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.
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.
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 Companyand 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.
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.
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.
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.
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.
Monitoring Heart Rhythm and Blood Pressure-The Omron/Kardia Pro Connection
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
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.
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.
In less than a month AliveCor plans to release its KardiaMobile 6L which will provide 6 ECG leads using a smartphone based mobile ECG system that is similar to the Kardia single lead system.
AliveCor’s website proclaims “This is your heart x 6.”
I was fortunate enough to obtain a demo version of the 6L and have been evaluating it.
My first impressions are that this is a remarkable step forward in the technology of personal ECG monitoring. I’m not sure if I would call it “your heart x 6” but I feel the ability to view six high quality leads compared to one is definitely going to add to the diagnostic capabilities of the Kardia device.
Kardia 6L Setup And Hardware
The 6L is similar in design and function to the single lead device.
I’m including this cool spinning video (from the AliveCor website) which makes it appear, slick, stylish and futuristic
Once paired to the Kardia smartphone app (available for iOS or Android smartphones for free) it communicates with the smartphone using BLE to create ECG tracings.
Like the single lead Kardia the 6L has two sensors on top for left and right hand contact. But in addition, there is a third on the bottom which can be put on a left knee or ankle.
The combination of these sensors and contact points yield the 6 classic frontal leads of a full 12 lead ECG: leads I, II, III, aVL, aVR, and aVF. This is accomplished, AliveCor points out “without messy gels and wires.
I found that using the device was simple and strait-forward and we were able to get high quality tracings with minimal difficulty within a minute of starting the process in all the patients we tried it on.
The Diagnostic Power Of Six Leads
Below is a tracing on a patient with known atrial fibrillation. The algorithm correctly diagnoses it. With 6 different views of the electrical activity of the atrium I (and the Kardia algorithm) have a better chance of determining if p waves are present, thereby presumably increasing the accuracy of rhythm determination
Depending on the electrical vector of the left and right atria, the best lead to visualize p waves varies from patient to patient, thus having 6 to choose from should improve our ability to differentiate sinus rhythm from afib.
In the example below, the Kardia 6L very accurately registered the left axis deviation and left anterior fascicular block that we also noted on this patient’s 12 lead ECG. This 6L capability, determining the axis of the heart in the frontal plane, will further add to the useful information Kardia provides.
For a good summary of axis determination and what abnormal axes tells us see here.
The History of ECG Leads
When I began my cardiology training the 12-lead ECG was standard but it has not always been that way. I took this timeline figure from a nice review of the history of the ECG
Einthoven’s first 3 lead EKG in 1901 was enormous.
It is mind-boggling to consider that we can now record 6 ECG leads with a smartphone and a device the size of a stick of gum
For the first 30 years of the ECG era cardiologists only had 3 ECG leads to provide information on cardiac pathology. Here’s a figure from a state of the art paper in 1924 on “coronary thrombosis” (which we now term a myocardial infarction) showing changes diagnostic of an “attack” and subsequent atrial fibrillation
In the 1930s the 6 precordial leads were developed providing more information on electrical activity in the horizontal axis of the heart. The development of the augmented leads (aVr, aVL, aVF) in 1942 filled in the gaps of the frontal plane and the combination of all of these 12 leads was sanctified by the AHA in 1954.
I’ll write a more detailed analysis of the Kardia 6L after spending more time using it in patient care.
Specifically I’ll be analyzing (and looking for published data relative to):
-the relative accuracy of the 6L versus the single lead Kardia for afib determination (which, at this point would be the major reason for current Kardia users to upgrade.)
-the utility of the 6L for determination of cardiac axis and electrical intervals in comparison to the standard 12 lead ECG, especially in patients on anti-arrhythmic drugs
For now, this latest output from the meticulous and thoughtful folks at AliveCor has knocked my socks off!
N.B. If one uses the single lead kardia device in the traditional manner (left hand and right hand on the sensors) one is recording ECG lead I. However, if you put your right hand on the right sensor and touch the left sensor to your left leg you are now recording ECG lead II and if to the right leg, ECG lead III.
I describe this in detail here. For certain individuals the lead II recordings are much better than lead I and reduce the prevalence of “unclassified” recordings.
My feeling is that by automatically including the leg (and leads II and III) the 6L will intrinsically provide high voltage leads for review and analysis, thereby improving the ability to accurately classify rhythm.
And (totally unrelated to the 6L discussion) one can also record precordial ECG leads by putting the device on the chest thus theoretically completing the full 12 leads of the standard ECG.
Please also note that I have no financial or consulting ties to AliveCor. I’m just a big fan of their products.
The skeptical cardiologist is a firm believer in the benefit of maintaining normal rhythm in most patients who develop atrial fibrillation (AF, see here.)
Sometimes this can be accomplished by lifestyle changes (losing pounds and cutting back on alcohol , treating sleep apnea, etc.) but more often successful long term maintenance of normal rhythm (NSR) requires a judicious combination of medications and electrical cardioversions (ECV).
It is also greatly facilitated by a compliant and knowledgeable patient who is regularly self-monitoring with a personal ECG device.
My article on electrical cardioversion (see here) was inspired by a patient (we’ll call her Sandy) who asked me in April of 2016, “how many times can you shock the heart?”
In 2016 I performed her fifth cardioversion and last week I did her sixth.
Her story of AF is a common one which exemplifies how excellent medical management of AF can cure heart failure and mitral regurgitation and create decades of AF-free, happy and healthy existence.
A Tale Of Six Cardioversions
Sandy had her first episode of atrial fibrillation in 2001 and underwent a cardioversion at that time and as far as she knew had no AF problems for 14 years. I’ve seen numerous cases like this where following a cardioversion, patients maintain NSR for a long time without medications but I’ve also seen many in whom AF came back in days to months.
In 2015 she saw her PCP for routine follow-up and AF with a rapid rate was detected. She had been noticing shortness of breath on exertion and a cough at night but otherwise had no clue she was out of rhythm.
When I saw her in consultation she was in heart failure and her echocardiogram demonstrated a left ventricular ejection fraction of 50% with severe mitral regurgitation. She quickly went back into AF after an electrical cardioverson (ECV) and reverted to AF again following a repeat ECV after four days on amiodarone.
Since amiodarone can take months to reach effective levels in the heart we tried one more time to cardiovert after loading on higher dosage amiodarone for one month. This time she stayed in NSR
Following that cardioversion she has done extremely well. Her shortness of breath resolved and follow up echocardiograms have demonstrated resolution of her mitral regurgitation.
She had purchased a Kardia mobile ECG device for personal monitoring of her rhythm and we were able to monitor her rhythm using the KardiaPro dashboard. Recordings showed she was consistently maintaining NSR after her 2016 ECV
I’ve written extensively on the great value of KardiaPro used in conjunction with the Kardia mobile ECG device for monitoring patients pre and post cardioversion for atrial fibrillation. Sandy does a great job of making frequent Kardia ECG recordings, almost on a daily basis so even though she has no symptoms we are alerted to any AF within 24 hours of it happening.
Amiodarone-The Big Medical Gun For Stopping Atrial Fibrillation
The recurrence of AF Sandy had in 2016 occurred 8 months after I had lowered her amiodarone dosage to 100 mg daily.
Amiodarone is a unique drug in the AF toolkit.
It is the by far the most effective drug for maintaining sinus rhythm, an effect that makes it our most useful antiarrhythmic drug (AAD).
It is cheap and well-tolerated.
Uniquely among drugs that we use for controlling atrial fibrillation it takes a long time to build up in heart tissue and a long time to wear off.
It is the safest antiarrhythmic drug from a cardiac standpoint. Unlike many of the other AADs we don’t have to worry about pro-arrhythmia (bringing out more dangerous rhythms such as ventricular tachycardia or ventricular fibrillation) with amio.
Amiodarone, however, is not for all patients-it has significant long term side effects that necessitate constant vigilance by prescribing physicians including thyroid, liver and lung toxicity.
I monitor my patients on amiodarone with thyroid and liver blood tests every 4 months and a chest x-ray yearly and I try to utilize the minimal dosage that will keep them out of AF.
In Sandy’s case it was apparent that 100 mg was too little but with an increase back to 200 mg daily, the AF remained at bay.
In early 2017, Sandy read on Facebook that amio was a “poison” and after discussing risks and benefits we decided to lower the dosage to 200 mg alternating with 100 mg. It is common and appropriate for patients to be fearful of the potential long term and serious consequences of medications. For any patient taking amiodarone I always offer the option of stopping the drug with the understanding that there is a strong likelihood of recurrent AF within 3 months once the drug wears off.
In October, 2018 with Sandy continuing to show normal heart function and maintain SR as documented by her daily Kardia ECG tracings we decided to further lower the dosage to 100 mg daily.
Six months later she noted one day that her Kardia reading was showing a heart rate of 159 bpm and diagnosing atrial fibrillation. AF had recurred on the lower dosage of amiodarone. She had no symptoms but based on prior experience we knew that soon she would go into heart failure.
Thus, her amiodarone was increased and a sixth cardioversion was performed. We could find no trigger for this episode (unless the bloody mary she consumed at a Mother’s Day Brunch 2 days prior was the culprit.)
Medical Management With Antiarrhythmics Versus Ablation
Many patients seek a “cure” for atrial fibrillation. They hear from friends and neighbors or the interweb of ablation or surgical procedures that promise this. Stopafib.org, for example, promotes these types of procedures saying “Catheter ablation and surgical maze procedures cure atrial fibrillation”
In my experience the majority of patients receiving ablation or surgical procedures (Maze procedure and its variants) ultimately end up having recurrent episodes of atrial fibrillation. Guidelines do not suggest that anticoagulants can be stopped in such patients. Often, they end up on AADs.
I’ve prepared a whole post on ablation for AF but the bottom line is that there is no evidence that ablation lowers the AF patient’s risk of dying, stroke, or bleeding. My post will dig deeper into the risks and benefits of ablation.
There is no cure for AF, surgical, catheter-based or medical.
In the right hands most patients can do very well with medical management combined with occasional cardioversion.
Who posseses the right hands?
In my opinion, most AF patients are best served by a cardiologist who has a special interest in atrial fibrillation and takes the time to read extensively and keep up with the latest developments and guideline recommendations in the area. This does not need to a be an electrophysiologist (EP doctor-one who specializes in the electrical abnormalities of the heart and performs ablations, pacemakers and defibrillators.)
I have a ton of respect for the EP doctors I work with and send patients to but I think that when it comes to doing invasive, risky procedures the decision should be based on a referral/recommendation from a cardiologist who is not doing the procedure.
In many areas of cardiology we are moving toward an interdisciplinary team of diagnosticians, interventionalists, surgeons and non-cardiac specialists to make decisions on performance of high-risk and high-cost but high-benefit procedures like valve repair and replacement, closure of PFOs and implantation of left atrial appendage closure devices.
It makes sense that decisions to perform high-risk , high-cost atrial fibrillation procedures also be determined by a multi-disciplinary team with members who don’t do the procedure.
This is a rule of thumb that can also be applied to many surgical procedures as well. For example, the decision to proceed to surgical treatment of carotid artery blockages (carotid endarterectomy) is typically made by the vascular surgeons who perform the procedure. In my opinion this decision should be made by a neurologist with expertise in neurovascular disease combined with a good cardiologist who has kept up with the latest studies on the risks and benefits of carotid surgery and is fully briefed on the latest guideline recommendations.
Many patients (and perhaps physicians) are confused as to how best to utilize personal ECG devices. I received this question illustrating such confusion from a reader recently:
I first came across your website a year ago during persistent angina attacks, and returning now due to increasing episodes of symptoms akin to Afib. I bought a Kardia 2 yrs ago for the angina episodes, and looking to buy the Apple Series 4 for the Afib, as I want to try a wearable for more constant monitoring. What I would greatly appreciate if you had a basic guide for both the Kardia & Apple devices, specifically when and how to best employ them for unstable angina and detecting undiagnosed Afib. As in, what can I as a patient provide to you as a doctor for diagnosis in advance of a formal visit. I’m a US Iraq vet medically retired in the UK, and most of my concerns get dismissed out of hand as “anxiety”, not sure why they thought a stent would cure my anxiety though
First. please understand that none of these devices have any significant role in the management of angina. Angina, which is chest/arm/jaw discomfort due to a poor blood supply to the heart muscle cannot be reliably diagnosed by the single lead ECG recording provided by the Apple Watch, the Kardia Band or the Kardia mobile ECG device. Even a medical-grade 12 lead ECG doesn’t reliably diagnose angina and we rely on a constellation of factors from the patient’s history to advanced testing to determine how best to manage and diagnose angina.
Second, as you are having episodes “akin to Afib”, all of these devices can be helpful in determining what your cardiac rhythm is at the time of the episodes if they last long enough for you to make an ECG recording.
The single lead ECG recording you can make from the Apple Watch, the Kardia Band and from the Kardia mobile device can very reliably tell us what the cardiac rhythm was when you were feeling symptoms.
The algorithms of these devices do a good job of determining if the rhythm Is atrial fibrillation. Also, if the rhythm is totally normal they are good at determining normality.
These tracings can be reviewed by a competent cardiologist to sort out what the rhythm really is.
In all of these cases, having an actual recording of the cardiac rhythm at the time of symptoms is immensely helpful to your doctor or cardiologist in determining what is causing your problems.
My recommendation, therefore, would be to make several recordings at the time of your symptoms. Print them out and carefully label the print-out with exactly what you were feeling when it was recorded and present these to the doctor who will be reviewing your case.
As I’ve mentioned in previous posts (see here), my patients’ use of Kardia with the KardiaPro online service has in many cases taken the place of expensive and inconvenient long term monitoring devices.
Case Example-Diagnosing Rare And Brief Attacks Of Atrial Fibrillation
I recently saw a patient who I think perfectly demonstrates how useful these devices can be for clarifying what is causing intermittent episodes of palpitations-irregular, pounding, or racing heart beats.
She was lying on a sofa one day when she suddenly noted her heart “pumping fast” and with irregularity. The symptoms last for about an hour. She had noticed this occurred about once a year occurring out of the blue.
Her PCP ordered a long term monitor, a stress test and an echocardiogram.
The monitor showed some brief episodes of what I would term atrial tachycardia but not atrial fibrillation but the patient did not experience one of her once per year hour long episodes of racing heart during the recording. Thus, we had not yet solved the mystery of the prolonged bouts of racing heart.
She was referred to me for evaluation and I recommended she purchase an Alivecor device and sign up for the KardiaPro service which allows me to view all of her recordings online. The combination of the device plus one year of the KardiaPro service costs $120.
She purchased the device and made some occasional recordings when she felt fine and we documented that these were identified as normal by Kardia. For months nothing else happened.
Then one day in April she had her typical prolonged symptom of a racing heart and she made the recording below (She was actually away from home but had the Kardia device with her.)
When she called the office I logged into my KardiaPro account and pulled up her recordings and lo and behold the Kardia device was correct and she was in atrial fibrillation at a rate of 113 BPM.
With the puzzle of her palpitations solved we could now address proper treatment.
Continuous Monitoring for Abnormal Rhythms
Finally, let’s discuss the wearables ability to serve as a monitor and alert a patient when they are in an abnormal rhythm but free of any symptoms.
My reader’s intent was to acquire a device for “constant monitoring”:
I’m looking to buy the Apple Series 4 for the Afib, as I want to try a wearable for more constant monitoring.
This capability is theoretically available with Apple Watch 4’s ECG and with the Kardia Band (using SmartRhythm) which works with Apple Watch Series 1-3.
However, I have not been impressed with Apple Watch’s accuracy in this area (see here and here) and would not at this point rely solely on any device to reliably alert patients to silent or asymptomatic atrial fibrillation.
In theory, all wearables that track heart rate and alert the wearer if the resting heart rates goes above 100 BPM have the capability of detecting atrial fibrillation. If you receive an alert of high HR from a non ECG-capable wearable you can then record an ECG with the Kardia mobile ECG to see if it really is atrial fibrillation.
At 99$, the Kardia is the most cost-effective way of confirming atrial fibrillation for consumers.
I hope this post adds some clarity to the often confusing field of personal and wearable ECG devices.
The skeptical cardiologist recently received this email from a reader:
With the new Apple Watch that’s out now, people have suggested my husband (who had a heart attack at 36) should get it since it could detect a heart attack. But I keep remembering what you said – that these devices can’t detect heart attacks and that Afib isn’t related to a heart attack most of the time – is that still the case? I don’t really know how to explain to people that it can’t do this, since absolutely everyone believes it does.
The answer is a resounding and unequivocal NO!
If we are using the term heart attack to mean what doctors call a myocardial infarction (MI) there should be no expectation that any wearable or consumer ECG product can reliably diagnose a heart attack.
The Apple Watch even in its latest incarnation and with the ECG feature and with rhythm monitoring activated is incapable of detecting a myocardial infarction.
To make this even clearer note that when you record an ECG on the Apple Watch it intermittently flashes the following warning:
Note: “Apple Watch never checks for heart attacks”
How did such this idea take root in the consciousness of so many Americans?
Perhaps this article in 9-5 Mac had something to do with it
In reality, the man received an alarm that his resting heart rate was high at night. Apparently he also was experiencing chest pain and went to an ER where a cardiac enzyme was elevated. Subsequently he underwent testing that revealed advanced coronary artery disease and he had a bypass operation.
Even if we assume all the details of this story are accurate it is absolutely not a case of Apple Watch diagnosing an MI.
A high resting heart rate is not neccessarily an indicator of an MI and most MIs are not characterized by high heart rates. We have had the technology with wearables to monitor resting heart rate for some time and no one has ever suggested this can be used to detect MI.
The rate of false alarms is so high and the rate of failure to diagnose MI so low that this is a useless measure and should not provide any patient reassurance.
The writer of this story and the editors at 9-5 Mac should be ashamed of this misinformation.
Several other news sources have needlessly muddied the water on this question including Healthline and Fox News:
In clear cut cases the Apple Watch could make the difference between life and death,” says Roger Kay, president of Endpoint Technologies Associates. Because you wear the Apple Watch at all times, it can detect an early sign of a stroke or a heart attack, and that early indication is critical, he says.
And the Healthline article on the new Apple Watch also incorrectly implies it can diagnose MI:
The device, which was unveiled last week, has an electrocardiogram (ECG) app that can detect often overlooked heart abnormalities that could lead to a heart attack.
And if you are felled by a heart problem, the fall detector built into the Apple Watch Series 4 could alert medical professionals that you need help
Fox News and Healthline should modify their published articles to correct the misinformation they have previously provided.
And it is still true that although both Apple Watch and Kardia can diagnose atrial fibrillation the vast majority of the time acute heart attacks are not associated with atrial fibrillation.
Readers, please spread the word far and wide to friends and family-Apple Watch cannot detect heart attacks!
My first patient this morning, a delightful tech-savvy septagenarian with persistent atrial fibrillation told me she had been monitoring her rhythm for the last few days using her Apple Watch 4’s built in ECG device.
I had been eagerly awaiting Apple’s roll out since I purchased the AW4 in September (see here) and between patients this morning I down-loaded and installed the required iPhone and Watch upgrades and began making AW4 recordings.
Through the day I tried the AW4 and the Kardia on patients in my office.
Apple Watch 4 ECG Is Easy and Straightforward
The AW4 ECG recording process is very easy and straightforward. Upon opening the watch app you are prompted to open the health app on your iPhone to allow connection to the Watch ECG information. After this, to initiate a recording simply open the Watch ECG app and hold your finger on the crown.
Immediately a red ECG tracing begins along with a 30 second countdown.
Helpful advice to pass the time appears below the timer:
“Try Not to move your arms.”
“Apple Watch never checks for heart attacks.”
When finished you will see what I and my patient (who mostly stays in sinus rhythm with the aid of flecainide) saw-a declaration of normality:
Later in the day I had a few patients with permanent atrial fibrillation put on my watch.
This seventy-something farmer from Bowling Green, Missouri was easily able to make a very good ECG recording with minimal instruction
The AW4 nailed the diagnosis as atrial fibrillation.
We also recorded a Kardia device ECG on him and with a little more instruction the device also diagnosed atrial fibrillation
After you’ve made an AW4 recording you can view the PDF of the ECG in the Health app on your iPhone where all of your ECGs are stored. The PDF can be exported to email (to your doctor) or other apps.
Apple Watch Often “Inconclusive”
The AW4 could not diagnose another patient with permanent atrial fibrillation and judged the recording “inconclusive”
The Kardia device and algorithm despite a fairly noisy tracing was able to correctly diagnose atrial fibrillation in this same patient.
I put the AW4 on Sandy, our outstanding echo tech at Winghaven who is known to have a left bundle branch block but remains in normal rhythm and obtained this inconclusive report .
Kardia, on the other hand got the diagnosis correctly:
One Bizarre Tracing by the AW4
In another patient , an 87 year old lady with a totally normal recording by the Kardia device, the AW4 yielded a bizarre tracing which resembled ventricular tachycardia:
Despite adjustments to her finger position and watch position, I could not obtain a reasonble tracing with the AW4.
The Kardia tracing is fine, no artifact whatsoever.
What can we conclude after today’s adventures with the Apple Watch ECG?
This is an amazingly easy, convenient and straightforward method for recording a single channel ECG.
I love the idea that I can record an ECG whereverI am with minimal fuss. Since I wear my AW4 almost all the time I don’t have to think about bringing a device with me (although for a while I had the Kardia attached to iPhone case that ultimately became cumbersome.)
Based on my limited sample size today, however, the AW4 has a high rate of being uncertain about diagnoses. Only 2/3 cases of permanent atrial fibrillation were identified (compared to 3/3 for the Kardia) and only 4/6 cases of sinus rhythm were identified.
If those numbers hold up with larger numbers, the AW4 is inferior to the Kardia ECG device.
I’d rather see the AW4 declare inconclusive than to declare atrial fibrillation when it’s not present but this lack of certainty detracts from its value.
What caused the bizarre artifact and inconclusive AW4 tracing in my patient is unclear. If anybody has an answer, let me know.
We definitely need more data and more studies on the overall sensitivity and specificity of the AW4 and hopefully these will be rapidly forthcoming.
For most of my patients the advantages of the AW4 (assuming they don’t already have one) will be outweighed by its much greater cost and we will continue to primarily utilize the Kardia device which will also allow me to view all of their recordings instantaneously in the cloud.
Note. The original version of this post had the wrong ECG tracing for the first “inconclusive” AW4 recording of a patient with permanent atrial fibrillation. H/t to discerning reader Vignesh for pointing this out months after the initial posting.
One of my patients has been on the cutting edge of personal cardiac monitoring devices and I asked him to share his recent experience with the QardioCore ECG strap. What he sent me is a fascinating description of how the device works (which is unique in this area) along with how it was crucial in diagnosing the cause of his recent symptoms. I’m sharing it below.
“QardioCore is a clinical-quality wearable electrocardiogram recorder. An electrocardiogram – often abbreviated as ECG or EKG – is a test that measures the electrical activity of the heart. With each heart beat, an electrical impulse (or “wave”) travels through the heart. This wave causes the muscle to squeeze and pump blood from the heart.
An ECG gives two major kinds of information. First, by measuring time intervals on the ECG, a doctor can determine how long the electrical wave takes to pass through the heart. Finding out how long the wave takes to travel from one part of the heart to the next shows if the electrical activity is normal or slow, fast or irregular. Second, by measuring the amount of electrical activity passing through the heart muscle, a cardiologist may be able to find out if parts of the heart are too large or are overworked. During an ECG, several sensors, called electrodes, capture the electrical activity of the heart.
QardioCore is ideal for health conscious individuals or those with known or suspected heart conditions to record their everyday ECGs, physical activity, sport performance and medical symptoms and share their data with their doctors. Medical professionals can use QardioCore to quickly assess heart rate and rhythm, screen for arrhythmias, and remotely monitor and manage patients who use QardioCore.
QardioCore should be only used in conjunction with professional medical advice, diagnosis, or treatment, and not as a substitute, or a replacement for it. Qardio creates products and services that conform to US quality, safety and security requirements for medical products, while delivering a modern user experience. QardioCore will begin selling in the US after receiving US Food and Drug Administration clearance.”
Unfortunately, the US FDA tends to move slowly, and we can only speculate as too why, but the device is not available for purchase here. However, I found a friend in France who purchased one for me and shipped me the device. It is not illegal for me to use the device here, but it is not allowed to be sold here in the US.
I use an Apple I-Phone 8Plus and have used both the AliveCor KardiaBand and the KardiaMobile found here (https://store.alivecor.com), and reviewed by the esteemed Skeptical Cardiologist in other posts as well. While I find it as a useful tool, my only dissatisfaction is that I want to passively monitor my heart during sporting activities and look for rhythm disturbances. While I’m no expert in either sporting activities or rhythm disturbances, I’ve completed some healthy reading and living on both subjects and have a general awareness of the topic.
The QardioCore device is simple to wear, comes with three belts that can be used and cleaned, and comes with a charging cable. Everything that the app, and the product does, seems to be accurately described on their web site, so I won’t cover off on details here. You can read more about it at this link: https://www.getqardio.com/qardioapp/My only dissatisfaction with this device, and other blue tooth devices, has nothing to do with the device itself. Apple seems to randomly disconnect from Bluetooth devices with their phones. I don’t pretend to know the specific mechanisms for the problem, but my blue tooth devices for bicycling, music headsets, and heart monitoring have all been plagued with intermittent blue tooth connection problems. So, at times, I find myself having to restart their app to keep the device connected, which is a minor annoyance.
I also use the QardioArm product to measure and monitor my blood pressure and am satisfied with it as well.
What follows is my anecdotal experiences of September 26, 2018 through the present day and I agreed to write about them here, in case it provides useful insight to others in some way.
As a person with a short-term history of heart problems, I tend to capture a lot of data with my devices. I monitor things like heart rate variability, blood pressure, Alivecor Kardia readings, sleep history, etc. I make an active attempt to monitor my levels of stress, but I know for certain that I lead a stressful life.I work longer hours than I should, probably sleep less than I should, exercise less than I like and should, and medicate and pray far less than I should.So, I don’t want to imply that anything that happened is the fault of the medical system, bad blue tooth connections, bad medical care, or bad advice from the Skeptical Cardiologist or any other medical professional. I tend to listen well, learn well, but I don’t always act as I should.But, I’m responsible for my choices, my decisions, and I live with the results of my actions.
With that said, I was sitting at the office on Wednesday September 26th, 2018 and was working away without a care in the world. As a computer programmer, I’m very sedentary and enjoy my work. I was wearing my QardioCore ECG strap at the time because I’m a big believer in capturing baseline data for my general living and lifestyle. I believe this data was invaluable in my first episode of heart problems, but have no supporting evidence to support my claim. At around 8:58:42 AM, I felt somewhat bad, and felt my heart racing. I glanced over at my phone which was showing the ECG trace at the time and noticed what I believed was Atrial Flutter at the time. But, after about 20 seconds, the ECG trace returned to normal, and I felt fine again. I made a quick note of the time, because I was busy, and continued working for the day.The Quardio App provides no diagnostic information, so it doesn’t analyze and interpret ECG patterns like the Alivecor Kardia app does. When I arrived at home later that day, I went back to look at the ECG trace, as the Quardio App easily allows that through features of the App. When I found the point in time of the ECG, I became concerned immediately because I believe that I was seeing a pattern that I recognized as Ventricular Tachycardia, a condition that comes in many forms, and has many causes, but can be fatal if not properly treated. As my cortisol levels increased, I contacted Dr. Google and just quickly verified that I wasn’t completely nuts, although I acknowledge there may be some partial nuttiness there. While going through this process, I experienced another 4 second episode which only increased my anxiety levels. After contacting my wife and asking her to return home, and informing some family members, I felt it best that I should contact the Skeptical Cardiologist after hours for input on my problem. I hate to bother the doctor, as he is a busy man, but contacted his after-hours number.While the operator on the other end of the line wondered what kind of nut case I was, she kindly contacted the doctor who promptly called me on my cell phone.I had informed the kind doctor that I had the device about three weeks prior, so he was already aware that I had the QardioCore. I quickly informed the doctor that I believed I had experienced at least one but possibly two cardiac events. After briefly talking, I hung up the phone and texted him photos of the screens from the Quardio App, so he could see the ECG tracings. Here are the photos that I sent to the Skeptical Cardiologist via text:
I believe this tool is valuable in many ways, but I believe that it was helpful for the Skeptical Cardiologist, as it helped narrow our focus of blood tests, scans, and potential procedures to run in a faster than normal basis. Normally, if I had not had evidence (accurate or not), I would have had to schedule an appointment, or go to ER. At that point, they would have either ordered an event monitor for me to wear while I was away from the hospital, or they would have had to admit me. Since I had a past history of Atrial Fibrillation, which isn’t quite as serious, we would have been sent home with an event monitor and instructions to take it easy and continue to take meds. We would have run more blood work, and more scans, but the point is that we would have been more broadly focused, as we would have had to generally guess as to the nature of the event and narrow it down.
I recognize that this is one of the controversies that is active in clinical cardiology, as I listen to podcasts by Dr. John Mandrola and others regarding the latest cardio devices, procedures and research. I realize that many Cardiologists are not in favor of devices like these, because they lead to uninformed conclusions, which leads to unneeded stress on both patients and their stressed-out doctors and cardiologists. I’ve listened to both sides of the argument, and I have my own opinions that I won’t express here. I will just say that I believe that this device saved me time, possibly my life (as I don’t know what I don’t know, unless I know to look), and some time in hastening and narrowing my therapy choices.
I will say that my wife and I were extremely happy with the services provided by his staff, himself, his colleagues, and the hospital staff as well. While I am confident I may be considered a difficult patient by some, or many, they were very thorough and kind in their treatment and explanation of my treatment options.
I hope that my experience adds helpful insight to the discussion. I’m confident that the Skeptical Cardiologist will add to this post, with his views on the events I’ve discussed above. And, I believe he appreciates having a Skeptical Patient every now and then as well.
As The Skeptical Patient wrote, this device is not sold in the United States. Having seen it in action now, I’m eager to get my hands on one and evaluate it further. It could dramatically alter home arrhythmia monitoring. For this patient it was incredibly helpful. If any of my European or Australian readers has experience with it please let me know.
Qardio makes a stylish, accurate and portable home BP monitor that I’ve written favorably about here.
N.B. Featured image of man running on beach with QardioCore is not of my patient.