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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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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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.

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Visit to Medtronic in San Francisco

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.

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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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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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