How To Actually Start A Healthy Lifestyle In The New Year

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Dr. Faye Bate cuts through the trends to give advice that’ll last past January the 2nd:

What actually works

…and is actually easy to implement:

Avoid an All-or-Nothing Mindset

  • Strict, perfectionist approaches often lead to failure and guilt.
  • Small, balanced efforts can be imperfect without being failures!
  • Sustainable habits should integrate seamlessly into daily life..

Focus on Unprocessed vs. Processed Foods

  • Don’t worry overly about calorie counts unless you have a very specific medical reason to do so.
  • Prioritize minimally processed, nutrient-dense foods over highly processed, empty-calorie-dense options.
  • Moderation is key—processed foods don’t need to be eliminated entirely; taking things down by just one tier of processing is already an improvement.

Choose Enjoyable Exercise

  • The best exercise is one you enjoy and can maintain long-term. If something’s not enjoyable, you’ll soon give it up.
  • Trends in fitness shouldn’t dictate your routine—do what works for you.
  • Same goes for “body goals”—fashions come and go, while you’re still going to have more or less the same basic body, so work with it rather than against it.

Prioritize Convenience

  • Convenience plays a critical role in maintaining healthy habits, for similar reasons to the enjoyment (very few people enjoy inconvenience)
  • Example from Dr. Bate: switching to a closer gym led to consistent workouts despite a busy schedule.
  • Apply the same principle to food: plan ahead and stock convenient, healthy options (e.g. frozen vegetables etc).

Keep It Simple

  • Do follow basic health advice: drink water, eat fruits and vegetables, move your body, and see a doctor if needed.
  • Avoid being swayed by sensationalized health trends and headlines designed to sell products—if you want it for a good while first, then maybe you’ll actually use it more than twice.
  • Stick to evidence-based, straightforward habits for long-term health. And check the evidence for yourself! Do not just believe claims!

In short: you will more likely tend to do things that are enjoyable and not too difficult. Start there and work up, keeping things simple along the way. It doesn’t matter if it’s not how everyone else does it; if it works for you, it works for you!

For more on all of these, enjoy:

Click Here If The Embedded Video Doesn’t Load Automatically!

Want to learn more?

You might also like to read:

The Science Of New Year’s Pre-Resolutions

Take care!

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  • Meningitis Outbreak

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    Don’t Let Your Guard Down

    In the US, meningitis is currently enjoying a 10-year high, with its highest levels of infection since 2014.

    This is a big deal, given the 10–15% fatality rate of meningitis, even with appropriate medical treatment.

    But of course, not everyone gets appropriate medical treatment, especially because symptoms can become life-threatening in a matter of hours.

    Most recent stats gave an 18% fatality rate for the cases with known outcomes in the last year:

    CDC Emergency | Increase in Invasive Serogroup Y Meningococcal Disease in the United States

    The quick facts:

    ❝Meningococcal disease most often presents as meningitis, with symptoms that may include fever, headache, stiff neck, nausea, vomiting, photophobia, or altered mental status.

    [It can also present] as meningococcal bloodstream infection, with symptoms that may include fever and chills, fatigue, vomiting, cold hands and feet, severe aches and pains, rapid breathing, diarrhea, or, in later stages, a dark purple rash.

    While initial symptoms of meningococcal disease can at first be non-specific, they worsen rapidly, and the disease can become life-threatening within hours. Immediate antibiotic treatment for meningococcal disease is critical.

    Survivors may experience long-term effects such as deafness or amputations of the extremities.❞

    ~ Ibid.

    The good news (but still don’t let your guard down)

    Meningococcal bacteria are, happily, not spread as easily as cold and flu viruses.

    The greatest risks come from:

    • Close and enduring proximity (e.g. living together)
    • Oral, or close-to-oral, contact (e.g. kissing, or coughing nearby)

    Read more:

    CDC | Meningococcal Disease: Causes & How It Spreads

    Is there a vaccine?

    There is, but it’s usually only offered to those most at risk, which is usually:

    • Children
    • Immunocompromised people, especially if HIV+
    • People taking certain medications (e.g. Solaris or Ultomiris)

    Read more:

    CDC | Meningococcal Vaccine Recommendations

    Will taking immune-boosting supplements help?

    Honestly, probably not, but they won’t harm either. The most important thing is: don’t rely on them—too many people pop a vitamin C supplement and then assume they are immune to everything, and it doesn’t work like that.

    On a tangential note, for more general immune health, you might also want to check out:

    Beyond Supplements: The Real Immune-Boosters!

    The short version:

    If you or someone you know experiences the above-mentioned symptoms, even if it does not seem too bad, get thee/them to a doctor, and quickly, because the (very short) clock may be ticking already.

    Better safe than sorry.

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  • What’s the difference between vegan and vegetarian?

    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 difference? is a new editorial product that explains the similarities and differences between commonly confused health and medical terms, and why they matter.

    Vegan and vegetarian diets are plant-based diets. Both include plant foods, such as fruits, vegetables, legumes and whole grains.

    But there are important differences, and knowing what you can and can’t eat when it comes to a vegan and vegetarian diet can be confusing.

    So, what’s the main difference?

    Creative Cat Studio/Shutterstock

    What’s a vegan diet?

    A vegan diet is an entirely plant-based diet. It doesn’t include any meat and animal products. So, no meat, poultry, fish, seafood, eggs, dairy or honey.

    What’s a vegetarian diet?

    A vegetarian diet is a plant-based diet that generally excludes meat, poultry, fish and seafood, but can include animal products. So, unlike a vegan diet, a vegetarian diet can include eggs, dairy and honey.

    But you may be wondering why you’ve heard of vegetarians who eat fish, vegetarians who don’t eat eggs, vegetarians who don’t eat dairy, and even vegetarians who eat some meat. Well, it’s because there are variations on a vegetarian diet:

    • a lacto-ovo vegetarian diet excludes meat, poultry, fish and seafood, but includes eggs, dairy and honey
    • an ovo-vegetarian diet excludes meat, poultry, fish, seafood and dairy, but includes eggs and honey
    • a lacto-vegetarian diet excludes meat, poultry, fish, seafood and eggs, but includes dairy and honey
    • a pescatarian diet excludes meat and poultry, but includes eggs, dairy, honey, fish and seafood
    • a flexitarian, or semi-vegetarian diet, includes eggs, dairy and honey and may include small amounts of meat, poultry, fish and seafood.

    Are these diets healthy?

    A 2023 review looked at the health effects of vegetarian and vegan diets from two types of study.

    Observational studies followed people over the years to see how their diets were linked to their health. In these studies, eating a vegetarian diet was associated with a lower risk of developing cardiovascular disease (such as heart disease or a stroke), diabetes, hypertension (high blood pressure), dementia and cancer.

    For example, in a study of 44,561 participants, the risk of heart disease was 32% lower in vegetarians than non-vegetarians after an average follow-up of nearly 12 years.

    Further evidence came from randomised controlled trials. These instruct study participants to eat a specific diet for a specific period of time and monitor their health throughout. These studies showed eating a vegetarian or vegan diet led to reductions in weight, blood pressure, and levels of unhealthy cholesterol.

    For example, one analysis combined data from seven randomised controlled trials. This so-called meta-analysis included data from 311 participants. It showed eating a vegetarian diet was associated with a systolic blood pressure (the first number in your blood pressure reading) an average 5 mmHg lower compared with non-vegetarian diets.

    It seems vegetarian diets are more likely to be healthier, across a number of measures.

    For example, a 2022 meta-analysis combined the results of several observational studies. It concluded a vegetarian diet, rather than vegan diet, was recommended to prevent heart disease.

    There is also evidence vegans are more likely to have bone fractures than vegetarians. This could be partly due to a lower body-mass index and a lower intake of nutrients such as calcium, vitamin D and protein.

    But it can be about more than just food

    Many vegans, where possible, do not use products that directly or indirectly involve using animals.

    So vegans would not wear leather, wool or silk clothing, for example. And they would not use soaps or candles made from beeswax, or use products tested on animals.

    The motivation for following a vegan or vegetarian diet can vary from person to person. Common motivations include health, environmental, ethical, religious or economic reasons.

    And for many people who follow a vegan or vegetarian diet, this forms a central part of their identity.

    Woman wearing and pointing to her t-shirt with 'Go vegan' logo
    More than a diet: veganism can form part of someone’s identity. Shutterstock

    So, should I adopt a vegan or vegetarian diet?

    If you are thinking about a vegan or vegetarian diet, here are some things to consider:

    • eating more plant foods does not automatically mean you are eating a healthier diet. Hot chips, biscuits and soft drinks can all be vegan or vegetarian foods. And many plant-based alternatives, such as plant-based sausages, can be high in added salt
    • meeting the nutrient intake targets for vitamin B12, iron, calcium, and iodine requires more careful planning while on a vegan or vegetarian diet. This is because meat, seafood and animal products are good sources of these vitamins and minerals
    • eating a plant-based diet doesn’t necessarily mean excluding all meat and animal products. A healthy flexitarian diet prioritises eating more whole plant-foods, such as vegetables and beans, and less processed meat, such as bacon and sausages
    • the Australian Dietary Guidelines recommend eating a wide variety of foods from the five food groups (fruit, vegetables, cereals, lean meat and/or their alternatives and reduced-fat dairy products and/or their alternatives). So if you are eating animal products, choose lean, reduced-fat meats and dairy products and limit processed meats.

    Katherine Livingstone, NHMRC Emerging Leadership Fellow and Senior Research Fellow at the Institute for Physical Activity and Nutrition, Deakin University

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

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  • Inverse Vaccines for Autoimmune Diseases

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    Inverse Vaccines for Autoimmune Diseases

    This is Dr. Jeffrey Hubbell. He’s a molecular engineer, with a focus on immunotherapy, immune response, autoimmune diseases, and growth factor variants.

    He’s held 88 patents, and was the recipient of the Society for Biomaterials’ Founders Award for his “long-term, landmark contributions to the discipline of biomaterials”, amongst other awards and honours that would make our article too long if we included them all.

    And, his latest research has been about developing…

    Inverse Vaccines

    You may be thinking: “you mean diseases; he’s engineering diseases?”

    And no, it’s not that. Here’s how it works:

    Normally in the case of vaccine, it’s something to tell the body “hey, if you see something that looks like this, you should kill it on sight” and the body goes “ok, preparing countermeasures according to these specifications; thanks for the heads-up”

    In the case of an inverse vaccine, it’s the inverse. It’s something to tell the body “hey, this thing you seem to think is a threat, it’s actually not, and you should leave it alone”.

    Why this matters for people with autoimmune diseases

    Normally, autoimmune diseases are treated in one or more of the following ways:

    • Dampen the entire immune system (bad for immunity against actual diseases, obviously, and is part of why many immunocompromised people have suffered and died disproportionately from COVID, for example)
    • Give up and find a workaround (a good example of this is Type 1 Diabetes, and just giving up on the pancreas not being constantly at war with itself, and living on exogenous insulin instead)

    Neither of those are great.

    What inverse vaccines do is offer a way to flag the attacked-in-error items as acceptable things to have in the body. Those might be things that are in our body by default, as in the case of many autoimmune diseases, or they may even be external items that should be allowed but aren’t, as in the case of gluten, in the context of Celiac disease.

    The latest research is not yet accessible for free, alas, but you can read the abstract here:

    Synthetically glycosylated antigens for the antigen-specific suppression of established immune responses

    Or if you prefer a more accessible pop-science approach, here’s a great explanatory article:

    “Inverse vaccine” shows potential to treat multiple sclerosis and other autoimmune diseases

    Where can we get such inverse vaccines?

    ❝There are no clinically approved inverse vaccines yet, but we’re incredibly excited about moving this technology forward❞

    ~ Dr. Jeffrey Hubbell

    But! Lest you be disappointed, you can get in line already, in the case of the Celiac disease inverse vaccine, if you’d like to be part of their clinical trial:

    Click here to see if you are eligible to be part of their clinical trial

    If you’re not up for that, or if your autoimmune disease is something else (most of the rest of their research is presently focusing on Multiple Sclerosis and Type 1 Diabetes), then:

    • The phase 1 MS trial is currently active, estimated completion in summer 2024.
    • They are in the process of submitting an investigational new drug (IND) application for Type 1 Diabetes
      • This is the first step to starting clinical safety and efficacy trials

    …so, watch this space!

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  • Cacao vs Carob – Which is Healthier?

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    Our Verdict

    When comparing cacao to carob, we picked the cacao.

    Why?

    It’s close, and may depend a little on your priorities!

    In terms of macros, the cacao has more protein and fat, while the carob has more carbohydrates, mostly sugar. Since people will not generally eat this by the spoonful, and will instead either make drinks or cook with it, we can’t speak for the glycemic index or general health impact of the sugars. As for the fats, on the one hand the cacao does contain saturated fat; on the other, this merely means that different saturated fat will usually be added to the carob if making something with it. Still, slight win for the carob on the fat front. Protein, of course, is entirely in cacao’s favor.

    In the category of vitamins and minerals, they’re about equal on vitamins, while cacao wins easily on the mineral front, boasting more copper, iron, magnesium, manganese, and phosphorus.

    While both have a generous antioxidant content, this one’s another win for cacao, with about 3x the active polyphenols and flavonoids.

    In short: both are good, consumed in moderation and before adding unhealthy extra ingredients—but we say cacao comes out the winner.

    If you’re looking specifically for the above-depicted products, by the way, here they are:

    Cacao powder | Carob powder

    Want to learn more?

    You might like to read:

    Enjoy!

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  • The 4 Bad Habits That Cause The Most Falls While Walking

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    The risk of falling becomes greater (both in probability and in severity of consequences) as we get older. But, many people who do fall do so for the same reasons, some of which are avoidable. Dr. Doug Weiss has advice based on extensive second-hand experience:

    Best foot forward!

    If any of these prompt a “surely nobody does that” response, then, good for you to not have that habit, but Dr. Weiss has seen many patients who thusly erred. And if any of these do describe how you walk, then well, you’re not alone—time to fix it, though!

    • Walking with Stiff Legs: walking with a hyperextended (straight) knee instead of a slight bend (5-15°) makes it harder to adjust balance, increasing the risk of falls. This can also put extra pressure on the joints, potentially leading to osteoarthritis.
    • Crossing Legs While Turning: turning by crossing one leg over the other is a common cause of falls, particularly in the elderly. To avoid this, when turning step first with the foot that is on the side you are going to go. If you have the bad habit, this may feel strange at first, but you will soon adapt.
    • Looking Down While Walking: focusing only on the ground directly in front of you can cause you to miss obstacles ahead, leading to falls. Instead, practice “scanning”, alternating between looking down at the ground and looking up to maintain awareness of your surroundings.
    • Shuffling Instead of Tandem Walking: shuffling with feet far apart, rather than walking with one foot in front of the other, reduces balance and increases the risk of tripping. Tandem walking, where one foot is placed directly in front of the other, is the safer and more balanced way to walk. It also helps disguise your numbers.

    For more details on all of these, plus visual demonstrations, enjoy:

    Click Here If The Embedded Video Doesn’t Load Automatically!

    Want to learn more?

    You might also like to read:

    Fall Special (How To Not Fall, And How To Minimize Injury If You Do) ← this never seems like an urgent thing to learn, but trust us, it’s more fun to read it now, than from your hospital bed later

    Take care!

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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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