My New Apple Watch 4 Is Nice: But It Won’t Record ECGs or Work With KardiaBand!

The skeptical cardiologist picked up an Apple Watch 4  at the Galleria Apple Store in St. Louis today.  The Apple employee who retrieved it told me that ECG recording capabilities were expected in the fall. Of course fall began today and it is not at all clear when, if ever, Apple will provide the software update to its AW4 that will provide ECG capabilities.

Fortunately, consumers already have the capability of  recording a medical grade single lead ECG with any Apple Watch 2 or 3-using the KardiaBand from AliveCor.

Apple has hubristically proclaimed the AW4 as the  ultimate guardian of our health and while setting it up I was asked if I wanted the watch to notify me if my heart rate dropped below 40 bpm for 10 minutes. Sure! Let’s see how irritating this feature will be.

 

 

After setting up the new watch I immediately attached my KardiaBand and installed the Kardia Apple Watch app.

I was able to open the Kardia app and it performed its normal SmartRhythm monitoring but when I tried to record an ECG, alas, nothing happened.

It appears that the KardiaBand does not work with the new Apple Watch 4. Yet.

I was informed by Ira Bahr at AliveCor that their “testing on AW4 is not yet complete. So at present, the device is not supported.”

Now I face a difficult decision-Do I wear my new AW4 with a non KardiaBand wrist band (and no ECG capability) or wear my old Apple Watch with the KardiaBand (and outstanding ECG capability.)

ACP

Were They Visions of Quilotoa Or The Birthplace Of Little Rocket Man?

The skeptical cardiologist periodically updates the “header image” for this blog, typically uploading an iPhone “pani” of somethinng he considers beautiful, cool or quirky from one of his travels.

I can’t recall any comments on the header images so I had presumed that nobody really cares what is up there.

However, for my last header image (which at the time of this writing should still be above) I used a picture from my recent trip to Ecuador.

Stunning views of the lake in the caldera of Quilotoa and the surrounding mountains. The hike down to the water is steep and dusty. Due to the altitude of 13,000 feet climbing up was really difficult and 3/4 of our party elected to pay 10$ for a donkey ride. Only the galloping gastroenterologist, David Lotsoff could make it up on his own two feet.

After returning from the Galapagos we drove north from Quito for 4 hours to Quilotoa and took the picture that is the current header image.

Per Wikipedia

Quilotoa (Spanish pronunciation: [kiloˈto.a]) is a water-filled caldera and the most western volcano in the EcuadorianAndes. The 3-kilometre (2 mi)-wide caldera was formed by the collapse of this dacite volcano following a catastrophic VEI-6 eruption about 600  years ago.

A reader, commenting on my aspirin post, added the following cryptic words:

Also, I would be (very) interested to know about your ‘attachment’ / interest in Chang Bai Shan (‘Great White Mountain’ on the border of China / N Korea; one of the world’s largest stratovolcanoes)??? FWIW, we have(nick-)named one of our grandchildren (boy) with this name. My wife is Chinese/Taiwanese; my daughter has lived for 15? years in Beijing… All speak Mandarin (& English)…
 
I had no idea what he was talking about until I googled chang bai shan and looked at this image of “Heavenly Lake” which looks remarkably similar to the view we had over the Lagoon inside Quilotoa.

 

 

“Changbaishan Nature Reserve is the largest reserve in China, covering over 850 square miles. The rocks of Changbaishan supposedly have a white shimmer, giving the area its name (changbai means “ever white” in Chinese). The vast reserve comprises a collection of craggy peaks encircling Heavenly Lake, which occupies the crater of a long dormant volcano.”

This Chinese tourism site notes that a third of the Heavenly Lake lies in North Korea ” and its environs are considered sacred by both the Chinese and North Koreans; in Korean the area is known as Paektusan, and the North Korean leader Kim Jong Il claimed it as his “birthplace”. The imperial Qing dynasty, a Manchu family, revered Changbaishan as a holy land and the cradle of the Manchurian race.”

Despite the attraction of seeing the birthplace of Little Rocket Man, I have decided not to put Changbaishan on my bucket list because

Heavenly Lake’s cross-border status demands careful hiking – as recently as 1998 a British tourist was incarcerated for a month in North Korea for accidentally stepping across the poorly demarcated international line.

Stratovolcanically Yours,

-ACP

N.B. One of our party (who shall remain eternally nameless) experienced symptoms likely related to the rapid ascent to 13000 feet.

Acute mountain sickness is the most common type of high-altitude illness and occurs in more than one-fourth of people traveling to above 3500 m (11 667 ft) and more than one-half of people traveling to above 6000 m (20 000 ft). Symptoms include headache, fatigue, poor appetite, nausea or vomiting, light-headedness, and sleep disturbances. Symptoms usually occur 6 to 12 hours after ascent and can range from mild to severe.

Here’s  a cool graphic from JAMA related to it

Revisiting Who Should Take Aspirin

Four years ago the skeptical cardiologist wrote the (in his extremely humble  and biased opinion) the definitive post on aspirin and cardiovascular disease.  Entitled “Should I take aspirin to prevent stroke or heart attack“,  it pointed out that although Dr. Oz had recently told almost all middle-aged women to take a baby aspirin and fish oil, there was, in fact no evidence to support that practice.

The publication of the ASPREE (Aspirin in Reducing Events in the Elderly) trial results in the latest issue of the New England Journal of Medicine further strengthens the points I made in 2014.

Between 2010 and 2014 the ASPREE investigators enrolled over 19,000 community-dwelling persons in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability.

(It’s important to look closely at the precise inclusion and exclusion criteria in randomized studies  to understand fully the implications of the results (for example, what qualified as cardiovascular disease) and I’ve listed them at the end of this post.)

Study participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. At the end of the study about 2/3 of participants in both groups were still taking their pills.

When I wrote about aspirin in 2014 I focused on cardiovascular disease. At that time, there was some reasonable evidence that aspirin might lower the risk of colorectal cancer. But when we look at outcomes the bottom line is how the drug influences the overall mix of diseases and deaths.

The ASPREE researchers chose disability-free survival, defined as survival free from dementia or persistent physical disability (inability to perform or severe difficulty in performing at least one of the six basic activities of daily living that had persisted for at least 6 monthas their primary end-point which makes a lot of sense-patients don’t want to just live longer, they want to live longer with a good quality of life. If aspirin, to take a totally hypothetical example) is stopping people from dying from heart attacks but making them demented it’s not benefiting them overall.

After 5 years there was no difference in the rate of death, dementia or permanent physical disability between the aspirin group (21.5 events per 1000 person-years) and placebo group (21.2 per 1000).

However those taking aspirin had a significantly higher rate of major bleeding (3.8%) than those taking placebo (2.8%).

The risk of death from any cause was 12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group.. Cancer was the major contributor to the higher mortality in the aspirin group, accounting for 1.6 excess deaths per 1000 person-years.

Screen Shot 2018-09-19 at 9.26.41 AM

And, despite prior analyses suggesting aspirin reduces colorectal cancer the opposite was found in this study. Aspirin takers were 1.8 times more likely to die from colorectal cancer and 2.2 times more likely to die from breast cancer.nejmoa1803955_t2

 

Did Aspirin Reduce Cardiovascular Events?

No. It did not.

A separate paper analyzed cardiovascular outcomes

After a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1000 person-years in the aspirin group and 11.3 events per 1000 person-years in the placebo group (hazard ratio, 0.95; 95% confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).

The ASPREE study confirms what I advised in 2014 and hopefully will further reduce the inappropriate consumption of aspirin among low risk individuals.

I’ve taken more patients off aspirin since 2014 than I’ve started on and what I wrote then remains relevant and reflects my current practice. Especially in light of the increase cancer risk noted in ASPREE patients should only take aspirin for good reasons.

Below is my 2014 post entitled “Should I Take Aspirin To Prevent Heart Attack or Stroke.”

Aspirin is a unique drug, the prototypical  two-edged sword of pharmaceuticals. It t has the capability of stopping platelets, the sticky elements in our blood, from forming clots that cause strokes and heart attacks when arterial plaques rupture, but it increases the risk of serious bleeding into the brain or from the GI tract. Despite these powerful properties, aspirin is available over the counter and is very cheap, thus anyone can take it in any dosage they want. 

Who Should Take Aspirin?

For the last five years I’ve been advising my patients who have no evidence of atherosclerotic vascular disease against taking aspirin to prevent heart attack and stroke. Several comprehensive reviews of all the randomized trials of aspirin had concluded by 2011 that

The current totality of evidence provides only modest support for a benefit of aspirin in patients without clinical cardiovascular disease, which is offset by its risk. For every 1,000 subjects treated with aspirin over a 5-year period, aspirin would prevent 2.9 MCE and cause 2.8 major bleeds.

(MCE=major cardiovascular events, e.g. stroke, heart attack, death from cardiovascular disease)

Dr. Oz, on the other hand, came to St. Louis in 2011 to have  lunch with five hundred women and advised them all to take a baby aspirin daily (and fish oil, which is not indicated for primary prevention as I have discussed here). When I saw these women subsequently in my office I had to spend a fair amount of our visit explaining why they didn’t need to take aspirin and fish oil.

After reviewing available data, the FDA this week issued a statementrecommending against aspirin use for the prevention of a first heart attack or stroke in patients with no history of cardiovascular disease (i.e. for primary prevention). The FDA pointed out that aspirin use is associated with “serious risks,” including increased risk of bleeding in the stomach and brain. As for secondary prevention for people with cardiovascular disease or those who have had a previous heart attack or stroke (secondary prevention), the available evidence continues to support aspirin use.

Subclinical Atherosclerosis and Aspirin usage

As I’ve discussed previously, however, many individuals who have not had a stroke or heart attack are walking around with a substantial burden of atherosclerosis in their arteries. Fatty plaques can become quite advanced in the arteries to the brain and heart before they obstruct blood flow and cause symptoms. In such individuals with subclinical atherosclerosis aspirin is going to be much more beneficial.

 

Guided Use of Aspirin

zerilloplaque
Large, complex atherosclerotic plaque in the carotid artery found by vascular screening in an individual with no history of stroke, heart attack, or vascular disease. This patient will definitely benefit from daily aspirin to prevent stroke or heart attack

We have the tools available to look for atherosclerotic plaques before they rupture and cause heart attacks or stroke. Ultrasound screening of the carotid artery, as I discussed here, is one such tool: vascular screening is an accurate, harmless and painless way to assess for subclinical atherosclerosis.

Coronary calcium is another, which I’ve written extensively about.

In my practice, the answer to the question of who should or should not take aspirin is based on whether my patient has or does not have significant atherosclerosis. If they have had a clinical event due to atherosclerotic cardiovascular disease (stroke, heart attack, coronary stent, coronary bypass surgery, documented blocked arteries to the legs) I recommend they take one 81 milligram (baby) uncoated aspirin daily. If they have not had a clinical event but I have documented by either

  • vascular screening (significant carotid plaque)
  • coronary calcium score (high score (cut-off is debatable, more on this in a subsequent post)
  • Incidentally discovered significant plaque in the aorta or peripheral arteries (found by CT or ultrasound done for other reasons)

then I recommend a daily baby aspirin (assuming no high risk of bleeding).

There are no randomized trials testing this approach but in the next few years several large aspirin trials will be completed and hopefully we will get a better understanding of who benefits most from aspirin for primary prevention.

Until then remember that aspirin is a powerful drug with potential for good and bad effects on your body. Only take it if you and your health care provider have decided the benefits outweigh the risks after careful consideration of your particular situation

Acetylsalicylically Yours,

-ACP

 

The inclusion criteria for ASPREE define significant cardiovascular disease as follows

a past history of cardiovascular or cerebrovascular event or established CVD, defined as myocardial infarction (MI), heart failure, angina pectoris, stroke, transient ischemic attack, >50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, coronary artery bypass grafting, abdominal aortic aneurysm

Apple’s Alternative Facts And The Giant Watch Restaurant Next Door To AliveCor

As I pointed out Friday,  Apple’s claim that the ECG sensor on their new Apple Watch 4  (available “later this year”) is  “the First ECG product offered over the counter directly to consumers” is totally bogus.

AliveCor’s Kardia mobile ECG device was approved by the FDA  for over the counter direct to consumer sales on February 10, 2014. Apple had to have known this as they worked with AliveCor to bring the first Apple Watch based ECG device to FDA approval in 2017.

I tried but failed to get AliveCor founder Dr. David Albert’s thoughts on Apple’s disinformation but Yahoo finance was able to speak to Vic Gundotra, the CEO of AliveCor:

Over at the headquarters of AliveCor, a startup based in Google’s hometown of Mountain View, they, too, were surprised by the announcement, CEO Vic Gundotra said in a phone interview on Thursday. Gundotra is a former Googler, widely known as the executive behind the Google+ social network.

Specifically, Gundotra says that his company was confused by Apple’s claims that the Series 4 will be the first over-the-counter ECG testing device for consumers. AliveCor is a 49-employee startup that makes over-the-counter ECG testing devices and software, including an FDA-cleared band for the Apple Watch, called KardiaBand, and a version that attaches to a smartphone, called Kardia.

Gundotra was also surprised by Apple’s claims of ECG primacy

“We were watching [the announcement], and we were surprised,” Gundotra said. “It was amazing, it was like us being on stage, with the thing we’ve been doing for 7 years,” referring to AliveCor’s product for detecting atrial fibrillation  (AFib), a tough-to-spot heart disorder that manifests as an irregular, often quick heart rate that can cause poor circulation.

“Although when they said they were first to go over-the-counter, we were surprised,” he continued. “Apple doesn’t like to admit they copy anyone, even in the smallest things. Their own version of alternative facts.”

One man’s alternative fact is another (less polite) man’s lie.

Gundotra apparently views Apple’s entry as a good thing

“We love that Apple is validating AFib; just wait until you see what AliveCor is going to do next,” he said. “We were a great restaurant in a remote section of town, and someone just opened a giant restaurant right next to us, bringing a lot more attention.”

And as I pointed out previously, the AliveCor mobile ECG device (not the Kardia Band) is significantly cheaper than an Apple Watch and has multiple studies showing its accuracy. Interestingly, Gundotra indicates AliveCor sales has increased after the Apple announcement,.

“Ours is $99, theirs is $399, our sales popped yesterday, big time,”

Antialternafactively Yours,

-ACP

Dear CVS, Homeopathy Is Bunk, Stop Selling It!

The skeptical cardiologist has mentioned homeopathy previously in a  post entitled Functional Medicine Is Fake Medicine. but I hadn”t heretofore commented on how pervasive and useless it is.

Science-Based medicine’s Jann Bellamy has recently written about a lawsuit by the Center for Inquiry (CFI) which claims the pharmacy giant CVS is fraudulently deceiving consumers by selling worthless homeopathic redemies.

There is a unanimous scientific consensus that homeopathy is total hogwash. You can read excellent articles at science-based medicine detailing the crazy pseudo-scientific ideas underlying homeopathy here.

The CFI press release summarizes homeopathy as follows:

Homeopathy is an 18th-century pseudoscience premised on the absurd, unscientific notion that a substance that causes a particular symptom is what should be ingested to alleviate it. Dangerous substances are diluted to the point that no trace of the active ingredient remains, but its alleged effectiveness rests on the nonsensical claim that water molecules have “memories” of the original substance. Homeopathic treatments have no effect whatsoever beyond that of a placebo.

Yet, CVS and other large pharmacy chains continue to sell homeopathic rubbish.

I agree with CFI’s Nicholas Little:

If the people in charge of the country’s largest pharmacy don’t know that homeopathy is bunk, they should be kept as far away from the American healthcare system as possible

The lawsuit claims pharmacy chain giant CVS fraudulently deceives consumers in the sale of worthless homeopathic remedies and was filed in late June by the Center for Inquiry (CFI), acting on behalf of the general public. The suit seeks both damages and an injunction against CVS’s deceptive marketing practices in the Superior Court of the District of Columbia, alleging violations of the District’s consumer protection act.

Come on CVS! Get this type of useless pseudo-scientific snake oil out of your stores and start helping your consumers make good choices.

Hogwashingly Yours

-ACP,

The New Apple Watch 4: Cardiac Accuracy Unknown, “Game-Changing” Benefits Overblown

On February 10, 2014 AliveCor, Inc. announced that its heavily validated personal  mobile ECG monitor had received FDA over-the counter clearance. Previously the device, which allows recording of a single-lead ECG and, in conjunction with a free smart-phone app, can diagnose atrial fibrillation was only available by prescription.

Since 2013, I have been successfully using this device with my patients who have atrial fibrillation (and writing about it extensively)

Apple COO Jeff Williams standing in front of (presumably) an ECG obtained by Apple Watch 4. It’s OK quality (but smallish p waves). Is that the best they could do? Notice that it is making a diagnosis of sinus rhythm. This PDF can be mailed “to your doctor.”

I was shocked, therefore, to hear the COO of Apple, Jeff Williams, announce that Apple will be offering in its new Apple Watch 4  “the first ECG product offered over the counter directly to consumers.”

This seemed blatantly inaccurate as AliveCor’s device clearly preceded by 4 years Apple’s claim.

Furthermore, AliveCor’s Kardia Band which converts any Apple Watch into a single-lead ECG  (which I’ve written about here and here) has been available and providing the Apple Watch-based ECGs since November 30, 2017.

AliveCor has an outstanding website which documents in detail all the research studies done on their products (there are dozens and dozens of linked papers) and all of their press releases dating back to 2012. It also explains in detail how the product works.

The title of their November 30, 2017 release was  FDA Clears First Medical Device Accessory for Apple Watch®

AliveCor shortly thereafter (December 12, 2017) announced Smart Rhythm , an Apple Watch app that monitors your rhythm and alerts you if it thinks you are in atrial fibrillation. I’ve discussed Smart Rhythm here.

Apple’s Watch will tell you that you are not in atrial fibrillation. Given that we don’t know how accurate it is, should that be reassuring?

The new Apple Watch’s rhythm monitoring app sounds a lot like Smart Rhythm but without any of the documentation AliveCor has provided.

So, within 10 months of Alivecor providing the world with the first ever wearable ECG (and proven its accuracy in afib) Apple seems to have come out with a remarkably similar product.

The major difference between Apple and AliveCor is the total lack of any reviewable data on the accuracy of the Apple device. Yes, that’s right Apple has provided no studies and no data and we have no idea how accurate its ECG device is (or its monitoring algorithm).

For all we know, it could diagnose sinus rhythm with frequent APCS or PVCs consistently as atrial fibrillation, sending thousands of Watch 4 wearers into a panic and overloading the health care system with meaningless alerts.

Apple’s website claims

Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram. It’s a momentous achievement for a wearable device that can provide critical real-time data for doctors and peace of mind for you.

Apple’s “momentous achievement” was actually achieved 10 months earlier by AliveCor and if its monitoring algorithm and ECG system are significantly worse than the proven AliveCor system they will be destroying the peace of mind of users.

Electrodes built into the Digital Crown and the sapphire back crystal allow sensing of cardiac electrical signals. Did Apple get this idea from AliveCor?

After describing the Apple Watch’s new health features, Jeff Williams introduced Ivor Benjamin, MD, the President of the American Heart Association. Benjamin proceeded to describe the new Apple Watch cardiac features as “game-changing”, noting that the AHA is committed to helping patients be “proactive.”

Does  Benjamin have access to the accuracy of the Apple Watch ECG sensor? If so, he and the AHA should immediately share it with the scientific community. If not, by endorsing this feature of the Watch he should be ashamed. Users need to know if he or the AHA was paid any money for this appearance. Also, we should demand to know if (as the prominent AHA logo suggested and news reports implied) the AHA is somehow endorsing the Apple Watch.

Frequent readers know I’m a huge Apple fan but this Apple Watch business makes me think something is rotten in the state of Apple.

Skeptically Yours,

-ACP

Boobies and Such Encountered In The Galapagos

I have returned from The Galapagos and a most amazing Voyage on the Samba.

Early AM kayak departure from the Samba

The experience was exhilarating, enlightening and enchanting (therefore exhausting) and at some point I shall edit a brief movie/slideshow and post it somewhere for those interested.

Until then, here’s a red-footed booby I encountered on the island of Genovesa where a veritable cornucopia of exotic birds feed, nest and fly about,  seemingly unconcerned  about human visitors.

Red-footed Boobies are spectacular divers, plunging into the ocean at high speeds to catch prey. They are beautifully adapted for diving, with sleek, torpedo-shaped bodies, closeable nostrils, and long wings that wrap around their bodies as they slice into the water. This one, nesting in a red mangrove, seemed unperturbed by me standing a foot away but was intrigued by my red (Olympus TG-5 underwater) camera.

Charles Darwin did not visit Genovesa and none of the boobies (blue or red-footed or otherwise) played a role in his Theory of Evolution to my knowledge. They are not endemic or unique to the Galapagos.

The Song Of the Flightless Cormorant

There are many endemic animal species in the Galapagos which likely influenced Darwin’s thinking. On the youngest island,

It is found on just two islands; Fernandina, and the northern and western coasts of Isabela. Distribution associates with the seasonal upwelling of the eastward flowing Equatorial Undercurrent (or Cromwell Current) which provides cold nutrient rich water to these western islands of the archipelago. The population has undergone severe fluctuations; the 1983 an El Niño-Southern Oscillation (ENSO) event resulted in a 50% reduction of the population to just 400 individuals. The population recovered quickly, however, and was estimated to number 900 individuals by 1999.

Fernandina,  I encountered the flightless cormorant. The Galapagos cormorant is the only flightless cormorant in existence.

Evolutionary biologist Patricia Parker (who is the senior scientist at the St. Louis Zoo) appears to be the leading researcher on endemic Galapagos bird species. She collected blood from the Galapagos cormorants, searching for mutations that might explain their useless wings.

She and her fellow researchers  discovered about a dozen mutated genes in the Galapagos cormorants known to trigger rare skeletal disorders in humans called ciliopathies, often characterized by misshapen skulls, short limbs, and small ribcages. Since Galapagos cormorants have short wings and an unusually small sternum, the researchers suspected this link was significant.

The Sexual Attractiveness of The Male Blue-footed Booby 

The blue-footed booby (BFB) is more famous on the Galapagos, primarily because of its mating dance but also because of its fascinating bright blue feet. During the mating dance the male booby prominently displays his sexy feet.

Blue-footed boobies on Isabela Island. Note the varying shades of blue in their feet

A fascinating study published in 2006 suggests that the brighter the blueness of the male booby feet, the healthier he is and the more likely he is to hook up with a female booby.

When male boobies were food deprived their feet became duller and when re-fed fresh fish the blueness brightened within 48 hours.

Variation of dietary carotenoids induced comparable changes in cell-mediated immune function and foot colour, suggesting that carotenoid-pigmentation reveals the immunological state of individuals.

In a second experiment the researchers captured male BFBs after their female mate had laid a first egg and painted a dull blue make-up on the male BFB feet. The females “decreased the size of their second eggs, relative to the second egg of control females, when the feet of their mates were experimentally duller. Since brood reduction in this species is related to size differences between brood mates at hatching, by laying lighter second eggs females are facilitating brood reduction.”

Another  study in 2011  found that  damage to the DNA  of sperm increases with the age of male blue‐footed boobies. Furthermore, like humans sexual attractiveness (foot colour) declines with age in the BFB and is correlated with sperm DNA damage. The authors speculated that. “By choosing attractive males, females might reduce the probability of their progeny bearing damaged DNA.”

I will leave discussions on the technique for acquiring BFB sperm and for applying make-up to their feet to less squeamish authors. In the meantime we can all rest easy with the knowledge that female BFBs like their human counterparts prefer youngish males with brightish  blue suede shoes.

Galapageinosly Yours,

-ACP

(Featured image credit: Cassiano “Zapa” Zaparoli)

Omega-3S From Fish Oil Supplements No Better Than Placebo For Dry Eye 

Yesterday, a patient I’m seeing for atrial fibrillation told me that he was taking fish oil supplements that his eye doctor had recommended and sold to him for dry eyes. This patient reads my blog and knows that I strongly recommend not taking fish oil supplements (unless your triglycerides are >500). At the time I told him I didn’t know the literature on fish oil and dry eyes but that I was skeptical of any proven benefit.

It turns out that in April of this year an NIH-sponsored study concluded that Omega-3s from fish oil supplements are no better than placebo for dry eye.

The NIH story on this study notes that

Despite insufficient evidence establishing the effectiveness of omega-3s, clinicians and their patients have been inclined to try the supplements for a variety of conditions with inflammatory components, including dry eye. “This well-controlled investigation conducted by the independently-led Dry Eye Assessment and Management (DREAM) Research Group shows that omega-3 supplements are no better than placebo for typical patients who suffer from dry eye.”

I suspect that one by one the various alleged benefits of fish oil supplements will be proven to be nonexistent.  I’m not sure the general public will stop buying snake or fish oil  then but I feel like one by one I’m getting my patients off them. Doing my part to save the ocean bottom-feeders.

Krillingly Yours,

-ACP

N.B. I’m writing this while flying to Miami to begin the great Galapagos adventure and the Voyage of the Samba.

A Call To Reconsider The Heimlich Experiment: Let’s Scientifically Determine The Best Approach To Choking Victims

What should you do if you encounter someone choking on food?

If you ask someone on an American street  the likely answer will be to “perform a Heimlich maneuver.”

This is understandable because we frequently hear of celebrities performing or having performed on them a Heimlich maneuver and saving or being saved from choking to death. In addition, we have  descriptions of individuals relating their own stories of lives saved.

For example, in May of 2016, 96-year-old Dr. Henry Heimlich, widely credited as the inventor of the eponymous abdominal thrust procedure, made headlines around the world when he reportedly performed it on a fellow retirement home resident in Cincinnati.

Surprisingly, despite the widespread belief that the Heimlich maneuver is the scientifically-affirmed treatment of choice for choking victims, there is only anecdotal evidence for its effectiveness as well as its dangers and there is no scientific consensus on the best approach to a person who is choking or has foreign body airway obstruction (FBAO).

The Origins of The Heimlich maneuver

In 1972,  Heimlich writes in his autobiography “Heimlich’s Maneuvers“,  he came across a NY Times article  which revealed that the sixth leading cause of accidental deaths in the
US  was  choking on a foreign body, usually food ,and that 3900 individuals were dying from foreign body airway obstruction (FBAO) a year.

 

The typical scenario for these deaths was first described  in a 1963 JAMA report on 9 patients who suddenly collapsed at a dinner table and were subsequently pronounced dead on arrival to the emergency room. Death had been attributed to coronary artery disease but  at autopsy these victims were found  to have food obstructing their airways  (4 by steak, 2 by beef, one by ham and one by kippered herring). The author termed these sudden deaths in resturants “The Cafe’ Coronary.”

In 1972 there was no consensus on how to treat victims of the Cafe’ Coronary and Heimlich noted that the three options were

  1. Inserting a large-caliber hypodermic needle into the trachea or performing a tracheotomy
  2. Utilizing an instrument designed to remove the object from the throat
  3. Slapping choking victims on the back.

Noting the risks of option one, the impracticality of option two and the lack of scientific evidence to support option 3,  Heimlich pondered a better approach, one that would utilize the residual air in the victim’s lungs to forcefully expel the lethal food bolus “like the cork from a Champagne bottle.”

Pop Goes The Cafe’ Coronary

Heimlich first described his  namesake maneuver in an article in Emergency Medicine in June of1974 entitled “Pop Goes The Cafe Coronary.”

Standing behind the victim the rescuer puts both arms around him just above the belt line, allowing head, arms and upper torso to hang forward. Then, grasping his own right wrist with his left hand, the rescuer rapidly and strongly presses into the victim’ abdomen, forcing the diaphragm upward, compressing the lungs and expelling the obstructing bolus

Heimlich states in the 1974 article that the procedure was adapted from “experimental work “with four 38-pound beagles.

Although admitting that these results might not be duplicated in humans, he indicates that “there is certainly no risk in recommending that the procedure be tried in actual cafe’ coronary emergencies.”

“then, as experiences are reported, the method can be evaluated.”

Shockingly, Heimlich, in this article (subsequently picked up and promoted by the lay press) proposed to  all Americans that they begin an experiment on helpless choking victims to see if his newly developed idea was of any benefit.

He requests in the last lines of this monumental communication that Americans help him gather information from the experiment.

“Should you use, or learn of anyone else using, the Heimlich method by the way, please report the results either to EM or me.”

Flimsy Experimental Basis For Heimlich

Four 38 pound beagles-The experimental work supporting an unsupervised, unregulated national experiment on choking victims!

Below is the sum total of the description Heimlich provides for his experiments:

After being given an intravenous anesthetic, each dog was “strangled” with a size 32 cuffed endotracheal tube inserted into the larynx. After the cuff was distended to create total obstruction of the trachea, the animal went into immediate respiratory distress as evidenced by spasmodic, paradoxical respiratory movements of the chest and diaphragm. At this point, with a sudden thrust. I pressed the palm of my hand deeply and firmly into the abdomen of the animal a short distance below the rib cage, thereby pushing upward on the diaphragm. The endotracheal tube popped out of the trachea and, after several labored respirations, the animal began to breathe normally. This procedure was even more effective when the other hand maintained constant pressure on the lower abdomen directing almost all the pressure toward the diaphragm.

We repeated the experiment more than 20 times on each animal with the same excellent results When a bolus of raw hamburger was substituted for the endotracheal tube, it, too, was ejected by the same procedure, always after one or two compressions.

This “experimental work” seems to have been sloppily done and would not have passed muster through a legitimate current day peer-reviewed scientific journal. It seems more like the observations of an 18th century  scientist than a 20th century one.

Here are a few of the red flags I see that suggest either these experiments weren’t really done or that they need to be repeated with better documentation or by an investigator who is unbiased as to the outcome.

  • The beagles are all exactly the same size
  • There are no measurements recorded. Of any kind.
  • Important data was not recorded: What anesthetic was utilized? What was the position of the animals? How long between experiments?. How many “more than 20 times” were the animals choked.? How big was the hamburger bolus?

Flimsy Experimental Work Embellished And Republished

A year later Heimlich was  apparently emboldened by reports of the successful application of his now namesake maneuver and his “special communication” ,published in JAMA, in October of 1975 reiterated his previous publication with a near identical description of the experiments on the four 38 pound beagles.

He added some more details to these experiments. For example, we learn the beagles were anesthetized, with thiamyial sodium given intravenously.

And he embellishes the method for choking the dogs

A cuffed, No. 32 endotracheal tube, the lumen plugged by a rubber stopper, was inserted under direct vision through the mouth into the larynx. The cuff was distended with 3 to 4 ml of air, causing total obstruction of the trachea, simulating a bolus of food caught in the human larynx. The animal immediately went into respiratory distress, as evidenced by spasmodic paradoxical respiratory move- ments of the chest and diaphragm.

At first, the rib cage was manually compressed in an attempt to increase the intrapulmonary pressure and expel the bolus. This procedure was unsuccessful. It was later realized that the compressibility of the lungs by this technique was inadequate due to the rigidity of the chest wall. Furthermore, any increase in intrapleural pressure would be dissipated by depressing the diaphragm.

Apparently realizing that he needed to provide some evidence that his abdominal thrusts were superior to chest compression He added to  his experimental description the following:

At first, the rib cage was manually compressed in an attempt to increase the intrapulmonary pressure and expel the bolus. This procedure was unsuccessful.

And adds a gratuitous explanation for the failure of the chest compression:

It was later realized that the compressibility of the lungs by this technique was inadequate due to the rigidity of the chest wall. Furthermore, any increase in intrapleural pressure would be dissipated by depressing the diaphragm.

Subsequently, I pressed the palm of my hand deeply and firmly upward into the abdomen of the animal a short dis- tance below the rib cage, thereby pushing against the dia- phragm. The endotracheal tube (bolus) popped out of the trachea.

Interestingly, there is no published, peer-reviewed paper verifying the research that Heimlich claims to have done in developing this procedure. And according to his son, Peter M. Heimlich, his father’s archives at a University of Cincinnati medical library include no documentation of the research on the beagles.

 

The Chest Thrust (Guildner Maneuver): A Superior Approach?

Two years later, Charles W. Guildner, an Everett, Washington anesthesiologist and American Heart Association (AHA) consultant, published the results of experiments he performed on six human volunteers which concluded that chest thrusts were  superior to abdominal thrusts in generating air flow out of the trachea and presumably more effective at clearing foreign bodies obstructing the airway of choking victims. Guildner’s results are supported by  a study by Audun Langhelle of Oslo, Norway, published in 2000 by the journal Resuscitation.

Langhelle compared peak airway pressure with standard chest compressions versus Heimlich maneuvers done by emergency physicians in cadavers with simulated complete airway obstruction in a randomized crossover design.  Mean peak airway pressure was significantly lower with the Heimlich maneuver than with the chest compressions.

Heimlich Markets and Bullies To Gain Prominence For His Maneuver 

Prior to 1976, the guidelines of the AHA and the American Red Cross (ARC)  recommended back blows as the best treatment for responding to a conscious choking victim. After a 1976 National Academy of Science conference on emergency airway management (at which Heimlich was an invited participant), both organizations adopted the following recommendations:

  1. Back blows (4)
  2. Manual thrust (4)
  3. If ineffective repeat back blows and manual thrusts until they are effective or until the victim becomes unresponsive.
Host Johnny Carson demonstrates the Heimlich maneuver on actress Angie Dickenson while Dr. Henry Heimlich watches on April 4, 1979..

For Heimlich, having his maneuver incorporated in US first aid guideliness only two years after he introduced it wasn’t enough. He then embarked on a ten-year media campaign he called “back blows are death blows” in which he accused the AHA and ARC of putting lives at risk because they continued to recommend that treatment.

In 1986, with support from Dr. C. Everett Koop, U.S. Surgeon General under President Ronald Reagan, Heimlich got his way. The AHA removed backblows from its guidelines and endorsed the Heimlich maneuver as the sole approach to the choking victim. The ARC followed suit.

Heimlich’s typical rhetoric on this issue can be found in a July, 1988 NY Times editorial where he extensively quotes Koop’s condemnation of back blows and states:

“The organizations and journals responsible for disseminating this medical error should advise Americans that the back slap, taught for more than a decade as a treatment for choking, causes death.”

Review Of The Literature Finds Abdominal Thrusts and Chest Compressions Equivalent

In 2005, the American Red Cross, after reviewing the scientific literature concluded that back blows, abdominal thrusts, and chest thrusts were equally effective for FBAO.

As a result, the ARC’s 2005 Guidelines for Emergency Care and Education essentially returned to their 1976-1985 recommndation to treat conscious, choking children and adults, now called “the five and five”: first perform 5 back blows; if that fails to remove the obstruction, proceed with 5 abdominal thrusts. If necessary, repeat the cycle.”

Heimlich, ever vigilant of the primacy of his maneuver, condemned this to the Cincinnati Enquirer in a 2013 interview.

Those recommendations “horrify” Heimlich. “There has never been any research saying the back slap saves lives,” he said. “We know the Heimlich maneuver works. So it comes down to a matter of life or death.”

Richard Bradley, MD writing in defense of this change on the Red Cross blog  in 2013 wrote:

A review of the scientific literature suggested that back blows, abdominal thrusts and chest compressions are equally effective. Additionally, the use of more than one method can be more effective to dislodge an object. These findings are consistent with those of international resuscitation societies.

The Red Cross certainly isn’t discounting the use of abdominal thrusts. But we include back blows, abdominal thrusts and chest compressions in our training because there is no clear scientific evidence to say that one technique is more effective than the others when treating a choking victim.

. “Additionally, the use of more than one method can be more effective to dislodge an object. These findings are consistent with those of international resuscitation societies.”

The AHA ‘s 2005  Adult Basic Life Support guidelines were published in Circulation recognizing that there was insufficient evidence to promote the Heimlich maneuver (like the ARC, now referring to it by the generic abdominal thrust) over back slaps or chest thrust

Chest thrusts, back blows/slaps, or abdominal thrusts are effective for relieving FBAO (Foreign Body Airway Obstruction) in conscious adults and children >1 year of age, although injuries have been reported with the abdominal thrust. There is insufficient evidence to determine which should be used first. These techniques should be applied in rapid sequence until the obstruction is relieved; more than one technique may be needed. Unconscious victims should receive CPR. The finger sweep should be used in the unconscious patient with an obstructed airway only if solid material is visible in the airway. There is insufficient evidence for a treatment recommendation for an obese or pregnant patient with FBAO.

Interestingly, the switch in recommendations and the change in terminology were likely influenced by Dr. Heimlich’s son investigative blogger Peter M. Heimlich,  Research by Peter and his wife  Karen M. Shulman has  resulted in scores of exposes  in the lay press about what they term Dr. Heimlich’s “wide-ranging unseen history of fraud,” and is documented on their website: http://medfraud.info

The AHA Goes Back To The Heimlich

In 2010, the AHA guidelines revisited foreign body airway obstruction (FBAO) and gave the abdominal thrust priority again “for simplicity in training.”:

Although chest thrusts, back slaps, and abdominal thrusts are feasible and effective for relieving severe FBAO in conscious (responsive) adults and children ≥1 year of age, for simplicity in training it is recommended that abdominal thrusts be applied in rapid sequence until the obstruction is relieved. If abdominal thrusts are not effective, the rescuer may consider chest thrusts. It is important to note that abdominal thrusts are not recommended for infants <1 year of age because thrusts may cause injuries.

The 2015 AHA guidelines did not update  the 2010 FBAO recommendations

Scientific Support For The Heimlich

An abstract presented at the 2012 AHA meetings reviewed the scientific literature to answer the question:

For adults, either conscious or unconscious, with obstructed airway, does any specific resuscitation techniques compared to currently recommended techniques, lead to different outcomes?”

This review found only two studies provided significant evidence to support recommendations

  1. one fair quality LOE 3b study suggests that peak airway pressures developed by chest compressions are significantly higher than the pressure from abdominal thrusts
  2. 2. one poor quality LOE 4 study suggests that for conscious adults with an obstructed airway, abdominal thrusts generate higher peak airway pressures when delivered when the victim is supine as compared to seated and that back blows do not generate any significant change in airway pressure.

The final conclusion of this review:

Clearly, there is a dearth of evidence to support basic life support treatment guidelines for this important problem.

 

Choking Treatment Recommendation in Australia/New Zealand/UK

In the resuscitation guidelines of medical organizations in Australia and New Zealand, the Heimlich maneuver is warned against as unproven and  to be avoided due to “life-threatening complications” associated with its use. Instead, first aid authorities in those countries recommend first performing a series of backblows followed by, if necessary, a series of chest thrusts, the treatment studied by Guildner (1976) and Langhelle (2000).

The Resucitation Council of the United Kingdom recommends the following for choking victims:

  1. Encourage to cough
  2. Give back blows (up to 5). Support the chest with one hand and lean the victim well forwards so that when the obstructing object is dislodged it comes out of the mouth rather than goes further down the airway.Give five sharp blows between the shoulder blades with the heel of your other hand
  3. Give abdominal thrusts.

Heimlich Maneuver: Time For A Reconsideration 

Thus, it is clear the Heimlich maneuver was recommended by Henry Heimlich for general usage without any human clinical studies to support its safety and efficacy. With Heimlich’s aggressive promoting of the technique it became the recommended way to treat choking conscious individuals despite experimental evidence showing it inferior to chest thrusts and no controlled human trials to support its safety and effectiveness.

Australia and New Zealand, countries free of Heimlich’s influence, do not recommend the Heimlich maneuver for choking victims.

It is entirely possible that chest thrusts are a safer and more effective maneuver for removing foreign bodies from choking victims. Since Dr. Heimlich died in December, 2016 perhaps the organizations that teach CPR can reevaluate their recommendations in this area without fear of public shaming or retribution.

Given the uncertainty in the treatment of choking victims and the number of deaths a national trial comparing chest thrusts versus abdominal thrusts as the initial procedure should be initiated as soon as possible.

Skeptically Yours,

-ACP

N.B. In Part Two of this analysis of the Heimlich maneuver we will review the evidence of the harm the Heimlich maneuvers have done over the years.

Apple AirPods Are Absolutely Awesome!

The skeptical cardiologist  began using Apple products during his cardiology fellowship in 1984.  My first research was done on an Apple II and my first personal computer was an original Mac.

These days I am unabashedly and totally immersed in Apple stuff which I use at work, at home, on vacation and while exercising.

In the last year I have fallen in love with Apple AirPods.

Mauricio Pesce/Flikr

I use these bluetooth earphones for listening to music and podcasts and telephone conversations and I like them far better than anything I have previously stuck in or around my ears.

Apple AirPods are amazing.

Here are  a few things off the top of my head that I find amazing about them…

  1. They come in an incredibly slick little white case that serves as storage and charging dock and looks like a container of dental floss. You literally never run out of juice if you put your earphones back in the case when you are done and charge it occasionally.
  2. Pairing with my iPhone and my various Macs is a breeze. Once paired the device automatically plays music through the AirPods if they are in your ears and nearby.
  3. They sense when they are in your ears, give you a tone that they are working and start playing from your paired device on their own.
  4. If you double tap on one of them you can have it advance to next song, bring up Siri, or  stop playing.
  5. If you bring up Siri you can give complex commands like call the Eternal Fiancée or remind me  to bring in Jen’s new shoes package on the porch.
  6. They are so comfortable you don’t notice you are wearing them.
  7. What about appearance you may ask?
    The eternal fiancee’ with q-tip in right ear

    Well, when I first started wearing them the Eternal Fiancée made fun of me because, she said, it  looked like I had  q-tips in my ears. Four months later she borrowed mine to go on a run and decided to order her own the next day

  8. What about the sound you may ask? I think the sound is awesome. I’m a musician and a music fanatic but don’t consider myself an audiophile. I find the sound quality on these little things perfect for my needs and equivalent to any headphones I have used.  I spend a lot of time while listening to songs picking out individual instruments and these are great for that.
  9. What if you forget and leave the AirPods out and they become almost fully discharged. Have no fear, within 10 minutes they are fully charged in the case and ready to go-amazing.
  10. They can survive a washing machine/dryer assault (see below).

AirPods: The Cons

Due to my tendency to lose various components of the AirPods the EF has marked hers with a red dot of  nail polish

There are some downsides…

-Because they are so small and unobtrusive I forget about them and lose them easily. You can actually use the Find My iPhone Apple feature to have them make a sound and track them down but a few months ago I misplaced one so badly I had to replace it.

–One quick visit to my local Apple Genius Bar and 69$ later I had a new right AirPod.

-Early on in my AirPods experience I left them in my running shorts pocket and they went through an entire washing and drying experience….. and after a several  hour  period of dormancy they worked perfectly well!

Can you tell the difference between the dental floss case and the Apple AirPods case?

-The case is so small and unobtrusive it is very easy to forget. I have left it on treadmills innumerable times. One time I left it on an airplane….Another visit to Apple required.

I am not alone in my love of the AirPods.

I came across this review on The Verge by Vlad Savov (“‘The Verge’s resident Bulgarian, headphone and mobile reviewer”)

But when I look at the limits of what’s possible today — in terms of miniaturization of audio and wireless components — I can’t see a better combination of price, features, and performance than what’s offered by the AirPods. The price is fair and the compromises are acceptable. I make it my job to review (and enjoy) super heavy and expensive headphones that do amazing things with music, recreating and illuminating every minute detail of a recording. That makes me extremely picky about any products I listen to, and the thing the AirPods share with the giant cans built by the likes of Audeze and Focal is that they convey the sense and intent of the music. And the reason I now reach for the AirPods even when I’m at home, the unique thing that delights all their users, is their unrivalled ease of use

AirPodsRulingly Yours,

-ACP

N.B.  The AirPods greatness at unobtrusively staying in your ear was initially thought to be a design flaw. This writer at Business Insider recently noted that

Most earbuds have gummy tips, which create a “seal” around the inside of your ear that’s important for two reasons. First, it creates an environment where outside sound can’t leak in, so you can listen to your music without being interrupted by outside noises, like a subway car or people walking on the street. Second, by creating that ideal environment, your music will actually sound better, especially lower bass frequencies.
The AirPods break that design rule. Instead of having gummy tips, they have a hard plastic shell, like Apple’s wired earbuds, the EarPods. They don’t create a tight seal, and sit on the inside of my ears instead of totally plugging them up. This design lets outside sound leak in, which is annoying, but it actually helps the AirPods stay in my ears.
Totally wireless earbuds rely on their seal for more than just audio quality. They actually need that tight seal to stay securely in your ears. Unfortunately, it doesn’t matter if I’m sitting, walking, or running — all of the gummy-tipped wireless earbuds I’ve tried fit into my ears nicely for a couple of minutes, then start loosening up.
Eventually, the seal the earbuds created breaks, and one or both of them fall out of my ears. Because the AirPods don’t have to maintain a seal, they’re the only totally wireless headphones I can reliably keep in my ears for more than a few minutes at a time.

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