Category Archives: Medical/Fitness Devices

An In-depth, Objective Comparison of Mobile ECG Devices: Emay versus Kardia

The skeptical cardiologist has been a huge advocate of personal mobile ECG monitoring to empower patient’s in understanding/monitoring their heart rhythm.

The deserved leaders in this field are the Apple Watch (4 and later) and Alivecor’s Kardia device which comes in single-lead and six-lead flavors.

Both Apple and AliveCor have gotten FDA approval for their mobile ECG device and have a body of published studies supporting their accuracy.

In contrast, there are a number of “copy-cat” mobile ECG devices which have been feeding on the success of Apple Watch and Kardia but do not have the bona fides the two leaders have.

I reviewed the SonoHealth ECG here and found it sorely lacking in comparison to Kardia in terms of accuracy of diagnosis and quality of recordings, the two most important aspects of a personal ECG monitor.

Dan Field, a physician  and reader of my blog, has been evaluating a device similar to the SonoHealth ECG made by Emay.

He has provided a point by point comparison of the two  devices in the chart below

Emay versus Kardia

His summary:

“The Kardia6L was clearly superior in almost every way except for price and even that was within the margin of error. ”

It should be noted that the single lead Kardia mobile ECG is actually cheaper than the Emay and retails for $99.

Let The (Mobile ECG) Buyer Beware

I ended my post reviewing SonoHealth’s ECG with a warning which applies equally to the Emay device:

The SonoHealth EKGraph is capable of making a reasonable quality single lead ECG. Presumably all the other devices utilizing the same hardware will work as well.

However, the utility of these devices for consumers and patients lies in the ability of the software algorithms to provide accurate diagnoses of the cardiac rhythm.

Apple Watch 4 and AliveCor’s Kardia mobile ECG do a very good job of sorting out atrial fibrillation from normal rhythm but the SonoHealth EKGraph does a horrible job and should not be relied on for this purpose.

The companies making and selling the EKGraph and similar devices have not done the due diligence Apple and AliveCor have done in making sure their mobile ECG devices are accurate.  As far as I can tell this is just an attempt to fool naive patients and consumers by a combination of marketing misinformation and manipulation.

I cannot recommend SonoHealth’s EKGraph or any of the other copycat mobile ECG devices. For a few dollars more consumers can have a proven, reliable mobile ECG device with a solid algorithm for rhythm diagnosis. The monthly subscription fee that AliveCor offers as an option allows permanent storage in the cloud along with the capability to connect via KardiaPro with a physician and is well worth the dollars spent.

Skeptically Yours,

-ACP

 

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.

ap-HG.jpeg

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.

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

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

Atrial Fibrillation Detection, Personal ECG Monitoring and Ablation: A Patient’s Story

One of the joys of writing this blog is the communication it allows me with discerning  individuals and patients across the planet. One such reader, Mark Goldstein, discovered he was in atrial fibrillation after purchasing an Apple Watch 4.

He now utilizes both the Kardia Mobile ECG and the Apple Watch to aid in his personal monitoring of his atrial fibrillation and has been actively pursuing a rhythm control strategy under the care of his electrophysiologist.

I asked him to share with my readers his experience which recently culminated in an ablation.

What follows is his description with my editorial comments in green.


December 2018 I bought a crazy, expensive Apple Watch. That watch may have saved my life. I spend much of my days at a treaddesk (a combination desk and treadmill). I was curious to find out how much exercise I was doing. I bought the watch, put it on, and starting walking as I do almost every day. Two hours later the watch had an alarm. It was warning me about something called “atrial fibrillation,” It said, “your heart has shown signs of an irregular rhythm.” What! I never heard of afib before. I quickly learned about it. Heart palpitations, no. Pain/pressure in the chest, no. Sweaty, faint, dizzy, etc., no, no. no. I checked the box for tired but I assumed it was because of the amount of exercise I was doing.

The next day I was fortunate that I had a physical scheduled a year ago. I told my doctor that my “crazy, expensive watch” thinks I have afib. My doctor laughed, telling me about how he had checked and probed every part of my body for the last 20 years (the probing part I remembered well). As the exam was concluding, he was puzzled by the afib warning so he grabbed my wrist to check my pulse. A few seconds later he was asking the nurse to give me an EKG. Darn, the watch was correct (and for me it was correct 99% of the time when I had afib and when I was normal – praise to Apple).

Recording from Mark’s Apple Watch 4 showing atrial fibrillation with controlled ventricular response. Heart rate is only 82 beats per minute. The AW algorithm correction identifies atrial fibrillation.

(This is a great example of how atrial fibrillation can be missed by the routine office physical examination. Some patients, especially those with non-rapid heart rates (due to rate slowing meds like beta-blockers or to intrinsically  slow conduction of electrical impulses) are minimally symptomatic and their pulses don’t feel that irregular. Because the first symptom of afib can be stroke I am an advocate of screening)

Shortly I got to meet a cardiologist (like Dr. Pearson, they are all nice people). Another EKG, afib confirmed. As we were talking about my symptoms or lack of symptoms, he said that afib was a bit like Eskimo’s describing snow. Each snowflake is unique and each afib patient is unique. I was in persistent afib. Probably had been in this state for two or three years since my heart rate jumped while sleeping, exercising, and at rest.

(Each afib experience is unique but not all cardiologists are nice people. Mark has been fortunate.)

The treatment plan was a cardioversion, an electrical shock to the heart, or as my cardiologist described it “like rebooting a computer.”

(See my post on cardioversion here.)

As a tech person, I understood that. The risk of not fixing my afib was five times the likelihood of a stroke. The risks were minimal so I chose the cardioversion.

(A common misconception is that ablation or cardioversion eliminates or substantially lowers the risk of stroke in afib. This is not the case. I’ll devote a future post to delve into this issue.)

Cardioversion one lasted four days before my Apple Watch started to detect afib.

(I’ve described in detail how helpful patient utilization of personal ECG monitoring is in letting me know the rhythm status of patients prior to and following cardioversion here.)

The cardiologist next step was cardioversion two along with a drug to help with rhythm control. Number two lasted a month before I saw my heart rate jump again. I thought something was wrong even though my watch was not detecting afib. Another EKG, this time the result was aflutter. The cardioversions were indeed like a reboot of the computer. If you have a virus on your computer, a reboot may be a temporary fix but eventually the virus will return.

(There are many drugs whose purpose is to suppress the recurrence of atrial fibrillation. Mark was prescribed the extended release version of propafenone, a Type IC antiarrhythmic drug (AAD)  similar in efficacy and side effects to flecainide. Type IC AADs should only be used in patients with normal left ventricular function (which was demonstrated in Mark by an echo) and without significant coronary artery disease (typically proven by a negative stress test).

To Ablate Or Not To Ablate

Now I got to meet an electrocardiologist. He said my afib would return and recommended an ablation. He said it was unlikely to be a permanent cure but it would help.

The aflutter disappeared after a day or so. I thought my afib was gone too but should I have an ablation? Ablations are relatively safe but since I was afib free why have the procedure?

I purchased the new Kardia Mobile six-lead portable EKG, a miracle of technology. Highly recommended for peace of mind. Just like my watch, I was seeing normal sinus rhythm. So why get an ablation?

A cardiologist had a YouTube video talking about the decision to have an ablation or any medical procedure. How will it affect the quality of your life or the quantity (how long will you live). This was a simple analysis and I like simple. I heard from my cardiologist that the evidence is that an ablation will unlikely extend my life nor will it reduce my lifespan. It was likely to not affect my lifespan. I confirmed this via independent research (be an informed patient, your outcomes will be better). See Dr Pearson’s articles about the CABANA study and the scientific evidence on ablation).  So an ablation and quantity of life were neutral.

Importance Of Quality Of Life

Quality of life was more interesting. Could I do the things wanted to do with my life? Did afib affect my day-to-day life? Could I walk up a couple of flights of stairs without breathing hard? Was I getting tired at 10AM? Could I exercise? At the time, the answer was easy. I could do everything I wanted to do. The afib affect was just about zero except for blood thinner drugs which I suspect I will take forever. No ablation.

Then “the day.” I woke and checked my sleep app on my phone. Heart rate at night jumped. Hmm! I went to the gym. My heart rate while walking jumped too. I did 30 seconds of high-intensity exercise and my heart rate monitor said 205 beats per minute. My heart was beating so hard I had to sit for five minutes. I knew something was wrong. Then I climbed a couple of flights of stairs, something that would never bother me. I felt a shortness of breath. I knew my afib was back. I also knew that the quality of my life was now being affected. I could not do things I wanted to do. My watch and Kardia Mobile EKG confirmed what I knew.

I called my electrocardiologist and scheduled an ablation. He was right. Afib would return.

(Mark tells me that he was taken off his propafenone one month after the second cardioversion because “the PA said I no longer needed it since I was in sinus rhythm.” My practice would have been to continue the propafenone as long as well tolerated and effective in suppressing afib recurrence. In my experience, the recurrence of Mark’s afib may not have been a failure of medical therapy. I treat patients similar to Mark by continuing the anti-arrhythmic drug since the minimal risks are lowered by regular monitoring and I regularly see maintenance of SR.”)

(Other antiarrhythmic medications were mentioned to Mark but as they required a 3 day hospital stay he was not interested.)


Stay tuned: Part two Of Mark’s post will be about the ablation procedure which he recently underwent.

Skeptically Yours,

-ACP

Mark Goldstein works in the field of cybersecurity in the WashingtonDC area and can be contacted at https://www.linkedin.com/in/markhgoldstein/

Which Ambulatory ECG Monitor For Which Patient?

The skeptical cardiologist still feels that KardiaPro has  eliminated  use of long term monitoring devices for most of his afib patients

However not all my afib patients are willing and able to self-monitor their atrial fibrillation using the Alivecor Mobile ECG device. For the Kardia unwilling and  many patients who don’t have afib we are still utilizing lots of long term monitors.

The ambulatory ECG monitoring world is very confusing and ever-changing but I recently came across a nice review of the area in the Cleveland Clinic Journal of Medicine which can be read in its entirety for free here.

This Table summarizes the various options available. I particularly like that they included relative cost. .

The traditional ambulatory ECG device is the “Holter” monitor which is named after its inventor and is relatively inexpensive and worn for 24 to 48 hours.

The variety of available devices are depicted in this nice graphic:

For the last few years we have predominantly been using the two week “patch” type devices in most of our patients who warrant a long term monitor. The Zio is the prototype for this but we are also using the BioTelemetry patch increasingly.

The more expensive mobile cardiac outpatient telemetry (MCOT) devices like the one below from BioTel look a lot like the patches now. The major difference to the patient is that the monitor has to be taken out and recharged every 5 days. In addition, as BioTel techs are reviewing the signal from the device they can notify the patient if the ECG from the patch is inadequate and have them switch to an included lanyard/electrode set-up.

The advantage of the patch monitors is that they are ultraportable, relatively unobtrusive and they monitor continuously with full disclosure.

The patch is applied to the left chest and usually stays there for two weeks (and yes, patients do get to shower during that time) at which time it is mailed back to the company for analysis.

Continuously Monitoring,

-ACP

A Review Of SonoHealth’s EKGraph Portable ECG Monitor: Comparison To Apple Watch ECG And AliveCor’s Kardia ECG

The skeptical cardiologist keeps his eyes open for new, potentially improved ways of personal mobile ECG monitoring and when I saw the following comments on an afib forum I was intrigued:

I recently started using a SonoHealth product that I find MUCH MUCH superior to Kardia..

Really? MUCH MUCH superior? The more someone utilizes all caps
to emphasize theirs points the less I tend to believe them. But, as I am on a mission to discover the truth in all things cardiologic I went to the SonoHealth website and encountered this:

The EKGraph would indeed appear to be MUCH MUCH superior to Kardia mobile ECG if the website marketing can be believed.

Like the Kardia the EKGraph offers a personal ECG monitor obtained using the fingertips and syncing to an app on your smartphone.

The EKGraph claims to have 3 lead capability, something it emphasizes in its marketing but it is only capable of displaying one lead at a time and ,  similar to Kardia one can obtain lead II and precordial ECG leads by putting one electrode on the leg or chest.

Also similar to Kardia, the EKGraph promises “rhythm detection.” As we shall learn, however, rhythm detection by the EKGraph cannot be trusted whereas Kardia has a wealth of published data supporting its accuracy.

Unlike the Kardia, the EKGraph does have a “bright LCD screen” which displays the ECG wave pattern and heart rate along with the heart rhythm diagnosis.

I emailed SonoHealth and they were  kind enough to send me one of their ECG devices to demo. After spending some time with it I can say unequivocally that it should not be purchased or utilized by any patient who wants reliable personal mobile ECG monitoring with accurate diagnoses.

A few days later a package arrived containing the EKGraph in an Applesque box which also contiained a USB charging cable. In addition they included a carrying case and a tube of ECG gel.

 

 

Working With The SonoHealth APP

To make a recording one puts the metal strip on the left side of the device on hand, arm or leg and the other metal strip on the right side of the device on an opposing limb or the chest.

This very happy model gives you a feel for the size of the device and the method of making a Lead I recording.

 

 

 

 

 

 

 

 

It is possible to made a decent single lead ECG tracing with this device and view the tracing on the associated smartphone app. However, the recordings are typically very noisy and full of artifact making it hard to discern the rhythm. The software appears to lack appropriate filtering.

The SonoHealth app is free but getting it registered was a problem. On the company website support area several readers have complained of the same problem over the last few months:

 I am having trouble registering on the phone because when I hit the red button to register, I see the email and username fields at the top of the form, but when I click on email, the info fields jump to name, and I can’t scroll up to access those two fields. I then get a notification that those two fields are required to register. Any suggestions?

There is no response to this issue posted 3 months ago from the company.

Syncing with the app via Blutooth is straightforward. Pressing the sync button transfers all new tracings to the app where they can be reviewed.

Tracings can be emailed or printed.

Rhythm Detection

The major problem with the EKGraph  is that its  ability to diagnose  rhythm  is  very limited. This device has no published data verifying the accuracy of its rhythm diagnoses whereas the Apple Watch 4 and Kardia ECG devices do.  It it is not approved by the FDA.

I used the device on my self and despite identical rhythms the EKGraph called one “tachycardia” and the other “bradycardia.”

I tried using the SonoHealth on patients in my office who were in normal sinus rhythm and received wild, seemingly random diagnoses.

Whatever algorithm the device is using to diagnose rhythm is clearly not making allowances for poor quality recordings.

This patient is in NSR but the EKGraph calls it “tachycardia, VPB bigeminy” mistaking the artifact between the normal QRS beats and ventricular ectopic beats.

Multiple Sketchy Companies Utilizing Similar Hardware

I have noted other mobile ECG device with a remarkably similar appearance to the EKGraph.  A search on Amazon yields AliveCor’s devices and  the SonoHealth Ekgraph . The Amazon comparison page shows 3 additional  EKGraph identical-appearing devices seemingly from 3 different sketchy companies all priced at $79.

A consumer asked SonoHealth about the identical external appearance of SonoHealth’s and EMAY’s devices  and the company’s response was::

As a small new company making a new design for the outside shell didn’t seem viable. A mold from scratch costs anywhere from $65,000-$85,000. So our manufacturer allowed us to use their current mold to make the EKGraph.

So even though the outside is similar the software side is totally different. We have new and improved software. There’s also our own SonoHealth app that we developed from scratch.

SonoHealth is a USA company that provides excellent customer support.

I would disagree with SonoHealth’s assessment-there is nothing to suggest their software is either new or improved or even accurate.

The app that they developed from scratch is clunky and difficult to use.

Ratings and Online Presence of SonoHealth

SonoHealth posts on its website alleged reviews of EKGraph. They are uniformly positive. It’s hard to find anything that isn’t 5/5 stars. Apparently, all the problems I found with the product are unique to me.

However, these reviews should be taken with a grain of salt. A few weeks after acquiring my SonoHealth EKGraph I received an email from the company offering a gift card if I followed their precise instructions in writing a review:

TERMS: In order to receive the $10 giftcard reward you MUST write both a Company and a Product review. We will send each reviewer the egiftcard to the email that they provided when leaving the review. (For verification purposes, the email you enter when leaving the review must match the email associated with your order.)

This manipulation of the review process is shady and calls into question the validity of any review on the company website or Amazon.

Let The (Mobile ECG) Buyer Beware

The SonoHealth EKGraph is capable of making a reasonable quality single lead ECG. Presumably all the other devices utilizing the same hardware will work as well.

However, the utility of these devices for consumers and patients lies in the ability of the software algorithms to provide accurate diagnoses of the cardiac rhythm.

Apple Watch 4 and AliveCor’s Kardia mobile ECG do a very good job of sorting out atrial fibrillation from normal rhythm but the SonoHealth EKGraph does a horrible job and should not be relied on for this purpose.

The companies making and selling the EKGraph and similar devices have not done the due diligence Apple and AliveCor have done in making sure their mobile ECG devices are accurate.  As far as I can tell this is just an attempt to fool naive patients and consumers by a combination of marketing misinformation and manipulation.

I cannot recommend SonoHealth’s EKGraph or any of the other copycat mobile ECG devices. For a few dollars more consumers can have a proven, reliable mobile ECG device with a solid algorithm for rhythm diagnosis. The monthly subscription fee that AliveCor offers as an option allows permanent storage in the cloud along with the capability to connect via KardiaPro with a physician and is well worth the dollars spent.

Skeptically Yours,

-ACP

AliveCor’s KardiaBand Will No Longer Be Sold And Smart Rhythm Is No More

The skeptical cardiologist was quite enthusiastic about AliveCor’s Kardia Band for Apple Watch upon its release late in 2017.

I was able to easily make high fidelity, medical grade ECG recordings with it and its AI  algorithm was highly accurate at identifying atrial fibrillation  (see here). This accuracy was subsequently confirmed by research.

Many skepcard readers spent $200 dollars for the Kardia Band and had found it to be very helpful in the management of their atrial fibrillation.

However, in December of 2018 Apple added ECG recording to its Apple Watch 4, essentially building into the AW4  the features that Kardia Band had offered as an add on to earlier Apple Watch versions.

In my evaluation of the Apple Watch I found it to be “an amazingly easy, convenient and straightforward method for recording a single channel ECG” but its algorithm in comparison to AliveCor’s yielded more uncertain diagnoses.

Given it size, prominence and vast resources, Apple’s very publicized move into this area seemed likely to threaten the viability of AliveCor’s Kardia Band.

But then-interim CEO (and current COO)  Ira Bahr later told MobiHealthNews that his company’s broader business wasn’t threatened by its new direct competitor.

“We’re not convinced that Apple’s excellent, engaging product is a competitor yet,” he said in February. “We believe that from a price perspective, this product is least accessible to the people who need it most. If you’re not an Apple user, you’ve got to buy an Apple Watch, you’ve got to buy an iPhone to make the system work. So their technology is excellent, but we think the platform is both complicated and expensive and certainly not, from a marketing perspective, targeting the patient populations we target.”

Indeed, AliveCor’s Mobile ECG device and its recently released 6 lead ECG are doing very well but the threat to the viability of KardiaBand was real and MobiHealth News announced Aug. 19 that AliveCor had officially ended sales of the Kardia Band.

An AliveCor representative told MobiHealthNews that the company “plans to continue supporting KardiaBand indefinitely” for those who have already purchased the device. The company’s decision was first highlighted by former MobiHealthNews Editor Brian Dolan in an Exits and Outcomes report.

Mr. Bahr has confirmed to me that AliveCor does plan to continue supporting KardiaBand indefinitely. This includes replacement of KardiaBand parts.

Did Apple Kill Smart Rhythm?

The informed reader who notified me of AliveCor’s decision also notes:

The official reason is that they could not keep up with the Apple Watch updates and therefore the Smart Rhythm feature did not work properly.

I think many of us knew from the beginning that smart rhythm was not very accurate But in spite of that the Kardia band provided a valuable convenience over their other products.

It does appear that Smart Rhythm is no more.

AliveCor’s website was updated 6 days ago to state that Smart Rhythm was discontinued:

” due to changes beyond our control in the Apple Watch operating system, which caused SmartRhythm to perform below our quality standards”

Likely, as my reader was told, the frequent  AW4 updates plus the lack of a large KardiaBand user base made it unprofitable for AliveCor to continue to support Smart Rhythm.

Smart Rhythm, of course was AliveCor’s method for watch-based detection of atrial fibrillation. It clearly had limitations, including false positives but given AliveCor’s track record of dedication to high quality and accuracy I assumed it would improve over time..

Apple, on December 6, 2018  with the release of its watchOS 5.1.2 for AW4 announced its own version of Smart Rhythm at the same time it activated the ECG capability of AW4.

Apple called this feature “the irregular rhythm notification feature” and cited support for its accuracy from the widely ballyhooed Apple Heart Study (which I critiqued here.)

The irregular rhythm notification feature (TIRNF)was recently studied in the Apple Heart Study. With over 400,000 participants, the Apple Heart Study was the largest screening study on atrial fibrillation ever conducted, also making it one of the largest cardiovascular trials to date. A subset of the data from the Apple Heart Study was submitted to the FDA to support clearance of the irregular rhythm notification feature. In that sub-study, of the participants that received an irregular rhythm notification on their Apple Watch while simultaneously wearing an ECG patch, 80 percent showed AFib on the ECG patch and 98 percent showed AFib or other clinically relevant arrhythmias.

Despite widely publicized reports of lives being saved by TIRNF we still don’t know whether its benefits outweigh its harms. It is not clear what its sensitivity is for detecting atrial fibrillation and I have reported one patient who was in atrial fibrillation for 3 hours without her AW4 alerting her to its presence.

For AW4 users, absence of an alert should not provide reassurance that your rhythm is normal.

Thus is does appear that the Goliath Apple hath smote the David AliveCor in the watch-based afib battle. This does not bode well for consumers and patients as I think as competition in this area would make for better products and more accountability.

Philorhythmically Yours,

-ACP

N.B.

Per AliveCor the KardiaBand currently works with all all Apple Watches except the original one.

The Apple TIRNF per Apple:

is available for Apple Watch Series 1 and later and requires iPhone 5s or later on iOS 12.1.1 in the US, Puerto Rico, Guam and US Virgin Islands. The irregular rhythm notification feature does not detect a heart attack, blood clots, a stroke or other heart-related conditions including high blood pressure, congestive heart failure, high cholesterol or other forms of arrhythmia.

I Am A Keto-Friendly Cardiologist And I Love Keyto

The skeptical cardiologist has become more selective with regard to who he will accept as a new patient.  In practical terms this means I now call patients who want to see me and discuss with them why they want to see me, how they were referred or heard about me, and what their expectations are.

This might seem a little odd but turns out to be an excellent way for me to meet and smooth entrance for these newbies into my practice and gather important records and recordings prior to the first visit.

Recently, when I asked one of these potential patients why they had sought me as their cardiologist, the wife told me that through her internet research she had gleaned that I was a “Keto-friendly Cardiologist.”

Given that I have challenged conventional dogma on the dangers of dietary saturated fat and cholesterol and have written about ketosis (see here and here) a few times on this blog and defended Dr. Atkins I do actually consider myself “keto-friendly”.   However my prospective patient’s wife was not aware of the skeptical cardiologist as a blog writer.

How or why I was identified as Keto-friendly cardiologist was not clear.

I realized I needed to make it perfectly clear. It is now time to come out of the keto closet.

I am a “Keto-friendly cardiologist”!

I have dozens of patients who have been very successful using very low carb/high fat diets to help them lose weight and gain control of their diabetes and hypertension.

I don’t poo poo low carb high fat diets and I think they are vey compatible with a heart-healthy existence.

(I also advocate my version of a “plant-based diet“.)

In fact, lately I’ve gone back to dabbling with a Keto Diet myself.

To aid me in the dabbling I have found a device called Keyto to be the key to success and understanding of my ketosis.

Keyto: Breath Sensor for Ketosis and Weight Loss

When I went back to dabbling with ketosis in early 2019 I was using the Keto-Mojo finger prick device to measure my blood levels of beta hydroxybutyrate. I liked the precision this offered  compared to urine dip sticks but grew to dislike the need to prick my finger and create blood loss.

About a month ago I ordered I discovered the keto breath sensor KEYTO and have found since then that  it wonderfully simplifies  the process of being on a keto diet.

Keyto costs $99 and comes in a box the size of a video cassette  case.

In the box is the sensor device, four blowing mouthpieces, a very simple user manual, a AAA battery and a cute little bag for carrying the device

Ethan Weiss, MD, a highly respected preventative cardiologist and founder of Keyto includes a welcoming message for users which summarizes the mission of Keyto:

We designed the Keyto program to help you over-achieve your weight loss and health goals. With the Keyto Breath Sensor in this box, and the Keyto App on your phone, you have the key to unlocking success. You’ll be eating delicious foods, losing weight, and many  users even report an increase in energy and focus

Using Keyto Is Simple and Convenient

Getting started with Keyto is very easy: download the Keyto smartphone app, log in and follow the straightforward directions for pairing the breath sensor with the app.

Once paired via Bluetooth making measurements is easy. It’s important to understand the breathing technique needed and to facilitate this I strongly recommend watching the brief explanatory video Weiss has provided. Basically, you want to use a normal breath and blow for 10 seconds so that you are near the end of expiration when the device makes its recording.

To initiate a measurement you push the plus sign on the main “Journey” screen in the app then push the on button on the sensor.

Usually, if the sensor has been turned on and the app is activated the app immediately connects to the sensor, occasionally I have had to turn the sensor off and on again to initiated the connection.

At this point the sensor begins  warming up, reaching a temperature of 400 degrees Fahrenheit over a period of about 80 seconds.

The app displays the progress and offers you the option of answering some questions about how you are feeling and doing on the keto diet.

I often take my BP while this is going on. Sometimes I read the New Yorker. Frequently I listen to Radiohead (Climbing Up The Walls). It takes a while. Pay attention, though. You don’t want to miss your blowing window and have to repeat the process.

 

The app will give you a warning about 10 seconds prior to the time you need to blow. The graph to the right appears when it is time to blow and you can view the sensors output as it tracks the acetone it is seeing over the 10 seconds that you blow.

At the end of the blow you wait a few seconds, eagerly awaiting your score. Will you be in Ketosis?

 

Finally, your score is revealed. In this case I was congratulated for being in light ketosis with a fat burn of “medium high.” The highest score is an 8.

You can add notes to the record of your score

If you blow a 6 the app tells you that your fat burn is high and that you are in ketosis: “metabolizing fat like a champion.”

Accuracy of Keyto

When I first began using Keyto I checked the Keyto numbers versus the beta hydroxybutyrate (BOHB)  numbers I was simultaneously getting from my Keto-Mojo meter.

I found a Keyto 3 corresponded to 0.8 BOHB, a Keyto 4 to 0.9 BOHB, and a 5 to 1.0 BOHB.  That was enough to convince me that the device was accurate and useful in measuring my level of ketosis.

Given that it is so convenient compared to a finger stick I have stopped using the Keto-Mojo completely.

My observations confirm what Weiss and Ray Wu, MD, the cofounders of Keyto describe in very lucid prose here.

In extensive user testing, Keyto is directionally consistent with the more accurate commercially available blood meter. Keyto and blood β-hydroxybutyrate trend directionally the same in the majority of cases. Both go up and down in similar magnitude at different ranges of ketosis. There are some differences which are likely due to biology – the kinetics of clearance of acetone and β-hydroxybutyrate are not identical.

Some of the differences are also likely due to how we designed the Keyto program. Our primary goal was to develop a system that would give users the information they need to know i.e. if they are in ketosis, which would ultimately help promote healthy behavior change. Therefore, we chose not to report acetone concentrations in PPM or to attempt to convert PPM to blood β-hydroxybutyrate (mmol/L). The Keyto Level system was simply more effective, motivating, and fun without adding complexity and false precision.

I can make multiple measurements throughout the day without worrying about the cost or the discomfort of a finger stick. The ability to make multiple measurements means that I am getting very rapid and frequent feed back on how my dietary and lifestyle choices are effecting my level of ketosis.

Warning! Because the device is so convenient-literally you can have it with you at all times-you may find yourself blowing into it excessively. This may irritate your friends and loved ones, especially those that aren’t on a keto diet.

Keyto is Legitimate

The Keyto website has an excellent introduction to the keto diet (keto 101) and has numerous other very helpful resources for those who seek to lose weight using the diet.

In general I get a good feeling of integrity and legitimacy from every aspect of the Keyto operation.

I have a tremendous professional respect for Ethan Weiss, the cardiologist behind Keyto. He’s very active on Twitter and is typically spot on with his comments. He’s done a podcast with Peter Attia which serves as an excellent summary of atherosclerosis and coronary artery disease. He does really good basic science research involving growth hormone.

Weiss is now doing his own podcast called Best Known Method by Keyto which I highly recommend. It is not, surprisingly, focused on the keto diet or the keyto brand but interviews thought leaders in cardiology like Ron Krauss and Lisa Rosenbaum.

If you want to read more about how the Keyto breath sensor works see here. This is a very clear and concise description of the science behind the device and it is complete with references.

Ultimately, although I consider myself a keto-friendly cardiologist, I’m most interested in the diet that helps my patients achieve  and sustain their goals of weight loss and better health. For many this is the keto diet.

And for those who find the keto diet is optimal for their health I will be advising them to acquire a Keyto breath sensor and check out the programs Keyto offers to support their health goals.

Acetonely Yours,

-ACP

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

When it comes to self-monitoring of blood pressure the best device (assuming equivalent accuracy) is the one that patients are most likely to use.

The Omron Evolv has become that device for the skeptical cardiologist as it combines a unique one-piece design with built in read-out with a quicker, more comfortable  yet highly accurate BP measurement technique.

My previous favorite BP device, the QardioArm remains a close second.

Evolv Form and Function

The Evolv is sleek and stylish in appearance and has no external tubes, wires or connectors. It runs on 4 AAA batteries.

 

 

The  cuff is pre-formed and is incredibly easy to self-administer to the upper arm. Measurement is simple. Press the start button and it immediately starts inflating the cuff.

The results are displayed on an LCD screen on the cuff.

The Omron uses an oscillometric technique to measure the blood pressure as it is inflating. This “inflationary” technique has been shown to be as accurate as measuring during deflation but is much quicker. A study using the recently developed “Universal Standard Protocol” for evaluating the accuracy of BP devices showed that the Omron Evolv was highly accurate compared to gold standard sphygmomanometry.

Omron has come up with some slick marketing terms for the inflationary and pre-formed wrap aspects:

  • Intellisense Technology – Inflates the cuff to the ideal level for each use.
  • Intelli Wrap Cuff – For an easy and accurate reading

With the inflationary technique the cuff knows when to stop inflating, (hence “intellisense”) therefore, there is less tendency to go to higher pressures compared to the deflationary technique and less potential for discomfort from those higher pressures.

Evolv Communication-Sharing Results

The Evolv communicates via Bluetooth with the Omron Wellness (or Connect) smartphone app. Your BP  and heart rate measurements are easily transferred to this app and can be viewed over time.

My blood pressure and heart rate measurements over the last week.

If  one clicks on the little export icon at the upper right had corner of this summary screen you can “export CSV” which creates a file of BP measurements over a defined period that can then be emailed to yourself, your curious friends, or your doctor.

Another option is to export the summary report but this is a premium feature and requires payment.

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Monitoring Heart Rhythm and Blood Pressure-The Omron/Kardia Pro Connection

I’ve discussed in detail how management of my afib patients who have the Kardia mobile ECG device and connect to me via the internet using KardiaPro Remote has tremendously advanced their care.

AliveCor has partnered with Omron and the Omron Connect (or Wellness) app is essentially the Kardia app which my patients utilize to record their ECG recordings and share them with me.

With this app, therefore, patients who have the connection subscription service can utilize the Omron app to share both their ECG and BP recordings with me online. This is really quite an amazing development.

Below are recordings from one of my patients that I took from the patient screen which I view online.

The data can be viewed in various formats including this one which gives a good idea of daytime variation in BP as well as percentage recordings in goal range.

 

For me, this ability to rapidly view patient’s blood pressures over time in meaningful ways greatly facilitates management. If we could find a way to seamlessly import these data directly into our EMR it would an even bigger step forward.

Speaking To Your BP Cuff

I don’t use Alexa but Omron highlights how the Evolv works with Alexa:

 

 

Somehow, this doesn’t seem helpful to me but I tried asking Siri (with both my Apple Watch and iPhone) if she could give me info on my blood pressure and she failed miserably

 

 

 

 

 

 

 

Evolv-The Future of BP Management?

To summarize why I am so enthusiastic about this BP cuff

  • Portability and compactness. One piece design without tubes or wires.
  • Rigorously proven accuracy
  • Esthetically pleasing
  • Quicker and more comfortable than “deflationary” cuffs
  • Read-out on cuff-no separate unit or smartphone required
  • Communicates well with highly functional app for organizing or reporting BP measurements over time
  • Coordination of ECG measurements from Kardia and BP measurements on app through KardiaPro facilitates physician management of patient’s cardiovascular conditions.

Oscillometrically Yours,

-ACP

N.B. In the course of researching the Omron Evolv I looked at multiple home BP monitor review websites online. Almost without exception these were worthless.  I suspect many of these device review sites are funded by companies making the products. Others just aggregate information from company websites and regurgitate it without analysis. Websites with apparent consumer reviews are also suspect as I have found unscrupulous vendors are manipulating the whole review process.

Fortunately, your trusty skeptical cardiologist remains unsullied by any financial connections to corporate America. Or corporate Japan for that matter  (It appears Omron has its headquarters in Kyoto, Japan). However, Omron, if you are listening perhaps you can send me for my review one of your new Complete combined BP and EKG monitoring devices!

 

 

 

 

And one final detail. I checked just now and you can purchase the Evolv at Amazon for $69. Bundles that connect you to your doctor through the cloud and get you an Evolv plus or minus the Kardia ECG device at a reduced price are available through both the Kardia and Omron websites and apps.