Remote ICD monitoring: where is my pony?

Have you ever seen the TV spot where two little girls are offered ponies by a shady banker? The first girl is given a toy pony while the second one gets a living animal. When the first girl protests, the banker dismissively replies, “You didn’t ask.” The voice over concludes: “Even kids know it’s wrong to hold out on somebody.”



While the ad cracks me up, it also reminds me that when it comes to remote follow-up and monitoring of ICDs and pacemakers, patients are getting toy ponies while doctors and industry are getting real ones.

Patients are asked to adopt this new technology and are pitched the conveniences of fewer office visits, lesser travel expenses, and the ability to send transmissions anytime from (almost) anywhere.

Medtronic’s web site, for example, promises patients “a new sense of freedom through remote monitoring.” It claims that “nearly 300,000 people around the world benefit from Medtronic’s home monitoring,” gaining more freedom, convenience and peace of mind. While I agree that these are definite benefits, they’re not significant enough to persuade me to adopt remote monitoring. They also do not compare to indisputable financial benefits both doctors and manufacturers enjoy from our adoption of the technology.

“By enabling routine device follow-ups remotely, doctors can quickly and thoroughly review the status of a patient’s heart condition, and schedule follow-up appointments only when necessary,” says Medtronic in this press release. The key word here is “quickly”. In a world of declining reimbursements, efficiency means profitability. Remote monitoring allows for doctors to “see” more patients without really seeing them.

Sadly, most of us are only too happy to jump on the bandwagon without giving it a second thought.

Should we want fewer office visits?

So, are fewer visits to the doctor a real benefit to us? Not necessarily. During my visits, I always ask for and bring home copies of my interrogation reports. I enjoy reviewing the report with my electrophysiologist and appreciate our interaction and access to his knowledge and expertise. I would not trade this valuable time for the convenience of remote monitoring alone. Sure, remote monitoring has its conveniences, but it also means having less access to information. And, to me, that’s a serious inconvenience.

What I see as a true benefit is 24/7 access to my heart’s data: the same data doctors and manufacturers download and access remotely from my implantable device.



The plastic toy pony.

Here’s the breakdown of what you’re giving up when you agree to the “plastic toy pony”:

• You are passing up the opportunity for valuable face time with your doctor. It’s your chance to ask questions and get educated about your condition. It’s about access. If you think you can call the clinic and get your EP on the line to answer your questions after transmitting your data, good luck and God bless your credulous heart.
• It’s much harder to get a copy of your interrogation report if you don’t go into the clinic. Ironically, with remote monitoring, your data is even less available to you. You must ask the clinic to mail you a copy of the report or use 20th century technology and have it faxed to you. If you’re already at the clinic, all it takes is to ask them to print you an extra copy.
• You must have a landline to use remote monitoring. If you’re like me and others who only use mobile phones and digital/VoIP phones, you’re out of luck. Most remote monitoring systems only work over traditional landlines. The only exception (as I write this) is Biotronik’s system. Biotronik is the pioneer in the field of remote follow-up and monitoring of pacemakers and ICDs. The data retrieved from their devices is transmitted to a center in Germany using the GSM (Global System for Mobile Communications) network. This is the main advantage of their system.

Moreover, as doctors Mark Schoenfeld and Dwight Reynolds ask in their article Sophisticated Remote Implantable Cardioverter-Defibrillator Follow-Up: A Status Report, (Pacing and Clinical Electrophysiology, April 2009), “If a patient spontaneously transmits data through the Internet that is not accessed nor responded to in a timely fashion, who is responsible, particularly if a poor outcome arises from delayed interrogation? This situation is not likely to arise during a scheduled clinic visit when the physician knows that a specific device interrogation is being made.”

As we look for ways to reduce heath care costs, remote monitoring and follow-ups for patients with pacemakers and ICDs is likely to become the standard of care. However, I believe patients must be made a part of the equation and be empowered to review all our data via the Internet. After all, it is OUR DATA. And as our own best advocates, we’re entitled to having access to it.

One thing is for sure. Until I can get a “real pony,” I'm holding off on remote monitoring.

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My heart, my data. Can I please have it now?

Today, I can send a text message to my bank and, within seconds, get an automated reply with all my balances, account activity, and even nearby ATM locations—all this from the convenience of my mobile phone.

So why don't I have the same level of access to the data collected by my implanted device?

This inconvenient limitation became quite clear during a recent health scare that landed me in the emergency room just two days before New Year’s Eve. As it turns out, my heart had suddenly developed one of the most common types of abnormal heartbeats: atrial fibrillation.


According to the American Heart Association, atrial fibrillation, or “a-fib,” afflicts 2.2 million Americans. When left untreated, it can lead to heart failure or stroke.

During the incident and until my arrival at the ER and proper diagnosis, I had no idea what was going on in my heart. I could only tell by the fast pulse, breathlessness, and fluttering in my chest that something was quite wrong.

My implantable cardioverter defibrillator (ICD), however, knew exactly what was going on. In fact, it had been busy logging the event and recording every missed beat. (The following day, the device was interrogated and a report was printed.)


What frustrates me is that I remained in the dark for hours until graciously informed by the attending physician that I had atrial fibrillation.

As well stated by Leslie A. Saxon, M.D., Chief of Cardiovascular Medicine and professor of clinical medicine at the Keck School of Medicine of USC, "Being a naked patient in a room with a doctor shouldn't be the only way to get information." I couldn't agree more.

As someone with hypertrophic cardiomyopathy and the son of parents who lived for years with atrial fibrillation, I should start getting used to (and prepared for) the idea of chronic a-fib.

All I need are 21st century tools to help me manage my heart disease. Having to drive to a hospital and wait for hours, just to be told what my device already knew, seems unreasonable and unnecessarily costly to say the least.

I only want the same convenient access to my device's data that I have to my dollars and cents. And I want it now. After all, isn't my heart more important than my bank account?

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Boston Scientific launches the very first iPhone app for ICD patients.

Boston Scientific has launched the first of a series of iPhone apps aimed at giving ICD patients a higher level of control and customer service. Patients can set up a personal profile and search for others based on device type, age, gender, number of shocks, etc.

It’s a great way for patients to meet, connect and support each other and a smart way for Boston Scientific to build their brand as a new era of empowered patients emerges.



Of course, the above is not true (at least not yet). It is only wishful thinking on my part. I have no knowledge that Boston Scientific (or other device manufacturer) is working on such an app.

But I hope the day will come when patients will be able to use their smart phones to find and connect with others, view our device's settings, review the electrogram of an arrhythmic event, or even download our heart's data from a remote monitoring network (Boston Scientific's Latitude Patient Management System, for example).

Other useful applications could include an app that allows for patients to keep an event log, recording activities such as eating, walking, or driving and symptoms such as palpitations, dizziness and shortness of breath. This data could be sent to a networked printer, transmitted by email, or downloaded to a personal computer and later matched up by a doctor or nurse to an interrogation report.

Ultimately, I'd really like to be able to download the electrogram for an arrhythmia, display a "dashboard" with my device's programming settings, event summary, pacing percentage, battery life, etc.

Such access to information could be a compelling selling point when it comes time for an ICD to get replaced. It's all about control. And control translates into true cardiac disease management.

And whoever provides us patients the highest level of control—and service—is more likely to get our business.

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Genetic testing and me.

Today I agreed to have my blood drawn for genetic testing for Hypertrophic Cardiomyopathy (HCM). I have really struggled with this decision. The way insurance companies are these days, I worry that something will be used against me in a way I can’t even imagine and I find myself suddenly without coverage. That would be devastating financially.

I am pre-approved by my insurance to have the testing and thanks to a broken lead earlier this year, my deductible has been met so there is no money out of my pocket. Logically, I know everything should be fine, but all those stories of people who thought they were covered being retroactively denied coverage really worry me. I know that the Genetic Information Non-discrimination Act (GINA) has passed and I know its intent to protect people from losing insurance coverage despite any information that genetic testing uncovers. But for ever law there seems to be a loophole and putting my faith in the government and regulations to protect me seems like a lost cause these days.

On the other hand, I understand this is a tricky disease and it seems to me that for all we know, there is a lot that we just don’t know yet. I believe that it is through genetic studies that HCM will come closer to being fully understood. The information I provide with my DNA may not help me directly, but it might help my children to understand their risks and will eventually help doctors solve the some of the mysteries of this heart disease. In the end, this is what motivates me and I agree to get the test. So I today headed back over to Stanford Cardiovascular unit to submit my blood for testing.

This is an easy thing on my part, give a small vile of blood and sit back and wait for the results. My veins are a little shy these days; they have been poked at a lot over the last three months so we decide to use the prominent vein on my hand. It sometimes hurts a little bit more but getting one stick is better then fishing around in my arm for a vein that doesn’t roll out of the way. A quick sign of a release paper and the blood draw and I am on my way. I won’t get any results until sometime after February next year.

I have talked to three others that have had this test and they tell me the same thing, their tests came back as ‘unknown’ meaning they didn’t have any of the known markers for HCM. I am not even going to pretend that I understand all this but if I have my numbers right, there are 17 known genetic mutations for HCM. Of those known mutations, there have been several studies that have shown some correlation with “prognostic significance”. I take that to mean, some genetic mutations that are known for HCM will map to higher likelihood of SCA and other known outcomes. Today I was told there are seventy other markers that may have some contribution. Some of these may not have been associated with HCM but may have been identified with symptoms like arrhythmias or excessive scaring and so on. So even if they don’t find the know causes for HCM, they may gather enough information to prove other markers that were previously unknown or may be able to say that I am more likely to have certain outcomes.

Or they may never get it all figured out, but so far all it cost me was a drive to the Stanford campus and a little blood.

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Boston Scientific advisory issued on the COGNIS and TELIGEN families of ICDs.

Boston Scientific has notified the ICD User Group of an important product advisory involving their COGNIS CRT-Ds and TELIGEN ICDs.

This product advisory information is not a recall, and affects only COGNIS and TELIGEN devices implanted below the chest muscles (commonly known as submuscular pectoral, or subpectoral implants). Devices placed subcutaneously (just under the skin) are not affected by this advisory.

About 95% percent of defibrillators are implanted subcutaneously. Less commonly, a doctor may choose to implant a device deeper, under the chest muscles. Boston Scientific has learned that devices implanted under the chest muscles may be subject to mechanical stress that could weaken the bond between the device casing and the lead connector, or header, portion of the device, and could impact the ability to deliver appropriate therapy.

According to Boston Scientific, a weakened header bond can also result in one or more of the following:

• Significant changes in measured lead impedance
• Noise on real-time or stored electrograms
• Intermittent inhibition of pacing
• Inappropriate anti-tachycardia pacing or shock therapy
• Loss of pacing therapy
• Loss of anti-tachycardia pacing and shock therapy

To date, Boston Scientific says it has received only two reports worldwide of implants located under the chest muscles with weakened header bonds. The patients implanted with these devices received inappropriate shocks and were required to have their devices replaced earlier than expected.

Boston Scientific has notified regulatory authorities of this problem and has communicated this issue to physicians. They have also submitted manufacturing process improvements to the FDA and will implement such changes when regulatory approval is received.

Again, only COGNIS and TELIGEN devices implanted below the chest muscles are affected by this advisory. Boston Scientific estimates that this consists of only about 5% of the 77,000 devices implanted worldwide.

WHAT YOU SHOULD DO:

• If you don’t already know what device model you have, check your ID card to determine whether you have a COGNIS or TELIGEN. If you don’t, this advisory does not apply.


• Talk to your doctor to determine whether your device is implanted under the skin, or under the chest muscle. If your device is implanted just under the skin, this advisory does not apply.


• Attend your regular device follow-up appointments


• Immediately contact your device doctor or clinic if you receive a shock

This advisory is publicly available on Boston Scientific’s website, under the Product Performance Resource Center link. A PDF of current Product Advisories can be downloaded here.

In addition to the above, Boston Scientific’s Patient Advocacy & Education and Patient Services teams are available to support you and answer any questions you may have. Patients should contact Boston Scientific Patient Services at 1 (866) 484-3268. Press “2” when prompted.

In an email to the ICD User Group, Boston Scientific explained that it’s taken the initiative to inform us in hopes that the information will get out there in a resposible and accurate manner. They’ve also stated that they recognize the importance of advocacy groups as an “important and credible resource for patients.”

Here’s a link to this Product Advisory on Boston Scientific’s web site.

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Device brand: be a part of the decision.

Your doctor may have told you that you need an implantable cardioverter defibrillator (ICD). The decision whether or not to get the ICD should not be taken lightly. Once it’s been implanted, the device and leads will be there for the rest of your life, so having an ICD means a lifelong commitment. You should understand all the facts, implications and future consequences of getting the device.

As a patient and patient advocate, I encourage you to do as I did and become an active participant in this important decision. There are several device makers, and the selection of a brand should not be left to the doctor alone.


You must not only consider the overall features of a generator, its longevity, charge times, and ability to reduce unnecessary RV pacing, but you must also take into account a device manufacturer’s ethical standards, its sense of corporate responsibility and the entire brand experience.

Read a related entry on the message board »

The ICD User Group is a non-profit resource for people living with ICDs, candidates for ICD surgery, and their friends and families. As patients ourselves, we encourage other patients to educate themselves, know their choices, and become active participants in their health care.

In reference to: Google Sidewiki entry on Medtronic’s Web site.

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WATCH: Living with your ICD -- Speaking Frankly

If you are a manufacturer of ICDs, or a hospital, and you must make a video to educate your patients, use real people.

This Boston Scientific video is an example of how it can be tastefully done. The nurse featured here is actually a real nurse. Most importantly, she doesn’t dumb down the message or speaks in a patronizing tone. She speaks frankly and explains it clearly.

There’s no talk of “magic wands” or “guardian angels on our shoulders”.

Watch and compare it with “Living with your ICD -- The ‘Magic Wand’”

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WATCH: Living with your ICD -- The "therapy"

In this third clip of the series “Living with your ICD”, the patient asks the doctor what he should expect to feel in the event of a shock to the heart.

The doctor‘s response is a long spiel on how each “therapy” is different (he never calls it a shock), how it depends on your heart’s behavior and on your personal perception.

“This is a common concern among new ICD patients. The fact is, each therapy is different. Depending on how your own heart is behaving and your personal perception. Remember, this is an intelligent device that your doctor can set to deliver the smallest amount of energy you need to regain control of your normal heart rhythm.”

Compare the above with a description from a patient who has actually been shocked. His own words.

“If the devil had a mechanical bull which shot electrical bolts out of its devil bull horns, and this bull ran full tilt down a steep hill and gored you in the chest, then you’d know how this $#!T felt!!! I’m sorry that some of you can identify with this.”

(Read the full post here.)

It would be much nicer to hear them acknowledge that no one can really tell you how it feels to be shocked in the heart unless they actually have an ICD that’s gone off!

Watch this overoptimistic, candy-coated, patronizing answer below.

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WATCH: Living with your ICD -- The "Space Program"

More from Dr. “Patronizing” in this manufacturer’s video of a mock support group for implantable defibrillator (ICD) patients.

In this clip, the doctor explains what happens during a follow up visit to interrogate the device.

He explains:

“Now, borrowing technology from the space program, called bidirectional telemetry, device settings can even be adjusted by the programmer.”

Whoa! slow down... doc! We're having a hard time following!

Watch.

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WATCH: Living with your ICD -- The "Magic Wand"

I recently attended a local ICD support group meeting in which a device manufacturer was invited to participate. They opened their talk with a 30-minute video of a mock support group in which ICD patients were played by a host of actors so bad that even this gig seemed beyond their acting abilities.

According to its description, the video was “taped in the friendly setting of an ICD support group” and included “easy-to-understand answers.”

Gee, I am so glad they dumbed it down for us patients.

In this 20 sec clip, a “patient” raises his hand and asks the doctor “what happens during these follow up sessions?" The patient is referring to the follow-up visits when the device gets interrogated.

The doctor then explains it in the most condescending tone possible:

“Well, we use a sort of ‘magic’ wand that we hold over the ICD implant spot. This… ‘wand’ is about the size and shape of a normal remote control device…”

Thank God for magic! Watch.

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