Category Archives: Atrial Fibrillation

Enlightened Medical Management of Atrial Fibrillation, Part III: Flecainide for Chronic Suppression

As a practitioner of enlightened medical management of atrial fibrillation the skeptical cardiologist utilizes predominantly two antiarrhythmic drugs: amiodarone and flecainide.

As I outlined in Part I of this series, amiodarone is our most efficacious drug for maintenance of normal sinus rhythm (NSR) but requires close monitoring for long term side effects. It is also the safest antiarrhythmic drug (AAD) for patients with AF who have structural heart  disease.

The AAD I use in AF patients with normal hearts is flecainide.

Flecainide is a class IC AAD  which produces a potent and selective blockade of the cardiac fast inward sodium (Na+) current resulting in conduction slowing.

We don’t utilize flecainide (or any Type IC AAD) in patients with significant coronary artery disease or significantly depressed function of the left ventricle because of concerns about it increasing risk of more dangerous heart rhythms in such patients.

In patients with normal hearts, however, flecainide is very safe, extremely well-tolerated, and reasonably effective at maintaining NSR when combined with significant lifestyle modification.

I have scores of patients who have been maintained in NSR for years to decades with flecainide, therefore I think patients with normal hearts should undergo an adequate trial of this AAD before moving on to ablation.

Chronic Suppression of Atrial Fibrillation

A reader with atrial fibrillation recently submitted his case history which describes a typical scenario for a patient who would be a great candidate for long term flecainide therapy:

I am a 62 year old active male. I play (mostly) non-checking ice hockey 3 times a week and bicycle on off days and have a daily yoga practice. I suffer from Hashimoto’s disease and hypertension. Both are adequately managed with medication. I have been in persistent Afib for about a year, not sure about prior to that, but expect it was paroxysmal for awhile prior to diagnosis. There is no obvious cause. I was immediately put on Diltiazem and Eliquis. A month later I received a successful Cardioversion but at my follow-up a week later it was noted that the Afib had returned and is again persistent. I also had an echocardiogram that did not reveal any valve or muscle abnormalities. The advice at the time was to continue on the Dilt unless symptoms worsened. I was taken off the Eliquis due a risk factor of 1 and my desire to resume hockey. After about three months I noticed more fatigue, occasional dizziness, regular palpitations, etc. so got an appointment for another echo and to see an Electrophysiologist. The results of the echo indicate some structural changes since the last echo. Thus the EP recommended 3 choices: 1. continue with just the Dilt, 2. get a stress test and if OK then go back on Eliquis and add Flecainide for rhythm control and get another Cardioversion, or 3. get back on Eliquis and get an ablation and a Cardioversion. I’m not sure which option to choose. The difference in the two echos didn’t seem too extreme – how long can I go with option 1? Option 2 seems less risky but also less effective. Option 3 has the best results but is more risky. What will be the future of my hockey playing? With options 2 and 3 I;ll take a break while on Eliquis but once I turn 65 my risk will be 2 and I’ll probably be on Eliquis from then on. Can I chance option 1 for 3 years? I check my BP daily and use a KardiaMobile 6L to self-monitor.

The reader’s case history is similar to many of my patients.

He started with brief paroxysms of AF that were self-limiting (paroxysmal AF) but at some point, an episode began that was not self-limiting (persistent AF.)

At this point there are two major decisions for patient and physician: 1) Should a blood thinner be started to reduce the risk of stroke? and 2) Should the patient be left in AF (which generally means AF will be present lifelong , thus permanent- aka longstanding persistent AF) or should we attempt to restore and maintain SR?

I’ve reviewed the decision-making process for anticoagulation here.

The second decision is more complicated, controversial, and requires a good and unbiased conversation between physician and patient about options for maintenance of NSR.

In my post entitled “Why I Favor the Early Restoration and Maintenance of Sinus rhythm For Most Patients with Atrial Fibrillation” I laid out my rationale for trying to restore and maintain SR for most patients. In this 62 year old otherwise very healthy and active individual I would strongly favor a very aggressive approach to maintaining SR.

Enlightened Use of Flecainide To Suppress Atrial Fibrillation


Let’s take the example of Ralph,  a 63-year-old man who I saw first 5 years ago.  At that time he was admitted to the hospital with a prolonged episodes of weakness and rapid heartbeat.  Atrial fibrillation with a high heart rate (rapid ventricular response) was the cause and after starting a blood thinner and slowing his heart rate with intravenous diltiazem we proceeded to electrical cardioversion (ECV).

The cardioversion was successful in converting him back to normal sinus rhythm and he was discharged on oral diltiazem and a blood thinner.

Diltiazem is not an anti-arrhythmic drug and has not been proven to lower the risk of recurrent atrial fibrillation but is used in this situation to slow the patient’s heart rate should atrial fibrillation recur. I tell patients that after a first ECV without adding an AAD it is highly likely that AF will recur but we can’t predict if that will be in 5 days or 5 years. Given this possibility of no recurrent AF for years I generally don’t start an AAD with first ECV.

I highly recommend to all my AF patients the acquisition and use of a mobile Kardia ECG device to monitor their heart rhythm. The Kardia (or Apple Watch if the patient has one) is particularly useful pre and post ECV to alert us to the development of AF.

Ralph noted his heart rate had increased about 7 days after the ECV and his newly acquired Kardia ECG device confirmed AF as the cause.

At this point, we had another patient-physician discussion about the value of maintaining NSR and the therapeutic options. Given the early recurrence of the AF,  just repeating the ECV makes little sense. If he had maintained NSR for 5 years just repeating the ECV would be a reasonable option.

To increase our chances of maintaining NSR I started flecainide 50 mg twice daily. Flecainide can be started as an outpatient (as opposed to sotalol or dofetilide which require 72 hours of monitoring in hospital) and it often converts the patient’s rhythm back to NSR without the need for an ECV.  In addition, flecainide as a generic is cheap and at low dosages extremely well-tolerated without significant side effects.

The starting dosage of 50 mg is low but one of my guiding principles for Enlightened Medical Management of AF (EMMOAF) is to use the lowest effective dosage of AAD possible in order to minimize adverse effects.

After 5 days on flecainide, an ECG showed normal  QRS and QT intervals but AF persisted and we performed another ECV. After this ECV, the patient remained in NSR for 2 weeks but again noted high heart rates and AF had recurred.  Following another discussion I had him increase the flecainide to 100 mg twice daily.

Some patients, again, will convert to NSR upon an increase of the flecainide from 50 to 100 mg twice daily, but Ralph remained in AF and we performed a third ECV.

By this time he had acquired a Kardia device and was able to monitor his rhythm. The higher dosage of flecainide was the dosage that worked for him as he maintained NSR after the ECV and has maintained NSR for 5 years since.

I have scores of patients who have a similar path to Ralphs’s with successful maintenance of NSR on flecainide for many years. Some of them converted without an ECV and some, like Ralph, required 3 ECVs.

If AF recurs after a prolonged period of maintenance of NSR with flecainide, the choices are

  • -Leave in AF and control the rate
  • -Leave flecainide at current dosage and repeat ECV
  • -Increase the dosage of flecainide (which may or may not convert rhythm on its own) and repeat ECV at higher dosage.

Enlightened management of these patients who are maintaining NSR on flecainide over many years requires periodic visits (I recommend every 6 months) with an enlightened cardiologist to assess for

  •  any signs or symptoms of structural heart disease
  •  any evidence of proarrhythmia or electrical conduction abnormalities
  •  significant QRS prolongation, ischemia or arrhythmias during exercise stress
  • proper concomitant use of dromotropic (rate-slowing) drugs such as beta-blockers or diltiazem.
  • appropriate use of blood thinners to reduce the risk of stroke or systemic embolism.

When utilized in the manner I’ve described, flecainide usage results in prolonged maintenance of NSR at an extremely low risk of adverse effects in most patients who have structurally normal hearts.

Its effectiveness is greatly increased by patient attention to the eight lifestyle factors that increase the risk of AF and I emphasize these factors to all my patients on a regular basis.

Flecainidingly Yours,

-ACP

N.B. I’ve answered my readers question as to which option I would recommend if he were my patient but not some of his other good questions. Those will be discussed in Part IV of this series. And later I’ll discuss the pros and cons of other AADs for AF.

N.B.2.  For more detailed information on flecainide I recommend this 2015 review in the World Journal of Cardiology

If you are prescribing or taking flecainide it is important to be aware of the CAST trial

(Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991;324:781–788. [PubMed] [])

 

a seminal study which showed that Type I C AADs are dangerous in patients who have had a myocardial infarction and reduced heart function.

“The publication of the Cardiac Arrhythmia Suppression Trial (CAST) study in 1989, which was designed to investigate the efficacy of class I antiarrhythmic agents moricizine, encainide or flecainide in patients after myocardial infarction with reduced ejection fraction and frequent ventricular ectopic beats, resulted in a major revision of the role of these antiarrhythmic drugs. Thus, while flecainide suppressed ventricular ectopy in those patients, a threefold increase of arrhythmic death was recorded compared to placebo[]. Based on CAST results, flecainide nowadays is not recommended for patients with structural heart disease and coronary artery disease. However, it is recommended as one of the first line therapies for pharmacological conversion as well as maintenance of sinus rhythm in patients with atrial fibrillation and/or supraventricular tachycardias without structural heart disease”

 

Subclinical Atrial Fibrillation-Seek And Ye Shall Find, But What Then?

For those of us over age 55 years there is a lifetime risk of developing atrial fibrillation (AF) of 37%. and with AF comes a 5 fold risk of stroke which can be reduced by oral anticoagulant therapy.

Because up to 25% of AF is asymptomatic investigators have recognized a need to screen for AF in high risk individuals with the goal of reducing stroke. When AF is found in individuals without symptoms by screening or from monitoring a patient’s pacemaker it is termed subclinical atrial fibrillation (SCAF.)

Surprisingly, there is no consensus on 1)  whether we should screen for SCAF 2) if we should screen for SCAF, how should we do it 3) whether individuals with SCAF  found  by screening should be treated with oral anticoagulants just as we treat clinical AF patients.

Two presentations at the 2018 American College of Cardiology Meeting in Orlando shed some light on the problem of SCAF.

The mHealth Screening To Prevent Strokes (mSTOPS) study took a novel  approach to identifying and enrolling patients. Working with Aetna, invitations were sent by email or snail mail to over a 100,000 Aetna members who did not have a diagnosis of AF and who were over age 74 year or younger but with CHADS2 risk factors.

The members were directed to a website for information on the the trial and were guided through an enrollment process for informed consent. Half were randomized to early monitoring and half delayed monitoring at 4 months.

Immediate monitoring involved the patient being mailed a 14 day patch type monitor (Zio Patch, iRhythm Technologies Inc.) within 2 weeks of consenting to the trial. Patients in the delayed monitoring group received the patch 4 months after consent.

The primary endpoint was a new diagnosis of AF at 4 months,  defined as greater than 30 seconds of AF by ECG or a new diagnosis listed on Aetna claims data.

Patients in the immediate or early monitoring group were 9 times more likely to have AF diagnosed than those in the delayed group (prior to them wearing the Zio)).

Diagnosis of AF in these participants were then compared to 5,310 observational controls matched for age, sex and CHADS-VASc score who did not undergo screening.

At the end of one year 6.3% of the monitored group had been diagnosed with AF versus 2.8% in the observational controls, a highly significant 3 fold increase in AF detection.

More patients in the monitoring group were started on therapy and had more testing done (at the discretion of their physicians who were informed of the results at the patient’s discretion).

There was no difference in stroke, MI or systemic thromboembolism at one year between the two groups but clearly this study was underpowered and nonrandomized so differences would have been unlikely and if present hard to interpret.

Does Manner of Detection of AF Matter

AF detected by screening and AF detected only by implanted devices share many similarities. For both, if we seek them we shall find them (one study showed in patients with no history of AF undergoing new pacemaker implantation during a mean follow-up period of 596 ± 344 days, 77 (29%) patients had at least one AF episode lasting ≥ 5 min.

At another session at ACC18 two EP doctors debated whether  a high stroke risk individual with 9 minutes of an atrial high rate episode (AHRE) of presumed AF detected by pacemaker should receive anticoagulation.

I ended up agreeing with the CON side of this debate for most patients because

-device detected AF has a lower stroke risk (precisely how much unclear and related to CHADSVAS score (but I’m going with 1/3) than clinically detected AF

-The ASSERT study only showed increased risk for >24 hours duration of device detected AF (DDAF)

-Unlike clinical AF we have no randomized controlled trial data supporting treatment with oral anticoagulants for DDAF.

(Of note, funding for many studies in this area comes from either makers of monitor devices like the Zio patch (iRhythm) used in mStops or the Medtronic loop recorder used in LOOP which detect SCAF or makers of the blood thinners doctors would be prescribing if SCAF is detected (like Janssen the maker of Xarelto.))

I haven’t learned the answer to the 3 key questions I posed at the beginning of this post since 2018 but more information continues to emerge.

For example, the ongoing Danish LOOP (Atrial Fibrillation Detected by Continuous ECG Monitoring) study is a randomized, controlled trial, randomizing subjects who are ≥70 years of age and have ≥1 of the following stroke risk factors: hypertension (HTN), diabetes, heart failure, or previous stroke, in a 1:3 ratio to receive an implanted loop recorder (ILR) (Reveal LINQ; Medtronic, Dublin, Ireland) with continuous electrocardiographic monitoring via the CareLink Network, or to standard of care.

The early results published late last year are fascinating and worthy of more detailed discussion. Briefly, 35% of participants had SCAF lasting>6 minutes. However, the AF burden was low, and progression was limited. In addition, symptoms were scarce, and the heart rate was only modestly elevated during SCAF.

This graph shows the time course of AF (blue bars) before and after a first AF episode >24 hours. Contrary to the idea that AF gets progressively more frequent with longer episodes, the natural history of AF in these patients varied wildly. Many had no prolonged episodes for  months before or after the first prolonged AF episode.

The final results of this study will tell us if seeking SCAF is worthwhile in reducing cardiovascular morbidity and mortality.

I see patients daily with brief episodes of AF detected by their pacemaker of which they are completely unaware. Currently, after a discussion with the patient about the risks and benefits of anticoagulation in this situation I will offer the option of anticoagulation if episodes >24 hours are noted, recognizing the lack of scientific studies to guide us.

Ideally, patients with <24 hours of DDAF will be enrolled in ongoing randomized trials which will give us the correct answer to these difficult questions. Similarly, we desperately need randomized studies on the effects of screening for AF on long term outcomes.

Skeptically Yours,

-ACP

 

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.

Should You Participate In The Apple Watch Heartline Study?

Apple and Johnson and Johnson are collaborating on an interesting research study which aims to analyze the impact of an app-based heart health program with Apple Watch on the early detection  of atrial fibrillation (AFib), and the reduction of stroke risk.

I tried to participate in this study but didn’t meet the entry requirements which are as follows:

  • Be age 65 or older
  • Be a resident of the United States for the duration of the study
  • Use an iPhone 6s or later, with iOS 12.2 or later (Learn more)
  • Have Original Medicare, sometimes called Traditional Medicare (Learn more)

Because I’m still working I have private health insurance and didn’t qualify.

According to the Heartline website:

The Heartline Study is a pragmatic, randomized, controlled, virtual research study, from Johnson & Johnson, in collaboration with Apple. The primary objective is to analyze the impact of features on Apple Watch, combined with a heart health engagement program, on early detection of atrial fibrillation and clinical outcomes such as stroke. In addition, the study seeks to determine the impact of a heart health engagement program paired with a medication adherence intervention among those participants receiving an oral anticoagulant therapy who have been previously diagnosed with AFib. The data will also be used to find novel markers to identify, predict, or evaluate other health conditions.

The study website indicates some participants may get to borrow an Apple Watch 5:

Some participants may be asked to obtain an Apple Watch Series 5 or later. These participants will be offered two options to obtain a watch: purchase a watch, or get one on loan for the duration of the study and return it when your participation in the study ends. Johnson & Johnson and Apple are committed to ensuring that participation in the study is not limited based on financial need. Not all participants will be asked to obtain a watch, so make sure to follow the instructions in the app.

Information for Healthcare Providers who are trying to decide whether their patients should participate Is here.

Here is the study in graphic form

 

Screen Shot 2020-03-01 at 8.23.01 AM There is an extensive FAQ section on the Healthline website which reveals the following companies roles:

Janssen Scientific Affairs, LLC, an affiliate of Johnson & Johnson, is the sponsor of the Heartline Study. Apple is supporting the study technology and design of the app. Evidation Health provides the technology and study operations that enable the Heartline app and study experience for participants. Best Buy operates the Apple Watch distribution program for eligible study participants.

 

The ostensible motive for Apple and J  and J is to improve outcomes in patients with afib.  Obviously Janssen will sell more of its blood thinner Xarelto if more cases of afib are identified.

Participants will be sharing lots of private information with Apple and Evidation.

Despite these concerns I would likely have participated if I qualified and I will recommend that interested patients consider participating in Heartline.

Skeptically Yours,

-ACP

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.

IMG_0009.jpeg

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.

Screen Shot 2020-02-23 at 12.59.16 PM
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.

Screen Shot 2020-02-23 at 12.39.22 PM

 

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

Eight Lifestyle Changes All Patients Should Make To Reduce The Recurrence Of Atrial Fibrillation

Previously, the skeptical cardiologist answered the question “Why Did I Go Into Atrial fibrillation?

An equally important question is “how can I reduce the chances that I have more spells of atrial fibrillation (AF)?”

I spend a fair amount of time discussing with my AF patients what lifestyle changes they can make in this regard. I’ve discovered, however, that many AF patients I am seeing for a second opinion seem unaware of the changes they can make to minimize AF recurrence.

Herein I give you the eight most important changes you can make to minimize both the onset and the recurrence of AF.

  1. Eliminate or substantially reduce alcohol.
  2. Lose weight if you are obese.
  3. Stop smoking. Stopping is associated with a 36% lower risk of AF.
  4. Get your blood pressure under good control.
  5. Get regular aerobic exercise. At least 150 minutes of moderate cardio exercise weekly.
  6. Eat A Healthy Diet. Don’t Eat Crap (as Younger Next Year says). In general, because obesity is such a big factor  in AF, I am fine with whatever diet plan has you at a BMI <28. Healthy diets controlling weight avoid ultra-processed foods, sugar-sweetened beverages, and minimize white rice, pasta, pastries, and potatoes. These diets include lots of fresh vegetables, nuts, olive oil, and fish. Full fat yogurt and cheese are fine in moderation. Eat real food, mostly plants, not too much as Michael Pollan has famously said.
  7. Get high-quality sleep. This means treating any sleep apnea properly in addition to standard advice for getting a good night’s sleep. The risk of AF is four times higher in patients with obstructive sleep apnea (OSA) independent of other confounding variables
  8. Reduce stress. Easier said than done I know. Everything from meditation to Yoga to retiring or cutting back at work to psychotherapy can be tried in this category. Go with whatever works for you. Knowing when you are in or out of AF by utilizing personal ECG monitoring devices may help reduce stress, especially if used under physician supervision.

Let’s dig a little deeper into some specific recent evidence on three which have a huge impact: alcohol, exercise, and obesity.

Alcohol and Atrial Fibrillation

In March, I wrote about the alcohol AF trial recently published in NEJM:

The Alcohol-AF Trial. Binge alcohol consumption (holiday heart) can trigger atrial fibrillation (AF) and observational studies show a higher incidence of AF with higher amounts of alcohol consumption.

This trial was the first-ever randomized controlled trial of alcohol abstinence in moderate drinkers with paroxysmal AF (minimum 2 episodes in the last 6 months) or persistent AF requiring cardioversion.

Participants consumed >/= 10 standard drinks per week and were randomized to abstinence or usual consumption.

Participants underwent comprehensive rhythm monitoring with implantable loop recorders or existing pacemakers and twice-daily AliveCor monitoring for 6 months.

Abstinence prolonged AF-free survival by 37% (118 vs 86 days) and lowered the AF burden from 8.2% to 5.6%

AF related hospitalizations occurred in 9% of abstinence patients versus 20% of controls

Participants in the abstinence arm also experienced improved symptom severity, weight loss and BP control.

This trial gives me precise numbers to present to my AF patients to show them how important eliminating alcohol consumption is if they want to have fewer AF episodes. The study further emphasizes lifestyle changes (including weight loss, exercise, and stress-reduction) can dramatically reduce the incidence of atrial fibrillation.

Obesity and Atrial Fibrillation

We have known for some time of a strong association between obesity and atrial fibrillation. We also know we can make sheep go into atrial fibrillation by making them obese and creating a diseased, fat-infiltrated left atrium.

More recently we have solid evidence that sustained weight reduction can significantly reduce the recurrence of AF.

The Australian LEGACY study took 355 AF AF patients with BMI>27 and offered them a weight management program:

Weight loss was categorized as group 1 (≥ 10%), group 2 (3% to 9%), and group 3 (<3%). Weight trend and/or fluctuation was determined by yearly follow-up. Endpoints included impact on the AF severity scale and 7-day ambulatory monitoring.

Weight loss ≥ 10% resulted in a 6-fold  greater probability of no AF recurrences compared with the other 2 groups. High weight fluctuation doubled the risk of AF recurrence.

Of course, all these factors are interrelated. Exercise, diet, stress, alcohol consumption, and sleep quality all impact weight control and obesity. Patients with AF should be working on all 8 levers for optimal benefit.

Given the LEGACY study findings, if you have AF and are obese, you should be using all lifestyle factors at your disposal to get your body weight down >10%. Do this in a slow and steady fashion with lifestyle changes that are sustainable for the rest of your life. You want to lose that weight and keep it off.

Exercise And AF

The most compelling evidence for the independent role of exercise in reducing AF comes from a Norwegian study of 51 patients with AF who were randomized either to aerobic interval training (AIT) or to their regular exercise habits. The patients randomized to AIT engaged in four 4-minute bouts of high-intensity (85 to 95% peak heart rate) aerobic exercise interspersed with 3 minutes of recovery.

There was a significant reduction in AF burden (measured by implanted loop recorders) in the exercise group, with the mean time in AF dropping from 8.1% to 4.8%, with no significant change in the control group. Patients in the exercise group experienced fewer and less severe symptoms whereas the non-exercising, control group had no change. In comparison with controls, patients randomly assigned to exercise also increased their peak oxygen consumption (Vo2peak), cardiac function, and quality of life, while improving body mass index and blood lipids

Screen Shot 2020-02-02 at 12.19.44 PM
Atrial fibrillation (AF) burden in patients with AF during the study. Mean time in AF was measured by an implanted loop recorder (n=36) before, during, and after 12 weeks of aerobic interval training (exercise) or usual care (control). Patients without AF during the study period are excluded. Mean changes from baseline to follow up were −6.2±8.9 percentage points (pp), P=0.02 for exercise; 4.8±12.5 pp, P=0.09 for control; and 11.0±3.9 pp, P=0.007 between groups. Error bars show the 95% confidence interval.

An accompanying editorial provides this graphic on the benefits of exercise training in AF

 

For all you readers without AF you can minimize your chances of developing AF by following these lifestyle recommendations.

Afibrillatorily Yours,

-ACP

N.B. A PDF summary of the 8 factors is available here (Lifestyle changes Afib)

N.B.2 For those wishing to mimic the Norwegian AIT protocol here is the complete description:

Endurance training was performed as walking or running on a treadmill 3 times a week for 12 weeks. Each session started with a 10-minute warmup at 60% to 70% of maximal heart rate obtained at exercise testing (HRpeak), followed by four 4-minute intervals at 85% to 95% of HRpeak with 3 minutes of active recovery at 60% to 70% of HRpeakbetween intervals, ending with a 5-minute cooldown period. During AF, patients exercised at the same treadmill speed and inclination as in the previous sessions in sinus rhythm, with the Borg scale of 6 to 20 as an aid to control intensity. When familiar with the training regimen, patients were allowed to perform 1 exercise per week at home, where exercise intensity was documented with a heart rate monitor (RS300X, Polar Electro, Kempele, Finland).

 

 

 

 

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