Physician review of the iPhone AliveCor ECG heart monitor, the clinical reality of the device

By: Satish Misra MD and Iltifat Husain MD

Satish Misra MD is a 3rd year Resident Physician at Johns Hopkins University School of Medicine who will be starting a cardiology fellowship at Johns Hopkins in July of this year. He is the Managing Editor of iMedicalApps. Iltifat Husain MD is the founder and editor-in-chief of iMedicalApps and a second year Emergency Medicine Resident Physician at Wake Forest University School of Medicine. 

In our video review, we take a close look at the AliveCor heart monitor’s features and real life functionality.  In the text portion of this review, we explain what the device can and cannot do — and attempt to bring clarity to this mobile heart monitor’s capabilities.  For example, we touch on how the device does not replace a 12 lead ECG and will miss heart attacks — an impression the general media appears to think is not the case and something the device makers never touted the device can do in the first place.  Overall, we walked away impressed with the elegance and simplicity of the device.

We did, however, find ourselves feeling that while anyone, including patients, should be able to readily use this device to capture reasonable single-lead tracings, we did not have a good sense of when (or whether) they should. Also, in defense of his product, Dr. Dave Albert (inventor) has referenced multiple times that AliveCor had 100% sensitivity and 96% specificity in identifying atrial fibrillation — however, published medical literature has shown a simple iPhone 4s camera app without the need of external hardware has a sensitivity of 96% and specificity of 98%, and costs significantly less than the AliveCor heart monitor ($199.99).  Something we discuss further in our conclusion.

Video Review:

Potential Use Cases

Event Monitor, but does the literature support its use? 

A potential use of the AliveCor heart monitor is as a non-continuous, patient-triggered event monitor. It’s not hard to imagine a patient walking into clinic for palpitations and walking out with one of these devices. The form factor of the device could help drive patient adoption.

This does not mean every patient should get one of these devices. As noted in a 2010 review of ambulatory arrhythmia monitoring in Circulation, these types of event monitors (which have been around for some time) have limitations. For example, they will not catch the initiation of an arrhythmia, which has diagnostic value. They will also miss short arrhythmias.

It’s also important to consider whether a dizzy, lightheaded patient — often the side effect of having active arrhythmias — will actually be able to successfully operate the device, as some studies have found that 25% of patients with continuous event monitors fail to trigger and transmit tracings when they are symptomatic despite nearly all of them being able to do it in a test environment. Patients who were more familiar with technology, at least to the level of using an ATM, were more likely to be successful [1,2].

Finally, as wearable sensors make big strides in miniaturization and connectivity, We wonder whether this device will be able to hold its own, at least for this indication.

Resource-limited settings

The portability, connectivity, and price point of the device all make it seem like a natural fit for settings where access to more advanced equipment like an EKG machine would be difficult. Scenarios range from third world countries to community outreach and home visits.

Use of screening in these situations is one we have heard proposed in other forums and it was the subject of an abstract presented at the 2012 AHA Conference. In terms of what the device would enable screening for, the first thing that comes to mind is rhythm abnormalities like conduction blocks, QT prolongation, atrial fibrillation, and so on. For most of these conduction abnormalities, there are not recommendations to routinely screen healthy individuals.  We do not think it would offer much information in regards to screening for prior ischemic heart disease or chamber abnormalities — especially since the device is only a single lead tracing of an ECG.

Post-Procedure

For patients who have recently had an EP procedure done and do not already have an implanted cardiac device, it could be used for periodic post-procedure follow-up. Imagine a patient who has undergone an atrial fibrillation or atrial flutter ablation; on discharge, they could be given this device and asked to obtain, say, three 2-minute tracings daily plus with symptoms.

There is some evidence that detecting early post-ablation recurrence of atrial fibrillation would have clinical significance, perhaps pushing for an earlier repeat ablation.  In these cases, we do not think a non-continuous event monitor such as AliveCor would be sufficient, as silent atrial fibrillation is quite common, and the intermittent nature of AliveCor would not be ideal for this pathology.

Silent Atrial Fibrillation 

There has been some debate about silent atrial fibrillation and CVA risk, with some recent studies identifying higher rates of silent atrial fibrillation in cryptogenic CVA patients when applying 30-day continuous monitoring as opposed to 24-48 hour monitoring. However, as far as large population screenings go, large trials have found no difference between simply palpating a pulse and getting an ECG in episodic screening interactions; in fact, palpation with follow-up ECG if needed is the recommendation of the European Society of Cardiology.

Perhaps one could make a case that the follow-up ECG could be replaced by a lower cost single lead tracing by AliveCor and potentially save an individual a trip to the clinic (and associated costs). However, with a new diagnosis of atrial fibrillation, we would think at least a history and physical exam would be warranted to evaluate for contributing etiologies (e.g. pulmonary disease, cardiomyopathy, etc) and a 12-lead ECG, not a single lead (AliveCor) in this case.

Key limitations

Heart Attacks

One important point is this device has significant limitations in the acute evaluation of chest pain associated with heart attacks. A single lead I tracing will miss many real ischemic events, enough that even if it was stone cold normal it would not change our suspicion of myocardial ischemia. If there are significant elevations or depressions, it would probably raise our suspicion for myocardial ischemia, but we would still need a 12 lead ECG, begging the question of how it changes management.  This doesn’t even touch on NSTEMI patients who do not necessarily show acute or dynamic ECG findings when having a heart attack and associated chest pain.  The lay public is often unaware a heart attack can be present without acute ischemic changes on ECG findings.

The issue of false positives

One additional issue worth considering is that of false positives. If this device does in fact expand screening for cardiac disease, there will certainly be an increased rate of false positives and it’s important to consider the consequences for those individuals. Perhaps it will be as simple as a follow-up 12 lead ECG. Or perhaps it will be detection of ST-segment deviations in asymptomatic individuals that will lead to trips to the local ER. In making determinations about the best application of this device, it will be important to consider and quantify these risks so we can ensure the benefits outweigh the risks.

Excessive screening and potential harm

The United States Preventive Services Task Force as recently as last year reinforced their screening ECG criteria, giving a Grade D recommendation for ECG screening in asymptomatic low risk individuals.  Grade D meaning they recommend against this type of medical practice. They went on to say there is evidence that suggests screening asymptomatic, low risk adults could result in harms, such as unnecessary invasive testing and procedures, over treatment, and labeling. Even the American Heart Association and American College of Cardiology’s guidelines suggest risk factors such as diabetes and hypertension necessary for screening ECGs.

Conclusion

All in all, the AliveCor Heart Monitor is wonderfully designed and easy to use; these are key strengths for adoption in healthcare. That is — if appropriate uses can be identified.

Before we would prescribe this device to a patient, there are many questions we would want answered first.

  • How well does it function with real-world, symptomatic patients?
  • Does the form factor overcome the limitations of an intermittent event monitor?
  • If its proposed use is screening, is it really better than current techniques (e.g. palpating a pulse for atrial fibrillation)? Or even using a cheaper camera app to do this?
  • Does the device allow me to find pathology that leads to an intervention that helps my patient without exposing them to unnecessary tests/procedures due to false positives?

This is our analysis on a device that, in some ways, has become the poster-child for mHealth devices.  That status can largely be attributed to the elegant design, ease of use, and low cost that make it far less intrusive and far more portable than traditional medical tools.

However, when it comes to clinical use, question remain. Other disruptive technologies, such as camera apps for arrhythmia detection or wearable sensors may provide more clinically relevant data at lower costs.  Furthermore, there are important outstanding questions regarding appropriate utilization of the AliveCor Heart Monitor to ensure we are in fact benefiting our patients and not harming them or wasting their resources with unnecessary testing — we encourage readers to click the medical literature hyperlinks in this article so you can see the data warrants real concern.

Overall, we’ve put the cart before the horse with the hype surrounding the AliveCor Heart Monitor, as is the case with many mHealth devices, by not understanding how we will use the information we gather before touting our ability to gather it in the first place.

We welcome your thoughts, especially your critiques of these points. As with much of mHealth technology, this device is in the earliest stages of its use in healthcare.  For mobile health devices to truly succeed, it is important we are able to recognize their appropriate use and also their limitations — otherwise we are only left with their hype, and worse — no improvement in patient outcomes.

As usual, there are no relevant disclosures for iMedicalApps.  iMedicalApps does not allow advertising from app developers and has no financial relationships with app developers or mobile hardware companies — unlike every other medical app/device/analyst/review site. 

1. Gula, L. J., Krahn, A. D., Massel, D., Skanes, A., Yee, R., & Klein, G. J. (2004). External loop recorders: determinants of diagnostic yield in patients with syncope. American heart journal, 147(4), 644–8. doi:10.1016/j.ahj.2003.10.036

2. Sivakumaran, S., Krahn, A. D., Klein, G. J., Finan, J., Yee, R., Renner, S., & Skanes, A. C. (2003). A prospective randomized comparison of loop recorders versus Holter monitors in patients with syncope or presyncope. The American Journal of Medicine, 115(1), 1–5. doi:10.1016/S0002-9343(03)00233-X

AliveCor ECG monitor Website 

Discussion ( 79 comments ) Post a Comment
  • First, I want to thank Drs. Misra and Husain for a fair and complete review of our AliveCor Heart Monitor. Now, I may have real issues with the validity of camera apps for AF detection vs an ECG (we have the camera available for pulse detection also), but I completely agree that our device is NOT indicated for the evaluation of ischemia or infraction as these require a 12-lead ECG. Last night a post AF ablation patient I know we’ll had an episode if tachycardia if >160bpm at rest at a sporting event. That patient transmitted their ECG using our device to their EP and a dx of SVT vs AF with RVR was made and appropriate therapy was initiated. No non-ECG could be used to make that important diagnostic decision. AFs, a LBBB and an incomplete RBBB.

    • Thanks so much for the comments. A big issue we had was the screening aspect the device promotes on the website and the data we were finding that screening in healthy individuals can potentially lead to harm.

      Btw, as the review mentioned, love the innovative aspect/hardware of the device.

      Iltifat Husain, MD iMedicalApps Editor
    • Dr. Albert, something else we didn’t mention in the article — will there be an iPhone 5 case coming soon? With the constant iterations of the iPhone, will there be some way users can use the dame device for all forms, or will they have to purchase a new AliveCor for every iPhone model?

      Iltifat Husain, MD iMedicalApps Editor
    • I am thinking of getting this for my son who is 9 years old. He has had 2 ablations and still feels that he has SVT. We have not been able to catch it on a monitor. Have you had success with catching short episodes of SVT on the Iphone monitor?
      Thanks!!

      • Absolutely. We have pediatric arrhythmia patients who have documented very infrequent arrhythmias using our device that were not picked up in multi-day holters or event recorders c

        David Albert, MD
      • Thanks! We just ordered the monitor and should be
        Shipped tomorrow for my son!! We are hoping this will
        help give us some answers;)

  • Are there any HIPAA issues?

    • All cloud-based data is encrypted in a HIPAA compliant db. All users should implement the built-in iPhone pin code which hardware encrypts all iPhone-stored data as with any medical App that stores PHI.

  • Great to see such a well written and researched article on AliveCor and MHealth in general. This is the type of scholarly discussion we need to help MHealth evolve beyond the hype filled space it has been to date to a real clinical solution. The evolution of MHealth relies on clinicians using the solutions out there and determining how they can be best used to improve the healthcare experience. It is a journey, and this article is a great step forward. It is the discussion amongst learned peers that will develop new models of care that will benefit our patients.

    Dr George Margelis
    • Thanks so much Dr. Margelis! With your extensive experience in medicine and tech, your comments mean a lot to us! We completely agree that it’s important for us as a physician and patient community to get beyond the hype — only then can we really improve patient outcomes. It’s important that we do not ignore the plethora of medical literature available and that we “first do no harm”.

      Iltifat Husain, MD iMedicalApps Editor
  • I did not see any substantive consideration of the device’s utility in first responder or veterinarian settings. I do not know if this was disregarded or just not considered. On another note, I do not believe the device gets enough traction in terms of its use as an event recorder. Even with the advent of the 24-hr Holter monitor, too many cardiac episodes go undiagnosed at home due to a lack event monitoring. The Alivecor ECG provides a low cost alternative that truly empowers the patient to take their health into their own hands. I am not implying that the patients will diagnose their own conditions based off of the recorded ECGs, but rather that they can take comfort knowing that they can securely monitor and save their health updates in order to empower their doctors to make better informed decisions. This aspect of the device is truly empowering for the patient.

    John Smith, patient
    • No one denies the ability of the device to monitor arrhythmias, and this is certainly one of the capabilities we referenced in our possible uses of the device. Of note, we also wonder how well an a-fib camera app would perform as well — as that is arguably more disruptive.

      Iltifat Husain, MD iMedicalApps Editor
  • I am a patient who has been converted from afib to sinus four times since 2003. I wanted to obtain the AliveCor ECG Monitor so that, if I once again lapsed into afib, I could either email or FAX the tracing to my cardiologist practice to prove to them that I was in afib and thereby save the step of having to visit their office for a confirmatory ECG. Ironically, I lapsed into afib five days before my AliveCor ECG Monitor arrived at my home. This time, the office believed me when I called, perhaps because I am a “frequent flier.” So I went straight to the hospital ER where I eventually was converted by one of the cardiologists of the practice. It might be difficult for physicians, especially those concerned with the policies of practice, to see things from a patient’s perspective, but do believe me that I am quite happy to have this tool at my disposal. As I use it, I learn more about the electrical characteristics of my heart. I observed the tracing of a premature contraction in real time, for example. And, thankfully, thought I do not experience STEMI, at least I understand now what it is (though with my technical background, I tend to think “Science, Technology, Engineering, and Math!”). Thanks for your thorough review, and thanks to Dr. Albert for bringing this very useful device to market.

    Steve Goldstein, Ph.D.
    • Steve, if you were feeling an abnormal heart rate, and your AliveCor monitor did not show A-fib, would you stay at home and not go to the doctor? Also, does your cardiologist read your AliveCor results?

      Iltifat Husain, MD iMedicalApps Editor
      • Good challenging questions! Each time that I lapsed into Afib, I knew it for sure, though the first time it happened, I didn’t know what it was. It is possible that other arrhythmias might occur that are nor Afib, and, for sure, should any occur, I would seek medical intervention, either at the cardiologist practice or a an ER. Because my AliveCor Monitor arrived after I had been converted from Afib, I really don’t know for sure what my Afib tracing would look like, though I can imagine it. As far as I know, my cardiology practice, recently re-named “Virginia Heart,” would not (yet) subscribe to AliveCor results, but, for sure, they would pay attention to a PDF of the tracing if I were to FAX or e-mail it to them. When I first bought up the possibility with a nurse on the EP service, she cited HIPPA privacy issues as a reason for not even considering accepting AliveCor input. But, later on, in a follow-up visit, when my cardiologist saw my (normal sinus) tracings, printed out on paper, his eyes brightened, and his immediate reaction was, “I can see that you are not in Afib!” Bottom line: acceptance of this and other “destructive technologies,” per Dr. Topol, will not happen overnight.

        Steve Goldstein, Ph.D.
        • Steve, you’ve provided great insight. But just to clarify, if you were feeling an abnormal heart rate, and your AliveCor monitor did not show A-fib, would you stay at home and not go to the doctor?

          Iltifat Husain, MD iMedicalApps Editor
        • Your REPLY button did not appear with your question: “Steve, you’ve provided great insight. But just to clarify, if you were feeling an abnormal heart rate, and your AliveCor monitor did not show A-fib, would you stay at home and not go to the doctor?”

          My Reply: If the abnormal heart rate were persistent, yes, I would go to a doctor or to the ER, even if the AliveCor monitor did not show Afib. If I were to experience transitory and non-recurrent palpitations, I would probably just stay home.

          Steve Goldstein, Ph.D.
  • Wanted to publish a great twitter dialogue that took place between myself and Dr. Albert.

    iltifatMD (@IltifatMD)
    3/12/13, 8:47 AM
    Review of AliveCor ECG monitor and why ECG screening isn’t necessarily a good idea imedicalapps.com/2013/03/physic…

    David E. Albert, M.D (@DrDave01)
    3/12/13, 9:08 AM
    @IltifatMD After 3 days at the ACC, hearing all the diagnoses made with @AliveCor ECG (I dx’d 2AFs at ACC ) I respectfully disagree!

    iltifatMD (@IltifatMD)
    3/12/13, 9:17 AM
    @DrDave01 @AliveCor anecdotal examples will always exist. doesnt mean best from populations standpoint,great tech tho imedicalapps.com/2013/03/physic…

    David E. Albert, M.D (@DrDave01)
    3/12/13, 9:22 AM
    @IltifatMD I don’t rely on anecdotes. I rely on science. We just screened 1000 seniors in 10 pharmacies and found 10 undiagnosed AF. Reality

    iltifatMD (@IltifatMD)
    3/12/13, 9:26 AM
    @DrDave01 Screening in elderly is a great example! Unfortunately website doesn’t delineate screening should be for mod/high risk, not 4 all

    David E. Albert, M.D (@DrDave01)
    3/12/13, 9:28 AM
    @IltifatMD OK – you got me. Absolutely true that ECG screening is NOT needed in asymptomatic folks under 50- the literature is clear.

    Iltifat Husain, MD iMedicalApps Editor
    • AliveCor is being used in an innovative project in Australia using community pharmacy as a screening service. It is quite an interesting project that utilizes pharmacists as educated screeners. It is a great example of classical disruptive innovation. It is these types of innovations we need to be looking for, not just gadget hype which is what we have been seeing to date. Hopefully we will see more reports of these types of clinical model innovation in the future.

      Dr George Margelis
      • As a pharmacist, I am very interested in this project. Do you happen to have any links or information you could supply on this project?

        Timothy Aungst, PharmD iMedicalApps Editor
        • The 1000 patient screening project in AU involved people over 65 at their pharmacies. Atrial Fibrillation prevalence rises exponentially with age over 50 but it’s NOT worth screening for until over 60. We found 10 people with previously undiagnosed AF (1%), which is consistent with the literature. Given the dramatically increased stroke risk in AF, identifying these patients is important. The authors are correct that the population to be screened is vitally important and we (I am a co-investigator) selected such a population in which the public health value is CLEAR.

          David Albert, MD
        • And Way faster and Way cheaper and one majors lesson (refer to the Time magazine cover story from 2 weeks ago), we in the US HAVE to figure out how to do more, and deliver quality care, for less $!

          David Albert, MD
  • I have used the AliveCor device for several weeks and am impressed with its ease of use. I recently cared for a 3y/o patient who had just undergone repair for Tetralogy of Fallot. On post-op day 1, I confirmed with my AliveCor that he was in post-op JET and initiated therapy even before the nurse hooked up his 12-Lead ECG. This patient was in a stable dysrhythmia but I imagine it would be just as useful in other situations.

    • I agree with David here, whilst palpation in a trained observer is useful, the simplicity of the AliveCor device and the capability to show the patient what webarebtalking about is a very useful engagement tool.

      Dr George Margelis
  • This excellent review misses the troubling privacy aspect of AliveCor that is also characteristic of many other mHealth and implantable devices. Why are patients coerced into sending personal data to the manufacturer? Why is there no open API to get the data other than in PDF format? Why can’t the tracings go digitally to my Dropbox?

    I’ve not been following iMedicalApps before now, so I apologize if this has been covered in other threads. If it hasn’t, then I would welcome a post and discussion of the role of devices and physicians in preserving individual choice and limiting unintentional surveillance.

    Adrian Gropper, MD
  • Thanks for an interesting view into the way Doctors view this device. As a patient, I have to admit my perspective is quite different. I don’t need anyone else to decide if I need the device, I can decide for myself. After all, it’s my $200. Hopefully OTC status will render the difference in perspective irrelevant.

    I had a traditional event monitor from a cardiologist. Amount billed to insurance – $2000! Value – nothing. I tried a few times to get an arrhythmia on 12-lead by showing up at a provider when arrhythmia struck. Cost – thousands. Value – nothing, they were all too slow (12-lead, a hour or so) or too limited (30-days, event monitor) to capture anything.

    The point of devices like this is that they are cheap enough to keep in a pocket, on demand, whenever you need them. The choice isn’t between 12-lead and 1-lead. The choice is between 1-lead and ‘Doc, my heart felt funny last night’.

    Will devices like this result in decreased office revenue, or decreased billings, or whatever metric you guys use? Probably. That’s one of the things that makes it attractive from a patient perspective. Save one useless office visit (see my attempts to capture on 12-lead above) and you’re way ahead financially.

    Will it result in more patients have some actual data regarding their situation? Will it result in Docs being able to provide actual help, or recommend a clear next step for treatment, instead of saying ‘Let’s keep trying to diagnose this’. Will it result in less wasted time, and extra time to help more patients? YES!

    I’d urge you to look at things from a patients perspective. I understand it’s more comfortable for you to see us in your office. Understand, however that each visit is a serious commitment of time and money for us (half a day of lost time and income, plus actual visit cost). We sometimes feel like we get little in return for either. The chance to capture some useful data on our own terms is too attractive to ignore. It represents actual progress towards diagnosis and understanding, not just ‘Let’s see each other again in 6 weeks’.

    • Joe
      You make a very valid point that we are often faced with a choice of limited data and no data, and whilst we recognise the limitations this may place on the accuracy of a diagnosis we can use it to direct our actions. A single lead ECG is better than “doc my heart did something funny last night”.
      However the challenge is in not turning healthcare into fast moving consumer goods type mindset where everyone carries a single lead ECG, just because they can and it makes sense commercially to the vendor, but we end up with a plethora of data which needs to be reviewed. Rather than save money we end up spending money on managing irrelevant data for patients who don’t need it.
      The great opportunity is for informed patients like you working with healthcare providers to develop new clinical models that use the technology. We can also use the technology to help develop the health literacy of the general population. Learning the various phases of the ECG as it relates to heart function is very useful for someone who has a heart problem, and can help them understand their treatment and rehabilitation. Devices like AliveCor have huge potential in that area, because for $200 the educational value to a patient is huge.

      Dr George Margelis
      • @Dr George

        Your point is valid (overscreening, false positives, etc…) but I wonder how silly we might sound having this same conversation about other medical data gathering devices that are now common.

        Can we imagine having the same conversation about BP monitors, pulseox monitors, cholesterol test kits, or blood glucose meters? All are cheap and easy for customers to buy, and none have caused a line of otherwise healthy patients who now fear the worst because they have a little more data.

        The same pattern holds for DIY tests like gastrointestinal bleeding tests, CRP tests, PSA tests, CA-125 tests, urinalysis strips, or even HIV tests. They are all available OTC, but I haven’t seen anything to suggest an overscreening epidemic.

        Patients who can benefit from the tools learn how to use them and people who don’t tend to stay away from that isle of the pharmacy. I think the same will happen with $200 ECG machines.

        • Actually the issue of over diagnosis and cyberchondria has become a major issue for many of us, and the associated mental health issues need to be taken into account, yet alone the overall productivity issues it causes. Have a look at Gilbert Welch’s book “Overdiagnosed”, he does a very good analysis of the financial and social cost associated with not using proper evidence based guidelines around healthcare delivery.

          I was astounded recently when I attended a local Quantified Self meetup when a young healthy young man told me he had just spent $1000 on getting a bunch of blood tests, which he was going to repeat every month to look for irregularities. First the way they were doing the tests had some very serious methodological faults, but without an understanding of the underlying physiology he was literally pouring money and blood down the sink. Unfortunately there are people who are willing to use pseudoscience to separate people from their money, and potentially put them at risk of more serious complications. We are very lucky that David Albert and the folk at AliveCor are not that type, but we do need to maintain the essential scientific rigor to ensure that others who enter the area are not.

          Finally we need to optimize our use of healthcare resources. We are about to face a huge growth in demand, and it is negligent of us if we do not ensure that those who need services can get them. If we flood the system with noise and irrelevant data that dilutes our ability to find those who can benefit, I think that overall we are doing ourselves and the community a disservice.

          Dr George Margelis
        • While the $1000 in blood tests make for an interesting story, I still don’t see signs of rampant individual overtesting. Much of whats discussed in Overdiagnosed comes from testing in a traditional office setting, not the patient initiated testing that we’re talking about.

          I’m sure you’re heard the old saying ‘The plural of anecdote is not data’.

          On a deeper level, I suspect we just disagree on the role of patients when it comes to their own health. We (everyone who thinks about the future of healthcare) are caught between a paternalistic rationing class who want to decide top-down what’s good for us and the idea that a large number of patients can take primary responsibility for their own well being.

          For simple well understood problems, top-down isn’t a bad idea. For some patients, top-down is as good as they’re going to get. They don’t have the interest or drive to make an impact on their own outcomes.

          For the rest of us, the second model (patient initiated bottom-up design) has the potential to be much more powerful. One key to this brave new world is getting information into patient hands, quickly, effectively, and economically. Devices like this can be an important piece of the puzzle, unless the paternalistic rationing crowd succeeds in keeping it locked behind the exam room door.

        • Don’t think there is a paternalist rationing issue at all. It’s important to use testing in appropriate individuals. The maker of AliveCor, Dr. Albert, himself states that routine ECG screening in an asymptomatic individual less than 50 isn’t required (reference Twitter conversation with Dr. Albert). I’d be interested to know if you agree w/ the maker of the device when it comes to this point they made. Unfortunately it appears anytime a point is raised about the potential dangers of over-testing physicians are now called out as being paternalistic and not patient empowering. Empowering a patient is much more than “letting them do tests”. Rather, it’s about the patient physician relationship, making the patient an active decision maker in their health by discussing their various options, and customizing treatment towards the patient — that is real empowerment.

          Iltifat Husain, MD iMedicalApps Editor
  • Interesting discussion. In Primary Care we have a number of patients who are deeply troubled by seemingly harmless palpitations. I can see this device being reassuring to them if they can see their rhythm is normal despite their symptoms. Which it often is.

    On the other hand the silent AF detected on those 1% pharmacy customers – I would be impressed if this detection rate was after AF was excluded by palpation of the pulse. Otherwise I can’t see the point. Putting a couple of fingertips on a wrist is never going to be quite as impressive as using this device but…….. I can see pharmacists loving this.

    • Dr Husain, now you are going down a blind path. To paraphrase an old saying, “one Nan’s irregular pulse is another man’s regular pulse!” There are many causes of an irregular pulse in seniors from sinus arrhythmia, to PVCs to PACS to any combination of those and NONE carry the risk of stroke of AF. Our device is FAR superior to a manual pulse evaluation because we can diagnose AF, not just screen for irregularity. Also, there are relatively regular AFs ( we have a database of many hundreds of AF recordings now). Again, while an irregular pulse demands per the ESC guidelines a follow-up ECG, we can bypass that step, saving time and money.

        • We screened 1000 patients with 10 devices and could screen many more. If every CVS, Walgreens & Walmart pharmacy had one, that would be less than 30k units. The per screen cost with auto analysis would be well under $1 per person screened (and maybe much lower). Taking the 40 Million over 65, then let’s say the cost is $1 per person- you have an incremental screening cost of $40 million for the entire “appropriate” US population and we would expect 0.5-1.0% incidence of undiagnosed AF for a total of 200k- 400k people with AF. Each year their stroke risk is about 5x their age-matched AF-free cohort. It wouldn’t take a very high stroke rate (treatment easily $25-50k up front and more costs down the line) to make economic sense. Warfarin is less than $100 per year.

          David Albert, MD
        • As an entrepreneur, I am a genetic optimist. The 20th century saw huge public health successes against polio and malaria and strep. The work is not done but many investments have great ROI. A young physician who is not optimistic about the future of medicine has picked the wrong profession. There will be great change but it will not impair progress.

          David Albert, MD
        • Hypotheses are never enough. Proving them are da bomb.

          David Albert, MD
      • I’m jumping in after being otherwise occupied all day. I was converted from my fourth occurrence of afib three weeks ago. Unfortunately, my AliveCor ECG monitor did not arrive at my home until five days later. I am 73. My docs increased my sotalol from 80mg b.i.d. to 120mg b.i.d. with a view to preventing another lapse into afib. I am experiencing both PACs and PVCs about an hour after taking a sotalol–as many as three in 30 seconds. While these are disturbing, my seeing the tracings and identifying them keeps them from being alarming, and I am still in sinus. If these persist, I shall visit the cardiologist armed with a half dozen or so ECG printouts taken with my AliveCor monitor. I’d hope that would obviate a need for yet another 24 hour Holter monitor exercise. So, for me as a patient, the monitor has value in at least two dimensions. Dr. Albert is my hero right now!

        Steve Goldstein Subscriber
      • Just to clarify Dr. Albert, I didn’t make that comment. That comment was made by Dr. Hannon. I think your comment of going down the blind path was aimed towards Dr. Hannon….

        Iltifat Husain, MD iMedicalApps Editor
    • Joe
      First thanks for a fascinating discussion, it is exciting to be able to partake in such a robust and well informed debate from the other side of the world with such ease. I wish I could have such a robust discussion locally, but sometimes life and other things get in the way.

      I suspect we differ less than you believe on the role of the patient. I have been an active and vocal advocate of patient empowerment for years and I hope many of my patients would agree. However I do have a foot in both camps and am a stronger believer in evolution over revolution, so that could influence my stance.

      Re evidence, absolutely agree and have been using the quote from the folk at Mayo for years. That is why we need studies like the one published on imedicalapps to get out there. We also need patient’s like you to give us the other side of the picture.

      We do however have a responsibility to ensure rational use of scant healthcare resources, and screening without evidence of effectiveness is a huge potential drain on the system. If our actions don’t improve the quality of life of our population, we should be concentrating our efforts elsewhere.

      Dr George Margelis
  • @Iltifat

    Empowering patients is _more_ than giving them some input into the decision making process. Patients have different goals and different tolerances for risk, reward, and cost. Whenever possible, patients should have the first option and the primary responsibility to decide their own best path. Do they need help along the way? Absolutely. It’s invaluable.

    The mythical ‘physician relationship’ is a wonderful goal, but it just doesn’t materialize much anymore in the real world. On my last overnight trip through the health care system I saw 5 different docs in less than 24 hrs, for a simple case. Each made significant decisions about the course of my care. I never saw any of them again. Some relationship….. The only one keeping track of all the different happenings was ME. I filled my very capable but not on call that night PCP in on the details once all was said and done.

    The charge of paternalism can be the first reaction every time over-testing concern comes up regarding a new device. I’d counter with a patient perspective, from which it seems that every new and useful tool is quickly squashed by a gatekeeper warning of the danger to befall us if we let the unwashed masses decide for themselves what to do with that tool.

    ECG is 100+ years old, completely non-invasive, and already available to anyone with a laptop and $5 of parts from Radio Shack. (Google ‘DIY ECG’ if you doubt it) The technology is already widely available to anyone who wants it. I don’t see the massive numbers of false positives or wasted resources resulting from this availability.

    I’m a less is more kind of guy, and would agree that widespread screening asymptomatic patients younger than 50 won’t be productive. That’s really not what we’re talking about.

    Say I want to spend $200 of my own money on this device? Maybe I’m concerned about a particular condition. Maybe I own an aging dog or horse with a breed specific tendency towards arrhythmia. Maybe I’m headed to a poorly developed country and want to leave it and my old iphone with nurses at a local clinic. Maybe I teach high school A&P and want to use it in class. Maybe I just think it’s cool and want to learn more about the way my own heart works.

    Are you willing to say I shouldn’t be able to do any of these things because I can’t be trusted to only use the device on ‘appropriate individuals’?

    In a world where widespread screening guidelines are as likely to be made by politicians as scientists (see the recent breast cancer dust-up), all I want is the ability to decide for myself what the best path is for me.

    • Joe, I still feel there the physician and patient relationship is important. That relationship is sacred to me, and one of the main reason many go to medical school. Trivializing that relationship is not ideal. You mentioned in a recent case you saw 5 different doctors in 24 hours for a relatively simple case. This isn’t necessarily a bad thing. At academic centers it’s easy to see up to 3 or more physicians in a single ER visit (senior residents, specialists, etc).

      I would encourage you to read the data presented in the article from the United States Preventative task force into why routine ECGs in the wrong patient population can lead to harm.

      I’m happy to hear you also agree that routine ECG screening in an asymptotic individual isn’t necessary. If you want to create an ECG machine and use it to self diagnose, then there is no one holding you back. But there is a reason it’s required to be prescribed by a physician. It’s not about trust, it’s about patient outcomes.

      Also the recent “breast cancer dust up” you mentioned — I’m assuming you mean the recommendations by the USPTF, was based on a compilation of review journals and great, great academic literature. It was not based by politicians. I think everyone will agree the last thing politicians would want to do is anger their electorate. The “dust up” was due to the poor form of how the Task Force presented their data.

      Either way, one of the main point this article was trying to show was that AliveCor is a beautifully built device, and that routine ECG screening for asymptotic individuals less than 50 isn’t necessary — something both the maker of the device agree with and you do as well. Although I disagree with how you categorize the patient – physician relationship, I’m glad we can at least agree on that. Thanks so much for your comments!

      Iltifat Husain, MD iMedicalApps Editor
      • Thanks for the feedback. A couple of quick points of clarification.

        (1) Rx is NOT required for an ECG. For years they have been available OTC. I can order from a medical supply house, or even Amazon and eBay. I own an ECG machine and use it regularly.

        Again I ask – should I not be allowed to own my ECG machine because I could go around screening inappropriate individuals? Should someone come and confiscate it from me?

        (2) On the ‘breast cancer dustup’. Yes, USPTF came out with some scientifically solid recommendations. It caused a PR backlash and federal legislators have since ensured that Medicare would cover screenings starting at 40. Senators from both parties have introduced bills directing HHS to ignore the USPTF guidelines. A handful of states have already passed laws dictating increased screenings in particular cases and more states have legislation pending – all against USPTF guidelines.

        The discussion has moved from an evidence based discussion to a political football. As I’m sure you realize, it’s only a matter of time before device makers lobby for legislated guidelines mandating the use of their devices.

        System wide guidelines and subject to system wide manipulation. It’s much harder to manipulate individual patients making individual decisions along with their doctors.

        • Joe

          Actually the ECG machines you have been able to buy online and via things like Skymall have been grey market- prescription-only devices sold OTC. While the FDA is not likely to enforce the law in these cases, the companies are at risk and are breaking the law. You can look up the prescription vs OTC clearances at the fda’s online database.

          David Albert, MD
  • Dr. Albert -

    Thanks for jumping in.

    Help me understand. I can go to a reputable medical supply house and buy a GE MAC 3500 with nothing but a credit card number. Are they breaking the law as well?

    In fact, I can’t find a medical supply house selling $1000+ ECG’s that mentions needing a prescription. Just for kicks, I called a couple and asked if I needed a prescription to buy. All said no.

    Is this a case where the letter of the law and standard practice are at odds?

    • Joe

      Absolutely they are breaking the law. Look in the user’s manual and it will say something like ” restricted for sale to a or on the prescription of a physician”.

      I have a Mac3500 and it’s Ok but they are not supposed to be sold OTC. Again, the FDA has more important things to do than police the grey market for prescriptive devices that have very little, if any, risk but that is the law. And no one speeds?

      • I do see something like that in the manual. Thanks for explaining.

        “….very little, if any, risk…”

        except for the rampant ECG over-screening that’s about to over run cardiology offices across the US ;)

        I’d only make a plea for an evidence based decision on the hazards of self ECG’s. So far, I’ve heard the horrible predictions but seen no data.

      • I just returned from Costa Rica. I had 3 cab drivers and they all had iPhones. iPhones cost much more there than in the US.

        The vast majority if ECG machines are prescription-only.

        • Ah, your residency is showing. Think that people who don’t fill a Walmart $4.00 script won’t have an iPhone? Ah, to be young again. People find a way to buy the things they want but not the things they need.

          David Albert, MD
      • Here goes that top-down vs bottom-up thing again.

        Put useful devices out there are our collective creativity will amaze you. There are plenty of smart people willing to make meaningful contributions to their own care. Keep the information behind protective walls, and we’ll never reap those benefits.

        Someone should have told the Wright Brothers that those parts are only approved for use in bicycles.

  • @ Satish

    Different perspectives are always interesting, and I appreciate you helping me to see yours.

    Can _everyone_ afford something like this? Of course not. Does that mean no one should have one, or only approved individuals should have one? I’d suggest that the proportion who can in the US is much higher than you image. If you’re watching a HDTV, you clearly found a few hundred dollars to spend on electronics.

    The point of any new device is that we don’t have data yet. So, we all approach something new with an inherent bias. My bias leans towards freedom, especially when there is so little risk. Why? Because it lays the groundwork for innovation and creativity. Clearly there is a group of people, many physicians included, whose bias leans toward maintaining control with the idea that they can protect everyone from any kind of risk.

    Which has more potential to cause harm – this device like this or a bottle of 500 Tylenol capsules? This device or a kids razor scooter? This device or a steady diet of Big Macs? This device or a moped?

    Will every patient be able to (or want to?) make their own decisions or reap the benefits of patient empowerment? Of course not. But think about the harm to new ideas and creative solutions if even the least risky device can’t be rolled out without layers of gatekeepers and randomized trials?

    Overall, our society is more educated, with more access to information than we have been at any point in human history.

    You’re right. I have an ECG. I can get a whole body MRI just for kicks if I wanted to (I don’t). So why do devices like this matter?

    A kid in Bangladesh can get hours of education on ECG interpretation via youtube and read high level medical textbooks on their iPhone. What if that kid also had the chance to hold an ECG machine? What if the cost dropped (like most electronics) so that the ECG was $50? What if I uprgraded my iphone (and my ECG device) and passed the old one along to a charity in Bangladesh? Maybe his grandfather would finally have a chance to figure out why he’s been feeling so tired lately. Maybe that kid will figure out how to imbed a bluetooth device into a chest patch so that 1 phone can monitor dozens of patients for $3 a pop? Maybe that $3 patch makes it back to your clinic and your poorest patients have the chance to benefit because that kid in Bangladesh had a tremendous amount of potential he was able to unleash it.

    It makes no sense to ignore that potential because a subset of people don’t want to or won’t be able to participate. Everyone won’t be able to make a substantial contribution, but there are 7 billion of us, and a handful of people will. Think of how much we lose if those few difference makers never get the chance.

    I know that all sounds dreamy, and of course I can’t guess exactly which devices will inspire those great ideas or where that 1 whiz-kid will be. I do know that when you get useful devices out into the wild, along with the information to use them, creative people will take advantage. They will be able to do things that you and I can’t even imagine.

  • I simply want to thank Satish, David, Iltifat and Joe for a delighting discussion. Its truly great to follow on so many levels, and I do believe that the adressed topics are of key relevance to the healthcare transformation that’s currently happening.

    Rune Paamand, M.Sc Medicine & Technology
  • Medicine and technology continue to converge at an accelerating rate leading to exciting apps like the AliveCor ECG heart monitor. I dare say, this is simply the tip of the proverbial “iceberg” as it regards the future of patient empowerment of their own healthcare. I would be interested to learn how board-certified cardiologists and/or cardiac technicians will be reimbursed for interpretations. Is this a self-pay service? Is it currently covered and billable to commercial payers? Thanks in advance for any insight.

      • The technician and cardiologist reviews are “self-pay” today which fits with the latest wave of high deductible insurance plans.

        • Do you see a time in the future that patients can get reimbursed for the cost of the AliveCor device from their insurance plan? Or will the model always be patient self-pay?

        • Given the prevalence of high deductable insurance plans, a lot of medical care is out of pocket or out of MSA now. There may well be coverage in the future under a CPT code but for now it is self-pay.

  • I know I come late to this debate, but having had my AliveCor monitor for about three months, I thought it may be useful to add the perspective of a UK patient. Here, of course, there is no restriction on purchasing the monitor – in fact I bought mine from Amazon.
    In April this year I was referred to my local NHS hospital complaining of chest pains. A preliminary diagnosis of angina was confirmed by angiogram in September this year, and I was referred for bypass surgery. During this period, surprisingly, I had only one ECG, though I did have an echocardiogram in June. Keeping in mind an axiom of Sherlock Holmes that it is a capital mistake to theorise without data, I decided to keep a diary of symptoms and regularly monitor my pulse and blood pressure; I bought the AliveCor monitor not so that I could attempt self-diagnosis, but so that I could show any anomalies to my GP.
    And I did just that: the monitor showed bursts of asymptomatic tachycardia after exercise. I showed the printouts to my GP (he was very impressed with the monitor) and he arranged for confirmation by Holter monitor. The results were then passed my cardiologist, which influenced his recommendations for medication.
    The point is that these results were obtained not after a session on an exercise treadmill in the surgery but after climbing a hill on my daily walk. I can use the monitor when and where necessary.
    Many patients regularly monitor their blood pressure at home; monitoring one’s heart seems to be a logical extension. In this country we live with an over-stretched NHS, and any relevant information that we can pass to our GPs must the welcomed.

  • This review is done for physicians, not patients. And it only showed a normal rhythm. There needs to be a review from a patient’s perspective.

    Does the device point out abnormal rhythms? That isn’t made clear. I assume it doesn’t, that one has to share it with their doctor? Because if it doesn’t do that, then why have it be by prescription only? Why does one need a prescription to see one’s own heart rhythm? I’m confused.

    • The clinical reviews by either the cardiac technician or Board Certified Cardiologists are not meant to substitute for a patient having their own doctor review the rhythm strip. However, they do provide interpretation of the rhythm as to whether it is normal or abnormal and even provide the specific rhythm diagnoses. In the US, this is a Class II device, deemed to need FDA clearance. However, this and other devices will be made OTC in the near future with a few limitations.

    • @Susan
      I slipped into afib again on Monday. The AliveCor tracing on my iPhone was unmistakeable. HR twice normal and irregular. When I went for a conversion on Tuesday, I brought a week’s worth of tracings to show the EP. Little by little, I’m trying to convert them to the efficacy of this monitor in the grubby hands of a patient.

      • We have thousands of patients using our device to track and record their rhythms everyday. Your story is unique to you but not unique in that we have hundreds of AF patients using our device every day. Thanks for the kind words and please keep providing us with feedback as to how you would like us to improve it.

        David E. Albert, MD
  • I just got the Alivecor EKG monitor. This is my second day to use the device.
    I need to disclose that I had an early training in cardiology by myself (7 years in medical school) and I am familiar with heart problems and EKG stuff. Unfortunately, I have suffered from unknown palpitation and sometimes chest pain for some time. I was put on some simple 1 lead (most recently ZIO) Holter monitors a few times and the qualities of those monitors were no good either and I decided to give Alivecor a try.
    I think It is brilliant idea to use the powerful computing and display hardware of iphone itself for EKG monitoring. It is convenient too since iphone users carry their phones all the times anyway.
    The Alivecor EKG monitor works very well when you hold the sensor absolutely still. The major problem for this device is that it is way too sensitive to motion. Any slight movement of body and fingers in touch with the medal sensors will make the EKG trace look very ugly. At the time when one has symptoms like palpitation including heart racing, some degree of chest pain, even dizziness and resultant anxiety, there is NO way for the device user to hold the Alivecor absolutely still. Then you come to realize whether the ugly EKG is due to your heart problem or slight fingers/body movement. The device’s ultra-sensitivity to motion put its practical use at huge risk in my opinion!
    Please keep innovating. I think the idea is brilliant. Is it possible to make two wires in triangle shape. One joint end plugs into a sensor and two terminal ends can be quickly connects to patient’s left and right arm quickly at the time when patient starts to feel discomfort?
    Please solve the motion sensitivity issue! I will be the first one to buy when this problem is solved. A lot of people need this kind of device however we need one which can be used in real practice.

    B Xia MD MPH MS

    • Try putting it in your chest. You can get much more stable recordings. Otherwise, sit down and rest your hands on your lap or a table. Remember to lick your fingers to wet the epidermis to improve the recording. Please let me know if any of these help. Thanks

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