Category Archives: mobile ECG

Atrial Fibrillation In The Time of Coronavirus: A Call For More Personal Remote ECG Monitoring

What is the best strategy for doctors and patients dealing with atrial fibrillation during the COVID-19 pandemic?

Clearly, at this time everyone needs to minimize visits to the doctor’s office, emergency room, urgent care center or hospital. But patients with paroxysmal atrial fibrillation by definition will have periodic spells during which their heart goes out of rhythm and many of these will occur during this period when we want to minimize contact with individuals outside the home.

In my practice, we are able to manage the majority of these episodes remotely by using a combination of personal ECG monitoring, online cloud ECG review capability, and home adjustment of medications.

Given the presence of coronavirus in the community and the potential for overload of acute care medical resources, outpatient/home management of atrial fibrillation is more important than ever.

I have described in detail in previous posts how we utilize Alivecor’s Kardia device in conjunction with the cloud-based KardiaPro subscription service to manage our afib patients remotely.  (See here and here.) The Apple Watch ECG can also be utilized for this purpose but is more expensive than Kardia and has no online review service.

With this approach we are able to minimize ER visits and hospitalizations. In addition, use of long-term monitors (which also requires a visit to an outpatient center for hook-up) has been greatly reduced.

Given heightened anxiety during the pandemic we are also seeing many patients experiencing palpitations, which are not due to their atrial fibrillation. These can be due to benign premature ventricular contractions or premature atrial contractions.

If an afib patient calls with symptoms of palpitations or rapid heart beat and they have a Kardia device or Apple Watch ECG we can review the recorded ECG, and can quickly make a determination of the cause and best treatment. If they don’t have one of these devices we have no idea what the cause is or the best treatment.

General Advice For Afib Patients 

Obviously, it would be great if patients don’t have episodes of afib during the pandemic.

Paying attention to the eight lifestyle factors which influence afib occurrence I’ve recently posted on is even more important during this stressful period. In particular, afib patients should be limiting the inclination to consume more alcohol and utilizing healthier ways to reduce stress.

Regular exercise has demonstrated benefits in reducing afib episodes and also reduces stress. Gyms are closed or closing, but with spring arriving, outside exercise is always possible. Even if you don’t have exercise equipment in your home there are many exercises you can do inside that provide cardio, strength, and flexibility training. Consider bodyweight exercises, jumping rope, hoping on to a small chair, or go find your old Richard Simmons exercise VHS tape. My wife and I have been enjoying the Seven app lately which takes us through a variety of exercises without the need for equipment. There are tens of thousands of exercise videos on YouTube.

Some afibbers find that meditation or relaxation apps or yoga helps with stress control.

Finally, make sure you have plenty of your prescription medications on hand and that you take them as prescribed without fail. Many pharmacies have home-delivery available for prescriptions.

Regarding medications, please note that good blood pressure control also reduces afib recurrence. Do not stop ACE inhibitors or ARBs as I discussed here.

A Call For More Self Monitoring

Given the importance of staying home right now, afib patients who do not have a method for self monitoring their heart rhythms should consider acquiring a Kardia device or Apple Watch.

Antifibrillatorily Yours,

-ACP

N.B. As I’ve mentioned multiple times I have no connections, financial or otherwise to Apple or Alivecor.

KardiaMobile, the original single lead personal ECG is selling for $84 right now. It’s available also on Amazon.

In my opinion, there is no compelling reason to prefer the Kardia6l, which costs $149 over the single lead KardiaMobile.

Both of these devices work with a Google or iPhone app which is free. To store recorded ECGs on Alivecor’s cloud service requires a subscription fee.

When I enroll my patients into KardiaPro I send them an email invitation which allows them to purchase the KardiaMobile plus have one year of cloud storage and connection to my KardiaPro dashboard for $120. Thereafter the one year KardiaPro service is $60/year.

Apple Watch 5 starts at $399. ECGS are stored in the iPhone app. No cloud storage. ECGs can be emailed as PDF.

Patients with Apple 4 Watches or later can send a PDF of their ECG via email or fax to their cardiologist (https://support.apple.com/en-us/HT208955). Check with your cardiologist if they can view a PDF.

NOTE: Apple has closed all of their retail stores outside of Greater China until March 27. Online stores are open at www.apple.com, or you can download the Apple Store app on the App Store so you can still buy an Apple Watch or an iPhone too.

Cheaper personal ECG devices are available. I’ve reviewed several of these and don’t recommend them. (See here and here.)

Thanks to Mark Goldstein  and Dan Field for review/editing of this post.

New Study Confirms Poor Apple Watch ECG App Sensitivity For Atrial Fibrillation

Although Apple, based on its internal research, claims that the Apple Watch (AW) ECG has a 98% sensitivity and a 99% specificity for detection of atrial fibrillation, doubts have been raised about its accuracy in the real world.

I have recently reported on Apple Watch’s inability to diagnose atrial fibrillation  (AF) when the heart rate is >120 beats per minute. This inherent limitation means AW has a built-in reduced sensitivity (which was not present in the testing group.)

In a Research Letter published online Feb. 24th in Circulation, Dr. Marc Gillinov, reports on the accuracy of Apple Watch in a population of patients who were post cardiac surgery  and therefore on cardiac telemetry with a high risk of going in and out of AF.

Rhythm assessments using the Apple Watch ECG were performed 3 times per day over 2 days on 50 patients. Comparison was made between the watch reading (Sinus rhythm, AF, or inconclusive) and an expert human interpretation of the PDF from the watch and simultaneously obtained telemetry rhythm strip.

The results were disappointing for the AW.

The AW4 notification correctly identified AF in 34 of 90 instances, yielding a sensitivity of 41%. Of 25 patients with at least 1 episode of AF, AF was identified in 19. Among patients in SR, none was designated as AF (ie, no false positives); however, rhythm was deemed inconclusive in 31% of patients, and there was no additional attempt to assess rhythm. Overall agreement between AW4 notification and telemetry was 61% (κ statistic = 0.33 [95% CI, 0.24–0.41]).

Screen Shot 2020-02-28 at 3.17.12 PM

This confirms my prediction that AW would identify less than half of AF cases.

I have to believe that the 29 cases diagnosed as “inconclusive” were due to the AW AF inherent blinding limitation related to rapid heart rate. If we presume these would all have been correctly identified as AF (if the AW had not been hamstrung) then the sensitivity increases to 70%.

The authors of this article don’t seem to understand the difference between unreadable (meaning too much artifact to make a diagnosis) versus inconclusive (which Apple only uses when the AF is > 120 BPM.) They conclude by saying:

The unreadable (ie, inconclusive) rate reported in that study was 6% compared with 31% in this pilot study.

They have muddled together unreadable and inconclusive.

I do strongly agree with their final conclusions

Variations in sensitivity between these 2 studies suggest the need for further validation before this technology is adopted by the public for AF detection. Physicians should exercise caution before undertaking action based on electrocardiographic diagnoses generated by this wrist-worn monitor.

Indeed, any diagnosis from the Apple Watch itself should be confirmed by a cardiologist who is an expert at interpreting these single-lead ECG recordings.

Conclusively Yours,

-ACP

Omron Complete Consolidates and Simplifies Home ECG and Blood Pressure Monitoring

The skeptical cardiologist has been testing out a unique and ingenious device which allows the simultaneous measurement of two key cardiovascular parameters: blood pressure and heart rhythm.  Omron partnered with AliveCor to create the Complete which is the first combination blood pressure monitor and electrocardiogram monitor.

Given that Alivecor’s Kardia Mobile ECG device is capable of accurately identifying atrial fibrillation, the Complete offers patients the ability to monitor for the two biggest treatable risk factors for stroke: atrial fibrillation and hypertension.

I have evaluated the Complete in both office and home settings and find it to be easy to use and highly reliable.

The main component of Complete is an attractive unit that measures 9 by 4 by 5 inches, weighs a little over a pound and combines the blood pressure monitor and the AliveCor sensors. It ships with a wide-range D-ring BP cuff which fits 9 to 17-inch upper arms and runs on 4 AA batteries.

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Recording Blood Pressure and ECG

You can easily record just blood pressure using the device right out of the box (after inserting the included 4 AA batteries.)  However, the full capabilities of the device are realized in conjunction with Omron’s Connect US/CAN Smartphone app which can be downloaded for free. Once paired with the app, the device can record and transfer ECGs along with blood pressure measurements to the app and the cloud.

The process of recording a single-lead ECG on the Complete  is nearly identical to the process when using the AliveCor Kardia mobile ECG device except that there are four sensors for Complete versus the two sensors on the Kardia device.

After opening the Omron app on your smartphone and pressing the “Record BP and EKG” button, you place the smartphone horizontally on the Complete cradle and put your hands on the sensors with thumbs on the tops sensors and 2-3 fingers on the lateral sensors as illustrated below.

Screen Shot 2020-02-23 at 12.40.24 PM

Once the device senses a good signal the ECG recording will automatically begin and continue for 30 seconds. It’s important to stay very still and quiet during this time to optimize the recording quality.

800x800_BP7900-front.jpg

Like the Kardia device if your fingers are too dry, electrical contact may be suboptimal. This can be fixed by wetting your fingers with an alcohol wipe, a spray from a sanitizer bottle or just water from the tap. See my discussion on this here.

I found the 4 sensors plus the stability of the device the sensors reside in made for a higher percentage of high-quality ECG recordings on the Complete versus the smaller Kardia device. Stability on the Kardia device is a particular issue for the elderly and we were able to consistently obtain good quality ECG recordings in my office on the frail and elderly with the Complete.

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Typical, easily-obtained, high-quality ECG recording obtained from the Complete

The PDF of the ECG can be emailed to yourself for storage or to your physician for his review. With a Premium plan upgrade, you can store the ECGS online or utilize KardiaPro which shares your BP and ECG data through the cloud with your physician.

Blood Pressure Plus ECG

You can choose to record BP and ECG separately or at the same time. To record both, place the BP cuff on your upper arm,  push the start/stop button and then put your fingers on the ECG sensors. While the ECG is recording, the BP cuff inflates and obtains the BP measurement.

As always when taking BP it is important to make sure the cuff is at the level of the heart.

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Using KardiaPro Online Dashboard With Complete

Many of my patients have both atrial fibrillation and hypertension. For them, the KardiaPro dashboard provides a unique online monitoring system that allows me to view both their blood pressure recordings and their ECG recordings in one spot.

Omron’s Complete now simplifies and consolidates the process of recording BP and ECG for such patients. A typical KardiaPro report from one of my combined AF and hypertensive patients  appears below.

kardiapro bp and ecg

Where Does Complete Fit In The Home Monitoring Universe?

I see Complete serving in two important areas.

The first is as a consolidated unit for patients with atrial fibrillation and hypertension. Complete provides an easy, quick, and stable method for these patients to home monitor their BPs and their rhythm.

The second area is in physician offices. The ability to record a high quality, medical-grade ECG simultaneously with blood pressure will improve the physician’s ability to screen for hypertension and rhythm abnormalities in an efficient manner.

Completely Yours,

-ACP

N.B. Looking at the Omron website today I note that Complete is selling for $159.99, a 20% discount.

AliveCor’s Kardia Mobile ECG Accurately Identifies Atrial Fibrillation >120 BPM

The skeptical cardiologist revealed recently that the  Apple Watch (AW) ECG app is incapable of identifying atrial fibrillation (AF) if the heart rate is greater than 120 beats per minute. It labels these recordings as “inconclusive”.

Since it is common for AF to present at rates >120 BPM, AW ECG will fail to notify many (if not most) of its users that they are in AF.

AliveCor’s Kardia mobile ECG device (both the single lead and the six lead), on the other hand, has no problems identifying AF >120 BPM. I have found that the Kardia ECG was highly accurate in patients with rapid AF from using the device in hundreds of my patients since 2013.

After writing about the AW AF flaw I opened my KardiaPro dashboard which connects to the online ECG recordings each of my patients has made.

Two of my patients with paroxysmal AF had gone into AF in the last 2  days and made recordings.

Both of them had rates > 120 BPM. In both cases, Kardia had easily made the diagnosis. AW would have declared these “inconclusive.”

Patients should be aware of this AW AF flaw. The absence of a declaration of possible AF on the AW ECG should not reassure anyone of the absence of AF.

AW users should have their high rate recordings reviewed by a cardiologist.

Alternatively, they could purchase a Kardia device and utilize it for heart rates over 120 BPM.

Tachyagnostically Yours,

-ACP

Apple Watch ECG Cannot Diagnose Atrial Fibrillation Faster Than 120 BPM

The Apple Heart Study received great fanfare at least year’s AHA meetings  and was subsequently published in the NEJM.  Many Apple Watch (AW) wearers having heard of this study may have concluded the device will reliably identify atrial fibrillation (AF).

In my commentary on the Apple Heart Study I pointed out several issues with relying on Apple Watch for AF diagnosis, most significantly false positive notifications. Recent patient experiences have, in addition, made me concerned about false negative notifications and a lack of sensitivity.

AW ECG is inherently limited in diagnosing AF above 120 BPM. This guarantees a substantial number (possibly the majority) of AF episodes will not be recognized. Such false negative notifications may falsely reassure patients that they don’t have AF and delay them seeking medical attention.

Recently, I saw a patient who was referred to me for an abnormal 12-lead ECG. While reviewing his symptoms we discovered that his AW had registered high heart rates, sometimes up to 150 beats per minute, which lasted for several hours. 

Although the AW had recorded this high heart rate it had not notified him of the possibility that he had atrial fibrillation or even that he had a high heart rate.

He had made the ECG recording below using the AW and the results came back inconclusive.

CL-120-AFIB-AW4.png

The AW ECG recording clearly shows atrial fibrillation going at a rapid rate-over 150 beats per minute-but the accompanying interpretation gives no hint that the patient had AF.

Based on the combination of an absence of any irregular heart rate/AF warnings from his AW and the absence of a diagnosis of AF when he made AW ECG recordings of the fast rates the patient assumed that he did not have atrial fibrillation.

Why is this? Apparently Apple has decided not to check for AF if  the heart rate is over 120 BPM.

Given that most patients with new-onset AF will have heart rates over 120 BPM (assuming they are not on a rate slowing drug like a beta-blocker) it appears likely that Apple Watch ECG will fail to diagnose most cases of AF.

I asked my patient to record an ECG with his watch every time he felt his heart racing after our office visit. A few days later he was sitting in an easy chair after Thanksgiving watching TV and had another spell of racing heart. This time the heart rate was less than 120 BPM and the AW was able to analyze and make the diagnosis.

CL-150-AFIB-AW4.png

The inability of AW ECG to diagnose AF when the rate is >120 BPM further adds to my concerns about widespread unsupervised use of the device. When we combine inconclusive high heart rate analyses with the unknown sensitivity of the irregular heartbeat notification algorithm the AW may be providing many patients who have atrial fibrillation with a false sense of security.

Skeptically Yours,

-ACP

An In-depth, Objective Comparison of Mobile ECG Devices: Emay versus Kardia

The skeptical cardiologist has been a huge advocate of personal mobile ECG monitoring to empower patient’s in understanding/monitoring their heart rhythm.

The deserved leaders in this field are the Apple Watch (4 and later) and Alivecor’s Kardia device which comes in single-lead and six-lead flavors.

Both Apple and AliveCor have gotten FDA approval for their mobile ECG device and have a body of published studies supporting their accuracy.

In contrast, there are a number of “copy-cat” mobile ECG devices which have been feeding on the success of Apple Watch and Kardia but do not have the bona fides the two leaders have.

I reviewed the SonoHealth ECG here and found it sorely lacking in comparison to Kardia in terms of accuracy of diagnosis and quality of recordings, the two most important aspects of a personal ECG monitor.

Dan Field, a physician  and reader of my blog, has been evaluating a device similar to the SonoHealth ECG made by Emay.

He has provided a point by point comparison of the two  devices in the chart below

Emay versus Kardia

His summary:

“The Kardia6L was clearly superior in almost every way except for price and even that was within the margin of error. ”

It should be noted that the single lead Kardia mobile ECG is actually cheaper than the Emay and retails for $99.

Let The (Mobile ECG) Buyer Beware

I ended my post reviewing SonoHealth’s ECG with a warning which applies equally to the Emay device:

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.

Skeptically Yours,

-ACP

 

Atrial Fibrillation Detection, Personal ECG Monitoring and Ablation: A Patient’s Story

One of the joys of writing this blog is the communication it allows me with discerning  individuals and patients across the planet. One such reader, Mark Goldstein, discovered he was in atrial fibrillation after purchasing an Apple Watch 4.

He now utilizes both the Kardia Mobile ECG and the Apple Watch to aid in his personal monitoring of his atrial fibrillation and has been actively pursuing a rhythm control strategy under the care of his electrophysiologist.

I asked him to share with my readers his experience which recently culminated in an ablation.

What follows is his description with my editorial comments in green.


December 2018 I bought a crazy, expensive Apple Watch. That watch may have saved my life. I spend much of my days at a treaddesk (a combination desk and treadmill). I was curious to find out how much exercise I was doing. I bought the watch, put it on, and starting walking as I do almost every day. Two hours later the watch had an alarm. It was warning me about something called “atrial fibrillation,” It said, “your heart has shown signs of an irregular rhythm.” What! I never heard of afib before. I quickly learned about it. Heart palpitations, no. Pain/pressure in the chest, no. Sweaty, faint, dizzy, etc., no, no. no. I checked the box for tired but I assumed it was because of the amount of exercise I was doing.

The next day I was fortunate that I had a physical scheduled a year ago. I told my doctor that my “crazy, expensive watch” thinks I have afib. My doctor laughed, telling me about how he had checked and probed every part of my body for the last 20 years (the probing part I remembered well). As the exam was concluding, he was puzzled by the afib warning so he grabbed my wrist to check my pulse. A few seconds later he was asking the nurse to give me an EKG. Darn, the watch was correct (and for me it was correct 99% of the time when I had afib and when I was normal – praise to Apple).

Recording from Mark’s Apple Watch 4 showing atrial fibrillation with controlled ventricular response. Heart rate is only 82 beats per minute. The AW algorithm correction identifies atrial fibrillation.

(This is a great example of how atrial fibrillation can be missed by the routine office physical examination. Some patients, especially those with non-rapid heart rates (due to rate slowing meds like beta-blockers or to intrinsically  slow conduction of electrical impulses) are minimally symptomatic and their pulses don’t feel that irregular. Because the first symptom of afib can be stroke I am an advocate of screening)

Shortly I got to meet a cardiologist (like Dr. Pearson, they are all nice people). Another EKG, afib confirmed. As we were talking about my symptoms or lack of symptoms, he said that afib was a bit like Eskimo’s describing snow. Each snowflake is unique and each afib patient is unique. I was in persistent afib. Probably had been in this state for two or three years since my heart rate jumped while sleeping, exercising, and at rest.

(Each afib experience is unique but not all cardiologists are nice people. Mark has been fortunate.)

The treatment plan was a cardioversion, an electrical shock to the heart, or as my cardiologist described it “like rebooting a computer.”

(See my post on cardioversion here.)

As a tech person, I understood that. The risk of not fixing my afib was five times the likelihood of a stroke. The risks were minimal so I chose the cardioversion.

(A common misconception is that ablation or cardioversion eliminates or substantially lowers the risk of stroke in afib. This is not the case. I’ll devote a future post to delve into this issue.)

Cardioversion one lasted four days before my Apple Watch started to detect afib.

(I’ve described in detail how helpful patient utilization of personal ECG monitoring is in letting me know the rhythm status of patients prior to and following cardioversion here.)

The cardiologist next step was cardioversion two along with a drug to help with rhythm control. Number two lasted a month before I saw my heart rate jump again. I thought something was wrong even though my watch was not detecting afib. Another EKG, this time the result was aflutter. The cardioversions were indeed like a reboot of the computer. If you have a virus on your computer, a reboot may be a temporary fix but eventually the virus will return.

(There are many drugs whose purpose is to suppress the recurrence of atrial fibrillation. Mark was prescribed the extended release version of propafenone, a Type IC antiarrhythmic drug (AAD)  similar in efficacy and side effects to flecainide. Type IC AADs should only be used in patients with normal left ventricular function (which was demonstrated in Mark by an echo) and without significant coronary artery disease (typically proven by a negative stress test).

To Ablate Or Not To Ablate

Now I got to meet an electrocardiologist. He said my afib would return and recommended an ablation. He said it was unlikely to be a permanent cure but it would help.

The aflutter disappeared after a day or so. I thought my afib was gone too but should I have an ablation? Ablations are relatively safe but since I was afib free why have the procedure?

I purchased the new Kardia Mobile six-lead portable EKG, a miracle of technology. Highly recommended for peace of mind. Just like my watch, I was seeing normal sinus rhythm. So why get an ablation?

A cardiologist had a YouTube video talking about the decision to have an ablation or any medical procedure. How will it affect the quality of your life or the quantity (how long will you live). This was a simple analysis and I like simple. I heard from my cardiologist that the evidence is that an ablation will unlikely extend my life nor will it reduce my lifespan. It was likely to not affect my lifespan. I confirmed this via independent research (be an informed patient, your outcomes will be better). See Dr Pearson’s articles about the CABANA study and the scientific evidence on ablation).  So an ablation and quantity of life were neutral.

Importance Of Quality Of Life

Quality of life was more interesting. Could I do the things wanted to do with my life? Did afib affect my day-to-day life? Could I walk up a couple of flights of stairs without breathing hard? Was I getting tired at 10AM? Could I exercise? At the time, the answer was easy. I could do everything I wanted to do. The afib affect was just about zero except for blood thinner drugs which I suspect I will take forever. No ablation.

Then “the day.” I woke and checked my sleep app on my phone. Heart rate at night jumped. Hmm! I went to the gym. My heart rate while walking jumped too. I did 30 seconds of high-intensity exercise and my heart rate monitor said 205 beats per minute. My heart was beating so hard I had to sit for five minutes. I knew something was wrong. Then I climbed a couple of flights of stairs, something that would never bother me. I felt a shortness of breath. I knew my afib was back. I also knew that the quality of my life was now being affected. I could not do things I wanted to do. My watch and Kardia Mobile EKG confirmed what I knew.

I called my electrocardiologist and scheduled an ablation. He was right. Afib would return.

(Mark tells me that he was taken off his propafenone one month after the second cardioversion because “the PA said I no longer needed it since I was in sinus rhythm.” My practice would have been to continue the propafenone as long as well tolerated and effective in suppressing afib recurrence. In my experience, the recurrence of Mark’s afib may not have been a failure of medical therapy. I treat patients similar to Mark by continuing the anti-arrhythmic drug since the minimal risks are lowered by regular monitoring and I regularly see maintenance of SR.”)

(Other antiarrhythmic medications were mentioned to Mark but as they required a 3 day hospital stay he was not interested.)


Stay tuned: Part two Of Mark’s post will be about the ablation procedure which he recently underwent.

Skeptically Yours,

-ACP

Mark Goldstein works in the field of cybersecurity in the WashingtonDC area and can be contacted at https://www.linkedin.com/in/markhgoldstein/

Enlightened Medical Management of Atrial Fibrillation, Part II: The Pill In The Pocket Approach

It has been estimated that patients with paroxysmal atrial fibrillation (PAF) have health care costs 5 times those without  afib. More than 50% of those costs are attributed to ER visits and acute care hospitalizations. The pill in the pocket (PIP)  approach can substantially reduce those hospital visits.

PIP addresses the complimentary patient priorities of minimizing daily drug burden and empowering patients to self-manage their episodes of sustained PAF thereby reducing the need to visit the ER or be hospitalized.

How Doth The Pill In Pocket Work?

With this approach, the patient upon experiencing a symptomatic episode of atrial fib takes (or as we doctors like to say “self-administers”) a single bolus of oral flecainide or propafenone (two so-called antiarrhythmic drugs or AADs.)

It is not necessary that the pill be in the pocket of the patient, indeed the pill might be in the pocket of the pastor of the patient or perhaps in the purse of the paramour of the patient. Indeed, the pill only need be near enough that the patient can pop it into his or her pie hole within a reasonable time period after the AF begins.

In properly selected patients, generally within 3 hours, the rhythm will suddenly pop back to normal

Prior to popping the AAD pill it is wise to have the patient pop a pill that slows the heart rate such as a beta blocker or cardizem or verapamil.

After popping the pill it wise to have the patient assume a supine position or at least a sitting position for a few hours or until the heart pops back to normal.

One Man And One Woman’s PIP Experience

I first saw Pete in 2017 on the day after his 60th birthday.  He awoke in the middle of the night feeling his heart fluttering. He was weak  and very light headed and came to our ER where he was noted to be in rapid atrial fibrillation.

He was given intravenous  cardizem which slowed his heart rate and made him feel better but did not convert him back to normal rhythm. We started him on the newer oral anticoagulant, Eliquis, to reduce his stroke risk.

The next day I performed a cardioversion on him after excluding the presence of left atrial thrombus with a transesophageal echocardiogram.

He did well for some time without recurrent afib but two years later he was again awoken from sleep around 1130 PM with a feeling of his heart fluttering and shortness of breath.

In the ER afib with rapid ventricular response was again noted and this time the ER doctor suggested that an electrical cardioversion be performed right away. Pete was told  there were “slight risks” to the procedure but he was nervous about doing it without me being on the case. His heart rate  was 106 and he was given an intravenous beta-blocker,  metoprolol to slow the heart rate.

The next morning we discussed options with him and decided to try the PIP approach to convert him back to normal rhythm. He received 300 mg flecainide orally at 11 AM and 1.5 hours later he converted to the normal rhythm.. The monitor strips recorded below captured the transition nicely.

pill in pocket flecainide

A 72 year old woman whom we shall call Miss Mystery X  presented with a sensation of weakness and dizziness beginning at noon. She had a history of paroxysmal afib. We had her come into office and ECG demonstrated atrial fibrillation at a rate of 100 BPM.

She was admitted to telemetry and given 300 mg flecainide and 45 minutes later the telemetry ECG strip below indicated conversion to normal sinus rhythm without any pauses, symptoms or hypotension. We discharged her later that day.

cooks-pip.png

For both of these patients we have carefully documented that they have a structurally normal heart by echocardiography and stress testing which is essential when utilizing flecainide. In addition, we carefully assess for stroke risk and anticoagulate them accordingly.

They now have available as outpatients a method for converting from afib to SR which is proven safe and effective for them.

I recently saw Miss X in the office after her hospital visit. She had just returned from a trip to Peru and Bolivia. Among other fascinating adventures she had flown over the Nazca Lines.

Aerial view of the “Heron”, one of the geoglyphs of the Nazca Lines, which are located in the Nazca Desert, near the city of Nazca, in southern Peru. The geoglyphs of this UNESCO World Heritage Site (since 1994) are spread over a 80 km (50 mi) plateau between the towns of Nazca and Palpa and are, according to some studies, between 500 B.C. and 500 A.D. old. Courtesy Wikimedia Commons.

Fortunately, she had no episodes of afib but should she have started fibrillating she knew that she had a safe and effective treatment that could convert her back to normal without the need of engaging foreign doctors and hospitals.

One of these two patients has acquired  the AliveCor Kardia Mobile ECG and will have the capability of transmitting to me his ECG via KardiaPro should his device alert him to the presence of atrial fibrillation. This capability further enhances the control that patient’s can have over the diagnosis and treatment of their afib episodes

The Science Behind The PIP Approach

The seminal article on the PIP approach was published in the New England Journal of Medicine in 2004 by Alboni, et al.

The paper reported on 268 patients with PAF presenting to the ER who had a structurally normal heart and were without disabling symptoms or low BP who were given larges oral doses of oral flecainide or propafenone. Overall, 210 patients converted to normal rhythm and were felt appropriate for out patient treatment.

This approach was quite successful:

During a mean follow-up of 15±5 months, 165 patients (79 percent) had a total of 618 episodes of arrhythmia; of those episodes, 569 (92 percent) were treated 36±93 minutes after the onset of symptoms. Treatment was successful in 534 episodes (94 percent); the time to resolution of symptoms was 113±84 minutes.

ER visits and hospitalizations for PAF were markedly reduced.

I tracked down Dr. Alboni through the scientific research social media site ResearchGate.net and asked him if he was still utilizing this approach and if he had any new data.

He responded.

the follow-up was terminated as reported in the paper. However, I have then observed that in patients > 75 years there are many side effects (unpublished data) and I do not utilize anymore the pill-in-the-pocket approach in these patients. I am still using flecainide and propafenone according to the doses and the methods described in the paper.

His 2004 paper enrolled patients 18 to 75 years of age and I have tended to restrict the PIP approach to my patients under age 76 due to concerns about more conduction disease and occult CAD in older patients.

When I pressed Dr. Alboni for more data or info on this he responded:

  • I observed a high incidence of side effects in patients > 75 years in the daily clinical practice, but I did not carry out a research because, after a concentration of side effects in a few patients, I did not prescribe anymore this treatment to old patients

PIP Current Practice

There is a nice paper on recent experience with the PIP approach which was published in 2018 by Josh Andrade who runs a multidisciplinary AF clinic in Vancouver, Canada

Consecutive patients aged 18-75 years of age attending the Vancouver multidisciplinary AF clinic and receiving PIP treatment were studied over a 3 year period. Entry criteria included, sustained symptomatic episode lasting >2 hours, frequency <1/month, absence of severe or disabling symptoms with AF episode

Patients with significant structural heart disease (LVEF<50%, “active ischemic heart disease”, severe LVH) were excluded along with those with the following features:

-Abnormal conduction (QRS>120ms, pr>200 ms, pre excitation)

-Clinical or ECG evidence of sinus node dysfunction/bradycardia or AV block

-hypotension with systolic blood pressure <100 mm Hg

Participating patients received their first PIP treatment while being monitored on telemetry in either an ER or hospital telemetry.  They were given the instructions below to give to the doctors in the ER.

Vancouver PIP sheet1

And they were provided with these instructions:

PIP vancouver 2

As the graph below shows, the PIP  approach resulted in a substantial reduction in ER visits, as well as a substantial reduction in the need for electrical or IV pharmacologic cardioversions

Adverse events (mostly low blood pressure but also 2 cases of conversion of  rhythm to a more rapid atrial flutter requiring cardio version) were noted in 16% of the initial PIP-AAD administrations and 19% failed to convert to NSR.

The Andrade PIP approach has patients receive a single dose of a rate-slowing drug 30 minutes prior to giving the AAD. This was done to prevent 1:1 conduction of atypical flutter. It’s not clear if this is beneficial and it could potentially contribute to episodes of bradycardia or hypotension.

In my practice I utilize flecainide over propafenone exclusively for both PIP therapy and chronic maintenance therapy. The generic version of flecainide for chronic therapy is twice daily versus thrice daily for propafenone and therefore preferred.  Dr. Andrade told me that when using the PIP approach:

In our clinic it’s probably 60:40 Propafenone to Flecainide.

Pill In The Pocket: Another Tool in The Toolkit For Enlightened Medical Management of Atrial Fibrillation

For the patient with PAF and relatively infrequent episodes of symptomatic afib the PIP approach can be very useful. Once established as safe and effective it allows the patient to avoid ER and hospital visits related to the PAF.

The ideal patient is less than 76 years of age and has a structurally normal heart.

PIP works really well for patients who are armed (pun intended) with a way to monitor their rhythm such as Apple Watch 4 or AliveCor’s Kardia Mobile ECG. Use of personal ECG monitoring in conjunction with a cardiologist practicing Enlightened Medical Management of afib is the optimal approach.

ProPIPically Yours,

-ACP

Which Ambulatory ECG Monitor For Which Patient?

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.

Continuously Monitoring,

-ACP

A Review Of SonoHealth’s EKGraph Portable ECG Monitor: Comparison To Apple Watch ECG And AliveCor’s Kardia ECG

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.

Rhythm Detection

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 Company and 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.

Skeptically Yours,

-ACP