As I pointed out Friday, Apple’s claim that the ECG sensor on their new Apple Watch 4 (available “later this year”) is “the First ECG product offered over the counter directly to consumers” is totally bogus.
AliveCor’s Kardia mobile ECG device was approved by the FDA for over the counter direct to consumer sales on February 10, 2014. Apple had to have known this as they worked with AliveCor to bring the first Apple Watch based ECG device to FDA approval in 2017.
I tried but failed to get AliveCor founder Dr. David Albert’s thoughts on Apple’s disinformation but Yahoo finance was able to speak to Vic Gundotra, the CEO of AliveCor:
Over at the headquarters of AliveCor, a startup based in Google’s hometown of Mountain View, they, too, were surprised by the announcement, CEO Vic Gundotra said in a phone interview on Thursday. Gundotra is a former Googler, widely known as the executive behind the Google+ social network.
Gundotra was also surprised by Apple’s claims of ECG primacy
“We were watching [the announcement], and we were surprised,” Gundotra said. “It was amazing, it was like us being on stage, with the thing we’ve been doing for 7 years,” referring to AliveCor’s product for detecting atrial fibrillation (AFib), a tough-to-spot heart disorder that manifests as an irregular, often quick heart rate that can cause poor circulation.
“Although when they said they were first to go over-the-counter, we were surprised,” he continued. “Apple doesn’t like to admit they copy anyone, even in the smallest things. Their own version of alternative facts.”
One man’s alternative fact is another (less polite) man’s lie.
Gundotra apparently views Apple’s entry as a good thing
“We love that Apple is validating AFib; just wait until you see what AliveCor is going to do next,” he said. “We were a great restaurant in a remote section of town, and someone just opened a giant restaurant right next to us, bringing a lot more attention.”
And as I pointed out previously, the AliveCor mobile ECG device (not the Kardia Band) is significantly cheaper than an Apple Watch and has multiple studies showing its accuracy. Interestingly, Gundotra indicates AliveCor sales has increased after the Apple announcement,.
“Ours is $99, theirs is $399, our sales popped yesterday, big time,”
On February 10, 2014 AliveCor, Inc. announced that its heavily validated personalmobile ECG monitor had received FDA over-the counter clearance. Previously the device, which allows recording of a single-lead ECG and, in conjunction with a free smart-phone app, can diagnose atrial fibrillation was only available by prescription.
Since 2013, I have been successfully using this device with my patients who have atrial fibrillation (and writing about it extensively)
I was shocked, therefore, to hear the COO of Apple, Jeff Williams, announce that Apple will be offering in its new Apple Watch 4 “the first ECG product offered over the counter directly to consumers.”
This seemed blatantly inaccurate as AliveCor’s device clearly preceded by 4 years Apple’s claim.
Furthermore, AliveCor’s Kardia Band which converts any Apple Watch into a single-lead ECG (which I’ve written about here and here) has been available and providing the Apple Watch-based ECGs since November 30, 2017.
AliveCor has an outstanding website which documents in detail all the research studies done on their products (there are dozens and dozens of linked papers) and all of their press releases dating back to 2012. It also explains in detail how the product works.
AliveCor shortly thereafter (December 12, 2017) announced Smart Rhythm , an Apple Watch app that monitors your rhythm and alerts you if it thinks you are in atrial fibrillation. I’ve discussed Smart Rhythm here.
The new Apple Watch’s rhythm monitoring app sounds a lot like Smart Rhythm but without any of the documentation AliveCor has provided.
So, within 10 months of Alivecor providing the world with the first ever wearable ECG (and proven its accuracy in afib) Apple seems to have come out with a remarkably similar product.
The major difference between Apple and AliveCor is the total lack of any reviewable data on the accuracy of the Apple device. Yes, that’s right Apple has provided no studies and no data and we have no idea how accurate its ECG device is (or its monitoring algorithm).
For all we know, it could diagnose sinus rhythm with frequent APCS or PVCs consistently as atrial fibrillation, sending thousands of Watch 4 wearers into a panic and overloading the health care system with meaningless alerts.
Apple’s website claims
Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram. It’s a momentous achievement for a wearable device that can provide critical real-time data for doctors and peace of mind for you.
Apple’s “momentous achievement” was actually achieved 10 months earlier by AliveCor and if its monitoring algorithm and ECG system are significantly worse than the proven AliveCor system they will be destroying the peace of mind of users.
After describing the Apple Watch’s new health features, Jeff Williams introduced Ivor Benjamin, MD, the President of the American Heart Association. Benjamin proceeded to describe the new Apple Watch cardiac features as “game-changing”, noting that the AHA is committed to helping patients be “proactive.”
Does Benjamin have access to the accuracy of the Apple Watch ECG sensor? If so, he and the AHA should immediately share it with the scientific community. If not, by endorsing this feature of the Watch he should be ashamed. Users need to know if he or the AHA was paid any money for this appearance. Also, we should demand to know if (as the prominent AHA logo suggested and news reports implied) the AHA is somehow endorsing the Apple Watch.
Frequent readers know I’m a huge Apple fan but this Apple Watch business makes me think something is rotten in the state of Apple.
Sometimes AliveCor’s Mobile ECG device yields unclassified interpretations of recordings. Understandably if you want to know whether your rhythm is normal or atrial fibrillation, the unclassified classification can be very frustrating.
There are various caues of an unclassified tracing with different solutions. Some unclassified recordings are due to a heart rate over 100 BPM or under 50 BPM and cannot be fixed. Similarly, some patients with ectopic beats like PVCS may consistently generate unclassified interpretations (see my discussion here).
Artifacts induced by poor recording techniques are common as a cause and almost always can be fixed.
These can be reduced by minimizing motion, extraneous noise, and maximizing contact with the electrodes. Follow all the steps AliveCor lists here.
For me, the following step is crucial
If your fingers are dry, try moistening them with antibacterial wipes or a bit of lotion
And be aware the device needs to be near the microphone of your iPad or smartphone.
Low Voltage As Cause of Unclassified Kardia Recordings
Another cause of unclassified interpretations is a low voltage recording (which I initially discussed here.).
At the recent ACC meeting I asked Alivecor inventor and CEO David Albert if he had any solutions to offer for those who obtain unclassified low voltage AliveCor tracings.
He told me that the cause is often a vertically oriented heart and that recording using the lead II technique can often solve the problem.
Lead II involves putting one electrode on your left knee and one your right fingers as described in this video:
Reader “J” recently sent me a series of Kardia ECG recordings, some of which were unclassified , some normal and one read as possible atrial fibrillation.
The unclassified and possible AF tracings looked like this:
They were very regular with a rate between 80 and 100 BPM but they totally lacked p waves. It was not clear to me what the rhythm was on these tracings.
Other tracings had lowish voltage but the p waves were clearly visible and Kardia easily classified them as normal
Still others had improved QRS voltage with clear p waves and were also classified appropriately as normal
After some back and forth emails we discovered that the ECG recordings with no p waves were always made using the chest lead recording. AliveCor-describes this as follows:
For an Anterior Precordial Lead, the device can be placed on the lower left side of the chest, just below the pectoral muscle. The bottom of the smartphone or tablet should be pointing towards the center of the body.
There is an abnormal cardiac rhythm that is regular between 80 and 100 BPM with no p waves and normal QRS called junctional tachycardia but in J’s case the absent p waves are related to the recording site.
Also, note that for this young woman the lead II voltage (Type B tracing) is much higher than the standard, lead I voltage (type A tracing).
Lead II With Pants On
After Dr. Albert told me of the advantages of Lead II I responded that it seemed somewhat awkward to take one’s pants off in order to make an ECG recording.
He immediately reached in his suit pocket and pulled out a pen-shaped device and began spraying a liquid on his left knee.
To my surprise he was able to make a perfect Lead II recording without taking his pants off!
Lessons learned from reader J and Dr. A:
Consider trying different leads if the standard Lead I (left hand, right hand) is consistently yielding unclassified ECG recordings
Try Lead II (left knee, right hand) to improve voltage and recording quality
You can record off your knee even with your pants on if you are prepared to spray liquids on your pants
The KardiaBand for Apple Watch from AliveCor has delivered on its unique promise of a medical grade single lead ECG recording made by placing your thumb on your wristwatch band.
The ECG recordings are equivalent in quality to those made by their previously available KardiaMobile (see my prior post here.) After more experience with the Band I think the ease of recording is superior to KardiaMobile and the ability to discriminate atrial fibrillation from normal sinus rhythm is similar to KardiaMobile.
By combining either a KardiaBand or a KardiaMobile device with Kardia’s SmartRhythm monitoring system for Apple Watch we now have the promise of personal monitoring to detect atrial fibrillation.
What is SmartRhythm?
SmartRhythm is AliveCor’s term for its system for monitoring your heart rate and activity levels in order to identify when your rhythm is abnormal.
The system “takes your heart rate and activity data gathered from the Apple Watch and evaluates it using a deep neural network to predict your heart rate pattern.”
The heart rate is obtained from the Apple Watch PPG sensor every 5 seconds. If it differs from what is predicted SmartRhythm notifies you to record an ECG.
If you’d like to learn more detail about the development of SmartRhythm and how it functions, AliveCor has an excellent informational piece here.
You can choose to have the Kardia SmartRhythm display come up whenever your Apple Watch awakens. It’s got information on your heart rate and activity over the preceding several hours
The AliveCor FAQ on SmartRhythm stresses that a notification does not always mean an abnormal rhythm. Clearly false positives can and will occur. The first day I wore my KardiaBand I had several of these.
Causes for false positives include exercise that Apple Watch couldn’t detect, stress or anxiety-in other words, situations where your heart rate is higher than predicted by how much activity you are doing.
The long term record of your SmartRhythm recordings resides on your iPhone . Here’s my record for the last week
Note that Kardia , in addition to tracking your heart rate, also shows you by the green, yellow and orange dots, the times that ECG recordings were made.
Green dots indicate recordings classified as normal and yellow as “unclassified.” In my case most of the unclassified recordings were due to heart rate >100 BPM associated with exercise.
There is one orange dot indicating that Kardia felt the ECG showed “possible atrial fibrillation.”
This happened when I took my Apple Watch off my wrist and put it on one of my patients who has permanent atrial fibrillation. I had him push on the KardiaBand sensor to make an ECG recording and it was correctly identified as atrial fibrillation.
Thus far I have had no notifications of “possible atrial fibrillation” while I have been wearing my watch thus the false positive rate appears acceptably low.
How Does SmartRhythm Perform During Exercise?
I checked out SmartRhythm’s ability to predict normal and abnormal heart patterns by wearing it during a session on my indoor bike trainer. The device did a good job of tracking both my heart rate and activity during the workout. You can view the most recent data by viewing your Apple Watch screen during the workout as below
Or for more detailed information you can view the complete history on your iPhone as below
The system accurately tracked my heart rate and activity (although AliveCor lists stationary bike as an activity that may result in false positives). During a session of weights after the aerobic workout despite erratic heart rates and arm movements it did not notify me of an abnormality. I also did 100 jumping jacks (which involves wildly flailing my arms) and the heart rate remained within the predicted boundaries.
What is more remarkable is that I was able while cycling at peak activity to make a very good quality ECG recording by taking my right hand off the handle bar and pushing my thumb down on the KardiaBand sensor on my left wrist.
This recording clearly displays p waves and is sinus tachycardia. It’s unclassified by Kardia because the rate is >100 BPM.
Afib Patient Experience
One of my patients last week, a 70 year old woman with paroxysmal atrial fibrillation, had already set up SmartRhythm monitoring on her Apple Watch.
I have this patient like many of my afibbers utilizing KardiaMobile to check an ECG when they think they are in afib.
However, she, like many of my afib patients, is totally unaware when her heart is out of rhythm. Such asymptomatic patients are alerted to the fact that they are in afib by detection of a rapid heart rate (from a heart rate tracking wearable or BP monitor) or an irregular heart beat (from BP monitor or by someone checking the pulse) or by a random recording of an ECG.
She’s started using SmartRhythm in the hopes that it will provide a reliable and early warning of when she goes into atrial fibrillation.
We discussed the possibility of stopping the flecainide she takes to maintain normal rhythm to test the accuracy of the SmartRhythm system for detecting atrial fibrillation in her but decided not to. She’s on an oral anticoagulant and therefore protected from stroke so development of atrial fibrillation will not be dangerous for her.
I eagerly await the first real world, real patient reports of SmartRhythm’s performance in atrial fibrillation detection.
If there are any afibbers out there who have had an episode of atrial fibrillation detected by SmartRhythm please let me know the details.
We need such anecdotes along with controlled trials to determine how useful SmartRhythm will be as a personal wearable system for detection of afib.
N.B. I’ve copied a nice section from AliveCor’s website which describes in detail the difference between measuring heart rate from the PPG sensor that all wearable devices use versus measuring the electrical activity of the heart with an ECG.
To understand how Kardia for Apple Watch works, let’s start by talking about your heart, how the Apple Watch and other wearable devices can measure your heart rate, and how an ECG is different from the information you get from a heart rate sensor alone.
Your heart is a pump. With each beat of your heart, blood is pumped through your arteries and causes them to expand. In the time between beats, your arteries relax again. On the underside of the Apple Watch is a sensor, called a photoplethysmogram (PPG), that uses green and infrared LEDs to shine light onto your skin, and detects the small changes in the amount of light reflected back as your arteries expand and relax with each beat of your heart. Using this sensor, the Apple Watch can tell how fast your heart is beating, and how your heart rate changes over time.
But, your heart rate does not tell everything there is to know about your heart. The PPG sensor on the Apple Watch can only see what happens after each heartbeat, as blood is pumped around your body. It can’t tell you anything about what is making your heart beat, or about what happens inside your heart during each beat. An ECG is very different, and tells you a lot more!
An ECG measures the electrical activity in your heart muscles. It detects the small pulse of electricity from the sinoatrial node (the body’s natural pacemaker, which normally initiates each heartbeat) and the large electrical impulses produced as the lower chambers of the heart (the ventricles) contract and relax. By looking at an ECG, a doctor can discern a wealth of information about the health and activity of your heart muscle, much more than you can tell from your heart rate alone. ECGs are the required gold standard for diagnosis of arrhythmias and many cardiac abnormalities, and can even be used to see evidence of acute heart attacks and even events that have occurred in the past.
Research has shown that taking frequent ECGs increases the likelihood of detecting certain arrhythmias, and decreases the mean time to diagnosis.
The Skeptical Cardiologist is a strong proponent of empowering patients with atrial fibrillation by utilizing personal cardiac rhythm devices such as Afib Alert or AliveCor’s Kardia.
I’ve written about my experiences with the initial versions of the Kardia mobile ECG device and the service it provides here and here.
I have been monitoring dozens of my afib patients using AliveCor’s Physician Dashboard.
Recently AliveCor changed fundamentally the way their app works such that for new users much of the functionality I described in my previous posts now requires subscribing to their Premium service which costs $9.99 per month or $99 per year.
What Has Changed With The Kardia App
The Kardia device which works with both iOs and Android smart
phones is unchanged and still generates a “medical-grade” single lead rhythm strips which appears within the Kardia app.
The app still is reasonably accurate at identifying atrial fibrillation or normal heart rhythms and offers a fee-based service for interpretation of unclassified ECGs.
However, for new purchasers of Kardia, the capability to access, email or print prior ECG recordings has gone away. Prior to March of this year, Kardia users could access prior ECG tracings which were stored in the cloud by touching the “Journal” button on the app. These older tracings could be emailed and they were available through the cloud for a physician like myself to review at any time.
Now new Kardia purchasers will find that when they make an ECG recording they have the option to email a PDF of the ECG but once they hit the DONE button it is gone and is not stored anywhere.
For my patients purchasing after March, 2017 this means that unless they purchase Kardia Premium service I will not be able to view their ECG recordings online.
An AliveCor account executive summarized for me the changes as follows:
We added a significant number of features over the past year and a half, and grandfathered all users on March 16th, 2017. New users now have the option to download and use Kardia for free, but the premium services are $9.99/mo or $99/year. Kardia Premium allows unlimited storage and history of their EKGs, summary reports with longitudinal data, blood pressure monitoring and tracking weight and medication.
Why Journal Functionality Is Important
If you purchased your AliveCor/Kardia device prior to March 16th, 2017 ago the journal functionality still works. Let’s call such customers “Journal Grandfathered”.
This Journal functionality is important in a number of ways:
My Journal Grandfathered patients can bring their phones with them during an office visit and we can review all of their ECG tracings.
Journal gGandfathered Kardia users can email their old tracings to their physicians or to anyone they wish (even the skeptical cardiologist!). They can also print them out and save PDFs of the tracings.
I can view through my online physician account all of my Journal Grandfathered patients. This means any time a patient of mine makes a recording that is unclassified or suggests atrial fibrillation I can be notified and immediately view it online.
This fundamental change took place as AliveCor attempts to convince purchasers of the Kardia device to use their Premium service.
Why AliveCor Changed The Kardia App Function
Dr. David Albert, inventor and cardiologist and the founder of AliveCor was kind enough to talk with me about this change.
He indicates that of the 150,000 AliveCor users, 10,000 are now using the Kardia Premium service. About 20% of new users elect Kardia Premium.
Prior to the change all AliveCor users had their old ECG recordings stored in the cloud in a HIPPA compliant fashion. This free service was costing AliveCor quite a bit and the company felt it was best to switch to a subscription service to provide this secure cloud storage.
With the change to the (relatively inexpensive) subscription service, patients will get additional features. As the AliveCor account executive described:
Kardia Premium allows unlimited storage and history of their EKGs, summary reports with longitudinal data, blood pressure monitoring and tracking weight and medication.
I’ve looked at the Premium service and it seems quite useful when combined with a connected physician utilizing Kardia Pro. I’ll evaluate the Premium service and the physician Kardia Pro service further and write a full post on its features in the near future.
If you are not grandfathered and want to stick with the Basic Kardia service you still have an immensely useful and inexpensive device which allows personal detection of your cardiac rhythm. Just remember to email yourself the ECG recording you just made before you hit DONE.
The skeptical cardiologist has many patients who are successfully using their AliveCor/Kardia devices to monitor for episodes of atrial fibrillation (afib).
However, a significant number of patients who have had atrial fibrillation also have premature beats. Sometimes patients feel these premature beats as a skipping or irregularity of the heart beat. Such palpitations can mimic the feeling patients get when they go into atrial fibrillation.
The ideal personal ECG monitor, therefore, would be able to reliably differentiate afib from premature beats for such patients.
Premature Beats: PVCs and PACs
I’ve discussed premature ventricular contractions (PVCs) here and here. Premature beats can also originate from the upper chambers of the heart or atria.
Such premature atrial contractions (PACs) have generally been considered benign in the past but a recent study showed that frequent (>30 s per hour) PACs or runs of >20 PACs in a row were associated with a doubling of stroke risk.
For patients who experience either PVCs or PACs the AliveCor device is frequently inaccurate.
PACs Misdiagnosed As Atrial Fibrillation
Here is a panel of recordings made by a patient of mine who has had documented episodes of atrial flutter in the past and who monitors his heart rhythm with Alivecor regularly:
Of the ten recordings , four were identified as “possible atrial fibrillation.”
Unfortunately only one of the four “possible atrial fibrillation” recordings has any atrial fibrillation: this one has 7 beats of afib initially then changes to normal sinus rhythm (NSR).
The other 3 recordings identified by AliveCor as afib are actually normal sinus rhythm with premature beats.
In addition, frequently for this patient AliveCor yields an “Unclassified” reading for NSR with PACs as in this ECG:
PVCs Misread As Atrial Fibrillation
I wrote about the first patient I identified in my office who had frequent PVCs which were misdiagnosed by AliveCor as afib here.
Since then, I’ve come across a handful of similar misdiagnoses.
One of my patients began experiences period palpitations 5 years after an ablation for atrial fibrillation. He obtained an AliveCor device to rec ord his rhythm during episodes.
For this patient,, the AliveCor frequently diagnoses “possible atrial fibrillation” but all of his episodes turn out not to be afib. In some cases he is having isolated PVCs:
At other times he has periods of atrial bigeminy which are also called afib by AliveCor. In this tracing he has atrial bigeminy and a PVC.
PVCs Read As Normal
Premature beats sometimes are interpreted by AliveCor as normal. A reader sent me a series of recordings he had made when feeling his typical palpitations. all of which were called normal. Indeed, all of them but one showed NSR. However on the one below the cause of his palpitations can be seen: PVCs.
I obtained the “Normal” tracing below from a patient in my office with a biventricular pacemaker and frequent PVCs who had no symptoms.
PVCs Read As Unclassified
A woman who had undergone an ablation procedure to eliminate her very frequent PVCS began utilizing AliveCor to try to determine if she was having recurrent symptomatic PVCs. She became quite frustrated because AliveCor kept reading her heart rate at 42 BPM and giving her an unclassified reading.
AliveCor is always going to call rhythms (other than afib) unclassified when it counts a heart rate less than 50 BPM or greater than 100 BPM.
In this patient’s case, every other beat was a PVC (red circles). Her PVCs are sufficiently early and with low voltage so the AliveCor algorithm cannot differentiate them from T Waves and only counts the normal sinus beats toward heart rate.
Accurate AliveCor Readings
I should point out that many of my patients get a very reliable assessment from their devices. These tracings from a woman with paroxysmal atrial fibrillation are typical: all the Normal readings are truly normal and all the atrial fibrillation readings are truly atrial fibrillation with heart rates above 100.
The Normal Detector in the AliveECG app notifies you when a recording is “normal”. This means that the heart rate is between 50 and 100 beats per minute, there are no or very few abnormal beats, and the shape, timing and duration of each beat is considered normal.
What qualifies as “very few” abnormal beats is not clear. The manual goes on to state that the AliveCor normal detector has been designed to be conservative with what it detects as normal.
What is clear is that premature beats significantly confuse the AliveCor algorithm. Both PVCs and PACs can create a false positive diagnosis of atrial fibrillation when it is not present.
Consequently, if you have afib and premature beats you cannot be entirely confident that a reading of afib is truly afib. Strongly consider having the tracing reviewed by a cardiologist before concluding that you had afib.
On the other hand if you are experiencing palpitations and make a recording with Alivecor that comes back as normal do not assume that your heart rhythm was totally normal. While highly unlikely to be afib, your palpitations could still be due to PACs or PVCs.
If a patient of mine has an abnormal or questionable AliveCor recording it is currently a very simple process for me to review the recording online through my AliveCor doctor dashboard. The recordings can also be emailed to me.
However, Kardia appears to be trying to move new AliveCor purchasers to a subscription or Premium service. In addition, Kardia keep giving me messages that “the doctor dashboard is going away.”
The skeptical cardiologist has been testing the comparative accuracy of two hand-held mobile ECG devices in his office over the last month. I’ve written extensively about my experience with the AliveCor/Kardia (ACK) device here and here. Most recently I described my experience with the Afib Alert (AA) device here.
Over several days I had my office patients utilize both devices to record their cardiac rhythm and I compared the device diagnosis to the patient’s true cardiac rhythm.
In 14 patients both devices correctly identified normal sinus rhythm. AFA does this by displaying a green check mark , ACK by displaying the actual recording on a smartphone screen along with the word Normal.
The AFA ECG can subsequently uploaded via USB connection to a PC and reviewed in PDF format. The ACK PDF can be viewed instantaneously and saved or emailed as PDF.
Normal by AFA/Unreadable or Unclassified by AliveCor
In 5 patients in normal rhythm (NSR) , AFA correctly identified the rhythm but ACK was either unreadable (3) or unclassified (2). In the not infrequent case of a poor ACK tracing I will spend extra time adjusting the patient’s hand position on the electrodes or stabilizing the hands. With AFA this is rarely necessary.
In this 70 year old man the AFA device recording was very good and the device immediately identified the rhythm as normal.
ACK recording was good quality but its algorithm could not classify the rhythm.
A 68 year old man who had had bypass surgery and aortic valve replacement had a very good quality AFA recording with correct classification as NSR
AliveCor/Kardia recordings on the same patient despite considerable and prolonged efforts to improve the recording were poor and were classified as “unreadable”
There were 3 cases were AFA diagnosed atrial fibrillation (AF) and the rhythm was not AF. These are considered false positives and can lead to unncessary concern when the device is being used by patients at home. In 2 of these ACK was unreadable or unclassified and in one ACK also diagnosed AF.
A 90 year old woman with right bundle branch block (RBBBin NSR was classified by AFA as being in AF.
The ACK algorithm is clearly more conservative than AA. The ACK manual states:
If you have been diagnosed with a condition that affects the shape of your EKG (e.g., intraventricular conduction delay, left or right bundle branch block,Wolff-Parkinson-White Syndrome, etc.), experience a large number of premature ventricular or atrial contractions (PVC and PAC), are experiencing an arrhythmia, or took a poor quality recording it is unlikely that you will be notified that your EKG is normal.
One man’s rhythm confounded both AFA and AC. This gentleman has had atrial flutter in the past and records at home his rhythm daily using his own AliveCor device which he uses in conjunction with an iPad.
During our office visits we review the recordings he has made. He was quite bothered by the fact that he had several that were identified by Alivecor as AF but in fact were normal.
A recording he made on May 2nd at 845 pm was read as unclassified but with a heart rate of 149 BPM. The rhythm is actually atrial flutter with 2:1 block.
Sure enough, when I recorded his rhythm with ACK although NSR (with APCS) it was read as unclassified
AFA classified Lawrence’s rhythm as AF when it was in fact normal sinus with APCs.
One patient a 50 year old woman who has a chronic sinus tachycardia and typically has a heart rate in the 130s, both devices failed.
We could have anticipated that AC would make her unclassified due to a HR over 100 worse than unclassified the tracing obtained on her by AC (on the right)was terrible and unreadable until the last few seconds. On the other hand the AFA tracing was rock solid throughout and clearly shows p waves and a regular tachycardia. For unclear reasons, however the AFA device diagnosed this as AF.
Accuracy in Patients In Atrial Fibrillation
In 2/4 patients with AF, both devices correctly classified the rhythm..
In one patient AFA correctly diagnosed AF whereas ACK called it unclassified.
This patient was in afib with HR over 100. AFA correctly identified it whereas ACK called in unclassified. The AC was noisy in the beginning but towards the end one can clearly diagnose AF
In one 90 year old man AFA could not make the diagnosis (yellow)
ACK correctly identified the rhythm as AF
One patient who I had recently cardioverted from AF was the only false positive ACK. AliveCor tracing is poor quality and was called AF whereas AFA correctly identified NSR>
The sensitivity of both devices for detecting atrial fibrillation was 75%.
The specificity of AFA was 86% and that of ACK was 88%.
ACK was unreadable or unclassified 5/26 times or 19% of the time.
The sensitivity and specificity I’m reporting is less than reported in other studies but I think it represents more real world experience with these types of devices.
In a head to head comparison of AFA and ACK mobile ECG devices I found
-Recordings using AfibAlert are usually superior in quality to AliveCor tracings with a minimum of need for adjustment of hand position and instruction.
-This superiority of ease of use and quality mean almost all AfibAlert tracings are interpreted whereas 19% of AliveCor tracings are either unclassified or unreadable.
-Sensitivity is similar. Both devices are highly likely to properly detect and identify atrial fibrillation when it occurs.
-AliveCor specificity is superior to AfibAlert. This means less cases that are not AF will be classified as AF by AliveCor compared to AfibAlert. This is due to a more conservative algorithm in AliveCor which rejects wide QRS complexes, frequent extra-systoles.
Both companies are actively tweaking their algorithms and software to improve real world accuracy and improve user experience but what I report reflects what a patient at home or a physician in office can reasonably expect from these devices right now.
The skeptical cardiologist has had several of his readers submit stories and tracings of AliveCor Mobile ECG recordings which yield unclassified or unreadable recordings. In some cases this is due to excess noise but a lot of these tracings suffer from low voltage: the height of the tracing is very small.
John, a skepcard reader, is typical.
Recently, he noted his heart was racing and made an AliveCor recording which came back interpreted by the app as normal
Three hours later he made a second recording which has drastically lower voltage: the only deflections visible are tiny QRS complexes, the p waves have disappeared. I think this is also normal sinus rhythm but because p waves can’t be seen this came back uninterpretable and if there were any irregularity AliveCor would have called it atrial fibrillation:
John has a theory on the cause of some of his low voltage recordings which I shall reveal in a subsequent post after testing it.
In the meantime, if any readers have suggestions as to causes of low voltage recordings or have noted similar issues please comment below or send recordings and observations to DRP@theskepticalcardiologist.com.
The skeptical cardiologist has often sung the praises of the AliveCor Mobile ECG for home and office heart rhythm monitoring (see here and here.) However, there is a significant rate of failure of the device to accurately identify atrial fibrillation. I’ve seen numerous cases where the device read afib as “unclassified” and normal sinus rhythm (usually with PVCs or PACs) called afib both in my office and with my patient’s home monitors.
In such cases it is easy for me to review my patient’s recordings and clarify the rhythm for them.
For those individuals who do not have a cardiologist available to review the recordings, AliveCor offers a service which gives an option of having either a cardiac technician or cardiologist review the tracing. The “cardiac technician assessment” costs $9 and response time is one hour. The “Clinical Analysis and Report by a U.S. Board Certified Cardiologist” costs $19 with 24 hour response time.
Obviously, I have no need for this service but I’ve had several readers provide me with their anecdotal experiences with it and it hasn’t been good.
One reader who has a familial form of hypertrophic cardiomyopathy utilizes his AliveCor device to monitor for PVCs. One day he made the following recording which AliveCor could not classify:
He then requested a technician read which was interpreted as “atrial fibrillation sustained.”
He then had requested the cardiologist reading which came back as Normal Sinus Rhythm.
Finally, he again requested the technician read and got the correct reading this time which is normal sinus rhythm with PACs
When my reader protested to Kardia customer service about this marked inconsistency: three different readings in a 24 hour period, a Kardia customer service rep responded :
I was able to review this with our Chief Medical Officer who advised that the recording shows Sinus Rhythm with PACs. The Compumed report seldom provides identification of PACs and PVCs as most cardiologists believe they are not significant findings. The sustained AFib finding was incorrect, so I have refunded the $5 fee you had paid.
Please let us know if you have any other questions.
As I pointed out in my post on palpitations, most PVCS are benign but some are not and patients with palpitation would like to know if they are having PVCS and/or PACs when they feel palpitations.
More importantly, the misdiagnosis of afib when the rhythm is NSR with PACs or PVCs can lead to extreme anxiety.
Heres a recording
I made in my office this morning on a patient with cardiomyopathy and a defibrillator.
This is very clearly NSR with PVCs yet AliveCor diagnosed it as “possible atrial fibrillation.”
The AliveCor algorithm is not alone in making frequent errors in the diagnosis of atrial fibrillation.
The vast majority of ECGs performed in the US come with an interpretation provided by a computerized algorithm and medical personnel rely on this interpretation until it can be verified or corrected by an overreading cardiologist.
One study demonstrated that computerized ECG interpration (ECG-C) is correct only 54% of the time when dealing with a rhythm other than sinus rhythm
Another study found that 19% of ECG-C misinterpreted normal rhythm as atrial fibrillation. Failure of the physician ordering the ECG to correct the inaccurate interpretation resulted in change in management and initiation of inappropriate treatment, including antiarrhytmic medications and anticoagulation, in 10% of patients. Additional unnecessary diagnostic testing was performed based on the misinterpreted ECGs in 24% of patients.
When lives or peace of mind are at risk you want your ECG interpreted by a cardiologist.
I would like to take this opportunity to personally issue a challenge to IBM’s Watson.
Hey, Watson, I bet $1,000 I can Interpret cardiac rhythm from an ECG with more accuracy than you can!
The AliveCor/Kardia mobile ECG device is a really nifty way to monitor your heart rhythm. Since acquiring the third generation device (which sits within or on my iPhone case and communicates with a smartphone app) I have begun routinely using it on my patients who need a heart rhythm check during office visits. It saves us the time, inconvenience (shirt and bra removal) and expense of a full 12-lead ECG which I would normally use.
In addition, I’ve convinced several dozen of my patients to purchase one of these devices and they are using it regularly to monitor their heart rhythms. Typically, I recommend it to a patient who has had atrial fibrillation (Afib) in the past or who has intermittent spells of palpitations.
Some make daily recordings to verify that they are still in normal rhythm and others only make recordings when symptoms develop.
Once my email invitation request is accepted I can view the ECGs recorded by my patients who have AliveCor devices as I described here.
This monitoring has in many cases taken the place of expensive, obtrusive and clumsy long term event monitors.
In general, it has been very helpful but the device/app makes occasional mistakes which are significant and sometimes for certain patients it does a poor job of making a good recording.
Alivecor Success Stories
One of my patients, a spry ninety-something year young lady makes an AliveCor recording every day, since an episode of Afib 9 months ago.
And when I say every day I mean it literally everyday. It could be because she is compulsive or perhaps she has programmed the AliveCor to remind her. When I log in to the AliveCor site and click on her name I can see these daily recordings:
After a month of normal daily recordings, she suddenly began feeling very light headed and weak with a sensation that her heart was racing.
She grabbed her trusty iPhone and used the AliveCor device attached to it to make a recording of her cardiac rhythm. This time, unlike the dozens of other previous recordings, the device indicated her heart rate was 157 beats per minutes , about twice as fast as usual.
After 5 hours her symptoms abated and by the time of her next recording she had gone back to the normal rhythm.
She made two other recordings during the time she felt bad and they both confirmed Afib at rates of 140 to 150 beats per minute.
In this case, the device definitely alerted her to a marked and dramatic increase in heart rate but was not capable of identifying this as Afib In my experience with several hundred recordings, the device accurately identifies atrial fibrillation about 80% of the time. On rare occasions (see here) it has misidentified normal rhythm with extra beats as atrial fibrillation
AliveCor/kardia users have the option of having their recordings interpreted for a fee by a cardiologist or a technician.
My patients can alert me of a recording and I can go online and read the ECG myself and then contact the patient to inform them of my interpration of their heart rhythm and my recommendations.
Another patient made the recording below:Although she is at high risk of having a stroke during the times she is in Afib, we had been holding the blood thinner I had started her on because of bleeding from her mouth. I had instructed her to take daily recordings of her rhythm with the AliveCor until she was seen by her dentist to evaluate the bleeding.
In this case, the AliveCor performed appropriately, identifying correctly the presence of Afib which was the cause of her nocturnal symptoms.
A young woman emailed me that her AliveCor device on several occasions has identified her cardiac rhythm during times of a feeling of heart racing and palpitations as “possible atrial fibrillation.” When she sent the recordings in to AliveCor to have a paid interpretation, however, the recordings were interpreted as sinus tachycardia with extra beats. Indeed , upon my review her rhythm was not Afib. Clearly, when the device misidentifies Afib, this has the potential for creating unnecessary anxiety.
It is not uncommon for a full, 12-lead ECG done in the hospital or doctor’s office by complex computer algorithms to misinterpret normal rhythm as Afib so I’m not surprised that this happens with AliveCor using a single lead recorded from the fingers.
The young woman was advised by AliveCor to try a few things such as using the device in airplane mode, sitting still and wetting her fingers which did not help. She was sent a new device and the problem persisted. She finds that putting the device on her chest gives a better chance of success.
She also runs into a problem I see frequently which is a totally normal recording labeled by the device as “unclassified.”
In this example, although I can clearly see the p-waves indicating normal sinus rhythm, the voltage is too low for the device to recognize.
Send Me Your AliveCor Problems and Solutions
I’m interested in collecting more AliveCor/Kardia success and failure stories so please post yours in the comments or email me directly at DRP@theskeptical cardiologist.com.
In addition, I’m interested in any tips AliveCor users have to enhance the success of their recordings: What techniques do you use to make the signal strength and recording better? What situations have you found that tend to worsen the signal strength and recording quality?
Still Unclassified Yours,
P.S. Tomorrow is Cyber Monday and I note that Kardia is running a “Black Friday” special through 11/28, offering the device at 25% off.
P.P.S. Kardia, You should change the statement on your website, “90% of strokes are preventable if you catch the symptoms early.” makes no sense. I think you mean that some strokes are preventable (I have no idea where the 90% figure come from) if one can detect Afib by utilizing a monitoring device to assess symptoms such as palpitations or irregular heart beat.