Tag Archives: accuracy

Apple Watch Fails To Notify Patient Of 3 Hour Episode Of Rapid Atrial Fibrillation

Apple claims that its Apple Watch can detect atrial fibrillation (AF) and appropriately notify the wearer when it suspects AF.

This claim comes with many caveats on their website:

Apparently it needs to record 5 instances of irregular heart beat characteristic of atrial fibrillation over at least 65 minutes before making the notification.

This feature utilizes the watch’s optical heart sensors, is available  in Apple Watch Series 1 or later and has nothing to do with the Apple Watch 4 ECG recording capability which I described in detail in my prior post.

Failure To Detect AF

A patient of mine with known persistent AF informed me yesterday that she had gone into AF and remained in it for nearly 3 hours with heart rates over 100 beats per minute and had received no notification. She confirmed the atrial fibrillation with both AW4 recordings and AliveCor Kardia recordings while she was in it.

The watch faithfully recorded sustained heart rates up to 140 BPM but never alerted her of this even though the rate was consistently over her high heart rate trigger of 100 BPM.

The patient had set up the watch appropriately to receive notifications of an irregular rhythm.

Reviewing her tracings from both the AW4 and the Kardia this was easily diagnosed AF with a rapid ventricular response.

What does Apple tell us about the accuracy of the Apple Watch AF notification algorithm? All we know is the unpublished , non peer-reviewed data they themselves collected and presented to the FDA.

From this link on their website Apple says:

In a study of 226 participants aged 22 years or older who had received an AFib notification while wearing Apple Watch and subsequently wore an electrocardiogram (ECG) patch for approximately 1 week, 41.6% (94/226) had AFib detected by ECG patch. During concurrent wear of Apple Watch and an ECG patch, 57/226 participants received an AFib notification. Of those, 78.9% (45/57) showed concordant AFib on the ECG patch and 98.2 % (56/57) showed AFib and other clinically relevant arrhythmias. These results demonstrate that, while in the majority of cases the notification will accurately represent the presence of AFib, in some instances, a notification may indicate the presence of an arrhythmia other than AFib. No serious device adverse effects were observed

This tells us that about 80% of notifications are likely to be Afib whereas 20% will not be Afib. It is unclear what the “other clinically relevant arrhythmias”  might be. If I had to guess I would suspect PVCS or PACS which are usually benign.

If 20% of the estimated 10 million Apple Watch wearers are getting false positive notifications of afib that means 2 million calls to doctor or visits to ERs that are not justified.  This could be a huge waste of resources.

Thus the specificity of the AF notification is 80%. The other important parameter is the sensivitiy. Of the cases of AF that last >65 minutes how many are detected by the app?

Apple doesn’t seem to have any data on that but this obvious case of rapid AF lasting for 3 hours does not give me much confidence in their AF detection algorithms.

They do have a lot of CYA statements indicating you should not rely on this for detection of AF:

It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.

My patient took her iPhone and Apple Watch into her local Apple store to find out why her AF was not detected. She was told by an Apple employee that the Watch does not detect AF but will only notify her if her heart rate is extremely low or high. I had asked her to record what they told her about the problem.

As I’ve written previously (see here) the Apple Watch comes with excessive hype and minimal proof of its accuracy. I’m sure we are going to hear lots of stories about AF being detected by the Watch but we need some published, peer-reviewed data and we need to be very circumspect before embracing it as a reliable AF monitor.

Skeptically Yours,

-ACP

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