Try This At Home: ABI Test For Clogged Arteries
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Arterial plaque is a big deal, and statistically it’s more of a risk as we get older, often coming to a head around age 72 for women and 65 for men—these are the median ages at which people who are going to get heart attacks, get them. Or get it, because sometimes one is all it takes.
The Ankle-Brachial Index Test
Dr. Brewer recommends a home test for detecting arterial plaque called the Ankle-Brachial Index (ABI), which uses a blood pressure monitor. The test involves measuring blood pressure in both the arms and ankles, then calculating the ratio of these measurements:
- A healthy ABI score is between 1.0 and 1.4; anything outside this range may indicate arterial problems.
- Low ABI scores (below 0.8) suggest plaque is likely obstructing blood flow
- High ABI scores (above 1.4) may indicate artery hardening
Peripheral Artery Disease (PAD), associated with poor ABI results (be they high or low), can cause a whole lot of problems that are definitely better tackled sooner rather than later—remember that atherosclerosis is a self-worsening thing once it gets going, because narrower walls means it’s even easier for more stuff to get stuck in there (and thus, the new stuff that got stuck also becomes part of the walls, and the problem gets worse).
If you need a blood pressure monitor, by the way, here’s an example product on Amazon.
Do note also that yes, if you have plaque obstructing blood flow and hardened arteries, your scores may cancel out and give you a “healthy” score, despite your arteries being very much not healthy. For this reason, this test can be used to raise the alarm, but not to give the “all clear”.
For more on all of the above, plus a demonstration and more in-depth explanation of the test, enjoy:
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The Autoimmune Cure – by Dr. Sara Gottfried
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We’ve featured Dr. Gottfried before, as well as another of her books (“Younger”), and this one’s a little different, and on the one hand very specific, while on the other hand affecting a lot of people.
You may be thinking, upon reading the subtitle, “this sounds like Dr. Gabor Maté’s ideas” (per: “When The Body Says No”), and 1) you’d be right, and 2) Dr. Gottfried does credit him in the introduction and refers back to his work periodically later.
What she adds to this, and what makes this book a worthwhile read in addition to Dr. Maté’s, is looking clinically at the interactions of the immune system and nervous system, but also the endocrine system (Dr. Gottfried’s specialty) and the gut.
Another thing she adds is more of a focus on what she writes about as “little-t trauma”, which is the kind of smaller, yet often cumulative, traumas that often eventually add up over time to present as C-PTSD.
While “stress increases inflammation” is not a novel idea, Dr. Gottfried takes it further, and looks at a wealth of clinical evidence to demonstrate the series of events that, if oversimplified, seem unbelievable, such as “you had a bad relationship and now you have lupus”—showing evidence for each step in the snowballing process.
The style is a bit more clinical than most pop-science, but still written to be accessible to laypersons. This means that for most of us, it might not be the quickest read, but it will be an informative and enlightening one.
In terms of practical use (and living up to its subtitle promise of “cure”), this book does also cover all sorts of potential remedial approaches, from the obvious (diet, sleep, supplements, meditation, etc) to the less obvious (ketamine, psilocybin, MDMA, etc), covering the evidence so far as well as the pros and cons.
Bottom line: if you have or suspect you may have an autoimmune problem, and/or would just like to nip the risk of such in the bud (especially bearing in mind that the same things cause neuroinflammation and thus, putatively, depression and dementia too), then this is one for you.
Click here to check out the Autoimmune Cure, and take care of your body and mind!
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Stevia vs Acesulfame Potassium – Which is Healthier?
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Our Verdict
When comparing stevia to acesulfame potassium, we picked the stevia.
Why?
You may be wondering: is acesulfame potassium a good source of potassium?
And the answer is: no, it is not. Obviously, it does contain potassium, but let’s do some math here:
- Acesulfame potassium is 200x sweeter than sugar
- Therefore replacing a 15g teaspoon of sugar = 75mg acesulfame potassium
- Acesulfame potassium’s full name is “potassium 6-methyl-2,2-dioxo-2H-1,2λ6,3-oxathiazin-4-olate”
- That’s just one potassium atom in there with a lot of other stuff
- Acesulfame potassium has a molar mass of 201.042 g/mol
- Potassium itself has a molar mass of 39.098 g/mol
- Therefore acesulfame potassium is 100(39.098/201.042) = 19.45% potassium by mass
- So that 75mg of acesulfame potassium contains just under 15mg of potassium, which is less than 0.5% of your recommended daily amount of potassium. Please consider eating a fruit instead.
So, that’s that, and the rest of the nutritional values of both sweeteners are just a lot of zeros.
What puts stevia ahead? Simply, based on studies available so far, moderate consumption of stevia improves gut microdiversity, whereas acesulfame potassium harms gut microdiversity:
- The Effects of Stevia Consumption on Gut Bacteria: Friend or Foe?
- The Artificial Sweetener Acesulfame Potassium Affects the Gut Microbiome
Want to give stevia a try?
Here’s an example product on Amazon
Enjoy!
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Increase in online ADHD diagnoses for kids poses ethical questions
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In 2020, in the midst of a pandemic, clinical protocols were altered for Ontario health clinics, allowing them to perform more types of care virtually. This included ADHD assessments and ADHD prescriptions for children – services that previously had been restricted to in-person appointments. But while other restrictions on virtual care are back, clinics are still allowed to virtually assess children for ADHD.
This shift has allowed for more and quicker diagnoses – though not covered by provincial insurance (OHIP) – via a host of newly emerging private, for-profit clinics. However, it also has raised significant ethical questions.
It solves an equity issue in terms of rural access to timely assessments, but does it also create new equity issues as a privatized service?
Is it even feasible to diagnose a child for a condition like ADHD without meeting that child in person?
And as rates of ADHD diagnosis continue to rise, should health regulators re-examine the virtual care approach?
Ontario: More prescriptions, less regulation
There are numerous for-profit clinics offering virtual diagnoses and prescriptions for childhood ADHD in Ontario. These include KixCare, which does not offer the option of an in-person assessment. Another clinic, Springboard, makes virtual appointments available within days, charging around $2,600 for assessments, which take three to four hours. The clinic offers coaching and therapy at an additional cost, also not covered by OHIP. Families can choose to continue to visit the clinic virtually during a trial stage with medications, prescribed by a doctor in the clinic who then sends prescribing information back to the child’s primary care provider.
For-profit clinics like these are departing from Canada’s traditional single-payer health care model. By charging patients out-of-pocket fees for services, the clinics are able to generate more revenue because they are working outside of the billing standards for OHIP, standards that set limits on the maximum amount doctors can earn for providing specific services. Instead many services are provided by non-physician providers, who are not limited by OHIP in the same way.
Need for safeguards
ADHD prescriptions rose during the pandemic in Ontario, with women, people of higher income and those aged 20 to 24 receiving the most new diagnoses, according to research published in January 2024 by a team including researchers from the Centre for Addictions and Mental Health and Holland Bloorview Children’s Hospital. There may be numerous reasons for this increase but could the move to virtual care have been a factor?
Ontario psychiatrist Javeed Sukhera, who treats both children and adults in Canada and the U.S., says virtual assessments can work for youth with ADHD, who may receive treatment quicker if they live in remote areas. However, he is concerned that as health care becomes more privatized, it will lead to exploitation and over-diagnosis of certain conditions.
“There have been a lot of profiteers who have tried to capitalize on people’s needs and I think this is very dangerous,” he said. “In some settings, profiteering companies have set up systems to offer ADHD assessments that are almost always substandard. This is different from not-for-profit setups that adhere to quality standards and regulatory mechanisms.”
Sukhera’s concerns recall the case of Cerebral Inc., a New York state-based virtual care company founded in 2020 that marketed on social media platforms including Instagram and TikTok. Cerebral offered online prescriptions for ADHD drugs among other services and boasted more than 200,000 patients. But as Dani Blum reported in the New York Times, Cerebral was accused in 2023 of pressuring doctors on staff to prescribe stimulants and faced an investigation by state prosecutors into whether it violated the U.S. Controlled Substances Act.
“At the start of the pandemic, regulators relaxed rules around medical prescription of controlled substances,” wrote Blum. “Those changes opened the door for companies to prescribe and market drugs without the protocols that can accompany an in-person visit.”
Access increased – but is it equitable?
Virtual care has been a necessity in rural areas in Ontario since well before the pandemic, although ADHD assessments for children were restricted to in-person appointments prior to 2020.
But ADHD assessment clinics that charge families out-of-pocket for services are only accessible to people with higher incomes. Rural families, many of whom are low income, are unable to afford thousands for private assessments, let alone the other services upsold by providers. If the private clinic/virtual care trend continues to grow unchecked, it may also attract doctors away from the public model of care since they can bill more for services. This could further aggravate the gap in care that lower income people already experience.
This could further aggravate the gap in care that lower income people already experience.
Sukhera says some risks could be addressed by instituting OHIP coverage for services at private clinics (similar to private surgical facilities that offer mixed private/public coverage), but also with safeguards to ensure that profits are reinvested back into the health-care system.
“This would be especially useful for folks who do not have the income, the means to pay out of pocket,” he said.
Concerns of misdiagnosis and over-prescription
Some for-profit companies also benefit financially from diagnosing and issuing prescriptions, as has been suggested in the Cerebral case. If it is cheaper for a clinic to do shorter, virtual appointments and they are also motivated to diagnose and prescribe more, then controls need to be put in place to prevent misdiagnosis.
The problem of misdiagnosis may also be related to the nature of ADHD assessments themselves. University of Strathclyde professor Matthew Smith, author of Hyperactive: The Controversial History of ADHD, notes that since the publication of Diagnostic and Statistical Manual of Mental Disorders in 1980, assessment has typically involved a few hours of parents and patients providing their subjective perspectives on how they experience time, tasks and the world around them.
“It’s often a box-ticking exercise, rather than really learning about the context in which these behaviours exist,” Smith said. “The tendency has been to use a list of yes/no questions which – if enough are answered in the affirmative – lead to a diagnosis. When this is done online or via Zoom, there is even less opportunity to understand the context surrounding behaviour.”
Smith cited a 2023 BBC investigation in which reporter Rory Carson booked an in-person ADHD assessment at a clinic and was found not to have the condition, then had a private online assessment – from a provider on her couch in a tracksuit – and was diagnosed with ADHD after just 45 minutes, for a fee of £685.
What do patients want?
If Canadian regulators can effectively tackle the issue of privatization and the risk of misdiagnosis, there is still another hurdle: not every youth is willing to take part in virtual care.
Jennifer Reesman, a therapist and Training Director for Neuropsychology at the Chesapeake Center for ADHD, Learning & Behavioural Health in Maryland, echoed Sukhera’s concerns about substandard care, cautioning that virtual care is not suitable for some of her young clients who had poor experiences with online education and resist online health care. It can be an emotional issue for pediatric patients who are managing their feelings about the pandemic experience.
“We need to respect what their needs are, not just the needs of the provider,” says Reesman.
In 2020, Ontario opted for virtual care based on the capacity of our health system in a pandemic. Today, with a shortage of doctors, we are still in a crisis of capacity. The success of virtual care may rest on how engaged regulators are with equity issues, such as waitlists and access to care for rural dwellers, and how they resolve ethical problems around standards of care.
Children and youth are a distinct category, which is why we had restrictions on virtual ADHD diagnosis prior to the pandemic. A question remains, then: If we could snap our fingers and have the capacity to provide in-person ADHD care for all children, would we? If the answer to that question is yes, then how can we begin to build our capacity?
This article is republished from healthydebate under a Creative Commons license. Read the original article.
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Mimosa For Healing Your Body & Mind
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Today we’re looking at mimosa (no relation to the cocktail!), which is a name given to several related plant species that belong to the same genus or general clade, look similar, and have similar properties and behavior.
As a point of interest that’s not useful: mimosa is one of those plants whereby if you touch it, it’ll retract its leaves and shrink away from you. The leaves also droop at nighttime (perfectly healthily; they’re not wilting or anything; this too is just plant movement), and spring back up in the daytime.
So that’s what we mean when we say “and behavior” 😉
Antidepressant & anxiolytic
Mimosa bark and leaves have long been used in Traditional Chinese Medicine, as well as (albeit different species) in the North-East of Brazil, and (again, sometimes different species) in Mexico.
Animal studies, in vivo studies, and clinical practice in humans, have found this to be effective, for example:
❝[Mimosa pudica extract] has anti-anxiety, anti-depressant and memory enhancing activities that are mediated through multiple mechanisms❞
Source: Effects of Mimosa pudica L. leaves extract on anxiety, depression and memory
Research is ongoing with regard to how, exactly, mimosa does what it does. Here’s a paper about another species mimosa:
(notwithstanding the genus name, it’s still part of the mimosa clade)
Anti-inflammatory & analgesic
In this case, mimosa has traditionally been used as a topical tincture (for skin damage of many kinds, ranging from cuts and abrasions to burns to autoimmune conditions and more), so what does the science say about that?
❝In summary, the present study provided evidence that the [mimosa extract], its fractions and the isolated compound sakuranetin showed significant anti-inflammatory and antinociceptive activities❞
Wound healing
About those various skin damages, here’s another application, and a study showing that it doesn’t just make it feel better, it actually helps it to heal, too:
❝Therapeutic effectiveness occurred in all patients of the extract group; after the 8th treatment week, ulcer size was reduced by 92% as mean value in this group, whereas therapeutic effectiveness was observed only in one patient of the control group (chi(2), p=0.0001). No side effects were observed in any patient in either group.❞
Very compelling stats!
Read more: Therapeutic effectiveness of a Mimosa tenuiflora cortex extract in venous leg ulceration treatment
Is it safe?
Yes, for most people, with some caveats:
- this one comes with a clear “don’t take if pregnant or breastfeeding” warning, as for unknown reasons it has caused a high incidence of fetal abnormalities or fetal death in animal studies.
- while the stem bark (the kind used in most mimosa supplements and most readily found online) has negligible psychoactivity, as do many species of mimosa in general, the root of M. tenuiflora has psychedelic effects similar to ayahuasca if taken orally, for example as a decoction, if in the presence of a monoamine oxidase inhibitor (MAOI), as otherwise MAO would metabolize the psychoactive component in the gut before it can enter the bloodstream.
That’s several “ifs”, meaning that the chances of unwanted psychedelic effects are slim if you’re paying attention, but as ever, do check with your doctor/pharmacist to be sure.
Want to try some?
We don’t sell it, but here for your convenience is an example product on Amazon 😎
Enjoy!
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Women and Minorities Bear the Brunt of Medical Misdiagnosis
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Charity Watkins sensed something was deeply wrong when she experienced exhaustion after her daughter was born.
At times, Watkins, then 30, had to stop on the stairway to catch her breath. Her obstetrician said postpartum depression likely caused the weakness and fatigue. When Watkins, who is Black, complained of a cough, her doctor blamed the flu.
About eight weeks after delivery, Watkins thought she was having a heart attack, and her husband took her to the emergency room. After a 5½-hour wait in a North Carolina hospital, she returned home to nurse her baby without seeing a doctor.
When a physician finally examined Watkins three days later, he immediately noticed her legs and stomach were swollen, a sign that her body was retaining fluid. After a chest X-ray, the doctor diagnosed her with heart failure, a serious condition in which the heart becomes too weak to adequately pump oxygen-rich blood to organs throughout the body. Watkins spent two weeks in intensive care.
She said a cardiologist later told her, “We almost lost you.”
Watkins is among 12 million adults misdiagnosed every year in the U.S.
In a study published Jan. 8 in JAMA Internal Medicine, researchers found that nearly 1 in 4 hospital patients who died or were transferred to intensive care had experienced a diagnostic error. Nearly 18% of misdiagnosed patients were harmed or died.
In all, an estimated 795,000 patients a year die or are permanently disabled because of misdiagnosis, according to a study published in July in the BMJ Quality & Safety periodical.
Some patients are at higher risk than others.
Women and racial and ethnic minorities are 20% to 30% more likely than white men to experience a misdiagnosis, said David Newman-Toker, a professor of neurology at Johns Hopkins School of Medicine and the lead author of the BMJ study. “That’s significant and inexcusable,” he said.
Researchers call misdiagnosis an urgent public health problem. The study found that rates of misdiagnosis range from 1.5% of heart attacks to 17.5% of strokes and 22.5% of lung cancers.
Weakening of the heart muscle — which led to Watkins’ heart failure — is the most common cause of maternal death one week to one year after delivery, and is more common among Black women.
Heart failure “should have been No. 1 on the list of possible causes” for Watkins’ symptoms, said Ronald Wyatt, chief science and chief medical officer at the Society to Improve Diagnosis in Medicine, a nonprofit research and advocacy group.
Maternal mortality for Black mothers has increased dramatically in recent years. The United States has the highest maternal mortality rate among developed countries. According to the Centers for Disease Control and Prevention, non-Hispanic Black mothers are 2.6 times as likely to die as non-Hispanic white moms. More than half of these deaths take place within a year after delivery.
Research shows that Black women with childbirth-related heart failure are typically diagnosed later than white women, said Jennifer Lewey, co-director of the pregnancy and heart disease program at Penn Medicine. That can allow patients to further deteriorate, making Black women less likely to fully recover and more likely to suffer from weakened hearts for the rest of their lives.
Watkins said the diagnosis changed her life. Doctors advised her “not to have another baby, or I might need a heart transplant,” she said. Being deprived of the chance to have another child, she said, “was devastating.”
Racial and gender disparities are widespread.
Women and minority patients suffering from heart attacks are more likely than others to be discharged without diagnosis or treatment.
Black people with depression are more likely than others to be misdiagnosed with schizophrenia.
Minorities are less likely than whites to be diagnosed early with dementia, depriving them of the opportunities to receive treatments that work best in the early stages of the disease.
Misdiagnosis isn’t new. Doctors have used autopsy studies to estimate the percentage of patients who died with undiagnosed diseases for more than a century. Although those studies show some improvement over time, life-threatening mistakes remain all too common, despite an array of sophisticated diagnostic tools, said Hardeep Singh, a professor at Baylor College of Medicine who studies ways to improve diagnosis.
“The vast majority of diagnoses can be made by getting to know the patient’s story really well, asking follow-up questions, examining the patient, and ordering basic tests,” said Singh, who is also a researcher at Houston’s Michael E. DeBakey VA Medical Center. When talking to people who’ve been misdiagnosed, “one of the things we hear over and over is, ‘The doctor didn’t listen to me.’”
Racial disparities in misdiagnosis are sometimes explained by noting that minority patients are less likely to be insured than white patients and often lack access to high-quality hospitals. But the picture is more complicated, said Monika Goyal, an emergency physician at Children’s National Hospital in Washington, D.C., who has documented racial bias in children’s health care.
In a 2020 study, Goyal and her colleagues found that Black kids with appendicitis were less likely than their white peers to be correctly diagnosed, even when both groups of patients visited the same hospital.
Although few doctors deliberately discriminate against women or minorities, Goyal said, many are biased without realizing it.
“Racial bias is baked into our culture,” Goyal said. “It’s important for all of us to start recognizing that.”
Demanding schedules, which prevent doctors from spending as much time with patients as they’d like, can contribute to diagnostic errors, said Karen Lutfey Spencer, a professor of health and behavioral sciences at the University of Colorado-Denver. “Doctors are more likely to make biased decisions when they are busy and overworked,” Spencer said. “There are some really smart, well-intentioned providers who are getting chewed up in a system that’s very unforgiving.”
Doctors make better treatment decisions when they’re more confident of a diagnosis, Spencer said.
In an experiment, researchers asked doctors to view videos of actors pretending to be patients with heart disease or depression, make a diagnosis, and recommend follow-up actions. Doctors felt far more certain diagnosing white men than Black patients or younger women.
“If they were less certain, they were less likely to take action, such as ordering tests,” Spencer said. “If they were less certain, they might just wait to prescribe treatment.”
It’s easy to see why doctors are more confident when diagnosing white men, Spencer said. For more than a century, medical textbooks have illustrated diseases with stereotypical images of white men. Only 4.5% of images in general medical textbooks feature patients with dark skin.
That may help explain why patients with darker complexions are less likely to receive a timely diagnosis with conditions that affect the skin, from cancer to Lyme disease, which causes a red or pink rash in the earliest stage of infection. Black patients with Lyme disease are more likely to be diagnosed with more advanced disease, which can cause arthritis and damage the heart. Black people with melanoma are about three times as likely as whites to die within five years.
The covid-19 pandemic helped raise awareness that pulse oximeters — the fingertip devices used to measure a patient’s pulse and oxygen levels — are less accurate for people with dark skin. The devices work by shining light through the skin; their failures have delayed critical care for many Black patients.
Seven years after her misdiagnosis, Watkins is an assistant professor of social work at North Carolina Central University in Durham, where she studies the psychosocial effects experienced by Black mothers who survive severe childbirth complications.
“Sharing my story is part of my healing,” said Watkins, who speaks to medical groups to help doctors improve their care. “It has helped me reclaim power in my life, just to be able to help others.”
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.
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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.
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