All posts by Dr. AnthonyP

Cardiologist, blogger, musician

Kardia’s Fascinating SmartRhythm For Apple Watch Is Very Cool: Will It Allow Personal Atrial Fibrillation Detection?

The KardiaBand for Apple Watch from AliveCor has delivered on  its  unique promise of a medical grade single lead ECG recording made by placing your thumb on your wristwatch band.

The ECG recordings are equivalent in quality to those made by their previously available KardiaMobile (see my prior post here.) After more experience with the Band I think the ease of recording is superior to KardiaMobile and the ability to discriminate atrial fibrillation from normal sinus rhythm is similar to KardiaMobile.

By combining either a KardiaBand or a KardiaMobile device with Kardia’s SmartRhythm monitoring system for Apple Watch we now have the promise of personal monitoring to detect atrial fibrillation.

What is SmartRhythm?

SmartRhythm is AliveCor’s term for its system for monitoring your heart rate and activity levels in order to identify when your rhythm is abnormal.

The system “takes your heart rate and activity data gathered from the Apple Watch and evaluates it using a deep neural network to predict your heart rate pattern.”

The heart rate is obtained from the Apple Watch PPG sensor every 5 seconds.  If it differs from what is predicted SmartRhythm notifies you to record an ECG.

If you’d like to learn more detail about the development of SmartRhythm and how it functions, AliveCor has an excellent informational piece here.

You can choose to have the Kardia SmartRhythm display come up whenever your Apple Watch awakens. It’s got information on your heart rate and activity over the preceding several hours

SmartRhythm display. The light blue vertical bars representing heart rate range during an interval. The continuous lines above and below the vertical bars show the boundaries of heart rate predicted by the neural network based on your measured activity from the Watch accelerometer. . Upper left corner is yellow triangle indicating that the system detected potential abnormal rhythm and recommended a recording. The dot on the right is an ECG recording. The vertical bars at the very bottom represent steps taken during an interval

The AliveCor FAQ on SmartRhythm stresses that a notification does not always mean an abnormal rhythm. Clearly false positives can and will occur. The first day I wore my KardiaBand I had several of these.

Causes for false positives include exercise that Apple Watch couldn’t detect, stress or anxiety-in other words, situations where your heart rate is higher than predicted by how much activity you are doing.

The long term record of your SmartRhythm recordings resides on your iPhone . Here’s my record for the last week

Note that Kardia , in addition to tracking your heart rate, also shows you by the green, yellow and orange dots, the times that ECG recordings were made.

Green dots indicate recordings classified as normal and yellow as “unclassified.” In my case most of the unclassified recordings were due to heart rate >100 BPM associated with exercise.

There is one orange dot indicating that Kardia felt the ECG showed “possible atrial fibrillation.”

This happened when I took my Apple Watch off my wrist and put it on one of my patients who has permanent atrial fibrillation. I had him push on the KardiaBand sensor to make an ECG recording and it was correctly identified as atrial fibrillation.

Thus far I have had no notifications of “possible atrial fibrillation” while I have been wearing my watch thus the false positive rate appears acceptably low.

How Does SmartRhythm Perform During Exercise?

I checked out SmartRhythm’s ability to predict normal and abnormal  heart patterns by wearing it during a session on my indoor bike trainer. The device did a good job of tracking both my heart rate and activity during the workout.  You can view the most recent data by viewing your Apple Watch screen during the workout as below

Or for more detailed information you can view the complete history on your iPhone as below

The system accurately tracked my heart rate and activity (although AliveCor lists stationary bike as an activity that may result in false positives). During a session of weights after the aerobic workout despite erratic heart rates and arm movements it did not notify me of an abnormality. I also did 100 jumping jacks (which involves wildly flailing my arms) and the heart rate remained within the predicted boundaries.

What is more remarkable is that I was able while cycling at peak activity to make a  very good quality ECG recording by taking my right hand off the handle bar and pushing my thumb down on the KardiaBand sensor on my left wrist.

This recording clearly  displays p waves and is sinus tachycardia. It’s unclassified by Kardia because the rate is >100 BPM.

Afib Patient Experience

One of my patients last week, a 70 year old woman with paroxysmal atrial fibrillation, had already set up SmartRhythm monitoring on her Apple Watch.

The Apple Watch face of my patient with the Kardia icon bottom right. Note also that she has a Starbucks reward available

I have this patient like many of my afibbers utilizing KardiaMobile to check an ECG when  they think they are in afib.

However, she, like many of my afib patients, is totally unaware when her heart is out of rhythm. Such asymptomatic patients are alerted to the fact that they are in afib by detection of a rapid heart rate (from a heart rate tracking wearable or BP monitor) or an irregular heart beat (from BP monitor or by someone checking the pulse) or by a random recording of an ECG.

She’s started using SmartRhythm in the hopes that it will provide a reliable and early warning of when she goes into atrial fibrillation.

We discussed the possibility of stopping the flecainide she takes to maintain normal rhythm to test the accuracy of the SmartRhythm system for detecting atrial fibrillation in her but decided not to. She’s on an oral anticoagulant and therefore protected from stroke so development of atrial fibrillation will not be dangerous for her.

I eagerly await the first real world, real patient reports of SmartRhythm’s performance in atrial fibrillation detection.

If there are any afibbers out there who have had an episode of atrial fibrillation detected by  SmartRhythm please let me know the details.

We need such anecdotes along with controlled trials to determine how useful SmartRhythm will be as a personal wearable system for detection of afib.

Fastidiously Yours,

-ACP

N.B. I’ve copied a nice section from AliveCor’s website which describes in detail the difference between measuring heart rate from the PPG sensor that all wearable devices use versus measuring the electrical activity of the heart with an ECG.

To understand how Kardia for Apple Watch works, let’s start by talking about your heart, how the Apple Watch and other wearable devices can measure your heart rate, and how an ECG is different from the information you get from a heart rate sensor alone.

Your heart is a pump. With each beat of your heart, blood is pumped through your arteries and causes them to expand. In the time between beats, your arteries relax again. On the underside of the Apple Watch is a sensor, called a photoplethysmogram (PPG), that uses green and infrared LEDs to shine light onto your skin, and detects the small changes in the amount of light reflected back as your arteries expand and relax with each beat of your heart. Using this sensor, the Apple Watch can tell how fast your heart is beating, and how your heart rate changes over time.

But, your heart rate does not tell everything there is to know about your heart. The PPG sensor on the Apple Watch can only see what happens after each heartbeat, as blood is pumped around your body. It can’t tell you anything about what is making your heart beat, or about what happens inside your heart during each beat. An ECG is very different, and tells you a lot more!

Three hearts showing a P-Wave, QRS-Complex, and a T-Wave

An ECG measures the electrical activity in your heart muscles. It detects the small pulse of electricity from the sinoatrial node (the body’s natural pacemaker, which normally initiates each heartbeat) and the large electrical impulses produced as the lower chambers of the heart (the ventricles) contract and relax. By looking at an ECG, a doctor can discern a wealth of information about the health and activity of your heart muscle, much more than you can tell from your heart rate alone. ECGs are the required gold standard for diagnosis of arrhythmias and many cardiac abnormalities, and can even be used to see evidence of acute heart attacks and even events that have occurred in the past.

Research has shown that taking frequent ECGs increases the likelihood of detecting certain arrhythmias, and decreases the mean time to diagnosis.

Review of Kardia Band Mobile ECG for Apple Watch

The skeptical cardiologist has been evaluating the Kardia Band from AliveCor which allows one to record single lead medical grade ECGS on your Apple Watch. What follows is my initial experience with setting up the device and using it to make recordings.

After ordering my Kardia Band for Apple Watch on 11/30  from AliveCor the device appeared on my door step 2 days later on a Saturday giving me most of a Sunday to evaluate it.

What’s In The Box

Inside the box I found one small and one large black rubber wrist watch band

The larger one had had a small squarish silver metallic sensor and the smaller one had a space to insert a sensor. It turns out my wrist required the smaller band and it was very easy to pop out the sensor and pop it into the smaller band.

After replacing my current band with the Kardia band (requires pushing the button just below the band and sliding the old band out then sliding the new one in) I was ready to go.

The Eternal  fiancée did not complain about the appearance of the band so I’m taking that to mean it passes the sufficiently stylish test. She did inquire as to different colors but it appears AliveCor only has one style and one color to choose from right now.

I have had problems with rashes developing with Apple’s rubbery band and switched to a different one but thus far the Kardia band is not causing wrist irritation.

Set UP

I didn’t encounter any directions in the box or online so I clicked on the Kardia app on the watch and the following distressing message appeared.

Prior to 11/30 Kardia Band only worked in certain countries in Europe so I suspected my AliveCor app needed to be updated.

I redownloaded the Kardia app from the Apple App Store , deleted it off my Watch and reinstalled it.

I was thrilled when the app opened up and gave me the following message

However, I was a little puzzled as I was not aware that setting up Smart Rhythm was a requirement to utilize the ECG recording aspect of Kardia Band. Since I have been granted a grandfathered Premium membership by AliveCor I knew that I would have access to Smart Rhythm and went through the process of entering my name and email into the Kardia app to get this started.

Alas, when the Watch Kardia app was accessed after this I continued to get the same screen. Clicking on “need help” revealed the following message:

Bluetooth was clearly on and several attempts to restart both the watch and the iPhone app did not advance the situation.

I sent out pleas for assistance to AliveCor.

At this point the Eternal Fiancee had awoken and we went to Sardella for a delightful brunch . I had this marvelous item:

Eggs Benedict Raviolo, Mortadella, Bread Ricotta, Egg Yolk, Brown Butter Hollandaise, Potatoes 15.
 Later on that day I returned to my Kardia Band iPhone and deinstalled, reinstalled , reloaded and restarted everything.
The First Recording
At this point it worked and I was able to obtain my first recording by pushing the record ECG button and holding my thumb on the sensor for 30 seconds.
I’ve made lots of recordings since then and they are good quality and have accurately recognized that I am in normal sinus rhythm.
The Smart Rhythm component has also been working. Here is a screen shot of today’s graph.
You’l notice that the Smart Rhythm AI gave me a warning sometime in the morning (which I missed) as it felt my rhythm was abnormal. I missed making the recording but am certain that I was not in afib.
Comparison of the Kardia Band recording (on the right) versus the separate Kardia device recording (on left)  shows that they are very similar in terms of the voltage or height of the p waves, QRS complexes and T waves. 
I felt a palpitation earlier and was able to quickly activate the Kardia Watch app and make a recording which revealed a PVC.
 In summary, after some difficulty getting the app to work I am very pleased with the ease of recording, the quality of the recording and the overall performance of Kardia Band. The difficulties I encountered might reflect an early adoption issue which may already be resolved. Please give me feedback on how the device set up worked for you.
I’ll be testing this out on patients with atrial fibrillation and report on how it works in various situations in future posts.
After more experience with the Smart Rhythm monitoring system which I think could be a fantastic breakthrough in personal health monitoring I’ll give a detailed analysis of that feature.
Everwatchingly Yours,
-ACP

Are You A Victim of Excessive Daytime Sleepiness?

The Skeptical Cardiologist has been analyzing the data on sleep apnea (OSA) and cardiovascular disease, utilizing his spectacular skeptical skills.

Recent guidelines from the American Academy of Sleep Medicine suggest that 30 million adults in the US have OSA and that OSA is causing all manner of problems.

I note patient awareness of the possibility of OSA is rising exponentially and many of my patient’s are being subjected to sleep studies because their wives are bothered by their excessive snoring.

The AASM guidelines state that

Increased risk of moderate to severe OSA is indicated by the presence of excessive daytime sleepiness and at least two of the following three criteria: habitual loud snoring; witnessed apnea or gasping or choking; or diagnosed hypertension

Although I have no reason to suspect that I have sleep disordered breathing (SDB-I feel like this term is becoming popular as it avoids the stigma of apnea), I decided to determine my  Epworth Sleepiness Scale which is often utilized   to measure excessive daytime sleepiness.

Developed by Dr. Murray Johns, this scale has its own website where you will learn that:

Johns (2002) introduced the term somnificity to describe the effects of different postures and activities on sleep propensity.

The somnificity of any particular posture, activity and situation is a measure of its ability to facilitate or impede sleep onset in the majority of people. It is not a characteristic of individual people or their sleep disorders.

and (no doubt after years of intense sleepiness research) Dr. Johns has discovered that:

Simply to lie down rather than stand up increases one’s likelihood of falling asleep – the change of posture increases one’s sleep propensity at the time.

After stumbling up on this revelation I have decided to test my hypothesis that playing electric guitar while standing has extremely  low somnificity. (I also hope to use the word somnificity in a normal daily conversation without biting my tongue.)

This self-administered questionnaire asks you to rate how likely you are (on a scale of 0=never to 3=high chance of dozing)  to doze off or fall asleep in certain situations. What follows are the situations with my observations and my self-rated score.

Sitting and reading    (Principles of Nuclear Medicine=3, Brave New World=0)                          1

Watching TV   1

Sitting, inactive in a public place (theatre or a meeting)     1

As a passenger in a car for an hour without a break     2

Lying down to rest in the afternoon when circumstances permit 3

sitting and talking to someone               1

sitting quietly after a lunch without alcohol      1

In a car while stopped for a few minutes in the traffic   2

They don’t ask about falling asleep while driving which seems much more important than the other situations. I’ve done that a lot.

The biggest soporific situation for me is sitting in a barber’s chair. No matter what small talk the hairdresser throws at me, I am asleep within 5 minutes. My bobbing head requires the rare skill of trimming a moving target.

My total score was 12 which puts me solidly in the land of sleep disordered breathing. In the original study by Johns  the patient’s with sleep apnea  (OSA-line 3 in below chart) had an  average score of 11.7.

The AASM guidelines indicate that I could have gotten into some OSA studies with my score, especially if I add in that I have been caught snoring, gasping and choking (sometimes all three simultaneously!) and I have hypertension.

The Eternal fiancée got a respectable score of 7. Apparently she never falls asleep at traffic lights, watching TV/movie or sitting after lunch and believes these are masculine traits. However, I think she should get double points for taking long, intentional naps throughout the day.

Somnificitically Yours,

-ACP

 

 

AliveCor’s Kardia Band Is Now Available: Mobile ECG On Your Apple Watch

AliveCor has finally gotten approval from the FDA to release its Kardia Band in the United States.

The skeptical cardiologist is quite excited to get his hands (or wrist) on one and just gave AliveCor $199 to get it.

The device incorporates a mobile ECG sensor into a wrist band that works with either 42 or 38 mm Apple watches. I’ve written extensively about AliveCor’s previous mobile ECG product (here and here) which does a good job of recording a single lead ECG rhythm strip and identifying atrial fibrillation versus normal rhythm,

Hopefully, the Kardia Band will work as well as the earlier device in accurately detecting atrial fibrillation.

According to this brief video to make a recording you tap the watch screen then put your thumb on the sensor on the band.

The app can monitor your heart rate constantly and alerts you  to make a recording if it thinks you have an abnormal rhythm.

I was alerted to the release of Kardia by Larry Husten’s excellent Cardio Brief blog and in his post he indicates that the alert service , termed Smart Rhythm,  requires a subscription of $99 per year.:

AliveCor simultaneously announced the introduction of SmartRhythm, a program for the Apple Watch that monitors the watch’s heart rate and activity sensors and provides real-time alerts to users to capture an ECG with the Kardia Band. The program, according to an AliveCor spokesperson, “leverages sophisticated artificial intelligence to detect when a user’s heart rate and physical activity are out of sync, and prompts users to take an EKG in case it’s signaling possible abnormalities like AFib.”

The Kardia Band will sell for $199. This includes the ability to record unlimited ECGs and to email the readings to anyone. The SmartRhythm program will be part of the company’s KardiaGuard membership, which costs $99 a year. KardiaGuard stores ECG recordings in the cloud and provides monthly summary reports on ECGs and other readings taken.

AliveCor tells me my Kardia Band will be shipped in 1-2 days and I hope to be able to give my evaluation of it before Christmas.

Please note that I paid for the device myself in order to avoid any bias that could be introduced by receiving largesse from AliveCor.

Proarrhythmically Yours

-ACP

N.B. Larry Husten’s article includes some perspective and warnings from two cardiologist and can be read here.

Another article on the Kardia Band release suggests that the Smart Rhythm program at $99/ year is a requirement.

Perhaps, AliveCor’s David Albert can weigh in on whether the annual subscription is a requirement for making recordings or just allows the continuous monitoring aspect.

Blood Thinners (Oral Anticoagulants) For Atrial Fibrillation: Who Should Take Them and Which One To Take

The most serious  adverse consequence of having atrial fibrillation is stroke. Since we have safe and effective ways of preventing afib-related stroke with oral anticoagulant drugs (blood thinners), a major decision for the newly diagnosed patient with atrial fibrillation is “should I take a blood thinner?”

To answer this question the afibber should engage in a lengthy discussion with his/her health-care provider which results in a shared and informed  decision. Such discussion must cover your risk of stroke, the benefits of blood thinners in preventing stroke, the bleeding risks of blood thinners and the pros and cons of the five oral anticoagulants available to prevent stroke.

Estimating Your Risk of Stroke With Afib

The best way we have of estimating a patient’s risk of stroke if they have atrial fibrillation (AF) is by the CHA2DS2-VASc scale (which I like to call the Lip scale)

Stroke Risk EstimationThis scale take the factors we know that increase the risk of stroke and assigns 1 or 2 points. The acronym comes from the first letter of the factors that are known to increase risk as listed to the left.

Most of the factors get 1 point, but prior stroke (S) and age>75 (A) get 2 points.

We then add up your points and use another chart (or app) to calculate the risk of stroke per year.

CHA2 stroke riskYour risk of stroke is very low if you have zero risk factors; it gets progressively higher as you reach the maximum number of 9.

Treatment with an oral anticoagulant (OAC),  either warfarin, or one of the four novel anticoagulant agents (NOACS), is recommended when score is >/=2 corresponding to a  risk of stroke  above 1-2% per year.

These blood thinners have consistently been shown to lower your risk of stroke or systemic embolization (when a clot from the heart goes somewhere other than the brain) by almost 70%.

The higher the risk, the more the benefit of these blood thinners in preventing stroke.

Both European and American guidelines recommend using the CHA2DS2-VASc score for initial risk stratification. The European  guideline recommends OAC therapy for males with a CHA2DS2-VASc score ≥1 and for female patients with a score ≥2., whereas the American guideline recommends use of OAC if the CHA2DS2-VASc  score is ≥2 for men and women.

I’ve been using the CHA2DS2-VASc scale for several years in my afib patients. I try to review the patient’s risk of stroke and their risk of bleeding during every office visit, and decide whether they should be on or off an OAC.

Bleeding From Blood Thinners

All OACs cause increase bleeding. They don’t discriminate between bad clots that cause strokes and good clots that stop you from bleeding.

If you’re taking one you are more likely to have nose bleeds, bleeding into the intesitnal tract or urine and you will bleed longer when cut and more profusely if in an accident. In lower stroke risk patients, the bleeding risk of OAC of 1% per year may outweigh the benefits conferred by stroke reduction.

I wrote a post entitled “Why Does The TV Tell me Xarelto Is a Bad Drug” which points out that law suits against the makers of the newer OACs are frivolous and that these NOACs are likely more safe and effective than warfarin.

In recent years, four new drugs for reducing strokes in patients with atrial fibrillation which are much less influenced by diet and medications have gained approval from the FDA. These are generally referred to as “novel anticoagulants” reflecting their newness, different effects from warfarin or aspirin, and their blood thinning properties.  The first  (brand name Pradaxa) was released to much excitement and fanfare in October, 2010.  The press release for this approval read as follows:

PRADAXA, an oral direct thrombin inhibitor2 that was discovered and developed by Boehringer Ingelheim, is the first new oral anticoagulant approved in the U.S. in more than 50 years. As demonstrated in the RE-LY® trial, PRADAXA 150mg taken twice daily has been shown to significantly reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin, the current standard of care for patients with non-valvular atrial fibrillation. PRADAXA 150mg taken twice daily significantly reduced both ischemic and hemorrhagic strokes compared to warfarin

What was very clear from the study with Pradaxa  and stated very clearly in all publications and patient and doctor  information sources was that just like warfarin, patients could have severe bleeding complications, sometimes fatal. Overall serious bleeding complications were about the same (the rate of major bleeding in patients Pradaxa  in the RE-LY trial was 3.1% versus 3.4% in the warfarin group) but Pradaxa had about 50% more bleeding from the gastrointestinal tract and warfarin about 50% more bleeding into the brain.

Another big difference between the novel anticoagulants and warfarin is that we have antidotes (Vitamin K, fresh frozen plasma) that can reverse the anticoagulation state rapidly for warfarin but until recently none for the newer drugs. (There is now available an antidote for Pradaxa).  This information also was made very clear to all doctors prescribing the medications in the package insert and educational talks. Despite this, in the major trials comparing these newer agents to warfarin, the newer agents were as safe or safer than warfarin.

The most feared bleeding complication on all OACs is bleeding into the head (intracranial hemorrhage). The risk of ICH is between 0.2 to 0.4 percent per year on warfarin. Studies show with the NOACs the risk is about half of the risk on warfarin.

Should You Take a NOAC or Warfarin?

Once the decision has been made to start a blood thinner, the next question is whether to take warfarin or a NOAC. Warfarin (brand name Coumadin) has been utilized since the 1950s  and prior to 2010 was  the only drug available for doctors to reduce clot formation in the heart and susbsequent strokes.. Warfarin is only effective and safe within a narrow window and its effects are strongly influenced by Vitamin K in the diet and most medications. Thus, frequent blood testing and adjustment in dosage is needed, and close monitoring of diet and changes in medications. Even with this close monitoring, serious and sometimes fatal bleeding occurs frequently with warfarin.

Here is a patient information sheet on warfarin which gives you an idea of issues you will need to be aware of when taking the drug. (WArfar patient handout)

If you do a Google search on warfarin you will quickly discover that it is used as a rat poison. Scientists isolate the chemical from  sweet clover that was causing cows to bleed and then developed a more potent form that they named warfarin in the 1940s. After developing blood tests that allowed the drug to be used safely  to dissolve clots it was approved for human use in the 1950s.

Warfarin or more potent variations on its chemical structure have been utilized as rat poison since the 1940s.

The rats are consuming much larger quantities of the blood thinner and are clearly not being monitored for blood thinness.

Some despicable sites peddling alternative or natural products such as this “Healthy Habits” site engage in fear-mongering over the warfarin/rat poison connection in order to promote totally unproven products. Healthy Habits indirectly suggests  that Nattokinase : is a safer, more effective natural alternative to warfarin” This remarkable enzyme has the ability to dissolve blood harmful clots involved in heart disease and strokes without upsetting normal healthy clotting.”

Such misinformation is dangerous and could lead to patients stopping a life-saving medication and suffering a stroke.

By the way, in this Xarelto (another NOAC competitor) ad, Screen Shot 2016-06-29 at 2.21.20 PMKevin Nealon says he chose Xarelto over warfarin because he wanted to eat salads. This is a common misconception and the makers of Xarelto should be ashamed for promulgating it.

I tell my patients it is fine to eat green, leafy vegetables while taking warfarin. The Vitamin K in the vegetables does influence the effectiveness of warfarin thinning blood but this is why we check the blood test to determine the appropriate dosage of warfarin for you and your personal dietary Vitamin K consumption , be it high or low.

Novel Oral Anticoagulant Drugs

The newer OACs, in contrast to warfarin do not require blood tests for monitoring of their efficacy because their levels are not significantly influenced by changes in diet or most medications.

In head to head studies versus warfarin four of these NOACs have demonstrated at least similar efficacy in preventing stroke and at most similar bleeding risk.

Due to their perceived advantages most new prescriptions for OACs are for NOACs. In contrast to 2014 American afib guidelines which don’t state a preference, the most recent European afib guidelines recommend choosing a NOAC over warfarin when initiating anticoagulant therapy in patients who are eligible for NOACs. (Ineligible patients include those with mitral stenosis, mechanical heart valves and end-stage renal disease.)

The ESC guidelines published in 2016, , make choosing a NOAC over warfarin a IA recommendation. This means there is a consensus that the treatment should be recommended (Class I recommendation) and that there is strong evidence from randomized controlled trials to support it (Level A.)

I have decided to primarily use Eliquis (apixaban) as my NOAC of choice based on my comparison of the different NOAC studies. If a patient’s insurance covers another NOAC better , making it cheaper then  I am happy to switch.

Because these four NOACs are new and brand name they are significantly more expensive than warfarin. Cost varies substantially based on type of insurance coverage and we can only determine how much a patient will pay for any given NOAC based on writing a prescription and having a pharmacy check out the cost.

I have found some patients paying nothing for their NOAC whereas some are paying several hundred dollars monthly. The more NOACs cost, the more likely the patient and I are to choose warfarin.

While waiting to determine if cost is going to be prohibitive I will typically provide the patient with samples of the NOAC chosen. The pharmaceutical companies making these NOACs are clearly making substantial profits off them and they are happy to provide lots of samples to doctors to influence the doctors to utilize their product.

NOACs are being extensively promoted both to physicians and directly to patients. Physicians have to be especially careful to make sure they are presenting a true summary of the relative risks and benefits of warfarin versus NOACs in light of these constant attempts to influence them.

Despite now having four NOACs with similar benefits and ease of use compared to warfarin, the cost of these agents doesn’t seem to have declined significantly from when the first NOAC came on the market. Personally, I would love to see Medicare step in and negotiate significantly lower costs for American senior citizens.

An abstract at the ACC meeting in March of 2017 suggested  a reduction in medical costs with NOACs despite their high costs. This was related to a lower rate of major bleeding complications: Xarelto cost $542 per patient compared with warfarin’s $500, or $42 more. Pradaxa, cost $367 to warfarin’s $452, saving $85.  Eliquis cost  $286 charge against warfarin’s $537 resulting in $251 in savings. Data were from from a study of U.S. Medicare patient records.

Aspirin May Not  Prevent Stroke In Afib

Many patients consider aspirin to be  a “blood thinner” that has some benefit in preventing clots and strokes in patients with afib. However,  aspirin is not considered a blood thinner or anticoagulant and is more properly  termed an anti-platelet agent.

I used to consider aspirin at doses of 120 to 200 mg daily provided some protection against stroke in afib and put afib patients on aspirin who were low risk for stroke or would not or could not take OACs.

More and more, however, experts are reaching the conclusion that the substantial bleeding complications from aspirin usage outweigh its very slight benefit in stroke prevention.

The most recent ESC guidelines, in fact, list aspirin therapy for stroke prevention in atrial fibrillation as IIIA. That means that overall it is felt to be harmful (III) with a high level of evidence (A.)

Bleeding risks for aspirin are similar to warfarin and Eliquis. Thus, patients should not consider aspirin as a safer alternative to prevent stroke in afib.

Finally, do not take any “natural” supplement that has been promoted as a blood thinner. These are neither safe nor effective. Remember that it took years of scientific investigation and careful testing in animals then humans before warfarin (the agent in sweet clover that caused cows to bleed ) was transformed into a safe and effective anticoagulant.

Antiemboligenically yours

-ACP

Sigmund Freud and the Cocaine Cure For Opioid Addiction

“I sneered at the poor mortals condemned to live in this valley of tears while I, carried on the wings of two leaves of coca, went flying through the spaces of 77,438 worlds, each more splendid than the one before.
An hour later I was sufficiently calm to write these words in a steady hand: “God is unjust because he made man incapable of sustaining the effect of coca all life long. I would rather have a life span of ten years with coca than one of 1000000 … (and here I had inserted a line of zeros) centuries without coca.

These are not the words of the skeptical cardiologist nor those of his childhood hero, Sigmund Freud.

They were, we learn in the early pages of  Frederick Crews’ new book “Freud: The Making of an Illusion,” written by the earliest European coca researcher, Paolo Mantegazza, “a boisterous Italian neurologist, anthropologist, and sexual reformer.”

Sigmund Freud apparently heartily endorsed Mantegazza’s
overwhelming positive observations on coca writing in his 1884 monograph “On Coca”:

“I have carried out experiments and studied, in myself and others, the effect of coca on the healthy human body,” ; “my findings agree fundamentally with Mantegazza’s description of the effect of coca leaves.”

As a teenager I eagerly read all the Freud books I could find at my local library. I offered to interpret my friend’s dreams based on Freud’s methods in “The Interpretation of Dreams.” I was fascinated by the separation of the mind into a moral superago, a conscious ego and an unfelt and dark id. I marveled at his ability to uncover deep hidden experiences and cure his patients. I tried to use his concepts and techniques to understand literature, life and art.

Over the ensuing decades, however, I gradually came to realize that most if not all of his work was nonsense. I embraced the scientific method and left psychology and psychoanalysis far behind.

I hadn’t really thought about Freud much until the release of Crews’ “Freud” which convincingly portrays Freud as a very poor scientist but excellent liar, self-promoter and charlatan.

It is a fascinating read even if you weren’t obsessed with Freud as a teenager.

Early in the book we learn that Freud, who had primarily been working in the field of histology (basically looking at tissue under a microscope), suddenly switched fields in order to garner attention and money.

In the 1880s cocaine was not regulated in any way. In fact:

“ In the United States, low-grade cocaine was being added to soda pop, cigars, and cigarettes, consumed as a general tonic, and prescribed to ease hay fever, sinusitis, and even teething. Meanwhile, one cocaine-laced wine,

Vin Mariani, in circulation since the 1860s, was still being consumed internationally in the first years of the new century. Its devotees included President McKinley, Czar Alexander II of Russia, and Queen Victoria, and it was endorsed in advertisements by Pope Leo XIII, who was said to carry it everywhere in a hip flask.”

Freud had heard of a German physician using cocaine to energize exhausted soldiers and obtained a gram of cocaine from the German pharmaceutical company, Merck.

“On April 30, 1884—Walpurgisnacht, or the folkloric night of supposed witchcraft and trafficking with the Devil—he tasted cocaine powder and imbibed his first .05 gram solution of it, marveling at its mood-elevating capacity. And from that night forward he would regard the drug as the most precious and restorative substance on earth.”

After this, Freud became a regular user of cocaine and within two months wrote his monograph “On Coca” which gushed over the curative properties of cocaine for a whole host of ailments but glossed over the potential dangers of the drug.

The monograph was riddled with errors. For example:

“Freud was confounding “the effect of coca leaves”—the leaves that Mantegazza had been excitedly gnawing in Peru in 1858, three years before cocaine had been chemically isolated—with cocaine itself. The very title of Freud’s paper—not “On Cocaine,” as it is sometimes cited, but “On Coca”—fostered that same confusion, which was never rectified in the body of the text. The misrepresentation was as gross as if he had judged the physiology of wine consumption by citing that of grapes, or as if he had confused hashish with hemp.”

Although his letters clearly show he had only had possession of cocaine months before completing the paper, he pretends to have extensive experience in using it for therapeutic purposes.

“At various points “On Coca” hinted that its author possessed a long and judicious familiarity with cocaine and its effects. “Time and again” (zu wiederholten Malen), wrote Freud, as if looking back on many years of pharmaceutical experience, he had relieved his colleagues’ stomach problems with cocaine. Copious experience with patients could also be inferred from his endorsement of cocaine regimens to intervene against depression, heart problems, and “all diseases which involve degeneration of the tissues.”

In particular, he enthusiastically endorsed its use in curing patients suffering from morphinism, an addiction to opioids. 

“As a physician, though, Freud was most exhilarated by the many cures of morphinism that had been narrated in back numbers of the Therapeutic Gazette.* “On Coca” conveyed an impression that such cures were commonplace in America. Coca, Freud wrote (meaning cocaine), appears to have “a directly antagonistic effect on morphine.”  Moreover, it probably doesn’t get stored within the organism, and therefore “there is no danger of general damage to the body as is the case with the chronic use of morphine.” Hospitalization of the patient, then, is quite unnecessary; the whole regimen can be brought to a successful end, with only trivial complications, in a matter of days. And Freud recounted that he had personally “had occasion to observe” just such a happy outcome.

Presaging our current problems with pharmaceutical industry sponsored research (chocolate, sugar, etc.) and predatory journals, it turns out that the Therapeutic Gazette was owned and edited by Parke-Davis pharmaceutical firm which had supplied the cocaine for the miraculous cures described in its pages.

Ernst Fleisch von Marxow
Freud convinced his friend, the distinguised scientist and academic Ernst Fleischl von Marxow, to utilize cocaine to cure his (Fleischls’) morphine addiction. Fleischl had became addicted to morphine after acquiring an infection which required having his thumb amputated.

Although the experiment was a total failure (Fleischl ended up addicted to both morphine and cocaine) Freud describes the treatment in his monograph as an unmitigated success.

“When the bare facts of Freud’s relations with Ernst Fleischl are set forth, it is tempting to regard Freud as a sociopath. Before Freud offered him cocaine, Fleischl, though continually suffering, was a brilliant scientist, polymath, and man of the world. Afterward, he gradually became what Freud called “a broken man” and “a mass of eccentricities,”1 subject to insomnia, hallucinations, inability to eat, personality changes, and horrific wasting as he lapsed into invalidism and died in 1891. Freud bore a large measure of responsibility for that transformation, yet he refused to own up to it during Fleischl’s lifetime. On the contrary, he represented his prescription of cocaine against Fleischl’s morphine  have as having been proved a signal success.”

Freud would go on to repeat the lie of successful cocaine treatment for opiod addiction in subsequent presentations and papers. He would collaborate with Parke-Davis to promote cocaine usage..

These actions undoubtedly contributed to a subsequent boom in cocaine usage and the eventual discovery of the dangers of cocaine addiction.

Fleischl’s cocaine habit became so large that the magnitude of his orders for cocaine from Merck caused the company to assume that he and Freud were engaged in active research with the drug.

It appears that science has always had its miscreants. We can see in Freud’s techniques for promotion of cocaine many of the methods that current day snake oil and nutraceutical salesman utilize.

Although we have developed higher standards for scientific studies and papers, the rise of predatory journals is jeopardizing scientific credibility in a manner similar to the Therapeutic Gazette of the 1880s.

Posthanksgivingly Yours,

-ACP

 

 

 

 

Is Chocolate Good For The Heart?

While in Paris recently,  allegedly researching the French Paradox, the skeptical cardiologist and his Eternal Fiancee’ participated in a Food Tour (Paris By Mouth).  Along with 2 other American couples, we were guided and educated by a Parisian food/wine expert as we wandered from one small shop to another in the St. Germain district of the Left Bank.

We collected the perfect Baguette Monge from Eric Kayser, delicious rillettes, terrine, and saucisson from Charcuterie Saint Germain, amazing cheese from Fromager Laurent Dubois, delightful  pastries from Un Dimanche a Paris, and unique and delicious chocolate from Patrick Roger.

The tour ended at La Cave du Senat wine shop, where we descended into a stone cellar and tasted all of the delicious foods while drinking wonderful wines.

The French Paradox refers to the fact that the French are among the world’s highest consumers of saturated fat, but have among the world’s lowest rates of cardiovascular disease. For those nutritional experts still obsessed with the dangers of all saturated fats, this poses a conundrum.

Cheese And The French Paradox

France consumes more cheese (27 kg per person per year) than any other country in the world (the US only consumes 16 kg per capita). Unlike Americans who have embraced low fat or skim versions of cheese, the French predominantly consume full fat cheese.

I wrote In Defense of Real Cheese  in 2014 and extolled the heart-healthy virtues of eating full fat , non factory-processed cheese.

Perhaps the French are protected against heart disease by their high consumption and love of real cheese ?

Chocolate And The French Paradox

Whereas cheese contains saturated fat and has been unfairly stigmatized as unhealthy, chocolate, similarly with high saturated fat content, seems to have been coronated as the king of food that is yummy but paradoxically is also heart healthy.

Could chocolate be the enigmatic protector of the hearts of the French?

Back on Boulevard Saint-Germain we entered the shop of Patrick Roger, who won the coveted Meilleur Ouvrier de France, in the craft of chocolate in 2000. The MOF is France’s way of recognizing the best artisans in various fields and occurs every 4 years. The standards are so high that in 2015 none of the 9 chocolatier competitors were felt to merit receiving the award.

The French clearly take their chocolate seriously but they don’t top the international charts at per capita consumption.

The Swiss consume 20 pounds of chocolate per year, whereas the French and US are tied for 9th, consuming 9.3 and 9.5 lbs. (Infographic from Forbes

 

 

Chocolate And The Heart

I’ve been meaning to write a post on chocolate and the heart since my encounter with high end chocolatiers in Paris and Bruges, and especially since May when there was much fanfare over a Danish study showing less atrial fbrillation in high chocolate consumers.

A NYTimes piece stimulated by the Danish study and entitled “Why Chocolate May Be Good For The Heart” typified the media headlines  and summarized the study thusly:

Scientists tracked diet and health in 55,502 men and women ages 50 to 64. They used a well-validated 192-item food-frequency questionnaire to determine chocolate consumption.

After controlling for total calorie intake, smoking, alcohol consumption, body mass index and other factors, they found that compared with people who ate no chocolate, those who had one to three one-ounce servings a month had a 10 percent reduced relative risk for atrial fibrillation, those who ate one serving a week had a 17 percent reduced risk, and those who ate two to six a week had a 20 percent reduced risk.

Previous large, well done observational studies also show that high chocolate consumption compared to no consumption is associated with a lower risk of cardiovascular disease.

Of course these being observational studies with only weak (but significant) associations, we cannot conclude that chocolate consumption actually  lowers the risk of developing afib or cardiovascular disease (causation.)

My favorite graph to hammer home this point is below and plots how much each country consumes in chocolate, versus the number of nobel laureates.

 

 

 

 

 

 

 

 

 

There is a good correlation here (Pearson’s (no relation unfortunately) correlation coefficient or r value) which is highly significant (p value <.0001). But does anyone seriously think a country can boost its Nobel Laureate production by promoting chocolate consumption?

The authors of the Danish afib trial, admit the possibility of residual or unmeasured confounding variables as a limitation in their discussion:

Although we had extensive data on diet, lifestyle and comorbidities, we cannot preclude the possibility of residual or unmeasured confounding. For instance, data were not available on renal disease and sleep apnoea. However, after adjusting for age, smoking status and other potential confounders, the association was somewhat attenuated but remained statistically significant.

Most chocolate authorities proclaim the health  benefits of dark chocolate over milk chocolate but in this Danish study:

We did not have information on the type of chocolate or cocoa concentration. However, most of the chocolate consumed in Denmark is milk chocolate. In the European Union, milk chocolate must contain a minimum of 30% cocoa solids and dark chocolate must contain a minimum of 43% cocoa solids; the corresponding proportions in the USA are 10% and 35%.16 Despite the fact that most of the chocolate consumed in our sample probably contained relatively low concentrations of the potentially protective ingredients, we still observed a robust statistically significant association, suggesting that our findings may underestimate the protective effects of dark chocolate.

Despite the fact that the participants in the Danish AFib study were likely mostly consuming  milk chocolate rather than dark chocolate,  the lead author of the study has been quoted as saying “dark chocolate with higher cocoa content is better… because it is the cocoa, not the milk and sugar, that provides the benefit.”

The Chocolate-Industrial -Research Complex

Julia Volluz, in a nicely written piece at Vox  entitled “Dark chocolate is now a health food. Here’s how that happened.” describes how “over the past 30 years, food companies like Nestlé, Mars, Barry Callebaut, and Hershey’s— among the world’s biggest producers of chocolate — have poured millions of dollars into scientific studies and research grants that support cocoa science.”

Here at Vox, we examined 100 Mars-funded health studies, and found they overwhelmingly drew glowing conclusions about cocoa and chocolate — promoting everything from chocolate’s heart health benefits to cocoa’s ability to fight disease. This research — and the media hype it inevitably attracts — has yielded a clear shift in the public perception of the products.

“Mars and [other chocolate companies] made a conscious decision to invest in science to transform the image of their product from a treat to a health food,” said New York University nutrition researcher Marion Nestle (no relation to the chocolate maker). “You can now sit there with your [chocolate bar] and say I’m getting my flavonoids.”

Flavonols and Blood Pressure

Dark chocolate and cocoa products are rich in chemical compounds called flavanols. Flavanols have attracted interest as they might help to reduce blood pressure, a known risk factor for cardiovascular disease. The blood pressure-lowering properties of flavanols are thought to be related to widening of the blood vessels, caused by nitric oxide.

The latest Cochrane Review on this topic commented on the poor quality of the studies involved:

Studies were short, mostly between two and12 weeks, with only one of 18 weeks. The studies involved 1804 mainly healthy adults. They provided participants with 30 to 1218 mg of flavanols (average of 670 mg) in 1.4 to 105 grams of cocoa products per day in the active intervention group. Seven of the studies were funded by companies with a commercial interest in their results, and the reported effect was slightly larger in these studies, indicating possible bias.

This graph from Volluz’s Vox article demonstrates how much chocolate you would need to consume to get the average amount of flavanols that participants in these studies received:

The Cochrane review felt there was

moderate-quality evidence that flavanol-rich chocolate and cocoa products cause a small (2 mmHg) blood pressure-lowering effect in mainly healthy adults in the short term.

Thus, for a very small drop in blood pressure you would have to make chocolate the main source of calories in your daily diet.

Consuming such large amounts of chocolate, even dark chocolate, would drastically increase your sugar consumption.

Further weakening any conclusions on the benefit of chocolate are that these are very short-term studies with markedly different baseline BPs, ages, and large variations in flavanol dosage.

Is Your Chocolate Produced By Slaves?

After reading the Danish AFib article, I purchased several bars of Tony’s Chocolonely chocolate that caught my eye at the Whole Foods checkout counter. The bars had interesting wrappers and on the inside of the wrapper I discovered that Tony’s Chocolonely’s claim to fame is that it is “slave-free.”

Per Wikipedia:

Tony’s Chocolonely is a Dutch confectionery company focused on producing and selling chocolate closely following fair trade practices, strongly opposing slavery and child labour by partnering with trading companies in Ghana and Ivory Coast to buy cocoa beans directly from the farmers, providing them with a fair price for their product and combating exploitation.

The slogan of the company is: “Crazy about chocolate, serious about people“.

I was previously unaware of the problem of child slavery and cocoa production. If you’d like to read more about it start here.

The Tony’s Chocoloney was so tasty I ended up consuming vast quantities of it at the end of the day and it disappeared rapidly. Currently the skeptical cardiologist’s house is chocolate free.

Should Chocolate Be Considered A Super Food or A Slave Food?

I can’t recommend chocolate to my patients as a treatment for high blood pressure or to reduce their risk of heart attack or stroke on the basis of the flimsy evidence available.

If you like chocolate, the evidence suggests no adverse effects of consuming it on a regular basis.

As far as flavanols obtained from cocoa and their benefits for cardiovascular disease, I eagerly awaiit the result of the ongoing Cocoa Supplement and Multivitamin Outcomes Study (COSMOS), a randomized trial looking at whether daily supplements of cocoa extract and/or a standard multivitamin reduces the risk of developing cardiovascular disease and cancer.

Patients and readers should recognize that there is an ongoing research/media campaign by Big Chocolate to convince them that chocolate is a SuperFood which can also be a dessert.

Flavanoidly Yours,

-ACP

Most Echocardiograms Done In the UK Are Free But Not Read By Cardiologists

In the course of researching a previous post on the cost of an echocardiogram, the skeptical cardiologist discovered a website in the UK ((HeartScan)) that offered a “private” echo at a cost of around $400.

Subsequently,  Antoinette Kenny, the creator of HeartScan, was kind enough to answer some questions I had about echocardiography in the UK.

 

From the HeartScan website. I presume this is Dr. Kenny, herself, performing an echocardiogram on a patient.

 

First she provided me with some background on her career. (Green text below from Dr. Kenny)

As you will know from HeartScan’s website (redesign of which is almost complete and will be launched next month) I am a cardiologist in the UK. I am still a fulltime NHS (UK’s public health service) cardiologist at one of the leading heart centres in the UK, the Freeman Hospital, Newcastle upon Tyne. I am Head of the Regional Echocardiography Department there providing TTE, TEE, stress echo, 3D etc. My career has also been heavily involved with the British Society of Echocardiography (BSE) which is affiliated with British Cardiovascular Society and promotes standards of practice for echocardiography in the UK including accreditation programmes for individuals and departments/private services.

Dr. Kenny is clearly well-trained and dedicated to providing high quality echocardiography.

And according to  HeartScan’s FAQs

At HeartScan you are secure in the knowledge that your Echo will be performed to the highest standards laid down by the British Society of Echocardiography. HeartScan is to date the only private provider in the UK to be awarded British Society of Echocardiography Departmental Advanced Accreditation.

Are Echos Free In The Uk?

You are correct, echocardiograms are free of charge through the NHS in the UK. However, there are waiting times involved for elective referrals and typically patients may have to wait for 6-12 weeks or longer in some geographical areas.  So some patients will chose to have their echocardiogram privately and self-fund.  Other patients are covered by health care insurance and will have their echo reimbursed by their health insurance provider

It would be unusual for someone to wait for more than 1-2 weeks for an echocardiogram in the US. I suspect the longer UK waiting time does not cause worse outcomes.

Hopefully, patients presenting with some conditions (acute heart failure  comes to mind)  are moved up in the queue.

How Does Dr. Kenny Determine What To Charge For Her Private Echocardiograms?

My services are very competitively priced and I chose this price point to be competitive with other private echo services but also add value to the patient in that the echo is reported by a cardiologist who is an echo specialist.  Other local private hospitals provide an echo privately at a higher cost (approx. £380-480 for a sonographer reported echo).

So £295 is the cost of what I believe is a very high quality echo with a high quality  report.  I guess I have tried to make private echo reported by an echocardiologist as available as I can.  Whilst we are a small clinic I do get patients who travel great distances for an echo as they tell me they trust the service (as they know it’s reported by a specialist) and find the pricing better than they can attain locally.

A Marked Difference In The Practice of Echocardiography Between In The US Compared To The UK

One of the main differences between the UK and US I think is that imaging cardiologists are very much in the minority here so that in a smaller hospital there may be no cardiologist who has echo expertise.  Therefore the Echo service is almost completely physiologist delivered.  In larger teaching hospitals over the last decade or so there has been an increased awareness of the importance of imaging and thus an increased training and appointment of imaging cardiologists.  However numbers are small in relation to the service load. For instance in my unit we perform almost 18,000 TTEs annually but there are only 1.5 Echo consultants (and we both do general cardiology also).  So the TTE service is physiologist reported with myself and my colleague running ongoing education and  QA programmes for the physiologists.  We only report a small percentage of TTE cases that are flagged up by the physiologists but we perform the TOE (TEE!) and DSE’s etc. Echo is a relatively small sub-specialty in the UK so echo cardiologists tend to know each other and lecture on each other’s teaching courses etc. But there are many hospitals with no cardiologist echo expertise.

I was amazed by this. In the US, sonographers record the examination and make measurements. In some (typically academic) centers the sonographers create a preliminary reports, however, an echo trained physician signs off on all reports.

I was curious what training and reimbursement these physiologists receive  as they doing, in essence,  what a cardiologist does in the US.

Salary and Training of Physiologists in UK

Yes, our cardiac physiologists have considerable responsibility!

Their training is changing with a programme of ” modernising scientific careers” that’s underway but I will send you on info regarding their training. In essence the previous model was to complete a university course and then train in the hospital in various disciplines. For those in cardiology they train in the cath lab, cardiac rhythm management and Echo so have a very broad base before then specialising in Echo ( or cardiac rhythm etc).

Salaries depend on experience and seniority but the salary for a cardiac physiologist who has attained BSE accreditation and reports independently is up to £42,000 a year.

I’m fascinated by this fundamental difference in the way echocardiography happens in the US versus the UK. I wonder how it impacts either clinical outcomes or the cost of medical care in the two countries.

I’ll be posting information on the training that UK physiologists go through in the near future.

I welcome comments from any UK readers on their experience with private or NHS echocardiograms, either good or bad.

I remain Anglophilically yours,

-ACP

 

N.B.  For your further edification, I’ve copied Dr. Kenny’s About Page from the HeartScan web page.

Perhaps Dr. Kenny can tell us what all those initials after her name mean.

About Dr Kenny

Dr. Antoinette Kenny, Director of HeartScan Ltd.
MB BCh BAO MD FRCP FRCPI

Dr. Antoinette Kenny is a full time Consultant Cardiologist and Specialist in Echocardiography (ultrasound heart scans) at the Regional Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne.  She is also an expert in cardiac screening for individuals involved in sport.

Dr. Kenny qualified in medicine in Dublin in 1983 and trained in clinical cardiology at St. James’s Hospital Dublin and Papworth Hospital Cambridge. She was awarded the Grimshaw-Parkinson  Fellowship from Cambridge University for her research towards an MD thesis in echocardiography at Papworth Hospital. She was made a Fellow of the Royal College of Physicians, London, in 1998 and of the Royal College of Physicians, Ireland, in 1999.

Following her clinical cardiology training and MD thesis she was appointed Fellow in Echocardiography at the Oregon Health Sciences University, Portland, Oregon, USA.  There she undertook training in advanced echocardiography, including three-dimensional echo techniques, with Professor David Sahn the internationally renowned specialist in echocardiography. In 1993, at the relatively young age of 33, she was appointed Consultant Cardiologist and Clinical Head of Echocardiography at The Regional Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne.  At that time only 19 (<5%) of consultant cardiologists in the UK were female and an even smaller percentage of cardiologists had achieved consultant status by the age of 33, facts which serve to highlight Dr. Kenny’s postgraduate career achievements.  (Source Royal College of Physicians Census).

Echo experience:
As Clinical Head of Echocardiography at Freeman Hospital for over 20 years, Dr. Kenny has gained a vast experience in assessing patients with heart failure, valve disorders and inherited cardiomyopathies.  Her expertise includes evaluation and selection of patients for advanced valve replacement techniques such as TAVI (transcutaneous aortic valve implantation) and minimally invasive surgery.  She is a member of the Specialist Heart Valve Team at Freeman Hospital providing specialist echocardiographic expertise for the selection of patients for valve surgery.

Sports Cardiology experience:
Dr. Kenny is also a cardiology adviser to the Football Association (FA) and a member of the FA cardiology consensus panel producing guidelines for cardiac screening.  She has performed cardiac screening for the Football Association since this programme was introduced for young footballers in 1996.

Dr Kenny has also been involved with investigation and heart screening in premiership football players for the last decade and provides heart screening for Newcastle United FC, Sunderland AFC and Middlesbrough FC, including their first team players. Dr. Kenny has particular expertise in distinguishing between the normal changes produced by athletic training (athlete’s heart) that could be misinterpreted as abnormalities and abnormal cardiac conditions that can pose a serious health risk.

Achievements:
Dr Kenny holds full accreditation with the British Society of Echocardiography, the national benchmark of quality in performing and interpreting Echo scans.  As an elected council member of the British Society of Echocardiography she has been involved with standards and quality in delivery of national Echo services.  She also held the post of Chairman of the Scientific and Research Committee of the British Society of Echocardiography with responsibility for organisation of the annual meeting and educational sessions.

She is co-author of a well received textbook of echocardiography which has been translated into other languages. Dr. Kenny is also a leader in education in echocardiography, co-directing a national Echo course and invited to lecture at both national and international Echo conferences.

Dr. Kenny has developed and led research studies in advanced applications of echocardiography over the last two decades and has published widely in peer reviews journals.

What Is Behind The Significant Changes In AliveCor’s Kardia Mobile ECG App?

The Skeptical Cardiologist is a strong proponent of empowering patients with atrial fibrillation by utilizing personal cardiac rhythm devices such as Afib Alert or AliveCor’s Kardia.

I’ve written about my experiences with the initial versions of the Kardia mobile ECG device and the service it provides here and here.

I have been monitoring dozens of my afib patients using AliveCor’s Physician Dashboard.

Recently AliveCor changed fundamentally the way their app works such that for new users much of the functionality I described in my previous posts now requires subscribing to their Premium service which costs $9.99 per month or $99 per year.

What Has Changed With The Kardia App

The Kardia device which works with both iOs and Android smart
phones is unchanged and still generates a “medical-grade” single lead rhythm strips which appears within the Kardia app.

Screenshot from AliveCor’s website showing the Kardia recording device being utilized with the obtained  typical ECG recording displayed on the smartphone app.

 

 

The app still is reasonably accurate at identifying atrial fibrillation or normal heart rhythms and offers a fee-based service for interpretation of unclassified ECGs.

However, for new purchasers of Kardia,  the capability to access, email or print prior ECG recordings has gone away. Prior to March of this year, Kardia users could access prior ECG tracings which were stored in the cloud  by touching the “Journal” button on the app. These older tracings could be emailed and they were available through the cloud for a physician like myself to review at any time.

Now new Kardia purchasers will find that when they make an ECG recording they have the option to email a PDF of the ECG but once they hit the DONE button it is gone and is not stored anywhere.

For my patients purchasing after March, 2017 this means that unless they  purchase Kardia Premium service I will not be able to view their ECG recordings online.

An AliveCor account executive summarized for me the changes as follows:

We added a significant number of features over the past year and a half, and grandfathered all users on March 16th, 2017. New users now have the option to download and use Kardia for free, but the premium services are $9.99/mo or $99/year. Kardia Premium allows unlimited storage and history of their EKGs, summary reports with longitudinal data, blood pressure monitoring and tracking weight and medication.

Why Journal Functionality Is Important

If you purchased your AliveCor/Kardia device prior to March 16th, 2017 ago the journal  functionality still works. Let’s call such customers “Journal Grandfathered”.

This Journal functionality is important in a number of ways:

  1. My Journal Grandfathered patients can bring their phones with them during an office visit and we can review all of their ECG tracings.
  2. Journal gGandfathered Kardia users can email their old tracings to their physicians or to anyone they wish (even the skeptical cardiologist!). They can also print them out and save PDFs of the tracings.
  3. I  can view through my online physician account all of my Journal Grandfathered patients. This means any time a patient of mine makes a recording that is unclassified or suggests atrial fibrillation I can be notified and immediately view it online.

This fundamental change took place as AliveCor attempts to convince  purchasers of the Kardia device to use their Premium service.

Why AliveCor Changed The Kardia App Function

Dr. David Albert, inventor and  cardiologist and the founder of AliveCor was kind enough to talk with me about this change.

He indicates that of the 150,000 AliveCor users, 10,000 are now using the Kardia Premium service. About 20% of new users elect Kardia Premium.

Prior to the change all AliveCor users had their old ECG recordings stored in the cloud in a HIPPA compliant fashion. This free service was costing AliveCor quite a bit and the company felt it was best to switch to a subscription service to provide this secure cloud storage.

With the change to the (relatively inexpensive)  subscription service, patients will get additional features. As the AliveCor account executive described:

Kardia Premium allows unlimited storage and history of their EKGs, summary reports with longitudinal data, blood pressure monitoring and tracking weight and medication.

 

 

I’ve looked at the Premium service and it seems quite useful when combined with a connected physician utilizing Kardia Pro.  I’ll evaluate the Premium service and the physician Kardia Pro service  further and write a full post on its features in the near future.

If you are not grandfathered and want to stick with the Basic Kardia service you still have an immensely useful and  inexpensive device which allows personal detection of your cardiac rhythm. Just remember to email yourself the ECG recording you just made before you hit DONE.

Nonarrhythmically Yours,

-ACP

Are Physicians Influenced By Pharmaceutical Gifts?

The Skeptical Cardiologist stopped giving talks for pharmaceutical companies 5 years ago and stopped accepting lunches from pharmaceutical reps because he wanted to be certain that he was not being influenced by them in his writing or patient care.

I made an exception 6 months ago and consumed panang curry provided by a pharmaceutical representative who was promoting the blood thinner Pradaxa.

He enthusiastically extolled the virtues of Pradaxa throughout the lunch and made some excellent points supporting the use of the drug. Shortly thereafter, when I was considering which of the newer blood thinners to prescribe for a patient , Pradaxa was foremost in my mind.

The scientific data that Boehringer Ingelheim wanted me to be aware of entered the crowded marketplace of ideas in my head that day but I prefer the data that enters my consciousness come from unbiased sources.

A new study from Georgetown University, published in PLOS One provides support for physicians eschewing pharmaceutical gifts.

The authors point out in their introduction that gifts are important:

Gifts, no matter their size, have a powerful effect on human relationships. Reciprocity is a strong guiding principle of human interaction. Even gifts of small value, such as “modest” industry-sponsored lunches, may foster a subconscious obligation to reciprocate through changes in prescribing practices. DeJong et al has shown that a meal with a value of less than $20 can increase the prescribing of branded statins, beta-blockers, ACE inhibitors, and antidepressants.

The study found:

Physicians who received small gifts (less than $500 annually) had more expensive claims ($114 vs. $85) and more branded claims (30.3% vs. 25.7%) than physicians who received no gifts. Those receiving large gifts (greater than $500 annually) had the highest average costs per claim ($189) and branded claims (39.9%) than other groups. All differences were statistically significant (p<0.05).

The conclusions of the study:

Gifts from pharmaceutical companies are associated with more prescriptions per patient, more costly prescriptions, and a higher proportion of branded prescriptions with variation across specialties. Gifts of any size had an effect and larger gifts elicited a larger impact on prescribing behaviors. Our study confirms and expands on previous work showing that industry gifts are associated with more expensive prescriptions and more branded prescriptions. Industry gifts influence prescribing behavior, may have adverse public health implications, and should be banned

Michael Joyce has written a detailed and insightful analysis of this paper at the excellent website, HealthNewsReview.org.

He points out the limitations of this and all observational studies:

Although the study cannot definitively establish cause-and-effect between a provider receiving such gifts and any subsequent upturn in their prescribing, it does make a significant contribution to a growing body of literature documenting how drug company largesse is clearly linked — either consciously or otherwise — to the way in which health care providers prescribe.

And the article quotes Daniel Goldberg, an expert on bioethics:

“First, in situations when the evidence is imperfect, and the decisions are subtle, as is so often true in medicine. In these ambiguous situations the evidence clearly suggests that gifts can sway doctors in one direction, even if there’s no evidence to support that as the best decision. Second, it frames decisions in pharmaceutical terms, even when there may be other options — proven to be better — that have nothing to do with drugs.

Drugs are just one tool. But we have ‘pharmaceuticalized’ health care to a point where many patients are conditioned to equate health with access to drugs.”

Since I consumed the panang curry, I’ve gone back to bringing in my own lunch. Thus, my lunch/breakfast typically consists of Trader’s Point full fat plain yogurt with lots of blueberries and raspberries, and perhaps some ground up flaxseed and/or almonds (although today I’ll be bringing in leftover-meatloaf and roasted root vegetables.)

It’s not as tantalizing as the curry, but it leaves my crowded brain free to ponder the multitude of unbiased data from scientific papers, rather than the talking points a pharmaceutical representative would prefer I ponder.

The end result, I hope, is unbiased blogging and prescribing-better information for readers and better care for patients.

-ACP