Category Archives: Stroke Prevention

AliveCor Is Now Kardia and It Works Well At Identifying Atrial Fibrillation At Home And In Office

I’ve been using the AliveCor Mobile ECG App/Device to record my patients’ heart rhythm in my office for about 6 months now.

It has for the most part taken the place of the more elaborate, but cumbersome and time-consuming, 12-lead ECG in patients where heart rhythm is my only concern.

I’ve also convinced about a dozen of my patients who have intermitent atrial fibrillation to obtain the device and they are actively using it to monitor at home their heart rhythm. Through the AliveCor website, I can view their recordings and see what their heart rhythm is doing when they have symptoms.

Last week, a patient of mine (I’ll call her Suzy) who has had significant prolonged episodes of atrial fibrillation associated with heart failure (but cannot tell when she is in or out of rhythm) notified me that her device was interpreting her rhythm as atrial fibrillation. She had not had any symptoms, but was making  daily recordings for surveillance.

Suzy called our office and we brought her in the next day and confirmed with a 12-lead ECG that she was indeed in atrial fibrillation with a heart rate of 120 beats per minute.

It’s pretty amazing that this little, inexpensive device can now replace expensive and elaborate long term cardiac monitors for many of my patients.

AliveCor Rebrands Itself to Kardia


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I’ve noticed that AliveCor has rebranded itself as Kardia. If you go to www.alivecor.com now you see the fourth generation device along with promotion of a “Kardia band” which apparently works with an Apple Watch to record your ECG.

The Kardia band is not available for purchase at this time but if and when I can get one, it might motivate me to purchase an Apple watch.

When I purchased my AliveCor device in June, 2015 it cost $74.99 from Amazon.com. The newer version is priced at $99 at both AliveCor and Amazon websites. I’m told by Dr. David Albert of AliveCor that this “fourth generation” version is more accurate, so I have purchased it to see if it reduces the problem of occasional bad recordings.

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You can see in this picture from the website that the formerly flat metal electrodes now have bumps. Dr. Albert says these result in more surface area for better contact with skin. We will see.

The Value of Early Detection Of Atrial Fibrillation

Meanwhile, I will be doing an electrical cardioversion (shocking or resetting the heart) on Suzy to get her back to normal sinus rhythm.  If we had not detected the asymptomatic onset of her rapid atrial fibrillation using the AliveCor/Kardia device, chances are we wouldn’t have known about it until her heart muscle weakened again and she became short of breath from heart failure.

I have Suzy on blood thinners to lower her risk of stroke associated with her Afib but for my patients who are not on blood thinners, detection of silent or asymptomatic AFib is even more important.

-Affibly yours,

-ACP

p.s. The skeptician in me feels this post borders on infomercialese.

Let me make it clear that I have no connection with the company formerly known as AliveCor and have received nothing from them (not even free test devices or Apple Watch Kardia Bands!) but I’m just really excited about the device and how it can help my patients (oh, please excuse me, this really sounds like marketing) “empower” themselves to take control of their heart rhythm.

In the course of writing this, I’ve discovered an academic paper evaluating 13 ECG smart phone type ECG devices so there are other devices you could try. I haven’t had the time or resources to evaluate them.

AliveCor Smartphone App Detects Atrial fibrillation: Potential for Stroke Prevention

Atrial fibrillation (AF)  is a common abnormal rhythm of the heart which causes 1 in 4 strokes. Those afflicted with AF may lack any symptoms or only have a vague sense of irregularity of their heartbeat and thus the first symptom of AF can be stroke.

The gold standard for diagnosing AF has long been the electrocardiogram (ECG or EKG) and typically the ECG involves placing 12 electrodes on the chest/arm/legs and recording the electrical activity of the heart on an expensive device.

I’ve been checking out a device made by Alive Cor which works with your smart phone to record a single channel ECG and is capable of accurately diagnosing if you are in the normal (sinus) rhythm or in AF.
Screen Shot 2015-07-12 at 8.45.49 AMYou can purchase the third generation (significantly smaller then earlier versions) AliveCor Mobile ECG from Amazon or from AliveCor directly for 74.99$ and it works with an app with both iOS and Android devices.

I used mine with my iPhone 6. At first I carried it separately, fearing the added bulk when stuck on to my iPhone case but after a while I realized that it was never with me when I wanted to use it and that there was a huge risk of losing it and so I used the backing adhesive to attach it to my case.

After pairing the device with the app you put two fingers on each of the metal pads and the smartphone screen displays the recording. After 30 seconds of recording it then interprets the rhythm.

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Typical recording in normal sinus rhythm. The red arrow indicates the small p waves which are the electrical signal of the upper chambers (the atria) depolarizing , the blue arrow indicates the electrical depolarization of the ventricles (QRS). The orange arrow indicates that the time interval between the QRS complexes is the nearly the same for each beat, indicating the regularity that we expect when in NSR compared to AF.

Above is a typical recording I made in my office on a patient who had a history of AF. The quality is good and I can clearly see that he is in normal sinus rhythm. The app correctly made the diagnosis of NSR and calculated his heart rate at 68 beats per minute.

One day I had most of my patients record their ECG’s using AliveCor and compared it to the standard 12-lead ECG we normally record. The device correctly identified the two patients with AF out of this group and correctly identified the normals.

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AliveCor recording of patient with AF with heart rate of 70 beats per minute. Note the absence of p waves before the QRS complexes and note the beat to beat variation in the RR interval (orange arrow)

This recording is from a patient with persistent AF which had recurred two weeks earlier. The device correctly identified AF.

Studies have documented that AliveCor Mobile ECG can accurately diagnose AF in a screening setting and the FDA approved the device for AF screening in 2014.

Given the high prevalence of silent AF, the strong association of AF with stroke and the availability of anticoagulants which reduce AF associated stroke by 70%, screening for AF with devices like AliveCor holds the promise of preventing large numbers of stroke.

(For my comments on taking the pulse and stroke prevention see here and on the inadvisability of a routine 12-lead ECG see here)

AliveCor allows physicians utilizing the Mobile APP and ECG to have a “dashboard” into which their patients can transmit their AliveCor ECG recordings.

I will be discussing this remarkable new device with my AF patients  who are smartphone enabled. I think it will advance our ability to more efficiently and quickly diagnose AF in them.

My standard approach if a patient with AF calls and says that they feel like they are out of rhythm is to have them come into the office for a full 12-lead ECG. If they are AliveCor enabled, they could make their own recording, and we could review that remotely and make a diagnosis without the office visit.

Let me know your thoughts on smartphone ECGs.

fibrillatorily yours,

-ACP

Why Does The TV Tell Me Xarelto is a BAD DRUG?

One of my patients called the office today concerned about a medication she was taking because she was “seeing about 4-5 commercials a day about how bad Xarelto is”.

She is the latest of many of my patients who have been inundated with ads like these which state in very strident tones that a drug is bad and that if “you or a loved one has had a serious bleeding problem” contact 1-800-BAD DRUG and see if you are eligible for compensation.

These drugs are not bad and the only reason these advertisements are being played is that tort lawyers sense an opportunity to make money.

To understand why they are flooding the TV market now I will have to give you some background on atrial fibrillation , stroke and the drugs available to reduce stroke risk.

Preventing Stroke Associated With Atrial Fibrillation

Patients with atrial fibrillation are at increased risk of stroke and since the 1950s the only drug available for doctors to reduce clot formation in the heart and susbsequent strokes was warfarin (brand name Coumadin). 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 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.

Novel Anticoagulants

In recent years, three 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

Differences Between Warfarin and the Novel Anticoagulants

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 none for the newer drugs. 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 Pradaxa Bad Drug Ads

Beginning about a  year after Pradaxa was released advertisements paid for by law firms seeking “victims” of Pradaxa  identical to the ones we are now seeing for Xarelto began to appear.

The Pradaxa ads went away in mid 2014 when these lawsuits were settled and almost immediately the lawyers began paying for Xarelto ads. Xarelto was the second “novel anticoagulant) to be approved by the FDA and, similar to Pradaxa, was proven to as effective as warfarin in preventing strokes with a similar rate of serious bleeding complications.

As the Wall Street Journal noted (with the catchy title “The Clot Thickens” and opening line “Is a blood thinner causing lawyers to smell blood?”)

“Spending (on Xarelto ads)  jumped to $1.2 million in July from just $8,000 in June, according to The Silverstein Group Mass Tort Ad Watch, which noted the number of ads that ran in July exceeded 1,800. …

The spending increased shortly after Boehringer Ingelheim, which sells a rival blood thinner called Pradaxa, last May agreed to pay $650 million to settle about 4,000 lawsuits over claims the drug caused serious bleeding episodes. The settlement likely emboldened attorneys to turn their sights toward Xarelto which, like Pradaxa, is one of a relatively new batch of blood thinners.”

The third drug to be approved for preventing strokes in atrial fibrillation was Eliquis. Data from the large, randomized study comparing it to warfarin suggest that it is more effective at preventing stroke than warfarin and significantly less likely to have bleeding complications. However, I predict that within the year (especially if the Xarelto lawsuits also are settled by its manufacturer) we will start to see lots of TV ads telling us that Eliquis is a BAD DRUG.

It’s important to remember that all drugs have benefits and side effects. Seemingly harmless antibiotics can increase your risk of dying suddenly (see here), rupturing your achilles tendon or developing a life-threatening colitis.

Xarelto is not a BAD DRUG. When prescribed to appropriate patients with atrial fibrillation with  appropriate precautions it prevents strokes which are potentially life-threatening or disabling. All blood thinners are two-edged swords: they stop good clots and bad clots.

Ignore The Ads

Patients are better off ignoring both positive, direct to consumer, advertisements, promoting these newer anticoagulants and negative, greedy-lawyer sponsored advertisements, soliciting “victims”.

Hopefully when your doctor discusses the choices of blood thinners with you he will present to you a balanced discussion of the pros and cons both of whether or not to take  a blood thinner and whether to take the old standby warfarin or one of the newer agents. An interactive discussion should follow in which your particular issues and concerns factor into the final decision.

 

Two Spades or Two Diamonds, Two Ladies and Two Studies

I saw two delightful eighty-something ladies recently whose cases highlight some important points about atrial fibrillation, stroke and long term heart monitors.

Ms. M was playing bridge and found that she had 7 spades solid (solid, Mrs M informed me, means you have 7 of the suit with all of the honors (ace, king, queen, jack). Instead of bidding 2 spades which she meant to do, she bid 2 diamonds, and her partner responded by bidding 5 diamonds. This miscommunication resulted in a disastrous hand for the pair.

Ms. K  told me she had had an episode of “mass confusion” two weeks earlier during which for 15 seconds her “thinking process was not working properly.”

These cases illustrate the subtlety and brevity with which transient ischemic attacks (TIAs) or mini strokes can manifest. In contrast to the normal forgetfulness that is associated with aging, these women recognized  a sudden, transient and disturbing major alteration in their baseline mental processing.

TIAs are basically strokes that resolve quickly, generally within 24 hours, and leave no residual symptoms. They are often a warning that larger, more permanent strokes will follow.

In both of these cases, when I first saw the patients, they were in normal or sinus rhythm but subsequent monitoring revealed atrial fibrillation (AF).

Cryptogenic Strokes

A quarter of the 500,000 strokes occurring annually in America are unexplained (the medical literature tends to use the exotic and Halloween-appropriate term, cryptogenic for unexplained strokes). This means that imaging of the brain and arteries to the brain finds no abnormalities that would cause a stroke and that the patient has no history of AF. Since there is such a strong association between atrial fibrillation, clot formation in the heart, and stroke, (see my post on AF here) doctors assume that an otherwise unexplained stroke in a patient with AF is due to a clot leaving the heart and landing in an artery to the brain. These patients benefit from medications which reduce the risk of clot formation (either warfarin or one of the newer anticoagulants everyone has been hearing about either from negative TV ads from lawyers or positive direct-to-patient drug company ads).

New evidence suggests that if we monitor the heart rhythm for 30 days of patients who have had unexplained strokes a significant percentage will manifest atrial fibrillation.

A Canadian study of 572 men over the age of 55 who had had a cryptogenic stroke or TIA found that atrial fibrillation lasting 30 seconds or longer was detected in 45 of 280 patients (16.1%) in those who underwent 30 day monitoring, as compared with 9 of 277 (3.2%) in those who were only monitored for 24 hours.

Another study evaluated 441 patients following cryptogenic stroke with half randomized to receiving an insertable cardiac monitor (we call these implantable loop recorders (ILR) in the US). The ILR is a small device that can be inserted under the skin in the left chest region and allows continuous monitoring of the heart rhythm. After 6 months, atrial fibrillation had been detected in 8.9% of patients in the ILR group, versus 1.4% of patients in the control group. At 12 months it was 12.4% versus 2%.

Neither of my two ladies felt palpitations (a sense of the heart beating irregularly) that would have suggested a problem with the heart. About half of my patients with AF will feel their heart fluttering or “flip-flopping” or racing when the heart goes out of rhythm but the rest of my patients feel nothing. Thus, AF can be silent and I have many patients whose first symptom was a TIA or stroke.

These two ladies and two studies have taught (or reinforced for) me the following:

TIAs can be very subtle. Patients need to be aware of transient episodes of significant confusion or speech difficulties and report them to their doctors. We doctors need to pay close attention when patients report such episodes.

The patient who has had a cryptogenic stroke or TIA should undergo long term cardiac rhythm monitoring looking for AF. My take on the literature at this point is that we don’t need to do the more expensive and invasive ILR. I think a 30 day monitoring device that is capable of automatically identifying AF is sufficient.