Category Archives: Uncategorized

Update On The Kardia Band Apple Watch Accessory: Accuracy In Atrial Fibrillation Pre and Post Cardioversion

As I described here, the Kardia Band (KB) is an FDA-approved Apple Watch accessory available to the general public without a prescription which records a high quality single-lead ECG.

I’ve been using mine now for a while and can confirm the ease and accuracy of the ECG recordings it makes. I find recordings made with my Apple Watch/Kardia Band are reliably high quality with minimal artifact (unless I’m running on a treadmill.)

Once the 30 second recording is completed, the Kardia app on the Apple Watch takes about 5 seconds to process the information using an AI algorithm and then makes a determination of normal sinus rhythm (NSR), atrial fibrillation or unclassified.

 

 

The New Study

A study published in the June JACC examined the accuracy of  Alivecor’s Kardia Band in detecting atrial fibrillation (AF.)

In the JACC study, investigators from the Cleveland Clinic studied  100 consecutive patients presenting for cardioversion from AF with recordings made before  and after the procedure. KB interpretations were compared to 12 lead ECGS read by electrophysiologists.

KB interpretations  identified AF with  93% sensitivity and 84% specificity. Of the total 169 recordings, 34% were unclassified due to short recordings, low-amplitude p waves, and baseline artifacts.

The authors concluded that the KB algorithm for AF detection, when it is supported by a physician review can reliably differentiate AF from NSR.

(Of note the lead author on this study is on the advisory board of Alivecor the maker of the KB and AliveCor (AliveCor, Mountain View, CA) provided the Kardia Band monitors which were connected to an Apple Watch and paired via Bluetooth to a smartphone device for utilization in the study. AliveCor was not involved in the design, implementation, data analysis, or manuscript preparation of the study.)

My Updated Kardia Experience

I have found the standard Kardia device to be immensely helpful in the management of my afib patients before and after cardioversions (see my prior description here). The paper mentions that 8% of these pre-cardioversion patients showed up for the procedure in normal sinus rhythm, noting that

For each of these patients, the automated KB algorithm did not erroneously identify AF, and the physician interpretation of the KB recording correctly confirmed SR in each case.

Needless to say, it is better to find out a cardioversion is not needed before the patient shows up for the procedure. I would estimate this happens about 5-10% of the time in my practice.

The Kardia device or the KB is also really helpful post cardioversion. If the patient makes daily recordings (which I can review on Kardia Pro online) h/she and I know exactly how long sinus rhythm persisted before reverting back to AF.

This is important information which impacts future management decisions.

Kardia Band Versus Standard Kardia Device

None of my patients have purchased the Kardia Band most likely due to the cost and the fact that they don’t have an Apple Watch. If you have an Apple Watch and want to monitor your heart rhythm I think the KB is a good choice. Otherwise, the original AliveCor mobile ECG device continues to do a fantastic job (in conjunction with Kardia Pro, see here).

The combination of Kardia and Kardia Pro has substantially reduced my use of expensive and annoying long term monitors in my AF population.

In my next update on the KB I will share a reader’s real world description of the pros and cons of the KB (with Smart Rhythm monitoring) in a patient post cardioversion for AF.

Skeptically Yours

-ACP

Is A Canine Cardiomyopathy Being Created By Crazy Chow?

The eye of the  skeptical cardiologist was caught by an FDA alert issued recently:

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

According to the alert:

reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients. These reports are unusual because DCM is occurring in breeds not typically genetically prone to the disease.

What Is Dilated Cardiomyopathy?

Dilated cardiomyopathy refers to a disease of the heart muscle characterized by enlargement and global weakness of the main pumping chambers, the ventricles.

The image below is from the echocardiogram of a human with a severe dilated cardiomyopathy.

Humans with DCM experience weakness, shortness of breath and swelling in the legs due to heart failure. Severe cases of DCM are at risk for dying suddenly.

Cardiomyopathy Used To Be A Disease of Large Dogs

According to Lisa Freeman a veterinarian at the Cummings Veterinary Center at Tufts University

Heart disease is common in our companion animals, affecting 10-15% of all dogs and cats, with even higher rates in Cavalier King Charles Spaniels, Doberman Pinschers, and Boxer dogs.

Dilated Cardiomypathy in dogs

typically occurs in large- and giant-breeds, such as Doberman pinschers, Boxers, Irish Wolfhounds, and Great Danes, where it is thought to have a genetic component.

The FDA alert indicates that DCM

 is less common in small and medium breed dogs, except American and English Cocker Spaniels. However, the cases that have been reported to the FDA have included Golden and Labrador Retrievers, Whippets, a Shih Tzu, a Bulldog and Miniature Schnauzers, as well as mixed breeds

Is Doggy Dilated Disease Due To Demented Diets?

Writing last year, Dr. Freeman noted that

“In the last few years I’ve seen more cases of nutritional deficiencies due to people feeding unconventional diets, such as unbalanced home-prepared diets, raw diets, vegetarian diets, and boutique commercial pet foods.  The pet food industry is a competitive one, with more and more companies joining the market every year.  Marketing is a powerful tool for selling pet foods and has initiated and expanded fads, that are unsupported by nutritional science, including grain-free and exotic ingredient diets.  All this makes it difficult for pet owners to know what is truly the best food for their pet (as opposed to the one with the loudest or most attractive marketing).  Because of the thousands of diet choices, the creative and persuasive advertising, and the vocal opinions on the internet, pet owners aren’t able to know if the diets they’re feeding have nutritional deficiencies or toxicities – or could potentially even cause heart disease.

Purina has a whole line of grain-free wet and dry dog food under their Beyond label

Apparently, it has become trendy in the pet world (just like the human world) to vilify grains as in this article highlighting potential signs of doggy grain allergy at the dogbaker.com.

Freeman notes that grains are not felt to significantly contribute to pet diseases:

Many pet owners have, unfortunately, also bought into the grain-free myth.  The fact is that food allergies are very uncommon, so there’s no benefit of feeding pet foods containing exotic ingredients.  And while grains have been accused on the internet of causing nearly every disease known to dogs, grains do not contribute to any health problems and are used in pet food as a nutritious source of protein, vitamins, and minerals.

The FDA alert notes that in 4 cases of doggy DCM (3 of which were golden retrievers) taurine levels were low and with a change back to a normal diet and taurine supplementation the cardiomyopathy resolved. However, some reported cases had normal taurine levels.

Reconsider Your Dog’s Diet

To avoid doggy DCM, Dr. Freeman recommends

  • Reconsider your dog’s diet. If you’re feeding a boutique, grain-free, or exotic ingredient diets, I would reassess whether you could change to a diet with more typical ingredients made by a company with a long track record of producing good quality diets.  And do yourself a favor –  stop reading the ingredient list!  Although this is the most common way owners select their pets’ food, it is the least reliable way to do so.  And be careful about currently available pet food rating websites that rank pet foods either on opinion or on based on myths and subjective information. It’s important to use more objective criteria (e.g., research, nutritional expertise, quality control in judging a pet food). The best way to select what is really the best food for your pet is to ensure the manufacturer has excellent nutritional expertise and rigorous quality control standards (see our “Questions you should be asking about your pet’s food” post).
  • If you’re feeding your dog a boutique, grain-free, or exotic ingredient diet, watch for early signs of heart disease – weakness, slowing down, less able to exercise, short of breath, coughing, or fainting. Your veterinarian will listen for a heart murmur or abnormal heart rhythm and may do additional tests (or send you to see a veterinary cardiologist), such as x-rays, blood tests, electrocardiogram, or ultrasound of the heart (echocardiogram).

Anticardiomyopathically Yours,

-ACP

Where Are My Generics Medications Made? India, China, or the US?

With the recent recall of valsartan due to carcinogenic Chinese contaminants the issue of where one’s generic medication is manufactured has become more important.

I take two generics: ramipril for my hypertension and rosuvastatin for my cholesterol/atherosclerosis and I had no idea where they came from when I discussed the rise of generics manufactured in China recently.

Where Is My Ramipril Made?

I called my St. Lukes pharmacist, Robert, and asked him if he could give me information on the origin of these pills.

Robert told me that my 10 mg ramipril capsule was distributed by a company called West-Ward located in New Jersey.  West-Ward was an independent Columbus, Ohio company but was purchased in 2016 by a very large pharmaceutical company , Hikma, based in Aaman, Jordan. Now the Hikma web site indicates West-Ward is no more and is simply called Hikma in the US.

According to a 2017  Columbus article

Hikma Pharmaceuticals Plc projects it will end 2017 with about $2 billion revenue, about $600 million of which is from generic drugs made by its U.S. subsidiary West-Ward. In the spring, the company had projected $800 million in generics sales.

Customer service at Hikma informs me that my ramipril was made in their Columbus, Ohio plant.

Where Is My  Rosuvastatin Made?

My rosuvastatin (generic of Crestor) was made by Glenmark Pharmaceuticals which, per wikipedia

 is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons.

Glenmark received FDA approval to market their generic rosuvastatin in the US in July, 2016. and at that time had 115 products authorized for distribution in the US market and 61 drugs pending approval with the US FDA.

My rosuvastatin according to Robert was made in India although the Glenmark product catalog does not reveal this information.

Generic versus Brand Name

I’ve talked about Crestor/rosuvastatin a few times on this blog and the development of a generic version has been very helpful for many of my patients. Looking online today I see that generic rosuvastatin goes for about 10$ per month compared to 260$ for Crestor.

Is it worth paying an extra 250$ per month to get brand name Crestor if, let’s say it was manufactured in the US? For most people it isn’t. For one thing, there is no guarantee of where your brand name drug is manufactured.

Crestor used to be made in a factory in Bristol, UK but this was shut down in 2017 and now I can’t tell where Astra-Zeneca makes the stuff. Frankly, I’m surprised that they are selling any of the drug which used to account for 5 billion dollars of their annual sales.

So my cholesterol drug is made in India by an Indian company and my blood pressure drug is made in Columbus, Ohio by a Jordanian company.

I never realized how globalized the pharmaceutical industry has become. Hopefully, the FDA is doing a good job of monitoring the safety and quality of products we rely on for our wellbeing which are manufactured all over the globe.

Skeptically Yours,

-ACP

“Anthony, You Have One More Research Citation”: Social Networking For Researchers

The skeptical cardiologist joined ResearchGate recently. Per wikipedia:

ResearchGate is a social networking site for scientists and researchers[3] to share papers, ask and answer questions, and find collaborators.[4]According to a study by Nature and an article in Times Higher Education, it is the largest academic social network in terms of active users,[5][6] although other services have more registered users and more recent data suggests that almost as many academics have Google Scholar profiles.[7]

I published lots of research during my academic career in cardiology (1987-1996) and have written a few papers in the last few years while in clinical practice. Since I verified with ResearchGate the publications I was co-author on they regularly send me notifications when they find that my work has been referenced by another paper.

Screen Shot 2018-07-03 at 6.33.50 AM

I find such notifications fascinating on a number of levels. First, it reminds me of a topic that I was incredibly interested in to which I contributed meaningful information. This, in turn has me ponder the importance of my prior research and the current status of knowledge in the area.

I feel a strong compulsion to click on the “view citing research” button to see who cited me and why. Once on the ResearchGate site there are multiple things to further distract me from whatever I was doing previously, ranging from a statistical summary of my works read to a listing of papers that have been cited.

Screen Shot 2018-07-03 at 6.34.44 AM

You can imagine how addictive this site is for me. For example, that top citation about atrial septal aneurysm from nearly 30 years ago is the first paper to describe the relationship of atrial septal aneurysm described by transesophageal echocardiography and stroke, a relationship which has become even more significant since the approval of atrial septal occluder devices for treatment of stroke caused by PFO.

That citation of “systolic anterior motion of the mitral chordae tendineae” reminds me that nothing significant has been written in this area since my paper. I couldn’t figure out the significance of chordal SAM then and to this day nobody has.

Clicking on “view citation” takes me to a page which shows me the citing paper along with their stats on my paper. From there I can click on a link to the citing paper which was published in a curious journal entitled Cureus.

Sure enough my paper is reference #7 (Systolic anterior motion of the mitral chordae tendineae: prevalence and clinical and Doppler-echocardiographic features) and the authors are listed as:

Anthony C. Pearson, MD'Correspondence information about the author MD Anthony C. Pearson

Tomasz J. Pasierski, MD

David A. Orsinelli, MD

Department of Internal Medicine, Division of Cardiology, The Ohio State University Columbus, Ohio, USA
with the technical assistance of Peter Gray and Karen Huschart
Reading the list of my co-authors and contributors brings back fond memories of days spent in research collaboration and discussion. I ponder catching up with long-lost colleagues.
ResearchGate also tantalizes me by showing how many times my 96 research publications have been cited-8,594 times.
ResearchGate gives me a score. Mine is 39.78 and is apparently higher than 97.5% of ResearchGate members.
I have no clue what the RG score means but I am  really happy to have a high one.
Alas, I have added ResearchGate to the list of websites clamoring for my attention and my (really limited) time.
Skeptically Yours,
-ACP

Three More Nails In The Omega-3 Supplement Coffin: Stop Taking Fish Oil Pills (The Complete Post)

If by now you are still taking fish oil supplements despite my last post on the topic I present three more reasons to stop wasting your money and destroying the ocean’s ecosystem.

The first nail: No Reason To Take Fish Oil Pills

A Cochrane review showing shows there is little or no effect of omega 3 supplements on our risk of experiencing heart disease, stroke or death.

This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and high-quality evidence suggests that increasing EPA and DHA has little or no effect on mortality or cardiovascular health (evidence mainly from supplement trials). Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias. Low-quality evidence suggests ALA may slightly reduce CVD event risk, CHD mortality and arrhythmia.

Second Nail. Peruvian Anchoveta: Put Them On A Pizza Not in A Pill

Paul Greenberg’s recently published book, The Omega Principle, emphasizes the damage the fish oil supplement business is doing to the ocean environment,

During a recent interview on Fresh Air on NPR he summarized the concerns:

GREENBERG: So omega-3 supplements come from this critical layer of the ocean biosphere that are small – what are called pelagic fish. They’re the silvery, little fish like anchovies and herring and other fish called menhaden that most people haven’t heard of, but it’s actually the most caught fish in the lower 48 of the United States. These fish are really essential for ecosystem dynamics in the ocean.

So the way that oceans work is that all the energies coming from the sun – it goes – all that energy is processed by plankton, by phytoplankton. And it’s really these fish that are – these little fish that are used for omega-3 supplements that transfer the energy from plankton to larger fish. So in other words, you know, you have the solar energy going into the plankton. The little fish then eat the plankton. And then they are in turn eaten by larger fish. So if you harvest this middle layer – if you overharvest this middle layer of anchovies, of herring, of menhaden – if you take them out of the picture, there’s no way for the energy to be transferred from phytoplankton up to larger predators. So I guess that’s my main concern here.

So in particular, where are the omega-3 supplements coming from? Most of the omega-3 supplement oil is coming from a fish called a Peruvian anchoveta. And it is the most caught fish in the world. In some years, Peruvian anchoveta harvests have equaled as much as 10 million metric tons. Just to give you some perspective, that’s like one-eighth of all the fish caught in the world. And the crazy thing about it is that those fish are completely, totally edible. I’ve eaten them. They’re delicious. You can have them on a pizza. You could do anything with them. But 99 percent of those Peruvian anchoveta are ground up into animal feed, boiled down into oil and turned into supplements. So to me, to my mind, that is not necessarily the wisest use to be made of this really, really important source both for the ecology of the ocean but also for humans

Nail Three. Save the Krill!

The supplement industry is incredibly creative in their marketing. As the uselessness of fish oil supplementation has become clear, supplement manufacturers have begun touting krill oil as superior to fish oil.

Claims like the following are all over the internet:

Krill have an edge over your ordinary fish – when you take a krill oil supplement, you also get astaxanthin along with your DHA and EPA. It’s an antioxidant. In terms of antioxidant power of potency, it’s been found to be 500x to 6,000x stronger than regular vitamins like vitamin E and vitamin C.

This is just hogwash. There is no good clinical evidence to support any health claim for krill oil in general or astaxanthin in particular. Please read my post on the failure of anti-oxidant supplements and vitamins and recognize that claims of antioxidant power do not indicate any health benefit.

A technical paper from Greenpeace review the importance of krill to to the marine ecosystem in the Antarctic and this paper, entitled “License to Krill” details the problem.

Do you want to be responsible for starving penguins, whales and seals??!

Let me reiterate my original 2013 fish oil post pithy summary:

the bottom line on fish oil supplements is that  the most recent scientific evidence does not support any role for them  in preventing heart attack, stroke, or death. There are potential down sides to taking them, including contaminants and the impact on the marine ecosystem. I don’t take them and I advise my patients to avoid them (unless they have triglyceride levels over 500.)

Prokrilly Yours

-ACP

 

 

 

 

Heart Healthy Breakfast Choices?: Cheerios, Honey-Nut Cheerios and Soluble Fiber Revisited

A reader commenting on my Plant Paradox post questioned nutritional  recommendations to consume fiber. This has prompted me to revisit a post I wrote in 2014 on Cheerios and Soluble Fiber.

I mentioned at that time that Honey-Nut Cheerios was the #1 selling ready-to-eat breakfast cereal and Cheerios #4. This update Screen Shot 2018-07-15 at 7.22.55 AMindicates little has changed in the rankings or consumption of breakfast cereal since then despite a more widespread recognition that added sugar is the major toxin in our diet and that these food items are basically a vehicle for sugar.

Apparently, Americans believe honey is not sugar. But Honey Nut Cheerios contain 9 times as much sugar as cheerios. Here are the top ingredients:

Whole Grain Oats, Sugar, Oat Bran, Corn Starch, Honey, Brown Sugar Syrup, Salt, Tripotassium Phosphate, Rice Bran Oil and/or Canola Oil,

General Mills tries to emphasize the healthiness of Honey Nut Cheerios, focusing on their close relationship with bees and the natural goodness of honey in its advertising along with other factors that we now know are not important (low fat, 12 vitamins and minerals, source of iron).Screen Shot 2018-07-15 at 7.56.32 AM

Little has changed with respect to the science supporting fiber consumption to reduce cardiovascular disease since 2014.  It is still weak and based on observational studies and surrogate biomarkers.

Between the lines below is my original post with current annotations in red.


The skeptical cardiologist usually eschews the breakfast offerings in the Doctor’s lounge. I’m not really interested in consuming donuts, muffins, or bagels with their high carbohydrate load. As I’ve ranted out about previously, the only yogurt available is Yoplait low fat , highly sugared-up yogurt which is arguably worse than starting the day with a candy bar.

A selection of breakfast cereals is available including Cheerios, Raisin Bran, and Frosted Flakes. Occasionally, when I have neglected to bring in my own full-faty yogurt, granola and/or fruit I will open up one of the Cheerios containers and consume a bowl mixed with 2% milk (full-fat, organic milk which I passionately advocate here and here is not available) (2018 update, I have said “cheerio” to all breakfast cereals and no longer eat Cheerios in the doctor’s lounge). 

Pondering the Cheerios packaging and the cute little O’s made me wonder whether this highly processed and packaged food with a seemingly endless shelf life was truly a healthy choice.

The “Ready-To-Eat”  And Allegedly Heart-Healthy Cereal

Cheerios and Honey-nut cheerios were  the #4 and #1 breakfast cereals in the US in 2013, generating almost a billion dollars in sales. Both of these General Mills blockbusters undoubtedly have reached their popularity by heavily promoting the concept that they are heart healthy.

The Cheerios label is all about the heart. The little O’s sit in a heart-shaped bowl. A prominent red heart with a check inside it attests to the AHA having certified Cheerios as part of its checkmark.heart.org program. Additional text states “low  in Saturated fat and cholesterol” and “diets low in saturated fat and cholesterol may reduce the risk of heart disease.”

Is The Fiber In Cheerios “Heart-Healthy” ?

Beta-glucan is a soluble fiber primarily located in the endosperm cell wall of oats. Early studies showed that oats and beta-glucan soluble fiber could reduce total and LDL (bad cholesterol) levels. The mechanism isn’t really known. (see the end of post for possible mechanisms). The Quaker oats web site oversimplifies the mechanism thusly :

“In your digestive tract, it acts as a sponge, soaking up cholesterol and carrying it out of the body”

This narrative fits with the oversimplified and now discredited descriptions of atherosclerosis which attribute it directly to consumption of cholesterol and fatty acids. See here if you’d like to appreciate how complex the process truly is.

The FDA Sanctions Oats As Heart Healthy

In 1997, the FDA reviewed 33 studies (21 showing benefit and 12 not) and decided to allow a health claim for foods that contain oats and soluble fiber. A minimum dose of 3 grams/day of oat beta-glucan was suggested for a beneficial reduction in blood cholesterol and (presumably, although never documented) a subsequent decline in coronary heart disease.

In 1998 Johnson, et al, published the results of a study funded by a grant from General Mills that showed that  inclusion of whole grain oat ready to eat cereal providing 3 grams of beta-glucan as part of a low fat diet reduced  LDL cholesterol by 4% after 6 weeks. HDL was unchanged. Patients in this study consumed 45 grams (1.5 oz) of cheerios at breakfast and then again in the evening. There was a total of 3 grams of soluble fibre in this amount of Cheerios. A control group consumed corn flakes in a similar fashion without change in LDL.

General Mills took this weak data and ran with it and began posting on Cheerios the following statements

 “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”

Although the FDA had approved verbiage indicating oats may reduce heart disease “when eaten as part of a diet low in saturated fat and cholesterol” the agency objected to General Mills claiming that Cheerios lowers cholesterol “when eaten as part of a diet low in saturated fat and cholesterol”.

The FDA  issued a warning letter to General Mills in 2009 in which the agency alleged “serious violations” of the FDC Act in the label and labeling of Cheerios cereal.

Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.

Lowering Cholesterol Is Not The Same As Preventing Heart Disease

The FDA was telling General Mills that it was OK to say that Cheerios may reduce heart disease but not that it can reduce cholesterol because that made it a drug. It makes no sense.

The only thing that had been demonstrated for oat soluble fiber and Cheerios in particular was a reduction in cholesterol. There has never been a study with oats showing a reduction in heart disease..

It’s the heart disease, the atherosclerosis clogging our arteries and causing heart attacks and strokes that we want to prevent. We could care less about lowering cholesterol if it doesn’t prevent atherosclerosis.

A recent review of studies since the FDA ruling shows that 70% of studies show some reduction in LDL with beta-glucan. Interstingly, the studies which added beta-glucan to liquids were generally positive whereas addition to solids such as muffins usually did not show benefit.

I’m going to accept as evidence-based the claim that whole oats can lower your LDL about 7% if you consume a very large amount of them on a daily basis.

However, the critical question for any drug or dietary intervention is does it prevent atherosclerosis, the root cause of heart attacks and strokes. There has been in the past an assumption that lowering cholesterol by any means would result in lowering of atherosclerosis.

This theory has been disproven by recent studies showing that ezetimibe and niacin which significantly lower LDL do not reduce surrogate markers of atherosclerosis or cardiovascular events any more than placebo when added on to statin drugs. (There is now weak evidence that ezetimibe does lower cardiovascular events ). The recently revised cholesterol guidelines endorse the concept of treating risk of atherosclerosis rather than cholesterol levels.


 

I do like the food writer Michael Pollan’s simple rules to “Eat Food. Mostly Plants. Not Too Much.” and this NY Times piece summarizes much of what is in his short, funny and helpful Food Rules book:

you’re much better off eating whole fresh foods than processed food products. That’s what I mean by the recommendation to eat “food.” Once, food was all you could eat, but today there are lots of other edible foodlike substances in the supermarket. These novel products of food science often come in packages festooned with health claims, which brings me to a related rule of thumb: if you’re concerned about your health, you should probably avoid food products that make health claims. Why? Because a health claim on a food product is a good indication that it’s not really food, and food is what you want to eat.

If you follow Pollan’s dictum you will get plenty of fiber, soluble or otherwise and you will avoid the necessity to obsess over the macronutrients in your diet, fiber or otherwise. Throw in some Cheerios and oatmeal every once in a while if you like them;  in their unadulterated state they are a heart-healthy food choice.

Cheerio,

-ACP

Dr. P’s Heart Nuts and The Flawed But Still Relevant PREDIMED Trial

The skeptical cardiologist was somewhat disheartened to read  the New York Times headline today that the  PREDIMED study was flawed. I frequently reference this landmark randomized trial of the mediterranean diet when I’m citing the cardiovascular benefits of nuts and EV olive oil.

Science mag summarizes the problem which prompted a re-analysis of the study:

A months-long inquiry by the Spanish researchers and NEJM staff uncovered that up to 1588 people in the trial hadn’t been properly randomized: Some were assigned to the same diet as someone else in their household (a common feature of diet studies, but not reported in the original paper). Others, who lived in a rural area, were assigned to different diets based on the clinic closest to them—for example, one group had to pick up a liter of olive oil each week. “The investigator realized he couldn’t get people to travel as far as they needed so he made his study ‘cluster randomized,’” by clinic rather than by individual, Drazen says.

The authors reanalyzed their data without those 1588 participants and found that despite the missteps, the conclusion held: Nuts, olive oil, and fatty fish remained a net positive on heart health, though the conclusions came with somewhat less statistical oomph than in the original paper.

Here’s what I wrote about nuts and the PREDIMED study when I first started distributing Dr. P’s Heart Nuts to my patients.

The skeptical cardiologist has finally prepared Dr. P’s Heart Nuts for distribution. IMG_8339The major stumbling block in preparing them was finding almonds which were raw (see here), but not gassed with proplyene oxide (see here), and which did not contain potentially toxic levels of cyanide (see here).

During this search I learned a lot about almonds and cyanide toxicity, and ended up using raw organic almonds from nuts.com, which come from Spain.

I’ll be giving out these packets (containing 15 grams of almonds, 15 grams of hazelnuts and 30 grams of walnuts) to my patients because there is really good scientific evidence that consuming 1/2 packet of these per day will reduce their risk of dying from heart attacks, strokes, and cancer.

IMG_7965The exact components are based on the landmark randomized trial of the Mediterranean diet, enhanced by either extra-virgin olive oil or nuts (PREDIMED, in which participants in the two Mediterranean-diet groups received either extra-virgin olive oil (approximately 1 liter per week) or 30g of mixed nuts per day (15g of walnuts, 7.5g of hazelnuts, and 7.5g of almonds) at no cost, and those in the control group received small nonfood gifts).

After 5 years, those on the Mediterranean diet had about a 30% lower rate of heart attack, stroke or cardiovascular death than the control group.

It’s fantastic to have a randomized trial (the strongest form of scientific evidence) supporting nuts, as it buttresses consistent (weaker, but easier to obtain), observational data.

Despite the statistical flaws PREDIMED is still an important study demonstrating the benefits of nuts.  PREDIMED was the best randomized trial data we had for nuts but there are tons of observational data which are very consistent and show a strong association between increased nut consumption and reduced mortality..

Consequently, I made up a new batch of Dr. P’s Heart Nuts in honor of the survival of PREDIMED and will be distributing them to patients today.

Meditativeterraneanly Yours,

-ACP

Which Exercise Is Best For Heart Health: Swimming or Walking?

Reader Pat asked the skeptical cardiologist the following question:

Which would be the better heart healthy choice? Walking briskly 3 x week or swimming for 45 minutes 2-3 x a week?

Swimming is an attractive alternative to walking or running for many of my patients with arthritis because it is a lot easier on the load-bearing joints of the lower extremities.

To my surprise there is at least one study (from Australia) comparing swimming and walking that was published in the journal Metabolism in 2010.

The investigators randomly assigned 116 sedentary women aged 50-70 years to swimming or walking. Participants completed 3 sessions per week of moderate-intensity exercise under supervision for 6 months then unsupervised for 6 months.

Compared with walking, swimming improved body weight, body fat distribution and insulin resistance in the short term (6 months).

At 12 months swimmers had lost 1.1 kg more than walkers and had lower bad cholesterol levels.

It should be noted that these differences barely reached significance .

Types of Activities And The Intensity of Exercise

My general recommendations on exercise (see here) give examples of different aerobic physical activities and intensities.

These activities are considered Moderate Intensity

  • Walking briskly (3 miles per hour or faster, but not race-walking)
  • Water aerobics
  • Bicycling slower than 10 miles per hour
  • Tennis (doubles)
  • Ballroom dancing
  • General gardening Vigorous Intensity

These types of exercise are considered Vigorous Exercise

  • Racewalking, jogging, or running
  • Swimming laps
  • Tennis (singles)
  • Aerobic dancing
  • Bicycling 10 miles per hour or faster
  • Jumping rope
  • Heavy gardening (continuous digging or hoeing, with heart rate increases)
  • Hiking uphill or with a heavy backpack

As a rule of thumb, consider 1 minute of vigorous exercise equivalent to 2 minutes of moderate exercise and shoot for 150 minutes per week of moderate exercise or 75 minutes of vigorous exercise.

Of course one can swim laps at peak intensity or at a very slow, leisurely pace so swimming laps doesn’t always qualify as “vigorous” exercise. Likewise one can play singles tennis languorously and be at a moderate or lower intensity of exercise.

It is entirely possible that the swimmers were working at a higher intensity during their sessions than the walkers and that could be the explanation for the differences seen between the two groups.

Ultimately, the best type of  exercise for heart health is the one you can do and  (hopefully) enjoy on a regular basis.

Antilanguorously Yours,

-ACP

N.B. Speaking of swimming. A year ago I wrote about longevity and featured Eugene, a 98 year old who could swim the length of a swimming pool underwater. Eugene turns 100 in 2 days.

Thoughts On Prolonged Bleeding Whilst Taking Baby Aspirin

I was hurriedly shaving the other day and felt a sharp stinging sensation in my philtrum.  Shortly thereafter, blood began pouring forth from the area and dribbling into my mouth.

I don’t typically name-check the area between the nose and the margin of the upper lip, but if one cuts the area (and wants to write about the experience), it is useful to have a single noun that describes it precisely.

This is not my philtrum but the graphic nicely demonstrates why the area is often called “cupid’s bow”. Courtesy of Wkipedia

The human philtrum is apparently vestigial; per Wikipedia

The philtrum (Latin: philtrum, Greek: φίλτρονphiltron, lit. “love charm”[2]), or medial cleft, is a vertical groove in the middle area of the upper lip, common to many mammals, extending in humans from the nasal septum to the tubercle of the upper lip. Together with a glandular rhinarium and slit-like nostrils, it is believed[by whom?] to constitute the primitive condition for mammals in general.

Although lacking function, it does cause a protrusion in the otherwise smooth facade of the face, and as a consequence, is at an increased risk for cuts.

Despite holding pressure on the cut for many minutes and daubing it with toilet paper, it continued to bleed. The bleeding continued on for much longer than I am use to, and after a while I realized that my bleeding was prolonged due to the aspirin I have been taking.

I’ve been following my own advice to those with documented significant atherosclerotic plaque, and have been taking 81mg aspirin daily. I began chewing daily my chewable aspirin after writing my post on the best form of baby aspirin to take. Prior to that it was only intermittently.

BARCing Up the Willow Tree

As a cardiologist I commonly hear patients complain about the nuisance of bruising and bleeding caused by the aspirin and other blood thinners I have prescribed them. Now I had joined their ranks.

Doctors mostly worry about major bleeding caused by aspirin; things like bleeding from the gastrointestinal (GI) tract, or into the head. A recent review found that baby aspirin doubles the risk of bleeding from the upper GI tract, and increases the risk of intracranial hemorrhage by a factor of 1.4.

There is relatively little concern about the type of minor bleeding I experienced. However, beginning in 2010, the Bleeding Academic Research Consortium (BARC) investigators came up with a more precise way of categorizing bleeding events, the BARC bleeding types.

By far, the most common bleeding on aspirin is the kind I had: Type 1 BARC.

Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional. Examples include, but are not limited to, bruising, hematoma, nosebleeds, or hemorrhoidal bleeding for which the patient does not seek medical attention. Type 1 bleeding may include episodes that lead to discontinuation of medications by the patient because of bleeding without visiting a healthcare provider.

Indeed, my Type 1 bleeding prompted me to skip my aspirin doses for the next few days.

Many patients do the same thing. Just this morning a patient told she had stopped taking her aspirin because she thought it was causing “little red spots” on her arms.

Does Prolonged Bleeding Mean You Are Taking Too Much Aspirin?

My philtrum persisted in bleeding, and as I felt the need to use my hands for something other than holding pressure, I put a band-aid on the area (actually a Nexcare), which temporarily stemmed the bleeding tide: I began pondering if I was taking too much aspirin.

Since aspirin is so widely used to prevent heart attacks and strokes caused by sticky platelets, why isn’t there a way to see how effective it is at making sticky platelets less sticky?  We have such methods for blood pressure meds (blood pressure levels) and cholesterol lowering drugs (cholesterol levels).

And for the older blood thinner warfarin, we have a blood test which helps us make sure the dosage of medication is keeping the blood thinning in a range that maximizes  effectiveness and minimizes bleeding risk.

It turns out there are lots of ways to measure how effective aspirin is in an individual, but no consensus on which particular method should be used, and authorities don’t recommend we make such measurements.

This article on platelet function tests lists 13 different platelet function tests, ranging from the mostly historical “bleeding time” to sophisticated tests of platelet aggregation.

The  Verify Now test (not available in the US) of platelet reactivity predicted in one study which patients would have BARC type I bleeding like mine.  The test did not predict major bleeding complications, things like GI bleeding and intracranial hemorrhage.

Those patients who had minor bleeding problems were more likely to be noncompliant, stopping their aspirin therapy.

I could easily visualize the following  scenario as the blood began pooling underneath my band-aid and progressing down my philtrum.

Let’s say I’ve just had a heart attack and had a drug-eluting stent placed in one of my coronary arteries. I’ve been started on aspirin and another anti-platelet drug. I cut myself and bleed excessively and prolongedly. I decide that the aspirin is the reason, and start skipping doses. The lower aspirin levels subsequently allow my platelets to become sticky again. As a result a clot forms in my coronary stent and a heart attack ensues.

Thus, prolonged bleeding from a cut, considered a minor side effect of aspirin therapy, could increase heart attack risk.

There is a clinically available test for aspirin effect called AspirinWorks.

The AspirinWorks Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-dehydrothromboxane B2 (11dhTxB2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. Unlike platelet aggregation tests, which require freshly drawn blood that must be evaluated within at least four hours, the AspirinWorks Test is performed on a random urine sample that can easily be obtained in any doctor’s office.

AspirinWorks points out the putative benefits of testing for aspirin effect:

An increasing body of evidence in the medical literature overwhelmingly supports clinically significant variability in aspirin effect, which has been well-established in findings from trials, including the Heart Outcomes Prevention Evaluation (HOPE) Study and the CHARISMA trial published in Circulation (Journal) (2002 and 2008). These trials have demonstrated that:

  1. Increased levels of urinary 11dhTxB2 are associated with as much as a four fold increased risk for adverse cardiovascular events or death.
  2. Statin treatment is associated with lower concentrations of 11dhTxB2
  3. 11dhTxB2 is an independent, modifiable predictor of risk for stroke, heart attack and cardiac death (CHARISMA).

I have never ordered this test and am unaware of any other physicians ordering it on their patients.

Doctors don’t test for aspirin effect in individual patients because it is expensive and it won’t change our approach in most cases.
Taking  81 mg aspirin daily might be too high a dose to optimize the balance between bleeding and clotting in me.  If I took it every other day I might have less Type I BARC episodes. However, we don’t have any good evidence that adjusting the dosage based on aspirin effectiveness testing will improve my outcomes.
Thus, we bleeders on baby aspirin (the BOBA) of the world must find better ways of dealing with minor bleeding.
When I changed the band-aid on my philtrum several hours after the initial cut, I began actively bleeding again. This time I decided to apply ice to the area to vasoconstrict the arteries. This, plus more pressure and time, almost completely stopped the bleeding.
Another Nexcare was applied to the area, and when it was removed the next morning, the bleeding did not resume.
There are a variety of other measures that can be tried with varying degrees of success, as described here (deodorant, lip balm, listerine, Visine) and here (styptic pencils and powders, cayenne pepper, tea bag, sugar, alum-ironically this article mentions making a paste out of aspirin and applying it to the cut).
There also appears to be a thriving industry devoted to commercial  products for stopping bleeding from minor cuts outlined here.
Should We Worry About Minor Bleeding?
Ultimately, the seemingly excessive bleeding one experiences upon incidentally cutting oneself while taking aspirin is best viewed as a reassuring sign that the drug is doing its job: Your platelets are less sticky, less likely to cause bad clots that cause strokes and heart attacks.
Platelets don’t know bad from good clots, they just react indiscriminately.
The small amount of blood that exudes from superficial cuts can be scary but it can be controlled with fairly simple measures.
The little red dots my patient experiences, although unattractive, are benign.
Styptically Yours,
-ACP

AliveCor Mobile ECG : Ways To Minimize Low Voltage and Unclassified Recordings

Sometimes AliveCor’s Mobile ECG device yields unclassified interpretations of recordings. Understandably if you want to know whether your rhythm is normal or atrial fibrillation, the unclassified  classification can be very frustrating.

There are various caues of an unclassified tracing with different solutions.  Some unclassified recordings are due to a heart rate over 100 BPM or under 50 BPM and cannot be fixed. Similarly, some patients with ectopic beats like PVCS may consistently generate unclassified interpretations (see my discussion here).

Artifacts induced by poor recording techniques are common as a cause and almost always can be fixed.

These can be reduced by minimizing motion, extraneous noise, and maximizing contact with the electrodes.  Follow all the steps AliveCor lists here.

For me, the following step is crucial

  • If your fingers are dry, try moistening them with antibacterial wipes or a bit of lotion

And be aware the device needs to be near the microphone of your iPad or smartphone.

Low Voltage As Cause of Unclassified Kardia Recordings

Another cause of unclassified interpretations is a low voltage recording (which I initially discussed here.).

At the recent ACC meeting I asked Alivecor inventor and CEO David  Albert if he had any solutions to offer for those who obtain unclassified low voltage AliveCor tracings.

He told me that the cause is often a vertically oriented heart and that recording using the lead II technique can often solve the problem.

Lead II involves putting one electrode on your left knee and one your right fingers as described in this video:

Reader “J”  recently sent me a series of Kardia ECG recordings,  some of which were unclassified , some normal and one read as possible atrial fibrillation.

The unclassified and possible AF tracings looked like this:

 

They were very regular with a rate between 80 and 100 BPM but they totally lacked p waves. It was not clear to me what the rhythm was on these tracings.

Other tracings had lowish voltage but the p waves were  clearly visible  and Kardia easily classified them as normal

Lowish voltage with p waves (Type B)

 

Good QRS voltage with clear p waves ( Type B

 

Still others had improved QRS voltage with clear p waves and were also classified  appropriately as normal

 

After some back and forth emails we discovered that the ECG recordings with no p waves were always  made using the chest lead recording.   AliveCor-describes this as follows:

  • For an Anterior Precordial Lead, the device can be placed on the lower left side of the chest, just below the pectoral muscle. The bottom of the smartphone or tablet should be pointing towards the center of the body.

Mystery solved!

There is an abnormal cardiac rhythm that is regular between 80 and 100 BPM with no p waves and normal QRS called junctional tachycardia but in J’s case the absent p waves are related to the recording site.

Also, note that for this young woman the lead II voltage (Type B tracing) is much higher than the standard, lead I voltage (type A tracing).

Lead II With Pants On

After Dr. Albert told me of the advantages of Lead II I responded that it seemed somewhat awkward to take one’s pants off in order to make an ECG recording.

He immediately reached in his suit pocket and pulled out a pen-shaped device and began spraying a liquid on his left knee.

To my surprise he was able to make a perfect Lead II recording without taking his pants off!

Lessons learned from reader J and Dr. A:

  • Consider trying different leads if the standard Lead I (left hand, right hand) is consistently yielding unclassified ECG recordings
  • Try Lead II (left knee, right hand) to improve voltage and recording quality
  • You can record off your knee even with your pants on if you are prepared to spray liquids on your pants

Pantsonically Yours,

-ACP

Unbiased, evidence-based discussion of the effects of diet, drugs, and procedures on heart disease

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