Category Archives: Atrial Fibrillation

Has REDUCE-IT Resurrected Fish OIl Supplements (And Saved Amarin)?

The answers are no and yes.

There is still no reason to take over the counter fish oil supplements.

In fact, a study published Saturday found that fish oil supplementation (1 g per day as a fish-oil capsule containing 840 mg of n−3 fatty acids, including 460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]

did not result in a lower incidence than placebo of the primary end points of major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type.

However, another study  published Saturday (REDUCE-IT) and presented at the annual American Heart Association Scientific Sessions to great fanfare found that an ethyl-ester formulation (icosapent ethyl) of eicosapentanoic acid (EPA, one of the two main marine n-3 fish oils)  reduced major cardiovascular events by 25% in comparison to placebo.

When I wrote about Icosapent ethyl (brand name Vascepa) in a previous blog post in 2015 there was no data supporting its use:

A fish oil preparation, VASCEPA,  available only by prescription, was approved by the FDA in 2012.

Like the first prescription fish oil available in the US, Lovaza, VASCEPA is only approved by the FDA for treatment of very high triglycerides(>500 mg/dl).

This is a very small market compared to the millions of individuals taking fish oil thinking that  it is preventing heart disease.

The company that makes Vascepa (Amrin;$AMRN)would also like to have physicians prescribe it to their patients who have mildly or moderatelyelevated triglycerides between 200 and 500 which some estimate as up to 1/3 of the population.

The company has a study that shows that Vascepa lowers triglycerides in patients with such mildly to moderately elevated triglycerides but the FDA did not approve it for that indication.

Given the huge numbers of patients with trigs slightly above normal, before approving an expensive new drug, the FDA thought, it would be nice to know that the drug is actually helping prevent heart attacks and strokes or prolonging life.

After all, we don’t really care about high triglycerides unless they are causing problems and we don’t care about lowering them unless we can show we are reducing the frequency of those problems.

Data do not exist to say that lowering triglycerides in the mild to moderate range  by any drug lowers heart attack risk.

In the past if a company promoted their drug for off-label usage they could be fined by the FDA but Amarin went to court and obtained the right to promote Vascepa to physicians for triglycerides between 200 and 500.

Consequently, you may find your doctor prescribing this drug to you. If you do, I suggest you ask him if he recently had a free lunch or dinner provided by Amarin, has stock in the company (Vascepa is the sole drug made by Amarin and its stock price fluctuates wildly depending on sales and news about Vascepa) or gives talks for Amarin.

If he answers no to all of the above then, hopefully, your triglycerides are over 500.

And although elevated triglycerides confer an elevated CV risk nearly all prior trials evaluating different kinds  of triglyceride-lowering therapies, including extended-release niacin, fibrates, cholesteryl ester transfer protein inhibitors, and omega-3 fatty acids have failed to show reductions in cardiovascular events

REDUCE-IT, Amarin trumpeted widely in September (before the actual data was published)  now provides impressive proof that it prevents cardiovascular disease. Has the skeptical cardiologist changed his mind about fish oil?

Vascepa Is Not Natural Fish Oil

Although Amarin’s marking material states “VASCEPA is obtained naturally from wild deep-water Pacific Ocean fish” the active ingredient is an ethyl ester form of eicosapentoic acid (EPA) which has been industrially processed and distilled and separated out from the other main omega-3 fatty acid in fish oil (DHA or docosohexanoieic acid).

Natural fish oil contains a balance of EPA and DHA combined with triacylglycerols (TAGS).

So even if the REDUCE-IT trial results can be believed they do not support the routine consumption of  over the counter fish oil supplements for prevention of cardiovascular disease.

Does REDUCE-IT  Prove The Benefit of Purified High Dose EPA?

REDUCE-IT was a large (8179 patients) randomized, double-blind placebo controlled trial

Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter  and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter  and had been receiving a stable dose of a statin for at least 4 weeks. In 2013 the protocol was changed and required a triglyceride level>200 mg/dl.

Participants were randomized to icosapent ethyl (2 g twice daily with food [total daily dose, 4 g]) or a placebo that contained mineral oil to mimic the color and consistency of icosapent ethyl and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group.

More importantly, the hard end-points of CV death, nonfatal stroke and heart attack were also significantly lower in the Vascepa arm compared to the “placebo” arm.

These results are almost unbelievably good and they are far better than one would have predicted given only a 17% reduction in triglycerides.

This makes me strongly consider prescribing Vascepa (something I heretofore have never done) to my higher risk patients with triglycerides over 200 after we’ve addressed lifestyle and dietary contributors.

Perhaps the high dose of EPA (4 grams versus the 1 gram utilized in most trials) is beneficial in stabilizing cell membranes, reducing inflammation and thrombotic events as experimental data has suggested.

Lingering Concerns About The Study

Despite these great results I have some concerns:

  1. The placebo contained mineral oil which may not have been neutral in its effects. In fact, the placebo arm had a significant rise in the LDL cholesterol.
  2. Enrolled patients were predominantly male and white. No benefit was seen in women.
  3. Higher rates of serious bleeding were noted in patients taking Vascepa
  4. Atrial fibrillation developed significantly more often in Vascepa patients (3.1%) versus the mineral oil patients (2.1%)

Finally, the trial was sponsored by Amarin Pharma. This is an aggressive company that I don’t trust.  The steering committee consisted of academic physicians (see the Supplementary Appendix), and representatives of the sponsor developed the protocol,  and were responsible for the conduct and oversight of the study, as well as the interpretation of the data. The sponsor was responsible for the collection and management of the data. All the data analyses were performed by the sponsor,

After i wrote my negative piece on Vascepa in 2015 a number of Amarin investors attacked me because Vascepa is the only product Amarin has and any news on the drug dramatically influences its stock price. Here is the price of Amarin stock in the last year.

The dramatic uptick in September corresponds to the company’s announcement of the topline results of REDUCE-IT. Since the actual results have been published and analyzed the stock has dropped 20%.

High Dose Purified and Esterified EPA-Yay or Nay?

I would love to see another trial of high dose EPA that wasn’t totally under the control of Amarin and such trials are in the pipeline.

Until then, I’ll consider prescribing Amarin’s pills to appropriate patients* who can afford it and who appear to have significant residual risk after statin therapy*.

But, I will continue to tell my patients to stop paying money for useless OTC fish oil supplements.

Megaskeptically Yours,-

ACP

N.B.* Appropriate patients will fit the entry criteria for REDUCE-IT described below.

Patients could be enrolled if they were 45 years of age or older and had established cardiovascular disease or were 50 years of age or older and had diabetes mellitus and at least one additional risk factor. Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter (1.69 to 5.63 mmol per liter) and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter) and had been receiving a stable dose of a statin for at least 4 weeks;

So either secondary prevention (prior heart attack or stroke) or primary prevention in patients with diabetes and another risk factor.

 

 

AliveCor’s Mobile ECG With Kardia Pro Is Eliminating Any Need For Short or Long Term Cadiac Monitors For Most of My Afib patients: A Tale of Four Cardioversions

I described in detail in March (see here) my early experience in utilizing AliveCor’s KardiaMobile ECG  device in conjunction with their Kardia Pro cloud service to monitor my patient’s with atrial fibrillation (afib). Since that post the majority of my new afib patients have acquired the Kardia device and use it regularly to help us monitor their afib.

This capability has revolutionized my management of atrial fibrillation. In those patients who choose to use AliveCor there is really no need for long-term monitors (Holter monitors, Zio patches, cardiac event monitors) and no need for patients to come to the office to get an ECG when they feel they have gone into afib.

When one of my Kardia Pro patients calls with symptoms or concern of afib, I quickly pull up their chart at Kardiapro.com and review their recordings to determine if they are in or out of rhythm. Most treatment decisions can then be handled over the phone without the need for ordering a monitor or an emergency room or office visit.

One 24 hour period will suffice to show how important KardiaPro is now to my management of my patients with afib

A Day In The Afib Life

Tuesdays I spend the day working in the heart station at my hospital. Typically, on these days I will supervise stress tests, read ECGs and echocardiograms, perform TEES and electrical cardioversions. On a recent Tuesday I had 3 patients scheduled for cardioversion of their atrial fibrillation.

The day before one of these patients called indicating that he suspected he had reverted back to normal rhythm (NSR) based on his Kardia readings. He had had a prior cardioversion after which we know (thanks to daily Kardia recordings) he reverted to afib in 5 days. Subsequently we had started him on flecainide, a drug for maintenance of NSR and scheduled him for the cardioversion.

Not uncommonly after starting flecainide patients will convert to NSR but if they don’t we  proceed to an electrical cardioversion.

I logged into KardiaPro and reviewed his dashboard and sure enough his last two ECGs showed sinus rhythm. I congratulated him on this and we canceled his cardioversion for the next day, saving the lab the time and expense of a cancellation the day of the procedure. The patient avoided much stress, time and inconvenience.

Screen Shot 2018-10-13 at 7.27.49 AM
ECG recordings showing the patient had transitioned from afib (bottom two panels) to NSR (top two panels) after starting flecainide.

It is important to note that in this patient there was no great jump in heart rate with afib compared to NSR. For many patients the rate is much higher with the development of afib and this is often detected by non ECG wearable monitors (like an Apple Watch.)  But for patients like this one, an ECG is the only way to know what the rhythm is.


A second patient with afib who had elected not to acquire an AliveCor ECG device showed up for his cardioversion on Tuesday and after evaluating his rhythm it was clear he had spontaneously reverted back to NSR.  Prior to my adoption of KardiaPro this was a common and scenario.


The third scheduled cardioversion of the day showed up in afib and we successfully cardioverted him back to NSR. I had not addressed utilizing AliveCor with him. Prior to the procedure he asked me about likely outcomes.

My standard response to this question is that we have a 99.9% success rate in converting patients back to NSR at the time of the cardioversion. However, I can’t predict how long you will stay in NSR after the cardioversion. NSR could last for 5 days or it could last for 5 years. Adding medications like flecainide or amiodarone can significantly reduce the risk of afib recurrence after cardioversion.

At this point he asked me “How do I know if I am in afib?” Whereas many afib patients immediately feel bad and are aware that they have gone out of rhythm, this man like many others was not aware.

Prior to AliveCor my answer would have been to check the pulse daily or look for evidence of high or irregular heart rates on BP monitors or fitness wearables. This scenario provided a wonderful opportunity to test the AliveCor’s accuracy at detecting AF in him. I pulled out my trusty AliveCor mobile ECG and prior to the cardioversion we made the recording below

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After the cardioversion we repeated the Alivecor recording and the rhythm (AliveCor’s interpretation) had changed from afib  to NSR.

Needless to say, this patient purchased a Kardia device the next day and since the cardioversion he’s made a daily recording which has confirmed NSR. I just logged into Kardia Pro and sure enough he made a recording last night and it showed NSR.


Later in the week I received a call from a patient I had electrically cardioverted a few days earlier. His Kardia device had detected that he had gone back into afib.

I logged into my Mac and saw his KardiaPro chart below.

Kardia Pro displays green dots corresponding to NSR and orange triangles corresponding to afib with 100% accuracy in this patient.

 

 

With perfect precision KardiaPro had verified NSR after the cardioversion lasting for 36 hours. For some reason after dinner the day after the cardioversion, the patient had  reverted back to afib. This knowledge greatly facilitates subsequent treatment and eliminates the need for in office ECGs and long term monitors.


Utilization of the Kardia device with the Kardia Pro monitoring service has proved for me to b a remarkable improvement in the management of patients with afib. Managing non Kardia afib patients feels like navigating a forest with a blindfold.

The improvement is so impressive that I find myself exclaiming to my assistant, Jenny, several times a week “How do other cardiologists intelligently care for afibbers without AliveCor?”

I have a few patients who balk at the 15$ per month charge for Kardia Pro and ask why the device and this monthly charge aren’t covered by insurance or Medicare. Given the dramatic reduction that I have noticed in my use of long-term monitors  as well as  office and ER visits in this population, CMS and third-party insurers would be wise to explore Kardia monitoring as a more cost-effective way of monitoring afib patients.

antifibrillatorily Yours

-ACP

N.B. I realize this post appears to be an unmitigated enthusiastic endorsement of a commercial product which is quite uncharacteristic for the skeptical cardiologist.

One might wonder if the skepcard is somehow biased or compensated for his endorsement of Kardia.

In all honesty, this sprung from my love of the device’s improvement in my afib management and I have received no payment, monetary or otherwise from AliveCor and I own none of their stock (and I’m not even sure if it is on the stock market.)

A Review Of The QardioCore ECG Strap From A Patient’s Perspective

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.


I’m a current patient of the Skeptical Cardiologist and have experienced recovery from 14 months of Atrial Fibrillation with Rapid Ventricular Response, and subsequent heart failure.   While I haven’t had symptoms of heart failure or Atrial Fibrillation in over 6 months, as a former long-distance cyclist, I had been following the progress for the FDA approval of the QardioCore device since it was announced over a year ago.   You can learn more about their device at https://www.getqardio.com/qardiocore-wearable-ecg-ekg-monitor-iphone/, but I’ve pasted text from their website here: (https://support.getqardio.com/hc/en-us/articles/115000257105-Electrocardiogram-ECG-EKG- )

“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:

 

 

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IMG_6829

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.

Qardiodynamically Yours,

-ACP

N.B. Featured image of man running on beach with QardioCore is not of my patient.

Apple’s Alternative Facts And The Giant Watch Restaurant Next Door To AliveCor

As I pointed out Friday,  Apple’s claim that the ECG sensor on their new Apple Watch 4  (available “later this year”) is  “the First ECG product offered over the counter directly to consumers” is totally bogus.

AliveCor’s Kardia mobile ECG device was approved by the FDA  for over the counter direct to consumer sales on February 10, 2014. Apple had to have known this as they worked with AliveCor to bring the first Apple Watch based ECG device to FDA approval in 2017.

I tried but failed to get AliveCor founder Dr. David Albert’s thoughts on Apple’s disinformation but Yahoo finance was able to speak to Vic Gundotra, the CEO of AliveCor:

Over at the headquarters of AliveCor, a startup based in Google’s hometown of Mountain View, they, too, were surprised by the announcement, CEO Vic Gundotra said in a phone interview on Thursday. Gundotra is a former Googler, widely known as the executive behind the Google+ social network.

Specifically, Gundotra says that his company was confused by Apple’s claims that the Series 4 will be the first over-the-counter ECG testing device for consumers. AliveCor is a 49-employee startup that makes over-the-counter ECG testing devices and software, including an FDA-cleared band for the Apple Watch, called KardiaBand, and a version that attaches to a smartphone, called Kardia.

Gundotra was also surprised by Apple’s claims of ECG primacy

“We were watching [the announcement], and we were surprised,” Gundotra said. “It was amazing, it was like us being on stage, with the thing we’ve been doing for 7 years,” referring to AliveCor’s product for detecting atrial fibrillation  (AFib), a tough-to-spot heart disorder that manifests as an irregular, often quick heart rate that can cause poor circulation.

“Although when they said they were first to go over-the-counter, we were surprised,” he continued. “Apple doesn’t like to admit they copy anyone, even in the smallest things. Their own version of alternative facts.”

One man’s alternative fact is another (less polite) man’s lie.

Gundotra apparently views Apple’s entry as a good thing

“We love that Apple is validating AFib; just wait until you see what AliveCor is going to do next,” he said. “We were a great restaurant in a remote section of town, and someone just opened a giant restaurant right next to us, bringing a lot more attention.”

And as I pointed out previously, the AliveCor mobile ECG device (not the Kardia Band) is significantly cheaper than an Apple Watch and has multiple studies showing its accuracy. Interestingly, Gundotra indicates AliveCor sales has increased after the Apple announcement,.

“Ours is $99, theirs is $399, our sales popped yesterday, big time,”

Antialternafactively Yours,

-ACP

The New Apple Watch 4: Cardiac Accuracy Unknown, “Game-Changing” Benefits Overblown

On February 10, 2014 AliveCor, Inc. announced that its heavily validated personal  mobile ECG monitor had received FDA over-the counter clearance. Previously the device, which allows recording of a single-lead ECG and, in conjunction with a free smart-phone app, can diagnose atrial fibrillation was only available by prescription.

Since 2013, I have been successfully using this device with my patients who have atrial fibrillation (and writing about it extensively)

Apple COO Jeff Williams standing in front of (presumably) an ECG obtained by Apple Watch 4. It’s OK quality (but smallish p waves). Is that the best they could do? Notice that it is making a diagnosis of sinus rhythm. This PDF can be mailed “to your doctor.”

I was shocked, therefore, to hear the COO of Apple, Jeff Williams, announce that Apple will be offering in its new Apple Watch 4  “the first ECG product offered over the counter directly to consumers.”

This seemed blatantly inaccurate as AliveCor’s device clearly preceded by 4 years Apple’s claim.

Furthermore, AliveCor’s Kardia Band which converts any Apple Watch into a single-lead ECG  (which I’ve written about here and here) has been available and providing the Apple Watch-based ECGs since November 30, 2017.

AliveCor has an outstanding website which documents in detail all the research studies done on their products (there are dozens and dozens of linked papers) and all of their press releases dating back to 2012. It also explains in detail how the product works.

The title of their November 30, 2017 release was  FDA Clears First Medical Device Accessory for Apple Watch®

AliveCor shortly thereafter (December 12, 2017) announced Smart Rhythm , an Apple Watch app that monitors your rhythm and alerts you if it thinks you are in atrial fibrillation. I’ve discussed Smart Rhythm here.

Apple’s Watch will tell you that you are not in atrial fibrillation. Given that we don’t know how accurate it is, should that be reassuring?

The new Apple Watch’s rhythm monitoring app sounds a lot like Smart Rhythm but without any of the documentation AliveCor has provided.

So, within 10 months of Alivecor providing the world with the first ever wearable ECG (and proven its accuracy in afib) Apple seems to have come out with a remarkably similar product.

The major difference between Apple and AliveCor is the total lack of any reviewable data on the accuracy of the Apple device. Yes, that’s right Apple has provided no studies and no data and we have no idea how accurate its ECG device is (or its monitoring algorithm).

For all we know, it could diagnose sinus rhythm with frequent APCS or PVCs consistently as atrial fibrillation, sending thousands of Watch 4 wearers into a panic and overloading the health care system with meaningless alerts.

Apple’s website claims

Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram. It’s a momentous achievement for a wearable device that can provide critical real-time data for doctors and peace of mind for you.

Apple’s “momentous achievement” was actually achieved 10 months earlier by AliveCor and if its monitoring algorithm and ECG system are significantly worse than the proven AliveCor system they will be destroying the peace of mind of users.

Electrodes built into the Digital Crown and the sapphire back crystal allow sensing of cardiac electrical signals. Did Apple get this idea from AliveCor?

After describing the Apple Watch’s new health features, Jeff Williams introduced Ivor Benjamin, MD, the President of the American Heart Association. Benjamin proceeded to describe the new Apple Watch cardiac features as “game-changing”, noting that the AHA is committed to helping patients be “proactive.”

Does  Benjamin have access to the accuracy of the Apple Watch ECG sensor? If so, he and the AHA should immediately share it with the scientific community. If not, by endorsing this feature of the Watch he should be ashamed. Users need to know if he or the AHA was paid any money for this appearance. Also, we should demand to know if (as the prominent AHA logo suggested and news reports implied) the AHA is somehow endorsing the Apple Watch.

Frequent readers know I’m a huge Apple fan but this Apple Watch business makes me think something is rotten in the state of Apple.

Skeptically Yours,

-ACP

Update On The Kardia Band Apple Watch Accessory: Accuracy In Atrial Fibrillation Pre and Post Cardioversion

As I described here, the Kardia Band (KB) is an FDA-approved Apple Watch accessory available to the general public without a prescription which records a high quality single-lead ECG.

I’ve been using mine now for a while and can confirm the ease and accuracy of the ECG recordings it makes. I find recordings made with my Apple Watch/Kardia Band are reliably high quality with minimal artifact (unless I’m running on a treadmill.)

Once the 30 second recording is completed, the Kardia app on the Apple Watch takes about 5 seconds to process the information using an AI algorithm and then makes a determination of normal sinus rhythm (NSR), atrial fibrillation or unclassified.

 

 

The New Study

A study published in the June JACC examined the accuracy of  Alivecor’s Kardia Band in detecting atrial fibrillation (AF.)

In the JACC study, investigators from the Cleveland Clinic studied  100 consecutive patients presenting for cardioversion from AF with recordings made before  and after the procedure. KB interpretations were compared to 12 lead ECGS read by electrophysiologists.

KB interpretations  identified AF with  93% sensitivity and 84% specificity. Of the total 169 recordings, 34% were unclassified due to short recordings, low-amplitude p waves, and baseline artifacts.

The authors concluded that the KB algorithm for AF detection, when it is supported by a physician review can reliably differentiate AF from NSR.

(Of note the lead author on this study is on the advisory board of Alivecor the maker of the KB and AliveCor (AliveCor, Mountain View, CA) provided the Kardia Band monitors which were connected to an Apple Watch and paired via Bluetooth to a smartphone device for utilization in the study. AliveCor was not involved in the design, implementation, data analysis, or manuscript preparation of the study.)

My Updated Kardia Experience

I have found the standard Kardia device to be immensely helpful in the management of my afib patients before and after cardioversions (see my prior description here). The paper mentions that 8% of these pre-cardioversion patients showed up for the procedure in normal sinus rhythm, noting that

For each of these patients, the automated KB algorithm did not erroneously identify AF, and the physician interpretation of the KB recording correctly confirmed SR in each case.

Needless to say, it is better to find out a cardioversion is not needed before the patient shows up for the procedure. I would estimate this happens about 5-10% of the time in my practice.

The Kardia device or the KB is also really helpful post cardioversion. If the patient makes daily recordings (which I can review on Kardia Pro online) h/she and I know exactly how long sinus rhythm persisted before reverting back to AF.

This is important information which impacts future management decisions.

Kardia Band Versus Standard Kardia Device

None of my patients have purchased the Kardia Band most likely due to the cost and the fact that they don’t have an Apple Watch. If you have an Apple Watch and want to monitor your heart rhythm I think the KB is a good choice. Otherwise, the original AliveCor mobile ECG device continues to do a fantastic job (in conjunction with Kardia Pro, see here).

The combination of Kardia and Kardia Pro has substantially reduced my use of expensive and annoying long term monitors in my AF population.

In my next update on the KB I will share a reader’s real world description of the pros and cons of the KB (with Smart Rhythm monitoring) in a patient post cardioversion for AF.

Skeptically Yours

-ACP

Is It Safe To Consume Grapefruit If You Take The Blood Thinner Apixiban (Eliquis)?

A patient of mine with atrial fibrillation taking the blood thinner eliquis told me that she had eaten grapefruit for two days in a row and then developed a nose bleed. She had heard of the interaction between grapefruit and certain medications and wondered if this had caused her nose bleed.

I was unaware of any eliquis/grapefruit interaction but thought this was a remarkably astute observation and question and set about to research it properly.

Among other things, I discovered that some researchers believe the grapefruit-drug interaction to be a widespread , underreported and  highly significant problem while others feel it is overblown and a rare cause of clinically important side effects.

For those, who prefer not to delves into the gory details I give you the crux of what BMS/Pfizer, the makers of apixiban (Eliquis) told me and with which I agree:

When consumed in usual dietary volumes, grapefruit juice is considered a moderate inhibitor of CYP3A4. Therefore a dose adjustment of apixaban is not expected to be required.

In other words, although not formally studied, there is no evidence that apixiban levels are increased by moderate grapefruit juice ingestion to a degree that would cause significant bleeding complications.

Although multiple sites on the internet (including the unreliable Web MD) will tell you of a potentially dangerous interaction between grapefruit and apixiban this theoretical interaction has not proven clinically significant.

Interactively Yours,

-ACP

Below is the full text of the letter BMS sent me

Bristol-Myers Squibb and/or Pfizer have not conducted any studies evaluating the concomitant use of apixaban and grapefruit juice. The decision to prescribe apixaban in patients who are concomitantly taking grapefruit juice is a clinical decision for the treating physician based on the individual’s circumstances and inaccordance with the full prescribing information for apixaban.

While in vitro data indicates grapefruit juice can inhibit both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp), clinical evidence suggests that grapefruit juice mediated interactions would be primarily due to the inhibition of CYP3A4 and the contribution of P-gp inhibition may be limited.1, 2 When consumed in usual dietary volumes, grapefruit juice is considered a moderate inhibitor of CYP3A4.1 Therefore a dose adjustment of apixaban is not expected to be required.

Apixaban is eliminated from the body through multiple pathways, with approximately 25% of the administered dose recovered as metabolites. The main metabolic pathway for apixaban is through CYP3A4/5, with minor contributions from other CYP isoenzymes. Apixaban is also a substrate of transport proteins P-gp and breast cancer resistance protein.3

  1. [1]  Hanley MJ, Cancalon P, Widmer WW,et al. The effect of grapefruit juice on drug disposition. Expert Opin Drug Metab Toxicol. 2011; 7(3):267-286.
  2. [2]  Farkas DG and Greenblatt DJ. Influence of fruit juices on drug disposition: discrepancies between in vitro and clinical studies. Expert Opin Drug Metab Toxicol. 2008;4(4):381-393.
  3. [3]  Eliquis® (apixaban) Package Insert. Bristol-Myers Squibb Company, Princeton, NJ and Pfizer Inc, New York, NY

Why I Favor The Early Restoration and Maintenance of Sinus Rhythm In Most Patients With Atrial Fibrillation

When your heart stops beating synchronously and goes into atrial fibrillation all sorts of bad things begin happening. The normal mechanisms for controlling how fast your heart is beating are lost and in most individuals the rate accelerates inappropriately. The strength of the atria’s pumping force and the normal precise synchronization of the upper and lower chambers  deteriorates.

You might logically conclude then, that all efforts should be focused on converting the rhythm back to normal,  for in the normal rhythm the heart can go back to beating regularly, efficiently  and synchronously the way nature intended.

Maintenance of this normal (sinus) rhythm (NSR), presumably, will eliminate the high risk of clot formation and stroke associated with atrial fibrillation (AF) , prevent heart failure, and prolong life.

AF is abnormal. the thinking goes, and normality is the state in which we were born and to which we should seek to return.

Is Normal Sinus Rhythm Superior to Atrial Fibrillation?

It would be hard to find a cardiologist who doesn’t believe that patients are better off in NSR than AF but the more difficult question and more clinically relevant question is “if your heart has gone into atrial fibrillation will you do better in the long run with a strategy of trying to convert the rhythm back to normal and keep it there (which involves medications (anti-arrhythmic drugs) and/or procedures) versus just controlling the heart rate and letting the atria fibrillate to their heart’s content.

Unfortunately, studies that have compared the  strategy of maintaining NSR (rhythm control) with leaving the heart to fibrillate have not shown a benefit in preventing stroke or death in the patients randomized to rhythm control

To quote the 2016 European Society of Cardiology  guidelines on AF

Although many clinicians believe that maintaining sinus rhythm can improve outcomes in AF patients, all trials that have compared rhythm control and rate control to rate control alone (with appropriate anticoagulation) have resulted in neutral outcomes.

(see references for this below)

However, findings from these studies can only be applied to the population studied, thus younger patients without structural heart disease and patients over age 80, who combined constitute up to 50% of the AF group were not represented in these comparison studies.

The elderly are more dependent on normal atrial function for maintenance of cardiac output and are more likely to have issues with anticoagulation, thus they may benefit more from maintenance of NSR than the young.

In addition, much of the morbidity and mortality in these trials was related to failure to anticoagulate patients who were in NSR. The stroke risk persists in this group, we have learned, because they may not recognize when AF occurs. Therefore, most authorities recommend lifelong  anticoagulation for those who have had  AF and have significant risk factors for stroke whether they

These and other  reasons for the  failure of the so-called rhythm strategy have long been debated but most experts blame it on the absence of a safe and effective method for maintaining NSR: the drugs  and procedures (catheter ablations) we have used create their own problems and don’t always work.

Why Then, Do I And Most Cardiologists Recommend Efforts To Maintain Normal Sinus Rhythm?

This is a question almost no AF patients ask. It is quite easy for a treating cardiologist to invoke the “normality” of NSR and the dangers of AF and most AF patients require no more justification. But they really should demand a compelling rationale.

For those who feel badly in AF despite treatment with medications to keep the heart rate normal cardiologists can justify the efforts because we are making patients feel better

The ESC guideline summarizes this as follows

For now, rhythm control therapy is indicated to improve symptoms in AF patients who remain symptomatic on adequate rate control therapy.

However, there are important limitations to letting symptoms guide our approach.

For one, symptoms are in the mind of the patient and cannot be measured objectively. For another, the symptoms a patient experience could be from something other than AF.

You might think that we can objectively verify that symptoms are due to atrial fibrillation if they resolve after converting the patient to sinus rhythm but symptoms can be heavily influenced by the patient’s perception that something has been done to fix them. This placebo effect is well-known from clinical trials of medications but may be even more prominent after procedures.

It is not uncommon for me to perform a cardioversion on a patient , see the patient in follow-up in AF and have them tell me how tremendous they have felt since the cardioversion.

The difficulty of objective symptom measurement is one of many factors contributing to  a tremendous variability in how cardiologists approach rhythm control  for AF.

Some cardiologists have concluded that maintaining SR is rarely worth the trouble and they add rate controlling medications and anticoagulants and see the patient back once a year. Let’s call these NSR Nihilists

On the other end of the spectrum, cardiologists who are true believers in the value of NSR run their patients through multiple anti-arrhythmic drugs, cardioversions and ablations to achieve that goal. When this is done excessively such cardiologists become NSR Overtreaters.

I put myself somewhere in between the Nihilists and the Overtreaters and consider myself a rational NSR advocate or enthusiast but one who has a very clear understanding of the dangers of over treatment and who recognizes that many patients have done well for decades in permanent AF.

Recording and observation of symptoms depends heavily  on the recorder and observer: the Nihilists are loath to find symptoms attributable to AF whereas the Overtreater may see any and all symptoms as due to AF.

Like other areas in life and medicine we have to look closely at hidden motivations and conflicts of interest to fully understand variations in behavior.

If one were to analyze the financial benefit from testing and procedures to treating cardiologists I have no doubt that the Overtreaters are getting a lot more than the Nihilists.

In an ideal world, cardiologists would not benefit more financially based on what procedures they recommend be performed on their patients but this is not the reality.

Reasons For NSR Maintenance Beyond Symptoms

 I’ve mentioned two solid reasons for aggressively trying to maintain NSR in a previous post:

A second group of patients, I think, benefits the most from maintaining sinus rhythm (rhythm control strategy): patients who develop heart failure when they go into AF.

These patients may not even know they are in AF because they don’t feel the typical symptoms initially.  After a few days or weeks or months of being in afib silently, however, they develop shortness of breath, weakness and leg  swelling – classic signs of heart failure.

When we look at the heart of such a patient by echocardiography, we often find one of two things causing the heart failure: a weakening of the heart muscle (cardiomyopathy) or significant leakage/backflow from the mitral valve (mitral regurgitation). Following cardioversion and maintenance of SR for weeks to months, the heart muscle strengthens back to normal and/or the mitral regurgitation improves dramatically and the heart failure resolves.

The 2014 ACC guidelines for management of AF admit the lack of randomized trials supporting maintenance of NSR but cite several factors that would “favor attempts at rhythm control” with which I generally agree. These are:

  • difficulty in achieving adequate rate control,
  • younger patient age,
  • tachycardia-mediated cardiomyopathy,
  • first episode of AF,
  • AF precipitated by an acute illness
  • patient preference.

If, after discussion of the options, a patient decides they prefer no attempts at maintaining NSR,  I try to make them aware that AF begets AF. The longer they stay in AF the larger and more diseased their atria become and the harder it is to stay in NSR with any techniques. In other words, this not a decision that can easily be reversed a few years from now if they start feeling poorly.

The ACC guidelines put it this way:

AF progresses from paroxysmal to persistent in many patients and subsequently results in electrical and structural remodeling that becomes irreversible with time . For this reason, acceptance of AF as permanent in a patient may render future rhythm-control therapies less effective. This may be more relevant for a younger patient who wishes to remain a candidate for future developments in rhythm-control therapies. Early intervention with a rhythm-control strategy to prevent progression of AF may be beneficial.

Many of the factors cited for leaning toward NSR maintenance are, of course, soft and vague.  One doctor’s young patient is another doctor’s old patient. The definition of adequate rate control is unclear. What qualifies as an acute illness?

My Approach to Maintenance of NSR

I favor a more aggressive approach to maintenance of NSR. I justify this because in my experience with meticulous attention to detail and with close monitoring of patients on anti-arrhythmic drugs I have observed that most patients do better in the long run with NSR Than AF.

Over thirty years of managing patients with AF and comparing those who are left to permanently be in AF versus those who maintain NSR  I see substantial differences. Let me cite two case examples to buttress my argument.

A 75-year-old man with permanent atrial fibrillation came under my care after his cardiologist retired. He had been in AF with rate well controlled and on anticoagulation since 2008. He is active without any symptoms.

He had an echocardiogram in 2008 with the new onset of AF and it showed a normal sized left and right atria and no valvular problems.

Over 10 years,  however, the size of both his atria have dramatically increased. His current echo shows severe enlargement of his left atrium (LA volume index=72 cm3/M2) and right atrium (RA area=26 cm2). He has developed significant leakage (regurgitation)  from both his mitral and tricuspid valves.

afmrlae

This is the norm for most patients who have been in AF for a long time.

The larger the left atrium gets over time, the more dysfunctional it becomes and the more likely clots are to form in the LA appendage. Although anticoagulation dramatically reduces the formation of LA clots, patients frequently have to come off anticoagulation for surgeries, spine injections, bleeding and other issues.

Would you rather have a left atrium that has been maintained in NSR or one that is massively enlarged and dysfunctional if you have to stop your anticoagulation?

The other exam example is of a 74 year old man whose AF was detected at the time of a colonoscopy. When I saw him he was without symptoms with normal lab and cardiac testing. We attempted one cardioversion without anti-arrhythmic drugs and within two weeks he reverted back AF. He elected not to start any anti-arrhythmic drugs and repeat the cardioversion and was doing fine when I saw him 6 months later.

However, shortly after that visit he ended up in severe heart failure with severe left ventricular  dysfunction and severe mitral regurgitation at an outside hospital. This time he agreed with a more aggressive approach to maintenance of SR and after prolonged amiodarone loading and a repeat cardioversion he has maintained SR for 6 months. The function of his left ventricle has improved to near normal (LVEF has increased to 49%) and there is no significant leakage from his mitral valve.

Whereas, most patients who feel fine in AF and elect to stay in it do well there is an unpredictable but significant number who despite adequate rate control develop cardiomyopathy and valvular regurgitation with resulting heart failure.

Medical Maintenance of SR

Yes, I’m convinced that patients can safely and effectively be maintained in SR with medical therapy and the occasional cardioversion.

I try not to fall in the camp of Overtreaters but consider myself a Rational Normal Sinus Rhythm Enthusiast and Advocate.

In my practice when atrial fibrillation reaches a point that requires addition of an anti-arrhythmic medication  I predominantly utilize two such drugs: amiodarone and flecainide.

Patients with structurally  normal hearts do well with flecainide and those with structural heart disease (heart failure, left ventricular hypertrophy, or significant coronary artery disease ) do well with amiodarone when they are monitored closely by a cardiologist with extensive experience using the drugs.

I’ll talk about each of these options  as well as cardiac ablation in detail in subsequent posts.

Antifibrillatorily Yours,

-ACP

Six studies showing no difference in outcomes between rhythm and rate control strategies.

AliveCor Mobile ECG : Ways To Minimize Low Voltage and Unclassified Recordings

Sometimes AliveCor’s Mobile ECG device yields unclassified interpretations of recordings. Understandably if you want to know whether your rhythm is normal or atrial fibrillation, the unclassified  classification can be very frustrating.

There are various caues of an unclassified tracing with different solutions.  Some unclassified recordings are due to a heart rate over 100 BPM or under 50 BPM and cannot be fixed. Similarly, some patients with ectopic beats like PVCS may consistently generate unclassified interpretations (see my discussion here).

Artifacts induced by poor recording techniques are common as a cause and almost always can be fixed.

These can be reduced by minimizing motion, extraneous noise, and maximizing contact with the electrodes.  Follow all the steps AliveCor lists here.

For me, the following step is crucial

  • If your fingers are dry, try moistening them with antibacterial wipes or a bit of lotion

And be aware the device needs to be near the microphone of your iPad or smartphone.

Low Voltage As Cause of Unclassified Kardia Recordings

Another cause of unclassified interpretations is a low voltage recording (which I initially discussed here.).

At the recent ACC meeting I asked Alivecor inventor and CEO David  Albert if he had any solutions to offer for those who obtain unclassified low voltage AliveCor tracings.

He told me that the cause is often a vertically oriented heart and that recording using the lead II technique can often solve the problem.

Lead II involves putting one electrode on your left knee and one your right fingers as described in this video:

Reader “J”  recently sent me a series of Kardia ECG recordings,  some of which were unclassified , some normal and one read as possible atrial fibrillation.

The unclassified and possible AF tracings looked like this:

 

They were very regular with a rate between 80 and 100 BPM but they totally lacked p waves. It was not clear to me what the rhythm was on these tracings.

Other tracings had lowish voltage but the p waves were  clearly visible  and Kardia easily classified them as normal

Lowish voltage with p waves (Type B)

 

Good QRS voltage with clear p waves ( Type B

 

Still others had improved QRS voltage with clear p waves and were also classified  appropriately as normal

 

After some back and forth emails we discovered that the ECG recordings with no p waves were always  made using the chest lead recording.   AliveCor-describes this as follows:

  • For an Anterior Precordial Lead, the device can be placed on the lower left side of the chest, just below the pectoral muscle. The bottom of the smartphone or tablet should be pointing towards the center of the body.

Mystery solved!

There is an abnormal cardiac rhythm that is regular between 80 and 100 BPM with no p waves and normal QRS called junctional tachycardia but in J’s case the absent p waves are related to the recording site.

Also, note that for this young woman the lead II voltage (Type B tracing) is much higher than the standard, lead I voltage (type A tracing).

Lead II With Pants On

After Dr. Albert told me of the advantages of Lead II I responded that it seemed somewhat awkward to take one’s pants off in order to make an ECG recording.

He immediately reached in his suit pocket and pulled out a pen-shaped device and began spraying a liquid on his left knee.

To my surprise he was able to make a perfect Lead II recording without taking his pants off!

Lessons learned from reader J and Dr. A:

  • Consider trying different leads if the standard Lead I (left hand, right hand) is consistently yielding unclassified ECG recordings
  • Try Lead II (left knee, right hand) to improve voltage and recording quality
  • You can record off your knee even with your pants on if you are prepared to spray liquids on your pants

Pantsonically Yours,

-ACP

Can AliveCor’s Mobile ECG Device Combined With Its Kardia Pro Cloud-Based Platform Replace Standard Long Term Rhythm Monitors?

In March of 2017 AliveCor introduced Kardia Pro, a cloud-based software platform that allows physicians to monitor patients who use the Kardia mobile ECG device.

I have been utilizing the Kardia mobile ECG  device since 2013 with many of my atrial fibrillation (AF)  patients and have  found it be very useful as a personal intermittent long term cardiac monitor. (see here and here)

I signed up for the Kardia Pro service about 3 months ago and all of my patients who purchased Kardia devices prior to March of 2017 have been migrated automatically to Kardia Pro by AliveCor.

Now (post March 2017),  patients who acquire a Kardia device must sign up for the Kardia Pro service at $15 per month to connect with a  physician.

I think this is money well spent and I’ll demonstrate how the service works with a few examples.

Monitoring Patients With Atrial Fibrillation

 I saw a 68 year old man with persistent atrial fibrillation that was first diagnosed at the time of pneumonia in late 2017.

He underwent a cardioversion after recovering from the pneumonia but quickly reverted back to AF. His prior cardiologist offered him the option of repeat cardioversion and long term flecainide therapy for maintenance of normal sinus rhythm (NSR) but he declined.

When I saw him for the first time in the office  a  month ago I  listened to his heart and to my surprise, noted a regular rhythm: an AliveCor recording in the office confirmed he was in NSR. The patient had been unaware of when he was in or out of rhythm

We discussed methods for monitoring his rhythm at this point which include a 24 Holter monitor, a 7 to 14 day Long Term Monitor, a Cardiac Event Monitor and a Mobile Cardiac Outpatient Telemetry device. These devices are helpful and although expensive are often covered by insurance.  They require wearing electrodes or a patch continuously and the results are not immediately available.

I also offered him the option of monitoring his AF using a Kardia device with the recordings connected to me by Kardia Pro.

He purchased the device on his own for $99, downloaded the app for his smartphone and began making recordings.

I enrolled him in my Kardia Pro account and he received an email invitation with a code that he entered which connected his account with mine, allowing me to view all of his recordings as they were made.

When I log into my Kardia Pro account I can now view a graphic display of the recordings he has made with color coding of whether they were considered normal or abnormal by Kardia.

The patient overview page also displays BP information if the patient is utilizing certain Omron devices which work with Kardia.

kardia pro wc monthly

The display shows that after our office visit he maintained NSR for 3 days (green dots) and then intermittently had ECG recordings classified as AF (yellow dots) or unclassified (black).

The more he used the device and got feedback on when he was in or out of rhythm the more he was able to recognize symptoms that were caused by AF.

I can click on any of the dots and six second strips of the full recording are displayed.  In the example below I clicked on 2/27 which has both an unclassified recording (which is atrial flutter) and an AF recording

Clicking on the ECG strips brings up  the full 30 second recording on a page that also allows me to assign my formal  interpretation. In the example below I added atrial flutter as the diagnosis, changing it from Kardia’s unclassified (Kardia’s algorithm calls anything it cannot clearly identify as AF that is over 100 BPM as unclassified.)

The ECG can then be archived or exported for entry into an EHR.

The benefits of this patient being connected
to me are obvious: we now  have an instantaneous patient-controlled method for knowing what his cardiac rhythm is doing whether he is having symptoms or not.

This knowledge allows me to make more informed treatment decisions.

The Kardia Pro Dashboard

When I  log into kardia pro I see this screen.

dashboard karia pro It contains buttons for searching for a specific patient or adding a new patient. Adding new patients is a quick and simple process requiring input of patient demographics including  email and birthdate.

From the opening screen you can click on your triage tab. I have elected to have all non normal patient recorded ECGS go into the triage tab.

Other Examples

Another patient’s Kardia Pro page shows that he records an ECG nearly every day and most of the time Kardia documents NSR in the 60s. Overall, he has made 773 recordings and 677 of them were NSR, 28 unanalyzed (due to brevity) , 13 unclassified and 55 showing AF.

Monitoring Rate  Control  In Patients With AF and Reversion Post-Cardioversion

Another patient I saw for the first time recently has had long-standing persistent AF.  His previous cardiologist performed an electrical cardioversion a year ago but the patient reverted back to AF in 40 hours.   Before seeing me he had purchased a Kardia mobile ECG device and was using it  to monitor his heart rate.

After he accepted my email invitation to connect via Kardia Pro I was able to see his rhythm and rate daily. The Kardia Pro chart belowshows his daily heart rate while in atrial fibrillation. We utilized this to guide titration of his rate controlling medications.  Such precise remote monitoring of heart rate in AF (which is often difficult to accurately assess by standard heart rate devices) obviates the need for office visits for 12 lead ECGs or periodic Holter monitors.

I performed a  second cardioversion on him after which he made  daily recordings documenting maintenance of NSR. With this system we can determine exactly when AF returns, information which will be very helpful in determining future treatment options.

Kardia Pro Plus Kardia Mobile ECG Creates Personal Intermittent Long Term Rhythm Monitor

There are many potential applications of the Kardia ECG device beyond AF monitoring (assessing palpitations, PVCs, tachycardia, etc.) but they are all enhanced when the device is combined with a good cardiologist connected to the device by Kardia Pro.

I’ve gotten spoiled by the information I get from my AF patients who are on  Kardia Pro now. When they call the office with palpitations or a sense of being out of rhythm I can determine within a minute what their rhythm is wherever I am (excluding tropical beaches and mountain tops)  or wherever the patient is (for the most part.)

On the other hand patients who are not on Kardia Pro have to come into the office for  12-lead ECGs. When they call I feel like my diagnostic tools are limited. Such patients usually end up getting one of the standard Long Term Monitoring (LTM) Devices. If I am fortunate, after a  few days to weeks , the results of the LTM will be faxed to my office.

I am optimistic based on this early experience with Kardia Pro that ultimately this service in conjunction with the Kardia Mobile ECG device (or similar products) will replace many of the more expensive and inconvenient long term monitoring devices that cardiologists currently use.

Skeptically Yours,

-ACP