Omron’s HeartGuide Wristwatch Blood Pressure Monitor Allows BP Monitoring During Daily Activities Unobtrusively: Can It Replace Ambulatory BP Monitors?

I’ve been evaluating a wearable wrist watch blood pressure monitor for the last week.

After a Twitter interaction with Omron stimulated by Dr. Wen Dombrowski, the Omron people loaned me one of their HeartGuide devices.

Omron’s website describes the device as follows:

Engineered to keep you informed, HeartGuide is a wearable blood pressure monitor in the innovative form of a wristwatch. In tandem with its companion app HeartAdvisor, HeartGuide delivers powerful new technology making tracking and managing your blood pressure easier than ever before. Proactively monitor your heart health by turning real-time heart data into heart knowledge and knowledge into action. With HeartGuide wherever you go, you’re in the know.

I and the AHA have  not recommended wrist BP devices.  My decision was based on my personal research in the 1990s on arterial waveforms and the influence of wave reflection.  Studies have clearly shown a change in the arterial wave form as it proceeds from the ascending aorta to the periphery.

Therefore, the skeptical cardiologist was skeptical of the value of the HeartGuide

After wearing the HeartGuide for a week and using it in a variety of situations to measure my blood pressure I am rethinking my recommendation against wrist blood pressure cuffs.

I’ll give my full analysis of the device after more evaluation but what I’ve discovered is that it can serve as an accurate and unobtrusive daytime ambulatory blood pressure monitor.

Ambulatory blood pressure monitoring (ABPM) utilizes a portable BP monitor which includes a brachial BP cuff and a device that inflates the cuff every 20-30 minutes, makes a measurement and stores all the recordings for off-line review. Studies have shown ABPM is a better predictor of CV mortality than either clinic BP or home BP monitoring.

It has not been widely utilized in the US because it is poorly reimbursed.

The HeartGuide sits on my wrist and whenever I feel like it, wherever I am, I can quickly and simply make a recording of my BP.

 

 

With the HeartGuide I have made  BP recordings in a variety of situations which I would never previously have considered.

For example, earlier this week I wore the HeartGuide to work. I measured my BP at home and it was 125/76. After dropping my gear off at my office I walked to the 6th floor of the hospital to see inpatients. This involved going down several flights of stairs, crossing to the hospital via a pedway and climbing several flights of stairs.

When I emerged on the 6th floor I stopped (because the Heart Guide does not like it if you are moving), triggered the Heart Guide and put my right hand over my heart (the Heart Guide likes you to put your hand on your heart). Within 90 seconds I knew my BP (it had increased to 143/81).

In order to do this unobtrusively I wandered into the patient waiting area and pretended to be watching NFL highlights on the TV.  Nobody seemed to notice I was taking my BP!

Subsequently, I was paged to do a transesophageal echo/electrical cardioversion and went downstairs to our “heart station” where a room full of RNs, a sonographer, an anesthetist and a patient awaited me. While talking to the patient about the procedure I triggered the Heart Guide and made another BP recording. Nobody noticed!IMG_5220

The Heart Guide BPs are displayed on the watch face for a few seconds and can be sent via BlueTooth to the OmronAdvisor smartphone app.

The graph above shows my BP was high at 807 AM while I was talking to the patient and still up after the procedure.

One day I wore the HeartGuide to the gym and made BP measurements under a variety of conditions.

HG leg press

The HeartGuide will not activate while walking on the treadmill no matter how hard I try to keep my arm still. It does not like motion of any kind.

But the first reading on the left was immediately after running on the treadmill. I then performed an isometric leg press hold on a weight machine and was able to obtain a recording during this maneuver of 140/88.  Shortly after the leg press I repeated the recording and it had dropped down to 104/69.

I have to say this is an abundance of BP information that is quite interesting and heretofore I had never been aware of. It opens up intriguing clinical possibilities.

I will have to spend more time analyzing the Heart Guide before writing my overall impression and recommendations but thus far I see it expanding our toolkit for understanding hypertension and personalizing cardiovacular medicine.

Try to imagine yourself standing like me outside a restaurant unobtrusively taking your blood pressure and ponder the possibilities!

Soon you may find that wherever you go, you’re in the know. But be aware of the possibility of being arrested for loitering while checking your BP.

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Omnimanometrically Yours,

-ACP

If you’d like to read a detailed description of the HeartGuide check out this review while eagerly awaiting my more serious and more complete analysis.

Statins And Memory Loss: The Latest Findings

In 2017 I wrote a post  entitled “Do Statins Cause Memory Loss? The Science, The Media, The Statin-Denialist Cult, and The Nocebo Effect” which concluded that there was no scientific evidence for cognitive side effects of the widely-utilized statin cholesterol lowering drugs.

Despite this, a common concern of my patients when we discuss potentially utilizing statin drugs to reduce their long term risk of heart attack and stroke is that the drug will rob them of their memory.

More studies have been published in this area and they continue to show absolutely no evidence for adverse association between statins and cognition.

A recent summative review found no beneficial or detrimental associations between statins and cognition in elderly cohorts with normal baseline cognition, impaired cognition or with incident dementia.

Finally, and most recently we have reassuring evidence from Australian researchers who meticulously studied  over a thousand participants aged 70-90 years in the Sydney Memory and Ageing Study.

Over 6 years the study found

-no difference in the rate of decline in memory or global cognition between statin users and never users.

-Statin initiation during the observation period was associated with blunting the rate of memory decline.

-Exploratory analyses found statin use was associated with attenuated decline in specific memory test performance in participants with heart disease and apolipoprotein Eε4 carriage.

-There was no difference in brain volume changes between statin users and never users.

For those who see statins as part of a conspiracy please note that there was absolutely no connection between the researchers and the statin pharmaceutical industry.

  • This study was supported by the Australian Government’s National Health and Medical Research Council (Dementia Research Grant 510124). Dr. Brodaty has served on the Nutricia Australia Advisory Board. Dr. Sachdev has served on the Australian Advisory Board of Biogen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

My 2017 post was triggered by a call from a reporter who wanted to discuss the “cognitive side effects” of statins. It goes into a fair amount of detail about media and internet fear-mongering and how this contributes to the nocebo effect which makes it more likely patients will experience adverse side effects from medicine.

At the end I discuss how we handle potential side effects in my practice.

I’ve copied it below as it remains highly relevant 2 years later.


Since I regularly prescribe statin drugs to my patients to reduce their risk of heart attack and stroke,  I am very concerned about any possible side effects from them, cognitive or otherwise. However, in treating hundreds of patients with statins, I have not observed a consistent significant effect on brain function.

When the U.S. Food and Drug Administration (FDA) issued a statement in 2012 regarding rare postmarketing reports of ill-defined cognitive impairment associated with statin use it came as quite a surprise to most cardiologists.

The FDA made a change in the patient information on all statin drugs which stated:

Memory loss and confusion have been reported with statin use. These reported events were generally not serious and went away once the drug was no longer being taken

This FDA statement was surprising because prior observational and randomized controlled trials had suggested that patients who took statins were less likely to have cognitive dysfunction than those who didn’t.

Early studies implied that statins might actually protect against Alzheimer’s disease.

In fact these signals triggered two studies testing if statins could slow cognitive decline in patients with established Alzheimer’s disease  One study used 80 mg atorvastatin versus placebo and a second 40 mg simvastatin versus placebo and both showed no effect on the decline of cognitive function over 18 months.

More recently, multiple reviews and meta-analyses have examined the data and concluded that there is no significant effect of statins on cognitive function. Importantly, these have been written by reputable physician-scientists with no financial ties to the pharmaceutical industry.

Data Show No Evidence of Causality Despite Case Reports

The FDA added the warning to statin patient information based on case reports  Occasional reports of patients developing memory loss on a statin do not prove that statins are a significant cause of cognitive dysfunction.

Case reports have to  be viewed in the context of all the other scientific studies indicating no consistent evidence of negative effects of the statins. Case reports are suspect for several reasons:

First, patients receiving statins are at increased risk for memory loss because of associated risk factors for atherosclerosis and advancing age. A certain percentage of such patients are going to notice memory loss independent of any medications.

Second. The nocebo effect: If a patient taking a statin is told that the drug will cause a particular side effect,that patient will be more likely to notice and report that particular side effect.

A recent study in The Lancet looked at reported side effects in patients taking atorvastatin versus placebo and found substantial evidence for the nocebo effect.

Analysis of the trial data revealed that when patients were unaware whether they were taking a statin or a placebo, the number of side effects reported was similar in those taking the statin and those taking placebo. However, if patients knew they were taking statins, reports of muscle-related side effects in particular increased dramatically, by up to 41 per cent.

Third, a review of the FDA post-marketing surveillance data showed the rate of memory loss with statins is not significantly higher than for other non-statin cardiovascular medications (1.9 per million prescriptions for statins , 1.6 per million prescriptions for losartan) and clopidogrel (1.9 per million prescriptions for clopidogrel.)

What Most Media Prefer: Controversy And Victims

I thought my experience and perspective on statins and cognitive function might be useful for a wider audience of patients to hear so I agreed to be interviewed. After I expressed interest the  reporter responded:

I would like to interview you and also a person who has experienced memory and/or thinking problems that they attribute to statin use.  
 I responded with “let me see what I can find,”  although I was concerned that  this reporter was searching for a cardiologist to support attention-grabbing claims of  severe side effects of statins rather than seeking a balanced, unbiased perspective from a knowledgeable and experienced cardiologist.
If I produced a “victim” of statin-related memory loss this would boost ratings.
I then began racking my brain to come up with a patient who had clearly had statin-related memory loss or thinking problems. I asked my wonderful MA Jenny (who remembers details about patients that I don’t) if she could recall any cases. Ultimately, we both came up without any patients for the interview. (Any patient of mine reading this with definite statin memory loss please let me know and I will amend my post. However, I won’t be posting anecdotes outside of my practice.)
I have had a few patients relate to me that they feel like their memory is not as good as it was and wonder if it could be from a medication they are on.  Invariably, the patient has been influenced by one of the  statin fear-mongering sites on the internet (or a friend/relative who has been influenced by such a site.)
I wrote about one such site in response to a patient question a while back:
The link appears to be a promotional piece for a book by Michael Cutler, MD. Cutler’s website appears to engage in fear-mongering with respect to statins for the purpose of selling his books and promoting his “integrative” practice. I would refer you to my post entitled “functional medicine is fake medicine”. Integrative medicine is another code word for pseudoscientific medicine and practitioners should be assiduously avoided.
The piece starts with describing the case of Duane Graveline, a vey troubled man who spent the latter part of his life attempting to scare patients from taking statins. Here is his NY Times obituary.
You can judge for yourself if you want to base decisions on his recommendations.
There is no scientific evidence to suggest statins cause dementia.
An Internet-Driven Cult With Deadly Consequences
Steve Nissen recently wrote an eloquent article which accuses statin deniers of  being  an “internet–driven cult with deadly consequences.”  Nissen has done extremely important research helping us better understand atherosclerosis  and is known for being a patient advocate: calling out drug companies when they are promoting unsafe drugs.
I have immense respect for his honesty, lack of bias, and his courage to be outspoken .  He writes:

“Statins have developed a bad reputation with the public, a phenomenon driven largely by proliferation on the Internet of bizarre and unscientific but seemingly persuasive criticism of these drugs. Typing the term statin benefits into a popular Internet search en- gine yields 655 000 results. A similar search using the term statin risks yields 3 530 000 results. One of the highest-ranking search results links to an article titled “The Grave Dangers of Statin Drugs—and the Surprising Benefits of Cholesterol”. We are losing the battle for the hearts and minds of our patients to Web sites de- veloped by people with little or no scientific expertise, who often pedal “natural” or “drug-free” remedies for elevated cholesterol levels. These sites rely heavily on 2 arguments: statin denial, the proposition that cholesterol is not related to heart disease, and statin fear, the notion that lowering serum cholesterol levels will cause serious adverse effects, such as muscle or hepatic toxicity— or even worse, dementia.”

He goes on to point out that this misinformation is contributing to a low rate of compliance with taking statins. Observational studies suggest that noncompliance with statins significantly raises the risk of death from heart attack.

The reasons for patient noncompliance, Nissen goes on to say, can be related to the promotion of totally unproven supplements and fad diets as somehow safer and more effective than statin therapy:

“The widespread advocacy of unproven alternative cholesterol-lowering therapies traces its origins to the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Incredibly, this law places the responsibility for ensuring the truthfulness of dietary supplement advertising with the Federal Trade Commission, not the U.S. Food and Drug Administra-tion. The bill’s principal sponsors were congressional representatives from states where many of the companies selling supplements are headquartered. Nearly 2 decades after the DSHEA was passed, the array of worthless or harmful dietary supplements on the market is staggering, amounting to more than $30 billion in yearly sales. Manufacturers of these products commonly imply benefits that have never been confirmed in formal clinical studies.”

Dealing With Statin Side Effects In My Practice

When a patient tells me they believe they are having a side effect from the statin they are taking (and this applies to any medication they believe is causing them side effects), I take their concerns very seriously. After 30 years of practice, I’ve concluded that in any individual patient, it is possible for any drug to cause  side effects.  And, chances are that if we don’t address the side effects the patient won’t take the medication.

If the side effect is significant I will generally tell the patient to stop the statin and report to me how they feel after two to four weeks.

If there is no improvement I have the patient resume the medication and we generally reach a consensus that the side effect was not due to the medication.

If there is a significant improvement, I accept the possibility that the side effect could be from the drug. This doesn’t prove it, because it is entirely possible that the side effect resolved for other reasons coincidentally with stopping the statin. Muscle and joint aches are extremely common and they often randomly come and go.

At this point, I will generally recommend a trial at low dose of another statin (typically rosuvastatin or livalo.)  If the patient was experiencing muscle aches and they return we are most likely dealing with a patient with statin related myalgias. However, most patients are able to tolerate low dose and less frequent administration of rosuvastatin or Livalo.

For all other symptoms, it is extremely unusual to see a return on rechallenge with statin and so we continue statin long term therapy.

Today a patient told me he thought the rosuvastatin we started 4 weeks ago was causing him to have more diarrhea. I informed him that there is no evidence that rosuvastatin causes diarrhea more often than a placebo and had no reason based on its chemistry to suspect it would. (Although I’m sure there is a forum somewhere on the internet where patients have reported this). Fortunately he accepted my expert opinion and will continue taking the drug.

If the symptoms persist and the patient continue to believe it is due to the statin, we will go through the process I described above. And, since every patient is unique, it is possible that my patient is having a unique or idiosyncratic reaction to the statin that only occurs in one out of a million patients and thus is impossible to determine causality.

Since statins are our most effective and best tolerated weapon in the war against our biggest killer, it behooves both patients and physicians to have a high threshold  for stopping them altogether. Having such a high threshold means filtering out the noise from attention-seeking media and the internet-driven denials cult thus minimizing the nocebo effect

Antinocebonically Yours

-ACP

Health Care Expenses Undermine American Prosperity; Let’s Start Restoring Medicine

I came across the website of Restoring Medicine recently and recommend you visit it if you are concerned about rising American healthcare expenses.

This graph shows the change in time of costs for various  consumer goods and services in the US over the last 20 years.

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While TVs and computer software costs are dropping, hospital services have increased 200%. As Restoring Medicine points out:​

Spending on health care threatens every aspect of American society. The time for common-sense reform has arrived. All of us can play a part in driving badly needed reforms, both in the marketplace and in the policy world. As Margaret Mead said, “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”

Restoring Medicine is a “grassroots movement of people who believe that transparency can cut waste, expose the money games and lower healthcare costs for everyone.”

They provide patients with a  toolkit to fight against overcharged bills.

This 15 step detailed guide starts with

1. Ask for an itemized bill:

    80% of medical bills contain an error. Review the services and let the hospital know of any that were not rendered. Look for duplicate charges. Hospitals will often delete line items when patients report inaccuracies. Use this tool to translate medical procedure codes and medical diagnosis codes into plain language so you can understand your bill.

Don’t hesitate to submit your story in the healthcare system to Restoring Medicine by filling out the form on their website here.

Restoratively Yours,

-ACP

Black Friday Sales Even A Skeptic Can Embrace

The skeptical cardiologist refuses to buy anything on Black Friday.  I don’t want to be manipulated into buying something just because it is cheaper for a while.

However, I have noticed that many of the cardiovascular products I recommend or have written about are substantially discounted today.

I present them in no particular order.

The QardioArm BP cuff which I have called the iPhone of BP devices is marked down from $99 to $69$ for a “limited time.”

While it is portable, stylish and accurate it is not, as Qardio ludicrously claims, “four times more effective at lower blood pressure.”

Omron, whose blue-tooth enabled BP devices connect to an online dashboard your doctor can visualize is offering 30% off through 12/31/2019 on all devices on their website.

I presume this includes the delightful Omron Evolv.

It may include the Omron Heart Guide, a wrist-based watch which measures BP. I’ll be writing my review of this device soon.

I’ve written a lot about the value of AliveCor’s Kardia Mobile ECG and the single lead device is marked down from $99 to $ 84 for Black Friday.

Finally, one of my favorite gadgets (see here), the Keyto ketone breath sensor sent me this email this morning.

I can’t vouch for the Keyto chocolate shake or the basil pesto that they are now including with Black Friday sales but I love the Keyto.

By the way, it wasn’t clear to me when I first got the Keyto device what kind of diet Keyto promotes. They favor a plant-based keto (with fish) diet which they consider “heart healthy.”  More on this down the line.

Appositely Yours,

-ACP

The Distortion of The Death of Dr. Robert Atkins Continues

Three years ago I carefully researched the details of the death of Robert Atkins and wrote about it on this blog. I was motivated by the grossly inaccurate portrayal of him promulgated on vegan and plant-based websites. Elsewhere on this website I have described in detail the death of Nathan Pritikin whose ultra-low fat diet stands in stark contrast to Atkins’ ultra-low carb diet.

The most important point I hoped to make was that we should not judge the benefits of any diet based on how the founder of that diet dies. There is far too much randomness in death and far too much genetic influence over our health to base dietary decisions on one man ( or woman’s) mode of departing existence.

Atkins suffered a completely random event slipping and falling on ice and suffering an epidural hematoma. Pritikin developed leukemia and died after committing suicide.

Unfortunately my article did not end the misinformation rampant on the internet about Atkins so I’m reposting it today for all of you who may be feeling guilty about eating too much on Thanksgiving yesterday.

One of the characters in my story, Michael Bloomberg, has recently announced that he is running for President.


In the spring of 2003 at the age of 72 years, Robert Atkins, the cardiologist and  controversial promoter of high fat diets for weight loss, fell  on the sidewalk in front of his Atkins Center for Complementary Medicine in Manhattan.  He lost his footing on a patch of ice, slipped and banged his head on the pavement.  At the time of his fall his book ”Dr. Atkins’ New Diet Revolution” lead the NY times paper-back best seller list.

He was taken to nearby Cornell Medical Center where a clot was evacuated from his brain. Thereafter he lapsed into a coma and he spent 9 days in the ICU, expiring on April 17, 2003.

screen-shot-2016-11-27-at-8-44-55-amThe cause of death was determined by the New York Medical Examiner to be “blunt injury of head with epidural hematoma.”

An epidural hematoma is a collection of blood between the skull and the tough outer lining of the brain (the dura) which can occur with blunt trauma to the head which results in laceration of the arteries in this area. It is a not  uncommon cause of death in trauma . Actress Natasha Richardson (skiing, see below)  died from this. Nothing about the manner in which Robert Atkins died would suggest that he was a victim of his own diet any more than  Natasha Richardson was.

However, within the year a campaign of misinformation and deception spear-headed by  evangelistic vegans would try to paint the picture that Atkins died as a direct result of what they perceived as a horribly dangerous diet.

Michael Bloomberg, then New York major,  was quoted as saying

“I don’t believe that bullshit that [Atkins] dropped dead slipping on the sidewalk.”

According to the Smoking Gun:

“The 61-year-old billionaire added that Atkins was “fat” and served “inedible” food at his Hamptons home when Bloomberg visited. The mayor’s inference, of course, was that Atkins was actually felled by his meat-heavy diet, that his arteries were clogged with beef drippings. “

Enter The Vegans

Richard Fleming, a physician promoting prevention of cardiovascular disease through vegetarianism and with close ties to an organization  called Physicians Committe for Responsible Medicine (PCRM) sent a letter to the NY Medical Examiner requesting a copy of the full medical examination of Atkins. The NYME office  should have only issued copies of this report to physicians involved in the care of Atkins or next of kin but mistakenly complied with this request.  Fleming, who would subsequently publish his own low fat diet book, conveniently gave the report to PCRM which is directed by animal rights and vegan physicians.

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From the front page of pcrm.org. The two major concerns of the group are converting everyone to veganism and animal rights.

Neal Barnard, the President of PCRM, in an incredibly unethical move sent the letter to the Wall Street Journal with the hope that the information would destroy the popularity of the Atkins diet, a diet he clearly despises..  Barnard said the group decided to publicize the report because Atkins’ “health history was used to promote his terribly unhealthy eating plan..” The WSJ subsequently published an article summarizing the findings.

To this day, advocates of vegetarianism and low fat diets, distort the findings of Atkins’ Medical Examination in order to depict high fat diets like his as dangerous and portray Atkins as a victim of his own diet.

To scientists and thoughtful, unbiased physicians it is manifestly apparent that you cannot base decisions on what diet plan is healthy or effective for weight loss on the outcome of one patient. It doesn’t matter how famous that one person is or whether he/she originated and meticulously followed the diet. It is a ludicrous concept.

Would you base your decision to engage in running  based on the death of Jim Fixx?  Fixx  did much to popularize the sport of running and the concept of jogging as a source of health benefit and weight loss. He died while jogging, in fact. An autopsy concluded that he died of a massive heart attack and found advanced atherosclerosis (blockage) of the arteries to his heart.

Fixx inherited his predisposition to heart disease and couldn’t run himself out of it. Multiple studies over the years have documented the benefit of regular aerobic exercise like running on longevity and cardiovascular risk.

Would you based your decision to engage in  a very low fat diet based on how Nathan Pritikin died?  Pritikin authored an extremely popular book emphasizing eliminating fat from the diet but developed leukemia and slashed his wrists,  committing suicide at the age of 69 years. Would vegetarians accept the premise that their preferred diet results in leukemia or suicidal depression based on Pritikin’s death?

The Distortion of Atkins Death

The NYME report lists Atkins weight at autopsy as 258 pounds. Low-fat zealots seized on this fact as indicating that Atkins was screen-shot-2016-12-17-at-5-32-56-ammorbidly obese throughout his life.  For example, a  you-tube video of an audio interview of Atkinas online posted by “plant-based coach”  has this obviously photoshopped head of Atkins put on the body of a morbidly obese man. Atkins actually weight around 200 pounds through most of his life and a hospital note on admission showed him weighing 195 pounds. A substantial weight gain of 63 pounds occurred in the 9 days after his admission due to the accumulation of fluid volume and swelling which is not uncommon in the critically ill.

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No autopsy was performed on Atkins but the NYME wrote on the document that he had “h/o of MI, CHF, HTN.”

MI is the acronym for a myocardial infarction or heart attack. As far as we can tell without access to full medical records, Atkins never had an MI. He did have a cardiac arrest in 2002. While most cardiac arrests are due to a cardiac arrhythmia secondary to an MI they can also occur in patients who have a cardiomyopathy or weakness in the heart muscle from causes other than MI.

In fact, USA Today reported that Stuart Trager, MD,  chairman of the Atkins Physicians Council in New York, indicated that Atkins was diagnosed with a cardiomyopathy at the time of his cardiac arrest and that it was not felt to be due to blocked coronary arteries/MI. Cardiomyopathy can be caused by viral infections or nonspecific inflammation of the heart muscle and would have nothing to do with diet.

Trager also stated that Atkins, as a result of the cardiomyopathy, had developed heart failure (CHF) and the pumping ability of his heart (ejection fraction) had dropped to 15% to 20%. While CHF can be due to heart attacks causing heart weakness in Atkins case it appears it was unrelated to fatty blockage of the coronary arteries causing MI and therefore likely not related  to his diet.

What Does Atkins Death Tell Us About His Diet 

The information about Atkins death tells us nothing about the effectiveness or dangers of his diet.  In one individual it is entirely likely that a genetic predisposition to cancer or heart disease overwhelms whatever beneficial effects the individual’s lifestyle may have had. Thus, we should never rely on the appearance or the longevity of  the primary promoter of a diet for the diet’s effectiveness.

The evangelists of low-fat, vegan or vegetarian diets like PCRM have shamelessly promoted misinformation about Atkins death to dismiss high fat diets and promote their own agenda. If their diets are truly superior it should be possible to utilize facts and science to promote them rather than a sensationalistic, distorted focus on the body of one man who slipped on the ice and fell to his death.

Epidurally Yours

-ACP

ISCHEMIA Shows Medical Therapy Outcomes As Good As Coronary Stents or Bypass For Most CAD Patients

The ISCHEMIA (International Study of Comparative Health Effectiveness With Medical And Invasive Approaches) study presented at the AHA meeting this week provides further evidence that a conservative approach utilizing optimal medical therapy is an acceptable strategy for most patients with stable coronary disease (CAD).

Cardiologists have known for a decade (since the landmark COURAGE study) that outside the setting of an acute heart attack (acute coronary syndrome or ACS), coronary stents don’t save lives and that they don’t prevent heart attacks.

Current guidelines reflect this knowledge, and indicate that stents in stable patients with coronary artery disease should be placed only after a failure of  “guideline-directed medical therapy.”  Despite these recommendations, published in 2012, half of the thousands of stents implanted annually in the US continued to be employed in patients with either no symptoms or an inadequate trial of medical therapy.

Yes, lots of stents are placed in asymptomatic patients.  And lots of patients who have stents placed outside the setting of ACS are convinced that their stents saved their lives, prevented future heart attacks and “fixed” their coronary artery disease. It is very easy to make the case to the uneducated patient that a dramatic intervention to “cure” a blocked artery is going to be more beneficial than merely giving medications that stabilize atherosclerotic plaque, dilate the coronary artery or slow the heart’s pumping action to reduce myocardial oxygen demands.

Stent procedures are costly  in the US (average charge around $30,000, range $11,000 to $40,000) and there are significant risks including death, stroke and heart attack. After placement, patients must take powerful antiplatelet drugs which increase their risk of bleeding. There should be compelling reasons to place stents if we are not saving lives.

What Did ISCHEMIA Prove?

ISCHEMIA (paper unpublished but slides available here) showed that an invasive strategy (employing cardiac catheterization with resulting stenting or coronary bypass surgery (CABG)) offered no benefit over optimal medical therapy in preventing cardiovascular events in patients with moderate to severe CAD.

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Rates of all-cause death were nearly superimposable over the years studied, reaching 6.5% and 6.4% at 4 years for the invasive and conservative groups,

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Inclusions and exclusion criteria are listed below. Patients with unnaceptable angina despite optimal medical therapy were not included. These patients clearly benefit symptomatically from revascularization (as long as their chest pain is actually angina and not from another cause.)

All patients had stress imaging studies demonstrating moderate to severe amounts of ischemia. Such patients with very abnormal stress tests in the past have typically been sent immediately to the cath lab.

Based on ISCHEMIA we now know in these patients there is no need to do anything urgently other than institute OMT.

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These patients were on good medical therapy which likely explains the very good outcomes in both conservative and invasive arms. The “high level of medical therapy optimization” is what cardiologists should be shooting for with LDL<70, on a statin with systolic blood pressure <140 mm Hg, on an antiplatelet drugg and not smoking.

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Interestingly coronary CT angiography (CCTA) was utilized prior to patients receiving catheterization. I’ve been  utilizing this noninvasive method for visualizing the coronary arteries increasingly prior to committing to an invasive approach.

Quality Of Life 

Finally, in a separate presentation the ISCHEMIA trial showed that the invasive strategy did improve symptoms and quality of life modestly. It did not improve quality of life in those without angina symptoms.

The ORBITA study (which I wrote about here) showed that a large amount of the symptomatic improvement in patients following stenting may be a placebo effect.

Importance Of ISCHEMIA

Hopefully the results of ISCHEMIA will cut down on the number of unnecessary catheterizations, stents and bypass operations performed. This, in turn, will save our health system millions of dollars and prevent unnecessary complications.

Outside the setting of an acute heart attack the best approach to patients with blocked coronary arteries is a calm, thoughtful, and measured one which allows ample time for shared decision-making between informed patients and knowledgeable physicians. Such decisions should carefully consider the ISCHEMIA, COURAGE and ORBITA results.

Nonischemically Yours,

-ACP

N.B. Ischemia is a fantastic acronym for this study. Doctors use it a lot to describe the absence of sufficient blood flow to tissues.

N.B.2 Although I deplore the number of unnecessary caths and stents performed in the US, especially in patients without symptoms and those with noncardiac chest pain, I still utilize them in my patients with flow-limiting coronary stenoses and unacceptable anginal chest pain with symptoms despite optimal medical therapy and have noticed outstanding results. This angiogram shows a tight, eccentric LAD blockage in such a patient who now, post stent, has had complete resolution of the chest pain that limited him from even short walks.

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Heart Rate Recovery: A Simple and Powerful Predictor of Mortality Now Available On Your Apple Watch

Apple Watch and other fitness trackers have the capability to provide us with information on cardiovascular parameters which reflect the activity of the autonomic nervous system (ANS). Measures of the activity of the ANS reflect the balance between the sympathetic nervous system (which activates fight and flight responses) and the parasympathetic nervous system (which activates “rest and digest” activities) and have been shown to be powerful predictors of mortality.

Most of the attention in this areas has been on heart rate variability (HRV) with various wearables trying to promote HRV as a surrogate marker for stress. The OURA ring people for example state without evidence that “high heart rate variability is an indication of especially cardiovascular, but also overall health as well as general fitness.”

Although unimpressed with the HRV data from Apple Watch or the OURA ring I have recently discovered that I can get a more useful parameter of ANS tone from my Apple Watch-Heart Rate Recovery.

What Is Heart Rate Recovery?

Heart Rate Recovery (HRR) is the rate of decline in heart rate after the cessation of exercise. Basically you measure heart rate right when you stop exercising and again a minute later (and/or two minutes later) and subtract one from the other.

Unlike HRV you don’t really need any high tech devices to make this simple but highly reproducible measurement. You can simply measure your pulse the old-fashioned way by putting a finger on your carotid or radial artery and counting the beats.

What happens to the heart rate during exercise has long been considered to be due to the combination of parasympathetic withdrawal and sympathetic activation.

The fall in heart rate immediately after exercise has been shown to be a function of the reactivation of the parasympathetic nervous system. It is accelerated in athletes and blunted in patients with heart failure.

Heart Rate Recovery As A Predictor Of Mortality

A 1999 study published in the New England Journal of Medicine found that abnormally low HRR doubled the risk of dying over 6 years.

The study examined outcomes in 2428 consecutive adults (mean age 57 years, 63 percent men) without significant prior cardiac disease who were referred to the Cleveland clinic cardiac lab for nuclear stress testing.  Patients underwent symptom-limited exercise on a treadmill using a standard or modified Bruce protocol.

Heart rate was recorded at peak exercise and then patients walked upright and were walking at a speed of 1.5 miles per hour at a grade of 2.5 percent when heart rate was checked a minute later.

Median HRR was 17 beats per minute, with a range from the 25th to the 75th percentile of 12 to 23 beats per minute. Abnormally low HRR was selected as <13 beats/min and was found in 639 patients (26 percent).

In univariate analyses, a low value for the recovery of heart rate was strongly predictive of death, conferring a four-fold increased risk. After adjustment for multiple confounding factors including age and exercise capacity, patients with HRR <13 beats/min had a two-fold risk of dying.

This 20 year old study and HRR remain highly relevant. The paper has been cited 1001 times since publication and thus far in 2019 58 papers have referenced it.

In a follow up study this same Cleveland Clinic group looked at nearly 10 thousand patients undergoing treadmill ECG testing and found HRR <13 beats/min doubled the 5 year risk of death. In the figure below mortality jumps markedly as HRR drops below 13 and quite dramatically if <10 beats/min.

m_joc00680f2

 

 

 

 

 

Subsequent studies from different investigators confirmed that HRR is associated with mortality, independent of workload and myocardial perfusion defects, treadmill risk score, and even after adjusting for left ventricular function and angiographic severity of coronary disease.

There has been a lack of consistency in these studies in stress protocols, activity post-exercise and optimal duration of heart beat measurement post exercise.

This 2001 JACC paper determined that a 2 minute HRR <22 beats/min provided a better cut-point than one minue HRR <13 beats/min in predicting mortality at 7 years in male veterans. Individuals underwent maximal treadmill followed by lying down and those with an abnormal HRR were 2.6 times more likely to die. The HRR was equivalent to age and exercise capacity for predicting death.

Apple Watch and Heart Rate Recovery

It’s not entirely obvious how to view the heart rate recovery data on your Apple Watch but it is routinely logged if you record an activity and end it precisely at the end of the activity.  To see it you must leave the activity app and open the Heart Rate APP.

Scroll to the bottom of the screen and you will see HR data on your most recent activity including the peak HR and one minute recovery heart rate.

Click on that tab and the full and awe-inspiring graph of your recovery heart rate over 3 minutes is revealed. Here is mine which followed a 1.5 mile run at 6-7 MPH. I did not walk at 1.5 MPH on a 2.5% grade in recovery which would be needed if one wanted to more carefully compare a personal HRR to the numbers from the 1999 NEJM study.

My data shows a peak HR of 121 BPM which dropped to 90 BPM at one minute (121-90=31). Two minute recovery is 121-78 or 43 bpm. Both values are WNL

 

IMG_2A2C306430A7-1

The Watch only stores data on your last workout but if you go to the Activity app on your iPhone (something I had never previously done)  you will find under the workouts tab a complete listing of all previous workouts.

 

 

 

 

Click on the workout of interest and all the data from the workout is wondrously revealed including cadence, pace and  near the bottom heart rate changes. Swipe the heart rate changes during exercise to the left and the heart rate recovery graph is revealed. This time you will have to do the subtraction for yourself

Heart Rate Recovery-Simple, Powerful And Intuitive Measure of Autonomic Tone

So there you have it. Heart Rate Recovery (unlike HRV) is a simple parameter, easy to understand and measure. It yields information on your vagal/parasympathetic tone and has been proven to be a powerful and independent predictor of your overall mortality.

It makes more sense to pay attention to HRR if one wants a measure of your body’s autonomic tone than HRV.

If your one minute HRR is <13 beats per minute or two minute HRR <22 beats per minute this is a bad prognostic sign. If you have not been diagnosed with significant cardiovascular disease consider seeing a physician for evaluation..

For those who have been sedentary and are deconditioned or overweight, consider an abnormal HRR as a wake-up call to modify your lifestyle and improve your mortality.

For  healthy, asymptomatic individuals the HRR can serve as a marker for your overall cardiovascular fitness. Monitor it along with your exercise capacity, peak heart rate and resting heart rate to raise your awareness of how your exercise is influencing your overall autonomic nervous system balance.

Autonomously Yours,

-ACP

Taking Blood Pressure Medication At Bedtime Lowers Risk Of Death, Stroke And Heart Attack

When should you take your once daily BP meds?

Increasingly, the skeptical cardiologist has been recommending to patients that they take BP meds at bedtime as evidence has mounted  that this does a better job of normalizing asleep blood pressure and minimizing daytime side effects.

Now a study published in European Heart Journal in October has demonstrated that routine ingestion of BP meds at bedtime as opposed to waking results in improved 24 hour BP control with enhanced decrease in asleep BP and increased sleep-time relative BP decline (known as BP dipping.)

More importantly, bedtime BP med ingestion in this randomized trial of over 19 thousand hypertensive Spaniards resulted in highly significant reductions in cardiovascular events including death, heart attack, heart failure and stroke over a 6 year median follow-up

The so-called Hygia Chronotherapy Trial was extremely well done and the results are powerful and should modify clinical practice immediately.

This figure demonstrates the dramatic and highly significant 45% reduction in all types of cardiovascular events measured. Note that stroke rate was halved!

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Here are the Kaplan-Meier curves showing early and progressive separation of the treatment curves.

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There was no difference side effects or compliance between the two groups.

The remarkable aspect of this intervention is that it costs nothing, introduces no new medications and has no increased side effects.

This study is practice-changing for me. We will be advising all hypertensive patients to take their once daily BP meds at bedtime.

Chronotherapically Yours,

-ACP

h/t Reader Lee Sacry for bringing this study to my attention

 

 

The Skeptical Cardiologist’s 2019 Guide to Self-Monitoring Hypertension (High Blood Pressure)

Because uncontrolled high blood pressure (hypertension) is a well documented risk factor for stroke, heart attack and heart failure I discuss it a lot on this site and with my patients.

I just updated my page on hypertension which summarizes my thoughts and recommendations on home BP self-monitoring along with the latest on the optimal BP goal.

What To Monitor and How To Measure

I primarily makes decisions on blood pressure treatment these days based on patient self-monitoring. I discuss this in detail in a post entitled  (Why I Encourage Self-Monitoring Of Blood Pressure In My Patients With High Blood Pressure.)

I have found self-monitoring of patient’s BP to substantially enhance patient engagement in the process. Self-monitoring patients are more empowered to understand the lifestyle factors which influence their BP and make positive changes.

Blood pressures are amazingly dynamic and as patient’s gain understanding of what influences their BP they are going to be able to take control of it.

If high readings are obtained in the office I instruct patients to use an automatic BP cuff at home and make a measurement when they first get up and again 12 hours later. After two weeks they report the values to me (preferably through the electronic patient portal or by Kardia Pro.)

I discuss in detail the recommended technique for BP measurementin my 2018 post entitled  “Optimal Home Blood Pressure Monitoring: Must The Legs Be Uncrossed and The Feet Flat?

The 2018 ACC/AHA guidelines on hypertension  specify in detail how to optimally make home BP measurements as follows:

• Remain still:

• Avoid smoking, caffeinated beverages, or exercise within 30 min before BP measurements.

• Ensure ≥5 min of quiet rest before BP measurements.

• Sit with back straight and supported (on a straight-backed dining chair, for example, rather than a sofa).

• Sit with feet flat on the floor and legs uncrossed.

• Keep arm supported on a flat surface (such as a table), with the upper arm at heart level.

• Bottom of the cuff should be placed directly above the antecubital fossa (bend of the elbow).

• Take at least 2 readings 1 min apart in morning before taking medications and in evening before supper. Optimally, measure and record BP daily. Ideally, obtain weekly BP readings beginning 2 weeks after a change in the treatment regimen and during the week before a clinic visit.

• Record all readings accurately:

• Monitors with built-in memory should be brought to all clinic appointments.

And, spoiler alert, it does matter if you cross or uncross your legs.

What Should The BP Goal Be?

For many patients with hypertension, SPRINT trial data published in 2015 suggest that a systolic blood pressure target of <120 mm Hg (intensive therapy) is preferable to a target of <140 mm Hg.

The SPRINT trial found that cardiovascular events like stroke and heart attack and death from these cardiovascular causes was lower by 25% in those patients treated intensively.  Overall death was lower by 27%

Read my post on SPRINT here and have a discussion with your physician about whether these more stringent BP goals are right for you. Keep in mind that the technique used in SPRINT likely gives us lower BP than home self-monitoring.

I discuss recent European and American BP guidelines which came to different BP goals after SPRINT in a post entitled “Becoming Enlightened About More Stringent Blood Pressure Goals: Sapere Aude”.

“As a 64 year old who has emerged from his nonage with hypertension, I have carefully examined the latest American hypertension guidelines especially in light of the SPRINT study and elected to add a third anti-hypertensive agent to get my average BP below 130/80. It’s worked for me with minimal  side effects but I carefully monitor my BP.

If I notice any symptoms (light-headed, fatigued) suggesting hypotension associated with systolic BP <120 mm Hg I tweak my medical regimen to allow a higher BP.

Like all of my patients I would prefer to be on less medications, not more but when it comes to enlightenment about the effects of hypertension, it is now clear that lower is better for most of us in our sixties down to at least 130/80*

Home Blood Pressure Monitoring Devices

You can get a good validated automatic BP monitor at Walgreens or CVS for around 35-40$.

But if you want to spend a little more you can get  BP devices which have added features such as style, portability, BlueTooth communication with smartphone apps and perhaps most importantly connection through the cloud with your physician.

My favorite BP cuff used to be the QardioArm (QardioArm: Stylish, Accurate and Portable. Is It the iPhone of Home Blood Pressure Monitors?)

I still love the QardioArm but lately I’ve been recommending the Omron Evolv for my patients who need monitoring as their recordings can be connected with me through Omron/Alivecor’s smartphone app:

The Omron Evolv One-Piece Blood Pressure Monitor: Accurate, Quick And Connected

For my patients using Omron Bluetooth BP monitors plus Alivecor’s Kardia Mobile ECG and the KardiaPro cloud connection I can view their rhythm and blood pressure at any time and analyze summary data via my patient dashboard as below.Finally, be aware that scam methods of BP measurement are being promoted to the public.

I wrote about one such  smartphone app called “Instant blood pressure”

Sphygmomanometrically Yours,

-ACP

Should You Choose The High-Dose Flu Vaccine?

Between patients last week the skeptical cardiologist skipped over to the employee health office at St. Luke’s and requested he be given a flu shot.

To my surprise, I was given a choice between a “high dose” flu shot which was “recommended for individuals 65 and older” and the regular quadrivalent flu vaccine.

I hadn’t been aware of this “high dose” flu shot previously thus had not had a chance to research it.  My time was limited and I decided to go with the high dose flu vaccine hoping that high dose did not also mean more chance for side effects.

Fortunately, I had no side effects and thus far have not contracted the flu.

Influenza More Deadly In Elderly But Vaccine Less Effective

Influenza, of course, is a huge killer which causes around 36,000 deaths per year in the United States. We adults 65 and older particularly vulnerable to complications of influenza and we are the ones that account for most of the more than 200,000 hospitalizations per year from the disease.

Hospital cardiology consultations typically spike during flu season as a bad case can worsen heart failure or trigger heart attacks and arrhythmias.

Although vaccination is the most effective intervention against influenza and associated complications, older individuals mount a lower antibody response to the vaccine compared to younger individuals.

Fluzone HD: High Dose Antigen Which Increases Antibody Reponse

To improve protect strategies to improve antibody responses to influenza vaccine in the older population, such as increasing the amount of antigen in the vaccine have been developed.

The vaccine I received is called Fluzone HD and is manufactured by the French pharmaceutical company Sanofi. It is a high-dose, trivalent, inactivated influenza vaccine (IIV3-HD) and contains four times as much hemagglutinin (HA) as is contained in standard-dose vaccines.

AFter studies demonstrating an acceptable safety profile and superior immunogenicity as compared with a standard-dose vaccine, IIV3-HD was licensed for use in the United States in December 2009,

Studies Show Improved Relative Efficacy Of Fluzone Compared to Standard Dose Flu Vaccine

A study published NEJM in 2014 proved the clinical superiority of Fluzone. It has a relative efficacy compared to standard vaccines of around 24%.

The CDC summarizes it as follows

Fluzone High-Dose (HD-IIV3) met prespecified criteria for superior efficacy against laboratory-confirmed influenza to that of SD-IIV3 in a randomized trial conducted over two seasons among 31,989 persons aged ≥65 years, and might provide better protection than SD-IIV3 for this age group . For the primary outcome (prevention of laboratory-confirmed influenza caused by any viral type or subtype and associated with protocol-defined ILI), relative efficacy of HD-IIV3 compared with SD-IIV3 was 24.2% (95% CI = 9.7–36.5%).

Subsequent studies have provided further support for the improved efficacy of Fluzone according to the CDC:

These findings are further supported by results from retrospective studies of Centers for Medicare and Medicaid Services (CMS) and Veterans Administration data, as well as a cluster-randomized trial of HD-IIV3 versus SD-IIV among older adults in nursing homes  A meta-analysis reported that HD-IIV3 provided better protection than SD-IIV3 against ILI (relative VE = 19.5%; 95% CI = 8.6–29.0%); all-cause hospitalizations (relative VE = 9.1%; 95% CI = 2.4–15.3); and hospitalizations due to influenza (relative VE = 17.8%; 95% CI = 8.1–26.5), pneumonia (relative VE = 24.3%; 95% CI = 13.9–33.4), and cardiorespiratory events (relative VE = 18.2%; 95% CI = 6.8–28.1)

Should You Choose Fluzone?

Most likely, now that I have had a chance to look in detail at the studies supporting Fluzone HD for the elderly and review the CDC recommendations, I would choose it for myself for  vaccination this year.

This is not a slam dunk decision and the CDC is actually quite wishy washy in its recommendations basically saying any formulation of vaccine is OK with them

For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV4 are acceptable options.

As the CDC points out, we need more studies comparing these different flu vaccines to help guide decision-making.

Skeptically Yours,

-ACP

Addendum. Dr. Chelsea Pearson, the prominent St. Louis internist,tells me she recommends Fluzone or Flublok to her patients 65 or older.

Flublok is a quadrivalent recombinant vaccine of standard dosage.

A head to head comparison of these two vaccines would be nice to help patients and physicians decide which to take.

Cost was not an issue in my decision but a year ago Canadian health officials felt the five-fold greater cost of flu zone HD was not warranted (see here.)

N.B. Be aware there is a quadrivalent flu vaccine from Sanofi also called fluzone.  From the FDA:

Tradename: Fluzone, Fluzone High-Dose and Fluzone Intradermal
Manufacturer: Sanofi Pasteur, Inc (for Fluzone High-Dose and Fluzone Intradermal only)
Indication:

  • Fluzone is indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
  • Fluzone High-Dose is indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
  • Fluzone Intradermal indicated for active immunization for use in adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

 

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

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