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

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

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



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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

WHAT YOU SHOULD DO:

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


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


• Attend your regular device follow-up appointments


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

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

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

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

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

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Device brand: be a part of the decision.

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

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


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

Read a related entry on the message board »

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

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

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WATCH: Living with your ICD -- Speaking Frankly

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

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

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

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

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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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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

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