All posts by Dr. AnthonyP

Cardiologist, blogger, musician

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

Joe’s Cafe: A Cornucopia of Visual and Musical Delights

The coolest music venue in St. Louis in my opinion is Joe’s Cafe.

Fortunately, for the skeptical cardiologist, the venue remains fairly obscure, even to music lover’s who reside in Saint Louis.

For example, last Thursday the Eternal Fiancee’ and I, along with Doug, the Guitarist of the Band of the skeptical cardiologist (GOBOSC) and his wife were able to sit within a couple of feet of Spencer Bohren as he played roots, blues, folk and Americana on a banjo, a lap steel or two, and an acoustic guitar.

Bohren, based out of New Orleans, also sang and told stories, often at the same time.

The GOBOSC and I, being musicians, appreciated the proximity which allowed us to observe closely what Bohren did with his non-finger-pick covered fingers and thumb.

You can watch a video of Bohren relating the history of a Blues song using five guitars here:

I’ve also seen Kinky Freidman at Joe’s. I’ve been a fan of Kinky’s since I heard “Get Your Biscuits In The Oven And Your Buns In The Bed” from his 1973 album Sold American. His wikipedia entry pretty accurately summarizes his career as follows:

American singer, songwriter, novelist, humorist, politician, and former columnist for Texas Monthly who styles himself in the mold of popular American satiristsWill Rogers and Mark Twain.[2] He was one of two independent candidates in the 2006 election for the office of Governor of Texas. Receiving 12.6% of the vote, Friedman placed fourth in the six-person race.

I had forgotten about the Kinkster since reading one of his (18) detective novels a few decades ago; I figured he had retired from the music business. To my surprise one day last year, I received an email from Joe’s Cafe indicating he would be playing there on an upcoming Thursday night.

I don’t usually allow semi-celebrities to have their pictures taken with me but since I love Kinky Freidman, I made an exception for him

Bill Christman, Impresario And Connoisseur Of Signs

Joe’s Cafe is the brain child of Bill Christman, a one time sign painter, now fine artist, and lover of good live music.

Bill decides who will perform, and introduces the acts, always with a quirky sense of humor, but a stern warning that we audience members should be listening when the artist is performing, and not talking or playing on iphones.

Bill Christman (right) introducing band. I forget why he had the arab headgear and why the man is playing the trumpet on the left. It’s always interesting at Joe’s Cafe!

Christman’s studio, Ars Populi sits next to Joe’s Cafe. According to the RFT:

Christman quit the sign-painting business more than two decades ago in order to devote himself full-time to fine art — Ars Populi doubles as his studio — and today St. Louisans can find his handiwork all over town, perhaps most famously at Beatnik Bob’s Museum of Mirth, Mystery & Mayhem inside the City Museum. His homage to bohemia, Joe’s Café, is the stuff of legend in Christman’s Skinker-Debaliviere neighborhood and beyond; its sporadic schedule of music events and invite-only policy have combined to create a speakeasy vibe that — improbable as it might seem in this day and age — is uncontrived and genuine.

Arrive early to Joe’s Cafe for the best seats (although there are no “bad” seats-some do require a climb up a wooden ladder to the balcony) so you can wander through the wonder of the back yard.

The view from the balcony is quite good. Be aware, however, that the only air conditioner in the place will be blowing cold air directly on you if you sit in these particular seats. Up in the balcony you may feel sufficiently distant to chat with your friends during the performance but please don’t. Music is King at Joe’s! Go to a bar (?TGI Friday’s)  if you want to chat with your friends when musicians are playing nearby.

Words are insufficient to describe what one encounters either inside or outside Joe’s Cafe, so let’s savor some snapshots of both.

First, some relatively random shots from outside:

It has been said of the interior:

at Joe’s, you enter another dimension, a place lit by red neon and dusty yellow incandescent marquee bulbs

The Eternal Fiancee’ describes the decoration as “the interior of Joe’s Cafe is the reality of what TGI Friday’s does a bad job of imitating.”

Spencer Bohren playing one of his lap steel guitars and singing Dylan’s “Ring Them Bells” (Ring them bells for the time that flies For the child that cries When innocence dies) a mere meter away from my table. The popcorn on the table is the only food or beverage one can purchase at Joe’s and it costs one (or two) bucks.

If you end up going to Joe’s Cafe be sure and tell them the skeptical cardiologist sent you. And please, don’t tell your friends and neighbors how cool it is.

Sonically Yours,

-ACP

N.B. Here’s the info Joe’s Cafe emails provide about performances.

Here’s the Joe’s Mostly Official Facebook page https://www.facebook.com/stlouisjoescafe/
which often has better information than these emails.

Joe’s is a BYOB, BYOF music club.
Admission: $10
Doors open around 7:00
Music starts at 8:00
Alcohol consumption ends at 10:15
Recycle your own stuff
Smoking outside only
Park on Des Peres Ave. Thou shalt not annoy our neighbors.

 

Low-Fat Versus Low-Carb Diet: DIETFITS Show Both Can Work If They Are “Healthy”

In the ongoing nutritional war between adherents of low-fat and low-carb diets, the skeptical cardiologist has generally weighed in on the side of lower carbs for weight loss and cardiovascular health.

I’ve questioned the vilification of saturated fat and emphasized the dangers of added sugar. I’ve even dabbled in nutritional ketosis.

The science in  nutrition is gradually advancing and the DIETFITS study recently published in JAMA is a welcome addition.

DIETFITS is a  really well done study which provides important insights into three huge questions about optimal diet:

  1. Should we choose a low-fat or a  low-carb diet for  weight loss and cardiovascular health?
  2. Do baseline insulin dynamics predict who will respond to low-fat versus low-carb diet?
  3. Can we predict who will respond to low-fat versus low-carb by genetic testing?

The Details Of DIETFITS

Stanford investigators recruited 609 San Francisco area individuals between the ages of 18 to 50 years with BMI of 28 to 40  and randomized them to a “healthy” low-fat diet or a “healthy” low-carb diet.

During the first 8 weeks of the study, low-fat participants were instructed to reduce fat consumption to <20 gm/ day while the low carb participants were instructed to reduce digestible carbohydrate to <20 gms/day.

Then individuals were allowed to add back fats or carbs back to their diets in increments of 5 to 15 g/d per week until “they reached the lowest level of intake they believed could be maintained indefinitely.”  Importantly no explicit instructions for energy restriction were given.

The “healthy” instructions for both groups were as follows

  1. maximize vegetable intake
  2. minimize intake of added sugar, refined flours and trans-fats
  3. focus on whole foods that are minimally processed, nutrient dense and prepared at home whenever possible

Dietfits Outcomes-Diet And Weight

Major findings

  1. Total energy intake was reduced by 500-600 kcal/d for both groups
  2. The low-fat vs the low-carb intake at 12 months was 48% versus 30% for carbs, 29 vs 43% for fat and 21 vs 23% for protein.
  3. Mean 12 months weight change was -5.3 kg for low-fat vs 6-6.0 kg for low-carb which was not significantly different
  4. There was no difference between groups in body fat percentage or waist circumference
  5. Both diets improved lipid profiles and lowered blood pressure, insulin and glucose levels
  6. LDL (bad cholesterol) declined more in the low-fat group whereas HDL (good cholesterol) increased more and triglycerides declined more in the low-carb group.

Thus both diets were successful for weight loss and both improved risk markers for cardiovascular disease after a year.

DIETFITS- Can Genes and Insulin resistance Predict Best Diet?

Surprisingly, the study found no significant diet-genotype interaction and no diet-insulin secretion interaction with weight loss.

This means that they could not predict (as many believed based on earlier studies) who will benefit from a low carb diet based on either currently available genetic testing or a generally accepted measure of insulin resistance.

As the authors point out, these findings “highlight the importance of conducting large, appropriately powered trials such as DIETFITS for validating early exploratory analyses.”

DIETFITS-Perspectives

As you can imagine this study has led to quite an uproar and backlash from dedicated combatants in the macronutrient wars.

A reasoned summary and response from Andreas Eenfeldt, a low carb proponent can be found on his excellent low carb/keto Diet Doctor site here.

Eenfeldt concludes

If I’m allowed to speculate, the reason that we did not see any major additional benefit from low carb in this study is that the groups ended up so similar when it came to bad carbs. The low-fat group ended up eating fewer carbs too (!) and significantly less sugar, while the low-carb group ended with a somewhat weak low-carb diet, reporting 130 grams of carbs per day.

Eenfeldt emphasizes that low-fat diets never “win” these macronutrient dietary skirmishes:

On the whole, this study adds to the 57 earlier studies (RCTs) comparing low carb and low fat for weight loss.

From a standing of 29 wins for low carb, zero for low fat and 28 draws, we now have 29 wins for low carb and 29 draws. The wins for low fat stay at zero.

Larry Husten at Cardiobrief.org in his analysis of the study quotes a number of experts including Gary Taubes, the low carb pioneering journalist

Taubes speculates “that the weight loss may have been similar not because any diet works if you stick with it and cut calories (one possible interpretation) but because of what these diets had in common — avoid sugar, refined grains, processed foods. Whether the low-carb arm would have done even better had Gardner kept their carbohydrates low is something this study can’t say. (And Ornish [low-fat diet proponent] would probably say the same thing about fat consumption.)”

The low-fat or vegan disciples seem to have had a muted response to this study. I can’t find anything from John McDougal , Dean Ornish, Caldwell Esselstyn or Joel Fuhrman.

Readers feel free to leave comments which  link to relevant analysis from the low-fat proponents.

Dietfits-Perspective Of The Participants

Julia Volluz at Vox wrote a fascinating piece recently which involved interviewing some of the participants in this study.

She points out that although the average DIETFITS participant lost over 10 pounds, “Some people lost more than 60 pounds, and others gained more than 20 during the year.”

LOW_FAT_LOW_CARBS_DIETS1__1_

She obtained permission from the lead author, Christopher Gardner  and interviewed  “Dawn, Denis, Elizabeth*, and Todd — two low-fat dieters and two low-carb dieters — about their experiences of succeeding or faltering in trying to slim down”

LOW_FAT_LOW_CARBS_DIETS1

I highly recommend reading the entire article for details but Volluz concludes

And that leads us to one of the burning mysteries of diets: how to explain why some people fail where others succeed — or the extreme variation in responses. Right now, science doesn’t have compelling answers, but the unifying theme from the four study participants should be instructive: The particulars of their diets — how many carbs or how much fat they were eating — were almost afterthoughts. Instead, it was their jobs, life circumstances, and where they lived that nudged them toward better health or crashing.

DIETFITS-Importance of “Healthy” Diet

Most likely the success of both of these diets is due to the instruction that both groups received on following a “healthy” diet. This guidance is remarkably similar to what I advocate and is something that combatants in the diet wars ranging from paleo to vegan can agree on.

The JAMA paper only provides the description I listed above but Volluz adds that participants were instructed to:

… focus on whole, real foods that were mostly prepared at home when possible, and specifically included as many vegetables as possible, every day … choose lean grass-fed and pasture-raised animal foods as well as sustainable fish ... eliminate, as much as possible, processed food products, including those with added sugars, refined white flour products, or trans-fats … prepare as much of their own food as possible. …

Indeed, if you want to see a very detailed description of the instructional process for participants check out the very detailed description of the methods here.

Yours in Health,

-ACP

N.B. I was searching for a reasoned response to this study from the low fat camp and to my surprise came across this fascinating video featuring the lead author of the study, Christopher Gardner, on (no fat/vegan) John McDougal’s YouTube site. Gardner is clearly on the side of sustainable, local , ethical food consumption but to his credit, his research , publications and comments on DIETFITS don’t reveal this.

Marketing Medicine, Changing Practice, And Groping Watchmen at the American College of Cardiology Meetings

In March, the skeptical cardiologist attended the annual Scientific Sessions of his professional organization, the American College of Cardiology. This year’s meeting was held in Orlando, a city which, for me, holds little allure beyond milder March temperatures than St. Louis.

The meetings are termed Scientific Sessions because lots of science is presented and discussed. The results of the latest, most important and “practice-changing” studies on cardiovascular drugs, devices, and diseases are released to much ballyhoo.

They take place in massive soul and leg muscle-sucking convention centers, where one typically has to hike several thousand meters to get from one presentation to another.

img_0991
The Orange County Convention Center-the second largest in the U.S., offering 7,000,000 sq. ft. of space, wifi everywhere, and the opportunity to garner 10,000 steps going from one room to another.

Medical science is best when not adulterated by commercial interest, but the ACC meeting is blanketed by advertisements for the latest (consequentially most expensive) and greatest (hopefully) life-saving drugs and devices.

A feature of these meetings is the draping of the escalators with drug marketing material. Look! Repatha now approved for a new indication!

img_0993

I used an app provided by the ACC to find sessions I was interested in, plan my itinerary and to interact with presenters. Quite irritatingly, every time I opened the app, I was presented with a commercial for, you guessed it, Repatha, one of two new (and really expensive) PCSK9 inhibitors.img_1022

I was so irritated by this advertising intrusion into my app use that I totally failed to find out what the new indication for Repatha was. (It was to prevent heart attacks and strokes, something the FDA decided in December, 2017, after reviewing the outcomes data from the FOURIER trial presented at the ACC last year (I listed this as #3 of my top cardiology stories of 2017).

Booth 1807 was in the sprawling “Expo” area of the conference, where drugmakers and device makers compete for the attention of cardiologists by offering espresso-based beverages, free nitrogen ice cream, made to order cannolis (the definite favorite of the Eternal Fiancee’, herself working the Expo for Scimage) and occasional kitsch, like rubber bouncy balls that light up when they hit a hard surface.

Typically, I avoid the cannoli and cappuccino but seek out the oddest opportunity to be seduced by the dark side.

One day I ventured into the Expo area to explore how companies were promoting their products in 2018 and before I knew it I was inside a heart,  grasping a left atrial appendage occluder.

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The skeptical cardiologist standing on the interventricular septum while occluding the left atrial appendage. This is how I ACC!

The Watchman device I was grasping has been approved for preventing stroke in patients with atrial fibrillation who are at high risk and can’t, or won’t, take blood thinners. Boston Scientific has been flying cardiologists to various cities for the last year to wine and dine them and fill them full of reasons to send their patients for the device. Thus far I have avoided going on such a boondoggle. (Read John Mandrola’s skeptical take on Watchman here).

If you didn’t get the message about Repatha from the app or the escalators, there were frequent presentations from investigators at various sites in the Expo floor.

img_1001
A lipid expert explaining why cardiologists should be prescribing cholesterol lowering PCSK9 inhibitors. Note the towering graphic “High LDL. Prior CV Event? Time to Act!”

The presenters are typically experts in the field, but are handsomely compensated for their time. Consequently, one cannot rely on this being unbiased information, so I avoid these like the plague. To the ACC’s credit, such presentations do not qualify for CME credit, and are labeled as industry-sponsored.

Despite my irritation with constant marketing and advertisements, and the bias these things introduce into cardiology practice, I get a lot out of attending the ACC sessions.

Full participation allows me to accumulate 34 hours of continuing medical education (CME), hours which I need to maintain certification in the various fields I specialize in, such as echocardiography, nuclear cardiology, vascular imaging, and coronary CT angiography.

I usually find several presentations which advance my knowledge base or change my viewpoint, and how I practice cardiology. This is ultimately good for my patients. I wrote about three of these for Medpage Today here. Consider reading the article, if only to experience the wonder that is the new and large photo of the skeptical cardiologist.

I’ll share some other thoughts from the meetings as time allows. Until then I remain

Skeptically Yours,

-ACP

 

 

 

Do Medical IDs Save Lives?

The skeptical cardiologist recently received a package from American Medical ID, which loudly proclaimed that “Medical IDs Save lives!” The company suggested that I “Fully Open” my display and place it in a prominent location.
I’m sure you’ve seen these types of displays in your doctor’s office:

I really don’t like promoting products in the office waiting room that haven’t been proven to be helpful, so I began wondering if medical IDs really do save lives.

American Medical is one of many for-profit medical ID jewelry makers who engrave various forms of jewelry with the medical information a patient gives them, with the hope that it will provide crucial information if the patient is unable to provide it themselves.

The first organization to provide this service was the Medic Alert Foundation, which, according to their website:

is a non-profit, charitable, and membership-based organization dedicated to the well being of others. Founded in 1956 by Dr. Marion and Chrissie Collins, the foundation’s mission is to protect and save lives by serving as the global information link between members and emergency responders during medical emergencies and other times of need. As a non-profit organization, MedicAlert Foundation is governed by a volunteer board of directors, comprised of highly respected national leaders from the healthcare profession and business.

MediAlert jewelry is supported by a 24/7 call center which claims to have access to the users medical records.

While communicating with first responders, MedicAlert will retrieve your MedicAlert health record and provide your health history – including medical conditions, medications/dosages, allergies, past surgical history. We will also provide your personal identification and emergency contact information to ensure you are quickly reunited with loved ones. If you are being transported to a facility, MedicAlert will also fax your health record so your information is available upon arrival

Medical ID Jewelry Accuracy

I am unaware of ever providing MedicAlert with medical information on any of my patients, so I assume the information that they have available is provided by the patient themselves, and may or may not be accurate and up to date.

Actually, one has to be concerned whether the patient information on any medical ID jewelry is up to date and accurate.  If it’s not accurate, it could potentially confuse care providers and lead to more errors in care.

Given the potential downsides of medical ID jewelry, is there any evidence that it saves any lives, let alone millions?

There are, of course, anecdotes. And these dramatic stories help propel sales of millions of bracelets and necklaces.

Stylish Medical ID Jewelry

Lauren’s Hope is a Missouri company which a heart-warming story of its genesis: Lauren, a teenager with type I diabetes did not want to wear her medical ID bracelet because it wasn’t stylish. A new interchangeable bracelet was created.

Named after its inspiration, Lauren’s Hope quickly became a bustling kitchen-table business. In its first year, the company saw phenomenal success, particularly after the infinitely talented Halle Berry wore her Lauren’s Hope medical ID bracelet on the Rosie O’Donnell show when discussing her own Diabetes diagnosis. Practically overnight, people who had grudgingly worn, or even refused to wear, the standard, plain metal medical ID bracelets of the past suddenly had attractive, durable, stylish options they could enjoy wearing and change to suit their mood, outfit, or activity.

Today, more than 500,000 people wear Lauren’s Hope medical IDs every day, and we’re proud to say that number just keeps growing.

The compelling argument for a Type I diabetic to wear a Medical ID bracelet is that if they become confused or unresponsive from hypoglycemia, a paramedic or bystander can immediately recognize the situation, give glucose and save a life.

The problem with this seemingly apparent benefit is that the paramedic should not assume an unresponsive person who is a diabetic is hypoglycemic; other causes should be considered and evaluated. Likewise, hypoglycemia should be considered and tested for in an unresponsive person who is not known to be a diabetic.

(Before excoriating me for the above heresy, let me state that I am not advocating that insulin-dependent diabetics rip off their Medical ID bracelets)

What does Science Tell Us?

If you do a Google search asking the question “Do Medical ID’s Save Lives?” the vast majority of search results are various links to Medical ID company websites.

I was unable to find any scholarly article which addressed the question of lives saved by medical ID jewelry, but I found one 2017 British paper which questioned the benefits after a review of the scanty literature on the topic.

The paper begins with a table listing their suggestions for potentially appropriate and inappropriate inscriptions on alert tags:

From a cardiac standpoint, the relevant conditions are 1) the one medical implant they mention-an ICD (implantable cardiovert-defibrillator)  2) prosthetic heart valves, and 3) anticoagulants.

I have to say that in my 30 years of practicing cardiology I have never advised a patient with one of these conditions to wear a Medical Alert ID.

The same considerations I mentioned for the unresponsive diabetic applies to these cardiac conditions. For example, some patients with pacemakers or ICDs should not get MRIs. If an MRI is indicated on a patient that cannot give a history, it is the responsibility of the radiologists and technicians to make sure that the patient has not had an implant that would put them at risk. Thus, a careful search of the body for signs of surgery is warranted, with a standard Xray if an implant is suspected (see here).

The British paper authors conclude:

The striking result of our literature review is that there is an implicit assumption that medical IDs work, and themselves lead to minimal harm. Our commercial review revealed that these products are readily available for purchase from several companies, with no mandatory governance or minimum standards to ensure the accuracy or appropriateness of the information provided.

With regard to MedicAlert Foundation

The UK headquarters of MedicAlert Foundation has provided support for > 300,000 members (www.medicalert.org.uk/about-us/our-history); worldwide, this number rises to millions (www.medicalert.org/about/who-we-are/history). Membership with MedicAlert Foundation includes the checking of medical content displayed on the jewellery for appropriateness by a team of registered nurses (although it is unclear in which jurisdiction these nurses should be registered). The information provided to them is reliant on patient self‐reporting with no required input from the patient’s physician or access to their medical records.

They point out that “self-declaration” of patient illnesses and allergies may worsen outcomes:

. Bojah et al. describe an ‘allergy to anaesthesia’ inpatient wristband, that demonstrates how reliance on patient self‐reporting has the potential to cause dilemmas at a time when patients may be unable to elaborate 19. In an unregulated environment, mistakes or confusion of drug intolerances with allergies could mislead. For example, in the context of antimicrobial therapy, ~ 10% of the general population in the UK claim to have a penicillin allergy; however, only < 1% truly have an adverse immunological drug reaction 20. Many patients could thus be denied the most effective treatment for their infection through a misunderstanding.

And that medical ID information is not vetted by doctors:

The current validity of information on ID bracelets is also questionable; no company requires physician input into the wording on medical alert devices, although some recommend consultation with the primary care physician or healthcare provider for advice on what information to have engraved 21. Some companies advise a non‐mandatory (and chargeable) yearly update of information 3.

What have we learned?

There is no evidence that Medical ID jewelry saves lives.

The information on Medical ID jewelry is patient determined, and may or may not be accurate or up to date.

The medical ID industry is totally unregulated. Government should institute minimum standards to ensure the accuracy or appropriateness of the information provided.

I’m interested in readers’ experience with medical IDs, good and bad, so please feel free to share your anecdotes.

Has your life been saved by a medical ID?

What information is on your medical ID?

Any adverse experiences with medical ID?

Skeptically Yours,

-ACP

N.B. In the course of this investigation I realized that my iPhone has a “medical ID” function that can be activated when the phone is locked and will display relevant medical information.

I added information with my emergency contacts, my medications and a few of my illnesses (including hyperskepticism) into the Medical ID section of the Apple Health app.

So, if you find me lying on the side of the road, look for my cell phone, push the two buttons on either side, wait a few seconds for the below screen, and perhaps you can save my life!

 

 

 

Do The Zen Diaries of Garry Shandling Yield Insight Into The Cause of His Death?

The skeptical cardiologist watched a little bit of the Judd Apatow HBO Documentary on Garry Shandling last night. For fans of the comedian like me, it is fascinating. As I watched I was reminded of two posts I had written about the cause of his death and the physician detective in me searched for clues to his ultimate demise.

Right after his sudden death at the age of 66, media sources reported that he had died of a massive heart attack “according to insiders.”

At the time, TMZ reported that  “Sources familiar with the situation tell TMZ Shandling died from a massive heart attack, with no prior warning whatsoever”

In a post I wrote entitled “Do You Know What is on Garry Shandling’s and Your Parent’s Death certificate?” I pointed out that his cause of death was unknown and that:

Although a heart attack resulting in ventricular fibrillation is the most common cause of a sudden, unexpected death in individuals over the age of 40, it is not the only one.

In fact, People  magazine reported that Sanders experienced shortness of breath and pain in his legs just a day before his death, and that he spoke to a doctor friend about his symptoms, who stopped by that night to check on him,

Shortness of breath and pain in the legs raise the possibility of a clot or DVT in the leg, which can break loose and embolize into the pulmonary arteries. Such a pulmonary embolism, if massive, can result in swift and sudden death.

I wrote another post on this after his autopsy was released.

His autopsy revealed that he  died from a pulmonary embolism, the disease I had raised as a likely  alternative cause of his sudden death in my post in April, 2016. The actual death certificate can be viewed here.

The medical report on his death reveals that Shandling had a prior
history of clots in the leg (s) (DVT) and that previously he had had an IVC filter implanted.

An IVC filter is an umbrella shaped device that is inserted into the major vein draining blood from the the lower half of the body (the inferior vena cava) to physically obstruct the vein and thereby prevent clots from reaching the pulmonary artery. These are used in cases where the normal medical treatment for blood clots (anticoagulants or blood thinners) can’t be utilized due to bleeding risk or have proven ineffective.

Although effective 95% of the time in preventing legs clots from migrating to the pulmonary artery there are reported failures and Shandling was clearly one.

Risk factors for DVT and PE include cancer, surgery and immobility. Shandling, it appears, was recently in Hawaii and long plane flights like the one he must have taken back to LA are notorious causes of immobility that can lead to DVT.

What Can We Learn From Shandling’s Death

Some take home points

-When some one dies suddenly and unexpectedly  it is not automatically due to a massive heart attack. Do not assume your family member or spouse who  was found dead in bed suffered a myocardial infarction.

-Unless the victim was quite old or had advanced cancer consider asking for an autopsy to find out the true cause of death. Whatever disease caused the death could be  inherited by the victim’s offspring.

-Pulmonary embolism can be a rapidly lethal disease. Consider a medical evaluation for it if you are experiencing leg pain/swelling, sudden, unexplained shortness of breath or chest pain which worsens upon taking a breath. If you have risk factors for leg clots or prior leg clots be even more vigilant.

 

Watching the Zen Diaries of Garry Shandling gave me no further insights into his death. Sudden death typically happens without warning to the victim and even those who are closest to him/her.

Antithrombotically Yours

-ACP

 

N.B. In the second post I talked about Carrie Fisher’s death (also widely reported falsely as due to a “massive heart attack”) and speculated that we might never know the cause of her death because I anticipated that her autopsy (with toxicology) would not be released.

I was right about her not dying of a “massive heart attack” .

Her cause of death was listed as sleep apnea with other factors.

The other factors appear to be LOTS of drugs:

“Fisher’s toxicology review found evidence of cocaine, methadone, MDMA (better known as ecstasy), alcohol and opiates when she was rushed to Ronald Reagan UCLA Hospital on Dec. 23, a toxicology report showed.”

No autopsy was done per family request but CT scanning was performed.

The Bad Food Bible: A Well-Written, Sensible and Science-Based Approach To Diet

The skeptical cardiologist has been searching for some time for a book on diet that he can recommend to his patients. While I can find books which have a lot of useful content, usually the books mix in some totally unsubstantiated advice with which I disagree.

I recently discovered a food/diet/nutrition book which with I almost completely agree. The author is Aaron Carroll,  a pediatrician, blogger on health care research (The incidental Economist) and a Professor of Pediatrics and Associate Dean for Research Mentoring at Indiana University School of Medicine.

He writes a regular column for the New York Times and covers various topics in health care. His articles are interesting,  very well written and researched and he often challenges accepted dogma.

Like the skeptical cardiologist, he approaches his topics from an unbiased perspective and utilizes a good understanding of the scientific technique along with a research background to bring fresh perspective to health-related topics.

Last last year he wrote a column, within which I found the following:

Studies of diets show that many of them succeed at first. But results slow, and often reverse over time. No one diet substantially outperforms another. The evidence does not favor any one greatly over any other.

That has not slowed experts from declaring otherwise. Doctors, weight-loss gurus, personal trainers and bloggers all push radically different opinions about what we should be eating, and why. We should eat the way cave men did. We should avoid gluten completely. We should eat only organic. No dairy. No fats. No meat. These different waves of advice push us in one direction, then another. More often than not, we end up right where we started, but with thinner wallets and thicker waistlines.

I couldn’t agree more with this assessment and as I surveyed the top diet books on Amazon recently, I saw one gimmicky, pseudoscientific  diet after another. From the Whole30 approach (which illogically  completely eliminates any beans and legumes, dairy products,  alcohol, all grains, and starchy vegetables like potatoes (see how absurd this diet is here)) to Dr. Gundry’s Plant Paradox (aka lectin is the new gluten (see here for James Hambling’s wonderful Atlantic article on the huckster’s latest attempt to scare you into buying his useless supplements).

It turns out Carroll published a useful book recently, The Bad Food Bible which critically examines diet and I agree with the vast majority of what is in it.

The first three chapters are on butter, meat, eggs and salt. His conclusions on how we should approach these 4 are similar to ones I have reached and written about on this site (see here for dairy, here for meat, here for eggs and here for salt).  Essentially, the message is that the dangers of these four foods have been exaggerated or nonexistent, and that consuming them in moderation is fine.

The remaining chapters cover topics I have pondered extensively,  but have not written about: including gluten, GMOs, alcohol, coffee, diet-soda and non-organic foods.

I agree with his assessments on these topics. Below, I’ll present his viewpoint along with some of my own thoughts in these areas.

Gluten

Carroll does a good job of providing a scientific, but lay-person friendly background to understanding the infrequent (1 of 141 Americans), but quite serious gluten-related disorder, celiac disease.

However, surveys show that up to one-third of Americans, the vast majority of whom don’t have celiac disease, are seeking “gluten-free” foods, convinced that this is a healthier way of eating. Carroll points out that there is little scientific support for this; there are some individuals who are sensitive to wheat/gluten, but these are rare.

He concludes:

“If you have celiac disease, you need to be on a gluten-free diet. If you have a proven wheat allergy, you need to avoid wheat. But if you think you have gluten sensitivity? You’d probably be better off putting your energy and your dollars toward a different diet. Simply put, most people who think they have gluten sensitivity just don’t.

I do agree with him that the “gluten-free” explosion of foods (gluten-free sales have doubled from 2010 to 2014) is not justified.

However, I must point out that my 92 year old father has recently discovered that he has something that resembles gluten sensitivity. About a year ago, he noted that about one hour after eating a sandwich he would feel very weak and develop abdominal discomfort/bloating. He began suspecting these symptoms were due to the bread and experimented with different bread types without any symptom relief.

Finally, he tried gluten-free bread and the symptoms resolved.

If you have engaged in this type of observation and experimentation on your self, and noted improved symptoms when not consuming gluten, then I think you’re justified in diagnosing gluten sensitivity, and by all means consider minimizing/avoiding wheat.

GMOS

Carroll begins his chapter on genetically modified organisms (GMOs) with a description of the droughts that plagued India in the 1960s and the efforts of Norman Borlaug to breed strains of wheat that were resistant to fungus and yielded more grain. By crossbreeding various strains of wheat he was able to develop a “semi-dwarf” strain that increased what was produced in Mexico by six-fold.

Despite the fact that numerous scientific and health organizations around the world have examined the evidence regarding the safety of genetically modified organisms (GMOs) and found them to be completely safe, there remains a public controversy on this topic. In fact a Pew Poll found that while 88% of AAAS scientists believe that GMOs are safe for human consumption, only 37% of the public do – a 51% gap, the largest in the survey.

This gap is largely due to an aggressive anti-GMO propaganda campaign by certain environmental groups and the organic food industry, a competitor which stands to profit from anti-GMO sentiments. There is also a certain amount of generic discomfort with a new and complex technology involving our food.

The National Academy of Sciences analyzed in detail the health effects of GMOs in 2016. Their report concludes:

While recognizing the inherent difficulty of detecting subtle or long-term effects in health or the environment, the study committee found no substantiated evidence of a difference in risks to human health between currently commercialized genetically engi-neered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops. GE crops have generally had favorable economic outcomes for producers in early years of adoption, but enduring and widespread gains will depend on institutional support and access to profitable local and global markets, especially for resource-poor farmers

Carroll does a good job of looking at the GMO issue from all sides. He touches on environmental downsides related to herbicide-resistant GMO crops and the problems created by patenting GMO seeds, but asserts that “these are the result of imperfect farming and the laws that regular agribusiness, not of GMOS themselves.”

Ultimately, despite these concerns, I agree with Carroll’s conclusion that:

“Foods that contain GMOs aren’t inherently unhealthy, any more are  than foods that don’t contain them. The companies that are trying to see you foods by declaring them ‘GMO-free” are using the absence of GMOs to their advantage–not yours.”

Alcohol, Coffee, and Diet-Soda

Carroll does a good job of summarizing and analyzing the research for these three topics and reaches the same conclusions I have reached in regard to coffee, alcohol and diet-soda:

-alcohol in moderation lowers your risk of  dying, primarily by reducing cardiovascular death

-coffee, although widely perceived as unhealthy, is actually good for the vast majority of people

For those seeking more details a few quotes


on alcohol:

“Taken together, all of this evidence points to a few conclusions. First, the majority of the research suggests that moderate alcohol consumption is associated with decreased rates of cardiovascular disease, diabetes, and death. Second, it also seems to be associated with increased rates of some cancers (especially breast cancer), cirrhosis, chronic pancreatitis, and accidents, although this negative impact from alcohol seems to be smaller than its positive impact on cardiovascular health. Indeed, the gains in cardiovascular disease seem to outweigh the losses in all the other diseases combined. The most recent report of the USDA Scientific Advisory Panel agrees that “moderate alcohol consumption can be incorporated into the calorie limits of most healthy eating patterns.”

Keep in mind that moderate consumption is up to one drink per day for women, and two drinks for men (my apologies to women in general and the Eternal Fiancee’ of the Skeptical Cardiologist in particular) and be aware of what constitutes “one drink.”

Also keep in mind that any alcohol consumption raises the risk of atrial fibrillation (see here) and that if you have a cardiomyopathy caused by alcohol you should avoid it altogether.


on coffee:

“It’s time people stopped viewing coffee as something to be limited or avoided. It’s a completely reasonable part of a healthy diet, and it appears to have more potential benefits than almost any other beverage we consume.
Coffee is more than my favorite breakfast drink; it’s usually my breakfast, period. And I feel better about that now than ever before. It’s time we started treating coffee as the wonderful elixir it is, not the witch’s brew that C. W. Post made it out to be.”

Strangely enough, coffee is usually my breakfast as well (although I recommend against adding titanium oxide to your morning java).  Why am I not compelled to consume food in the morning?  Because breakfast is not the most important meal of the day and I don’t eat until I’m hungry.


on diet-soda:

Carroll notes that many Americans are convinced that artificial sweeteners are highly toxic:

“no article I’ve written has been met with as much anger and vitriol as the first piece I wrote on this subject for the New York Times, in July 2015, in which I admitted, “My wife and I limit our children’s consumption of soda to around four to five times a week. When we let them have soda, it’s . . . almost always sugar-free.”

He notes, as I have done, that added sugar is the real public enemy number one in our diets. He reviews the scientific studies that look at toxicity of the various artificial sweeteners and finds that they don’t convincingly prove any significant health effects in humans.

Some believe that artificial sweeteners contribute to obesity, but the only evidence supporting this idea comes from observational studies. For many reasons, we should not highly value observational studies but one factor, “reverse causation,” is highly likely to be present in studies of diet sodas. If diet soda consumption is associated with obesity, is it the cause, or do those who are obese tend to drink diet soda. Observational studies cannot answer this question but randomized studies can.

Carroll points out that:

the randomized controlled trials (which are almost always better and can show causality) showed that diet drinks significantly reduced weight, BMI, fat, and waist circumference.”

Simple Rules For Healthy Eating

Carroll concludes with some overall advice for healthy eating:

-Get as much of your nutrition as possible from a variety of completely unprocessed foods

-Eat lightly processed foods less often

-Eat heavily processed foods even less often

-Eat as much home-cooked food as possible, preparing it according to rules 1, 2, and 3

-Use salt and fats, including butter and oil, as needed in food preparation

-When you do eat out, try to eat at restaurants that follow the same rules

-Drink mostly water, but some alcohol, coffee, and other beverages are fine

-Treat all calorie-containing beverages as you would alcohol

-Eat with other people, especially people you care about, as often as possible

These are solid, albeit not shocking or book-selling, rules that  correspond closely to what I have adopted in my own diet.

In comparison to the bizarre advice from nutrition books which dominate the best-selling diet books, I found The Bad Food Bible to be a consistent, well-written, extensively researched, scientifically-based, unbiased guide to diet and can highly recommend it to my readers and patients.

Semibiblically Yours,

-ACP

Still More Evidence That Fish Oil Supplements Do Not Prevent Cardiovascular Disease

Avid readers of the skeptical cardiologist know that he is not an advocate of fish oil supplements.

One of my first posts (1/2013) was devoted to taking down the mammoth OTC fish oil industry because recent scientific evidence was clearly showing no benefit for fish oil pills.

I concluded:

", the bottom line on fish oil supplements is that  the most 
recent scientific evidence does not support any role for them  inpreventing 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.)"

Despite a lack of evidence supporting taking them, the fish oil business continues to grow,  buttressed by multiple internet sites promoting various types of fish oil (and more recently krill oil)  for any and all ailments and a belief in the power of “omega-3 fatty acids”.

Another Meta-Analysis Concludes No Benefit To Fish Oil Supplements

A publication this month evaluated the 10 randomized controlled trials involving 77 917 thousand individuals that have studied fish oil supplements in preventing heart disease. The writers concluded that fish oil supplements do not significantly prevent any cardiovascular outcomes under any scenario.

It was written by a group with the ominous title of “The Omega-3 Treatment Trialists’ Collaboration.”

The Omega-3 Treatment Trialists’ Collaboration was established to conduct a collaborative meta-analysis based on aggregated study-level data obtained from the principal investigators of all large randomized clinical trials of omega-3 FA supplements for the prevention of cardiovascular disease, using a prespecified protocol and analysis plan. The aims of this meta-analysis were to assess the associations of supplementation with omega-3 FAs on (1) fatal CHD, nonfatal MI, stroke, major vascular events, and all-cause mortality and (2) major vascular events in prespecified subgroups.

The authors conclusions:

. Randomization to omega-3 fatty acid supplementation (eicosapentaenoic acid dose range, 226-1800 mg/d) had no significant associations with coronary heart disease death (rate ratio [RR], 0.93; 99% CI, 0.83-1.03; P = .05), nonfatal myocardial infarction (RR, 0.97; 99% CI, 0.87-1.08; P = .43) or any coronary heart disease events (RR, 0.96; 95% CI, 0.90-1.01; P = .12). Neither did randomization to omega-3 fatty acid supplementation have any significant associations with major vascular events (RR, 0.97; 95% CI, 0.93-1.01; P = .10), overall or in any subgroups, including subgroups composed of persons with prior coronary heart disease, diabetes, lipid levels greater than a given cutoff level, or statin use.

Nothing. Nada. No benefit.

There is clearly no reason to take fish oil supplements to prevent cardiovascular disease!

American Heart Association Sheepishly Recommends Fish Oil Supplements

If the science was conclusive on this in 2013 why did the American Heart Association (AHA) issue an “advisory” in 2017  suggesting that the use of omega-3 FAs for prevention of coronary heart disease (CHD) is probably justified in individuals with prior CHD and those with heart failure and reduced ejection fractions?

The AHA advisory is clearly misguided and relies heavily in its discussion on a 2012 meta-analysis from Rizos, et al. published in 2012.

Oddly, this is the study that prompted me to write my first fish oil post in 2013

The AHA advisory totally distorts the completely negative conclusions of the Rizos meta-analysis, writing:

A meta-analysis published in 2012 examined the effects of omega-3 PUFA supplementation and dietary intake in 20 RCTs that enrolled patients at high CVD risk or prevalent CHD and patients with an implantable cardioverter-defibrillator (total n=68 680). That meta-analysis demonstrated a reduction in CHD death (RR, 0.91; 95% CI, 0.85–0.98), possibly as the result of a lower risk of SCD (RR, 0.87; 95% CI, 0.75–1.01).11

Strangely enough, if you look at the conclusions of Rizos, et al. they are

No statistically significant association was observed with all-cause mortality (RR, 0.96; 95% CI, 0.91 to 1.02; risk reduction [RD] -0.004, 95% CI, -0.01 to 0.02), cardiac death (RR, 0.91; 95% CI, 0.85 to 0.98; RD, -0.01; 95% CI, -0.02 to 0.00), sudden death (RR, 0.87; 95% CI, 0.75 to 1.01; RD, -0.003; 95% CI, -0.012 to 0.006), myocardial infarction (RR, 0.89; 95% CI, 0.76 to 1.04; RD, -0.002; 95% CI, -0.007 to 0.002), and stroke (RR, 1.05; 95% CI, 0.93 to 1.18; RD, 0.001; 95% CI, -0.002 to 0.004) when all supplement studies were considered.

Nothing. Nada. No significant benefit!

The AHA was so confused by their own advisory that in the AHA news release on the article they quote Dr. Robert Eckel, a past AHA president as saying he remains “underwhelmed” by the current clinical trials.

“In the present environment of evidence-based risk reduction, I don’t think the data really indicate that fish oil supplementation is needed under most  circumstances.”

The end of the AHA news article goes on to quote Eckel as indicating he doesn’t prescribe fish oil supplements and the science advisory won’t change his practice:

Eckel said he doesn’t prescribe fish oil supplements to people who have had coronary events, and the new science advisory won’t change that. “It’s reasonable, but reasonable isn’t a solid take-home message that you should do it,” he said.

AHA: Wrong On Coconut Oil and Fish Oil

It’s hard for me to understand why the AHA gets so many things wrong in their scientific advisories. In the case of the recent misguided attack on coconut oil , their ongoing vilification of all saturated fats, and their support for fish oil supplements I don’t see evidence for industry influence. The authors of the fish oil supplement advisory do not report any financial conflicts of interest.

There is, however, one bias that is very hard to measure which could be playing a role: that is the bias to agree with what one has previously recommended.  The AHA issued an advisory in 2002 recommending that people take fish oil. Changing that recommendation would mean admitting that they were wrong and that they had contributed to the growth of a 12 billion dollar industry serving no purpose.

Personally, I am aware of this kind of bias in my own writing and strive to be open to new data and publications that challenge what I personally believe or have publicly recommended.

In the case of fish oil supplements for preventing cardiovascular disease, however, the most recent data supports strongly what I wrote in 2013:

Don’t take fish oil supplements to prevent heart disease.

Americans want a “magic-bullet” type pill to take to ward off aging and the diseases associated with it. There isn’t one. Instead of buying pills and foods manipulated and processed by the food industry which promise better health, eat real food (including fish) eat a lot of plants and don’t eat too much.

Piscinely Yours,

-ACP

N.B. I have no patients on the two prescription fish oil supplements available, Lovaza and Vascepa. I wrote about Vascepa here

Below is an excerpt:

Like the first prescription fish oil available in the US, Lovaza, VASCEPA is only approved by the FDA for treatment of very high triglycerides (>500 mg/dl).

This is a very small market compared to the millions of individuals taking fish oil thinking that  it is preventing heart disease.

The company that makes Vascepa (Amrin;$AMRN)would also like to have physicians prescribe it to their patients who have mildly or moderatelyelevated triglycerides between 200 and 500 which some estimate as up to 1/3 of the population.

The company has a study that shows that Vascepa lowers triglycerides in patients with such mildly to moderately elevated triglycerides but the FDA did not approve it for that indication.

Given the huge numbers of patients with trigs slightly above normal, before approving an expensive new drug, the FDA thought, it would be nice to know that the drug is actually helping prevent heart attacks and strokes or prolonging life.

After all, we don’t really care about high triglycerides unless they are causing problems and we don’t care about lowering them unless we can show we are reducing the frequency of those problems.

Data do not exist to say that lowering triglycerides in the mild to moderate range  by any drug lowers heart attack risk.

In the past if a company promoted their drug for off-label usage they could be fined by the FDA but Amarin went to court and obtained the right to promote Vascepa to physicians for triglycerides between 200 and 500.

Consequently, you may find your doctor prescribing this drug to you. If you do, I suggest you ask him if he recently had a free lunch or dinner provided by Amarin, has stock in the company (Vascepa is the sole drug made by Amrin and its stock price fluctuates wildly depending on sales and news about Vascepa) or gives talks for Amarin.

If he answers no to all of the above then, hopefully, your triglycerides are over 500.

.

 

 

 

 

What Should Your Maximal Exercise Heart Rate Be?: The Importance Of Using The Right Age-Predicted HRmax Formula

A reader who runs 5Ks posted a question recently which indicated concern that his heart rate during intense exercise was much higher than his age-predicted heart rate.  He writes

I’m 65, exhaustion HRmax is 188, HRave for 5k is usually 152-154 and interval HRmax is usually 175-179 depending on how hard I push”

He wondered if he should be concerned about being a “high-beater.”

This prompted the skeptical cardiologist to examine the literature on age-predicted maximal heart rate which led to the shocking discovery that the wrong formula is being utilized by most exercise trainers and hospitals.

First , some background.

The peak heart rate achieved with maximal exertion or HRmax has long been known to decline with aging for reasons that are unclear.

The HR achieved with exercise divided by the HRmax x 100 (percentage HRmax) is widely used in clinical medicine and physiology as a basis for prescribing exercise intensity in cardiac rehab programs, disease prevention programs and fitness clinics.

During stress tests we seek to have patients exercise at least until  their heart rate gets to at 85% of HRmax.

The Traditional Formula For HRmax

The formula that is widely used for HRmax is

HRmax = 220-age

It appears to have originated from flawed studies in the early 1970s. These studies included subjects with cardiovascular disease, smokers and patients on cardiac medications.

The Improved HRmax Formula

Tanaka, et al in 2001 performed a meta-analysis of previous data on HRmax along with accumulating data in their own lab. This was the first study to examine healthy, unmedicated, nonsmokers. In addition each subject achieved a verified maximal level of effort as documented by metabolic stress testing.

Their analysis obtained the regression equation (which I term the Tanaka equation)

HRmax = 208-(0.7 x age) 

Below is the graph of the laboratory measurements from which the regression equation was obtained.

Relation between maximal heart rate (HRmax) and age obtained from the prospective, laboratory-based study.(Tanaka, et al)

This graph shows how  inaccurate the traditional equation is, especially in older  individuals like my reader:

Regression lines depicting the relation between maximal heart rate (HRmax) and age obtained from the results derived from our equation (208 − 0.7 × age) (solid linewith 95% confidence interval), as compared with the results derived from the traditional 220 − age equation (dashed line). Maximal heart rates predicted by traditional and current equations, as well as the differences between the two equations, are shown in the table format at the top.(from Tanaka, et al)

The traditional equation in comparison to the Tanaka equation  overestimates HRmaxin young adults, intersects with the present equation at age 40 years and then increasingly underestimates HRmaxwith further increases in age. For example, at age 70 years, the difference between the two equations is ∼10 beats/min. Considering the wide range of individual subject values around the regression line for HRmax(SD ∼10 beats/min), the underestimation of HRmaxcould be >20 beats/min for some older adults.

There are likely lots of perfectly healthy individuals in their sixties and seventies then who have heart rates at maximal exertion that exceed by 10 to 20 beats per minute the HR max predicted by the traditional formula.

This is due to a combination of the inaccuracy of the traditional formula and the wide variation in normal HR max at any given age (standard deviation (SD) of approximately 10 beats/min.)

Thus, my reader at age 65 would have a HRmax predicted by the Tanaka equation as

208-0.7 x 65=162

If we allow for a 10 BPM range of normality above and below 162 BPM we reach 172 BPM which gets close to  but doesn’t reach the reader’s 188 BPM.

If you examine the scatterplot of the Tanaka data you can see that several of the points for age 65 reach into the 180s so chances are my reader is still within normal limits

The Bottom Line on HRmax

The widely used traditional formula for predicting HR max is inaccurate.

Athletes, trainers, physicians and hospitals should switch to using the superior Tanaka HR max formula.

Individuals should keep in mind that there is a wide range of HR response to exercise in normals and variations of 10 BPM above and below the predicted response are common and of no concern.

Chronotropically Yours

-ACP

Addendum. The 220-age formula is so heavily etched into my brain that I used 220 instead of 208 when I initially calculated the predicted max HR for my reader. this has been corrected.Thanks to Chris Sivewright for pointing this out.

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

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