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Insertable Cardiac Monitor

More than two million people in the U.S. have atrial fibrillation – an abnormal heart rhythm that can lead to stroke or heart failure.

Now a new device, about one-third the size of a triple-"A" battery allows doctors to monitor their patients for A-fib on a continuous basis.

69-year-old Larry Parker is always on the go.

"I'm pretty active. We ride bikes, we kayak.  We dance," Larry Parker told Ivanhoe.

But his active lifestyle came to a halt earlier this year, when he found himself gasping for breath after moving some furniture.

"Told my wife I've got to sit down. I felt real, real dizzy. Never felt like that before, ever," said Parker.

Diagnosed with atrial fibrillation, Larry had surgery to treat his irregular heartbeat. Now 3 months later, he's back at the hospital — this time to have a new tiny monitor implanted in his chest.

"It's one of the most impressive breakthroughs that I've been associated with." John Seger, M.D., Cardiac Electro Physiologist at the Texas Heart Institute told Ivanhoe.

Doctor John Seger says the paper-clip size device called "Reveal Linq" will automatically alert him if Larry has any A-fib episodes for up to three years – helping protect Larry against stroke and heart failure.

"Probably 15-percent of strokes in the united states are on the basis of atrial fibrillation," said Dr. Seger.

The procedure can be done in minutes.

"A little pressure now," Dr. Seger told Parker.

"Painless, well not totally, but it was tolerable." Parker said.

And gives Larry peace of mind to do the things he loves.

The device is 87-percent smaller than previous generations of monitors and allows patients to live an active lifestyle. Since our interview with Larry, he says he's feeling good and plans on skydiving for his 70th birthday later this month. (October 25)

BACKGROUND: A normal heart beat responds to perfectly timed electrical impulses that allow the heart to pump blood to the rest of the body. For those with Atrial Fibrillation (A-Fib), the electrical impulses are so fast and chaotic, the atria is not able to pump blood into the ventricle effectively. While there is no one cause for A-Fib, an underlying heart problem may be an association. In 10-percent of A-Fib cases, no previous heart disease is found, and the cause may be related to diet, lifestyle, metabolic imbalances, or genetic factors. Still, in some patients, no pre-determined cause is found.

(Source: http://my.clevelandclinic.org/heart/atrial_fibrillation/afib.aspx)

TREATMENT: A-Fib can be treated with certain antiarrhythmic medications as well as rate control medications, which slow the heart rate, but don't control the rhythm. Pacemakers are the traditional device used to help treat irregular heart rhythm. With the pacemaker, electrodes are ‘wired' through the heart, and a small metal box containing a battery and generator are placed in the chest, then both are connected. A doctor can program the pacemaker's computer with an external device and look at the recordings of the pacemaker to adjust it for each individual patient.

(Source: http://my.clevelandclinic.org/heart/atrial_fibrillation/afib.aspx#treated, http://www.nhlbi.nih.gov/health/health-topics/topics/pace/during.html)

NEW TECHNOLOGY: No wires, no surgery. The Reveal Linq is the smallest heart monitor on the market today. One of the main benefits of this device is that it monitors your heart before, during, and after a fainting spell; this allows doctors to identify any other underlying causes of A-Fib, or any heart-related issues. While wirelessly monitoring the heart, the device sends recorded data to a patient monitor which then uploads the data to Medtronic servers for doctor review. Alarms can be preset by the overseeing physician, allowing for quick treatment. Another major component of the Reveal Linq is that the battery lasts up to three years, continuously monitoring and storing data.

(Source: http://www.medtronic.com/patients/fainting/device/our-insertable-cardiac-monitors/reveal-linq-icm/, http://www.medgadget.com/2014/02/medtronic-reveal-linq-insertable-cardiac-monitor-going-on-sale-worldwide-video.html)

FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT:

Fernando Vivanco

Medtronic

(763) 505-3780

Fernando.vivanco@medtronic.com

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com

John Seger, M.D., Cardiac Electro Physiologist at the Texas Heart Institute discusses a new heart monitor that can help monitor atrial fibrillation.


We are talking about A-fib and this new device to monitor it; can you talk about the scope of the problem from atrial fibrillation and how many people it impacts?

Dr. Seger: Well atrial fibrillation is a very common disease. Around five to ten million Americans have it. So atrial fibrillation is a very common problem in America and its growing, because it's a disease of aging and it is highly associated with stroke so probably fifteen percent of strokes in the United States are on the basis of atrial fibrillation. And the older you are the greater your risk of stroke with atrial fibrillation.

So tell us how this new device plays into that.

Dr. Seger: So in the past when we were screening people for atrial fibrillation we would have to give them monitors that would connect to them physically, wires. And a lot of particularly older people had trouble keeping track of their wires and phoning in the information to us. And what this new development allows is for us to inject a very small device which will automatically detect episodes of atrial fibrillation. And automatically relay that information to us.

So the patients can be anywhere, they don't have to be in the hospital?

Dr. Seger: The patients can be anywhere; the device connects to another device which you keep by your bed. And so every day and we can program when that time is like for shift workers that might sleep at different times. But typically we'll have it send the information over every night at midnight. So where there's no delay in the diagnosis then of atrial fibrillation, we will know if we program the device to tell us within twenty-four hours of a patient developing an episode of atrial fibrillation that that's occurred.

So it almost sounds like a fit bit?

Dr. Seger: It's kind of like a fit bit but it also automatically notifies the doctor when there's a problem.

So that's the important part because you want to be able to diagnose this immediately?

Dr. Sager: You want to be able diagnose it – well not only that atrial fibrillation is an intermittent disease. So if I monitor you even for as long as a month if you don't happen to have an episode of atrial fibrillation in that month, we would figure that maybe you didn't have atrial fibrillation. And the day after you turn your monitor in you might have an atrial fibrillation event. We know that when atrial fibrillation starts it can be very intermittent. It might occur once every three or four months and so it's a challenge-it could be a challenge to diagnose. And so this device also allows us to investigate other heart rhythm abnormalities. So let's say somebody faints and we don't know exactly why their fainting. Do they need a pacemaker or do they need some other type of therapy? If they're fainting very frequently which is usually the case again we're constrained on how were going to investigate that. And what this device allows us to do is to inject this device simply, quickly and then be able to follow that patient for three years and if they don't faint again for a year we'll have that information at the time that they have their symptom.

How big of a breakthrough would you say this is in the medical community?

Dr. Seger: For my practice, for the practice of doctors that treat heart rhythm disturbances it's one of the most impressive breakthroughs that I've been associated with. Because it really is something that allows us to monitor people, know what's going on within twenty-four hours at a reasonable expense and a very mild inconvenience to the patient.

It seems like a very minimal inconvenience and then they can go about their daily lives and not worry about wires.

Dr. Seger: Well we tell people too it's like going to the dentist. You know you go to the dentist you know, we can insert this with just a little local anesthetic; we don't have to give them sedation. So they can drive themselves to the hospital, get the monitor injected and then go home. It's not something that we give them sedation where they've got to sit around after it or have family members come and be available to take them home.

Besides being smaller how does this one compare to the last generation of the reveal?

Dr. Seger: It's ninety percent smaller. And the previous generation did not automatically notify, the patient had to physically connect it to a phone line and then download it over the telephone. The current system is totally automatic.

For travel purposes Larry said that he was going to (Spain) celebrate his anniversary in Spain.

Dr. Seger: Right, so this device will communicate with any cell tower. So it doesn't have to be – – they have agreements with all companies and also – what's the other thing they have Votaphone(?), so I think even on some cruise ships you know you can take it. But if you do go somewhere let's say four-week and you don't want to take the box you know, you would have to take that little box with you. The device then would ping the box with the data.

You come back and then download everything?

Dr. Seger: If you go somewhere you don't want to take the box with you then it will keep all the information on your trip. And when you come back it will then download it to us.

That's a nice feature.

Dr. Seger: It's pretty remarkable stuff. Did you see the device?

Yes.

Dr. Seger: And you see I mean it's literally the size of one of these big paperclips.

So you don't have to get any kind stitches or anything?

Dr. Seger: There are no stitches, there are no antibiotics to prevent infection that kind of thing we just stick it in and you go home.

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.


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