Tag Archives: Smart Rhythm

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.

Review of Kardia Band Mobile ECG for Apple Watch

The skeptical cardiologist has been evaluating the Kardia Band from AliveCor which allows one to record single lead medical grade ECGS on your Apple Watch. What follows is my initial experience with setting up the device and using it to make recordings.

After ordering my Kardia Band for Apple Watch on 11/30  from AliveCor the device appeared on my door step 2 days later on a Saturday giving me most of a Sunday to evaluate it.

What’s In The Box

Inside the box I found one small and one large black rubber wrist watch band

The larger one had had a small squarish silver metallic sensor and the smaller one had a space to insert a sensor. It turns out my wrist required the smaller band and it was very easy to pop out the sensor and pop it into the smaller band.

After replacing my current band with the Kardia band (requires pushing the button just below the band and sliding the old band out then sliding the new one in) I was ready to go.

The Eternal  fiancée did not complain about the appearance of the band so I’m taking that to mean it passes the sufficiently stylish test. She did inquire as to different colors but it appears AliveCor only has one style and one color to choose from right now.

I have had problems with rashes developing with Apple’s rubbery band and switched to a different one but thus far the Kardia band is not causing wrist irritation.

Set UP

I didn’t encounter any directions in the box or online so I clicked on the Kardia app on the watch and the following distressing message appeared.

Prior to 11/30 Kardia Band only worked in certain countries in Europe so I suspected my AliveCor app needed to be updated.

I redownloaded the Kardia app from the Apple App Store , deleted it off my Watch and reinstalled it.

I was thrilled when the app opened up and gave me the following message

However, I was a little puzzled as I was not aware that setting up Smart Rhythm was a requirement to utilize the ECG recording aspect of Kardia Band. Since I have been granted a grandfathered Premium membership by AliveCor I knew that I would have access to Smart Rhythm and went through the process of entering my name and email into the Kardia app to get this started.

Alas, when the Watch Kardia app was accessed after this I continued to get the same screen. Clicking on “need help” revealed the following message:

Bluetooth was clearly on and several attempts to restart both the watch and the iPhone app did not advance the situation.

I sent out pleas for assistance to AliveCor.

At this point the Eternal Fiancee had awoken and we went to Sardella for a delightful brunch . I had this marvelous item:

Eggs Benedict Raviolo, Mortadella, Bread Ricotta, Egg Yolk, Brown Butter Hollandaise, Potatoes 15.
 Later on that day I returned to my Kardia Band iPhone and deinstalled, reinstalled , reloaded and restarted everything.
The First Recording
At this point it worked and I was able to obtain my first recording by pushing the record ECG button and holding my thumb on the sensor for 30 seconds.
I’ve made lots of recordings since then and they are good quality and have accurately recognized that I am in normal sinus rhythm.
The Smart Rhythm component has also been working. Here is a screen shot of today’s graph.
You’l notice that the Smart Rhythm AI gave me a warning sometime in the morning (which I missed) as it felt my rhythm was abnormal. I missed making the recording but am certain that I was not in afib.
Comparison of the Kardia Band recording (on the right) versus the separate Kardia device recording (on left)  shows that they are very similar in terms of the voltage or height of the p waves, QRS complexes and T waves. 
I felt a palpitation earlier and was able to quickly activate the Kardia Watch app and make a recording which revealed a PVC.
 In summary, after some difficulty getting the app to work I am very pleased with the ease of recording, the quality of the recording and the overall performance of Kardia Band. The difficulties I encountered might reflect an early adoption issue which may already be resolved. Please give me feedback on how the device set up worked for you.
I’ll be testing this out on patients with atrial fibrillation and report on how it works in various situations in future posts.
After more experience with the Smart Rhythm monitoring system which I think could be a fantastic breakthrough in personal health monitoring I’ll give a detailed analysis of that feature.
Everwatchingly Yours,
-ACP