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?

Medtronic’s hitting the Twittersphere. Should others follow?

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)

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

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.

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

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.