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

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?

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That little beep could be telling you something

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

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

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

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

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

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

Hear the alerts of a Medtronic ICD:

• Low alert or high alert.

Alternating High/Low or On/Off tones:

Your ICD has detected an alert condition (low battery, abnormal lead impedance, electrical reset condition, etc.) This tone will last for 30 seconds (in older models) or 10 or 20 seconds (in newer models). You should contact your physician if you hear this tone. In the vast majority of cases this is not an emergency or life threatening condition—but it is important to find out what is going on. The alternating tone alarm will never go off just once. It will go off regularly at consistent intervals until the ICD is interrogated at the clinic and the condition that triggered it is resolved in some way. Most commonly the alarm will go off daily at the exact same time each day. This time is programmable and they likely told you when it would be or maybe even let you select it when they set up your device.


• No condition.

Steady tone at one fixed pitch:

Everything is OK. Indicates that a magnetic field have been detected by the ICD. The tone will last for 30 seconds (in older devices) or 10 or 20 seconds (in newer devices). Every time the ICD detects the magnetic field the alarm will re-sound. During the time your ICD is in the magnetic field, it is DISABLED (shocks are TURNED OFF). When your ICD leaves the field, everything returns to normal (if you are no longer hearing the alarm, you have left the field).

There are several reasons for this ICD feature. First, if for some reason your ICD needs to be temporarily shut off (for example, if you're having surgery), then this tone would let doctors know that when they place a magnet over the ICD they have in fact disabled the ICD. Second, it is a way to check that the ICD is OK without having to go to the clinic—this feature is being used for checking the Medtronic Marquis devices that are affected by the battery recall. They also try to hear this All-OK tone after a surgery or procedure in order to verify that their equipment didn't damage your ICD.

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WATCH: ICD saves life of Belgium soccer player.

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!

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

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.

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My journey from patient to consumer of health care.

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.

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New study on longevity finds that Medtronic ICDs are superior.

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.

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Lead Encapsulation

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.

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Is ICD therapy being over-prescribed to us?

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.

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Call with Medtronic

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.

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