ICD User Group

Are you smarter than a 5th grader?

2010-07-06T12:16:00.000-07:00

An article published today in the The Wall Street Journal reports that “when it comes to understanding medical information, even the most sophisticated patient may not be smarter than a fifth grader.”

Sad news. The Centers for Disease Control and Prevention (CDC) confirms that nearly 9 out of 10 American adults are considered health illiterate, lacking the skills needed to manage their health.

The Institute of Medicine defines health literacy as “The degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”

Being health illiterate may affect your ability to fill out complex forms, manage your chronic disease, and understand how to take your meds. And for patients with implantable devices, it includes fully understanding the benefits and risks of device therapy.

Here’s an example. A recent survey published by the National Council on Aging (NCOA), revealed that nearly a third of electronic implantable device patients and more than half of their caregivers did not recall being told about the risks of magnetic resonance imaging (MRI) at the time of implant.

The survey also found that 3 in 10 devicepatients have had an MRI despite the risks, and of this group, nearly 20% reported problems with their electronic implantable device after having had the MRI.

Educate yourself. Limited health literacy amounts to as much as $238 billion a year in unnecessary health care costs. It also leads to poorer health outcomes, and that’s definitely something you cannot afford.

Watch:

The complete Wall Street Journal article can be found here.

Are patients becoming immune to device recalls?

2010-07-02T21:59:00.000-07:00

Laurie Racenet, EP Insights blogger and device nurse at the Alaska Heart Institute, poses an intriguing question: “Are patients becoming immune to device recalls?”

In her post, “Device Recalls and Patient Reaction,” Ms. Racenet explains her surprise in getting only a handful of phone calls after a recent device recall. She speculates that this might have been due to patients’ growing indifference toward frequent recalls.

She asks: “Are we doing such a wonderful job of communicating device recalls that patients are less anxious, and therefore don’t feel the need to call?” or “Have we had so many recalls and sent so many letters that patients are beginning to ignore us?”

Neither. I believe lack of understanding is partially to blame. After all, if all patients understood that a fractured lead may provoke an unwanted storm of inappropriate shocks or that replacing a recalled faulty battery will risk an infection years earlier than previously expected, we’d all be anxious.

In my view, most of us don’t know enough about device therapy to truly evaluate our risks when faced with a recall. And if we don’t understand it, we can’t grasp its consequences and Ms. Racenet gets fewer phone calls.

Sadly, doctors don’t spend nearly enough time educating their patients. I realize that in a world of declining reimbursements, no one has time for that. So, doctors will focus on the positive and not spend any time discussing adverse events or the possibility of a recall.

The good news is that modern technology is bringing together patients and helping close this gap. Today, patients are becoming connected and exchanging lots of useful information on treatments, sharing experiences, talking about brands and discussing recalls. And this might be yet another reason why Ms. Racenet isn’t getting as many phone calls as she used to.

Patients aren’t ignoring doctors. We’re just finding the information we need elsewhere. Often from each other.

On becoming empowered, educated and engaged.

2010-06-18T10:42:00.000-07:00

I was recently asked to elaborate on some practical advice on how ICD patients can become more empowered, educated and engaged in their own care. The context of the discussion was surrounding the different ICD brands existent currently on the market and whether or not patients should partake in the conversation regarding brand.

So, here are some tips.

Today’s health care system has taken much of the control away from patients (and from doctors too). So, as patients—in order to get some of that control back—we must start taking responsibility for our health in ways that we haven’t had to do in the past. We must stay vigilant every step of the way, making sure that we’re receiving good (and safe) medical care.

Empowerment:

Be wise. Learn as much as you can about the chronic condition that led you to have the ICD or CRT-D. Know and understand your risks and learn how to voice your wishes with confidence and authority. Be a strong advocate for yourself.

Education:

In order to have an intelligent discussion with your doctor about ICD therapy, you must have a good grasp of the topic at hand. Sure, if you’re like me, you’re probably not going back to school to become an electrophysiologist. But the more you know about ICDs and your condition in particular, the better you are at having a productive conversation with the doctor.

Also, learn all you can about device therapy and form your own opinions on what’s best for you. Discuss your options with your doctor and participate in the decisions about your device. Ask lots of questions, pick your doctor’s brain and use your doctor as an expert partner (or consultant) as opposed to someone who makes all the decisions for you.

I communicate with my doctor as I do with my financial advisor. He advises me on what he thinks is the best course of action, but bottom line is, (with apologies to our former president), “I’m the decider.”

It’s important to be completely at ease with your doctor. If he or she doesn’t like it when you ask questions, doesn’t listen to you, or is unwilling to spend the time it takes to explain things in terms you understand, fire the doctor and get one who will.

Lastly, whenever you go in for a device interrogation, ask for a copy of your report, bring it home with you and look it over. This is a great way to learn about your device and settings, to fuel your curiosity and help you learn.

Engagement:

The Society for Participatory Medicine (of which I am a member), defines this growing trend as “a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners.”

In this context, a discussion about device configuration, settings, percentage of pacing, leads and even device brands, is perfectly acceptable and expected.

About brands:

Doctors talk about device brands with vendors all the time. Manufacturers constantly pitch doctors about the superiority of their brands, including battery technology, lead reliability, device longevity and charge times.

I am a strong believer that patients should be privy to all this valuable information, too.

Bottom line: All devices can be pretty much programmed to deliver the best therapy for you. So, it might not be about asking for this brand or that brand but really about having an open conversation with the doctor. This is about access to information and participation in all aspects of your care.

Plain and simple, it’s all about the exercise of true informed consent.

(Book featured in the photo: Cardiac Pacing, Defibrillation and Resynchronization: A Clinical Approach)

Device makers, the patient is your brand.

2010-05-07T16:52:00.000-07:00

Years ago, I worked with a creative director who would constantly say to our clients: “Your customer is your brand.” I don’t know how many times I heard him repeat that. His point was that customers always have something important to say about the brands with which they interact.

Today, due to the power of social media, customers are even more likely to share their brand experience with others.

Ever since receiving an implantable device in 2007, I’ve felt this was also true for patients and their devices. Almost three years have passed since I first heard the names Medtronic, Boston Scientific and St. Jude Medical. But as we advance toward a model of health care in which the active role of the patient is emphasized, we all become invariably more engaged in the co-creation of the brands that help keep us alive.

So, I wasn’t surprised to come across this clip in which Dave deBronkart (a.k.a. e-Patient Dave) corroborates this very point. When asked which message he would relay to the CEO of a pharmaceutical company, this is what he had to say:

“Increasingly it’s not possible to control the message about your brand, about your product, about its benefits, its side effects. And that if you want to steal a march on the competition, and if you want to fortify your company’s foundation, what you ought to be doing is building things on the foundation of the future world in which smart patients who talk to each other become a primary source of information.”

Here’s some more food for thought. In the clip below, Grant McCracken (anthropologist, blogger and author of “Chief Culture Officer”) explains the notion of brand co-creation:

“The old contract in marketing said [that] you load up the cannons, you come up with a very simple message, you say it as loudly as you can and as often as you can until the dimmest person in the world understands that, say, a Ford Fiesta stands for excellence in engineering, or something.

The new contract in marketing says that this is just irritating for everyone. What we want instead is something closer to a conversation, and the buzzword that people are now using is this notion of co-creation that says that if you want a vital, animated brand you want to bring in people like this guy, in the spot we just saw, to help create that brand, to co-create the brand.”

Watch:

Remote ICD monitoring: where is my pony?

2010-01-24T20:14:00.000-08:00

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.

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

2010-01-07T08:32:00.000-08:00

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?

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

2009-12-30T17:20:00.001-08:00

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.

Genetic testing and me.

2009-12-18T16:50:00.000-08:00

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.

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

2009-12-09T19:04:00.000-08:00

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.

Device brand: be a part of the decision.

2009-10-30T11:08:00.001-07:00

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.

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.

WATCH: Living with your ICD -- Speaking Frankly

2009-10-26T15:28:00.000-07:00

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’”

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

2009-10-26T11:09:00.000-07:00

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.

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

2009-10-26T09:56:00.000-07:00

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.

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

2009-10-25T19:01:00.000-07:00

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.

A four-wheeled defibrillator.

2009-10-25T16:02:00.000-07:00

I flipped the page and the ad immediately caught my eye. The headline read "A four-wheeled defibrillator."

The rest of the copy said:

Pump a little adrenaline into your life with the Impreza WRX. 265-horsepower provides the thrust. Symmetrical All-Wheel drive provides the grip. Combined, they deliver a 0 to 60 time of just 4.7 seconds, and a shock to your heart every time you hit the accelerator.

I even like the car, but I can guarantee you that I don't want what the ad promises.

(Seen on DETAILS magazine, November 2009)

October 2009 Bay Area Events.

2009-10-08T10:28:00.000-07:00

Saturday, 10/10: ICD User Group’s Monthly Meeting

It’s sudden cardiac arrest awareness month and we’re meeting again this Saturday, October 10, from 2:00 to 4:00 PM in Sunol. We’ll gather for some light food and a nice chat at our usual place, Bosco’s Bones & Brew. Bosco’s is located at 11922 Main Street, Sunol.

Friday, 10/16: Stanford ICD Patient Day

The Stanford Arrhythmia Service will be hosting an ICD Patient Day on October 16, 2009 at the Palo Alto Westin Sheraton, from 8:00 AM to 2:00 PM. The program will cover a variety of topics, including the future of ICDs and options for patients with frequent arrhythmias. Samuel sears, PhD, an international authority on helping patients cope with the fear of ICD shocks, will be the key note speaker. You must call (650) 723-7111 for more information or to confirm your attendance. Download the invite here.

Saturday, 10/17: Charged Hearts 19th Annual Meeting

Kaiser’s annual ICD patients meeting will happen on October 17, 2009 at the Napa Valley Marriott Hotel, from 8:00 AM to 2:30 PM. Participants will have a chance to explore the psychological implications of living with an ICD, including issues of anxiety and depression. Dr. Sears will also speak at this event. You must RSVP by calling (707) 651-5544 no later than Monday, 10/12. Please leave your name, phone number, number of people in your party, and your lunch preference: grilled salmon, or braised beef short ribs.

Saturday, 10/24: ICD Patient Education and Support Group

Kaiser San Jose’s quarterly support group and informational session will be held on October 24, 2009, at Kaiser Permanente, 276 International Circle (Family Health Center, 3rd floor, Rooms A, B and C), from 10:00 AM to 2:30 PM. Dr. Nicole Varnell, PharmD, will speak about common medications and a technical specialist from St. Jude Medical will cover the basics of ICDs. You must RSVP no later than Monday, 10/20, to Thuy-Hong Vo, RN, (408) 972-7431.

The patient: Caught in a tug of war between doctors and industry.

2009-09-23T09:35:00.000-07:00

It’s been interesting to watch the debate that’s ensued from the publishing of MADIT-CRT earlier this month.

If you’re not familiar with the MADIT-CRT trial, it suggests that patients with early-stage, mildly symptomatic heart failure, who are indicated for ICD implantation, may benefit from the addition of cardiac resynchronization therapy (CRT). The study was supported by a research grant from Boston Scientific and well received by other device makers who foresee a lift in CRT-D sales.

But not everyone is cheerful.

A particularly interesting commentary on this has come from a prominent electrophysiologist and blogger, Dr. Richard Fogoros (a.k.a. DrRich). In a recent post titled “The Implantable Defibrillator Chickens Come Home To Roost,” DrRich speculates whether Boston Scientific sponsored the study “largely in order to entice (or shame) doctors into finally offering their heart failure patients an implantable defibrillator.” Still, he predicts results might not generate the expected increase in demand for CRT-Ds and that “the implantable defibrillator industry is probably going to be very disappointed with the reaction of the medical establishment to the MADIT-CRT trial.”

The problem seems to be that while manufacturers persistently try every possible way to drive up demand for their most expensive devices, doctors have lagged behind in prescribing them to patients. The reasons as to why ICDs have remained “underutilized” is unknown, but it’s been theorized that physicians might still be skeptical about the efficacy of ICDs and that patients might lack an understanding of this life-saving therapy.

Back to DrRich, he makes two eye-opening points:

SUDDEN DEATH:

“Sudden death has no constituency,” says DrRich. He claims that neither society nor patients themselves are really interested in preventing sudden cardiac death. His point is that while sudden death itself is “free,” giving someone an ICD or treating them for an underlying cardiac disease is a lot more costly to insurers and to society in general. As DrRich puts it, sudden death is actually “a boon to our federal budget.” A chilling thought (and rude awakening) for those of us at risk.

ARBITRARY PRICING:

DrRich also has some harsh words for industry. He says that prices for implantable defibrillators are “artificially and arbitrarily high,” thus precluding “any reasonable penetration of this life-saving technology into the vast population of patients who might benefit from it.” He contends that, while pacemakers are sold for $3,000 to $6,000, CRT devices (in essence, 3-lead pacemakers) are sold for $25,000 to $35,000.

According to DrRich, the lack of constituency for sudden death coupled with the high cost of ICDs and CRT-Ds results in “a business model that is fundamentally broken.”

NOT TO BE TAKEN LIGHTLY

As someone at risk of sudden death (who now lives with an ICD,) I don’t take DrRich’s commentary lightly. According to his online bio and public LinkedIn profile, DrRich “is a former professor of medicine who spent over 20 years as a full-time clinical cardiologist, medical researcher, teacher and author” as well as recent Medical Advisor to Guidant (now, Boston Scientific.)

And as I write this, you can still find his name in the advisory board of Boston Scientific’s LifeBeat Online listed as “Consultant to research and development of medical devices.”

SO, WHAT DOES THIS MEAN TO US, PATIENTS?

If anything, it means that we must remain vigilant advocates for our own best interests.

Industry will do whatever they can to drive product demand, and doctors will have their own biases regarding when to follow clinical guidelines. So, do as I do: Educate yourself and become an active participant in your own health care.

Related read: Is ICD therapy being over-prescribed to us?

Medtronic’s hitting the Twittersphere. Should others follow?

2009-09-16T10:32:00.000-07:00

While I applaud Medtronic’s first real foray into the Twittersphere, I must say the experience left me wanting more.

As a patient (and potentially lifetime consumer of their heart devices), it’s great to see that Medtronic is not only listening, but also willing to engage. I followed their tweets broadcasted from this year's HFSA Scientific Meeting in Boston, but got little out of them.

Medtronic appears to have aimed their tweets mainly at conference attendees, not at folks who, like me, couldn’t be at the conference. No doubt the twitpics were a very nice touch. But perhaps, next time we can also get links to press releases, result studies and even, dare I say it, a video or two.

Boston Scientific, St. Jude and other device makers don’t seem to have yet awaken to the power of social media and the impact patients are having in this brave new online world of Web 2.0. But I hope they’ll soon follow Medtronic's example.

MDTHeartFailure Twitter page:
http://twitter.com/MDTHeartFailure

Hashtag #HFSA:
http://twitter.com/#search?q=%23HFSA

Medtronic Advisory issued on the Concerto and Virtuoso (UPDATED)

2009-09-11T09:02:00.000-07:00

Yesterday, Medtronic issued a Physician Communication to doctors who implant Concerto CRTDs and Virtuoso ICDs regarding a batch of devices from 2005 and 2006 in which faulty battery capacitors were used. The capacitors in the affected devices were manufactured by an outside vendor, and more recent models of these devices no longer use this component.

The problem seems to affect only about 6,300 devices and may cause premature battery depletion. Medtronic recommends that physicians follow-up the affected devices every three months and that the patient alert feature be programmed "ON-High" (this is what the alarm sounds like) for the Low Voltage Battery alert.

As reported by Dr. Wes (who, by the way, scooped the WSJ), this is not a recall and it suggests none of the affected devices have failed or caused deaths.

Click here to see if your Concerto CRT device or Virtuoso ICD is affected.

This is the link, if you prefer to copy and paste it:
http://CVSNList.medtronic.com

UPDATE (10:51 AM PDT):

I just got some additional information on this. Medtronic reiterates that there is no safety issue here. This is not a recall and patients don't have to do anything other then they're already doing. Medtronic is not recommending prophylactic explant or anything like that because there will be no sudden loss of output and the devices will function and deliver therapy as needed.

Also, Medtronic has said they intend to honor the warranty on these devices and provide reasonable unreimbursed medical coverage for patients who must have the devices replaced early due to this advisory.

Again, look up your device's serial number at http://CVSNList.medtronic.com. If your device is affected, you'll likely receive a letter from Medtronic.

Here's a little more context:

There have been more than 200,000 Concerto CRTDs and Virtuoso ICDs implanted worldwide. Medtronic has identified 6,300 worldwide that may be impacted (a little over 3% of all Concertos and Virtuosos).

You are right about the copper supplier; unfortunately, we don't name our suppliers contractually (it was a copper supplier to one of our other component suppliers). The copper used in the remaining devices doesn't have the same porosity issue.

I just obtained a copy of the letter to physicians:

And here's Medtronic's official statement:

Medtronic notified physicians that a relatively small number of Concerto CRT-Ds (cardiac resynchronization therapy-defibrillators) and Virtuoso ICDs are not lasting as long as projected. Affected devices may have a higher than normal current drain on the battery due to a specific component issue. However, this gradual current drain on the device battery does not pose a patient safety concern, and there have been no reports of patient injuries. There is no risk of sudden loss of output and these devices will continue to deliver therapy as needed until they reach End of Service (EOS). Patients do not have to do anything differently. They should keep up with their regular device check-ups.

WATCH: Visit to Medtronic SF in 3 Minutes

2009-09-10T11:48:00.000-07:00

Last night's visit to Medtronic's cath lab was a success! Thanks to everyone at Medtronic who made this happen.

WATCH: Lisa Salberg on chronic illness and the health care reform.

2009-09-09T10:06:00.000-07:00

Lisa Salberg is CEO and Founder of the Hypertrophic Cardiomyopathy Association, an organization with thousands of members from all over the world. Lisa is also a vigorous patient advocate who has actually read the proposed Obama health bill. Here's a portion of a recent interview in which Lisa addresses some of the myths being perpetuated by the media.

We don't usually delve into political discussions, but I just had to post this.

Here's the transcript of the clip:

We are human. We are all going to die. It's OK to talk about that. And it's OK to die with dignity. And... they're making it sound like we want everybody to die and we don't want to provide them with health care.

Nothing could be further from the truth that I've read in either of these bills. We want people to get access to care. We want them to have the care they want and they and their doctor have agreed upon. And we don't want people to be hooked up to machines if they don't want it, we don't want them to be taken off machines if they don't want it. It's individual choice. And we need to make sure people have access to that.

So, your question as to why are people acting like they're acting, I think they're acting this way out of fear of the unknown. And we keep bantering about a term... "Socialized Medicine"...

It's not socialized medicine. We're going to have the same infrastructure that we've had, we're going to ensure that people have access to care who were otherwise disenfranchised from the system.

You see, if you don't have a chronic illness, then it's not so real to you. If you're not a few minutes away—by virtue of the loss of a job—of losing access to what keeps you alive, maybe you don't really understand this problem.

See this? This is my implantable defibrillator. If this goes bad and I don't have health insurance, I need seventy thousand dollars to pay for a new one to be put in my chest so I can remain an active participant in society and continue to contribute by virtue of my taxes, and my contributions to making society a better place. And I think I'm worth it. I think other people with chronic diseases are worth it too. And to say that they should be disenfranchised and set aside or made to go broke because they happen to have a medical condition that happens to be costly to manage, that's not what we are as a society. We take care of each other, and we set up systems to ensure that we can take care of ourselves as best as we can!

I couldn't agree more. Thank you, Lisa!

The complete interview can be seen here:
http://www.ourblook.com/Heathcare/Lisa-Salbergn-on-Healthcare-Reform.html

And here's a link to the HCMA's web site:
http://4hcm.org

2009-09-01T20:46:00.000-07:00

So, it has been exactly four days since the doctors at Stanford turned off my ICD after one of my leads fractured. This was done to help me avoid the unpleasant experience of an inappropriate shock. That is the clinical name for a defibrillating shock that happens by mistake; when your heart is not really in a dangerous arrhythmia. By some handy programming and a bit of luck, I was able to avoid that experience.

I have had my ICD for three years. During that time, I have ridden the full roller coaster ride of emotions from fear, loathing, joy, relief, anxiety and anger. It has been with the diligent search of knowledge and the support of some really incredible people that I have survived all this. After all that, you would think that having the darn thing go silent for a few days would be a relief… it has been anything but.

I have long grown used to the little bumps and jiggles that are my heart. Even the breath stealing flutter of a NST doesn’t freak me out anymore. Or at least it didn’t until last Friday. Now every little extra beat is sending me through the roof. How funny that the thing in my chest that I have cursed and hated is now the thing I miss.

In my logical mind, I know they would have never let me out of the hospital on Friday if I were at severe risk of V-fib. But in the rest of my mind, it is freaky to feel my heart mis-behave and know that there is no back up in place. As I have gone through my days I wonder if people around me would know what to do if I suddenly fell over. I have been worried about being alone just in case something goes wrong. I never would have expected this feeling but I have to admit, I miss my ICD. I hate that I have to go through another surgery to fix it, but I can’t wait to get in all patched up and get back to hating it again.

That little beep could be telling you something

2009-08-30T21:47:00.000-07:00

Last Thursday night while lying in bed, I heard a faint beeping sound. We had been out earlier in the evening with friends. While I usually try to eat healthy, I had indulged in too much fried food and I had two glasses of wine, so I was feeling heavy and sluggish. Without worry and in that dreamy, almost asleep state I tried to figure out where the sound was coming from. As it was one of the rare warm nights in the Bay Area and our window was open, I figured it must be a truck backing up somewhere in the distance and the sound just traveled. Now that I had the noise categorized, I drifted off to dreamland.

But the next morning, while having a cup of coffee heard the sound again. The first thing I did was check my laptop... then I checked Phillip's laptop, then I checked the coffee maker. Then, as I was walking down the hall to check the alarm clocks, I remember the sound from last night and at that same moment realized the sound was coming from me. What a strange feeling.

This is my first beeping experience and it is not at all what I thought it would sound like. I thought it would be more of an English emergency siren. When I had to go in for the Fidelis lead check up (yes, I have one of those) they played the alarm for me and it was a two toned sound, like an English Emergency siren. This is not that sound at all. It is a single tone, off/on beep. And it was in my chest. Weird.

My ICD is only three years old. I don't get paced and there had been no previous indications that my battery was getting low. However, I do have a lead that has been recalled by the manufacturer, that is always a concern.

I called my cardiologist’s office, explained the alarm sound and they had me send in a carelink report (Medtronic’s remote monitoring system). They told me there would be a delay, but they would get the information as quickly as they can and call me back. About an hour later, the nurse called and told me that the impendence levels had changed and that I needed to come in immediately. They didn’t have to tell me why. I understood. I knew the monitoring on the recalled lead has be set so that it will trigger an alarm if there is a change as that is the first signal that the lead has fractured. A fractured lead can cause a “noise” in the system that the device can read as an arrhythmia. This could lead to the device delivering a shock when I don’t really needed, an inappropriate shock.

What threw me was the tone of the alarm. Since this is coming from inside your body, the sound is a little muted, but is was audible. As I mentioned already, the alarm they demonstrated for me was a two tone, high/low sound. But the alarm I heart was a single pitch, off/on sound. I am still not sure why that was different, but the alarm got my attention, I called the doctor and the doctors had me come into the office. In the end it didn’t matter which sound it was, it worked as it should have to help me avoid inappropriate shocks.

Hear the alerts of a Medtronic ICD:

Low alert or high alert.

Alternating High/Low or On/Off tones:

You should contact your physician if you hear this tone.

No condition.

Steady tone at one fixed pitch:

Anxiety and the ICD Recipient

2009-08-13T19:12:00.000-07:00

I recently had a conversation with someone from a medical device company and during the discussion she mentioned that she was surprised that someone that has never been shocked experienced anxiety about having an ICD. I was surprised she didn’t know that we did.

Anxiety is a constant topic with us. We have all experienced it and we have all supported those around us going through it. It is not something that we go through once. Many of us have gone through several ups and downs since being implanted. And what is more, it is the first thing most people on the forum will ask about. It has led to some great discussions among us wired folks and I thought I would share some of the collective advice.

First and foremost, understand that anxiety is a normal and common reaction. Very often we are getting the diagnosis of a major heart issue AND a recommendation to receive some pretty amazing technology all in a short period of time. To most people, this ICD stuff sounds like something from Star Trek and we are trying to learn medical terms we have never heard before at the same time. It takes some getting used to. I think the best way to address the anxiety is to break it down into manageable pieces.

Don’t be afraid to talk to your doctor about anxiety. Doctors are beginning to understand that it is not a walk in the park for those of us with ICDs and heart disease. Heart disease of any kind is enough to cause depression. Add to that the fear that we are going to get a shock (even though we understand we need it) and it can be overwhelming. Doctors can help with medication if needed. But they can’t do a thing to help you if you don’t mention it to them.

Find out everything you can about your heart condition. There are many things that cause dangerous arrhythmias, find out what is causing yours. No matter how complicated it is, there is a name for it… even it is something obscure like Non-focal Reticulated Cardiomyopathy. Ok, I just made that up but trust me, there is a name for your condition. Ask your doctor to explain it and don’t be afraid to ask him/her to explain any words or terms you are unfamiliar with. Then you will be able to read about and understand what is happening to your heart and why all this is necessary. From there, you and your doctor and come up with a plan to treat you going forward.

Look for a support group. I guess you have already done that by finding this site. But see if your local clinic or hospital has a group that meets in person. We didn’t have anything like it in the Bay Area (CA) so we started our own. It really helps to be able to talk to someone face to face about those moments when you are afraid to walk up the stairs or to be alone. If you are in the Bay Area, join us. If you are not, check with your clinic or hospital to see if they offer this type of program.

Learn as much as you can about your device. Ask your doctor to explain how it works, what kind you have and why he/she choose that model. Ask for a copy of your interrogation report and learn the different program settings. Knowing how it works really helped me get to a comfortable place mentally. I have a Medtronic device and found that they have lots of support information available to recipients. I think all the companies do this. I know it seems silly, but having one to hold and touch makes this seem a little easier for me. Ask your doctor to show you a device if you haven’t seen one already.

Finally, understand that it takes a little time. You are dealing with diagnosis, devices and mortality here. That is a lot to deal with. But it does get better. It won’t happen over night. But little by little you will get back to your old self or at least something very close to it.

Visit to Medtronic in San Francisco

2009-08-09T09:00:00.000-07:00

Wednesday, 9/9/09, 6—8 PM

(Sorry, RSVPs are no longer being accepted.)

Join us for a visit to Medtronic’s office in San Francisco. This month, we will not meet on the second Saturday, as customary. Instead, we’re gathering on a Wednesday evening from 6 to 8 PM at Medtronic’s office in San Francisco.

ABOUT THE MEETING:

Medtronic has offered us privileged access to their Cath lab, where they train professionals and demonstrate products to physicians.

Medtronic will give us a short presentation covering a variety of advanced topics of interest, including a brief history of ICDs, leads and lead replacements, and a look into the future.

The presentation will be followed by a tour of their simulated implant lab. Clinical Specialists will be available to answer our questions, and refreshments will be served.

THE PROGRAM WILL FEATURE:

Educational Presentation by Medtronic
Virtual Cath Lab Experience
Refreshments

This will probably be one of our best meetings yet. Don’t miss it!

LOCATION:
303 Second St.
Suite 850 North
San Francisco, CA 94107 (Google map)

DATE & TIME:
September 9, 2009
6:00 PM — 8:00 PM

If you have RSVP'd, your name will be at the door. You may arrive as early as 5:30 PM.

TRANSPORTATION AND PARKING:

303 SECOND STREET is located at walking distance from BART and MUNI, with easy access from the Bay Bridge, highways 101 and 280.

If you’re driving, consider the rush hour traffic. There are plenty of indoor parking spaces in the City Park Public Parking garage at the North Tower off Folsom Street. Medtronic has kindly offered to validate parking for this event. Let me know if you have special transportation needs.