Tag Archives: afib

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

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

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).

 

 

 

 

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

AliveCor’s KardiaBand Will No Longer Be Sold And Smart Rhythm Is No More

The skeptical cardiologist was quite enthusiastic about AliveCor’s Kardia Band for Apple Watch upon its release late in 2017.

I was able to easily make high fidelity, medical grade ECG recordings with it and its AI  algorithm was highly accurate at identifying atrial fibrillation  (see here). This accuracy was subsequently confirmed by research.

Many skepcard readers spent $200 dollars for the Kardia Band and had found it to be very helpful in the management of their atrial fibrillation.

However, in December of 2018 Apple added ECG recording to its Apple Watch 4, essentially building into the AW4  the features that Kardia Band had offered as an add on to earlier Apple Watch versions.

In my evaluation of the Apple Watch I found it to be “an amazingly easy, convenient and straightforward method for recording a single channel ECG” but its algorithm in comparison to AliveCor’s yielded more uncertain diagnoses.

Given it size, prominence and vast resources, Apple’s very publicized move into this area seemed likely to threaten the viability of AliveCor’s Kardia Band.

But then-interim CEO (and current COO)  Ira Bahr later told MobiHealthNews that his company’s broader business wasn’t threatened by its new direct competitor.

“We’re not convinced that Apple’s excellent, engaging product is a competitor yet,” he said in February. “We believe that from a price perspective, this product is least accessible to the people who need it most. If you’re not an Apple user, you’ve got to buy an Apple Watch, you’ve got to buy an iPhone to make the system work. So their technology is excellent, but we think the platform is both complicated and expensive and certainly not, from a marketing perspective, targeting the patient populations we target.”

Indeed, AliveCor’s Mobile ECG device and its recently released 6 lead ECG are doing very well but the threat to the viability of KardiaBand was real and MobiHealth News announced Aug. 19 that AliveCor had officially ended sales of the Kardia Band.

An AliveCor representative told MobiHealthNews that the company “plans to continue supporting KardiaBand indefinitely” for those who have already purchased the device. The company’s decision was first highlighted by former MobiHealthNews Editor Brian Dolan in an Exits and Outcomes report.

Mr. Bahr has confirmed to me that AliveCor does plan to continue supporting KardiaBand indefinitely. This includes replacement of KardiaBand parts.

Did Apple Kill Smart Rhythm?

The informed reader who notified me of AliveCor’s decision also notes:

The official reason is that they could not keep up with the Apple Watch updates and therefore the Smart Rhythm feature did not work properly.

I think many of us knew from the beginning that smart rhythm was not very accurate But in spite of that the Kardia band provided a valuable convenience over their other products.

It does appear that Smart Rhythm is no more.

AliveCor’s website was updated 6 days ago to state that Smart Rhythm was discontinued:

” due to changes beyond our control in the Apple Watch operating system, which caused SmartRhythm to perform below our quality standards”

Likely, as my reader was told, the frequent  AW4 updates plus the lack of a large KardiaBand user base made it unprofitable for AliveCor to continue to support Smart Rhythm.

Smart Rhythm, of course was AliveCor’s method for watch-based detection of atrial fibrillation. It clearly had limitations, including false positives but given AliveCor’s track record of dedication to high quality and accuracy I assumed it would improve over time..

Apple, on December 6, 2018  with the release of its watchOS 5.1.2 for AW4 announced its own version of Smart Rhythm at the same time it activated the ECG capability of AW4.

Apple called this feature “the irregular rhythm notification feature” and cited support for its accuracy from the widely ballyhooed Apple Heart Study (which I critiqued here.)

The irregular rhythm notification feature (TIRNF)was recently studied in the Apple Heart Study. With over 400,000 participants, the Apple Heart Study was the largest screening study on atrial fibrillation ever conducted, also making it one of the largest cardiovascular trials to date. A subset of the data from the Apple Heart Study was submitted to the FDA to support clearance of the irregular rhythm notification feature. In that sub-study, of the participants that received an irregular rhythm notification on their Apple Watch while simultaneously wearing an ECG patch, 80 percent showed AFib on the ECG patch and 98 percent showed AFib or other clinically relevant arrhythmias.

Despite widely publicized reports of lives being saved by TIRNF we still don’t know whether its benefits outweigh its harms. It is not clear what its sensitivity is for detecting atrial fibrillation and I have reported one patient who was in atrial fibrillation for 3 hours without her AW4 alerting her to its presence.

For AW4 users, absence of an alert should not provide reassurance that your rhythm is normal.

Thus is does appear that the Goliath Apple hath smote the David AliveCor in the watch-based afib battle. This does not bode well for consumers and patients as I think as competition in this area would make for better products and more accountability.

Philorhythmically Yours,

-ACP

N.B.

Per AliveCor the KardiaBand currently works with all all Apple Watches except the original one.

The Apple TIRNF per Apple:

is available for Apple Watch Series 1 and later and requires iPhone 5s or later on iOS 12.1.1 in the US, Puerto Rico, Guam and US Virgin Islands. The irregular rhythm notification feature does not detect a heart attack, blood clots, a stroke or other heart-related conditions including high blood pressure, congestive heart failure, high cholesterol or other forms of arrhythmia.

Does Aspirin Have A Role In Stroke Prevention In Atrial Fibrillation Or Is It Time To Start Stopping It?

Old habits die hard in medicine.  For decades the skeptical cardiologist and his cardiology brethren and sistren have prescribed aspirin to prevent stroke in patients with atrial fibrillation.

For those patients with atrial fibrillation (AF)  who were considered low risk  it was felt that aspirin provided some benefit in preventing the clots that fly out of the heart (and land in arteries elsewhere in the body) at an acceptably low risk of bleeding. For higher risk patients more powerful and effective agents (oral anticoagulants) are usually recommended.

The American guidelines on AF (2014)  gave a IIB recommendation to aspirin. IIB is not a ringing endorsement having been described as “this is our suggestion, but you may want to think about it.”

  • For patients with nonvalvular AF and a CHA2DS2-VASc score of 1, no antithrombotic therapy or treatment with an oral anticoagulant (OAC) or aspirin may be considered. (Level of Evidence: C)* 

However, in the last 5 years the significant bleeding risks associated with taking low dose aspirin have become more widely appreciated.

Thus, in the 2016 European guidelines on the management of AF the authors state that  “the evidence supporting antiplatelet mono therapy (e.g. aspirin or clopidogrel) for stroke prevention in AF is very limited” and the bleeding rate” is similar to OAC”:

Aspirin and other antiplatelets have no role in stroke prevention (III A). The combination of anticoagulation with antiplatelets increases bleeding risk and is only justified in selected patients for a short period of time; for example, in patients with an acute coronary syndrome or stent, balancing the risk of bleeding, stroke and myocardial ischaemia (IIa B/C).

Stroke risk evaluation is based on the CHADS-VASc score. With a score ≥2 in male and ≥3 in female patients, anticoagulation for stroke prevention is clearly recommended, while in a score of 1 in males and 2 in females, anticoagulation should be considered. No antithrombotic therapy of any kind should be prescribed in patients with a CHADS-VASc score of 0 (males) or 1 (females).

Antiplatelet therapy increases bleeding risk, especially dual antiplatelet therapy (2.0% vs. 1.3% with antiplatelet monotherapy; P < 0.001), with bleeding rates that are similar to those on OAC. Thus, antiplatelet therapy cannot be recommended for stroke prevention in AF patients.

 The focused update (2019) on AF from America said nothing about aspirin alone for AF.

It’s not just European experts who feel this way.  At a 2016 Cardiovascular CME conference, American experts in the field were unanimous in their condemnation of aspirin use

“The European guidelines have done away with aspirin for stroke prevention in atrial fibrillation. It barely made it into our current US guidelines. I don’t think aspirin should be in there and I don’t think it will be there in the next guidelines. The role of aspirin will fall away,” said Bernard J. Gersh, MB, ChB, DPhil, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota. “It’s not that aspirin is less effective than the oral anticoagulants, it’s that there’s no role for it. There are no good data to support aspirin in the prevention of stroke in atrial fibrillation.”

“The use of aspirin has probably been misguided, based upon a single trial which showed a profound effect and was probably just an anomaly,” said N.A. Mark Estes III, MD, Professor of Medicine and Director of the New England Cardiac Arrhythmia Center at Tufts University in Boston, and a past president of the Heart Rhythm Society

I would just take it off of your clinical armamentarium because the best available data indicate that it doesn’t prevent strokes. I’m certainly not using it in my patients. Increasingly in my patients with a CHA2DS2-VASc of 1, I’m discussing the risks and benefits of a novel oral anticoagulant,” said Dr. Estes.


Those are amazingly definitive statements. But, as I’ve learned  we can’t just except what the “experts” and the guidelines tell us we have to look at the original studies informing these decisions.

In 1991 the seminal study proving the benefits of warfarin in preventing stroke (Stroke Prevention in Atrial Fibrillation (SPAF) trial) was published.

It compared warfarin (measured by PT ratio) to placebo and aspirin 325 mg to placebo in preventing stroke in AF patients. Warfarin reduced stroke by 67% and aspirin by 42%. The risk of significant bleeding was similar at around 1.5% per year for all three arms.

Based on this and other AF trials (AFASAK, CAFA, SPINAF, EAFT, et al. ) when I gave talks or taught cardiology fellows in the 1990s my message (similar to this presentation) emphasized the superior benefits of warfarin compared to aspirin (especially when monitored by INR in a 2.0 to 3.0 range) in higher risk AF patients. Overall it was felt that aspirin (dosing varying from 100 to 325 mg) reduced stroke/embolism by 20-30% compared to placebo and would offer benefit to those patients at low risk or who could not tolerate warfarin.

Based on the 2014 American guidelines (and a focused update in 2019 which did not address this issue) I had not been actively taking my low risk patients off baby aspirin.

I was prompted to re-research this question and write this post because a 58 year old woman with paroxysmal AF and hypertension  called the office today asking if I wanted her to take a baby aspirin daily. She has a CHADS2VASC score of 2 (woman and hypertension) and falls into the category where we should have an in depth conversation about the risks and benefits of anticoagulant therapy.

I have that discussion with her each visit and thus far we’ve decided to hold off on starting an anticoagulant drug like Eliquis. She has promised to record her ECG daily (using her Kardia Mobile ECG device) and report any onset of AF. If AF recurs we will have another discussion about Eliquis.

I spent several hours pouring over the original  studies and more recent studies, reviews and meta-analyses and reached the following conclusions:

With the advent of the newer oral anticoagulants (NOACs) in the last decade which offer better stroke reduction and less bleeding than warfarin patient-physician  discussions should be about taking a NOAC or not. Aspirin should not be considered as a lower risk/effective alternative as its benefits are minimal and bleeding risks similar to NOACs.

I told my patient no on the daily baby aspirin and from now on I will recommend stopping aspirin (assuming no other reason to be on it) to all my low risk AF patients.

Antithrombotically Yours,

-ACP

N.B.

The components of the stroke risk score- CHA2DS2-VASc = Congestive Heart failure, hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65–74, and Sex (female);


For those interested in a discussion on why females get a point in the risk score but a different cut-off for OAC therapy this is from the ESC guidelines:

 Many risk factors contribute to the increased risk of stroke in patients with AF as expressed in the CHA2DS2-VASc score. The evidence for female sex as a risk factor has been assessed in many studies. Most studies support the finding that females with AF are at increased risk of stroke. One meta-analysis found a 1.31-fold (95% CI: 1.18–1.46) elevated risk of stroke in females with AF, with the risk appearing greatest for females ≥75 years of age (S4.1.1-35). Recent studies have suggested that female sex, in the absence of other AF risk factors (CHA2DS2-VASc score of 0 in males and 1 in females), carries a low stroke risk that is similar to males. The excess risk for females was especially evident among those with ≥2 non–sex-related stroke risk factors; thus, female sex is a risk modifier and is age dependent (S4.1.1-49). Adding female sex to the CHA2DS2-VASc score matters for age >65 years or ≥2 non–sex-related stroke risk factors


If you’re curious what constitutes a IIB recommendation it is described in the yellow box below  My best summary is still “not a ringing endorsement”.



If you want to see the ESC guideline recommendations in detail