All posts by Dr. AnthonyP

Cardiologist, blogger, musician

Six Things Employees Should Know About Nutritional Supplements – Courtesy of Quizzify

The skeptical cardiologist recently received an email from Al Lewis, who continues to do great work on his blog and with his company, Quizzify. The email quizzed me about supplements, a topic I’ve written about extensively.

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The linked article is well worth reading and should be required reading for all employers and employees. If there are any CEOs or HR officers in my readership take note and consider changing your approach to employee wellness.


Six Things Employees Should Know

The vast majority of your employees take nutritional supplements, whose consumption just reached an all-time high. That increase means someone, somewhere – maybe even your very own wellness vendor – is telling them this is a good idea.

Or maybe they are thinking: “Hey, what harm can they do?”

Plenty, as it turns out.

Here are six things employees should know about nutritional supplements.

1. Virtually all the benefits of supplements with virtually none of the risk can be achieved by taking a regular multivitamin

There is plenty of evidence for the health benefits of virtually all vitamins and minerals and even a couple of supplements, so much evidence that we have room to highlight only a few.

Examples include fish oil for menopausal women with dry eye or possibly people at high risk of heart attack. Or folic acid for pregnant women and iron for pregnant women who are anemic. Or Vitamin D for people who have dark skin, live in cloudy climates, avoid all sun exposure and/or don’t each much dairy. And of course, Vitamin B12 for vegans. (Vitamin B12 is found only in animal products.)

Women likely benefit from small combined extra amounts of calcium and Vitamin D…but as noted below, don’t overdo it.

The 10% of the population who drink to excess really should be taking daily multivitamins. This is partly because alcohol interferes with absorption, and partly because they aren’t getting enough calories from real foods.

With these exceptions, most people should be getting enough vitamins in a balanced diet, but a few cents a day of an “insurance” multivitamin pays for itself just in the psychological benefit of not worrying about that. However, the story changes when we talk about megavitamins, and especially when we talk about other supplements.

2. Almost every megavitamin which once showed “promise” in fighting cancer, heart disease, etc. doesn’t. Quite the opposite, they may cause harm.

Niacin, once thought to have magical properties against heart attacks, has been completely debunked. Vitamin E supplements could prevent cancer in some women but cause it in others, depending on genes. Men who are concerned about prostate cancer (meaning all of us) should specifically avoid Vitamin E supplements, which likely increase the odds of it. Vitamin D in large quantities is the latest to be debunked, just last month. Taking too much may cause osteoporosis, rather than prevent it.

And monitor your own wellness vendors. Interactive Health, for example, tests every employee for anemia. This is contrary to the advice of clinical guidelines, which oppose anemia screening except for pregnant women, where evidence is mixed. Employees who then take iron supplements risk stomach pain, nausea, vomiting and serious long-term complications.

The good news? It is possible large amounts of Vitamin C do offer modest benefits with respect to common colds, and that those possible benefits outweigh the possible harms. But just large amounts, like 200-400 mg., not massive amounts — and not so large that you need pills.

3. If you have to go to GNC to obtain a supplement, or order it through the mail, it has no value and may cause harm.

CVS and Whole Foods want to make money too, and fancy supplements are expensive high-margin items. So if a supplement has even the slightest inkling of value, they’ll stock it.

As a random example we picked because we like the name, consider horny goatweed, as a treatment for erectile dysfunction (ED). Along with the name, it also has a great back story, something about Mongolian herders observing goats getting aroused after grazing on it.

It is actually proven to work, and not just on goats. It also works on rats. For the rest of us, there is zero evidence. Plus, ED is one of those conditions where, if something worked, we’d know about it by now.

At least the likelihood of harm is pretty low to other than your wallet.

4. There is no such thing as FDA approval for supplements

Supplements are notorious for lax quality control, unproven health claims, and contamination. Did we mention unproven claims? The FDA has no say in the matter of unfounded health claims.

It’s also not entirely clear that these pills contain the ingredients they claim to contain in the quantities they profess to contain. These supplements turn out to be much harder to manufacture to specs than regular synthetically derived pills.

5. They may interact with “real” drugs you are taking

Just because supplements are derived from natural sources doesn’t mean they don’t act like real drugs inside your body. And, like real drugs, they can interact with other drugs. For instance, if you are taking Vitamin E and Advil or Advil PM or a baby aspirin, your risk of bleeding profusely in an accident goes way, way up, because all are blood thinners. The risk isn’t just accidents — small everyday bruises may become big bruises.

Make sure you list supplements when describing to your doctor what you take…though it’s questionable whether (aside from the basics, like that blood-thinning example) the doctor would be aware of these interactions. There are too many to track, and some interactions simply aren’t studied.

It all comes back to this: a one-a-day multivitamin/mineral supplement is more than enough for most people. Not just for the benefits, but for avoidance of the risk of interaction, side effects and unknown long-term impacts.

6. One other “supplement” benefits almost every body system and has no side effects

You guessed it – exercise, the key to health and longevity. If there were a dietary supplement that provided even a small fraction of the benefits of exercise, we’d know about it by now.

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I agree with Al on most everything above except I don’t recommend a multivitamin to my patients. I think a good, balanced diet provides all the vitamins, minerals and unknown nutrients for the vast majority of individuals.

After reviewing the literature I wouldn’t recommend supplementing Vitamin C to prevent colds. I agree with the conclusions from a recent review which admitted there may be a slight benefit from Vitamin C supplements in reducing the severity and duration of the common cold

the practical significance of these findings is not very convincing. It does not seem reasonable to ingest additional vitamin C outside of dietary intake throughout the year if the only benefit is the potential for a slightly shortened cold duration and lessened symptoms.

The National Institutes of Health recommend daily intake of 90 mg of vitamin C for males and 75 mg for females with a focus on getting those amounts from dietary sources, namely, fruits and vegetables. Citrus fruits are a great source of vitamin C. A medium orange has 70 mg of vitamin C, and a medium grapefruit has 78 mg of vitamin C. The National Institutes of Health suggests that consuming 5 varied servings of fruits and vegetables daily can provide more than 200 mg of vitamin C. Supplementation may be needed for those specific patients with marginal vitamin C status such as the elderly and chronic smokers, but the majority of the population should focus on getting vitamin C from their diet.

Inquisitively Yours,

-ACP

Source: Six things employees should know about nutritional supplements – Quizzify

N.B. I have no connection, financial or otherwise, with Quizzify but I did try to get my hospital to consider switching to them from the rather silly wellness vendor we currently have.

This promotional material appears at the end of Al’s article.

Quizzify provides the education employees need to be health-literate, wiser and more confident healthcare consumers

Teach employees how to navigate the ins and outs of their health benefits and gain valuable information about better health practices. With quizzes reviewed by doctors at Harvard Medical School, Quizzify helps employees live healthier lives and save money on healthcare… without collecting any private health information.

Benefits are of no value if employees don’t use them. You can customize Quizzify so that your quiz questions can explain exactly what the value is…and our “learn more” links can point employees to exactly where they need to go.

Omron Complete Consolidates and Simplifies Home ECG and Blood Pressure Monitoring

The skeptical cardiologist has been testing out a unique and ingenious device which allows the simultaneous measurement of two key cardiovascular parameters: blood pressure and heart rhythm.  Omron partnered with AliveCor to create the Complete which is the first combination blood pressure monitor and electrocardiogram monitor.

Given that Alivecor’s Kardia Mobile ECG device is capable of accurately identifying atrial fibrillation, the Complete offers patients the ability to monitor for the two biggest treatable risk factors for stroke: atrial fibrillation and hypertension.

I have evaluated the Complete in both office and home settings and find it to be easy to use and highly reliable.

The main component of Complete is an attractive unit that measures 9 by 4 by 5 inches, weighs a little over a pound and combines the blood pressure monitor and the AliveCor sensors. It ships with a wide-range D-ring BP cuff which fits 9 to 17-inch upper arms and runs on 4 AA batteries.

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Recording Blood Pressure and ECG

You can easily record just blood pressure using the device right out of the box (after inserting the included 4 AA batteries.)  However, the full capabilities of the device are realized in conjunction with Omron’s Connect US/CAN Smartphone app which can be downloaded for free. Once paired with the app, the device can record and transfer ECGs along with blood pressure measurements to the app and the cloud.

The process of recording a single-lead ECG on the Complete  is nearly identical to the process when using the AliveCor Kardia mobile ECG device except that there are four sensors for Complete versus the two sensors on the Kardia device.

After opening the Omron app on your smartphone and pressing the “Record BP and EKG” button, you place the smartphone horizontally on the Complete cradle and put your hands on the sensors with thumbs on the tops sensors and 2-3 fingers on the lateral sensors as illustrated below.

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Once the device senses a good signal the ECG recording will automatically begin and continue for 30 seconds. It’s important to stay very still and quiet during this time to optimize the recording quality.

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Like the Kardia device if your fingers are too dry, electrical contact may be suboptimal. This can be fixed by wetting your fingers with an alcohol wipe, a spray from a sanitizer bottle or just water from the tap. See my discussion on this here.

I found the 4 sensors plus the stability of the device the sensors reside in made for a higher percentage of high-quality ECG recordings on the Complete versus the smaller Kardia device. Stability on the Kardia device is a particular issue for the elderly and we were able to consistently obtain good quality ECG recordings in my office on the frail and elderly with the Complete.

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Typical, easily-obtained, high-quality ECG recording obtained from the Complete

The PDF of the ECG can be emailed to yourself for storage or to your physician for his review. With a Premium plan upgrade, you can store the ECGS online or utilize KardiaPro which shares your BP and ECG data through the cloud with your physician.

Blood Pressure Plus ECG

You can choose to record BP and ECG separately or at the same time. To record both, place the BP cuff on your upper arm,  push the start/stop button and then put your fingers on the ECG sensors. While the ECG is recording, the BP cuff inflates and obtains the BP measurement.

As always when taking BP it is important to make sure the cuff is at the level of the heart.

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Using KardiaPro Online Dashboard With Complete

Many of my patients have both atrial fibrillation and hypertension. For them, the KardiaPro dashboard provides a unique online monitoring system that allows me to view both their blood pressure recordings and their ECG recordings in one spot.

Omron’s Complete now simplifies and consolidates the process of recording BP and ECG for such patients. A typical KardiaPro report from one of my combined AF and hypertensive patients  appears below.

kardiapro bp and ecg

Where Does Complete Fit In The Home Monitoring Universe?

I see Complete serving in two important areas.

The first is as a consolidated unit for patients with atrial fibrillation and hypertension. Complete provides an easy, quick, and stable method for these patients to home monitor their BPs and their rhythm.

The second area is in physician offices. The ability to record a high quality, medical-grade ECG simultaneously with blood pressure will improve the physician’s ability to screen for hypertension and rhythm abnormalities in an efficient manner.

Completely Yours,

-ACP

N.B. Looking at the Omron website today I note that Complete is selling for $159.99, a 20% discount.

Things You Won’t See On The Skeptical Cardiologist: Ads and Clickbait

Readers of the skeptical cardiologist should know that he is protecting them from all sorts of crappy advertisements and meaningless sponsored content on this website.

To my horror the other day as I was putzing around trying to create an afib specific website I saw crawling across my screen what has to be the mother of all annoying clickbait-THE ONE VEGETABLE THAT DESTROYS YOU FROM THE INSIDE!

Getting rid of these advertisements was fairly simple-I upgraded the site to a more premium level.

In the last 12 months, however I feel like The Skeptical Cardiologist has passed some critical traffic threshold and entered the radar screens of digital marketers.

These digital marketers apparently spend their days trying to get their useless content and links placed on sites that have useful content. They do this by crafting emails which appear to be from real readers who are interested in my website and want to help by placing some of their content.

Testosterone Nerd

You’ll be happy to know that I have not agreed to post anything from testosterone nerd whose “main motto is to provide useful infos (sic) for our visitors.”

Greetings from Testosterone Nerd,

I ‘m very much fond of your blog posts and will read all of your posts, it is really interesting and informative.

To let you know a little bit about me, I’m from Testosterone Nerd and our main motto is to provide useful infos for our visitors. It’s all aboutSupplements, Therapies, Food for Fitness etc… Our writers are mainly focusing to provide informative content to visitors who are interested to know more about health and fitness. As I said before, I went through your website and read lots of blog posts and I feel they touch the realm of my work and expertise.

Now we have created FREE detailed infographics which explains about “Ways To Boost Testosterone”. If you’re interested to check out it, please response to this e-mail. So we will provide you to view it.

Waiting for your reply.

Regards, Lilly

Neither did I accept this offer from a “digital marketing manager”

Hello,
I am Kerry Rose, a digital marketing manager. Your website made a good impression on me! So, it would be great if you consider posting my written article. If it’s possible, could you please inform me about the conditions of publishing of my sponsored post with a dofollow link to my website. It is a website for students (custom paper writing service).
In case you have any questions feel free to contact me by email.
Thank you very much for your time.
Hoping to hear from you soon.
Sincerely,
Kerry Rose

Nor this one from the “outreach manager” at No BS Marketplace (which appears to specialize in BS). These people always begin with some casual greeting presumably to humanize their communication and they follow up with emails weekly which convey a sense of sadness that you are not responding to them.

Hey there,

Have you had a chance to look over my last email about paid guest post and sponsored content opportunities on your website?

Here is an article we recently wrote for an advertiser that was published on The Advocate https://www.theadvocate.com.au/story/6175536/best-places-in-australia-to-visit-with-your-motorhome/?cs=7659

As a global marketplace, we work with over 2,000 advertisers who are looking for opportunities on websites like yours. check out our website to learn more about us https://nobs.link/

I’d love to hear from you.

Thanks,
Michelle Atkinson
Outreach Manager

NO BS Marketplace

Please don’t click on the above links no matter how tempting it might be. You will only fuel the advertising fires.

Finally, despite numerous requests I have not agreed to have the skeptical cardiologist listed among the hundreds of questionable healthcare websites on Blog Frog which self-describes as a “influencer platform” across “multiple verticals.”

We consider BlogFrog a next-generation influencer marketing platform. Because we know how important to find good quality content for your business can be, we network communities and websites together to create a larger interest-based social network.

No, dear readers and patients, the skeptical cardiologist website remains pure as the driven snow., unsullied by disgusting clickbait, irritating advertisements, paid guest posts, links to worthless information, or promos for useless supplements.

Snowwhitishly Yours,

-ACP

Image by Simon Steinberger from Pixabay

Ultra-Processed Foods Contribute Half of the Calories and 90% of the Added Sugar to US Diets

In 2016 I wrote a post entitled “Ultra-Processed Foods Contribute Half Of The Calories And 90% Of The Added Sugar to US Diets.’

In the last week, I have discovered two excellent discussions further supporting the role these ultra-processed foods (UPFs) play in our obesity epidemic

Brazil Leads In Recognizing The Dangers of Ultra-Processed Foods

Last week The Guardian published a long article which does a great job of providing an easily digested background to the concept of UPFs and their influence on obesity. A lot of that background comes from the work of a Brazilian MD, Carlos Monteiro:

The concept of UPFs was born in the early years of this millennium when a Brazilian scientist called Carlos Monteiro noticed a paradox. People appeared to be buying less sugar, yet obesity and type 2 diabetes were going up. A team of Brazilian nutrition researchers led by Monteiro, based at the university of Sao Paulo, had been tracking the nation’s diet since the 80s, asking households to record the foods they bought. One of the biggest trends to jump out of the data was that, while the amount of sugar and oil people were buying was going down, their sugar consumption was vastly increasing, because of all of the ready-to-eat sugary products that were now available, from packaged cakes to chocolate breakfast cereal, that were easy to eat in large quantities without thinking about it.

I highly recommend you read the full article in the Guardian on this important topic. It is extremely well-written  and the author has interviewed both Monteiro and Kevin Hall for the piece.

If your time is limited, I give you what I wrote in 2016 but which appears never to have been publicly published.


The skeptical cardiologist has been ranting about the deleterious effects of added sugars from highly processed food in our diets ad nauseam (see here or here)

I’ve been meaning to follow up on some recent evidence showing the major role that the sugar industry played in vilifying fat and obscuring the dangers of excess sugar in the diet.

Here are two items to help you further understand this process:

  1. In September, a researcher at the University of California, San Francisco, uncovered documents showing that Big Sugar paid three Harvard scientists in the 1960s to play down the connection between sugar and heart disease and instead point the finger at saturated fat. Coca-Cola and candy makers made similar headlines for their forays into nutrition science, funding studies that discounted the link between sugar and obesity.

  2. An observational study published from Monteiro, et al.  in BMJ Open confirms the presumed close association between highly processed foods and added sugar and adds further to the evidence that sugar, not fat, is the major nutrient which most of us should minimize in our diet

Carlos Monteiro and his colleagues begin this paper by noting that dietary guidelines are increasingly recommending limiting added sugar to <10% of dietary calories because of evidence that:

“a high intake of added sugars increases the risk of weight gain, excess body weight and obesity ;type 2 diabetes mellitus, higher serum triglycerides and high blood cholesterol; higher blood pressure and hypertension; stroke; coronary heart disease; cancer; and dental caries. Moreover, foods higher in added sugars are often a source of empty calories with minimum essential nutrients or dietary fibre which displace more nutrient-dense foods and lead, in turn, to simultaneously overfed and undernourished individuals.”

The study analyzed the relationship between processed food consumption, total calories and calories from added sugar using data from the National Health and Nutrition Examination Survey 2009–2010.

They divided foods into four categories:

unprocessed or minimally processed foods (such as fresh, dry or frozen fruits or vegetables, grains, legumes, meat, fish and milk)

processed culinary ingredients’ (including table sugar, oils, fats, salt, and other substances extracted from foods or from nature, and used in kitchens to make culinary preparations)

processed foods’ (foods manufactured with the addition of salt or sugar or other substances of culinary use to unprocessed or minimally processed foods, such as canned food and simple breads and cheese)

ultra-processed foods (formulations of several ingredients which, besides salt, sugar, oils and fats, include food substances not used in culinary preparations, in particular, flavours, colours, sweeteners, emulsifiers and other additives used to imitate sensorial qualities of unprocessed or minimally processed foods and their culinary preparations or to disguise undesirable qualities of the final product.

The most common ultra-processed foods in terms of energy contribution were breads; soft drinks, fruit drinks and milk-based drinks; cakes, cookies and pies; salty snacks; frozen and shelf-stable plates; pizza and breakfast cereals.

The findings:

ultra-processed foods account for 58% of  all calories in the US diet, and contribute nearly 90% of all added sugars. 


Kevin Hall’s Stunning Study

The second item about UPFs was an episode of the podcast Best Known method which featured the NIH nutrition researcher Kevin Hall discussing ultra-processed foods with Ethan Weiss.

The early part of the podcast reviews Hall early training in physics and mathematics and transition into mathematical modeling of metabolism. Ultimately he ended up testing the hypothesis that a diet of UPF with similar macronutrient composition would result in greater weight gan than an unprocessed diet

The results were published in Cell Metabolism last year and are summarized in this neat graphic.Screen Shot 2020-02-17 at 6.53.54 PM

Yes. you read that correctly.

In 20 inpatient adults (10 men and 10 women) the ultra- processed diet caused increased ad libitum energy intake and weight gain despite being matched to the unprocessed diet for presented calories, sugar, fat, sodium, fiber, and macronutrients

Hall had expected negative results from this study but now believes something about UPFs beyond their macronutrient composition causes many individuals to overeat and gain weight. Whereas in 2016 I thought the major culprit was the added sugar in UPFs, Hall’s study suggests it is not just added sugar or missing fiber in the diet that is leading to excess eating and weight gain.

Identifying Ultra-Processed Foods

I provided some guidance on identifying UPFs in my unpublished 2016 post:

If you have difficulty in determining what  foods should be considered  ultra-processed   I recommend  getting a copy of Michael Pollan’s small and delightful booklet, “Food Rules: An Eater’s Manual.”

The first section entitled “Eat Food” provides 21 short, memorable phrases to help you identify and avoid ultra-processed foods: concoctions that he terms “edible food-like substances.”

Some of the key rules:

Don’t eat anything your grandmother wouldn’t recognize as food.

Avoid food products that contain ingredients that no ordinary human would keep in the pantry

Avoid food products that contain high fructose corn syrup

Avoid foods that have some form of sugar (or sweetener) listed among the top three ingredients

Avoid food products that contain more than five ingredients

And one that I particularly like as it emphasizes the misleading health claims of low fat diary:

Avoid food products with the wordoid “lite” or the terms “low-fat” or “nonfat” in their names.

Ultraunprocessedly Yours

-ACP

N.B. As I indicated in “I Am a Keto-friendly cardiologist and I Love Keyto” “I have tremendous professional respect for Ethan Weiss, the cardiologist behind Keyto.  It is ironic that he announced at the beginning of his Best Known Method podcast with Kevin Hall that Keyto was changing its name to KeyEats and its first products are (seemingly) ultra-processed food bars.

Does A Normal Cardiac Catheterization Mean Your Coronary Arteries Are Truly “Clean?”

For far too long, many patients have undergone a cardiac test that carries grave risks with the misunderstanding that they are getting the definitive assessment of their coronary arteries.

Chances are if you have visited an emergency room in the USA with chest pain and you weren’t clearly having an acute heart attack, you ended up getting one of two tests:  a stress test or an invasive coronary angiogram (ICA).

What Is A Cardiac Catheterization?

For decades the ICA (commonly termed “cardiac catheterization or cath”) was considered the “gold standard” for the assessment of the arteries to the heart (the coronary arteries.)  This invasive test involves inserting a tube (catheter) into either an artery in the wrist or groin, threading the catheter up the artery to the aorta and injecting contrast dye directly into the coronary arteries.

The x-ray movie images (angiogram) obtained then show the dye within the lumen of the arteries. If the column of dye is impinged upon an obstruction is diagnosed. However, early plaque in the arteries doesn’t necessarily stick into the lumen and typically resides in the wall, hidden from these “lumenograms.”

Below are the freeze-frame images of the left coronary artery invasive angiogram from a man we shall call Jerry who underwent catheterization in his 40s for atypical chest pain. He was told he had normal arteries, that they were “clean”.

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Given the news that his arteries had no plaque build-up, he felt no need to modify his lifestyle or take cholesterol medications in order to avoid the fate of early death from myocardial infarction that his father had suffered at age 50.

Limitations Of The Cardiac Cath In Identifying Atherosclerotic Plaque

When I first saw him a year after the cardiac cath I told him that although his previous cardiologist had told him all was fine with his coronary arteries he could, in fact, have significant diffuse subclinical atherosclerosis and still be at high risk for a heart attack.

This came as quite a shock to Jerry as he, like most laypeople, view the cardiac cath as the “gold standard” for assessment of the coronary arteries. For most patients, a normal cath has been viewed as  a warranty against heart attack

Although ICA has been the gold standard for the diagnosis of coronary artery disease, lumenography only shows the internal arterial lumen and does not see the vessel wall with its developing atherosclerotic plaque. Previous studies analyzing serial angiograms from patients presenting with acute coronary syndrome (ACS) have suggested that in nearly two-thirds of the culprit lesions, the coronary angiogram obtained a few months before the acute event demonstrated a non-significant stenosis.

Identifying Early Plaque Using Coronary Calcium Scans

I recommended the patient get a coronary artery calcium (CAC) scan to look for early coronary plaque and this demonstrated two small calcific plaques in the proximal portion of his LAD coronary artery. His calcium score was 9 which is higher than 82% of 45-year-old white males.

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Now that we had visual proof of the plaque in his arteries he was motivated to change his lifestyle to reduce the risk of suffering his dad’s fate. In addition, he was now willing to take medications to further reduce risk.

A year later he was admitted to our hospital with palpitations and chest tightness. This time as I was his cardiologist we performed a noninvasive test-a coronary CT angiogram (CCTA). This demonstrated the two small areas of calcification in the LAD we had noted on the calcium scan but in addition, we were able to see surrounding those foci of calcification substantial premature build-up of soft plaque.

LAD CCTA

Following the CCTA and a more definitive assessment of his coronary artery status we were able to tell him there was no significant blockage of the coronaries and therefore no need for any stenting or bypass procedure.

Just as important, however, was the knowledge that he had a substantial plaque in the LAD which puts him at risk for heart attack.

With this knowledge, we were able to convince him to undergo substantial lifestyle changes to reduce his long term risk of heart attack and stroke. In addition, he was started on statin therapy to further reduce those risks.

The CCTA is performed using a special X-ray scanner and the risks are a small amount of radiation plus the risks of administration of intravenous radioiodine contrast. The injected dye material can cause allergic reactions in those predisposed and worsen kidney function in patients with underlying kidney disease.

What Are The Risks of Cardiac Cath?

Patients acquiring information from the website of the American Heart Association would conclude a cath is no big deal:

Cardiac cath is usually very safe. A small number of people have minor problems. Some develop bruises where the catheter had been inserted (puncture site). The contrast dye that makes the arteries show up on X-rays causes some people to feel sick to their stomachs, get itchy or develop hives.

Even the NIH website downplays the risks, terming it a “relatively safe procedure” with rare complications.Screen Shot 2019-10-27 at 6.59.25 AM

However, the procedure is associated with substantial morbidity ranging from internal bleeding requiring surgery to disabling stroke. Although the risk of dying from the procedure has declined over the last 30 years it is still around .05%.

I have included a recent detailed summary of potential complications at the end of this post.


There are definite indications for getting a cardiac catheterization and I refer patients for this procedure on a daily basis. The clearest benefit is in patients presenting with clear evidence for myocardial damage (elevated troponin levels) from a myocardial infarction. In such patients the known benefits of opening tightly blocked coronary arteries outweigh the risks of the procedure.

However, patients should think twice and have an extensive discussion with the cardiologist recommending the test when there has been no evidence for myocardial damage.

Most importantly, patients should know that a declaration of “clean arteries” or “the arteries of a twenty-year-old” from the results of a cardiac cath do not guarantee freedom from cardiac events down the line. To detect early and premature atherosclerotic plaque build-up which corresponds to a very high lifetime risk of heart attack and stroke other techniques that look at the arterial wall and not the lumen are needed.

For the youngish, vascular ultrasound imaging for measurement of carotid IMT and soft plaque detection is useful, whereas CAC or CCTA is more useful in subjects over age 40 years of age.

Atherophobically Yours,

-ACP

N.B. As promised a long laundry list of complications for your edification.

The risk of major complications during diagnostic cardiac catheterization procedure is usually less than 1%, and the risk and the risk of mortality of 0.05% for diagnostic procedure. For any patient, the complication rate is dependent on multiple factors and is dependent on the demographics of the patient, vascular anatomy, co-morbid conditions, clinical presentation, the procedure being performed, and the experience of the operator. The complications can be minor as discomfort at the site of catheterization to major ones like death.

But there are very serious complications of the procedure that can result in death or serious disability.

From a recently updated review of cath complications

Local Vascular Complications

Hematoma/Retroperitoneal Bleeding

These are among the most common complications seen after cardiac catheterization procedures. Hematomas are usually formed following poorly controlled hemostasis post sheath removal. Most hematomas are self-limiting and benign, but large rapidly expanding hematomas can cause hemodynamic instability requiring resuscitation with fluids and blood.  The incidence of this complication is significantly reduced in transradial access. In patients with transfemoral access, retroperitoneal bleeding should be suspected if there is a sudden change in the hemodynamic stability of the patient with or without back pain as there may not be any visible swelling in the groin for some of these patients. The incidence of this complication is less than 0.2%. Strong clinical suspicion along with immediate imaging, usually with CT scan, helps make a diagnosis of this problem. Identification of the bleeding source is essential for patients with continued hemodynamic deterioration. These life-threatening bleeds are more frequent when the artery is punctured above the inguinal ligament. Most patients are managed with a reversal of anticoagulation, application of manual compression and volume resuscitation and observation. Patients with continued deterioration with need coiling of the bleeding source vessel, or balloon angioplasty or covered stents for bleeding from larger vessels.

Pseudoaneurysm

When the hematoma maintains continuity with the lumen of the artery, it results in the formation of a pulsatile mass locally, defined as a pseudoaneurysm. This will be associated with bruit on examination. They happen following low access in the superficial femoral artery as opposed to the common femoral artery. These are usually diagnosed by ultrasound Doppler imaging or CT angiography. Small pseudoaneurysms of the less than 2 to 3 cm in size may heal of spontaneously and can be followed by serial Doppler examinations. Large symptomatic pseudoaneurysms can be treated by either ultrasound-guided compression of the neck of pseudoaneurysm or percutaneous injection of the thrombin using ultrasound guidance or may need surgical intervention.

Arteriovenous Fistula

Direct communication between the arterial and venous puncture sites with ongoing bleeding from the arterial access site leads to the fistula formation and are associated with a thrill or continuous bruit on examination. These usually will require surgical exploration as they are unlikely to heal spontaneously and may expand with time.

Dissection

This is an infrequent complication and occurs in patients with an increased atherosclerotic burden, tortuous arteries, or traumatic sheath placement. Non-flow limiting dissections usually heal spontaneously following sheath removal. A flow limiting large dissections could lead to acute limb ischemia and should be treated immediately with angioplasty and stenting. Vascular surgery is usually reserved for patients with failed percutaneous techniques.

Thrombosis and Embolism

This complication is extremely rare with the use of the low profile catheters and predisposing factors include small vessel lumen, and associated peripheral arterial disease, diabetes mellitus, female sex, large diameter sheath, and prolonged catheter dwell time. Treatment involves removal of the occlusive sheath, percutaneous thrombectomy in conjunction with vascular surgery consultation.

Vascular Complications after Transradial Access

The most frequent complication after transradial access is about a 5% risk of radial artery occlusion. This is a clinically insignificant complication if the Allen test is normal. Patients with incomplete palmar arch and abnormal Allen test may have symptoms of hand ischemia after radial artery occlusion.

Radial artery spasm is another frequent complication, and this can be avoided by the use of local vasodilatory medications and systemic anxiolytics. Perforation of the radial artery is an extremely rare complication and is usually managed with prolonged external compression and rarely requires vascular surgery intervention.

Other Major Complications

Death

The incidence of death with cardiac catheterization has decreased progressively and is less than 0.05% for diagnostic procedures. Patients with depressed left ventricular systolic function and those presenting with shock in the setting of acute myocardial infarction are at increased risk. In some subsets of patients, the risk of mortality can be more than 1%. Other factors that would increase the risk include old age, the presence of multivessel disease, left main coronary artery disease, or valvular heart disease like severe aortic stenosis.

Myocardial Infarction

The reported incidence of periprocedural myocardial infarction for a diagnostic angiography is less than 0.1%. This is mostly influenced by patient-related factors like the extent and severity of underlying coronary artery disease, recent acute coronary syndrome, diabetes requiring insulin, and technique-related factors.

Stroke

The overall risk of stroke in recently reported series is low at 0.05% to 0.1% in diagnostic procedures and can increase to 0.18% to 0.4% in patients undergoing intervention. This can be a very debilitating complication associated with a high rate of morbidity and mortality. The risk is higher in patients with extensive atherosclerotic plaque in the aorta and aortic arch, complex anatomy, procedures requiring multiple catheter exchanges or excessive catheter manipulation, or the need for large-bore catheters and stiff wires.

Dissection and Perforation of the Great Vessels

Dissection of the aorta, perforation of the cardiac chambers, perforation of the coronary arteries is an extremely rare complication. The risk is higher in procedures with intervention as opposed to diagnostic procedures only. Patients with type A aortic dissection involving the ascending aorta will require surgical correction. Patients with a cardiac chamber or coronary perforation resulting in the accumulation of the blood in the pericardial space will need urgent pericardiocentesis to restore hemodynamic stability and immediate surgical consultation.

Atheroembolism

Cholesterol emboli from friable vascular plaques can give rise to distal embolization in multiple vascular beds. These are usually recognized by digital discoloration (blue toes), livedo reticularis. This can also manifest as a neurological squeal or renal impairment. The risk of this complication is minimized by exchanging catheters over a long wire and minimizing the catheter exchanges. Retinal artery occlusion causes Hollenhorst plaque.

Allergic Reactions

Allergic reactions can be related to the use of local anesthetic, contrast agents, heparin or other medications used during the procedure. Reactions to the contrast agents can occur in up to 1% of the patients, and people with prior reactions are pretreated with corticosteroids and antihistamines. Use of iso-osmolar agents decreases the risk compared to high osmolar agents. When severe reactions do occur, they are treated similarly to anaphylaxis with intravenous (IV) epinephrine (initial dose 1 ml of 1:10000 epinephrine).

Acute Renal Failure

The incidence of the reported contrast nephropathy is quite variable (range 3.3% to 16.5%) in the patients undergoing cardiac catheterization resulting in a transient increase in the serum creatinine levels after exposure to contrast material. In the National Cardiovascular Data Registry, the incidence of contrast-induced acute kidney injury was 7.1%, among the patients undergoing elective and urgent coronary intervention. The risk is higher in patients with underlying moderate to severe renal disease, people with diabetes, elderly, females, patients on diuretics, ACEI, and metformin. Adequate pre-hydration, use of iso-osmolar agents, and techniques to minimize the amount of dye used will help prevent this complication. Renal atheroemboli can also cause renal failure and are associated with other signs of embolization.

Infection

Cardiac catheterization is performed using sterile technique, and local or systemic infection is extremely rare. Routine prophylaxis for endocarditis is not recommended during cardiac catheterization procedures.

Radiation Injury

Radiation skin injury can occur if a patient is exposed to excessive doses of radiation to one particular area of the body and manifestation could range from mild erythema to deep ulceration. Skin biopsies should be avoided for these lesions as they would make the underlying condition worse. This complication should be managed by a combined team of cardiologists, dermatologists, and plastic surgeons.

Arrythmias

The occurrence of the ventricular fibrillation or ventricular tachycardia during the procedure could be related to irritation or ischemia of the myocardium by the catheter, contrast material or occlusive balloons. These arrhythmias occur more frequently in people presenting with acute ST-elevation myocardial infarction and treatment includes cardioversion along with anti arrhythmic drugs and restoration of the flow to the occluded artery. Atrial tachyarrhythmias can occur following the irritation of the right atrium during right heart catheterization and is usually self-limiting.

 

 

 

 

 

AliveCor’s Kardia Mobile ECG Accurately Identifies Atrial Fibrillation >120 BPM

The skeptical cardiologist revealed recently that the  Apple Watch (AW) ECG app is incapable of identifying atrial fibrillation (AF) if the heart rate is greater than 120 beats per minute. It labels these recordings as “inconclusive”.

Since it is common for AF to present at rates >120 BPM, AW ECG will fail to notify many (if not most) of its users that they are in AF.

AliveCor’s Kardia mobile ECG device (both the single lead and the six lead), on the other hand, has no problems identifying AF >120 BPM. I have found that the Kardia ECG was highly accurate in patients with rapid AF from using the device in hundreds of my patients since 2013.

After writing about the AW AF flaw I opened my KardiaPro dashboard which connects to the online ECG recordings each of my patients has made.

Two of my patients with paroxysmal AF had gone into AF in the last 2  days and made recordings.

Both of them had rates > 120 BPM. In both cases, Kardia had easily made the diagnosis. AW would have declared these “inconclusive.”

Patients should be aware of this AW AF flaw. The absence of a declaration of possible AF on the AW ECG should not reassure anyone of the absence of AF.

AW users should have their high rate recordings reviewed by a cardiologist.

Alternatively, they could purchase a Kardia device and utilize it for heart rates over 120 BPM.

Tachyagnostically Yours,

-ACP

Apple Watch ECG Cannot Diagnose Atrial Fibrillation Faster Than 120 BPM

The Apple Heart Study received great fanfare at least year’s AHA meetings  and was subsequently published in the NEJM.  Many Apple Watch (AW) wearers having heard of this study may have concluded the device will reliably identify atrial fibrillation (AF).

In my commentary on the Apple Heart Study I pointed out several issues with relying on Apple Watch for AF diagnosis, most significantly false positive notifications. Recent patient experiences have, in addition, made me concerned about false negative notifications and a lack of sensitivity.

AW ECG is inherently limited in diagnosing AF above 120 BPM. This guarantees a substantial number (possibly the majority) of AF episodes will not be recognized. Such false negative notifications may falsely reassure patients that they don’t have AF and delay them seeking medical attention.

Recently, I saw a patient who was referred to me for an abnormal 12-lead ECG. While reviewing his symptoms we discovered that his AW had registered high heart rates, sometimes up to 150 beats per minute, which lasted for several hours. 

Although the AW had recorded this high heart rate it had not notified him of the possibility that he had atrial fibrillation or even that he had a high heart rate.

He had made the ECG recording below using the AW and the results came back inconclusive.

CL-120-AFIB-AW4.png

The AW ECG recording clearly shows atrial fibrillation going at a rapid rate-over 150 beats per minute-but the accompanying interpretation gives no hint that the patient had AF.

Based on the combination of an absence of any irregular heart rate/AF warnings from his AW and the absence of a diagnosis of AF when he made AW ECG recordings of the fast rates the patient assumed that he did not have atrial fibrillation.

Why is this? Apparently Apple has decided not to check for AF if  the heart rate is over 120 BPM.

Given that most patients with new-onset AF will have heart rates over 120 BPM (assuming they are not on a rate slowing drug like a beta-blocker) it appears likely that Apple Watch ECG will fail to diagnose most cases of AF.

I asked my patient to record an ECG with his watch every time he felt his heart racing after our office visit. A few days later he was sitting in an easy chair after Thanksgiving watching TV and had another spell of racing heart. This time the heart rate was less than 120 BPM and the AW was able to analyze and make the diagnosis.

CL-150-AFIB-AW4.png

The inability of AW ECG to diagnose AF when the rate is >120 BPM further adds to my concerns about widespread unsupervised use of the device. When we combine inconclusive high heart rate analyses with the unknown sensitivity of the irregular heartbeat notification algorithm the AW may be providing many patients who have atrial fibrillation with a false sense of security.

Skeptically Yours,

-ACP

What Can Be Learned From The Italian Healthcare Experience?

Since traveling to Italy, the skeptical cardiologist has been in contact with Nicola Triglione, a native of Southern Italy who completed his cardiology fellowship in Milan.

As he has spent some time training in Seattle, WA and recently set up his practice in Milan, I asked him to compare and contrast the Italian health care system to our American system.


The Italian Perspective

by Nicola Triglione,

Medico Specialista in Cardiologia

 

Italy ranks among the World Health Organization’s top 10 countries for quality health services. The Italian healthcare system is far from perfect though, as this rating is mainly based on equality of access and health outcomes such as life expectancy and healthy life years.

Let’s take a closer look at the national healthcare system (NHS).

Universal Access To Care

Italy’s NHS is tax-funded, regionally-based and it provides universal coverage, largely free of charge at the point of service. Italian territory is made up of 20 administrative Regions, which are extremely varied in size, population, and levels of socioeconomic development. The well-known divide between Northern and Southern areas is still relevant nowadays.

Regions are responsible for ensuring the delivery of services through a network of population-based local health authorities and both public and private accredited hospitals.

The Origins Of Healthcare In Italy

During the Italian Renaissance, hospitals were the embodiment of physical and spiritual healing. The poor received free treatments, senior doctors were employed and food and wine were served to patients. Monks and nuns did the nursing with almost one nurse per patient. There are similarities with the contemporary era, in fact, the medical models developed by Tuscan hospitals formed the foundations for today’s healthcare practices.

The NHS was established by the government in 1978 in order to fight public dissatisfaction with the existing system. Those who want to have a ruthless and ironic portrait of the Italian healthcare before this date should watch one of the greatest Alberto Sordi’s movies “Be sick..it’s free” (1968).

 

 

 

 

 

 

 

 

Contained Healthcare Expenditure

In 2015 total health expenditure in Italy was about 9% of GDP, 75% of which was financed by the public sector. Out-of-pocket expenditure accounted for 23% of healthcare expenditure and the remaining 2% related to voluntary schemes like private insurances and mutual funds. There are two main types of out-of-pocket expenses: 1) co-payments for diagnostic procedures, pharmaceuticals and specialist consultations; 2) direct payments by users for the purchase of private health care services and over-the-counter drugs.

One of the most reassuring aspects of Italy’s NHS is that emergency care is considered a right, and it’s available to anyone in Italy whether or not they are registered in the national system. Residents have free or limited cost emergency care, and even visitors can access emergency care at a very low co-payment.

Yes, if you plan to break your leg while on vacation then Italy is the destination of choice.

What About Non-Urgent Visits?

If you are sick, you go to your General Practitioner and thanks to your national health card you do not pay anything at the time of the visit. If you need a specialist, things might become complicated because waits can be long. The average wait time for a cardiological visit is 67 days. At best, it’s 51 days in the north-east and 79 days in central Italy. So what do wealthy Italians do? They go to a private pay doctor who charges more than the government rate and the patient pays the difference. The fees are usually very reasonable, compared to other countries with similar costs of living.

On the other hand, the US is the only country spending 17 percent of its GDP on healthcare and according to many, it doesn’t get the expected value. It wasn’t uncommon during my stay in the US hearing colleagues defining the American healthcare system as “broken”.

Drug companies and emergency rooms charge whatever they want. As a result, they get lower patient compliance and therapy adherence.

What else? Hospital services and diagnostic tests cost more. Doctors get paid more, however education does have a cost, in fact, medical-school graduates carry a median $200,000 in student debt. A lot more money goes to planning and managing medical services at the administrative level.

Choice And Access

To me, one particular misconception about the US system is the notion of choice. People are led to believe that buying into a private insurance plan means they will have more choices. In reality, I think that sometimes the choice of care is neither on patients nor on doctors. More often it is insurance companies that decide when, where and for how long people can receive treatments.

I have no doubt that the best healthcare is available in the US, but how many Americans have access to it?

In my opinion, the US could work on providing universal access to treatments and medications, with minimal point-of-service payments as well as prices softened by government negotiation.

In the last 10 years, American citizens have witnessed nearly a doubling in prescriptions and health-related costs have become the leading cause of personal bankruptcy. We have the same issue in Italy, though hubris instead of money drives the phenomenon. In fact, it’s a common belief that a longer prescription means a smarter and considerate prescriber. That’s why in the last few years some virtuous Italian Regions have established a medication reconciliation clinic where general practitioners, internists, and pharmacists work together in order the refine the art of deprescribing.

The Exodus Of Doctors

As I have already pointed out, the Italian NHS is far from perfect. In fact, although medical facilities are considered to be adequate for any emergencies, some public hospitals are overcrowded and under-funded. Public finances are constrained by high levels of government debt. Consequently, resources available for welfare expenditure are considerably lower than in other countries. More than ten thousand Italian doctors left Italy to go working abroad between 2005 and 2015 in search of meritocracy, better career prospects, and higher salaries.

Of course, they miss the five weeks’ vacation, the maternity leave, and the sick leave but once they experience healthcare elsewhere they wouldn’t return to Italy unless the circumstances changed. Italy is not an attractive place to work for doctors because of poor working conditions, little career progression, low salaries and so on.

Life Expectancy

However, people who live here are some of the healthiest in the world. Long story short, Italy boasts excellent life expectancy and healthy life expectancy rates, 82.7 and 72.5 years, respectively. Life expectancy is the third highest in Europe, after Switzerland and Spain.

 

 

What’s the secret ingredient?

References:

Italian Ministry of Health, Open Database 

Italian National Institute of Statistics, Health statistics

Dott. Nicola Triglione 
Medico Chirurgo
Specialista in Cardiologia s
Dr. Triglione can be contacted on LinkedIn or by his email address

N.B. As Nicola pointed out, the cost of healthcare in the US (including both government and private expenses) equals 17.1% of the national GDP, compared to 9.1% in Italy. whereas life expectancy in Italy is 4 years higher than in the US.

Eight Lifestyle Changes All Patients Should Make To Reduce The Recurrence Of Atrial Fibrillation

Previously, the skeptical cardiologist answered the question “Why Did I Go Into Atrial fibrillation?

An equally important question is “how can I reduce the chances that I have more spells of atrial fibrillation (AF)?”

I spend a fair amount of time discussing with my AF patients what lifestyle changes they can make in this regard. I’ve discovered, however, that many AF patients I am seeing for a second opinion seem unaware of the changes they can make to minimize AF recurrence.

Herein I give you the eight most important changes you can make to minimize both the onset and the recurrence of AF.

  1. Eliminate or substantially reduce alcohol.
  2. Lose weight if you are obese.
  3. Stop smoking. Stopping is associated with a 36% lower risk of AF.
  4. Get your blood pressure under good control.
  5. Get regular aerobic exercise. At least 150 minutes of moderate cardio exercise weekly.
  6. Eat A Healthy Diet. Don’t Eat Crap (as Younger Next Year says). In general, because obesity is such a big factor  in AF, I am fine with whatever diet plan has you at a BMI <28. Healthy diets controlling weight avoid ultra-processed foods, sugar-sweetened beverages, and minimize white rice, pasta, pastries, and potatoes. These diets include lots of fresh vegetables, nuts, olive oil, and fish. Full fat yogurt and cheese are fine in moderation. Eat real food, mostly plants, not too much as Michael Pollan has famously said.
  7. Get high-quality sleep. This means treating any sleep apnea properly in addition to standard advice for getting a good night’s sleep. The risk of AF is four times higher in patients with obstructive sleep apnea (OSA) independent of other confounding variables
  8. Reduce stress. Easier said than done I know. Everything from meditation to Yoga to retiring or cutting back at work to psychotherapy can be tried in this category. Go with whatever works for you. Knowing when you are in or out of AF by utilizing personal ECG monitoring devices may help reduce stress, especially if used under physician supervision.

Let’s dig a little deeper into some specific recent evidence on three which have a huge impact: alcohol, exercise, and obesity.

Alcohol and Atrial Fibrillation

In March, I wrote about the alcohol AF trial recently published in NEJM:

The Alcohol-AF Trial. Binge alcohol consumption (holiday heart) can trigger atrial fibrillation (AF) and observational studies show a higher incidence of AF with higher amounts of alcohol consumption.

This trial was the first-ever randomized controlled trial of alcohol abstinence in moderate drinkers with paroxysmal AF (minimum 2 episodes in the last 6 months) or persistent AF requiring cardioversion.

Participants consumed >/= 10 standard drinks per week and were randomized to abstinence or usual consumption.

Participants underwent comprehensive rhythm monitoring with implantable loop recorders or existing pacemakers and twice-daily AliveCor monitoring for 6 months.

Abstinence prolonged AF-free survival by 37% (118 vs 86 days) and lowered the AF burden from 8.2% to 5.6%

AF related hospitalizations occurred in 9% of abstinence patients versus 20% of controls

Participants in the abstinence arm also experienced improved symptom severity, weight loss and BP control.

This trial gives me precise numbers to present to my AF patients to show them how important eliminating alcohol consumption is if they want to have fewer AF episodes. The study further emphasizes lifestyle changes (including weight loss, exercise, and stress-reduction) can dramatically reduce the incidence of atrial fibrillation.

Obesity and Atrial Fibrillation

We have known for some time of a strong association between obesity and atrial fibrillation. We also know we can make sheep go into atrial fibrillation by making them obese and creating a diseased, fat-infiltrated left atrium.

More recently we have solid evidence that sustained weight reduction can significantly reduce the recurrence of AF.

The Australian LEGACY study took 355 AF AF patients with BMI>27 and offered them a weight management program:

Weight loss was categorized as group 1 (≥ 10%), group 2 (3% to 9%), and group 3 (<3%). Weight trend and/or fluctuation was determined by yearly follow-up. Endpoints included impact on the AF severity scale and 7-day ambulatory monitoring.

Weight loss ≥ 10% resulted in a 6-fold  greater probability of no AF recurrences compared with the other 2 groups. High weight fluctuation doubled the risk of AF recurrence.

Of course, all these factors are interrelated. Exercise, diet, stress, alcohol consumption, and sleep quality all impact weight control and obesity. Patients with AF should be working on all 8 levers for optimal benefit.

Given the LEGACY study findings, if you have AF and are obese, you should be using all lifestyle factors at your disposal to get your body weight down >10%. Do this in a slow and steady fashion with lifestyle changes that are sustainable for the rest of your life. You want to lose that weight and keep it off.

Exercise And AF

The most compelling evidence for the independent role of exercise in reducing AF comes from a Norwegian study of 51 patients with AF who were randomized either to aerobic interval training (AIT) or to their regular exercise habits. The patients randomized to AIT engaged in four 4-minute bouts of high-intensity (85 to 95% peak heart rate) aerobic exercise interspersed with 3 minutes of recovery.

There was a significant reduction in AF burden (measured by implanted loop recorders) in the exercise group, with the mean time in AF dropping from 8.1% to 4.8%, with no significant change in the control group. Patients in the exercise group experienced fewer and less severe symptoms whereas the non-exercising, control group had no change. In comparison with controls, patients randomly assigned to exercise also increased their peak oxygen consumption (Vo2peak), cardiac function, and quality of life, while improving body mass index and blood lipids

Screen Shot 2020-02-02 at 12.19.44 PM
Atrial fibrillation (AF) burden in patients with AF during the study. Mean time in AF was measured by an implanted loop recorder (n=36) before, during, and after 12 weeks of aerobic interval training (exercise) or usual care (control). Patients without AF during the study period are excluded. Mean changes from baseline to follow up were −6.2±8.9 percentage points (pp), P=0.02 for exercise; 4.8±12.5 pp, P=0.09 for control; and 11.0±3.9 pp, P=0.007 between groups. Error bars show the 95% confidence interval.

An accompanying editorial provides this graphic on the benefits of exercise training in AF

 

For all you readers without AF you can minimize your chances of developing AF by following these lifestyle recommendations.

Afibrillatorily Yours,

-ACP

N.B. A PDF summary of the 8 factors is available here (Lifestyle changes Afib)

N.B.2 For those wishing to mimic the Norwegian AIT protocol here is the complete description:

Endurance training was performed as walking or running on a treadmill 3 times a week for 12 weeks. Each session started with a 10-minute warmup at 60% to 70% of maximal heart rate obtained at exercise testing (HRpeak), followed by four 4-minute intervals at 85% to 95% of HRpeak with 3 minutes of active recovery at 60% to 70% of HRpeakbetween intervals, ending with a 5-minute cooldown period. During AF, patients exercised at the same treadmill speed and inclination as in the previous sessions in sinus rhythm, with the Borg scale of 6 to 20 as an aid to control intensity. When familiar with the training regimen, patients were allowed to perform 1 exercise per week at home, where exercise intensity was documented with a heart rate monitor (RS300X, Polar Electro, Kempele, Finland).

 

 

 

 

The Full Omron HeartGuide Review: Is This Wearable Wristwatch Blood Pressure Monitor Right For You?

The Omron HeartGuide (OHG) is a digital wristwatch that takes oscillometric measurements of blood pressure. Named to TIME Magazine’s Best Inventions of 2019 list, the promise of this device was succinctly summarized by an Omron executive: “Integrating a blood-­pressure monitor into a sleek watch that also measures sleep and activity makes staying on top of cardiovascular health easy and provides a fuller picture of overall wellness.”

Previously on the skeptical cardiologist, I described my excitement at the HeartGuide’s ability to “serve as an accurate and unobtrusive daytime ambulatory blood pressure monitor.” After wearing the HeartGuide for a week and using it in a variety of situations to measure my blood pressure I had begun rethinking my usual recommendation against wrist blood pressure cuffs.

For me, the great attraction of the OHG was and still is the ability to measure your BP “anytime, anywhere.”

Despite my unabashed enthusiasm for the Heart Guide’s ability to provide facile daytime BP monitoring, certain limitations need to be recognized.

Herein is my more detailed, objective and pragmatic review of the device.

What Is In The Cube?

The OHG  is available on the Omron website for $499 but upon checkout currently, Omron is providing a 10% discount along with free economy shipping.

The device is available in medium and large wrist sizes. I sized my wrist as a medium using the measuring tool on their website.

Proper wrist sizing is crucial for accurate BP measurement.

The OHG ships in a black cube.

Inside the cube you will discover:

  • 1 Monitor
  • 1 Paper Sizing Guide
  • 1 Instruction Manual
  • 1 Quick Start Guide
  • 1 Charging Clip
  • 1 AC Adapter
  • 1 Charging Cable
  • 2 Replacement Cuff Sleeves

The OHG is large but stylish in appearance. It weighs 115 grams and the watch dial has a diameter  of 1.9 inches.

I found it took about 2 hours to fully charge the battery and that the device remained charged for about 48 hours.

Preparing For Blood Pressure Measurement

For accurate BP measurement, it is important to follow very closely the directions Omron provides.  The band should be positioned about 1 inch (2 fingers) below “the base of the hand.” The fit should be “snug.” Your index finger should not easily slide between the band the wrist.
The instructions ask you to sit in a chair for measurement and “position at heart level.” However, as I discussed in my previous post I found that I could make BP measurements under a variety of circumstances beyond chair sitting.
The OHG is fairly finicky about stability and positioning.  The directions for positioning state “position HeartGuide at heart level with 2 inches space between wrist and chest.” To ensure accuracy “do not bend your wrist or look at the display during measurement.”
Here’s what Omron says about its “Heart Zone Indicator”:

Your monitor has a built-in heart zone indicator that is used as an aid in determining if your monitor is at the correct height and position. It has been designed to work with most people so that when your wrist is at the correct position relative to your heart, your monitor will vibrate once. If it does not vibrate, your monitor may not be at the correct height and position relative to your heart.

Due to differences in individual size and physique, this feature may not be helpful in all cases and you may wish to turn off this feature. If you feel the position of the wrist, according to the heart zone indicator’s guidance, does NOT match your heart level, please turn off this feature and follow your judgment.

It’s not clear to me how the OHG knows that it is at heart level. I experimented with various positions including lying on my back and standing with my wrist definitely at heart level. Sometimes the OHG agreed, others not.

It is clear, however, that it does not like significant movement. It would not make a measurement if I was walking at any speed or while exercising on an elliptical or stationary bicycle.

Measuring A Blood Pressure

Once positioned properly simply push the top button on the watch and put your wrist in the appropriate position. You will notice a vibration followed by an initial mild inflation of the cuff that lasts about 15 seconds followed by a pause of a few seconds then a full , tight inflation of the cuff.

The entire process takes over a minute and is significantly slower than the upper arm BP cuffs I have been using.

When completed, the cuff deflates and the systolic and diastolic blood pressure along with pulse rate are displayed.

Not infrequently after triggering the device  I received an error message. Most commonly I encountered  Errors 4 or 5 which indicates excessive movement or talking

 

 

Accuracy

Before I could recommend the OHG in particular or wrist BP cuff devices, in general, I needed to know how they compared to the gold standard brachial artery, upper arm BP cuff.

I asked Omron for data supporting the accuracy of the OHG and they provided me with a copy of a 2019 paper entitled “Validation of two watch‐type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060‐2:2013 guidelines: Omron HEM‐6410T‐ZM and HEM‐6410T‐ZL”

The lead author of this study is an MD, PhD working at the Jichi School of Medicine in Japan and his 3 co-authors all work for Omron Healthcare, Kyoto, Japan, which provided funding for the research so this skeptical cardiologist takes this information with a grain of salt.

The introduction to this paper points out that ambulatory blood pressure monitoring is important to help identify individuals who have higher blood pressure outside the clinic. Such individuals have masked hypertension, the opposite of white-coat hypertension.

The researchers concluded that both the large and medium wrist HeartGuide devices were accurate and fulfilled criteria set by the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization.

Here are the Bland-Altman plots from that study

Note that although the average difference between the reference BP and the HeartGuide systolic BP is close to zero there is a significant variation from zero for individual measurements with some 20 mm Hg higher and some 20 mm Hg lower.

My experience confirms this significant individual variation. I took a number of simultaneous measurements using the HeartGuide on one wrist and a brachial BP cuff on the contralateral arm. I did this over multiple days under differing circumstances and with the devices on different arms.

I found that the HeartGuide systolic blood pressure was on average 10 mm Hg lower than the brachial BP when my blood pressure was high (>140 mm Hg).  When my systolic BP was between 120 and 130 mm Hg the HeartGuide was 5 mm Hg lower than the brachial and when my blood pressure was less than 120 mm Hg the Heart Guide and brachial BPs were identical.

I made similar measurements on other volunteers and found some had consistently identical wrist and brachial SBP whereas others had consistently higher blood pressures by wrist compared to brachial techniques.

Because of this individual variation I highly recommend users calibrate the OHG (or any wrist-based BP cuff) versus a standard BP cuff over a series of days with multiple measurements to see how the two measurements compare. If you find a consistent over or underestimate then the device can be used with this known adjustment.

Comfort, Form, Fit

The OHG is big. and it is bulky. The fastening strap is made of thick rubber and underneath that is the inflatable microcuff which works like the larger cuffs designed for brachial/upper arm measurement.

I was always aware of something on my wrist when I was wearing it. The OHG cannot be accessed if you are wearing a coat or any garment with thickish sleeves. Getting most upper garments on and off while wearing the OHG is a chore.

In the picture below you get a feel for how the OHG interacts with long sleeve garments. My shirt sleeve would not slip over it. When I was wearing a coat or sweatshirt I could not access or view the OHG as its large size prevented pulling back the sleeve.

IMG_5214.jpeg

Some Other Things the OHG Does

The OHG measures steps and it tells time. Omron also indicates it can be used to measure sleep quality. Frankly, I  did not test this feature because I felt I would not be able to sleep comfortably with the device on my wrist.

The OHG pairs via Bluetooth with the Omron smartphone app “Heart Advisor.” The app displays imported BP, pulse, activity and sleep data in various graphic formats.

IMG_5458

Data can be exported from the Heart Advisor app by email in either an Excel or PDF file. This feature would allow the user to conveniently send recorded BPs to their physician.

The OHG sends an alert when you receive a text message or phone call but you can’t see the text message or answer the call.

Overall Pros and Cons

I am still a fan of the OHG despite the limitations I have indicated above.

I don’t see most people using the OHG as their every day smartwatch The inconvenience and discomfort factors for most will outweigh the benefits.

However, I do see a very beneficial role in wearing the OHG periodically for targeted purposes. For example, it could be worn to work once per week to determine how one’s blood pressure is reacting to stressful situations or to the gym to assess one’s blood pressure before and after a workout. At least one study suggests that BP obtained at work is superior to 24 hour or sleep BP in predicting end-organ damage (manifested by echocardiographic left ventricular hypertrophy) from hypertension

If Omron can develop a method for the device to automatically trigger during sleep and provide accurate nocturnal BP measurements this would be a huge advance in the management of hypertension.

Skeptically Yours,

-ACP

N.B.Technical Specifications for the OHG

Model: BP8000-M
Display: Transflective memory-in-pixel LCD
Memory: Blood pressure measurement up to 100 times, Activity measurement up to 7 days, Sleep measurement up to 7 times, Event up to 100 items
Transmission method: Bluetooth® low energy technology
Power source: 1 Lithium ion polymer rechargeable battery, AC adapter
Battery lifespan: Will last for approximately 500 cycles, 8 times/day measurements in normal temperatures of 77 °F (25 °C) when new battery fully charged
Battery life: A typical user can expect to charge HeartGuide approximately 2-3 times per week, depending upon the frequency of use of HeartGuide’s features
Weight: Approximately 4.1 oz (115 g)
Dimensions: Diameter approximately 1.89” (48 mm), Case thickness approximately 0.55” (14 mm), Band width approximately 1.18” (30 mm)
Measurable wrist circumference: Medium – 6.3” to 7.5” (160 to 190 mm), Large – 7.1” to 8.5” (180 to 215 mm)