Tag Archives: mobile ECG

AfibAlert Versus AliveCor/Kardia: Which Mobile ECG Device Is Best At Accurately Identifying Atrial Fibrillation?

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.

Normal/Normal

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.

Chaput AFA SR

ACK recording was good quality but its algorithm could not classify the rhythm.

GC Unclassified

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 NSRChaput AFA SR

AliveCor/Kardia recordings on the same patient despite considerable and prolonged efforts to improve the recording were poor and were classified as “unreadable”

Scott AC unreadable
Alivecor tracing shows wildly varying baseline with poor definition of p wave

 

False Positives

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.

VA AFA read as AF
Slight irregularity of rhythm combined with a wider than normal QRS from right bundle branch block and poor recording of p waves likely caused AFA to call this afib
VA unclassified RBBB
AliveCor tracing calls this unclassified. The algorithm does not attempt to classify patients like this with widened QRS complexes due to bundle branch block.

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.IMG_8399.jpg

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.

Screen Shot 2017-05-06 at 11.48.47 AM
These are recordings Lawrence made at home that i can pull up on my computer. He makes a daily recording which he repeats if he is diagnosed with atrial fibrillation. In the two cases above of AF a repeat measurement was read as normal. Of the two cases which were unclassified , one was normal with APCs and the other was actually atrial flutter

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.

Screen Shot 2017-05-06 at 11.47.37 AM

Sure enough, when I recorded his rhythm with ACK although NSR (with APCS) it was read as unclassified

Screen Shot 2017-05-06 at 11.49.49 AM

AFA classified Lawrence’s rhythm as AF when it was in fact normal sinus with APCs.

AFA Mcgill AF

 

 

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 AFScreen Shot 2017-05-06 at 8.39.06 AMScreen Shot 2017-05-06 at 8.11.53 AM

In one 90 year old man AFA could not make the diagnosis (yellow)

Screen Shot 2017-05-06 at 11.35.40 AM

ACK correctly identified the rhythm as AF

Screen Shot 2017-05-06 at 11.37.51 AM

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>

Screen Shot 2017-05-06 at 8.42.46 AMScreen Shot 2017-05-06 at 8.42.26 AM

 

 

Overall Accuracy

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.

Summary

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.

-ACP

How Well Does The AfibAlert Remote Hand-Held Automatic ECG Device Work For Detection of Atrial Fibrillation?

I’ve been evaluating the ability of a mobile hand-held ECG device called AfibAlert to detect atrial fibrillation for the last few weeks.

I found that the device made very reliable and consistent recordings of cardiac rhythm and did a reasonably good job of detecting atrial fibrillation (afib).

The device  came in a plastic case with a USB cable for uploading recordings and two metal bracelets which attach to electrodes and provide an alternative recording method.

The device itself is about 6 by 3 by 1 inch.

 

Recordings are made by placing your thumbs on the silver/siver chloride electrodes

After a few seconds the display in the center will give heart rate and after 45 seconds the
device will make a decision about your rhythm:

If it diagnoses normal sinus rhythm a green check appears and if it diagnoses  afib a red telephone appears.

If it is confused you get yellow circular arrows.

As the maker of the device explains:

Lohman Technologies’ patented algorithm analyzes the patient’s heartbeat and the appropriate icon illuminates to show what action is needed. AfibAlert’s® algorithm was validated against 51,000+ ECG strips from the MIT-BIH Atrial Fibrillation Database with known diagnosis. The Afib monitor’s results were excellent, with 94.6% accuracy in detecting the presence of arrhythmias. Each recording produces a 45-second diagnostic quality ECG rhythm strip

The device I tested does not allow you to immediately see the ECG tracing. The recordings are uploaded to a PC via USB cable and then can be viewed as a PDF document.

I made 17  recordings on patients in my office one day. The age range was 50 to 93 years and most  patients were able to rapidly and easily  grasp the device with thumbs appropriately positioned to make interpretable recordings.

Only 2/17  came back. yellow. In both cases, I repeated the recording and the device was able to make the correct diagnosis. Twice I got the yellow signal on an elderly, partially blind patient who had trouble keeping his thumb on the electrode.

In 15  cases of normal sinus rhythm the device correctly identified NSR.

In one case of atrial fibrillation the device correctly identified atrial fibrillation.

 

 

In one case of SR with
APCs the device
incorrectly identified afib

 

Overall the device correctly classified 88% of the tracings. This was superior to the device I normally utilize ( AliveCor/Kardia mobile ECG)  in head to head comparison (I’ll present this comparison in a subsequent post).

My bullet points on the AfibAlert device:

-5 stars for Ease of Recording

-5 stars for Quality of recording

In all cases that uploaded, the recordings were very clear and free of artifact. The device did not upload yellow signal events and I presume more artifact is present in these recordings.

-2 stars for Convenience.

I found the software and uploading to be very awkward and slow. The company indicates new software soon to be released along with the ability to interface directly with iPads or smartphones that hopefully will improve this factor.

The inability to instantaneously view the ECG tracings means I cannot use it in my office to screen patients for arrhythmias. However, if a patient is solely using it to determine if afib is present or absent, this information is available right away.

-3 stars for Accuracy.

It does a reasonable job of identifying the patient who is in normal rhythm versus one in atrial fibrillation.

However, like AliveCor and other devices which strictly look at the variability of the pulse, it can be easily fooled by premature beats, especially when they are frequent, and inappropriately classify these as afib resulting in false positives.

In addition, when afib rates are very slow and thus much less variable it is likely AfibAlert will incorrectly classify them as normal thus resulting in false negatives.

False Negatives and False Positives

False negatives result in delayed diagnosis of afib. Patients will be falsely reassured that their rhythm is normal when it is not.

False  positives result in needless anxiety and testing/treatment.

If afib monitoring devices are to be successful they have to have a very low frequency of both types of inaccuracy.

The solution to inaccuracy of interpretation, of course, is to have a cardiologist over-read the tracings.

AfibAlert recordings are available online for review by your personal physician after being uploaded. This requires your physician to have an account with AfibAlert. There is no capability for having the recordings over read by an online cardiologist for a charge.

As far as I can tell the device is only available for purchase in the US and only on the AfibAlert website.

Interestingly, you cannot purchase AfibAlert  without a prescription from a physician.

Why this is mandated for AfibAlert and not AliveCor is a mystery to me.

 

 

Alertly Yours,

-ACP

 

 

Getting To The Heart Of Father’s Day

The skeptical cardiologist received an email from the folks at AliveCor a few days ago with the subject line:

Dad’s heart matters – Kardia Mobile for Dad will give you peace of mind and make Dad happy

The email contains this image of an older well-dressed man (withScreen Shot 2016-06-18 at 9.03.26 AM lots of bling) standing in a beautiful meadow near the ocean. The man has decided to turn his back on the ocean and check his heart rhythm using the AliveCor/Kardia (AliveCor has changed the name of its ECG devices to Kardia) mobile ECG. This man is a happy dad! (Unless his heart rhythm is interpreted as atrial fibrillation. Then the beach walk is ruined.)

The email asks the question “What if Dad’s heart really was an open book?”

Uhh, he’d be dead? Clearly books don’t function well at pumping 5 or 6 liters of blood through the cardiovascular system every minute whether they are open or closed. Perhaps  the question is using either  the heart or an open book as a metaphor?

The advertisement goes on to suggest that I get my dad an AliveCor device for father’s day  “So you always know what his heart is thinking.”

I believe this is the marketing person’s attempt to extend the metaphor of the open book, i.e., you know exactly what dad’s brain is thinking, now you can extend this knowledge to his heart.  The metaphor of the heart “thinking” is quite poor but poor metaphors are the norm today.

Bad metaphors and bad writing abound on father’s day because 90 million greeting cards are purchased and given as (according to the Greeting Card Association)  “a meaningful expression of personal affection for another person.” Despite the increasing use of Facebook and its ilk to transmit emotions, the Greeting Card Association assures us that “The tradition of giving greeting cards … is still being deeply ingrained in today’s youth, and this tradition will likely continue as they become adults and become responsible for managing their own important relationships.

Mobile Ecg Monitor As A Father’s Day Gift

I have to say that despite the horror of the writing in this email advertisement it got me thinking about getting my father a Kardia device. I’ve suggested  previously that  an AliveCor device would make a good gift for Christmas for a loved one who has intermittent unexplained palpitations or atrial fibrillation but had not considered this for my dad.

For one thing he does not possess a smart phone which is required to  make the Kardia device functional. For another, he doesn’t have atrial fibrillation (that we know of. Perhaps if I knew what his heart was thinking we would find out that it likes to fibrillate late at night,)

Perhaps it’s time to upgrade my Dad to an iPhone I began thinking.

But wait! He has an iPad mini (that he seems to only use for FaceTime conversations.)

Further research reveals that Kardia is not only compatible with iPhone and Android smartphones but apparently iPads and IPod Touch.Screen Shot 2016-06-19 at 8.04.27 AM

Taking Care of Dad’s Heart

What about the rest of the slick advertising copy in my email?

And now you can know the way to help take care of it. Kardia gives Dad a medical-grade EKG in only 30 seconds. It even gives him expert analysis and tracking, with reports getting shared directly with his physician

This part is pretty clear and correct. I use Kardia daily in my office to record patient’s heart rhythm and I have a dozen patients now who make recordings outside of the office. They can have their recordings read by a random cardiologist for a fee or establish a link with me as their provider and I can review them through my account for free.

 Is It The First Father’s Day Gift That Leads To More Father’s Days?

The ad ends with the remarkably brazen statement that “It’s the first Father’s Day gift that leads to more Father’s Days.”

While I find the device more helpful in many instances than current expensive and intrusive long term monitoring devices for detecting and monitoring atrial fibrillation and other abnormal heart rhythms, it is a huge leap to suggest that this translates somehow into a longer life span.

To AliveCor’s credit, despite such ridiculous marketing drivel , studies presented at the recent Heart Rhythm Society Scientific Meetings suggest:

  • Kardia Mobile Superior to Conventional Monitoring: Researchers at the Leeds General Infirmary found that the AliveCor monitor is superior to conventional Holter monitoring in patients with palpitations, providing a higher diagnostic yield, more detected arrhythmias, with a similar workload.

  • Kardia Mobile Leads to Improved Patient Compliance:Researchers at the University of Buffalo found that AliveCor provides a diagnostic yield comparable to a 30-day ambulatory looping event monitor and that the smartphone-based ECG monitor can be used as a first approach for the diagnosis of palpitations.

  • Kardia Mobile provided more information resulting in changes in arrhythmia patient management than traditional external event recorders in a study from researchers at the University of Miami.

  • AliveCor’s AF algorithm was reported to be superior by researchers at Arizona State University to the patient’s own ability to detect AF via symptoms.

    But even if these studies make it to publication they don’t suggest the device provides any improved longevity. In fact, such data, do not exist for any monitoring device.

Happy Father’s Day, Dad! Don’t be surprised when we FaceTime later today that I’ve found another use for your iPad.

Paternally Yours,

-ACP

N.B. Clearly I receive no consulting, speaking or P.R. writing fees of any kind from AliveCor. Nor do they provide me with any free devices. What’s more, when I lose one of their devices they don’t replace it.  I am totally free of any conflict of interest.

 

AliveCor Mobile ECG Misidentifies One Patient’s Heart Rhythm

The skeptical cardiologist has been evaluating the AliveCor mobile ECG device for use with a smartphone to detect atrial fibrillation.  In my initial post on this I found it to be accurate in identifying atrial fibrillation in my patients.

The AliveCor stuck (in a very crooked fashion) on the back of my (not particularly clean) iPhone 6 and ready to record YOUR heart rhythm.
The AliveCor stuck (in a very crooked fashion) on the back of my (smudgy) iPhone 6 and ready to record YOUR heart rhythm.

I’ve been using it in my office fairly regularly and encouraging my patients with intermittent AF to acquire the device and use it to monitor their heart rhythm.

When they make recordings they can be uploaded to me via internet for my review.

The other day I was examining a patient who I was seeing for syncope (passing out) and I noticed when listening to his heart that his pulse was very irregular.

I pulled out my iPhone with AliveCor stuck on the case and made the recording you see below. Screen Shot 2015-09-08 at 2.24.05 PM

Although the AliveCor app diagnosed it as “possible AF” it is very clearly normal sinus rhythm with frequent premature ventricular contractions (PVC), a totally different (and more benign) rhythm.

I’ll continue on with this evaluation and I’ll be particularly interested in how AliveCor performs in other patients with PVCs which are a common cause of palpitations in the general population.

If AliveCor cannot differentiate AF from PVCS it may lead a lot of users to become unduly concerned about their heart rhythm.

palpitatingly yours

-ACP

 

AliveCor Smartphone App Detects Atrial fibrillation: Potential for Stroke Prevention

Atrial fibrillation (AF)  is a common abnormal rhythm of the heart which causes 1 in 4 strokes. Those afflicted with AF may lack any symptoms or only have a vague sense of irregularity of their heartbeat and thus the first symptom of AF can be stroke.

The gold standard for diagnosing AF has long been the electrocardiogram (ECG or EKG) and typically the ECG involves placing 12 electrodes on the chest/arm/legs and recording the electrical activity of the heart on an expensive device.

I’ve been checking out a device made by Alive Cor which works with your smart phone to record a single channel ECG and is capable of accurately diagnosing if you are in the normal (sinus) rhythm or in AF.
Screen Shot 2015-07-12 at 8.45.49 AMYou can purchase the third generation (significantly smaller then earlier versions) AliveCor Mobile ECG from Amazon or from AliveCor directly for 74.99$ and it works with an app with both iOS and Android devices.

I used mine with my iPhone 6. At first I carried it separately, fearing the added bulk when stuck on to my iPhone case but after a while I realized that it was never with me when I wanted to use it and that there was a huge risk of losing it and so I used the backing adhesive to attach it to my case.

After pairing the device with the app you put two fingers on each of the metal pads and the smartphone screen displays the recording. After 30 seconds of recording it then interprets the rhythm.

Screen Shot 2015-07-12 at 8.56.47 AM
Typical recording in normal sinus rhythm. The red arrow indicates the small p waves which are the electrical signal of the upper chambers (the atria) depolarizing , the blue arrow indicates the electrical depolarization of the ventricles (QRS). The orange arrow indicates that the time interval between the QRS complexes is the nearly the same for each beat, indicating the regularity that we expect when in NSR compared to AF.

Above is a typical recording I made in my office on a patient who had a history of AF. The quality is good and I can clearly see that he is in normal sinus rhythm. The app correctly made the diagnosis of NSR and calculated his heart rate at 68 beats per minute.

One day I had most of my patients record their ECG’s using AliveCor and compared it to the standard 12-lead ECG we normally record. The device correctly identified the two patients with AF out of this group and correctly identified the normals.

Screen Shot 2015-07-12 at 9.26.42 AM
AliveCor recording of patient with AF with heart rate of 70 beats per minute. Note the absence of p waves before the QRS complexes and note the beat to beat variation in the RR interval (orange arrow)

This recording is from a patient with persistent AF which had recurred two weeks earlier. The device correctly identified AF.

Studies have documented that AliveCor Mobile ECG can accurately diagnose AF in a screening setting and the FDA approved the device for AF screening in 2014.

Given the high prevalence of silent AF, the strong association of AF with stroke and the availability of anticoagulants which reduce AF associated stroke by 70%, screening for AF with devices like AliveCor holds the promise of preventing large numbers of stroke.

(For my comments on taking the pulse and stroke prevention see here and on the inadvisability of a routine 12-lead ECG see here)

AliveCor allows physicians utilizing the Mobile APP and ECG to have a “dashboard” into which their patients can transmit their AliveCor ECG recordings.

I will be discussing this remarkable new device with my AF patients  who are smartphone enabled. I think it will advance our ability to more efficiently and quickly diagnose AF in them.

My standard approach if a patient with AF calls and says that they feel like they are out of rhythm is to have them come into the office for a full 12-lead ECG. If they are AliveCor enabled, they could make their own recording, and we could review that remotely and make a diagnosis without the office visit.

Let me know your thoughts on smartphone ECGs.

fibrillatorily yours,

-ACP