safe?

    Beyond the obvious “get protected when offered boosters/updates” (see also: The Truth About Vaccines), other good practices include the same things most people were doing when the pandemic was big news, especially avoiding enclosed densely-populated places, washing hands frequently, and looking after your immune system. For that latter, see also:

    Beyond Supplements: The Real Immune-Boosters!

    Take care!

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  • Hearty Healthy Ragù

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    Ragù is a traditional Italian meaty sauce with tomato, and is the base for a number of other Italian dishes. It can be enjoyed as-is, or with very minor modifications can be turned into a Bolognese sauce or a lasagna filling or various other things. Our variations from tradition are mainly twofold here: we’re using nutrition-packed lentils instead of meat (but with a couple of twists that make them meatier), and we’re not using wine.

    Traditionally, red wine is used in a ragù (white wine if you want to make it into a Bolognese sauce, by the way), but with all we’re doing it’s not necessary. If you want to add a splash of wine, we’re not going to call that a healthy ingredient, but we’re also not the boss of you

    You will need

    • 1 large onion (or equivalent small ones), chopped roughly
    • 1 bulb garlic (or to your heart’s content), chopped finely or crushed
    • 4 large tomatoes, chopped (or 2 cans chopped tomatoes)
    • 1 tube (usually about 7 oz) tomato purée
    • 1 cup brown lentils (green lentils will do if you can’t get brown)
    • 1 tbsp chia seeds
    • 1 tbsp black pepper, cracked or coarse ground
    • 1 bunch fresh basil, finely chopped (or 1 tbsp, freeze-dried)
    • 1 bunch fresh oregano, finely chopped (or 1 tbsp, freeze-dried)
    • 1 tbsp nutritional yeast (failing that, 1 tbsp yeast extract, yes, even if you don’t like it, we promise it won’t taste like it once it’s done; it just makes the dish meatier in taste and also adds vitamin B12)
    • 1 tsp cumin, ground (note that this one was tsp, not tbsp like the others)
    • 1 tsp MSG, or 2 tsp low-sodium salt
    • 4 cups water
    • Olive oil for frying (ideally Extra Virgin, but so long as it’s at least marked virgin olive oil and not cut with other oils, that’s fine)
    • Parsley, chopped, to garnish

    Method

    (we suggest you read everything at least once before doing anything)

    1) Put the lentils in a small saucepan, or if you have one, a rice cooker (the rice cooker is better; works better and requires less attention), adding the chia seeds, MSG or low sodium salt, and nutritional yeast (or yeast extract). as well as the cumin. Add 4 cups boiling water and turn on the heat to cook them. This will probably take about 15–20 minutes; you want the lentils to be soft; a tiny bit past al dente, but not so far as mushy.

    2) Fry the onion in some olive oil in a big pan (everything is going in here eventually if the pan is big enough; if it isn’t, you’ll need to transfer to a bigger pan in a bit). Once they’re nearly done, throw in the garlic too. If the lentils aren’t done yet, take the onions and garlic off the heat while you wait. After a few times of doing this recipe, you’ll be doing everything like clockwork and it’ll all align perfectly.

    3) Drain the lentils (if all the water wasn’t absorbed; again, after doing it a few times, you’ll just use the right amount of water for your apparatus) but don’t rinse them (remember you put seasonings in here!), and add them to the pan with the onions and garlic; add a splash more olive oil if necessary, and stir until all the would-be-excess fat is absorbed into the lentils.

    Note: the excess fat to be absorbed by the lentils was a feature not a bug; we wanted a little fat in the lentils! Makes the dish meatier and tastier, as well as more nutrient-dense.

    4) add the tomatoes and tomato purée, stirring them in thoroughly; add the basil and oregano too and stir those in as well. Set it on a low heat for at least 10–15 minutes, stirring occasionally to let the flavors blend.

    (if you happen to be serving pasta with it, then the time it takes to boil water and cook the pasta is a good time for the flavors to do their thing)

    5) take it off the heat, and add the parsley garnish. It’s done!

    Enjoy!

    Want to learn more?

    For those interested in some of the science of what we have going on today:

    Take care!

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  • Revive and Maintain Metabolism

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    It’s Q&A Day at 10almonds!

    Have a question or a request? You can always hit “reply” to any of our emails, or use the feedback widget at the bottom!

    In cases where we’ve already covered something, we might link to what we wrote before, but will always be happy to revisit any of our topics again in the future too—there’s always more to say!

    As ever: if the question/request can be answered briefly, we’ll do it here in our Q&A Thursday edition. If not, we’ll make a main feature of it shortly afterwards!

    So, no question/request too big or small

    ❝How to jump start a inactive metabolism and keep it going? THANKYOU❞

    The good news is, if you’re alive, your metabolism is active (it never stops!). So, it may just need perking up a little.

    As for keeping it going, well, that’s what we’re here for! We’re all in favor of healthy longevity.

    We’ll do a main feature soon on what we can do to influence our metabolism in either direction, but to give some quick notes here:

    • A lot of our metabolism is influenced by genes and is unalterable (without modifying our genes, anyway)
    • Metabolism isn’t just one thing—it’s many. And sometimes, parts of our metabolism can be much quicker or slower than others.
    • When people talk about wanting a “faster metabolism”, they’re usually referring to fat-burning, and that’s just a small part of the picture, but we understand that it’s a focal point for many.

    There really is enough material for a whole main feature on metabolic tweaks, though, so watch this space!

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  • Creatine: Very Different For Young & Old People

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    What’s the Deal with Creatine?

    Creatine is best-known for its use as a sports supplement. It has a few other uses too, usually in the case of helping to treat (or recover from) specific medical conditions.

    What actually is it?

    Creatine is an organic compound formed from amino acids (mostly l-arginine and lysine, can be l-methionine, but that’s not too important for our purposes here).

    We can take it as a supplement, we can get it in our diet (unless we’re vegan, because plants don’t make it; vertebrates do), and we can synthesize it in our own bodies.

    What does it do?

    While creatine supplements mostly take the form of creatine monohydrate, in the body it’s mostly stored in our muscle tissue as phosphocreatine, and it helps cells produce adenosine triphosphate, (ATP).

    ATP is how energy is kept ready to use by cells, and is cells’ immediate go-to when they need to do something. For this reason, it’s highly instrumental in cell repair and rebuilding—which is why it’s used so much by athletes, especially bodybuilders or other athletes that have a vested interest in gaining muscle mass and enjoying faster recovery times.

    See: Creatine use among young athletes

    However! For reasons as yet not fully known, it doesn’t seem to have the same beneficial effect after a certain age:

    Read: Differential response of muscle phosphocreatine to creatine supplementation in young and old subjects

    What about the uses outside of sport?

    Almost all studies outside of athletic performance have been on animals, despite it being suggested as potentially helpful for many things, including:

    • Alzheimer’s disease
    • Parkinson’s disease
    • Huntington’s disease
    • ischemic stroke
    • epilepsy
    • brain or spinal cord injuries
    • motor neuron disease
    • memory and brain function in older adults

    However, research that’s been done on humans has been scant, if promising:

    In short: creatine may reduce symptoms and slow the progression of some neurological diseases, although more research in humans is needed, and words such as “promising”, “potential”, etc are doing a lot of the heavy lifting in those papers we just cited.

    Is it safe?

    It seems so: Creatine supplementation and health variables: a retrospective study

    Nor does it appear to create the sometimes-rumored kidney problems, cramps, or dehydration:

    Common questions and misconceptions about creatine supplementation: what does the scientific evidence really show?

    Where can I get it?

    You can get it from pretty much any sports nutrition outlet, or you can order online. For example:

    Click here to check it out on Amazon!

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  • From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA

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    In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

    In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

    MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

    “It changed the face of cardiac medicine,” Oz said in a video.

    But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

    The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

    Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

    The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

    In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

    In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

    “With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

    An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

    She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

    In other words: They were expected.

    Inspiration in Italy

    When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

    With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

    Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

    A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

    But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

    “I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

    Oz did not respond to a request for comment on that statement.

    As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

    Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

    Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

    Endorsed ‘With Trepidation’

    Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

    Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

    Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

    One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

    FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

    Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

    The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

    Selzman voted yes on the last question “with trepidation,” he said at the time.

    In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

    “The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

    “At least you’re trying to do something for them,” he said.

    Conflicting Studies

    In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

    The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

    A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

    The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

    Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

    Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

    “There are some people who say, ‘Oh, well, you know, these results may have been manipulated,’” he said. “But I can guarantee you that’s not the truth.”

    ‘Nationwide Scheme’

    A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

    The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

    The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

    The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

    Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

    Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

    Reports to the FDA

    As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

    According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

    As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

    Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

    The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

    Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

    MitraClip’s risks weren’t a surprise.

    Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

    Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

    The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

    “These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

    But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

    A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

    If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

    KFF Health News audience engagement producer Tarena Lofton contributed to this report.

    KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

    Subscribe to KFF Health News’ free Morning Briefing.

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