ICD User Group

I will get back to you.

2012-01-25T07:18:00.000-08:00

I’ve been on a journey to unlock data from my implantable defibrillator for over two years now. While I’ve had quite a few successes, nothing compares with the overwhelmingly positive response received after a video of my talk at TEDxCambridge went live last week.

It was followed by an interview with Brooke Gladstone of NPR’s “On the Media” in which she asked: “Who owns the data from inside your body”?

These two developments caused my inbox to overflow with offers from hackers (listen to the interview) and emails from NPR listeners from the UK, Canada, and the entire U.S.

I was unprepared for such an overwhelming response. So, if you’re one of the people who wrote to me, please know what I will get back to you in time.

This has been a wild and unexpected ride, but I wouldn’t have it any other way.

Fighting for the right to access my heart’s data

2012-01-19T12:14:00.000-08:00

Karen Sandler: a cyborg lawyer running on proprietary software

2011-12-29T23:00:00.000-08:00

Should patients have the right to inspect and scrutinize the software that runs the implantable devices that keep them alive? Karen Sandler thinks so. Karen is a lawyer, executive director of the GNOME foundation, and Hypertrophic Cardiomyopathy patient who’s received an implantable defibrillator for primary prevention of sudden cardiac arrest.

In this talk, Karen explains how the FDA never reviews the source code that runs our ICDs and pacemakers and makes a case for free and open platforms for life-critical software.

“I don’t want to rely on one company for any part of my life. I don’t want to rely on Medtronic for my heart, and I don’t want to rely on any other company for any other thing. I want everybody to be able to see the source code. And I specially want to see the source code. We’re at a crossroads and it’s time to change.”

Watch:

Also, an interview with Karen Sandler:

VIDEO: A town hall meeting with the FDA

2011-12-01T12:37:00.000-08:00

A town hall meeting with the FDA: democracy at work.

2011-09-22T21:04:00.000-07:00

Dr. Jeff Shuren, Director,
FDA CDRH

Today, I had the exceptional opportunity to speak before Dr. Jeff Shuren director of the FDA’s Center for Devices and Radiological Health (CDRH). The CDRH is the center within the FDA that is responsible for pre- and post-market regulation of medical devices. Pacemakers and ICDs are under the center’s purview.

The town hall meeting was organized with the objective of having the FDA engage in discussions about issues of importance to the public. It was the third and last meeting being held this year.

It was a unique experience that filled my heart with patriotism, and an inspiring feeling of health activism and civic participation. I felt like a true patient advocate.

This is the message I delivered:

Good morning. 

Thank you for the opportunity to be here.  My name is Hugo Campos and I am a heart patient  living with an implantable cardiac defibrillator.  

Each year, hundreds of thousands of Americans are implanted with pacemakers, loop recorders and cardiac defibrillators like mine. However, not a single one of these patients has access to the wealth of personalized data that is continuously collected by their implantable devices.  It is time for us to change this.

Pacemakers and ICDs are small, battery-powered, electrical impulse generators that are implanted in patients with slow heart beats or who are at risk of  sudden cardiac arrest.

In addition to providing life-saving therapy, these medical devices collect and store advanced diagnostic information pertaining to their normal function and a patient’s clinical status. This information is transmitted to a secure and private network owned by the manufacturer of the device.

Some of the data collected is made available to clinicians through a secure Web site, enabling them the convenience of monitoring patients without the need for in-office visits.

However, this data is not made available to the patient who originates it.

Studies have shown that remotely monitored patients experience a significant reduction in time from  clinical event to clinical decision and also benefit from shorter hospital stays and reduced costs per hospitalization.

This clearly makes the point that access to information saves lives and money.

Yet, even in light of such evidence, patients continue to be denied the right to access such useful and incredibly rich data about their bodies.

The main obstacle, in my view, has been the Cardiac Rhythm Management industry itself, which claims that a pacemaker or defibrillator is put into a patient’s body for the therapy it delivers, not for the information it gathers, and that making this data available to patients does not fit their business model.

The types of information collected by a modern ICD, for example, vary from trivial to potentially critical. Among other things, the device monitors its own battery voltage, the amount of time it takes to deliver a life-saving shock, collects and stores intracardiac electrograms, and monitors a patient’s heart rhythm, daily activity, arrhythmia episodes, and even the build-up of fluid in the lungs — which is critical to patients dealing with congestive heart failure.

In addition, patients who are at risk for atrial fibrillation and atrial flutter, have a higher propensity for stroke and heart failure. Atrial arrhythmias can also cause the ICD to deliver inappropriate shocks. So, rapid patient awareness of atrial fibrillation is crucial for those at risk.

Access to our data can do more than just help patients take control of our disease. It may also help with timely identification of device-related malfunctions, and ultimately, contribute to better patient engagement and improved health outcomes.

Knowledge is power. And a patient privy to his data is an empowered partner in his own health and healthcare. Access to my device’s data can help me track, understand and manage my condition better, become more active in my care, and work more effectively with my providers.

I rely on the FDA to protect me. And I need the FDA to stand with me in this quest for openness, access and transparency.

In the spirit of the new rules proposed last week by Health and Human Services Secretary, Kathleen Sebelius, that strengthen patients’ rights to access their own laboratory test results directly from labs, I would like to ask the FDA to follow suit and publicly declare that patients also have the right to the raw data collected and stored by the manufacturers of their implantable devices.

I have the right and the responsibility to care for myself, but cannot do so without information. It is time to fix this and put patients and our families at the center of our own care. And I call on the FDA to help us get there.

Thank you.

The highlight of the morning came at the end of the meeting when the audience was given the opportunity to ask questions. I asked Dr. Shuren who owns the data collected via remote monitoring by the manufacturer of my implantable device. He replied: “As a patient myself, I view the data on me... it’s my data.”

Hoorah!

Attendees at the FDA CDRH town hall meeting of 9/22
in South San Francisco, during a break.

It isn’t nice, I want my data!

2011-07-29T17:08:00.000-07:00

Each year, hundreds of thousands of pacemakers, ICDs and loop recorders are implanted in people all over the world. However, these patients have no access to the vast amount of critical data that is collected by their devices. I am one of those patients.

This song is inspired by the classic protest song “It isn’t nice” by Malvina Reynolds.

Follow along:

It isn’t nice to grab my data
from my implantable device.
Then to hog it, keep it from me.
That’s not right, I’ve told you twice.
It isn't nice, it isn't nice,
How can it be so hard to see
that I am the patient, it’s my data,
my heart, my ICD.

You ask me why I want these numbers
that you collect through my phone line
Then I give you all these reasons,
You still say no, that is not fine.
It isn't nice, it isn't nice.
It is my heart, my ICD
All I want is access, why on Earth...
won’t you give it to me?

Your excuse is: I'm unable
to make sense of the reports.
Will you please not patronize me.
Do I have to take this to the courts?
It isn't nice, it isn't nice.
How can it be so hard to see?
After all I am the patient
And the one with the ICD.

I think I know what your concerns are.
You want to keep me in the dark
I may learn who has the pacer
with longer life and bigger spark.
It isn't nice, it isn't nice,
How can it be so hard to see?
It’s time for you to unlock this,
I’m the one with the ICD.

I know it’s not nice to hack my pacer,
or intercept my Carelink call,
There are nicer ways to do it,
but you always seem to stall.
it isn’t nice, it isn’t nice,
but if my data is kept from me,
I just have no choice, I gotta have it

Why won’t you hear my plea?
One day you’ll go into retirement.
I hope still to be around,
with full access to my data.
Before they put me in the ground
It would be nice, it would be nice
If you are finally made to see
That the data is mine, just hear me out!
We have to set it free!

The battery life of my cardiac device

2011-06-07T22:43:00.000-07:00

Sitting down with my interrogation reports is never fun. But it always makes me wonder what I’d be able to find if I had all of those numbers plugged into a database or spreadsheet. My clinic is unable to send me reports electronically, and so my only choice is to have them printed out on letter-sized or 110 mm thermal paper, which fades over time.But if I want to know how my device’s battery is performing, I have to spend a little time combing through all the pages of my reports and entering the numbers I find into Excel.I have all my printouts since the day after implant, 3 1/2 years ago, 44 months ago to be precise. In this amount of time, I’ve had 16 device interrogations, including two of them during a cardiac rhythm class I took at the Arrhythmia Technologies Institute (ATI) earlier this year.The above graphic shows the battery depletion curve of my ICD in comparison to an estimated Lithium/SVO battery discharge curve found in my school materials. I also took into account the estimated longevity published by the manufacturer for this model of ICD at 100% sensing and with semi-annual capacitor formations (as it is in my case).

It’s only an estimation, but it shows that my implant battery seems to be behaving according to plan. It’s an example of how access to our data can give patients some peace of mind. And aside from not getting a shock, that’s all I can hope for.

Hacking into my heart device’s data

2011-05-29T07:14:00.000-07:00

All options have always been on the table regarding access to my implantable cardiac device’s data. But tapping my remote monitoring unit to get it has been among the options of last resort.

So, yesterday at the first Quantified Self conference, I announced my collaboration with Kyle Machulis, a software and hardware engineer who’s building open source libraries for whatever health equipment he can get his hands on. And that includes remote monitoring units used by pacemaker and implantable cardioverter-defibrillator (ICD) patients, eager to access their data.

Kyle Machulis, of OpenYou.org, presented at The Quantified Self Conference in Mountain View, CA.

Above, a portion of the OpenYou table at the Quantified Self Conference. A commonly used remote monitoring is seen among a series of gadgets. In the Ziploc bag, an implantable defibrillator.

A poster announced our collaboration and bold experiment.

The ICD

The implantable cardioverter-defibrillator is a small, battery-powered electrical impulse generator implanted in patients who are at risk of sudden cardiac death. The device is programmed to detect a life-threatening arrhythmia and correct it by delivering a jolt of electricity to the heart. It also has the ability to perform biventricular pacing in patients with congestive heart failure or bradycardia (slow heart rhythm).

In addition to providing life-saving therapy, the ICD also collects and stores comprehensive patient, device and physiological data that can indicate progression of the patient’s heart disease. Data collected by the ICD is automatically transmitted to a proprietary (and closed) network and made available to authorized physicians via the Internet, thus giving them efficient access to make informed decisions when and where needed.

No access for patients

The main problem with remote monitoring is the fact that it excludes patients from accessing this trove of personal medical data, thus giving them no opportunity to learn from it.

Only time will tell whether or not we will be successful in our experiment. But as Kyle says about the practice of keeping patients from their data: “[It] needs to stop, and we’re here to make that happen. It’s your data, it’s your right to have complete access to it.”

View the Quantified Self poster here (link downloads a PDF).

Online data access: at the bank and at the clinic

2011-05-23T23:44:00.000-07:00

In addition to providing life-saving therapy, ICDs also collect and store comprehensive patient, device and physiological data that can indicate progression of the patient’s heart disease. Data collected by the ICD is automatically transmitted to a proprietary network and made available to physicians via the Internet, thus giving them efficient access to make informed decisions when and where needed.

However, ICD and pacemaker patients have no access to this trove of personal medical data.

Take a look at this conversation between a banker and her customer:

1 of 7

2 of 7

3 of 7

4 of 7

5 of 7

6 of 7

7 of 7

Now, what makes it OK in the context of Health Care? Think about it.

1 of 7

2 of 7

3 of 7

4 of 7

5 of 7

6 of 7

7 of 7

Medtronic partners with Ford for SYNC-enabled in-car blood glucose monitoring.

2011-05-19T22:07:00.000-07:00

This is very cool. Medtronic and Ford are collaborating to bring health connectivity to Ford cars equipped with Microsoft SYNC.

I can't wait for this technology to be available to patients with implantable defibrillators (ICDs). Maybe one day the system could recognize an ongoing dangerous arrhythmia and slow down or stop the car to prevent an accident.

Watch:

Quantified Self and ICDs

2011-05-15T12:02:00.000-07:00

Watch this brief interview with Gary Wolf, co-founder of Quantified Self and contributing editor at Wired Magazine, where he discusses how self tracking can hold the key to unparalleled insight into self-improvement and personal efficiency.

Self tracking is also critical to people living with heart failure, diabetes and other chronic conditions. It has the potential to keep us out of the hospital.

Unfortunately, patients living with ICDs, pacemakers and other cardiac implantable electronic devices have no access to the massive amounts of data collected by their active implants. Such data, generally collected remotely by a device’s manufacturer, is in part made available to clinicians but never to the patient who originates it.

“There’s a feeling among technical people, and I think it’s spreading, that it would be good to seize the tools of information production and at least know as much about ourselves as other people do”, he says.

Watch:

The first Quantified Self Conference happens in two weeks, May 28-29, 2011, at the Computer History Museum in Mountain View, CA.

Register here.

Dear DrWes (What they do not know)

2011-04-06T18:05:00.000-07:00

Earlier today, DrWes wrote of his indignation over attending a cardiology conference where attendees wore badges outfitted with RFID tags. He wondered what the organizers knew about him and if he’d still get credit for the sessions he walked out early on.

Given that RFID is a technology once limited to tracking cattle, I can see how offensive it could be to use it to track cardiologists. But I digress.

Here’s my response to the post:

DrWes,

I see your frustration, but you don't have my sympathy.

I live in a world where an electronic device implanted in my chest counts my every heart beat, tracks my physical activity, looks at the build up of fluid in my chest, knows my implant date, and even the dates of visits to my EP’s office. It also tracks its own performance and the possibility of its malfunction.

Yet it shares none of this information with me, the originator of the data and its rightful owner.

But wait, it doesn't stop here. The implantable device is wirelessly connected to a proprietary, closed network created and run by the same people who built it. And in addition to my data “they” also track data collected from half a million other people like me.

Furthermore, the manufacturer has unrestricted access to all of this data and can use it however it sees fit. For example, it can look at how the leads of my ICD are performing in comparison to similar models implanted in other people and make adjustments or improvements to their product line based on this valuable information.

No one ever asked me if I’d like “opt out” of sharing this data with the corporation who sold me the gadget. And yet I am kept out of the loop and in the dark. (Sure, they’ll humor my occasional request for a print out just to shut me up. But that's far from enough in my view.)

Such is my world. I'm sure you’ll agree it is, in some ways, like roaming the conference rooms of 2011 ACC not knowing how your RFID data will be used. But one thing can be said about remote patient monitoring. It sure seems a lot more like remote patient surveillance, doesn’t it?

Hugo Campos
ICD User Group

Are cardiologists from UMC of Southern Nevada taking payments to use Biotronik devices?

2011-04-05T01:39:00.000-07:00

That’s what Nevada state officials are trying to determine. It’s perfectly legal for physicians to take consulting fees from a device manufacturer, but it sure can look suspicious when a patient ends up getting a device made by the company that’s been paying his doctor a monthly fee. A pacemaker or implantable defibrillator can cost up to $35,000.

A recent New York Times article alleges that cardiologists from UMC of Southern Nevada took money from Biotronik to use the company’s medical devices. According to the paper, 95 percent of last year’s implants at UMC were Biotronik devices. In contrast, Biotronik has an estimated 5 percent share of the US market for pacemakers and implantable defibrillators.

Earlier this year, St. Jude Medical agreed to pay $16 million to settle allegations that the company paid kickbacks to doctors who implanted its heart devices in patients.

Watch the report by a Las Vegas NBC affiliate:

(Here’s a link to AdvaMed’s Code of Ethics as mentioned above.)

WATCH: Unboxing a Medtronic CareLink Monitor

2010-11-17T21:05:00.000-08:00

This home video of a patient unboxing his newly-arrived Medtronic CareLink Home Monitor is as thrilling as the product he’s about to unveil. It’s also a perfect example of how medical device companies design their products without much consideration to patient experience. Health care products are often made to be doctor-centric, procedure-centric, or institution-centric. Hardly ever patient-centric.

If you’re unfamiliar with home monitoring, it allows for patients to send data from their pacemakers or ICDs over a phone line for a doctor to review. The data transmitted is available to the clinic, the manufacturer, and in some cases even to a third-party contractor. However, it’s not available electronically to patients, even though it is technically ours. If you’ve been to this blog before, you probably already know how I feel about this.

WATCH:

The patient’s commentary is priceless. Here’s how he describes what he finds in the box:

“Oh, a telephone cord. Not a USB cord, a telephone cord.”

“It looks like a telephone answering machine.”

“There’s a switch here for tone or pulse, depending on which type of phone you have. I don’t have either kind.”

And how he expresses his disappointment, after reading about data transmission:

“That doesn’t sound very interesting. I’d like to see it printing on my own screen or something. That would be nice.”

Yes, I agree. Giving us access to data that is rightfully ours would indeed be very nice, if not the right thing to do.

Unfortunately, Medtronic and other ICD and pacemaker manufacturers don’t see it this way. Dr. Marshall Stanton, VP of Clinical Research at Medtronic’s Cardiac and Vascular Group said at USC’s Body Computing Conference in 2009 that they’re not in the business of providing data to patients. Information collected by the device is only valuable to physicians, and that patients do not wish to see it on a regular basis. Watch Dr. Stanton here (links to YouTube).

I disagree. If you believe, as I do, that outcomes matter and that an empowered patient population will become healthier, manufacturers must share this data with patients in a way that it can be used to change behavior and improve our quality of life and health outcomes.

Above: Medtronic’s CareLink Home Monitoring system next to its cellular accessory (M-Link), introduced earlier this year. The grey contraption with its many wires and boxy companion is not the most attractive thing you can have on your nightstand. And for as long as patients remain excluded from the data loop, it is certainly a sight you’ll not find in my home.

Medtronic offers sneak peek of leadless pacemaker.

2010-10-29T22:41:00.000-07:00

We had heard of Medtronic’s plans to develop a leadless pacemaker, but the company had been tight-lipped about it until yesterday, when Dr. Stephen Oesterle, Senior VP for Medicine and Technology, revealed the minuscule device during a talk at TEDMED 2010 in San Diego.

The idea of a totally self-contained intracardiac pacemaker is not new. It was first published in the Journal of Electrocardiology in 1970. But it's become recently viable due to advances in battery technology and circuit miniaturization. The tiny device, shown here by Dr. Oesterle, is delivered directly into the patient’s right ventricle through a catheter.

Here are some of the advantages of a totally self-contained intracardiac pacemaker:

It’s a less invasive system. No surgery is required, thus carrying a lower risk of infection.

It’s simpler to implant, potentially exposing the patient to less radiation during implant. (It is implanted through the femoral vein.)

Fewer acute and chronic complications (such as infection and skin erosion).

Better patient aesthetics, since no surgical pocket is needed for the generator.

Lower cost and reduced length of hospital stay.

And best of all, there are no leads to fail. Leads are—arguably—the weakest link in a permanent pacing system.

And its disadvantages:

Larger diameter catheters are needed for implantation (increased risk).

Multiple-chamber pacing is more complex.

There are longevity limitations.

It's difficult to be explanted or repositioned.

Must be abandoned at end of service (instead of replaced)

Another potentially serious adverse event is the possibility of device dislodgement and its escape into the circulatory system.

Mobile connectivity.

Now here comes the even better part of the story. The device will be capable of communicating wirelessly with a nearby smartphone.

This signals the direction we’re heading regarding connectivity where data can be gathered by the device and be communicated to a smartphone for either the patient or the physician to act upon as needed.

It might still be three to five years before the leadless pacemaker hits the U.S. market, assuming it gets FDA approval and achieves market accceptance. But it represents, in my view, a significant step in the right direction.

One thing is for sure: it looks like Medtronic might be listening when we ask for real-time access to the data in our implantable devices.

Design we can all live with.

2010-09-29T12:36:00.000-07:00

Creating a Patient-Centered Future for Health Care.

Read more on Fast Company’s Co. Design and on Worrell’s NEW Magazine here.

Infographic: ICDs at a Glance

2010-09-17T08:05:00.000-07:00

Do you know how many ICDs were implanted from 2006 to 2009? How about how many patients were women, black, or were implanted with a single-lead device? Curious? Than this infographic is for you. It was created based on data published by the Heart Rhythm Society in September 2010. Take a look.

A PDF of the full report, “Review of the Registry's Fourth Year, Incorporating Lead Data and Pediatric ICD Procedures, and Use as a National Performance Measure,” can be dowloaded here.

This blog’s cloud tag

2010-09-12T14:49:00.000-07:00

Here’s what this blog’s word cloud tag looks like (according to Wordle, a self-described “toy for generating word clouds from text that you provide”).

Wouldn’t you say I stay on topic most of the time?

Access to the data in my ICD would save me money. I want it now.

2010-09-07T11:50:00.000-07:00

Believe it or not, up until the 1960s, the VW Beetle had no fuel gauge. If you were fortunate enough to own one of those popular German automobiles, you knew that making regular stops at gas stations made a lot of sense if you wanted to lessen your chances of getting stranded on the side of the road.

The dashboard of a 1965 VW Beetle with no fuel gauge. Photo from here.

Today, a person living with a modern implantable cardioverter defibrillator (ICD) has as much up-to-date information about his device as the driver of a ’65 Beetle had about his vehicle’s fuel level 50 years ago. Patients must rely on regular (and costly) stops to an electrophysiologist’s office to ensure they won’t suddenly find themselves by the side of the road.

It begs the question:

Why should physicians be the only ones with the keys to such useful and vital information?

They shouldn’t—particularly as health care becomes more participatory and more and more patients demand to be in the driver’s seat when it comes to their health.

During the most recent visit to my EP’s office, the doctor checked my device, told me all was well, and sent me home with a $445 bill. (My insurance later adjusted it by $140, dropping it to the amount I now owe the clinic: $305.)

Ever since getting the ICD almost three years ago, I’ve been making regular visits to the EP’s office every four to six months. It adds up.

Like the driver of a ’65 Beetle who frets about running out of gas, I long for the day when my ICD will warn me by SMS, instant message or email of an impending peril.

Paying hundreds of dollars for unnecessary visits to my doctor is like paying for visits to the mechanic whether you need him or not. You would be just as unhappy if all he did was reassure you that the car was fine and sent you home with a bill for $400.

Today, most ICDs can be monitored remotely by the manufacturer and the doctor’s clinic. But the data collected by the device is not available to the single most important stakeholder in this equation: the patient.

All I’m asking for is to take on some of the responsibility for monitoring my own device. More access means improved health outcomes and better quality of life. But it also means keeping more money in my pocket.

Me, age 5, next to my parents' late sixties VW Beetle. Photo taken in 1971.

Dr. Saxon: Patients deserve their data.

2010-08-26T19:22:00.000-07:00

Here’s a point of view you don’t usually hear from cardiologists.

In this TEDxUSC talk, Dr. Leslie Saxon, Chief of Cardiovascular Medicine and Professor of Clinical Medicine at the University of Southern California, advocates for a patient’s right to access the data stored in their implantable cardioverter defibrillators (ICDs).

(SCROLL DOWN FOR THE VIDEO)

The modern ICD—which, according to Dr. Saxon, can cost upwards of $35,000—is a sophisticated electronic device that is implanted under the skin of patients that are at risk of sudden death due to ventricular fibrillation. It can achieve a survival rate of 99%. Without a defibrillator (implanted or external), a victim’s chance of survival is reduced to 2%.

Among many other features, the ICD can record and store intracardiac electrograms and allow for the data to be remotely accessed by the physician. However, such data remains largely out of reach of patients.

Almost every time I bring this up with a doctor or EP nurse, I get the question: “But what would you do with this data if you had access to it?”

Plenty. It’s about having all the tools at my disposal to have as much control over my chronic condition as possible. Knowledge is power and a patient privy to this knowledge is an empowered patient. It’s only when we can access our data, share it and compare it with data from fellow ICD patients that we’ll be able to know how it can benefit us individually. And it will.

Dr. Saxon predicts a future with a health care ecosystem that plays into other ecosystems already existing in the popular culture. Only then we can really liberate health care, destigmatize it and improve patient outcomes.

As Dr. Saxon puts it, it’s about creating “the consumer of the future, the sophisticated health care consumer who’s going to partner with their doctor in their health care.”

“Patients deserve their data,” says Dr. Saxon. “Patients want their data on demand. They’re demanding it, and patients should have it.”

Bravo!

WATCH:

Image from here.

When your ICD’s reed switch fails.

2010-07-30T18:30:00.000-07:00

But first, what’s a reed switch?

Implantable defibrillators have a built-in tiny reed switch that is activated whenever a magnet is placed over the device. The presence of a magnetic field near the reed switch causes it to close and tells the device to temporarily suspend tachycardia detection and therapy.

For as long as the magnet is over the device, no shocks are delivered to the patient in case of ventricular tachycardia (VT) or fibrillation (VF). Once the magnet is removed, the switch opens again, restoring the device’s ability to deliver shocks.

This is a particularly useful feature during surgical procedures where electrocautery is used. Electrocautery and certain other types of surgical tools may cause the ICD to deliver unnecessary shocks due to oversensing.

Figure: magnetic reed switch.

The bad news:

Last week, Boston Scientific announced that the reed switch in some of their ICDs might get permanently stuck. It goes without saying that a jammed reed switch in your ICD would not be good, since it would preclude the delivery of potentially life-saving shocks.

Boston Scientific says that the affected ICDs were manufactured during 2006 and 2007 and include the CONTAK RENEWAL models 3 and 4, and the VITALITY DR HE. Affected devices are no longer available for implant, but there are still about 34,000 people out there with these devices.

To know if you have one of these devices, go to Boston Scientific’s online “Device Lookup Tool” and enter your device’s model and serial numbers. These numbers can be found in your medical device ID card.

Boston Scientific says that the risk of harm is remote and that no deaths or injuries have been reported. A PDF of this current advisory can be downloaded here.

Now, the good news:

Boston Scientific ICDs (and CRT-Ds) can be programmed to recognize a magnet or to ignore it altogether. So, in the unlikely event that your device’s reed switch gets stuck, your doctor can program the ICD to ignore the defective switch and the device will no longer inhibit tachycardia therapy.

Also, it’s good to know that the ICD will emit audible tones (synchronized to your heart beat) whenever the reed switch is closed or in the event it needs to tell you something is wrong. So, if the device is beeping, have it checked out right away.

More information, including copies of the letters to physicians and patients can be viewed and downloaded from the Heart Rhythm Society's web site.

Image from here.

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 ICD 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. Yes, I have it. It’s fantastic!)

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:

Listen to Low alert or high alert.

Alternating High/Low or On/Off tones:

You should contact your physician if you hear this tone.

Listen to 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.

WATCH: ICD saves life of Belgium soccer player.

2009-06-12T21:53:00.000-07:00

I don’t know how much explaining is necessary here. This amazing video says it all.

In the clip, Anthony Van Loo, a 20-year old Belgium soccer player collapses during a match and is resuscitated by his Implantable Cardioverter Defibrillator (ICD). The device delivers a shock to restore his heart rhythm.

Most of the press has been reporting the incident as a heart attack. This is not accurate. Instead, Van Loo must have suffered what is called an “arrhythmia”. Arrhythmias are disturbances in the normal heart rate and electrical rhythm, and are usually life-threatening. Two of the most dangerous types of arrhythmia are called Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF). Such abnormally fast heart rhythms prevent the heart from pumping blood to the brain, resulting in loss of consciousness. If left untreated, these dangerous rhythms will deteriorate into a cardiac arrest. Read about the difference between cardiac arrest and heart attack.

According to this Time story (Saving Athletes from Cardiac Arrest, by Carolyn Sayre), “Sudden Cardiac Arrest [...] affects more than 400,000 people in the U.S. and is the leading cause of death in competitive athletes.”

Van Loo is known to suffer from an unspecified heart condition that makes him susceptible to life-threatening arrhythmias. He’s been allowed to return to playing soccer after the implantation of an ICD.

I'm sure glad I have an ICD. Truly amazing stuff!

How is cardiac arrest different than a heart attack?

2009-06-12T19:16:00.001-07:00

A lot of people confuse the two.

Heart Attack: Think of it as a “plumbing” problem.

It is a circulatory problem in the heart that causes one or more of the arteries delivering blood to the heart muscle to get blocked. Without oxygen, the muscle becomes damaged and dies.

Sudden Cardiac Arrest: Think of it as an “electrical” problem.

A Sudden Cardiac Arrest is usually caused when the heart’s lower chambers suddenly develop a rapid, irregular rhythm causing the ventricles to quiver rather than contract. This prevents the heart from pumping blood effectively and the supply of blood to the brain is compromised.

MP3 player headphones can cause potentially dangerous interactions with pacemakers and ICDs.

2009-05-15T07:30:00.000-07:00

This topic has been widely reported in the press since late last year when Dr. William Maisel of Beth Israel Medical Center in Boston revealed the findings of his study. Even CNN covered it.

But I just came across this video and thought it would be good to post it here.

Dr. Maisel and his team of researchers found a detectable interference with the device by the headphones in 14 of the 60 patients studied (23%). They observed that 15 percent of the pacemaker patients and 30 percent of the defibrillator patients had a magnet response.

For pacemakers, this means that the device inappropriately paced the heart without regard to the patient's underlying heart rhythm. For implantable defibrillators, this means that the ICD's antitacnycardia therapy was temporarily suspended due to the presence of the magnet.

My journey from patient to consumer of health care.

2009-03-19T20:42:00.000-07:00

I was only six years old when, on a chilly December morning, I watched my grandmother casually wander into the bathroom for a shower. That was the last time I saw her alive. She was 66.

Almost four decades have passed and the image of my father and step-grandfather violently breaking down the door and carrying out her naked body into the light has remained vivid in my memory. We never knew for sure what took her life.

As a kid, I learned to get used to my heart skipping a beat or speeding up for no apparent reason. I knew that if I would stop just for a moment and wait, the discomfort would go away. Palpitations were quite frequent and I assumed other kids had them too. As an adult, I often thought they were a sign of an unbalanced diet, or the result of too much caffeine and stress.

But then, at 37, I passed out after running up a flight of stairs to catch a commuter train. My heart had gone faster to keep up with my body’s demand for oxygen but had failed to slow down after I stopped running. It just continued to beat faster and faster. I fainted on the platform that day and missed my train.

This is where the scariest chapter of my life begins. After that syncope, and a year of misdiagnoses, I was finally told I suffered from a somewhat common type of genetic heart disease: Hypertrophic Cardiomyopathy.

HCM afflicts 1 in 500 people worldwide, and may cause the heart to develop a deadly arrhythmia, resulting in sudden death. The Hypertrophic Cardiomyopathy Association, HCMA, says on their Web site that nearly 50% of all cases on file are of patients who lived with improper diagnoses for many years.

My first cardiologist suspected mitral valve prolapse (MVP), and my second one never told me I was at risk of sudden death. Per the latter’s advice, I resumed my life as before, unaware of the serious risks. I had to suffer two additional syncopes before I decided that I needed to take matters into my own hands, educate myself about my condition, and seek the care of an HCM specialist. And in my quest, I turned to the Internet for help.

According to iCrossing, a global digital marketing company based in Arizona, 59% of adults use online resources to obtain health information, versus 55% who rely on their doctors. Their study “How America Searches: Health & Wellness” (January 2008) indicates that the Internet has for the first time, ranked ahead of doctors as the number one source of health- and wellness-related information.

But most importantly, the study revealed that social media are increasingly relevant to health and wellness, with 34% of health searchers using Wikipedia, online forums and message boards to delve into health-related topics.

It’s a radical finding: patients aren’t learning from their doctors or even from Web sites as much any more. Patients are learning from each other.

In my experience, as soon as I realized my doctors weren’t giving me the answers I sought, I joined the HCMA online community and got plenty of answers from a network of patients like me. It was the beginning of my transformation from patient to consumer of health care.

After changing doctors and receiving an implanted cardioverter defibrillator (ICD), I joined two other patients and created a local support group. The Bay Area ICD User Group's mission is to educate patients on ICDs and ICD therapy, address concerns and questions, facilitate improved communication with our doctors, and to serve as a network for sharing experiences.

Today, I no longer think of myself as a lonely patient. I have become an empowered medical consumer who finds comfort, validation, and knowledge in the experiences of others like me. I have also learned to embrace my heart disease. It has given me the opportunity to better myself and to meet many wonderful people along the way.

I now realize that my grandmother’s sudden death was likely due to an undiagnosed cardiomyopathy—perhaps HCM. All we knew back then was that Grandma Lourdes had an “unusually large heart.” But as a kid, I always knew that.

Above, from right, grandma Lourdes, me (age 6), mom, and a friend.

Sprint Fidelis Leads Linked to 13 Deaths

2009-03-14T11:45:00.000-07:00

Medtronic has acknowledged that 13 people may have died in connection with the Sprint Fidelis lead.

Sprint Fidelis Defibrillator leads were approved by the FDA in 2004 and manufactured for a little over 3 years, from September of that year to October 2007. In early 2007, it was reported that the leads might have been fracturing at a higher rate than Medtronic's other leads. This eventually lead to a recall.

The New York Times reports that about 150,000 in this country still have the Sprint Fidelis lead. This number includes members of our local ICD group.

A fractured lead can cause a patient's death if it precludes the ICD from detecting a dangerous arrhythmia, thus preventing it from delivering a lifesaving shock. It can also cause the ICD to fire for no reason, delivering an unnecessary shock.

Full NY Times article here.

New study on longevity finds that Medtronic ICDs are superior.

2009-01-14T22:40:00.000-08:00

From time to time the question of who makes the best ICD comes around (even if I’m the one bringing it up). But since there are few comparative studies among ICDs of different manufacturers, the answer is not an easy one.

Luckily, a study published by Europace late last year (Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems) helps shed some light on the topic of longevity.

A team of doctors in Bologna, Italy, looked into the longevity of Medtronic, Guidant and St. Jude Medical devices implanted from 1/1/2000 to 12/31/2002, a 3 year period.

They found that, under comparable conditions, Medtronic ICDs outlasted Guidant and St. Jude Medical devices, with replacement rates being, respectively, 42%, 95.3%, and 97.2%.

At the end of the follow-up period (12/31/07), 56 of 57 (97.2%) St. Jude Medical, 41 of 43 (95.3%) Guidant, and 10 of 24 (42%) Medtronic devices had been replaced. Among these 124 patients, 17 still had the device in service: 11 single-chamber ICDs (8 MDT, 2 GDT, 1 SJM), 2 dual-chamber ICDs (MDT), and 4 CRT-D (MDT).

At the time the study was done, St. Jude Medical and Guidant used Wilson Greatbatch batteries, while Medtronic devices had their own proprietary batteries.

Device longevity is a big deal to us, patients, since it translates into fewer replacements and a lower risk of complications. Longevity also has a significant impact on the cost per service life of an ICD. In other words, the up-front cost of a device is of limited value when estimating its long-term cost-effectiveness.

From a total of 153 patients:

80 received a single chamber ICD (1 lead)
59 received a dual-chamber ICD (2 leads)
14 received CRT-D devices (3 leads)

The bottom line? Medtronic ICDs last longer.

But I do have to wonder if the newer Boston Scientific devices COGNIS and TELIGEN with proprietary battery technology would have given the Medtronic devices a run for their money.

HCM patients with Blue Cross Blue Shield coverage in danger of loss of access to HCM center in Boston.

2009-01-08T09:38:00.000-08:00

This news does not directly affect us in California, but it's a big deal to our HCM friends who are treated at the Hypertrophic Cardiomyopathy (HCM) clinic at Tufts Medical Center in Boston, MA.

The HCM Center at Tufts Medical Center is the first such treatment and research facility in the Northeast. It provides patients and their families with comprehensive, multidisciplinary treatment for this genetic heart disease that affects 1 in 500 people. Sudden cardiac death (SDC) due to HCM is a tragic complication of this disease and ICDs are an effective treatment to prevent SCD in select patients. The risk of sudden cardiac death ranges between 1-5% per year.

On January 31, 2009 Tufts Medical Center's contract with Blue Cross Blue Shield of Massachusetts (BCBSMA) will expire (read the news coverage here).

This means that those patients with procedures already planned will have a grace period of between 30 and 90 days to complete care. However, after that, their plan will no longer cover Tufts as a network provider. Patients with HMO coverage will not be permitted to go to Tufts and those with PPOs and other plans will be viewed as out of network.

Whether you personally have BCBSMA or use the services of Tufts should not matter. We all must speak out about this issue. Write to BCBSMA to urge them to negotiate in good faith and for the benefit of their patients. Your community, your family, your HCMA friends need your support now.

Watch this important message from Lisa Salberg, president of the Hypertophic Cardiomyopathy Association (HCMA).

Act now! The HCMA is asking everyone to write to grievances@bcbsma.com. You may use this sample letter:

To: Blue Cross Blue Shield of Massachusetts

I am a supporter of Tufts Medical Center and I value the hospital and its physicians as high-quality, efficient providers of excellent medical care. I was surprised and dismayed to learn that Blue Cross Blue Shield of Massachusetts is not paying reasonable rates for the services of these important health care providers at Tufts Medical Center and Floating Hospital for Children.

I believe this is unfair. I hope Blue Cross realizes that it must provide Tufts and its physicians, fair and reasonable reimbursements so that they can continue to offer expert care, as they have for over 200 years.

I strongly urge Blue Cross Blue Shield of Massachusetts to offer Tufts Medical and its physicians a reasonable rate increase and to resolve this issue as soon as possible.

Sincerely,
NAME HERE

Please take a moment to urge BCBSMA to negotiate in good faith and for the benefit of their patients. Tufts Medical Center and Floating Children's Hospital are a top rated, high quality system with a proven track record of cost effective health care, and one of only 17 programs nationally with a specialized HCM program.

Time for fresh beginnings

2008-12-31T11:46:00.000-08:00

Another year is heading for the history books. It was quite a year too, even with all the great things that happened (yes we can!) honestly, I am ready to see it go. And I am ready to shake off the remnants of last year that are holding me back and start fresh with a new year and a new outlook.

I took a trip to the Mendocino coast. I have never seen an ugly day here. It doesn't matter if it is sunny and warm, or foggy and overcast, this area sings to my soul. I spent three days either sitting in a hot tub or by the fire, looking at the ocean or listening to it at night. No phones, no cell phone service and no TV. Just time to think.

I have mentioned before in other posts how our group has grown over this past year. It is amazing and wonderful. I have made some friends that I know I will never want to lose track of. I have learned some things that frankly sort of scare me. But mostly I think I have learned one thing, my heart disease is not going to hold me back. It may slow me down a little. It is not going to make my life any easier, but it isn't really making it harder... just different.

I have plans for this year that include getting back into scuba diving, losing the holiday weight I put on and who knows, maybe even climbing up the stairs without worrying about passing out. But mostly, I want to go six months without seeing a doctor. No offense to my wonderful medical teams, but I just saw way too much of them last year.

I am also hoping to see this group grow. We have three bloggers now from our group and we have made some great connections with local clinics that should see more people at the meetings. Kaiser is working with us to get us a place to meet in the south bay and we are continuing to secure east bay sites.

Our plans are simple, continue to meet on the second Saturday of each month at rotating location around the bay. We will also build on the relationships we have made with Bay Area heart centers and other support and education groups.

While we are a local focused group, we will also always have our extended online family at the icdsupportgroup.com. That group has members from all over the world and is growing rapidly everyday.

If you have been thinking about joining us for a meeting, this up coming year is the time to do it. Hope to see you soon and Happy New Year to the wired and the un-wired alike.

So, what is your group going to be?

2008-12-15T18:06:00.000-08:00

Over the past year, we have been asked this quite a bit. It always sort of throws me. We didn’t really start this group with a grand plan. We were really just a few people going through the same thing that wanted to get together and talk.

That first meeting was just supposed to be for lunch, but three hours later, we finally parted ways. We had so much to talk about and it just felt good to talk to people going through the same thing. I think we knew then that we were on to something. Back then we couldn’t find any groups for ICD patients. So, after finding each other in an online forum, we decided to start our own.

Since then we have found many great people, some other groups and have gotten lots of support from clinics and hospitals in the area. But still the question keeps coming up, what are we going to be? We discussed it at a few of our meeting with no real decision. But this weekend, at our December meeting, we finally came to agreement.

It was funny how it happened, I asked the question and we began discussing ideas, then suddenly we ended up in several small conversations all talking about what was coming up, what we were going through and what the device companies are developing. Sitting back listening to snippets here and there was amazing. Just then, another member spoke up and pointed out that this is what we want to be… simply a place that anyone can come and talk about anything related to having an ICD.

It sounds so simple, but it just isn’t out there. Other groups have hosted events and have guest speakers to give presentations and doctors will continue to want to talk to us but no one out there is just letting us talk to each other. Every conference and “support” meeting we have found outside of our own spent a good deal of time talking to us about what we are going through. At our meetings, we do quick introductions, get things started with a topic or two and by then, it is a chat session, sometimes to the whole group, sometimes to each other in small groups. But it never fails that we end up spending two or three hours just talking.

As a group, we will also continue to answer email questions or talk on the phone, learn everything we can about this technology and when asked we will visit anyone in the hospital who wants us there. The one thing we have that all the doctors and experts don’t have is real first hand knowledge of what it feels like to live with these devises and we are happy to share it… or just listen while a new member talks.

That is where our group stands out. We are just going to be a place people can come to talk.

Stanford — Patient ICD Day Report

2008-12-07T21:13:00.000-08:00

Sorry I’ve been slow to post this. But here it is. Jennifer McNulty was kind enough to let us post her very detailed notes and fabulous report on last month’s Stanford Patient ICD Day. Thank you so much Jennifer! We really appreciate it.
–Hugo

(PS: Jennifer notes that this report has been reviewed by Drs. Sears, Hsia, Vagelos, and Linda Ottoboni of Stanford.)

Patient ICD Day offers strategies for coping with psychological burdens of heart disease

For the first time in history, patients are living with heart disease, presenting both a privilege and a burden, particularly for about 95,000 patients who are living with an Implantable Cardioverter Defibrillator (ICD).

That was the picture painted Friday, during a Stanford Patient ICD Day that drew about 125 people to the Sheraton Hotel in Palo Alto, where they heard from medical experts, an ICD patient, and from Dr. Samuel Sears, the leading expert on the psychological aspects of living with an ICD.

The first speaker of the day, Sears discussed the "special knowledge" ICD patients gain through hardship.

"You have some unique stressors. There’s universal understanding that heart problems can be scary," said Sears, a nationally recognized expert in the psychological needs of ICD patients. "Those fear factors can play into your thoughts. It requires some psychological fitness training."

Experiencing shock distinguishes ICD patients from other patients, and it is "universally stressful," acknowledged Sears.

Sears expressed deep respect and admiration for ICD patients. "I have a tremendous window on your life," said Sears, a professor of health psychology at East Carolina University in Greenville, North Carolina. "You’re the first generation to have to live with heart disease."

The television show Survivor is popular, he said, because viewers get a front-row seat to watch people cope with adversity. "But the real survivors are in this room," he said. "You’ve overcome threats and challenges. You’re the ones who’ve earned the show’s motto—‘outwit, outplay, outlast.’"

Sears and other speakers emphasized the life-saving nature of ICDs, which numerous studies confirm are the most successful treatment for patients suffering arrhythmias. Yet life with an ICD presents unique challenges that require adjustments, said Sears, who discussed his work helping patients make the shift "from victimhood to survivorship."

The ICD is a "magnificent invention that saves lives better than anything else we have, and one of the challenges is to believe in the device," he said. "It’s a modern-day challenge. You’re the first generation trying to do it."

"Coping requires a menu of strategies—there’s no formula," said Sears, noting that the "more strategies means more success."

ICD patients who adopt stress-management strategies enjoy clear benefits, including lower anxiety, said Sears, whose most recent research results were published in the July 2007 issue of PACE.

"My purpose today is to increase your confidence in your ICD," said Sears, who challenged patients to "add one new strategy" that will help them achieve a high quality of life.

Sears described his role as a patient advocate by saying he helps people "encounter the threats of heart disease" and sort through what they need to change, what they need to accept, and "to try not to mix up the piles."

Heart disease "takes some things away from you," including your innocence about the health care system, said Sears. Living with an ICD forces patients to make changes and ties them to a regimen of medications, doctor appointments, dietary awareness, and specific strategies designed to manage arrhythmias.

Those suffering from what Sears described as a "victim" mindset tend to focus on what they’ve lost. "They emphasize how difficult it is, their desire to go back to life the way it was before their illness," said Sears, adding that they also feel walled off from others who they’re certain can’t understand what they’re going through.

By contrast, patients who make the shift to survival emphasize a positive, future-oriented outlook, said Sears. "They say, ‘I don’t want to lose any more,’" said Sears. "They engage others in their quest."

Yet Sears acknowledged that "nobody can be a survivor every minute of every day."

"I’m okay with negative emotions. They’re part of the process," he said, as long as patients remain on a positive trajectory.

Grieving one’s losses is part of moving toward acceptance and cultivating a positive attitude about life, said Sears, who encouraged patients to identify the precious—and often fleeting—moments that make them grateful to be alive.

"What are the moments you’re glad to be here? What are those moments for you, and who in your life is there with you? Recognizing the value of those moments—that’s the special knowledge," said Sears.

Identifying one’s "lifelines" is another step toward survival, according to Sears. Lifelines may include a patient’s health care team, family members, and a support group.

Referring to another television show, Who Wants to Be a Millionaire?, Sears emphasized the importance of multiple lifelines. "Most of you have one perfect lifeline—a spouse, partner, loved one, parent, or adult child, but to be on the show, you have to have five lifelines," said Sears. Patients need three or more people with whom to share their emotions, he said.

"I know three people is a lot," said Sears, quipping that he couldn’t find three people to help him move a couch recently. But the challenge is to be "more deliberate about providing and receiving support."

Similarly, Sears urged patients to figure out what they love to do and "build it into your life. Quality of life is an achievement, not an entitlement."

Activities of pleasure, mastery, and responsibility can be rewarding, distracting, and replenishing—although they are not necessarily how we spend our time.

"Coping with heart disease can lead you to be disengaged," said Sears, who urged patients to reengage with people and activities that matter to them. "Disengaging stacks the deck against you for quality of life," he said, noting that often people aren’t sure what they like to do.

"No amount of medical care can tell you that, but knowledge is power," said Sears. "Know your condition and know your device. Many patients tell us they feel privileged to be around this device, but it’s also intimidating. The more you learn, the more confident you become."

Sears urged ICD patients to get to know their health care team, the manufacturer of their device and its capabilities, and to seek emotional comfort from other patients, support groups, and web sites.

One of the most common side effects for ICD patients is second-guessing their decision to have the device implanted, said Sears. "It’s a leap of faith," he said. But studies comparing the outcomes of ICD patients and those whose arrhythmias are treated with medication are definitive: "Devices save lives better than medication," said Sears. "That knowledge builds confidence."

Quality of life is at least as good for patients with ICDs as for those whose conditions are managed only with medication, said Sears, who urged patients to seek the information and stress-management strategies that will give them the confidence to live their lives to the fullest.

ICD patients face ever-present reminders of their own mortality, from the device itself and the potential of being shocked to the actual experience of being shocked. Such reminders can produce fury and resentment, as they did for one patient Sears described. That patient eventually made peace with his situation and came to experience such reminders as "love reminders" that help reinforce his will to live.

Stress-management strategies include deep breathing, various relaxation techniques, imagery, and focusing on life’s special moments. "And they really are just moments," he said. "It’s those moments that matter, that make taking your medicine and going to doctor appointments worth it."

Linda Ottoboni, the arrhythmia nursing clinical coordinator at Stanford University, echoed Sears’s remarks when she introduced the session called "Surviving Therapy and Confronting One’s Mortality." While health care providers view each successful shock as cause for celebration, the experience of being shocked makes patients feel acutely vulnerable. "It’s the elephant that sits in the room," she said.

A patient’s perspective

The patient’s perspective was presented by Hugo Campos, 42, who described his own journey "from being a healthy person to dealing with cardiomyopathy and having an ICD," which included depression, anxiety, and terror.

Campos has hypertrophic cardiomyopathy (HCM). He received an ICD last November and describes his approach to "living with adversity" as proactive. "I’m crazy about learning as much as I can," he said. But it hasn’t always been that way.

Following fainting episodes at age 11 and age 37, and years of frequent heart palpitations, Campos was misdiagnosed twice—first with vasovagal syncopy and then with mitral valve prolapse. When he was ultimately diagnosed with hypertrophic cardiomyopathy, his doctor reassured him that it was "not the dangerous form." But a third fainting episode, at age 40, scared him. Campos turned to the Internet, where he learned about the Hypertrophic Cardiomyopathy Center at Stanford University.

"That’s when I learned that I had three of five risk factors for sudden cardiac arrest," recalled Campos, whose doctors recommended an ICD. "I had three days to research the three manufacturers of ICDs. I wanted to be a stakeholder."

Following the implant, Campos was devastated. "I went home to depression and anxiety, which I was completely unprepared for," he said. Waking up in tears at night, Campos recalled touching his chest, feeling the ICD, and asking himself what he'd allowed to be done. "It was awful," he recalled.

By communicating with other ICD patients, Campos realized that his feelings were common—"the universal reaction to the implant." Yet only three pages of the 130-page book published by ICD manufacturer Medtronic were devoted to the patient’s emotional adjustment, and that was limited to descriptions of the ICD as a "guardian angel."

"It would have helped to know it was okay to be frightened—about the device and the reason we have it," said Campos. "We all feel this way."

For Campos, an active member of the Bay Area ICD User Group, seeking information and support has helped him come to terms with the ICD. "It’s what works for me. It is how I cope," he said. "I just need a lot of information and knowledge to put me at ease."

Patting his chest, Campos said, "I’m taking this to the grave. It’s a matter of survival and commitment. Every time I feel it, it reminds me how serious I have to be about this. All I want is to be able to live a good life as well as I can, despite adversity."

The Bay Area ICD User Group meets every month on the second Saturday of the month. Campos’s presentation is available online.

During the discussion of mortality, Sears mentioned an article in the October 2008 edition of the Journal of the American Medical Association. The study, which explored whether it "help or hurt" to discuss death with patients, concluded there’s no evidence of harm—and some indication that patients experience more confidence, improved quality of life, and less invasive treatments if mortality is discussed, he said.

The statistics regarding sudden cardiac arrest (SCA) make a compelling case for ICDs, according to Sears: Without an ICD, only 5 percent of patients survive SCA; nearly 450,000 patients die each year. "Part of adjusting to heart disease is to not really think much about this part of the story," said Sears, who showed clips from a television program that aired this fall, highlighting the choices of two heart patients: One had an ICD implanted after suffering cardiac arrest, and the other chose to forego the procedure. He died the day after the interview was filmed.

Several ICD patients in the audience described their own experiences, including one man who has survived melanoma, lymphoma, two heart attacks and now has an ICD. Commiserating, Sears spoke directly to the man: "The truth is this is just flat hard. You’ve had things taken away. Very generally, when we lose things, there’s depression, the grief of loss, whereas anxiety is the fear of loss." Encouraging the man to engage his mind as actively as possible, Sears urged him to shift gears, use different strategies, surround himself with "good people," and be tolerant of all of his emotions.

Responding to an audience question about the appropriateness of ICDs for older patients, Sears said emphatically, "Age is not a reason not to get one." A forthcoming journal article presents compelling data on the benefits of ICDs for patients between in their 70s, 80s, and 90s, he said. An 86-year-old woman in the audience, diagnosed with cardiomyopathy 20 years ago, said she had a defibrillator implanted at age 83. "I’m still dancing," she said.

Minimizing therapy

In other presentations, Henry Hsia, an associate professor of cardiovascular medicine at Stanford University, discussed implant techniques and ICD therapy. Heart failure is on the rise and the relative risk of rhythm-related death is greater among ambulatory patients who are "relatively healthy" and living with cardiac dysfunction compared to those with severe heart-failure symptoms. Patients with ICDs represent a "relatively tiny" portion of the population that would benefit from prophylactic ICD protection, he said.

Hsia reiterated the life-saving role played by ICDs and emphasized their value compared to patients whose conditions are treated only with medication. He noted their relative cost-effectiveness, as well.

In a second talk, about minimizing ICD therapy, Hsia described the configuration of the devices and their role in the treatment of patients suffering from heart arrhythmias. Patients describe the experience of being shocked differently, from "discomfort" to "a kick in the chest," he said.

Minimizing therapy requires a three-pronged approach: Device-related strategies include monitoring leads and programming the ICD to deliver appropriate pacing and shocks, if necessary; arrhythmia-related strategies are designed to minimize the recurrence of heart rhythms that inappropriately trigger the ICD; and patient-related strategies focus on treating the underlying condition, whether the primary issue is a structural problem or an electrolyte problem.

Optimizing ICD programming can be daunting, noted Hsia. "We utilize probably only 30 percent of the available features," he said.

Optimizing medication to treat the underlying disease is important. "Amiodarone and beta blockers are the best combination to avoid shocks, but they might increase the energy required," he noted.

Surgical ablation can be a "tricky" but highly effective treatment, but it is very complex, said Hsia. "It’s a big surgery with significant risk," he said, noting that the technique was developed before the advent of defibrillators and not many surgeons perform the procedure. Catheter ablation is an alternative strategy, he said.

Optimizing cardiac function

Optimizing cardiac function was the topic of a talk by Randy Vagelos, a professor of medicine and medical director of the cardiac care unit at Stanford. About 5 million people in this country have congestive heart failure (CHF), an affliction that affects men and women in equal numbers, he said. About 550,000 new cases are reported each year; 10 out of every 1,000 patients are younger than 65 years old. CHF represents the single largest expense for Medicare, noted Vagelos. Only 4,000 patients receive a heart transplant each year.

Soaring rates of heart failure are attributable to a "perfect storm" of conditions: People are living longer, more sedentary, more overweight, and suffer from high rates of high blood pressure, diabetes, and left ventricular hypertrophy (LVH), said Vagelos.

LVH, a thickening of the wall of the left ventricle, predicts the onset of heart failure later in life, he said. Because LVH is correlated with high blood pressure, controlling blood pressure at a young age is key. "One heart attack increases the likelihood of heart failure subsequently," he noted.

Yet many patients don’t have symptoms, said Vagelos, noting a study that found that up to 70 percent of patients' conditions went undetected.

One study of the causes of hospital readmission for CHF patients found that nearly 50 percent of readmissions were attributed to dietary noncompliance (24 percent) or prescription noncompliance (24 percent), said Vagelos. "This is a real target for health care systems," he said. Other causes included failure to seek care (19 percent) and inappropriate medication (16 percent).

Dr. Paul Wang discusses Sudden Cardiac Arrest

2008-11-08T21:03:00.000-08:00

This is a very informative interview with Dr. Paul Wang, Director of the Stanford Cardiac Arrhythmia Service and Cardiac Electrophysiology Laboratory.

Part 1 of 3

Dr. Wang defines Sudden Cardiac Arrest, explains that chances of survival decrease by 10% at every minute defibrillation is delayed.

Part 2 of 3

Doctor Wang talks about Ejection Fraction, Ventricular Fibrillation, and the need for ICDs.

Part 3 of 3

In this final segment, Dr. Wang talks further about AEDs (Automated External Defibrillators) and ICDs (Implantable Cardioverter Defibrillators). He also explains that for every five patients who would benefit from an ICD, only one is implanted.

2008-10-23T22:28:00.000-07:00

Suitcase packed? Check

Work notified and time off approved? Check
Guess room set up for mom to visit during the recovery time? Check
Surprisingly large dust bunnies under the living room couch removed? Check

I have been running around trying to get ready for the pending surgery. My ICD has moved out of the pocket and is causing some issues and they are going in to fix it. While in there, they are going to pull that recalled lead and replace it with a new one.

I expect everything to go well, but as with any surgery that involves the heart, you would be silly not to get things in order before you go in. I have updated my will, I have my advance health care directives on file at the hospital and with my cardiologist and I have all my important papers in order for my family to find… just in case.

I have cleaned out my closets because that just needed to be done and I have stocked up on the dry goods and essentials so I don’t have to worry about grocery shopping while I can’t raise my left arm or lift anything for the first few months. I have made arrangements for my mom to come out for six weeks to help out and my kids can drive now and will be able to help out by running errands as needed. I think I am set. Now all I have to do is survive the actual operation.

Work has been a great distraction. I really enjoy my job right now and I have lots to keep my mind occupied so I don’t dwell on the surgery risks. My fingers are numb from typing up all the reports, but that way, when I go home, I get to whine about working too hard and not face the worries I have crammed into the corners of my mind.

However, it was a struggle this week to deal with writing up my Individual Development Plan. This is an exercise we go through annually where we document our short term and long term goals and work with our bosses to get assignments to meet those goals. I had just completed my will detailing what to do with my earthly remains should there be a complication. Somehow trying to figure out what I want to be in five years just seemed silly after that. I just want to survive next Thursday.

It is not that I expect anything to go wrong; it is just that I am at the point where I can’t do anything else about it. I have gotten everything within my control, controlled. Now it is all in the hands of others and hope they are all having a good day and things go well. And that is the hard part.

11/7/08 Stanford — Patient ICD Day

2008-10-21T14:21:00.000-07:00

This event is being hosted by Stanford Electrophysiology and Arrhythmia Services.

Friday, November 7
10:00 am – 2:00 pm
Sheraton Hotel
625 El Camino Real,
Palo Alto, CA
(650) 328-2800

Guest Speaker:

Samuel F. Sears Jr., Ph.D.
Professor,
East Carolina University
Department of Psychology and Internal Medicine

Agenda:
10:00 - Welcome — Linda Ottoboni, RN, MS
10:00 - Living with an ICD — Dr. Sam Sears
10:40 - Implant techniques and function of ICD/CRT therapy — Paul Wang, MD
11:00 - A Patient’s Perspective — Hugo Campos, Bay Area ICD User Group
11:20 - Optimizing Heart Function — Randy Vagelos, MD
11:45 - Lunch
12:15 - Minimizing Therapy, Medication, Ablation, ICD Programming — Henry Hsia, MD
12:45 - Surviving Therapy and Confronting Mortality — Dr. Sam Sears
01:30 - Questions and Answers Panel
02:00 - Conclusion

In order to attend this event, you must RSVP by calling
(650) 723-7111 or emailing patientICDday@doctor.com no later than Wednesday, November 5th.

For questions, please contact Linda Ottoboni at (650) 498-5914.

11/8/08 Kaiser — Charged Hearts 18th Annual Meeting

2008-10-20T13:23:00.000-07:00

This event is being hosted by Kaiser Permanente.

Charged Hearts is Kaiser Permanente's ICD Support Group. At the group's 18th annual meeting, doctors, nurses, and representatives from device companies will be present and, if the turnout is as great as last year's, there should be over 250 attendees. Many topics will be discussed, including daily living and challenges for both patients and family members, dealing with medications, anxiety, shocks and recalls. See details below.

Saturday, November 8
10:30 am – 2:00 pm
Napa Valley Marriott
Grand Ballroom
3425 Solano Avenue,
Napa, CA
(707) 253-8600

Guest Speaker:

Samuel F. Sears Jr., Ph.D.
Professor,
East Carolina University
Department of Psychology and Internal Medicine

In order to attend this event, you must RSVP by calling
(707) 651-5544 no later than Monday, November 3rd.

When calling, please leave the following information:

Your name
Phone number
Number of people in your party
Your selection of one of two lunch entrées:

• Sake Glazed Salmon w/Wasabi Aioli and Tobiko accompanied by Bamboo Rice & Stir Fry Vegetables
• Red Wine Braised Beef Short Ribs with Roasted Shallots, Chive Mashed Potatoes, Seasonal Vegetables & Demi Glace

For questions, please contact Anne McHarg at (707) 651-2758

Hope to see you there!

The wires that bind us

2008-10-04T08:42:00.001-07:00

The September meeting of the Bay Area ICD User Group met at my house and we had several new members. Of course the usual members were there as well and we had a blast. I was a little worried opening my home to people I didn't know, but once everyone showed up, it seemed like we were old friends right away.

I know the experiences we share over our hearts and ICDs make us seem like family, but everyone was also friendly and such great personalities that as usual the evening went by way to fast. Our two hour meeting went to four and I spent another hour or so talking with one of our newest members in the driveway.

His story is fascinating to me. He has had his ICD for 8 years and never talked to another person that had one. He has also been shocked and many of us haven't so he had a lot to share with us. Just from hearing what he has been through, the rest of us learned a lot. We showed each other our scars and commented on who had the best placement.

After everyone had left, I thought about the night. We had teachers, marketing developers, preachers and project managers sitting around the room sharing what they were going through and discussing the technology behind our devices. We were comparing doctor experiences and the different shapes of the device demo models we had on display.

It seems like we were all from different paths, from different backgrounds and even heading in different directions. Some of us have been dealing with ICD and heart disease for years; some of us are new to all this and still trying to learn the right terms. But we are going through it together, learning about amazing technology and leaning on each other during the tough times and having fun on the way. It is the wires in our hearts that brought us together and bind us together.

DFT testing may have little bearing on the efficacy of shocks

2008-09-14T10:42:00.000-07:00

Thanks everyone for a successful meeting! Here’s the link I promised regarding our discussion whether DFT (Defibrillation Threshold) testing is still necessary at the time of implantation.

According to the article, new analysis indicates that DFT testing has little bearing on the efficacy of delivered shocks or long-term mortality. It quotes Dr. Joseph Blatt (University of Washington, Seattle), who says that “when we look carefully at the data, we don’t really see that it provides any particular benefit.”

DFT Testing puts a patient under further risk of sudden death. It’s a low risk (<0.1%), but is it really worth it?

This is from the book The Nuts and Bolts of ICD Therapy (by Tom Kenny, Blackwell Publishing, 2005.)

“In some cases, the implanting physician may opt to forego DFT testing because it is painful, time-consuming, and consumes battery energy, If the implanting physician intends to program the device to maximum output anyway, DFT testing (which would allow programming less than maximum output values) may not be worth the effort. Furthermore, many patients are likely to be shocked only rarely and then for serious situations. For such patients, programming maximum energy therapy is appropriate, and DFT testing is not necessary. Increasingly, DFT testing is omitted at implant. However, when performed, DFT testing can help physicians optimize the output settings of the device.

The goal of any DFT test is first to induce an arrhythmia and then to allow the device to shock the patient and convert the rhythm. If DFT testing is to be conducted, the anesthesiologist should be advised to administer deeper sedation, since this portion of the procedure is definitely considered painful. The entire team should be readied. At the programmer, it may be necessary to select options for DFT testing, since many devices offer a variety of ways to do this sort of testing.”

I took my own advice, I asked for what I wanted.

2008-08-28T22:15:00.001-07:00

So, the doctors all agree on one thing, my device is out of the pocket, it is causing pain and could eventually cause nerve damage and it's putting undo stress on the lead that has been recalled. As such, the doctors all agree that it is medically necessary to go back in and move the ICD back into place. While in there, time to pull that re-called lead and replace it with one that isn’t at a higher risk of fracture.

What they don’t agree on is the placement. Since I have lost 34 pounds, the cushion I had that covered the device has significantly thinned out. My activities may have put some stress on the device too, I am not sure. But either way the subcutaneous placement I had before isn’t working anymore.

The first EP, we will call him Dr. No, said that he would move the device to the same subcutaneous placement of before. Even though I pointed out that it would show and would be quite disturbing to me. Dr. No also said he wouldn’t be able to use the vertical incision like I had before, but instead would use the more traditional horizontal incision. I pointed out what I thought was obvious, I am not a small-chested girl and the horizontal incisions are problematic when you got that much weight pulling on the scar tissue. It tends to stretch and pull the tissue resulting in a large obvious scar. He said no, he couldn’t work with the vertical scar. Also, I asked him about moving the device to a sub-pectoral placement so that I wouldn’t have to worry about dislodging it again and when I lose the next 25 pounds it wouldn’t show. Guess what he said, no.
I was pretty bummed out. I wanted that bad lead out more than I can really say, but I didn’t want to have an ugly lump on my chest. I kept thinking that it was easy for Dr. No to say no. At the end of the day, he got to go home and forget about it. I couldn’t. I wouldn’t be able to ever forget about it. Every time I took off my shirt, I would remember.

After I fretted about it for awhile, I brought it up at one of our meetings. I mentioned that felt that Dr. No wasn’t even considering my lifestyle or situation, he was just doing what he has always done. Then I wondered what my first EP (we’ll call him Dr. Rock star) would do.

I don’t know why I didn’t think of it sooner, why not just go see Dr. Rock star. I called and had an appointment within the week. I went in and he agreed with the facts that the device has moved significantly and that the lead should come out at the same time. However, he was completely open to working with the vertical scar and that based on my lifestyle and thinning body, a sub-pec would be the best placement for me. It pays to ask for what you want and it pays to check with more than one doctor. In the bay area, we are very lucky to have the options of many great doctors, it would be crazy not to look around for the one that takes your needs into consideration.

Sex, race, and ICDs

2008-08-18T21:54:00.000-07:00

Two studies published last year in The Journal of the American Medical Association (JAMA) found some serious disparities between men and women regarding implant rates of ICDs for primary prevention of sudden death.

One study (JAMA. 2007;298(13):1517-1524) found that among Medicare patients, men were about 2-3 times more likely than women to receive an implantable cardioverter-defibrillator (ICD) for the prevention of sudden cardiac death.

The second study (JAMA. 2007;298(13):1525-1532) concluded that the rate of ICD use among eligible black female patients (28.2 percent) were significantly lower than that of white male patients (43.6 percent).

We need to understand why women (and particularly African-American women) are less likely to receive a needed ICD.

It's hard to believe that sex and race still influence a doctor's decision on whether to offer an ICD to an eligible patient.

And I can fly

2008-08-17T12:02:00.000-07:00

As my posts show, I have been trying to get on with life and not let the ICD in my chest stop me from having fun.

This hasn't been easy. While I am generally an optimistic person, there have been times that things seemed bleak. Last year was a tough one for me and it took some time to pull out. I was lucky, I had some people around me that cared. I had support that really came through.

This year has been much better. I have come to terms with the fact that there are somethings I can control and some things I can't. At work, I got a better job for a boss that knows what he is doing. At home, I got those fixer upper projects started and well, those still suck a little but at least I am trying. And as for my health, I have things I can control and things that I just can't. I can control my weight and activity level. I can't control the way my heart is formed. I can't control the way the heart cells conduct the electrical signals, or don't conduct. And I can't control when this ICD lights up.

By focusing on the things I can control, I have lost 32 pounds and I have a target of 28 more. I have increased my activities and feel great. Also by focusing on these things, I find that the spector of the things I can't control seem to fade into the background.

That fact has allowed me to push myself a little more. The more I get out and do, the more I feel secure that I can get out and do it. And now, I can fly... well, indoor skydive anyway. It was fun, and I will most likely do it again. Then, I guess I will figure out what I will tackle next... heck, maybe I will even try walking up the stairs someday.

Lead Encapsulation

2008-08-15T07:12:00.000-07:00

Every day, as I go to work, I walk by trees that have grown into the metal enclosure that was originally put there to protect them. The metal structures were never adjusted or removed. So, the tree trunks and metal have melded. As the trees grow, the metal rods continue to be enveloped by them. The metal can no longer be removed.

The picture is a bit unsettling, but the trees look quite healthy and keep on living seemingly unaware of their predicament.

I want to be like those trees.

Life with an ICD

2008-08-01T15:49:00.000-07:00

When I was first diagnosed with HCM and told in the same visit that I would need to get an ICD I thought life would be over. All I could think of was what I wouldn’t be able to do. I had an image of weak, sick people trying to avoid anything strenuous. Not that I was a health club maniac or anything, but I love going out in the middle of nowhere to camp, enjoy a nice scuba diving or hike where cars can’t go... basically anything outside and near water was what made me happy. It made all those days at work worth it. It is two years later now and I am amazed at what I can still do.

Since my implant, I have gone ocean kayaking on the Sea of Cortez, snorkeling in Hawaii, camping every place I could and even got in some pheasant hunting. Just this last weekend, I went white water rafting. I know it doesn’t seem like much, but when you go from being afraid to get up off the couch to actively seeking outdoor activities, it is a major mind shift.

The bottom line is this… being the recipient of an ICD does not end your life, it just changes it a little. Your heart condition itself may have more of an impact on what you do, but the device doesn’t.

I think now that I can do most things, just with a little modification. For example, I can’t jump out of airplanes but I am going to go indoor skydiving in a couple of weeks. I can’t scuba dive at depths lower than 45 feet (device limitation, not heart) but in February, I will be heading to the Florida keys to do some shallow but scenic dives in the marine reserves there. I can’t go on roller coasters any more, but that is ok… I have been on some great ones in my life. So, life is not over. It is adjusted a bit, but definitely not over.

Is ICD therapy being over-prescribed to us?

2008-07-19T20:55:00.000-07:00

Think about this. A couple of months ago I attended a conference on Hypertrophic Cardiomyopathy where a leading cardiologist presented a slide that showed the U.S. as the number one country in defibrillator implants in the world.

The graph showed the U.S. with 421 implants per million population (2003 data). Germany was a far second with 133 implants per million. All other countries followed, Japan being the last on the list, with only 17 implants per million.

Just look at the graph and you must ask yourself:

Why the huge gap between us and them?

Is ICD therapy being over-prescribed to us? On the contrary, experts say. Despite us being ahead of the rest by a 3 to 1 ratio disparity, some doctors (and device makers) say that we still have a long way to go before we can raise the U.S. number of implants to what it really should be.

They claim that Sudden Cardiac Arrest (SCA) continues to be a leading cause of death in this country and that clinical evidence clearly supports ICDs as first-line therapy for prevention of SCA.

So, I get it. We need to be implanting a lot more ICDs to get our doctors and device manufacturers happy. But how many more?

Dr. Anne Curtis, director of cardiology at the University of South Florida and former president of the Heart Rhythm Society (HRS), says that this number should be between 700 and 1,100!

During a talk at the HRS 2008 conference on May 16 in San Francisco, Dr. Curtis explained:

There’s been some analysis of Managed Care in Medicare Databases showing that ICD usage is 416 per million population in the United States which has been contrasted with an identified range of over 700 to 1,100 ICD candidates per million. So we are using ICDs in only about half of the eligible patients.

(Watch the video on Medtronic’s site. Registration is required.)

She’s not alone. The report cited by Dr. Curtis concludes that, based on discharge diagnoses, many patients who could benefit from ICDs are not receiving this therapy today. The report ends by suggesting that the reasons for this “underutilization” of ICDs in the U.S. should be addressed.

As a pace-free and shock-free ICD recipient, and in face of such disparity, I have to wonder if I really needed my device.

After all, at an estimated cost of $90,000 over a lifetime, and in a world where big business often puts money before ethics, it’s hard not to raise an eyebrow.

July 2008 User Group Meeting

2008-07-19T10:37:00.000-07:00

We had our monthly meeting at one very beautiful horse ranch this month. Guin, our host has a very scenic ranch and invited the group for a summer style BBQ. We had great food, good conversation and a wonderful view. What could be better?

Instead of my usual rambles, I will just post up a link to the images. Enjoy!

Our Amazing Little Pumps

2008-07-12T10:33:00.000-07:00

At a recent doctor visit, I got to hear my own heart beat. Granted, due to the underlying cardiomyopathy, it didn’t sound like what I expected, but it was interesting to hear the thing that has occupied so much of my concern for the last two years.

I am coming up on the two year anniversary of my implant and that has me thinking about all the people that have been listening to my heart... and there have been lots! From nurses to doctors to well, more doctors. I wondered what they actually hear. We have all heard heart beats. Can they tell that much from just a quick listen. Really what was the big deal?

After we covered all my questions and any recent info with the doctor, he motioned to the exam table and I hopped up. As he was about to take a listen, I mentioned that I wanted to hear it too. He immediately gave me his stethoscope and helped me position the ear buds and placed the drum to his heart. My first thought was that it sounded just like the heart beat from the Dark Side of the Moon album. Thump thump. Thump thump. Thump thump. Then he placed it to my heart… and there it was… Thump thump swish. Thump thump swish. Thump thump swish. It turns out I really do march to a different beat.

Since then, I keep thinking about my heart beats. Ever second of every day, my heart keeps going. Granted at times it races dangerously fast but so far it has corrected itself. And, just in case it doesn’t some day… I got the ICD standing by. Until then, my thump thump swish goes on.

Beta-blockers and ICDs

2008-07-05T09:57:00.000-07:00

Here’s a question that just came in from Australia. It's about beta-blockers and ICDs.

Hi, I’m in Australia and looking for information about beta-blockers and adverse effects.

The hospital is considering me for a pace-maker/defibrillator if the drugs don’t work. At the moment the beta-blockers are actually killing me and I can’t find anyone else with my symptoms. I thought I would be able to get off the beta-blockers if I had an implant but one of the nurses said that's not true.

I can’t continue with the beta-blockers because I have had several near death experiences on them. On one occasion the ambulance guy said he only just arrived in time, a couple of minutes more and I’d have been dead. I end up in the ER almost weekly with this reaction. Do you have any advice or know where I can look for advice?

Let me preface this by saying that I’m neither a doctor nor we have doctors in our group. I, and others in the Bay Area ICD User Group, are recipients of ICDs with a panoply of heart conditions (dilated cardiomyopathy, HCM, Brugada Syndrome, etc). I write to you from my experience as a patient, and not as a doctor.

Having said that, I believe that the key to your answer is in your underlying heart condition (which you don’t mention). Has your cardiologist given you a diagnosis?

ICDs are usually prescribed as treatment for abnormal heart rhythms. Depending on your heart condition, this could mean a rhythm that's abnormally slow (bradycardia) or a rhythm that’s too fast (tachycardia).

You say that the hospital is considering you for "a pace-maker/defibrillator if the drugs don’t work." This "either-or" approach sounds unusual to me. An ICD is not a substitute for pharmacological therapy. In fact, it is more commonly used in conjunction with a drug or drugs. Look at it as just one of the tools doctors have in their toolboxes to manage your heart disease.

Beta-blockers, on the other hand, are used to help control your heart rate. They are there to slow down your heart, to lower your blood pressure and are often used in combination with diuretics, digoxin and ACE inhibitors.

Again, I don’t know what disease afflicts your heart. But I believe your nurse is right in saying that the ICD implant will likely not get you off beta-blockers. I, for example, am on beta-blockers and have an implant.

You also say that the beta-blockers are "killing" you and you can’t find anyone else with your symptoms and mention near death experiences as a reason to stop the beta-blockers.

Keep in mind that when you just start taking beta-blockers, your symptoms often become worse while your heart adjusts to the medication. This can take up as long as two and a half months.

However, there’s also a possibility that the beta-blockers are slowing your heart too much. Beta-blockers can be harmful if you have extremely low blood pressure or a slow pulse. It can cause you to feel dizzy or light-headed.

You should not stop taking your beta-blocker without speaking to your doctor first. Even if you feel that it is not working. Beta-blockers should not be stopped abruptly or your symptoms might worsen.

If you still feel you’re not getting the answers you seek regarding your medical care, I’d suggest you get a second opinion from a different cardiologist. Remember, as a patient, YOU are your own best advocate!

Best of luck to you.
Hugo.

Effective communication with our doctors

2008-07-01T18:51:00.000-07:00

I am getting ready for my check up appointment with my HCM Cardiologist and I am feeling little apprehensive about the visit. Ever since the diagnosis, visits to the doctors seem suddenly anything but routine. It is sort of like walking on a thin line, I want to know what is going on, but I don’t want to hear anything bad. The truth of the matter is I really only want good news. And there will be some, I have lost a good amount of weight and effectively reduced my BMI, I have been more active and so I feel a bit stronger and less winded. I know that puts less strain on my heart so that is good. However, there is also the dramatic increase in pacing from my device that has been going on since I have been on medication and that worries me. Also an increase in the pain around my heart and a disturbing inability to sleep laying flat are definitely on the chat list.

I don’t know what these latest symptoms are from, it could be a side effect of the medication or it could be from the underlying heart condition itself. Either way, these questions are worrisome and I need to discuss it with my doctor. And that is where my stress comes in. How do I talk to my doctor, give him the information he needs and get answers and not seem like some freaked out hypochondriac? In other words, how do I become an active participant in my medical care?

With that in mind, a book recently caught my eye… “How Doctors Think” by Jerome Groopman, M.D. The book gave me a bit of insight into the pressure on a doctor. Without coming off as a preachy or defensive, but the book offers a perspective from their point of view.

The way doctors think is something that is drilled into them from the beginning of their training. In a nut shell they are taught to look at the symptoms, think of the known causes for them and test to see if you which one is the cause. The problem is that many illnesses and diseases have similar symptoms. To deal with this, the law of averages comes in, and doctors are taught to think of the most common cause. Often, this means that doctors toss out the symptoms that don’t fit, or stop considering any other causes in a sort of tunnel vision way. When the cause it not the most common problem AND the patient just doesn’t let the doctor know the symptoms are still present, misdiagnoses occur.

I remember going to my primary care physician several times for other reasons and in passing mentioned the ‘racing heart and light headiness’ I would sometimes feel. I had felt them forever but they did seem to be increasing in frequency and becoming stronger. The typical office visit would go like this; after we had discussed whatever else I went to see her for I would mention the sudden fast heart rate, she would bring up hormone fluctuations or maybe sensitivity to caffeine, she would ask me if I wanted to do an EKG and I would say no it isn’t important, and we would not pursue it. Each time I brought it up, I would feel silly and worry that she would think I was looking for something to be wrong. And really, I wanted to believe it was nothing harmful so I just stopped mentioning it. There had been two deaths from ‘heart attacks’ in my family (Grandfather and Uncle) but my cholesterol, blood pressure and heart rate were all good so I was not at risk for heart attacks so why pursue it? About a year later, while I was being prepped for small procedure that had nothing to do with my heart but required general anesthesia they decided to run an EKG because I was over 40 years of age. That test found a problem, that lead to a referral for an echocardiogram that showed the typical thickening of the septum between my ventricles that led to the diagnosis of obstructive hypertrophic cardiomyopathy (HCM). HCM as it is now known is the leading cause of sudden cardiac death world wide.

Now two years later, I have learned a great deal about the disease, about treatment options, about my family history and about my own symptoms that had been present since I was a child but never properly diagnosed. However, I am still learning how to be an active participant in my health care.

This is made difficult by the changes roles currently taking place in healthcare. Doctors are no longer the pinnacle of knowledge they once had been (Doctor/Gods). They are under scrutiny from insurance companies, governmental regulations and laws, patients and even their peers as they never have been before. The information on the internet and in TV commercials is mostly helpful but at times misleading and inflammatory. And don’t forget that personal injury lawyers are waiting in the shadows to jump on the smallest little thing. To make ends meet doctors often have to increase their patient loads.

That leads to shortened visit times and rush to get to the next patient. I have to be honest here, my doctor takes as much time with me as I need and I am grateful for that but since he does that with all his patients, that means he is often running late. That makes me feel like I need to hurry to help him catch up and so I tend to hurry through my issues and most often forget to mention something. This is a disservice to my doctor as it may be that the things I don’t mention are important and he should have known before he decided on any changes in my treatment.

What can we do with the time we have with our doctors? Here are a few suggestions.

Make sure you have the right fit for a doctor. Doctors are people too and each has their own personality. That doesn’t change just because they put on a white coat. As with all people, some get along well and some don’t. If you don’t feel comfortable for any reason, find a new doctor.
My PCP always touches me on the arm during our hellos and initial conversation. That makes me feel like she cares and is there for me, but anyone who knows me, knows I value touch (I am touch happy to the core). But that may not be the same for the next patient. If you are uncomfortable with your doctor, how can you have open and relaxed dialog? And, speaking of dialog, your doctor should never talk down to you, if you don’t understand what they are saying, tell them to write it down. That applies to terms, medication names and treatment plans (how do you think I learned how to spell hypertrophic cardiomyopathy, my doctor wrote it down for me)
Make a list of questions ahead of time. Don’t skip over any of these questions even if the doctor is in a hurry.
Add these questions to your list:

A. What are the other possible causes for these symptoms? The book specifically brings this question up to help your doctor break out of the tunnel vision that may result from earlier conversation. If nothing else, this question will remind him/her to keep the other possible causes in mind and your doctor should be willing to talk to you about them.

B. What are the expected results of this treatment/medication. With medication, don’t forget to ask about side effects and possible interactions with other meds!!

C. If this test/medication/treatment doesn’t bring about the expected results, what is the next step?

This isn’t anything earth shattering, but these small steps will help to focus your questions for your doctor, ensure you tell your doctor everything and make the best of both your time.

Call with Medtronic

2008-06-18T12:00:00.000-07:00

Late last month, Kat and I traveled to New Jersey to attend the annual conference of the Hypertrophic Cardiomyopathy Association. While at the conference, we met a Medtronic PR manager and told her about our local San Francisco Bay Area ICD User group.

In light of our chat, she invited us to participate on a call with other Medtronic employees to tell them about our ICD User Group, what we do, as well as to hear our stories.

This was also a great opportunity to ask them some questions. Here are the answers we got.

Q. Patients believe they have the ability to influence their doctors over what brand/device model they’ll receive. While EPs and sales reps eventually retire, patients do not. A patient's experience with ICD therapy is a life-long journey. Thus, we believe patients must be included in the decision-making process as equal-part stakeholders. How often are patients part of the decision over device manufacturer?

A. Patients have more say now than ever before as to which manufacturer's device is implanted. Some patients are very active in this decision-making process and others are not, either because they did not know they had a choice or prefer to not be in the position to have to decide.

Q. I saw in one of your brochures (series Leadership Defined) that Medtronics ICDs use a proprietary battery charging technology that allows for a charge time of 16 seconds (on the Virtuoso DR and Concerto CRT-D). The brochure also says that Boston Scientific and St. Jude ICDs use conventional Silver Vanadium Oxide (SVO) in their batteries resulting in a charge 10 seconds longer for the Boston Scientific Vitality DR and Contak Renewal ICDs (St. Jude charging times are not available). Another brochure claims that “Medtronic had the greatest percent of ICDs in service after 5 years, and the only manufacturer with devices in service after 8 years.” These sound like significant advantages for patients who have to endure occasional life-saving shocks and periodic device replacements. How come we never hear these points from our doctors?

A. Unfortunately, doctors don’t always have statistics like this readily available to discuss with patients and most patients don’t ask. It is easy to get the information and in the case of charge times, something that we definitely talk about with doctors, but each doctor uses the information differently.

It is becoming easier for patients to access this information and that is a good thing. We are going in the right direction, getting information like this out to patients so they can be more involved in the decisions that are made about their treatment. Medtronic has a great tool in our websites www.medtronic.com and www.hearthelp.com for both current patients and those thinking about device therapy. We also have people available to answer questions on the phone.

Q. Your web site says that "no other company offers as broad a line of ICDs and leads" (I counted 14 different ICD models alone). What's the main difference among the ICD models offered by Medtronic and are these differences significant enough for a patient to care about them?

A. Some differences are due to new technology for treating patients and other differences are related more to the diagnostics of the device as we discussed on the phone. Some differences can be significant to some patients based on their heart condition. An example of this would be “MVP (Managed Ventricular Pacing)”.

Studies have shown the unnecessary pacing in the ventricle can be detrimental to a patient in the long term. MVP allows the devices to cut back significantly on unnecessary ventricular pacing. MVP can not be used in every situation so this feature may or may not benefit an individual patient based on their heart condition

Q. How about the leads? Why so many different models? Should patients demand one model over another? What are the advantages of one lead over the next one?

A. Leads have different designs that work better in certain patients just like therapies in the devices work better for different heart conditions. Leads are actually very intricate medical devices in themselves. Some act strictly to pace and sense what the heart is doing. Some do that and also deliver defibrillation therapies. Some are designed to be placed on the outside of the heart and some on the inside like your leads. Some leads have a silicone outer insulation and some are polyurethane. This makes the lead more or less rigid and also more or less slippery.

Some doctors prefer the feel of one versus another during the implant procedure. Some leads are designed to attach directly to the heart tissue while others simply anchor themselves to the fibers attached to the heart wall. Some leads for the left ventricle essentially just sit in the Coronary Sinus and wedged themselves into place. There are many factors that can be considered with lead selection, just like device selection.

Q. The wireless models for Boston Scientific incorporate encrypted data, but Medtronic’s wireless devices do not and one model (Medtronic Maximo DR) was able to be hacked into during outside testing (download PDF of the study here). While it may be a long shot that anyone would do this, what is being done to address this issue?

A. The data on your Carelink transmissions (if you use a home monitor) is encrypted from the monitor to the network over the phone lines. It is not encrypted from the device to the monitor or from the device to the programmer. Medtronic is aware of the study that was done. This scenario is not likely to occur outside of a laboratory setting.

The person “taking over” the implanted device would have to know a person has a device and have intent to hack in. They would also have to be within a certain distance of the implanted device. Without giving an exact distance, unless a patient is sleeping, they will know the person is there and most certainly wonder what they are doing. With that said, I know this has generated discussions within Medtronic regarding changes to future devices. This is not something we had to think about years ago, but we do need to change as technology changes and patient safety is our number one responsibility and priority.