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Vitamin-Sized, Leadless Pacemaker Transforms Use of Device

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Vitamin-Sized, Leadless Pacemaker Transforms Use of Device

Sep 14, 2016

For the past 50 years, pacemakers have hardly changed, but a new device has the potential to change how pacemakers work. The device is the size of a large vitamin and is implanted via catheter rather than surgery. No need for a skin pocket or wires, and no visible signs the patient even has a pacemaker. Cardiologist Dr. Roger Freedman talks about the new leadless pacemaker implantation and how to know if it’s a good fit for you.

Episode Transcript

Interviewer: A revolutionary new pacemaker, and we'll talk about it next on The Scope.

Announcer: Health tips, medical news, research and more for a happier, healthier life. From University of Utah Health Sciences, this is The Scope.

Scott: For about the past 50 years, at least since they were invented, pacemakers have basically been the same. But now there's a new option called a leadless pacemaker. It's really small, about the size of a large vitamin, and completely self-contained so it doesn't require wires or a surgical pocket like the old pacemakers did.

Dr. Roger Freedman is a cardiologist that specializes in implanting pacemakers in patients that require one. How do leadless pacemakers change things for patients that need pacemakers? First of all, it's so much smaller, that must be nice.

Dr. Freedman: Yes, Scott so as you say, ever since pacemakers were invented approximately 50 years ago, the design of pacemakers has been about the same. And that's consisted of what we call "the generator" which goes under the skin near the collarbone, which is connected to the heart, with one or two or three wires that travel from the collarbone area down to the heart through veins.

Interviewer: Yeah, and the generator was about the size of a silver dollar about a quarter inch thick?

Dr. Freedman: Yeah, they started out larger, and then most recently they've been the size of, I'd say, a large pocket watch.

Interviewer: Got it. But you had to make a little pocket in order for that to fit in and the surgical operation was a little bit more complicated as well, wasn't it?

Dr. Freedman: That's right. So there'd be an incision about an inch and a half long in that pocket under the skin for the generator to fit in.

Interviewer: Yeah, and then the wires would run down to the heart.

Dr. Freedman: That's right.

Interviewer: And this new version, the leadless pacemaker, they say it's the size of a large vitamin, and it doesn't have those wires, it just goes right by the heart?

Dr. Freedman: So the pacemaker, the new pacemaker, as you say, has no wires, and the entire pacemaker is about the size of a large vitamin pill and everything that was in the generator that we're familiar with, the battery, the electronics, the small computer, has now been miniaturized to the point where it fits into this vitamin capsule and that capsule gets delivered directly to the heart, so everything is self-contained within the heart.

Interviewer: And what size incision do you need to put this one in?

Dr. Freedman: There is no incision, so it's delivered through a catheter in leg up to the heart and once the pacemaker is attached to the inside of the heart he catheter comes out and there's no scar, there's no awkward sign that the patient even has a pacemaker.

Interviewer: Yeah, so the surgical procedure is non-existent really because there is no surgery, necessarily.

Dr. Freedman: I wouldn't even call it surgery.

Interviewer: Yeah, and it's so much smaller, how long does that battery last?

Dr. Freedman: So projections are that the battery would last 12 years, which is actually longer than conventional pacemakers last. And this is possible because the manufacturer has designed a very good connection between the pacemaker and the heart such the amount of electrical current required to pace the heart is less than conventional pacemakers.

Interviewer: So how does this change things for patients other than the surgery sounds a lot better, you don't have that surgical pocket anymore, that bump in your skin. What other advantages does a leadless pacemaker have?

Dr. Freedman: Conventional pacemakers don't have a high complication rate but there is a small incidence of complications including infection, including problems with the lead or leads, that connect the generator to the heart and because this newer pacemaker doesn't have a lot of those components a lot of the complications are totally avoided and it's been estimated that the complication rate of the newer pacemaker is going to be about half the complication of conventional pacemakers.

Interviewer: That's pretty incredible. Is everybody a candidate that would have normally got a regular pacemaker for the leadless pacemaker?

Dr. Freedman: Not yet. So right the now the leadless pacemaker is suitable only for patients who need really the simplest of pacemakers. Pacemakers that in their conventional design would only have require one lead, and that's about 10% of patients needing pacemakers. So it's still a minority of patients, but this is clearly the wave of the future and it's very exciting. I've been putting in pacemakers for decades and I would say this is the single most exciting breakthrough in all that time.

Interviewer: So I understand that not everybody can install, is that what you call it installing?

Dr. Freedman: Implant.

Interviewer: Can implant this type of a pacemaker, yet.

Dr. Freedman: Right, so actually, we are the only hospital in the state, in fact in the whole intermountain region that has access to this pacemaker. There's no other hospital in the city, in the state and even a five or six state area that has access to this pacemaker.

Interviewer: So at this point if somebody was interested in this leadless pacemaker option, they had the meeting with their cardiologist or doctor and they're not able to implant this type of . . . how would they get the new one then?

Dr. Freedman: Well they would call the cardiovascular division telephone number and we would see them initially for an office evaluation and make sure that they were an appropriate candidate for this kind of pacemaker. And then of course, we would talk to their own physician and make sure that he or she was agreeable and then we would proceed.

Interviewer: And why is it at this point that it's just available here in the state?

Dr. Freedman: So there's only a single manufacturer who has marketed this pacemaker and they're rolling it out very carefully only to selected sites, where they have the greatest confidence that it's going to be used properly. And in fact, I had to go Florida for a full day of training to implant this to make sure that it was done safely.

Interviewer: And how long of a procedure is this? Somebody comes in when are they leaving?

Dr. Freedman: Currently we're still keeping the patient for one overnight but I think in the future, once we have a little bit more experience we may discharge the patient on the same day.

Interviewer: All right. Is there anything else we should mention about this new technology? It sounds fantastic, it's like a picture of the future.

Dr. Freedman: Just that we're very excited about it and I would just tell patients that if they're having a pacemaker recommended and I think they might be a candidate for this, give us a call and we'd be happy to evaluate you.

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